Selected pre-publication abstracts and discussion from ...
The UNU as a Forum for Bioethics.
- Hamed Zakri Ph.D.,
Director, United Nations University, Institute of Advanced Studies, Yokohama, JAPAN
(Presented by A. Watanabe, Vice Director)
The mission of the UNU/IAS is to undertake research and postgraduate education on issues at the forefront of knowledge, policy development and learning. The term advanced studies refers to a multidisciplinary approach to research problems, aiming at issues of concern for the entire humankind.
One of the themes of interest to UNU/IAS is bioethics, the ethical implications of the advancements in scientific and medical technology. In June 2003 we organized together with the Embassy of France in Japan, the Embassy of Germany in Japan and the Japanese-German Centre Berlin a roundtable on “Bioethics and Biotechnology: What is at Stake for Humanity Now?”
One of the many very interesting issues emerged from the presentations was the topic about human cloning. While reproductive cloning is unacceptable to the community of nations, the big question remains cloning for biomedical research, or “therapeutic” cloning. The debate extended widely and during the November 2003 General Assembly meeting of the UN, the discussions were postponed for one year. It is therefore a highly timely research topic for our institution, to investigate the position of particularly the developing countries on this important issue. A report is to be prepared in order to be presented to the General Assembly this year, and our contribution is expected to facilitate decision and policy making in this very delicate matter.
On the other hand, we are aware that bioethics refers also to insuring basic needs such as clean water, healthy nutrition, basic health care and education to all people. As part of our biodiplomacy initiative, we will link research on biodiversity, traditional knowledge and intellectual property rights protection to access to medicine. By building a network of specialists in these fields in developing countries, our aim is to identify issues priority issues in global bioethics and bring them to the attention of policy makers.
This Roundtable, taking place concurrent with the Fifth Asian Bioethics Conference (ABC5) and the Ninth International Tsukuba Bioethics Roundtable (TRT9) will benefit from the expertise of all of you, more than hundred scholars from all over the world. National perspectives and the international dimension of bioethics have to be considered in order to reach a consensus that incorporates the concerns and features of different cultures. Bioethics is a code of conduct, a common code for all humanity, for each individual to follow. Therefore it’s universal character, which respects cultural diversity, religions, traditions and customs. Having a clear image of what is real and tangible as compared to the mirage perceived towards biotechnology, which is expected to cure all ills of humankind.
We are looking forward to the excellent results of these discussions and of the entire four days meetings here in Tsukuba and wish you all a pleasant and fruitful stay in Japan.
Identifying Priority Areas in Global Bioethics
- Mihaela Serbulea, M.D., Ph.D..
UNU/IAS Postdoctoral fellow, United Nations University, Institute of Advanced Studies, Yokohama, JAPAN
Email:serbulea@ias.unu.edu
Over the last century life expectancy has increased to as much as two-fold in many parts of the world. Antibiotics, vaccines, anesthetics are just a few examples of the medical progress which made the achievement possible. Organ transplantation has advanced to the extent of breaking definitions of death and religious taboos.
In the last decades, reproductive technology has facilitated birth for long-awaited children, pushing the biological barriers but also creating new challenges to family structures. Pain therapy and palliative treatment have enabled extensive surgical procedures but also raised the problem of euthanasia to be linked to the notion of human dignity. At the beginning of life, the debate on abortion continues, while new areas of terra incognita are opened. Embryonic stem cell research/therapy is seen as a panacea; the human genome project has opened large avenues of hope for the treatment of hitherto incurable diseases but also a Pandora's Box of questions. Eugenics has started to be feared again, gene therapy is still experimental and unexpected risks are becoming obvious.
The dramatic, exponential progress in science and particularly in medical technology has yet to be supported by legislation to regulate the new possibilities, which may permit the age-old dream of humankind to achieve “youth without end and life without death” to become reality.
While researchers should be free to continue pursuing effective and safe methods of treatment, the benefits, including applications in biology, genetics and medicine, should be made available to all, in line with the eighth UN Millennium Development Goal – “to develop a global partnership for development”, as stated in the Universal Declaration on the Human Genome and Human Rights: “The applications of research […] shall seek to offer relief from suffering and improve the health of individuals and humankind as a whole.”
Therefore, the UNU/IAS develops a project on bioethics with the main objective to identify gaps in bioethics research, policy making needs, and find interesting case stories from different cultures.
The UN General Assembly will reopen the discussion on the global convention to regulate human cloning. On 6 November 2003 the United Nations narrowly voted to postpone for two years the debate on competing human cloning resolutions that had divided the General Assembly. However, one month later, without a vote, the General Assembly decided to discuss the issue in late 2004, without a prior meeting of the Ad Hoc Committee or the Working Group of the Sixth Committee. (See Annex 1)
The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. Everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics. That dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity. “Man is not just any mammal. Animals can be reproduced through cloning. But humans are shaped by education, science and culture. Not by cloning.” (Koichiro Matsuura, Director-General UNESCO).
Given the highly sensitive issues of cultural variety and the important impact of the expected legislation on the heritage of humanity in a symbolic sense, it might be of interest to present to the UN General Assembly meeting in late 2004 a collection of reports reflecting the attitudes expressed by the representatives of different religious and world views.
A worldwide network will link specialists in medical and environmental ethics and other related fields including philosophy, law, decision-making, theology, etc. from a wide array of countries. Participants at the Fifth Asian Bioethics Conference (ABC5/TRT9) which was held 13-16 February 2004 in Tsukuba are the first who have signed up into the network. The project is open to all to join.
In addition to cloning, the interested persons with local experience and experts will contribute reports of approximately 10,000 words on the status and priority areas of bioethics in their respective region. Especially, academics and those already active in practical bioethics projects (e.g. NGOs) from developing countries are sought. The articles will be published and all contributions acknowledged.
On the other hand, new pandemics are threatening entire populations; viral- and sub-viral-induced diseases produce health scares which are difficult to be dealt with even in economically developed countries. However, is biotechnology the answer to world’s most pressing problems, such as hunger and poverty? Or is it rather a matter of resource distribution?
The World Health Organization acknowledges that about 80% of the world’s people still have no access to modern health care services and depend primarily on traditional systems of health care. FAO estimates that one person dies every two seconds of hunger. Access to health care and medicines, clean water, education and the quality of medical interventions are immediate problems affecting lives of more than half the world. It thus appears that (health) education and improvement of doctor/patient relationship are greater priorities than stem cells or genetics.
A significant result of the UNU/IAS project will be the fact that through the established contact points, isolated researchers from developing countries will be supported and integrated in a constructive bioethics network. The generated reports coming from various regions of the world will produce a volume of open access information as a short-term outcome.
At the same time, we are aware of the dilemmas faced by the majority of the planet’s people and consider the humble attention given to traditional medicine on an international and institutional level, including by the World Health Organisation (WHO). It was said already in Alma Ata that “primary health care for all by 2000 cannot be achieved without traditional medicine getting equal recognition as conventional western treatment.”
However, amid the neglect by many governments and health institutions, it is western pharmaceutical companies and universities that are showing greater interest in traditional medicine, with an eye on the potentially huge profits from it in the future.
With the World Trade Organisation push for patent rights it is the patenting of community knowledge that is in danger. Many African universities are doing research in medicinal herbs available in the continent - and western multinational companies are getting increasingly interested in traditional healing methods in Africa. If researchers are not given enough incentives, they could go out with the results.
Due to the neglect of traditional medicine systems by developing-country governments, their people could end up having to pay western companies to use their own traditional medicines in the future. More than 65% of Indian people depend on indigenous medicine. Access to and control of indigenous medicine should be with local communities. Multinational companies, with the collaboration of local officials, are already in the process of patenting knowledge that has been with local people for centuries.
The privatisation of health care has turned medicine away from preventive health care toward an industry of high-tech curative capital-intensive care, where traditional healing systems get a low profile.
Through the established network of traditional medicines practitioners and researchers, together with local and national decision makers, it is our aim to strengthen medical care at the peripheral level and at the same time conduct clinical trials on the respective methods, while giving careful consideration to the sensitive cultural and environmental issues. These activities will benefit the researchers in developing countries, who will publish their results in recognized scientific journals, the traditional practitioners, who will be encouraged to share their knowledge and given information on applicable hygiene and nutrition basics, the suffering people, who will have more confidence in more types of medicine and more options, and ultimately the local and national governments, who will appreciate a reduction of cost through preventive and natural medicine.
The actual situation can be replaced by a win-win situation, where traditional knowledge can be incorporated in practice, without the need for patents, by rendering it to the public domain. Biodiversity and cultural diversity could be more efficiently preserved through regulations and encouragement, rather than the present approach in uniformization in the name of modernization. The loss of habitats and habits can be reduced, contributing to the goal of balancing nature and development.
The research will focus on case studies reflecting approaches to integrate traditional medicines into the national health systems in various countries and at the same time adding to health literacy improvement.
Poverty: With Special Attention To Bioethics
- Shinryo N. Shinagawa, M.D..
Emeritus Professor of Hirosaki University
036-8223 Fujimi-cho 32-3, Hirosaki, JAPAN
E-mail: shinryo@smile.ocn.ne.jp Fax: 0172-32-8053 Tel: 0172-32-3921
As I was born in a large family, not so rich, experienced the Kanto Great Earthquake of 1923 in Tokyo, the World War II and its miserable sequelae in 1940s, worked as a clinician and a medical teacher in a rural poor district of Northern Japan, and made trips around the world including many developing countries, my concern and experience on poverty is great unusually and probably covers wide fields and topics. This paper is a short summary of my own personal experience and perspective especially from a medical and bioethical viewpoint.
There are a variety of poverty. They are economic, materialistic, social, intellectual, emotional, and philosophical poverties. Although I am of an opinion that the most serious poverty in today’s world is neither economic nor materialistic but emotional and philosophical, now I am discussing only on economic and materialistic poverty.
Classifications of Economic and Materialistic Poverty
Causes of economic and materialistic poverty have been identified in a variety of sources, ranging from an unbalance between natural and human resources to deficiencies in the administration of income support and the injustice of the economic and social system. Economic and materialistic poverty has been classified in many ways. Here, I am introducing three examples of classifications.
The first is a classification of poverty according to dimensions or the width who suffer from. In other words, as seen in Table I, there exist from a personal, individual and case poverty to the world-wide and global poverty.
Table I. A Classification Of Poverty To Width And Dimension
1. Personal, individual and case poverty
2. Familiar or domestic poverty
3. Communal or regional poverty
4. Social class poverty
5. National poverty in developing countries
6. Nations-Group’s, continental or subcontinental poverty
7. World-wide or global poverty
The second is a classification based on reasons of poverty mainly from a medical viewpoint. As seen in Table II, they are hereditary, congenital or acquired, short-term or long-lasting, cycling, cyclical or continuous, avoidable or not, and so on.
Table II. A Classification Of Poverty From Medical Viewpoint
1. Hereditary, congenital and acquired poverty
2. Short-term and long-term poverty
3. Temporary, cyclical and continuous poverty
4. Regional/localized and general/widespread poverty
5. Individual and constitutional poverty
6. Relievable/controllable/amendable and unrelievable/Uncontrollable poverty
7. Avoidable and unavoidable poverty
The third is a classification according to the socio-economic origins. As seen in Table III, topics on Origin of Poverty today most widely discussed are all probably included in this table.
Table III. Origin And/Or Reason Of Poverty
1. Natural and geographical origin such as desert, no or too little rainfall and water, and too low or too high temperatures
2. Overpopulation
3. Shortage in natural resources
4. Epidemics and pandemics
5. Low standard in intelligence and education
6. Low development in science and technology, and shortage in skilled and well-educated workforce
7. Delay in productions of agriculture, industry and so on
8. Mal-distribution of wealth caused by social dysfunctions such as corrupt politicians, police and judges, and bureaucratic resistance to reform
9. Defects in such social factors as good governance, healthy competence, access to free and full information, an efficient and transparent legal system, and so on
10. Human disasters such as political instability, insecurity, conflict, war, terrorism and so on
11. Natural catastrophes and disasters
12. Lacks in democracy, political, economic and religious freedom, and minority right
Control and Overcome of Poverty from a Viewpoint of a Physician
The most important is population control. Needless to say, population should be controlled quantitatively. But from now and in the future, qualitative control of population should be studied. Although this is a very difficult and controversial issue, a study and discussion on this issue should be started. Here I would like to introduce only one example on this problem. That is a problem of year-by-year increasing survival rate of an extremely low birth weight neonate with a variety of serious handicaps and disabilities, and of a vegetable person with serious and incurable brain damage.
The best medicine is the prophylaxis. In a health care system, in medical education, a more emphasize should be placed on self-care and public health care, and primary health care besides modern medical high-technology.
On the other hand, American life-style of overproduction and over-consumption which is strongly influencing on the medical practice and an increase in medical expense should be re-studied and corrected if possible.
At the same time, control of arms and their trades is one of the most important ways in prevention and amendment of poverty. Recently most politicians of the world and mass media are discussing only on Weapons of Mass Destruction. However, more important in most developing countries for the prevention and treatment of poverty is a control of small arms such as guns, rifles, land mines and so on.
Globalization of economy and international trade should be promoted, but never be unilateral. Globalization in economy should be moderate-speedy, sustainable, and world-wide acceptable.
The United Nations has been dysfunctioning since 1990s or more earlier. The Third Generation of LEAGUE OF NATIONS or of UNITED NATIONS should be investigated sincerely because numerous errors and defects are now evident in LEAGUE OF NATIONS in Geneva and today’s UNITED NATIONS in Manhattan, NY. The Third Generation of LEAGUE OF NATIONS or of UNITED NATION should be able to play a role of policemen for the international security and peace-keeping, and be equipped with standing military power enough to control the international conflict and war.
As one of the most common reasons of intra- and international conflict and war is moral and ethical diversity and difference among races, tribes, nations, and religions, world-wide comparative studies on morals, ethics, religions, habits, and laws are all very necessary.
On this regard, I have an opinion that every ethic and law have two spheres. They are basic essential, and superficial phenomenal. The former should be common and universal throughout the world, and the latter may be variant and different each other from race to race, from country to country, from time to time. I am calling the former as “Genoethics”, and the latter as “Phenoethics” or “Phenomenoethics” parallel to the biological terms “Genotype” and “Phenotype”. To realize a world where the basic common international and global ethics and laws, and the traditional specific, national and local ethics and laws can peacefully coexist is one of my long-time dreams.
Table IV. Possible Ways Of Control And Amendment Of Poverty In The World
1. Control of population: Not only quantitatively but also qualitatively
2. Development and popularization of self-care, public health, and primary, secondary and tertiary health care
3. From American-style overproduction/overconsumption life-style culture to the sustainable and circulating (life-)style culture
4. Comprehensive control of all small arms besides control of nuclear, biological and chemical mass-destructive weapons
5. Balanced and moderate-speed Globalization in economy, trade and technology
6. Establishment of THE NEW WORLD ORDER based on The Third Generation of UNITED NATIONS or LEAGUE OF NATIONS supported by The International Policepower and standing Military Force
7. Studies on WORLD-COMMON ETHICS (GENOETHICS) focused on Human, Social and World Security besides and paralleled with world-wide, global or international laws. At the same time, traditional habit/culture-based ethics (PHENOETHICS or PHENOMENOETHICS) should be respected.
Vicious Cycle of Poverty
It is well-known that poverty is a key factor in the vicious cycle with ill-beings, diseases, crimes, and a series of anti-social behaviors and actions. However on the contrary, poverty has a possibility to become a trigger or a motivation of diligence, new idea, creation and discovery in science and technology, and various social matters, and sometimes poverty produces humanitarian heroes.
Poverty Security and Social Welfare in Japan
Finally, a short history of poverty security and social welfare system in Japan will be introduced. It is widely said in Japan that poverty security and social welfare were initiated by the Buddhism priests and Emperor’s family in the early 8th Century. For a long time, however, poverty security and social welfare covered the very limited persons in very limited districts and areas.
In 1946, just after the World War II, Japanese people adopted the New Constitution, and in its Article 25 an important policy was announced. That is: "All People shall have the right to maintain the minimum standards of wholesome and cultured living. In all spheres of life, the State shall use its endeavors for the promotion and extension of social welfare and security, and of public health."
This article 25 is the foundation of Poverty Security and Social Welfare System in post-war Japan. Along a line of this Article 25, the following laws passed the Diet, and they contributed greatly to establish a series of related laws and to realize one of the countries with social welfare, of peace-loving and -enjoying country, and with the longest life-expectancy although Japan is a poor country especially in natural resources.
Related social welfare laws in Japan are as follows.
1. The (Minimum) Livelihood Protection Law for Very Poor People (since 1946) *,
2. The Child Welfare Law(since 1947),
3. The physically Handicapped Persons Welfare Law (since 1949),
4. The National Health Insurance Law (since 1958),
5. The National Pension Act (since 1959), and
6. The Elderly People Welfare, Protection and Health Insurance Law (since 2000).
＊ The (Minimum) Livelihood Protection Law is subgrouped into the protections and/or supports of the
1. Minimum Livelihood in General,
2. Housing,
3. Education of children,
4. Health care,
5. Childbirth,
6. Re-education for the re-employment, and
7. For the cremation of the corpse and the Funeral
References
1. Shinagawa, S. (1997): An Essay on Standardization of Ethics – With Special Reference to Genoethics. Journal of Health Care, Medicine & Community 12: 46 -- 53
2. Van Dervort, Th.R. (1997): International Law, and Organization (An Introduction). SAGE Publisher, London & New Delhi
3. Landes, D.S. (1999): The Wealth and Poverty of Nations. David S. Landes, New York & London.
4. Palais des Nations – Musée de la SDN (2001): From the League of Nations to the United Nations – “the spirit of Geneva” in the service of peace. Genève.
Public Health and the WTO Free Trade Rules-Access to Patented Medicines in Developing Countries
- Yang Yi-Ching.
Candidate of the LL.M., International Law Section, Shoochow University Law School.
Shoochow University Law School, Taiwan, ROC
Email: yiching.yang@msa.
Introduction
Whether the WTO free trade rules are good or bad for public health is hotly debated. This paper is based on the free trade rules of the World Trade Organization (WTO), it aims to examine whether these rules can offer feasible mechanisms or exceptions for WTO Members to take adequate trade-related public health measures to address their public health problems. It especially focuses on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the public health crisis in the developing countries whose economic conditions are not promising, but with the urgent needs of accessing patented medicines for the HIV/AIDS pandemic.[1]
The scale of the HIV/AIDS pandemic has been evident for some years,[2] and the HIV/AIDS is the first health issue to have been treated as a global security threat by the United Nations.[3] On the contrary, the response of the international community to disease crises, and more generally to the public health situation in developing countries, has been poor. Without the affordability to access patented medicines; any unauthorized use of these medicines by the developing countries would be in breach with certain articles in the TRIPS Agreement. The adoption of the “Ministerial Declaration on the TRIPS Agreement and Public Health”(Doha Declaration) by Ministers on 14 November 2001, in Doha,[4] in addition to the joint study by the World Health Organization (WHO) and WTO Secretariat of “WTO Agreements & Public Health” in 2002,[5] seemed to illustrate the international community tends to address issues of trade and public health, inter alia, the adequacy of over emphasized patent protection in the free trade regime for the pharmaceutical products in certain developing countries. And the adoption of the Decision on “Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health”(General Council Decision) by the General Council on 30 August 2003 created the form of an interim waiver, which allows WTO Members producing generic copies of patented pharmaceutical products under compulsory licences to export these products to the Members with too little or no pharmaceutical manufacturing capability.[6] However, it remains to be observed if these legal instruments provide sufficient special treatments or exceptions on access to drugs under the TRIPS Agreement for developing countries, and furthermore, provide the legal grounds for all Members to establish their national public health policies, on the basis of autonomy.
To address this issue, the present paper is divided into three major parts. Part Ⅱ aims to briefly explore the connection between public health and the relevant WTO free trade rules. Parts Ⅲ turns to deal with the situations of certain developing countries with regards to the special needs of patented medicines for HIV/AIDS pandemic, the barriers from the free trade requirements to these countries in setting national policies for HIV/AIDS prevention and treatment, and the flexible explanations and amendments of the TRIPS Agreement to Members’ public health crises. Part Ⅳ seeks to examine, and if possible, to suggest, whether and to what extent the current WTO free trade rules, especially the TRIPS Agreement, can respond properly to the public health needs.
Public Health and the WTO Free Trade Rules
Health is defined as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”[7] “Public health” refers to all organized measures (whether public or private) to prevent disease, promote health, and prolong life of the population as a whole.[8] It is no doubt that the protection of public health is ultimately important to all human beings and state governments, but historically, international lawyers had not been much interested in the field of public health. Similarly, public health officials and experts often ignored international law as an instrument for constructing or making public health policies. For lack of an active interaction between public health and international law, public health issues only had limited developments under international law in the past, including in the field of international trade law. However, the globalization and liberalization of international trade eventually have promoted and created the strong linkage between public health and trade at the contemporary age. In fact, Trade liberalization can affect health in multiple ways. Sometimes the impact is direct and the effect is obvious, as when a disease crosses a border together with a traded good. Other times, the effects of trade liberalization are more indirect. For example, reducing tariffs may lead to lower prices for medical equipment and health-related products; changing international rules concerning patent protection may affect the prices of medicines and vaccines; importantly also, there is a positive link between freer trade and economic growth, which can lead to reduced poverty and higher standards of living, including better health.[9] Whether free trade is good or bad for public health, the free trade rules provided by WTO Agreements unavoidably have made certain impacts and restrains on WTO Members as they adopt, take, or implement trade-related public health regulations, measures, or policies. Therefore, Members’ autonomy and right of protecting public health might be limited or restricted under various WTO free trade requirements.
The WTO Rules Relevant to Public Health
Good health for all population is an accepted international development goal and one building block for sustainable economic development, which is a goal that the WTO is working towards.[10] According to a Joint Study by the WHO and WTO Secretariat, there are eight major public health issues covered by, or involved with, WTO Agreements: (a) infectious disease control; (b) food safety; (c) tobacco; (d) environment; (e) access to drugs; (f) health services; (g) food security and nutrition; and, (h) emerging issues (such as biotechnology). And the WTO rules and Agreements, which are most relevant to these health issues, are the General Agreement on Tariffs and Trade 1994 (GATT 1994), the Agreement on Application of Sanitary and Phytosanitary Measures (SPS Agreement), the Agreement on Technical Barriers to Trade (TBT Agreement), the General Agreement on Trade in Services (GATS), and the Agreement on Trade-related aspects of Intellectual Property Rights (TRIPS Agreement).[11]
1. GATT 1994 Article XX (b)
Article XX (General Exceptions): “Subject to the requirement that such measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on international trade, nothing in this Agreement shall be construed to prevent the adoption or enforcement by any contracting party of measures: …(b) necessary to protect human, animal or plant life or health; …”
Before the establishment of the WTO, the same health exception had been existed since the adoption of the General Agreement on Tariffs and Trade 1947 (GATT 1947). GATT 1994 Article XX (b) guarantees WTO Members’ right to take trade measures to restrict the imports and exports of goods, which are necessary for protecting the life or health of human, animal or plant. This provision recognizes that Members have the right to fulfilling their legitimated objective of protecting public health, and indicates that the WTO respect Members’ national autonomy in public health policies.
Both the health issues on infectious diseases and tobacco control have connections with GATT 1994 Article XX (b). In order to prevent the risk of infectious diseases spread by the cross-border transportation of goods, WTO Members have the right to apply import-restricted measures necessary for the protection of human health. Based on the reason of health, many countries need and seek to establish tobacco control policies for decreasing the tobacco consumption and the exposure of cigarette smoke by prohibiting the import of tobacco products.[12]
GATS Article XIV (b)
Article XIV (General Exceptions): “ Subject to the requirement that such measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where like conditions prevail, or a disguised restriction on trade in services, nothing in this Agreement shall be construed to prevent the adoption or enforcement by any Member of measures: …(b) necessary to protect human, animal or plant life or health; …”
Under GATS Article XIV, Members have the right to take any measure necessary for protecting human, animal or plant life or health, and can be exempted from obligations provided under the GATS. But there are the same provisos applied in GATT 1994 Article XX. These provisos include that: (1) application of a measure must not discriminate arbitrarily or unjustifiably between countries where like conditions prevail, and (2) it must not constitute a disguised restriction on trade in services. Therefore, public health measures taken on the basis of the GATS Article XIV may still be challenged by other Members under the WTO dispute settlement mechanism if they feel these provisos have not been respected.
The most relevant health issue with the GATS is health services. Some risks to equity, access and quality of services available to the poor will be accompanied with the opening of the health services to foreign competition. Some evidence indicates that benefits of opening markets are concentrated among the wealthy. A potential benefit of foreign direct investment is that it may provide high-quality services that are not currently available domestically. In the absence of government regulation, these services are, however, likely to be only available to those who can afford it.[13]
2. SPS Agreement
Preamble, paragraph 1, “ Reaffirming that no Member should be prevented from adopting or enforcing measures necessary to protect human, animal or plant life or health, subject to the requirement that these measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade;”
In light of the preamble of the SPS Agreement, there are two main objectives concluded: (1) Members have the right to take necessary SPS measures for protecting human, animal or plant life or health; and (2) these measures shall not be applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade. But when reading the full context of the SPS Agreement, it is hard to find out any provision about promoting Members’ public health. On the contrary, many specific mechanisms are establish to supervise whether SPS measures constitute a discrimination or a disguised restriction,[14] whether these measures are based on scientific principles and with sufficient scientific evidence,[15] and whether they are compliant to a reasonable assessment of risk where Member’s level of health protection are higher than the relevant international standards, guidelines or recommendations.[16]
Through the application of SPS measures, Members can screen importing food, animals, and plants at the border for avoiding risks from these imports, and prohibit importing these imports, which are not conformed with the health standard of importing Members. The applicability of SPS measures is decisive to the protection of public health in Members’ territories. Thus in order to be compliant with the obligations under SPS Agreement, Members’ right and autonomy to take public health policies relevant to the application of SPS measures may be affected. And there are many public health issues covered under the SPS Agreement, including infectious disease control, food safety, environment, and biotechnology.
3. TBT Agreement
Preamble, paragraph 6, “Recognizing that no country should be prevented from taking measures necessary to ensure the quality of its exports, or for the protection of human, animal or plant life or health, of the environment, or for the prevention of deceptive practices, at the levels it considers appropriate, subject to the requirement that they are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail or a disguised restriction on international trade, and are otherwise in accordance with the provisions of this Agreement;”
The purposes of the TBT Agreement is to ensure Members’ right to restrict trade for some “legitimate objectives” by applying TBT measures, including product requirements, procedures etc., and to require Members to be compliant with non-discrimination principles and not to create unnecessary obstacles to trade. Under the TBT Agreement, the protection of human health or safety, the protection of animal or plant life or health, and the environment protection are listed as “legitimate objectives”.[17] Members are free to adopt necessary TBT measures to obstruct trade by the public health reasons, but shall follow the principles of non-discrimination, prevention of disguised restricts on international trade, and the proportionality between the legitimate objective of TBT measure and the extent of trade restrict. As a result that many national public health policies, such as infectious disease control, tobacco control, environment, and biotechnology, need to be supported by TBT measures, and Members’ right to take TBT measures are bound under the TBT Agreement, these public health issues may arise in the field of this Agreement.
The WTO Free Trade Principles and the Public Health Regulations
Although Members are guaranteed and authorized to take necessary trade measures for public health under the WTO Agreements above, it is still clearly observed that all the health-related articles or regulations have some similar provisos, whether provided in the chapeaux or designed into the other specific mechanisms for preventing the protectionism. For example, GATT 1994 Article XX, GATS Article XIV, and the SPS Agreement require that any measures, including those justified with legitimate health objectives, should not be applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on international trade; The TRIPS Agreement Article 8.1[18] also requires that any measure Members adopt for protecting public health are limited to be consistent with this Agreement; and the same provisos can be found in the TBT Agreement and the SPS agreement.
Accordingly, even if there are some health-related exceptions or regulations under certain WTO Agreements, which can offer a justified legal basis for any Members who takes any health-related measure, this measure should still be consistent with some provisos to guarantee certain free trade principles. Therefore, Members’ right to protecting public health is limited by these basic free trade principles at the WTO.
2 The Public Health Problem on Access to Drugs in Developing Countries
In the case of difficulties of access to drugs in developing countries, there are many factors that influence access to drugs. WHO has recognized four principle factors: rational selection and use of drugs, affordable prices, sustainable financing, and reliable health and supply systems.[19] Among these factors, two main common characteristics can be extracted, the abilities of purchase and the abilities of manufacture. From international law perspective, some legal obstacles indeed exist and need to be removed. The exclusive rights of patented medicines under the TRIPS Agreement and its patent system are criticized and assumed as the main legal obstacle. This part focuses on how the WTO considers the importance of public health issues and makes effort to dealing with the problem between the accessibility to drugs and the TRIPS Regime.
The Situations of Access to Patented Medicines Necessary to HIV/AIDS Pandemics in Developing Countries
In the statistics made by the Joint United National Programme on HIV/AIDS (UNAIDS), there are estimated 34-46 million people living with HIV/AIDS at the end of 2003, and 2.5-3.5 million people died from the HIV/AIDS during 2003. The Sub-Saharan Africa has the largest infection population of 25-28.2 million people, and the adult prevalence rate runs to 7.5-8.5 %. The South and South-East Asia has the second high infection population of 4.6-8.2 million people, and the Asia and Pacific Area accounts for 0.7-1.3 million people infected.[20] And 95% of people infected are living in developing countries.[21] The cruel reality is that 6 million people having HIV/AIDS infections in developing countries urgently need the antiretroviral treatment, but only fewer than 0.3 million people can be treated.[22] Only 5% of these developing countries’ people can receive necessary AIDS medicines for the antiretroviral therapy, and all the others can do is wait for dieing.
In such a serious situation of HIV/AIDS epidemics, developing countries claim that it results from the patent protection under the TRIPS Agreement, because 20-year exclusive rights of patented medicines can make pharmaceutical companies pricing their patented medicines highly, and can affect and impede the affordability of drugs to poor developing countries. Although the ultimate purposes of patent protection in the pharmaceutical field is to promote the research and development of new medicines, to provide new technology for the public, and to advance public wealth and health, with regard to the immediate HIV/AIDS crisis, people in need can’t wait for 20 years because they have already died before the termination of patent protection term. The incentive benefit of drug patent holders and the public health needs should be carefully balanced. The evaluation of the TRIPS consistency of measures taken by countries in the context of the AIDS crisis thus involves balancing the need for the development of new medicine against the need for affordable access to existing treatments. The balance should favour affordability in cases involving developing countries, especially least developed countries.[23]
According to UNAIDS, the high prices of HIV treatments are due, in part, to patent protection which allows control over their manufacture and sale.[24] There is evidence to suggest that the effect of patents on affordability is significant with drug prices falling sharply when generic substitutes enter a market to compete with drugs upon patent expiry.[25] The patent system under the TRIPS Agreement creates some legal obstacles on access to drugs in developing countries, including both problems on developing countries’ ability to purchase and to manufacture. The High Commissioner supports WHO’s call that “when establishing standards of patentability for pharmaceuticals, countries should consider the implications for health of those standards,”[26] and suggests that several provisions, for instance Article 31 Compulsory Licenses[27] and Article 6 Exhaustion,[28] in the TRIPS Agreement can offer flexibility to promote access to affordable essential drugs.
The Explanations and Treatments of Public Health Approach under the TRIPS Agreement
How the TRIPS Agreement is interpreted and implemented could have life or death consequences for the citizens of less well-developed nations.[29] To response these health-related critiques, the WTO takes two steps to interpret and amend the TRIPS Agreement. The first step is the adoption the Doha Declaration, which declares the flexibilities in applying the TRIPS mechanisms and interpreting the TRIPS provisions, and deals with the problem of lacking ability to purchase patented medicines in developing countries. The second step is the adoption of the General Council Decision, which temporarily amend the requirements of compulsory licenses of Article 31(f) and (h), and provides a practicable arrangement of compulsory licenses for these developing countries with insufficient or no manufacturing capacity.
3 The Ministerial Declaration on the TRIPS Agreement and Public Health
Before the Doha Declaration, developing Members without affordability to necessary patented medicines had confronted some difficulties and pressures about exercising compulsory licenses. For example, Brazil’s president decreed that his government could grant compulsory licenses on patents in a national emergency in 1999. The decree has been exercised to ensure affordable access to AIDS medications., but the United States challenged Brazil’s patent law by lodging a complaint at the WTO under the TRIPS Agreement.[30] Considering the patent protection under the TRIPS Agreement is possible to affect members’ accessibility of patented medicines and right to protecting public health, the WTO declares the public health approach of explaining the TRIPS Agreement in the Doha Declaration, in which three major flexibilities of the TRIPS mechanisms are provided to be applied by members without, but in need, affordability to patented medicines. These flexibilities include interpreting each provision of the TRIPS Agreement in light of the principle of public health protection, recognizing Members’ right to granting compulsory licenses and Members’ public health crises as a national emergency or other circumstances of extreme urgency, and guaranteeing members’ freedom to establish their exhaustion regime without challenge.
In the Doha Declaration Paragraph 5(a), Ministers declare that “Accordingly and in the light of paragraph 4 above,[31] while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include: (a) In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.” This paragraph is practically a statement to remind Members that the provisions on the TRIPS Agreement should be interpreted by the principle of purposes and objectives, which has concluded in the Vienna Convention on the Law of Treaties Article 31,[32] and, for example, Members’ right to protecting public health can be found in the TRIPS Agreement Article 8.1 (Principles).[33]
In light if the Doha Declaration Paragraph 5(b) and 5(c), Ministers state that “(b) Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. (c) Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.” Ministers, on the one hand, reaffirm Members’ right to granting compulsory licenses, including with the ground of public health, and on the other hand, presume public health crises as a national emergency or other circumstances of extreme urgency, in which situation Members can be exempt from the obligation of negotiating for reasonable commercial terms and conditions with the right holder in a reasonable time.[34] Besides, these statements create the effective defense that Members have the sovereignty discretion to decide which constitutes the ground of compulsory licenses or a national emergency. It is much easier for developing Members without affordability of patented medicines, to exercise compulsory licenses.
In the Doha Declaration Paragraph 5(d), Ministers clarify that “The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4.” The most important effect of this statement is to permit and guarantee Members’ right to parallel imports of patented medicines. In the international environment of differential pricing on drugs, Members can shop patented from lower pricing countries.
Accordingly, Members with the difficulty of affordability of patented medicines can be free to take adequate public health policies to manufacture or to import necessary drugs through granting compulsory licenses or admitting parallel imports. Otherwise, in the Doha Declaration Paragraph 7, Ministers also declare that “We reaffirm the commitment of developed-country Members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country Members pursuant to Article 66.2. We also agree that the least-developed country Members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016, without prejudice to the right of least-developed country Members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Council for TRIPS to take the necessary action to give effect to this pursuant to Article 66.1 of the TRIPS Agreement.” This paragraph is only designed for least-developed country Members (LDCs), but not applied by developing country Members. LDCs’ transition periods of Patent (Section 5) and Protection of Undisclosed Information (Section 7) in respect of pharmaceutical products are prolonged for five year, extended from 1 January 2011 to 1 January 2016.
In the case of the difficulty in exercising compulsory licensing, Ministers instruct the TRIPS Council to conceive an expeditious solution for Members with insufficient or no manufacturing capacities in the pharmaceutical sector.[35] Finally, the General Council adopted a decision on this problem submitted by the TRIPS Council in August 2003.
The Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health
Considering the difficult of access to drugs for some Members with insufficient or no manufacturing capacities in the pharmaceutical sector, the General Council Decision is adopted as an interim amendment to the TRIPS Agreement Article 31 (f) and (h), and provides a practicable manner to make these Members benefit from compulsory licenses.
There are two major waivers and some relevant requirements of the implementation of these waivers. Firstly, it is a waiver of the TRIPS Agreement Article 31(f) that the products made under compulsory licenses should be predominantly supplied to the domestic market of the Member by whom these compulsory licenses are granted. The obligations of an exporting Member under Article 31(f) of the TRIPS Agreement shall be waived with respect to the grant of a compulsory license to the extent necessary for producing pharmaceutical products and export these pharmaceutical products to an eligible importing Member.[36] Secondly, there is a waiver about preventing the double royalty from a compulsory license under the TRIPS Agreement Article 31 (h). Where a compulsory licence is granted by an exporting Member under the system set out in this General Council Decision, adequate remuneration pursuant to Article 31(h) of the TRIPS Agreement shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member. Where a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall be waived in respect of those products for which remuneration is paid in the exporting Member.[37]
The purpose of the system under the General Council Decision is designed to offer a solution for Members with insufficient or no manufacturing capacities in the pharmaceutical sector, but it may be possible that these pharmaceutical products made and exported by this system may re-flow out of the markets of target eligible importing Members. The problem of “black market” is also another point in the General Council Decision. In order to ensure that the products imported under the system set out in this General Council Decision are used for the public health purposes, eligible importing Members shall take reasonable measures within their means, proportionate to their administrative capacities and to the risk of trade diversion to prevent re-exportation of the products that have actually been imported into their territories under the system.[38] Furthermore, Members shall ensure the availability of effective legal means to prevent the importation into, and sale in, their territories of products produced under this system and diverted to their markets inconsistently with its provisions, using the means already required to be available under the TRIPS Agreement. If any Member considers that such measures are proving insufficient for this purpose, the matter may be reviewed in the Council for TRIPS at the request of that Member.[39]
Whether the Free Trade Rules of the TRIPS Agreement, and Other WTO Agreements, Provide Sufficient and Adequate Mechanisms and Explanations to Address the Public Health Needs in Developing Countries
The TRIPS Agreement and Public Health
As the result of the legal binding instrument of the Doha Declaration,[40] the WTO recognizes Members’ right to protecting public health, reaffirms Members’ sovereignty discretion to determine which can constitute the grounds of compulsory licenses or a national emergency, and guarantee Members’ freedom to choice adequate exhaustion regime. Through these flexibilities of provisions, Members without affordability of patented medicines can legitimately collect necessary drugs by exercising compulsory licenses or parallel importation. In 2001, Brazil Extracted prices concessions from Merck and Roche by threatening to issue compulsory licenses on their patents and to manufacture generic versions of their AIDS drugs. The Brazil experience serves as a case study on how TRIPS affects the bargaining power of a developing country in negotiations with multinational pharmaceutical companies and the cost of access to AIDS treatment.[41] It indicates that WTO Members can manufacture generic copies or import necessary patented medicines form cheaper price countries if they have problems on access to patented medicines. However, it should be understood that removing the legal obstacle from the TRIPS Agreement couldn’t address all problems on access to drugs resulting from lack of public health infrastructure or failure of national public health policy.
Furthermore, the title of “Declaration on the TRIPS and Public Health” reflects the developing Members’ position that the Doha Declaration should not be narrowly directed, and applied, only to “the section of patented medicines”, “the problem of HIV/AIDS disease or other epidemics” and other limiting circumstances, but can be referred to all health-related problems involving to the TRIPS Agreement. It means that the flexible explanations of public health approach can not only be limited to deal with problems on access to patented medicines, but also can be applied to Sections other than Patent Section of the TRIPS Agreement, and to all kinds of public health crises other than the crisis of lacking necessary drugs. In this broad perspective, this Doha Declaration is landmark to reach the compromise between the intellectual property rights protection under the TRIPS Agreement and the public health needs. The public health approach of interpretation and applications of the TIRPS Agreement is possible to continue its activated development in terms of various existing and potential public health problems both in developing country Members and developed country Members.
The Response of WTO Free Trade Rules to Public Health Issues
It is the premier turning point to explicitly express the attitude of the WTO to flexibly interpret and expeditiously amend Members’ treatments under the TRIPS Agreement towards public health protection. Besides the TRIPS Agreement, there are lots of health-related exceptions and regulations affecting Members’ public health policies under the GATT 1994, the GATS, the SPS Agreement, and the TBT Agreement. But until now, it is hard to find substantial amendment or positive development towards public health needs in these current WTO free trade rules. The GATT 1994 Article XX and the GATS Article XIV still provide some trade preconditions for preventing protectionism, even if those health-and-trade measures have a reasonable health objective and are necessary to reach this objective. And there are also several free trade rules and specific mechanisms about non-discrimination principles and the prevention of negative effects on international trade, established in the SPS Agreement and the TBT Agreement, to examine the consistency of Members’ SPS or TBT measures, no matter whether these measures have important objectives or necessities for protecting public health. As a matter of fact, it should be recognized that the nature of the WTO is an organization in charge of trade issues and trade liberalization. To expect the WTO puts more emphases on public health protection than free trade promotion is not realistic.
Yet concerns have been expressed by some observers that WTO rules could constitute a threat to sound public health policies. The disagreements over hormone-treated beef or, potentially, trade in genetically modified foods and recent discussions on TRIPS and access to medicines, illustrate possible tensions between national health and trade policies. Minimizing possible conflicts between trade and health, and maximizing their mutual benefits, is an example of policy coherence. To make progress towards policy coherence, constructive engagement is critical on the key health-and-trade policy issues, including infectious disease control, food safety, tobacco, environment, access to drugs, health services, food security and some emerging issues relevant to health such as biotechnology, currently under consideration within the WTO.[42] It is only a start point to deal with public health issues at the WTO at present, and it is true that basic free trade principles are the most respects. However, the WTO has highlighted these health-related issues, and all these issues are addressed at regular committee meetings, and even are prepared and discussed for new negotiations, like the negotiations on trade and environment.
Access to Drugs and Medical Services in Turkey: Asian and European
- Sahin Aksoy, M.D., Ph.D..
Harran University, Faculty of Medicine Department of Medical Ethics and History of Medicine, Sanliurfa, TURKEY
Email: saksoy@harran.edu.tr
Fair distribution of health care resources is fundamentally important in a country. Every country has its own system to provide these medical and social services. In this study, access to drugs and medical services in Turkey will be presented. Firstly, some relevant basic information about Turkey like economical, social and political structure will be given. Secondly, the health care organization of the country will be explained. In this section historical background of the system will be explored as well as its current status. Thirdly, the social insurance system will be explained and some figures will be given to have a better understanding of the health care context in the country. Finally, the current status on access to drugs and medical services in Turkey will be evaluated from an ethical point of view.
Country Context
Turkey is a nation state with almost 68 million population comprising people from different ethnic backgrounds. It has a young population with 55 percent under the age of 20 (Republic of Turkey, Prime Ministry State Institute of Statistics, 2002). The major faith tradition in Turkey is Islam (95 percent) though there also are small populations of Jews, Christians and others. Although Turkey is a secular state by its governmental system, since there is such a great majority of Muslims, religion plays a significant role in ethical reasoning in public mind, although not at the official level (Aksoy, 2003: 229). Turkey is a unique country in its region as a Muslim State officially committed to adapt western life style and tradition. The reason for mentioning this is that, in decision making process, especially at the end of life, it plays a significant role that will be detailed later.
Health Care Context
Health care reform started in Turkey after the mid-1940s (Akdur, 2000:14). In those post-war years Turkey, like many European countries, was a young republic with smaller (18 million) and aged population. There were many diverse health problems in those years to struggle with including malnutrition, malaria, pneumonia, tuberculosis, small pox and other infectious diseases. Besides these, the infant mortality rate was significantly high. As a new republic with large territories, the Turkish Republic needed population growth and as a result abortion was banned in those years (Ozgen, 1984: 10).
According to the new establishment in the health care system, there were three levels in health care provision. The first level was health centres, wherein general practitioners (GPs), midwives and nurses gave basic health services and preventive care to the public. These centres are vital in health care system since these are the only health care facilities that provide preventive health services free of charge, for a very nominal fee. These institutions have played an important role in the health awareness of the people. The second level of health care services was provided at state hospitals. Patients with social security of any kind, that we will explain these later, can apply to these institutions for free treatment. Patients with no social health insurance can also use any hospital by paying for services that is provided. The third level health care services are provided at university and specialist hospitals. These institutions give free curative health services to referred patients who have social security of any kind. In the Turkish health care system, normally, the patients should follow this chain. That means that a patient is referred to a state hospital by a GP, and referred to a university hospital by a specialist if necessary. However, this system does not work very well and anyone can go to a university hospital directly if he wishes, thus causing waste of time and resources. There are various factors that affect the preference of individuals. These are the knowledge, attitude and behaviour of the individual, and the socio-economic and cultural features of the society. Besides the age, gender, marital status, type of residence, education, socio-economic status, job, social security, and health level of the users, the distance between the family home and health facilities, the type of health service, and the opinion of the users about the effectiveness and quality of the health services are other factors affecting the usage of health services. (Ozgur et al., 2003:72)
There are primarily five different kinds of health insurance services in Turkey: Emekli Sandigi (The Retirement Fund) for civil servants and their families, Sosyal Sigortalar Kurumu (The Social Insurance Institution) for laborers and their families, Bag-Kur (The Social Insurance Institution for Craftsmen, Tradesmen and Other Self Employed) for independent businessmen and their families, Yesil Kart (Green Card) for poor people with no social security and their families, and the Private Health Insurance services. In all services except in Green Card the person must pay premiums in order to benefit from these services. These premiums are reasonably affordable and worth paying because the coverage is almost unlimited. Individuals are eligible to receive any service with their insurance, including high-grade operations and intensive care services. (Aksoy, in press)
Eighty seven percent of the population is under the coverage of one of these insurance services, and 83 percent is covered by health services. The distribution is 19 percent ‘The Retirement Fund’, 42 percent ‘The Social Insurance Institution’, 22 percent ‘The Social Insurance Institution for Craftsmen, Tradesmen and Other Self Employed’ and 4 percent others (SPO, 2001).
Priorities in Health Services
Every country has its own priorities in health services. Although most attention in the West has focused on the elderly as terminal patients, in some countries the major focus might be on younger adult AIDS patients or on children dying from malnutrition or infectious diseases. In each of these categories, the issues might be similar but the solutions differ significantly from country to country. Turkey still has problems in providing basic health services and preventive care, and the high infant mortality rate (39 deaths per 1000 births) compared to other European countries is an indication of this. Despite these problems, many other services have been quite well developed in recent years. The following tables and figures provide some information on changes over the last several decades (Ministry of Health, 2001).
Table: Changes in Health Services in Turkey
| |A |B |C |D |E |
|1980 |961,000 |85,000 |22 |1650 |- |
|1990 |1,895,000 |136,638 |24 |1115 |6.2 |
|2000 |2,673,000 |172,449 |25.8 |826 |5.5 |
A: The number of in-ward patients in health care institutions
B: The number of beds in health care institutions
C: The number of beds per 10,000 patients
D: The number of patients per one physician
E: The number of stay-days in the hospital
These figures indicate that, although they are not yet sufficient, the health care services, especially to in-ward patients have significantly improved during this period. These improvements reflect largely on care to elderly patients and palliative care. In palliative care, as in the rest of the health care, the intrinsic aim is to bring about a ‘medical good’. A ‘medical good’ is used as a blanket term to cover medical treatments such as those which lead to the amelioration or sometimes cure of disease processes, the relief of suffering, the prolongation of life, the dressing of wounds or injuries, and many others. In terms of palliative care, Turkey has limitations. As it is seen in Table , the number of beds per 10,000 patients is only 25.8, compared to 51 in the UK, 67 in Japan, 97 in Germany, and 101 in France (The World Bank, 1997: 44). This situation prevents doctors from keeping patients for long in hospitals. This especially applies to the terminal patients that need palliative care.
Conclusion
As a conclusion it is possible argue that in terms of access to drugs and medical services and health care provision Turkish health care system is a good example for just and ethical health care allocation. The state, especially with the regulations of the present government, makes its duty in terms of health care provision. However, the problem lies, in Turkey, at the level of public. There are hundreds of thousands people who claim social and health care benefits from the government with false statements. These unjust claims weaken the power of governments to enable peoples’ fair access to drugs and medical services.
References
1) Akdur, R. 2000. Turkiye’de Saglik Hizmetleri ve Avrupa Toplulugu Ulkeleri ile Kiyaslanmasi. (Health Care Services in Turkey and Its Comparison with EU Countries) A.U. Yayinlari, Ankara.
2) Aksoy, S. “End of Life Decision-Making in Turkey.” In Ed. Blank, RH and Merrick, JC. End of Life Decision-Making: A Cross-National Study, MIT Press, London, in press.
3) Aksoy, S. “Turkish Perspectives in Bioethics.” In Eds. Peppin, J.F. and Cherry, M.J. Regional Perspectives in Bioethics. Swetz & Zeitlinger Publishers, Lisse, 2003:227-34.
4) Ozgen, E. 1984. "Cocuk Dusurme ve Dusurtme Suclarinda Ulkemizdeki Son Durum." (The Latest Situation of Abortion in the Country) Nufusbilim Dergisi 6, ss. 5-25. (In Turkish)
5) Ozgur, S., AI. Bozkurt, S. Sahinoz, B. Ozcirpici, T. Sahinoz, E. Ilcin, G. Saka, A. Ceylan, Y. Palanci, H. Acemoglu, F. Akkafa and B. Bektas. 2003. “Utilization of Health Facilities in Southeast Anatolian Project (SEAP) Region’. Turkish Journal of Public Health 1;2:71-9.
6) Republic of Turkey, Prime Ministry State Institute of Statistics.
7) Republic of Turkey, Prime Ministry State Planning Organization. (SPO)
8) The Ministry of Health. 2001. Saglik Hizmetlerinin Yurutulmesi Hakkinda Yonerge (Guideline for Health Care Services). Ankara (in Turkish)
9) The World Bank. 1997. HNP Human Development Network, pp. 44-45.
Dalits in India are a Nation within a Nation
- Rev. N. Manova Santhosham, B.Sc., M.A, B.D..
Presbyter, Church of South India, Diocese of Madras, INDIA
Formerly, Director, Eco-Vision Ministry, (C.S.I)
Email: msanthosham@
Dalits are the most exploited section of the Indian population due to the Brahminical concept of “Manu Dharma Sastra”. The British government classified these Dalits under the “Depressed” class and granted a few rights to them at the end of 19th century, after repeated representation from Dalit leaders.
The word “Dalit” means oppressed. Mahatma Pooley and Dr. B.R. Ambedkhar were the pioneers in highlighting the oppression of Dalits through systematic Hindu religious concepts. As per the Manu Dharma Sastra, Dalits are outside the four castes in India and hence they are treated as untouchables. Even today this pure and impure concept brings about misery in the daily lives of millions of Indian persons.
Attempts in demystifying the legends of dalits
Dr. B.R. Ambedkhar highly educated delit in the early 20th century played a greater role in demystifying the legends of dalits. “The purpose of my mission is to exalt my community and I have no other ambition in my life” were the words of Dr. B.R. Ambedkhar. Since Dr. B.R. Ambedkhar lost hope in Hinduism he embraced Buddhism and thousands followed him. In order to create awareness among dalits he introduced three slogans i.e. Educate, Organize and Agitate.
Dalits role in Emancipation
As early as 19th century dalit were able to question their rights in India. Till the Christian missionaries started schools in India dalits were not allowed to get education in schools. (T.P. Kamalanathon , The historical facts about Scheduled Caste’s Struggle, 1985,page 9) Having good education in Mission schools dalits were able to get jobs in East India company. In 1891 the dalits of the Madras Presidency formed an organisation called Dravida Magha Jana sabha’ and a conference was held on 1st December 1891 at Ooty. Ten resolutions were passed demanding civil rights, Educational concessions, Removed of certain rules in the Jail Manuel, Economic advancement share in the appointment in government series in including the village officers and political rights,
Present condition of dalits
As per the mind of majority Hindu the dalits are untouchables which can be seen in village where dalits live in unhealthy conditions called ‘Cheri’ and the caste Hindu live separately in a well planned inhabitation (i.e. Divided in terms of settlements ) The caste Hindu will not enter the dwelling place of dalits and the dalits are not allowed to pass through the caste villages. Electricity, Road drinking water and access to burial place are denied to dalits even today. Above all in some villages two different cups are used to serve tea or coffee in hotels., which indicates the caste Hindus do not drink the cups used by dalits.
Who “ Oppose” the liberation of dalits?
The dominant castes are against the liberation of dalits. Now the Brahiminical concepts can not be seen only among Brahmins but in the minds of rest of the dalits in India. Because of reservation policy to uplift dalits the backward classes and most backward classes in Indian society oppose dalits. Few old sayings were created by caste hindus to create division among backward classes creating doubts about dalits integrity in general.(For instance ‘dalits and the shade of the palmyra tree have no stability’ )
The reason for the opposition is dalits leaders and dalit organisation have succeeded in getting reservation in government jobs and Legislative councils for dalits.
Anti-Conversion law and its supporters
The Hindus are against the religious conversion of dalits. They fear that Hinduism may became minority if most of the dalits become Christians or muslims.
If Hinduism became minority they can not preserve the caste system. Dr. Lohia called the caste system as the “ Paralysis of Indian Mind”. Because of this fear Indian government is influenced by them not to grant educational and political privilege to dalit Christians. Which was sanctioned to dalits who become Buddhist in India.
Influenced by Brahiminical concept of caste system Tamilnadu government in India promulgated a law called ‘Anti Conversion Bill’ in 2002. Which was largely opposed. This law was opposed by so many dalit leaders, chrisitan and musilm leaders since it has the blessings of caste Hindus who uphold caste system in india.
Artrocities against dalits
The number of incidents of crimes against dalits is on the range of 55,000 to 65,000 per year in recent times. Before 1976 it was between 16,000 to 18,000 incidents per year. Analysts say crimes against dalits and tribals increased by as much as 89% between 1992 and 1994. However the total of 1.6 lakh cases of crime against the scheduled castes (British Government brought all the depressed classes under ‘Scheduled caste’) and tribes framed between 1955 and 1986 only 4,322 resulted in conviction.
Many of the cases of atrocities arise from issues of wage hike, as the dalit agricultural labourers demand just and equital wages..
Hidden culture of dalits
The indigenous inhabitants had become a people without their own history, without their own culture individuality though they retain certain amount of cultural distinctness. But their history lies hidden in their folk songs, stories, myths, religious symbols and practices which on the one hand reveal elements of ancient conflicts (Dr. D. Kosambi, The culture and civilization of Ancient India P.16) The important task before dalits is to reconstruct this ancient history in the light of available material evidence, Brahimanical religious literature and dalits own traditions, myths and practices. It is not easy to nurture and strengthen the dalit identify and their struggles for liberation without the aid of their history. It is shame to the indians since 200 millions of dalits live in poverty and devoid of basic rights.
Conclusion
Dalit's miseries should be studied contextually in India with historical evidences before making programmes to liberate them from their present oppression. External forces like dominant castes in India and people who uphold caste system be also identified in order to combat against the oppressive elements.
The Bioethics of Rational Pharmacotherapy in Russia: Objective and Subjective Problems and their Solutions
- Konstantin S. Khroutski; M.D., Ph.D..
Dotsent, Head of the Course of Pharmacology,
Department of Specialised Therapy, Institute of Medical Education,
Novgorod State University after Yaroslav-the-Wise;
Derzhavina str. 6-a, Novgorod Velikiy, 173020, RUSSIA
Email: hrucki@mail.ru hks@novsu.ac.ru
- Olga A. Khroutski, Pharm.D
Manager of a drugstore,
Teacher at the Department of Pharmacy, Institute of Medical Education,
Novgorod State University after Yaroslav-the-Wise;
B.Moskovskaya str. 116/2, Novgorod Velikiy, 173020, RUSSIA
Email: mdc-zdorovo@mail.ru
The 'Gatekeeper' Role of a Pharmacist for the Entire Medical System
The pharmaceutical profession has undergone radical shifts in ethics in the last few decades due to new technologies in various fields of science. However, the bioethical aspects of pharmaceutical contribution to the solution of the problem of rational pharmacotherapy still is staying beyond the mainstream of bioethical topics and bioethicists' activities. Prof. Darryl Macer was among the first who has focused our attention on the figure of pharmacist who "has to face bioethical issues in daily practice, especially with over-the-counter drugs and remedies in which case the pharmacist should view their role as a kind of gatekeeper for the medical system, informing while serving the customers." He also regards that generally "the area of pharmacy and bioethics has not been explored as much as some," hence; "bioethics challenges us to reexamine our decisions and the relationships we have with others." (Macer, 2000).
1.1. The missed bioethical object of the patient who has made a decision on self-medication.
Among the aims of my presentation is the disclosure of the novel bioethical object: of the patient who has made a decision on the self-medication – patient medicating himself (MH-patient). Strictly speaking, in this case, the diseased man stops to be a patient but rather becomes merely the visitor of a drugstore (MH-visitor) – one who is suffering from a diseases or disorder, but who has decided to medicate himself. In turn, such a customer of drugs (MH-person) will certainly bypass the safety net performed by licensed health professionals. In other words, he or she will sacrifice safeguards of straight professional supervision and directly fall under the danger of drug's adverse affecting (by losing an opportunity for the correct diagnosis or the identification of a contraindication to the drug).
We have, herein, a difficult problem: all the acceptable drugs, being used by a customer medicating himself (MH-visitor of a drugstore), should be safe, effective, affordable and meet real medical indications. Thereby, pharmacist is an actual 'the last barrier' to the adverse and even dangerous effects of medications and, hence, druggist is a genuine "gatekeeper" of man's wellbeing and health (as it concerns the rational pharmacotherapy).
2. The Problem of Self-Medication and Over-the-Counter Dispense of Medicines in Russia
Russian specialists in pharmacoethics (N.V.Elstein, 1996; J.M.Lopukhin, 2001; G.B.Fedoseev, 2003; and other) stress the following points:
It has happened in Russia the spontaneous and mass re-classification of the majority of prescription drugs and their transition into the category of over-the-counter medicines.
The type of MH-visitor of a drugstore is a common phenomenon in Russia of-today.
From 30% to 60% of all drugs are used by patients without the reasonable grounds.
Self-medication is one of the key problems of public health care in modern Russia.
2.1. The causes of the self-medication in Russia.
What is the origination of this phenomenon in Russia? What does compel contemporary Russian diseased man to stray the successive visit to the doctor, but, instead, to use the information for self-medication from his own experience, or to follow the advises of his neighbour, or 'recipes' of mass media? To authors' view, some reasons are evident:
1) First of all the economical factor must be introduced. Self-treatment cuts the expenses of public health care services and increases the access to medicines for the population. This judgement fully agrees with the conclusion of WHO’s expert L.Rago (2001). For instance, the allocation of finance to Russian health care budget is only 2,4% of the Entire National Product, whole in Great Britain – 5,9%, and the U.S.A. – 13%. At the same time, the capacity of Russian pharmaceutical market is near 4 billions of American dollars, while in Japan – 10 $ billions, and in Germany – 20 $ billions.
2) MH-visitor of a drugstore in Russia has a real opportunity to purchase the needed medicines for his or her self-medication. (This is a natural consequence from the aforementioned points).
3) The low standard of current Russian system of primary free medical service. This factor leads to a patient’s avoidance of the meeting with a doctor, if he or she considers the disease not to be too serious. I mean, here, a) the limits of time at physician’s disposal: doctor on duty at adult polyclinic (outpatient department) has officially, in contemporary Russia, no more than 15 minutes on the reception of a patient; b) not infrequently long queues in adult polyclinics that cause unwillingness to repeat the visit to the doctor; c) contemporary Russian physicians, due to the deficit of financing, have not a possibility to undergo regularly the courses of updating and improvement of their qualification.
2.2. The comparison of pharmaceutical sales in Russia and the world. In my context, it is relevant to compare the consumption of medicines in Russia and the world. In this order, I present two tables: The first reflects on the global pharmaceutical sales; The second shows the 10 best-selling drugs in Russia.
Table 1. Leading therapy classes in 2002 global pharmaceutical sales
|Rank |Audited World Therapy Class |2002 Sales ($bn) |% Global sales ($) |% Growth (constant $) |
|1 |Antiulcerants |21.9 |6% |+9% |
|2 |Cholest. & Triglyceride Reducers |21.7 |5 |+12 |
|3 |Antidepressants |17.1 |4 |+5 |
|4 |Antirheumatic Non-Steroidals |11.3 |3 |+1 |
|5 |Calcium Antagonists, Plain |9.9 |3 |-1 |
|6 |Antipsychotics |9.5 |2 |+19 |
|7 |Erythropoietins |8.1 |2 |+18 |
|8 |Oral Antidiabetics |8.0 |2 |+2 |
|9 |ACE Inhibitors, Plain |7.8 |2 |0 |
|10 |Cephalosporins & Combinations |7.6 |2 |-3 |
Source: IMS World Review 2003
Table 2. 10 best-selling drugs of 2003 in Russia in the first quarter of the 2003
|Rating |The original name |Thousand US$ in sales |
|1 |Drotaverinum (No-spani) |6534 |
|2 |Viagra |5837 |
|3 |Essentiale H |5285 |
|4 |Vitrum |5225 |
|5 |Vinpocetinum |4805 |
|6 |Mezym-fortae |4504 |
|7 |Coldrex-Hotram |4336 |
|8 |Actoveginum |4247 |
|9 |Terra-Flu |4086 |
|10 |Fervex |3761 |
Source: CMI 'Pharmexpert'
As we can clearly see, the leading therapy classes in the world fully comply with the achievements of evidence based medicine. On the contrary, Russian sales expose the total predominance of symptomatic medicines. For example, amidst the therapeutic classes, the first four positions are occupied by: 1. The means for the treatment of cold. 2. Vitamins. 3. Antibiotics. 4. Analgesics.
At the same time, the medicines for treatment the diseases of heart occupy only the ninth position.
2.3. The corollaries. Due to the analysis of the data of medicinal consumption in Russia and the world, and by virtue of the above stated arguments, the following conclusions can be brought about:
a. The contemporary Russian health care system, in conditions of rigorous prescriptive distribution of medicines, is unable to function efficiently.
b. Self-treatment in Russia, due to the disclosed causes, is a natural (spontaneous) process and the compensating phenomenon regarding the insufficiency of the state provision of medicines.
c. The existing situation with mass self-medication comprises a clear danger of wrong and careless application of medicines and, therefore, directly threatens every involved person in Russia with health disturbances.
The general corollary: Over-the-counter dispense of medicines in Russia has the objective and necessary significance. At the same time, this is a hidden threat to every involved person. Therefore, insofar we cannot return at present to rigorous distribution of medicines, taking into account the current hard period of building democracy in Russia, we are to employ actively objective and subjective means in resolving the problem of self-medication.
3. Objective Goals of Bioethical Activity
We call these aims as referring to the 'Above-Drugstore' level of pharmacoethical activity. The latter can correspond to the following directions:
1) to form a state (official) long-term policy aimed at the cultivation of the active attitude of a Russian citizen towards his or her individual health;
2) to enhance the quality of education and scholarship with respect to rational pharmacotherapy;
3) to reconsider the ethical norms of pharmacist-patient interrelations;
4) to activate, in every possible way, the development of the process of informing a patient with respect to the use of medicaments;
5) perfection of the measures that eliminate the delay of diagnostics and treatment of the diseases, which are not the subject to self-medication in any case.
3.1. Objective activities on the 'Drugstore'-Level.
Tackling the problem of self-medication, the governing body and personnel of a drugstore might propose and actually perform the agency in the following directions:
1. In provision the working places with necessary facilities (PC, the use of Internet, formularies, State Pharmacopoeia, etc.) – to effectively retrieve and be easy in representing up-to-date, evidence based, practical information on rational drug therapy;
2. In regular attendance of postgraduate scholarships, courses, conferences, etc. – to continually improve professional competence and constantly enhance personal qualification;
3. In regular employing a teacher of clinical pharmacology – to deliver lectures on clinical pharmacology and to consult patients;
4. Maintaining a phyto-bar at the trade department of the drugstore – to apply the phyto-therapy and, thus, assist in lessening the severity of the symptoms of many chronic (and some acute) diseases.
4. The Subjective Line of Activity – The Ethical Notion of the 'Doctor of Pharmacotherapy' in a Drugstore
Finally, a separate direction is occupied with a pharmacist personal endeavours to grow up ethically – to achieve the interactive level of the 'Doctor of Pharmacotherapy'. Who is this figure in a drugstore? 'Doctor of Pharmacotherapy' (DPT) deals with a MH-person – medicating himself visitor of the drugstore. This type of a pharmacist's agency is solely consistent with the personal mature level of professional activity, mainly depending on the inherent intention and willingness of the pharmacist to actively develop in qualificatory and ethical directions. In other words, ethically matured ‘Doctor of Pharmacotherapy’ is a specialist who demonstrates professional ability and personal calling (and responsibility) to conduct good (equal, respectful, careful) pharmacist-visitor communication and obtain, in this way, the capability to assist the visitor in independent arriving at the right decision in his/her choosing the proper medicine. I argue that the advanced DPT-pattern of rational pharmacotherapy is deeply consistent with “good life” (eu-bios) for a patient (in the case of his/her self-medication), as far as it optimises the appropriate selection of the right medicinal remedy and safeguards the patient from adverse and even dangerous taking of inappropriate drugs and dosages.
4.1. 'Doctor of Pharmacotherapy' – a notion, ideal, and process.
'Doctor of Pharmacotherapy' (DPT) is simultaneously a notion, ideal, and process. It is an ethical notion, in so far as it is not a subject of a college (university or post-graduate) curriculum and training; for, DPT is an ideal of personality growth for the conscientious pharmacists, who voluntary (inherently) and deliberately express the willingness to reach the DPT-level - of ability to actively serve and promote (in a continuos process of improving her or his competence and communication skills, and enhancing service and care) the well-being (with respect to rational pharmacotherapy) of every patient (especially, of MH-client). In other words, DPT-pharmacist, while communicating with a patient on the basis of mutual trust and respect, strives to achieve the best possible outcome for the patient, previously having inquired her or his specific clinical and life circumstances, and providing her/him with complete appropriate information on the needed medicines – of all – 1) to prevent the adverse and dangerous effects of self-treatment; 2) to enhance the availability of proper treatment for the diseased man; and, ultimately, 3) to improve the entire quality of the person’s life. The detailed characteristic of this topic is given in the EJAIB 12(3), 2002.
5. Conclusion
To resolve the problem of self-medication, in Russia and other countries, we urgently need the objective optimisation of education and scholarship in pharmacy and development of the entire use of pharmaceuticals and the provisions of pharmaceutical care - towards the enhancement of the profession of pharmacy.
Simultaneously, the original shifts might be realised exactly on the personal (subjective, in subject-subject pattern) bioethical level of a pharmacist on duty (working druggist) – to ultimately achieve the grade of rational pharmacotherapy for the MH-type of a diseased man (MH-visitors of a drugstore).
'Doctor of Pharmacotherapy' might be a real challenge to current bioethics. That is a main reason of putting forward the bioethical notion of a 'Doctor of Pharmacotherapy' – of a person (pharmacist) who is inherently inclined and independently aims to transcend on the higher professional level of serving the patients by virtue of: a) continuous pursuing and gaining excellent knowledge in pharmaceutical care; and b) acquiring the ability to effectively communicate and assist a patient (chiefly, in her or his making the personal decision on purchasing the right medicine) on the grounds of mutual trust and respect, and evaluating each visitor of the drugstore as a unique person.
Maybe, the personalisation of biomedicine will get its beginning just in pharmacy.
6. References
Aeticheskij kodeks farmatsevticheskogo rabotnika Rosii (provisora i farmatsevta) (Ethical code of the pharmaceutical worker in Russia (pharmacist and pharmaceutist) (1999) Apteka i rijnok (Pharmacy and Market) 8: 17-21
Lopukhin, J.M. (2001) "Bioetika v Rosii (Bioethics in Russia)", Vestnik Rossijskoj akademii nauk (Vestnik of the Russian Academy of Sciences) 71(9): 771-4.
Khroutski, O.A. & Khroutski, K.S. (2002) "Pharmacy and Bioethics – Towards the 'Doctor of Pharmacotherapy' in a Drugstore", Eubios Journal of Asian and International Bioethics 12(3): 97-103.
Macer, D.R.J. (2000) "Bioethics and pharmacy", International Pharmacy Students Association Newsletter ()
Ozolina, V.M. & Vitola, A.Ja. (2003) "Pharmatsevticheskoje obespechenie v Latvii. Problemye samolecheniya (Pharmaceutical provision in Latvia. Problems of self-medication)", Pharmatsiya (Pharmacy) 2: 16-19.
Rago, L. (2001) "Vyegodye i riski samolecheniya (Benefits and risks of self-medication)", Pharmateka 1: 9-12.
Shetinina, M. (2000) "Patsient nushdaetsuya v zashite (Patient needs the protection) ", Farmatsevticheskij vestnik (Pharmaceutical Newsletter) 43(194): 10-11.
Access to Medical Therapy and Genomics in China: Ethical Issues in the International HapMap Project
- Yanguang Wang, M.D., Ph.D..
Center for Applied Ethics, Chinese Academy of Social Sciences, CHINA
Email: Ameliaw2002@
1. Introduction of International HapMap Project
The International HapMap Project is a multi-national collaborative project conducted by six countries including the U.S.A., the U.K., Japan, Canada, Nigeria and China. The HapMap is being developed with DNA samples from four populations: Yoruba People of Ibadan, Nigeria, Japanese and Han Chinese. The HapMap Project is searching and studying the common patterns of genetic variations, describing the original block architecture of genes and the whole tag SNP in the four distinct populations, and interpreting the differences of the DNA sequences and the diversity of human genome. By The HapMap Project, researchers will provide entirely genetic information as an effective tool for the future analysis of linkage between diseases and genes as well as discovery of genes associated with diseases. Meanwhile it is helpful to understand the variation of DNA sequences in human origin and during the course of evolution and migration.
2. To get samples from donors in International HapMap Project in China
Investigators in China collected the Han Chinese samples from the donors in the Beijing Normal University residential community because it is made up of mostly Han people who are mostly students from nearly every province in China. Investigators collected the 180 Han Chinese samples from donors in Beijing Normal University on Sep 22, 2003, Sep 29, 2003 and Oct 6, 2003. A Community Advisory Group (CAG) was established for Chinese site to consider ethical and sampling issues. The Community Advisory Group included genomic and population genetics researchers and ELSI experts. Cell lines will made from the two thirds of samples and maintained at the Coriell Repository in New Jersey, U.S.A., which houses the world’s largest collection of human cell lines. The remaining portion was stored in Beijing Genomics Institute. By putting all the information in a scientific database on the Internet, The cell lines and DNA from the samples will be made available to researchers around the world with qualified protocols approved by appropriate ethics boards.
3. Informed Consent in International HapMap Project in China
In the collection of samples for this Project, the key issue is to make perfect informed consent form. During the investigators collected the Han Chinese samples from donors in the Beijing Normal University residential community, the Informed consent was regarded as the important element. The Community Advisory Group (CAG) was working to solve the ethical and sampling issues in International HapMap Project in China and reassess further the scientific strategy and to integrate consideration of ELSI into all phases of the Project.
Community Advisory Group (CAG) enabled donors to learn how the samples got from their community by the constructing of the ELSI committee of Human Genome of North China. Before the Investigator to get the blood sample, the director of the HapMap project in China have given a lecture to the people of the Beijing Normal University residential community, he explicitly explained what is the knowledge needed from the HapMap project, future implication and potential risk for the informed consent and handout the reference materials of international HapMap project, the reference materials HapMap project in China and the informed consent form for the HapMap project in China.
After this lecture, the donors filled the informed consent form and a survey was done to review the procedure of informed consent. From the survey, we knew that some donors worried, “Will my sample be used for the special research in the International HapMap Project, partially or totally?” From the worrying, it seems that the donors did not get the full information and real understood of the HapMap project. In fact, the HapMap project is “The Haplotype Map project (HapMap) and Other research on Genetic Variations”, the HapMap will help make studies of other research on Genetic Variations to conduct, and thus more of them will be done.
Some donors wondered, “We heard that the International HapMap project have promoted to give $50 to each donors, but we only got 50 Chinese Yuan (US$6), no person told us that why”. They asked this question and worried someone might deduct and grafted the extra money, even though the most of them would like to be volunteers. The Community Advisory Group(CAG), ELSI committee in China The Chinese donors did not be informed that the money for compensation decided and whether it came from Chinese budget. The funding for The HapMap from China and USA was mixed for ELSI funds. The flexibility was found to allocate some funds for this project.
For such a real new project, the Community Advisory Group(CAG), ELSI committee and investigator was expected to inform participants well in order to make them understanding full about the purposes of HapMap and how to use it in future, as well as its possible risks. The ensuring to get informed consent will formulate the trust between researchers and participants and promote the whole societies to participate and cooperate in future research.
4. Compensation to donors in China
The Chinese donors were given 50 Chinese Yuan by the project in China for Compensation. There were disputes on how to compensate to the donors, such as whether or not the donors should get some compensation? How much the money given is the limit to induce the donor? Some volunteers questioned whether the compensation of 50 Yuan conflicts with humanitarianism for they would like to be a donor just to make a contribution for the developing of science, some others asked how much the participants were compensated in the other country as well as how to ensure its justness.
From the international guideline, to the human subject involved in the genetics research, any compensation should neither lead to tempting participants to donate nor result in depreciating them. As to by what means and how much to compensate, as well as whether in term with identical standards or in accordance with China’s situation, this issues was discussed further by The Community Advisory Group and ELSI Committee.The Community Advisory Group and ELSI Committee understudied even though the international project said the limited $50 to the US donor, the other countries can decide the money number according to the context of his country. In Chinese context, 50 Yuan is not a lure to most of volunteers, it would be admitted very little.
Moreover, the Community Advisory Group and ELSI Committee got a consensus that, the 50 Yuan of compensate for the donor was due to compensate the donor for their time and body hurt, and to compensate the participants who help a science research is a common thing in China, 50 Yuan is almost a standard amount for participation in research involving blood draws in China.
The Prospective donors in China were told that they will be compensated before they came in to donate, it was not the same ting happened in Nigeria, the Prospective in Nigeria were told that they would be compensated after they came in to donate to guard against the risk that they would be induced to participate by the prospect of material benefit. The reason is 50 Yuan in China is not of an observable a lure. Also from the Chinese context, the most of Chinese donors who are younger university students would like to get a souvenir for this meaningful participation, so, excepting to the 50 Yuan, the project decided to give donors each a souvenir to appreciate their participation and encourage their humanitarianism.
munity Engagement in China
Because the Hapmap will allow researchers to compare patters of genetic variation not only among individuals but also between populations, the Project raises issues of group concern. The Populations/ELSI Group involved in the initial planning for the Project thus recognized early on that some meaningful process of group engagement or consultation was necessary before individual informed consent could be obtained, and that this process should continue after the samples were collected. The goal was to give people who were being approached for participation an opportunity to discuss the ethical, social, and cultural issues the Project raises and provide some input into the way their samples should be collected and described. Community Engagement is more important in the context of Chinese culture that the population is short of the knowledge of human genome and thinking of the less of the aware of human right.
The preparatory meeting for Community Engagement in China was held in the end of May in 2002, more than one year before the collection of samples for this Project. The participants included people with a range of educational, occupational, and socioeconomic backgrounds, making it an ideal model to engage a socially defined community for participation. Dr C. Zeng gave a brief introduction to the project. Dr. V. Ota Wang who came from NIH to be a monitor of China for International HapMap Project gave a report on Community engagement and sample collection. The discussed problems included that the Organization; Next steps; Working group member selection (8x8x8); Participation incentive (community engagement, blood donation; Post blood collection community activity; Support letters (Working Group leaders and Coordinating Group members). The preparing meeting for Community Engagement in China also discussed the concept of Chinese Community. In the context of Chinese culture, the concept of community participant should include of the family participant, so the family element should be consider during the proceeding to get the informed consent from the donors.
Even though, the appearance of the SARS epidemic in the middle of the process required compressing the community engagement activities into a shorter time frame in China, even though, investigators held several public forums and conducted individual interviews and focus groups with more than 100 people from diverse backgrounds and 22 different provinces in China, the Community Engagement was far from perfect, but when done well it could help researchers better understand people’s attitudes, beliefs, and concerns. The information gained also can help researchers report the findings of their research in a way that is respectful of local concerns. In addition, the process provides potential sample donors extensive information about the Project and its implications in an interactive manner over an extended period of time, making them better informed when offered the opportunity to take part. We hope the Community Engagement will be continued for the Community involved, so that is convenient for other relevant scientists and publics to learn and obtain the information concerning this Project and genetic knowledge.
6. Confidentiality and privacy in China
Confidentiality and privacy to donors was confirmed on International HapMap Project in China, the names or any other information that could identify them or their family of the volunteers who provided their blood samples’ were not be included in the HapMap database, only their sex and ethnic or geographic group were noted. But just after the collection of the blood sample was finished, one question was raised, some Chinese Scientifics wanted to keep a name list signed by the donors who got the souvenir in hand hoping the name list would be useful for the future research, for example some future study may need to know the ages of the volunteers or some future research on disease using Hapmap can benefit the volunteers.
The advice was given by ELSI committee of International HapMap Project that the name list was destroyed soon, because the use of DNA samples and the donors information should be prevented from recognizing the identities of the persons concerned, which can not be pursued by using anonymous or encoded samples. Here, it is for sure that all the informed consent forms have been retained in Beijing Genomics Institute, unavailable to others. That is, volunteers’ names are not involved in the samples, and ninety samples selected randomly among one hundred eighty ones are encoded and used in the HapMap, so it is no way to find out who provided them and no researchers or investigators could tell them.
As we know, the HapMap is expected that many more association studies will be done, and the ethnic or geographic group can be known from the samples and the research results of the HapMap. If future studies should lead to the discovery of genetic variants associated with a disease, the frequencies of those variants could be determined for each population identified in the HapMap sample sets. Because If a higher frequency of a disease-associated variant were found in the samples from Han Chinese population and this information were then erroneously over-generalized as applying to all or most of its members, the entire population could be stigmatized or suffer “genetic discrimination”. Some Chinese is worrying about such “genetic discrimination” to the Han Chinese, if Han Chinese population are carrying certain genes related with diseases in view with their misunderstanding and other false information, which could affect their employment, insurance, marriage and so on.
Some Chinese made argument against such worrying, they thought that naming the populations was a more ethically appropriate choice. The Han population information in the HapMap will be the very feature that will make the resource useful for finding disease-associated genes that can be used for disease gene discovery. In addition, because the goal of the Project is not to “define” populations. No claims are made about the genetic “purity” of the sample sets or, by extension, the populations in which donors are members, such claims would be scientifically spurious, since human populations are the products of countless social, historical, and demographic processes, and thus can never be sharply defined. The same thing happen to the population genetics diseases, the genetics diseases will be caused not only by gene but also by the elements of environment. If researchers who conduct future research with the samples or with HapMap data do cognizant of these complexities when designing and reporting on their studies, the “genetic discrimination” to the Han Chinese will be prevented.
7. How to use the database for the Chinese
By putting all the information in a scientific database on the Internet, The Han Chinese cell lines and DNA from the samples will be made available to researchers around the world with qualified protocols approved by appropriate ethics boards. But some Chinese donors expressed worries about how to use the database in this HapMap in our survey questionnaire. They worried that: “If all the information resulted from this project will be released on the Internet, how to ensure it would not be used to make against human existence and development?”
Chinese Project’s ELSI Group is trying to let the donors know: even though the cell lines and DNA from the samples will be made available to academic, government, and commercial researchers around the world, They also worried “Would my DNA be integrated with animals’ and to make recombination to create new species? but all protocols have been determined by the Coriell Institute’s IRB, all protocols should be consistent with the terms of the informed consent documents used to collect the samples and approved by any other relevant ethics committees.
Chinese Project’s ELSI Group is learning the international document about how to use the HapMap database, the ways how to continue the Community engagement. We hope a educational campaign for genetics researchers, the press, and the public will be done to ensure the database and findings will be used in a right way, and be of real to benefit the Chinese.
The HapMap Project is expected eventually to benefit the health of all people. Most of the benefits however, will not be immediately apparent, and some may take years to materialize. Thus, in the very short term, the main beneficiaries will not be sample donors, their families, or their communities.
Now, as required by Chinese law, a second set of the Han Chinese samples is retained in China, China contributed a significant level of funding and will benefit directly from the Project by participating in the genotyping donors and Han Chinese. We hope that the guideline on how to control other researchers who do not follow the suggestion of ethics committees, and how to use the HapMap, the samples, and the database will work out in the near future.
References
1. NIH: The Haplotype Map Project (HapMap) and Other Research on Genetic Variations, 2003.
2. Draft of Integrating Science and Ethics in the International HapMap Project, Dec, 2003.
⑶.HUGO Ethics Committee: Statement on DNA Sampling, Control and Access，Genome Digest, Vol. 6, No. 1, March 1999, p.8-9。
⑷.UNESCO: Draft International Declaration on Human Genetic Data, Paris, 2003.
Risks, Risk Management and Remedy in ELSI – What Can We Learn from the “Drug Relief Fund” of Taiwan
- Niu Huei-Chih, LL.M., Ph.D..
Institute of Law for Science and Technology, National Tsing Hua University, Taiwan, ROC
Email: hcniu@mx.nthu.edu.tw
It is almost beyond argument that biotechnology could offer a great deal of benefits to humans as a whole; equally this modern technology may bring potentially adverse effects to human societies. Risks derived from biotechnology can be classified as social risks, scientific risks, commercial risks and risks of legislation. Uncertainty is a common feature of all these risks. Uncertainty exists not solely in terms of potential risks of application of biotechnology to human society, nature and the environment; but also as a reaction of the public to biotechnology. To address these risks in addition to uncertainty, a four-step risk management is introduced in this paper. It is believed that by means of risk assessment, risk management, adoption of necessary regulations, measures, and remedies, risks can be properly dealt with in most circumstances.
However, it is also true that a victim of risk will not gain compensation unless he/she suffered legally cognizable damages; for instance, when one party involved was proven guilty of negligence. In other words, no one should be blamed when the injury or loss were due to unforeseeable scientific risks, regardless of the degree of harm suffered by the victim. In Taiwan, the Drug Relief Act tends to address similar situations when persons harmed through the proper usage of legal pharmaceuticals receive prompt relief. It also adopts the Drug Relief Fund to administer the work of drug relief. To examine if such a fund can offer a solution to the potential risks of biotechnology, the operation of this fund will be described in detail in this paper.
Cultural Diversity-Biodiversity-Traditional Medicine Linkages in India: An Ecoethical Impact Analysis
- Abhik Gupta, Ph.D..
Department of Ecology & Environmental Science, Assam University, Silchar 788-011, INDIA
Email: agecol@
Introduction
India is a country having rich and diverse health traditions. The ayurveda, the siddha and the unani systems of medicine are backed by a large number of texts, thereby enjoying standardized theoretical as well as practical backings. These three systems may thus be regarded to constitute the classical systems of Indian medicine. They have qualified practitioners who are trained in some 100 colleges of ayurveda, 2 of siddha and 20 of unani (Balasubramanian, 2000). However, India also has an age-old folk tradition in medicine perpetuated through oral tradition by the 2500-odd endogamous communities outside the mainstream caste system and the 500-odd tribes (Malhotra, 1984). The folk medicine practitioners of these communities not only use herbal medicine, they, especially those belonging to the tribal groups, also use animal parts and products. Besides being given orally, plant roots and various animal parts are also worn as amulets and applied externally on the body of the patient. Various ritualistic treatments are also prescribed for certain diseases. While the use of many plants are common to ayurveda, siddha, unani and folk medicine systems, the latter uses a large number of plant species the use of which are not prevalent in the classical systems (Shankar et al., 2000). Furthermore, even for those plants that are used both in the classical and the folk systems, certain additional and unique uses are found in folk medicine. Again, folk medicine is not a uniform and homogenous codified system. Different tribes and ethnic groups use different plants or may have different uses for the same plant. Thus the richness of biodiversity, which made possible the medicinal use of a large number of plant or even animal species, as well as cultural diversity manifested in the form of a myriad ethnic groups, that have carved out their own unique cultural niches, have contributed significantly towards the development of the vast array of health traditions in India. The exchanges that occurred among different cultures also led to mutual enrichment of the health traditions, and this is perhaps reflected in the considerable overlap in the use of medicinal plants and animals among the different systems. However, this has also led to a situation where the intellectual property rights (IPR) issues pertaining to the use of medicinal organisms and products have become highly complicated and difficult to resolve. This paper aims to highlight the intricate linkages among biodiversity, cultural diversity and health traditions in India with special reference to its north eastern region, which is not only a biodiversity ‘hot spot’, but also a haven for cultural diversity, as it is home to a myriad tribes and other endogamous ethnic groups. Furthermore, it also attempts to address the ethical, ecological and legal intricacies in relation to IPR issues.
Biodiversity, Cultural Diversity and Traditional Medicine
India is rich in biodiversity. It has two of the world’s twenty five ‘biodiversity hotspots’ and is regarded as a megabiodiversity center. It has some 36165 (45000 according to some estimates) species of plants. Among its fauna, it is home to 840 species of annelids, 5050 species of mollusks, 60383 species of insects, crustaceans and other arthropods, 2546 species of fishes, 204 of amphibians, 1228 of birds and 372 of mammals (Kothari, 1997). A substantial part of this biodiversity is exploited by almost all the traditional systems of medicine. Of some 7500 plants used in traditional medicine, 1769 are used in ayurveda, 743 in siddha, 653 in unani and 4671 in folk medicine. Besides, the Tibetan, homoeopathy and modern systems also use many medicinal plants. Many plants in this list have common use in the different systems, while the use of many others (or their component parts) is unique to a particular system (Shankar et al., 2000). Sometimes, the same plant may find different uses in different systems.
The rich biodiversity in India is also paralleled by the equally rich cultural diversity. Besides the 2500-odd endogamous communities that are outside the caste system, there are about 500-odd tribes who largely inhabit the remote hill and foothill areas of central, west, south, and northeast India (Table 1). Each of these tribes has its own distinct culture, pharmacopoeia and worldview. Table 2 is an illustrative, but far from exhaustive list of such unique uses of medicinal plants in the folk medicine of a few North East Indian tribes (Syiem et al., 1999; Lalramnghinglova, 1999; Jamir, 1999; Marngar, 1999; Ghosh, 2000).
Table 1. Distribution of tribes in India.
|Region |Number of Tribes |
|South and west India |261* |
|Central India |272* (*many common tribes) |
|North India |32 |
|Andaman & Nicobar Islands |18 |
|North East India |222 |
|Arunachal Pradesh |20 major & 40 minor tribes |
|Assam |21 major & 35 other tribes |
|Manipur |20 major & 7 other tribes |
|Meghalaya |Khasi, Pnar, Garo & 50 others |
|Mizoram |Mizo, Hmar & 35 others |
|Nagaland |16 tribes |
|Tripura |18 major and 15 others |
Table 2. Number of plants having unique medicinal use in 5 tribes of North East India.
|Tribe and State |Number of plants used in addition to those used in Ayurveda |
|Naga (Nagaland) |Jaundice – 2 |Diabetes - 2 |
| | | |
| | | |
|Dimasa (Assam) |Jaundice - 1 |Antihelminthic - 3 |
| |Cancer - 2 | |
|Meitei (Manipur) |Gastrointestinal – 4 |Diabetes - 1 |
| |Analgesic, anti-inflammatory – 1 | |
|Khasi (Meghalaya) |Gastrointestinal – 2 |Diabetes - 2 |
| |Hypertension - 8 |Analgesic, anti-inflammatory – 1 |
| |Snake bite - 2 |Insect repellant – 1 |
| |Cancer - 1 | |
|Mizo (Mizoram) |Gastrointestinal – 7 |Cardiotonic – 1 |
| |Analgesic, anti-inflammatory - 4 |Snake bite – 2 |
| |Jaundice/hepatitis - 3 |Cancer - 1 |
The link between biodiversity, especially that of plants, and medicine was appreciated early in India. Caraka Samhita, an ancient ayurvedic text mentions in a verse that the remedies for the diseases prevalent in a given region can be found in the herbs growing naturally in that region. Again, the development of specialized branches of medicine has also often taken place in response to the biodiversity. For instance, an estimated 427 plant species are used in the treatment of snakebites, scorpion and centipede stings and similar afflictions, which are treated by specialist medicine men called Visha Vaidyas in south India and Ojhas in eastern and northeastern India. Certain tribes like the Irulas of Kerala have many antidotes for snakebites and other poisonous bites (Hafeel and Suma, 2000). Another unique group are the traditional bonesetters found in many tribal and other communities. In northeast India, especially south Assam, a group of traditional bonesetters called Khandals enjoy great reputation and have a flourishing trade in setting fractured bones. Besides splints and other mechanical supports, the bonesetters also use various herbal oils for massage and external application.
The folk medical practitioners, especially those belonging to tribal communities, also have a large number of animal parts/products in their pharmacopoeia. Table 3 lists some of the commonly used animal species in North East Indian traditional medicine. An estimated 76 species of animals are used all over India in tribal medicine (Hafeel and Suma, 2000).
Many of the animal species hunted or trapped for medicinal purposes are endangered to varying degrees at a global or national level (Table 4). Thus the demand for these animals for use in traditional medicine is an important contributing factor to their continued decimation in their natural habitats. Not only animals, in south India alone, an estimated 112 species of plants are under various degrees of threat as per the IUCN (Shankar, 1999). Therefore, unless ex-situ ‘farming’, propagation, and culture of medicinal plants and animals are immediately undertaken on a scale large enough to meet the rapidly increasing demands of the market, the traditional medicine “industry” is likely to become unsustainable and ecologically destructive.
Table 3. Animals used in traditional medicine by different North East Indian communities.
|Animal |Parts used |Disease |User Tribe |
|Bear (Melursus ursinus) |Gall bladder |G.I. tract |Naga and others |
| | |leech repellant | |
| |Fat |Rheumatism |Naga |
| |Penis |Male impotency |Naga |
|Bat |Flesh |Night blindness |Naga |
|Deer |Horn and Bone |Ear; Fever |Naga |
|Various fish and invertebrates, e.g., |Whole animal or different parts |Various diseases, such as |Various groups, especially |
|Clarias batrachus, Macrognathus | |chicken pox, high fever, |Meitei |
|aril,Channa stewartii, Monopterus spp., | |dermatitis, weakness and | |
|Brotia costula, Pila globosa, Periplaneta | |debility, eye infection, etc. | |
|Americana, Dacus sp., etc. | | | |
Table 4. Use of endangered animals in the traditional medicine of N.E. India.
|Animal |Part Used |Disease |User Community |
|Pangolin (Manis pentadactyla) |Scale, flesh |Various diseases |Naga, Hmar |
|Slow Loris (Nycticebus coucang) |Fur, skin, bone |Various diseases |Zeme Naga |
|Hoolock Gibbon (Hylobates hoolock) |Flesh |Various diseases |Dimasa, Hmar, Zeme Naga |
|Tiger (Panthera tigris); Leopard (P. pardus) |Claw and other body parts |Increasing virility and |Various tribal and |
| | |other ailments |non-tribal communities |
|Turtles and tortoises, e.g., Aspideretes gangeticus, |Flesh, eggs, carapace of |Rheumatism and gout, piles, |Various tribal and |
|A. hurum, Chitra indica, Indotestudo elongata, Cuora |softshell turtles, blood, |wounds, etc. |non-tribal communities |
|amboinensis, Pyxidea mouhati, Har-della thurjii, |etc. | | |
|Manouria emys, etc. | | | |
Cross-cultural Exchanges in Traditional Medicine
Notwithstanding the fact that it is convenient to classify and compartmentalize the Indian health traditions into distinct systems, viz., ayurveda, siddha, unani, folk, etc., the compartments are by no means watertight. Just as Hinduism, the dominant religion in India, represents the confluence of a multitude of belief systems represented by the Aryan and the Pre-Aryan communities, the health traditions have also assumed their present form and compiled (either in written or oral form) their respective pharmacopoeias through a long history of sharing of knowledge on medicine possessed by the multitude of communities. For instance, cultural and knowledge exchange between the Indo-Aryans and the autochthonous Non-Aryan (or Pre-Aryan) ethnic groups led to the enrichment of traditional knowledge contained in the various ancient texts such as the Caraka Samhita. The medicinal use of several plants such as Basella alba, Moringa oleifera, Allium cepa, A. sativum, Calotropis spp., Swertia chirata, etc., were most likely a part of the Pre-Aryan knowledge system that were subsequently assimilated in ayurveda. Similarly, both siddha and unani systems were enriched by and in turn contributed to the enrichment of ayurveda. While the Vedic texts written between c. 1500-1000 B.C. list only 289 medicinal plants, this number increased to around 650 in Caraka and Susruta Samhitas composed around 500 A.D., and further to about 1800 in various ‘Nighantus’ (ayurveda texts) that were compiled between 500 and 1900 A.D. (Shankar et al., 2000). Caraka Samhita praises the goatherds, shepherds, cowherds and forest dwellers for their extensive medicinal knowledge, thereby indicating that even the classical systems of medicine evolved and got enriched by exchanges of knowledge among the different communities (Balasubramanian, 2000).
Traditional Medicine and Intellectual Property Rights: Legal-Ethical Issues
Intellectual Property Rights (IPR) that are rights to thoughts, ideas and information regarding new inventions and processes, enable an inventor to exclude imitators from the market for a specified time period. While there is less or no ambiguity in IPR such as copyrights, industrial patents and trademarks, considerable controversies and complexities are generated when such rights are extended to living beings or technologies related to living beings (Kothari, 1997). In India, traditional medicine has both commercial and non-commercial uses. As stated earlier in this paper, a much larger number of both plant and animal species are used by folk medicine practitioners as compared to those used in codified systems like ayurveda, siddha or unani. Hence, several ethical as well as legal questions arise when products made or chemicals isolated from such plants are granted patent rights. It is also seen that when a pharmaceutical corporation screens plants for their potential medicinal properties, their job becomes much easier if they have access to the traditional knowledge that is conserved and perpetuated by the communities through oral traditions (RAFI, 1994). Even the Indian ayurvedic industry, which obtains its raw materials from local people, pays them a pittance compared to the actual value of the plants (Kothari, 1997). Furthermore, the large volume of ethnobotanical literature that is now available in India (Jain, 1997) allows any bioprospector to lay access to traditional knowledge and then collect the plants by luring local agents who are not likely to be aware of the true value of the material that they are collecting and supplying. Of the vast profits thus amassed by the industry, very few, or more often, none is reverting back to the communities that are the traditional guardians of this knowledge. The situation is further complicated by the fact that it is very difficult to identify the original source of a particular knowledge because of the sharing of information that has been taking place among communities and among the knowledgeable persons of different systems of health traditions. Furthermore, many tribes and other ethnic groups have patchy distributions over a large area, but share a fair amount of ancestral knowledge about a given plant or plants. Sharing benefits with one particular group in a given area may imply injustice to the other groups of the same tribe or community residing in other areas. For example, the Tropical Botanic Garden and Research Institute (TBGRI) of Kerala has undertaken a “benefit-sharing exercise” with the Kani tribals of Kerala for a drug developed on the basis of the knowledge, information and natural resources traditionally nurtured by the Kanis (Anuradha, 2000). However, many Kanis also live in Tamil Nadu, and hence are also the inheritors of the same knowledge base. Depriving them of the benefits, may, therefore, be looked upon as unfair. Again, the traditional healers of the Khasi tribe in Meghalaya, North East India, are known to prescribe the plant Acorus calamus for treating mental disorders (Syiem et al., 1999), while the same property is mentioned in a very ancient ayurveda text. In the event of isolation of any chemical from this plant having such a medicinal property, how could the case of benefit sharing be resolved?
There is an ongoing debate on the provisions of the TRIPS agreement vis-à-vis public health and the traditional rights of communities on medicinal knowledge. The declaration at the Doha Ministerial recognized that the exclusive rights provided by patents are an important incentive to development of new drugs. Patents provide market incentives for innovators to risk time, energy and resources to develop and bring to the market new technology. It also states that a system of patent rights for pharmaceuticals provides numerous benefits to society. However, TRIPS contains terms that allow countries some flexibility to seek compulsory
licences or parallel imports of drugs under patent. However, these provisions do not offer any solution to the question of rights of communities over their traditional knowledge in medicine.
The following ethical and legal questions naturally arise in the above context:
1. Is the patenting of life forms unethical? If so, then is the patenting of products isolated from life forms unethical too? After all, the products, known or unknown, are integral components of the said life form.
2. If a life form is known in traditional knowledge, then is patenting/registering of a GM variant of the said life form unethical, or is to be treated as a new creation, and hence ethically permissible to be patented?
3. How and to whom the benefits be transferred? The same organism may be used by different communities, and/or in standardized texts of ayurveda, siddha, unani, etc.
4. A community’s traditional knowledge on a given plant might not have been recorded in literature. Can it stake a claim subsequently, and if so, how does it claim and where?
5. A further complication arises because of the existence of the same or similar knowledge on the same organism in neighbouring countries.
In the case of endemic organisms, it is relatively easy to sort out IPR problems. But many plants are either native or naturalized in many countries. This complicates the grant of IPR. Some examples are:
Aloe vera: widely used in ayurveda and by ethnic groups in India, originally from Canary Islands. Application for US patent was made.
Adhatoda vasica: Indo-Malayan region, extensive use in ayurveda and by ethnic groups.
Ricinus communis: from Africa, widely used in Indian medicine.
Cassia fistula: China, Indo-Malayan, used in ayurveda.
Catharanthus roseus: Native of Madagascar, widely used including ayurveda.
Bear gall-bladder: in Chinese medicine and in the TK of many North East Indian tribes. Who got the knowledge from whom?
Murraya paniculata: used in Phillipines for G.I. tract afflictions, and by the Munda tribe of Central India for snake-bite.
It has been argued that patenting is an incentive for researchers to develop new remedies for the welfare of mankind. Are we justified in denying that right? At the same time, patent rights supersede and violate the ‘inherent natural rights’ of a human being to healthcare and essential medicines. Should our ethical decisions be governed by the market forces or by humanitarian concerns?
Access to Drugs in Rural India
In India, we have a paradoxical situation: WHO estimates that 65% of Indians, especially those from rural areas, are dependent on traditional medicine for treating diseases. However, large-scale habitat destruction is severely reducing medicinal plant availability. This is one of the reasons why the number of traditional healers is declining in almost all rural communities. Youth belonging to families of traditional healers are rarely interested to opt for their ancestral profession. This reluctance is also an important reason for loss of traditional knowledge. At the same time, herbal medicines and cosmetics are in high demand among the environmentally/medically conscious urban elite. These items are often prohibitively costly and can be largely accessed by the urban rich. Herbal treatment centres cropping up in cities and metropolises are exorbitantly priced, and mostly cater to the welfare of the rich. In contrast, the age-old, affordable (sometimes non-monetized) traditional healing systems in rural areas are being rapidly replaced by less qualified medical practitioners, and is catered by sub-standard, spurious or even banned drugs. Some of the banned drugs frequently prescribed by doctors in rural areas or to poor urban patients include:
1. Hydroxyquinoline – for gastrointestinal disorders
2. Clioquinal – for gastrointestinal disorders
3. Chloramphenicol – given in diarrhoea, often has fatal side effects
4. Analgin – anti-pyretic ‘pain-killer’, causes ‘aplastic anaemia’
5. Oxyphenbutazone/phenylbutazone – anti-inflammatory, can have fatal side effects
6. Anabolic steroids – can cause hormonal imbalance and various physiological problems.
Conclusions
Thus, on the one hand, habitat destruction and unsustainable harvesting of medicinal plants (and trapping/hunting of animals) pose a grave threat to biodiversity, as well as the indigenous medicinal resources in India, where many states and regions, including the North Eastern region and the other tribal areas, are progressively losing their forest cover (FSI, 1999). On the other hand, the rapid spread of consumerist philosophy and aggressive advertisement of mass-produced drugs are leading to an erosion in the traditional knowledge base, especially the folk medicinal knowledge transmitted orally. Homogenization of cultures is also contributing to a loss of faith in age-old practices that were environment-friendly. Many minor languages along with their oral knowledge are facing extinction. All these factors perhaps lead to an ecological-ethical crisis in cultural diversity, biodiversity and traditional medicine. There is an ethical vacuum as old systems are not being replaced by equally value-oriented modern ones. Unless there is a conscious attempt to fill in this ethical vacuum, no long-term goals in conserving and perpetuating culture-biodiversity-traditional knowledge can be achieved. It is also to be realized that these three aspects cannot be addressed in isolation, but warrant a holistic and pro-active, and most importantly, people-oriented approach for resolving the crisis.
References
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Biobanks, genomics and databases: a question of attribution
- Minakshi Bhardwaj, Ph.D..
CESAGen, University of Lancaster, UK
Email: m.bhardwaj@lancaster.ac.uk
Introduction
Since the sequencing of the human genome in the year 2000, attention has turned to functional genomics and the need to move beyond genes to understanding of complex interactions between genes- genes, genes- environment, genotype-phenotype. With public health becoming an important measure of quality of life in modern society and with recent interests in pharamcogenomics and nutrigenomics, the importance of genetic databases is self-evident. Although there is a consensus that databases will play a key role in future genomic research, but understanding of what constitutes a database is still limited and there are overlapping conceptions of biobanks and databases. One of the reasons of such conceptions is the multiple research opportunities in the understanding of variability in human health as individual health and also public health. The scale of hopes from biobanks is exaggerated with the possibilities of using genetic databases for epidemiological studies and increased attention to individual genetic constitution as causative agents for disease, in addition to traditionally recognized agents and encouraging ‘more prevention and less cure’ concept in public health. Hence the understanding of a population genetic make up will be important along with disease causing mechanisms related to environmental factors and lifestyles.
This paper will try to conceptualize different understandings of the biobanks and genetic databases and complexities of using genetic databases for population studies and genetic association studies pose challenges scientific and ethical challenges for the aims and scopes of biobanking.
Genetic databases and biobanks
WHO defines database as any methodical or systematic collection of data, structured in a fashion that allows accessibility to individual or collective elements of that database by electronic, manual or any other means. It is essential to note that it does not mention collections of biological materials. UNESCO’s International Declaration on human genetic data specifies the scope of genetic databases by defining human genetic data as information about heritable characteristics of individuals obtained by analysis of nucleic acids or by other means. We can interpret from this definition also that genetic databases include ‘analyzed and processed’ information from the biological samples collected for various studies. However, we can see that with scope of databases expanding, there is more inclusion in defining the human genetic research databases including collections of biological material, as defined by Australian Law Reform Commission (ALRC), the term ‘human genetic database’ may refer to many kinds of collections of genetic samples and genetic and other health information. Genetic samples contained in research collections can include a wide range of human biological materials such as extracted DNA, body fluids, cells and sections of tissue. The information in a human genetic database may include molecular genetic data, standardised clinical data, genealogical data, and information on the health, lifestyle and environment of an individual. We can say that most of the definitions about databases are context bound and defined within the aims and aspects of research under taken; with no standardised definition at international level. Differences in the definitions also reflect differences in the understanding of genetic databases and what constitutes a human genetic database.
The ‘biobanks’ as term became popular in research communities in the mid 1990s when population based studies came at the forefront of genomic research with The controversies surrounding Icelandic Health Sector database attracting considerable attention from ethical and scientific perspective. Since then a number of similar projects are initiated in different countries, including UK, Estonia, Sweden, Latvia, Canada, Newfoundland, Australia, Tonga, Singapore, Japan, China and many others. These projects are unique and distinctive for the scale of participation and collections of blood samples from hundreds and thousands of ordinary people across populations from which derived genetic information can be linked to personal medical health data, lifestyles or geneology. It is hoped that they are potential key to develop scientific understanding and therapeutic treatmetns for common multifactorial conditions, as well as determining individual or groups of people have different reactions to pharmaceutical drugs.
Either genetic databases or biobanks are not new phenomena. Clinical Genetic databases have existed for a long time carrying medical health records of various genetic conditions and also family genetic register services have been active in several countries where the health care systems are robust and providing active counseling to the registrant families. The modern genetic databases for biological and medical research have been classified into various types including research material in question, DNA, RNA, nucleic acids, polymorphism databases, for example and the genetic condition associated with it.
Traditionally biobanks are systematic collections of cells, tissues, blood samples stored for analysis and research, which could be based on phenotypic conditions of diseases and clinical traits for example, immune diseases, metabolic or neurodegenerative, cancer. We can also include blood banks, organ banks, sperm banks, and IVF banks under this umbrella.
Since the proliferation of biobanks and lack of clarity about specific research aims, new concept of human genetic research databases (HGRD) has emerged (OECD 2003). The term is used significant in several ways. The existing biobanks have been created as ‘depositories’ after a basic clinical research, as a comprehensive analyzed datasets rather the making collections prior to setting up the research aims and protocols. Also recent planned biobanks are used for both diagnostic and treatment and for general research purposes. The ‘new’ biobanks are controversial because they are more opportunistic as they are ‘deposits’ of human genetic material collected across populations and stored for ‘future’ research, without specific targets, methodological approach and insufficient ethical considerations. It can be argued that in future such deposits may be looked upon as equally important health insurance as any other present day health insurance.
HGRDs for genetic epidemiological studies
Evidently, human genetic makeup is looked upon as one of the causative agents for future functional genomics research, along with other biological agents. One of the aims of biobanks is for understanding associations between genes and the spread and clinical manifestations of an infection in population. Genetic epidemiological studies combine genetic and epidemiologic information to identify genes that influence expressions of complex human phenotypes, such as infectious disease related traits. Epidemiological information can include measured risk factors that could influence the trait under study, for example, age and intensity of infection. There are different methodologies used in genetic epidemiology, that are based on gene models using genetic markers or other methods such as sibling pair studies based on familial relationships between research participants (Abel L and Dessein AJ 1998). Genetic databases provide opportunities for such studies linking environmental factors causing a certain infectious disease in a population and genes associated with particular traits shown in a population. However there are also major obstacles in determining such correlations because of the specificity of the existing databases and use of different methodologies.
A fundamental problem with the biobanks especially with genetic epidemiological studies is in determining which and how many samples to be collected, for the research needs that may arise tomorrow. One of the other problems commonly seen in all kinds of population based association studies is the presence of undetected population structures leading to false positive or missed real effects (Marchini J et.al 2004). Hence population based studies for heterogeneous populations could significantly be problematic and the validity of such studies may be questionable when linking across gross levels of population structures. These concerns also influence the designing, interpretation and reporting of association studies and there are not any standardized methodologies used although several guidelines have been suggested. However attempts are now made to develop standardized association databases of disease classes and the unique categories of the databases, for example standardizing databases of unique genes, diseases, positive/negative association studies and several others (Becker K et.al 2004).
Need for methodological improvements in biobanks
Diagnostic biobanks, therapeutical biobanks and disease oriented research biobanks have been existing for a long time in clinical research based on biological samples from patients or donors, while the new population based research biobanks are based on biological samples (parts of) from the general population with or without disease (EU workshop 2003). Europe already has comparative advantage in the field of biobanks which could be of great value for preventive medicine, therapy, and monitoring of environmental and genetic diseases. However, despite major investments there are still major obstacles in using even existing biobanks for general public health purposes. The existing biobanks for clinical research are mixture of disease specific biobanks that are often not linked, along with differences in the methodological approaches for designing, implementing, interpreting and reporting studies. The rapid advances in bioinformatics approaches for analyzing and curating databases, biobanks and health registries challenge the need to identify new methodologies for identifying how best to cross link the technological methods with optimized access to biobanks and databases. There is also a space for improvement in practical quality control and storage systems of different kinds of biobanks parallel to the need of develop a common accreditation system for different access methods, screening and evaluation systems especially for international studies.
Future Uses of Biobanks
Adverse drug reactions are an enormous public health problem and in the UK figures show that adverse drug reactions cost between £ 2-4 billion per year. Adverse drug reactions could not only be because of toxicity of drugs but also drugs may be in effective to some people. Drugs based on genetic make up of individuals are new opportunities to explore individual’s inherited response to drugs and designing tailor made drugs to the needs of each person, rather than one type of drug for entire population. Collections of biological samples across populations will provide fundamental material to do research for genomic medicine. Pharmacogenetics refers to individual narrow differences in response to drugs metabolism based on individual genetic variations. Until now pharmaceutical industries have been focusing their efforts on pharmacogenetics research using DNA samples collected from clinical trials. The sequencing of human genome has increased our understanding of genes and gene expression and there is a growing research agendas, especially by the pharmaceutical industries to use this knowledge in drug development and how new drug may affect gene expression, usually on multiple genes, under the theme of pharamcogenomics. Pharmacogenomics is general study of all different genes that determine drug behavior, and specific allelic variations/ SNPs in population will be helpful as a diagnostic tool to predict a person’s response to drug (Berg 2004). Hence population biobanks will play a significant role in predictive genomic medicine that proposes screening healthy individuals to identify those who carry alleles that increase their susceptibility to common diseases.
Another area of popular investigation of future use of biobanks is diet and individual health. UK Department of Health White paper (2003), Our inheritance, Our Future: Realising the Potential of Genetics in the NHS states that, ‘It is hoped that it would help in better understanding gene interaction with external factors would be understood better and such information will help people with certain genetic profiles to take precautions or change habits in their daily lives; for instance to avoid certain foods, chemicals or environmental factors’. The science of nutrigenomics will provide a molecular understanding for how common dietary chemicals, i.e. nutrition affect health by altering the genetic structure or expression. It is argued that diet can be a serious risk factor for a number of diseases and diet regulated genes and their normal variants are likely to play role in the onset and progression of some chronic diseases.
There are several overlapping issues in the applications of pharmcogenomics and nutrigenomics, although both are involved in public health strategies. The practical issue of individual consultations across populations to achieve individual health targets is fundamental to such propositions. How much control an individual will have across the acquired information, along with limits to the daily choices people make for health and pleasure. Principle potential concerns of privacy and rights of people also relate to the applications of genomics for drugs and nutrition.
Complexities of Ethics
A) A public good
Whilst it can be debated that some of the issues that are raised in conducting research with human subjects in biomedicine are a universal ethical concerns and have seen great evolution in ethical and legal frameworks same evolution has not accompanied genetic databases. One of the reasons of genetic databases raising new and different ethical concerns is that in traditional medical ethics, individualism has prevailed and move to population biobanks put group interests and it has invoked principles of solidarity and benefit-sharing; conceptions of gift and global public goods (Chadwick 2004). Arguably these new ethical principles are also reflective of the individual and the group interests at stake when promoting use of biobanks and the contradictions in their applications in the governance systems and with the public perception an increasing phenomenon in regulatory and policy arenas, peoples choices as not only individuals bit also members of the different groups will be challenging for ethics as it raises a question of identity, and in the case of biobanks, a ‘relation identity’. We identify ourselves as individuals but more so we construct our identities in relation to others and the environment.
The HUGO ethics committee in its statement on Genetic databases describes databases as global public goods, defining “Global public goods are those whose scope extends worldwide, are enjoyable by all with no groups excluded, and, when consumed by one individual are not depleted for others”. In terms of ‘good’ the knowledge of human genome and its universality is a good thing, as seen in the availability of genomic databases existing as free and open knowledge in public domain, a more normative approach is seen in the HUGO statement on Benefit Sharing relating to the Human Genome, states that ‘the human genome is part of the common heritage of humanity…therefore the Human Genome Project should benefit all humanity’, implying that the human genome should be seen as a global public good. We can say that this definition implies that human genome should be preserved as it is and not altered. However, the knowledge of human genome if not ‘applied’ will not be of much use and therefore even if it is public ‘good’, as in the case of other natural resources, its value on its own as a good is debatable. Nevertheless, as information held in the genetic databases imply its usefulness as an action of public good, the availability of other resources to access to such knowledge is limited and therefore public good as a non tangible, value led entity is beyond the reach the majority and hence arguably not a public good.
B) Individual versus communitarian ethics
Retrospectively, genetic databases also raise issues of individual justice versus social justice. If we consider human genetic research databases as a common public good, it also denotes several aspects of social and communitarian justice. The notion of benefit sharing derives from the notion of distribution of benefits to the communities rather than individuals, at the same time countering tensions between individual and communitarian interests (Wilson 2004). Because population biobanks are a social phenomenon, and distribution of benefits emerging from the research outcomes of the biobanks should also be shared. However, what constitutes a benefit is a matter of consideration, given in some cases we talk about collections for future genomics research, more specifically sharing of non tangible benefits as knowledge to participants. If communities are expected to share the benefits of the research, initially there are equal demands for sharing the burdens of the society.
We can argue that participation in biobanks creates new tensions between weighing individual burden versus the benefits to the society and raises ethical concerns over infringement of individual choices and rights of people and the notion of distributive justice. Human genetic research databases created across entire population leave less choice for individual people to exercise their rights, especially when a specific genetic trait is found across population and some may not want to know about their genetic makeup.
At more methodological level, questions are raised on the procedural issues of informed consent, privacy, access and ownership rights for example. Which kind of informed consent is appropriate for human genetic research databases and the issues of re-consent for every new study undertaken. In the case of several population-based biobanks, there are also indications of using ‘opt in and opt out’ procedures for consent from individuals, developed after the controversies of Icelandic health sector database which based on the assumption that all individuals in a health care system are ‘assumed’ to give consent for the use of their genetic and medical information.
More so at global level, the concept of benefit sharing, is based on the principles of distributive justice and compensatory justice with parallel developments in the concepts of new ethical concepts of solidarity and equity. Chadwick and Berg (2001) have suggested that underlying the concept of benefit sharing is the “ethically strong ideal of equal opportunities”, which results in the “duty of those who are well off to share with the poor”. Although many big developing countries, China, India for example, are considered as ‘empowered’ in genomics research, the benefits to ordinary participants are still beyond the reach due to crude ethical and regulatory frameworks (Bhardwaj 2004), with complexities of genetic make up of communities in developing world more very often perceived as entangled to the cultural and socio-economic conditions by the west.
C) Public participation in biobanks
Public is central to the biobanks in every aspect. The success and failure of databases rely on the public participation, not only as donors of samples and personal information but also as participants in the policy frameworks. They are key to developing scientific understanding and therapeutic treatments for common multifactorial diseases. There are different discourses of ‘public involvement’ but not a universally acceptable definition. Active public involvement also based on information and knowledge provided to the public and various representations of ‘genomics’ in the public domain are also reflective of the public engagement. In the case of genetic databases, different countries have adopted different terminologies to describe public participation, gene donors, human subjects, research subjects, participants, research participants etc. These not only reflect the ambiguity of the role and limitations to public participation but also restrict the rights of the ordinary participants in exploring their roles as a ‘participant’ along with other participants such as researchers in such mega endeavors. Theoretical reflections on the public participation and public engagement have emphasized the need to make public participation as not the rights, responsibilities and obligations of ‘participants’ but more dynamic and active processes of citizen involvement (Weldon 2004). However, it is debatable how much collective and individual control can practically be possible in the governance of databases and how issues of public engagement will transform the governmentality of databases and citizen oversight.
Conclusion
The question of attribution in the case genetic databases is reflected in every aspect. Different methodological, ethical, political as well as conceptual, empirical and analytical approaches are undertaken when analyzing genetic databases with arguments in favor or against research as well as ethical considerations. This paper has not addressed all the issues surrounding databases, but proceeded with an attempt to highlight tensions, complexities and complementarities between the lines of claims in favor or against in the ethical debates around databases. Sometimes difficulties in representation of biobanks and genomics also arise due to massive scopes that lie ahead and implications of the research, as well as spontaneity of the different approaches taken for one issue.
Acknowledgments
The support of the Economic and Social Research Council (ESRC) is gratefully acknowledged. The work was part of the programme of the ESRC Centre for Economic and Social Aspects of Genomics (CESAGen).
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13. Wilson S. (2004). Population Biobanks and social justice: Commercial or Communitarian models? TRAMES, Vol. 8, No 1-2, 2004.
The Ethical Justification of Placebo Trials: The Continuing Challenge
- Alireza Bagheri, M.D..
Dept. of Neurology, Inst. of Clinical Medicine
University of Tsukuba, Tsukuba, 305-8575, Japan/ IRAN
Email:bagheria@
Introduction
Biomedical researches often involve fundamental conflicts between ethical principles. Making a balance and satisfying all principles, i.e. conducting scientifically sound research, acting in the patient’s best interest, respecting individual autonomy, as well as observing distributive justice, are often the most difficult tasks in conducting ethically sound clinical trials. It becomes even more complicated when a clinical trials are sponsored or conducted by a developed country but carried out in a developing country.(Shapiro and Meslin 2001).
Since the 1990s a series of placebo controlled trials which aimed to prevent prenatal transmission of HIV has provoked one of the most intense controversies in international research ethics. Despite the existence of an approved effective drug, (long-course zidovudine -AZT), the placebo controlled trials of short-course zidovudine, were designed to determine whether relatively affordable courses of zidovudine given to pregnant women would reduce the risk of mother-to-child transmission.
While few would argue against the use of placebo in drug trials where there are no effective treatments, the bulk of papers have criticized the use of placebo controls when an effective therapy exists (Lurie and Wolfe 1997). The question: whether placebo-controlled trials can be ethically justified in conditions for which proven effective treatments exist has divided experts into two groups: one group supports placebo controlled trial, even if there is a proven effective therapy, another group is against it. Both groups claim that their argument is based on ethical considerations and also believe that justice lies on the side they support.
Where the root of the problem lies?
In a group of clinical trials designed to compare a new preventative/diagnostic/ therapeutic method, at least two human subject groups are needed. The new treatment tests in one group and second group should receive either well-known effective therapy or a placebo. Obviously patients in the placebo group, may receive nothing and remain untreated. In fact such a clinical trials are designed to answer two possible questions: if there has already been an effective therapy then the question would be: whether the new method is as good as, the accepted effective treatment? and if such an effective therapy has not yet been developed, the question is: whether the new method is better than nothing? The controversy is starts at this point: a group claims that if an effective therapy exists then a new therapy should be tested against it, and there is no need to use a placebo arm where patients receive “no treatment”. (Freedman, Glass and Weijer 1996 a; 1996b) In other words the research question is whether new drug is as good as the accepted effective drug and researchers are not allowed to deprive subjects from the current existing treatment.
Incapability of international guidelines to solve the problem
The international guidelines are also not quite clear on the issue. For example, the declaration of Helsinki which was revised in 2000, took the position of absolute prohibition of placebo controls to test the efficacy of new treatment when proven effective treatment exists for a given condition. However, it came under criticism and the backlash to those critiques caused the World Medical Association to issue a "Note of Clarification" concerning the stance of the Declaration of Helsinki on the use of placebo controls (World Medical Association 2001). This statement marks a fundamental departure from the revision of October 2000. The "Note of Clarification" states that despite the availability of proven effective treatment, placebo-controlled trials may be ethically justifiable in two circumstances: (1) Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method, or (2) Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm. As it has been noted these conditions are subjects to arbitrary interpretation.
Arguments for and against placebo controlled trials
Earlier it has been mentioned that the debate on the use of placebo has been heated by the trials on short-course AZT regime and arguments which criticized PCTs to build their reasons upon the nature and process of this trials. Therefore, it seems necessary to explain AZT trial in more detail. The researches have shown that long-course AZT, a well-known antiviral drug effective against HIV can reduce the vertical transmission of HIV from 25% to 8% (Connor 1994). This current effective regimen consists of administering of AZT to the pregnant mother for 28 weeks during her pregnancy, intravenous administration during delivery, and six weeks of AZT to the baby after birth. While this effective treatment (long term AZT) exists in developed countries, the problem is that: the majority of HIV- infected women in resource-poor countries do not have access to such an effective drug (the 076 regime). Therefore the ethical questions arise that, are researchers allowed to conduct a trial which the current therapy will be ignored for some patient in placebo group? In the other words, is it ethically sound to conduct a placebo controlled trials to find out a new drug for the same disease but in a different geographical and economical condition just because the current therapy is so expensive that it is not affordable for the people in this area. This argument has divided the scientific as well as the ethics community into two groups, critics and supporters.
In fact, we face a situation where on the one hand, this well known effective therapy is not affordable in some countries because of financial problems, lack of infrastructure in their health systems, and on the other hand the use of placebos in evaluating other new drug is inevitable.
How defenders support PCT’s
The ethical reasoning underlying support of placebo controls in randomized clinical trials when proven effective treatments exist are as follow:
1- Physician-investigators obligation: F. Miller and H. Brody argue that: the obligations of physician-investigators are not the same as the obligations of physicians in routine clinical practice. Investigators have a duty to avoid exploiting research participants, not a therapeutic duty to provide optimal medical care. (Miller and Brody 2002).
It is worthwhile to mention that in a counter argument Robert Veatch notes that the relationship and the duty of the physician-investigator does not change but what changes is that the patient now has an additional reason to decline the offer of standard treatment in favor of randomization: he or she may want to make a modest contribution to science. (Veatch 2002)
2- Risk/Benefits assessment: because the subjects in placebo group are not being exposed to excessive risks for the sake of scientific investigation this argument claims that it is not unethical to use placebo arms.
3- Modest Contribution to science based on informed consent and patients’ voluntariness and altruism: based on this argument enrolling patient volunteers in placebo-controlled trials that withhold proven effective treatment is not fundamentally unethical as long as patients are not being exploited. They understand that they are volunteering to participate in an experiment rather than receiving personalized medical care directed at their best interests. (Veatch 2002, Appelbaum 2000)
4- Defenders say that women in the trial who receive placebo are not being made worse off than they would be if they were not in the trial at all. ( Levine 1998)
5- Failure to conduct a PCTs. is unethical. After giving some example Peter Cohen argues that the history demonstrates that a treatment can be universally held to be correct despite its being inefficacious or even harmful because the early studies were uncontrolled. (Cohen 2002).
How opponents criticize PCT’s
The opponent’s stance is that placebo-controlled trials are unethical whenever they are used to evaluate new treatments for conditions when proven effective treatments exist. The following lists the most well-known reasons.
1- Freedman and his colleagues have developed two arguments in support of this ethical stance: First, the use of placebo-controlled trials in the face of proven effective treatments violates the physician's therapeutic obligation to offer optimal medical care to patients. Physicians should promote the medical best interests of patients by offering optimal medical care, while Placebo controls in this situation are contrary to the medical best interests of patients. Second is that testing new treatments against placebo when proven effective treatments exist lacks scientific and clinical merit. (Freedman 1987; 1990; Freedman, Glass, and Weijer 1996a; 1996b).
2-Risk exposure vs offering treatment. In clinical trials risks of prescribed treatments are justified by the potential therapeutic benefits to patients but subjects in a placebo, forgo proven effective treatment and accordingly, they are exposed to risks associated with a lack of treatment that are not justified by potential medical benefits.
3- When proven effective treatments exist, there is no scientific or clinical value in testing a novel treatment against placebo (Rothman and Michels 1994). Instead, we want to know whether the new treatment is as good as or better than standard therapy, not whether it is better than "nothing" or no treatment.
4- Clinical Equipoise. When experts in the clinical community are uncertain or in a state of disagreement about whether the new treatment is as good as or better than the standard therapy, this state of uncertainty in the clinical community is known as "clinical equipoise" (Freedman 1987). Use of placebo controls in the face of proven effective treatment violates clinical equipoise because it is already known that the placebo is inferior to standard treatment.
5- Opponents of placebo-controlled trials contend that reference to the "standard of care" in developing countries to justify placebo-controlled trials is ethically suspect. Because when people receive no treatment at all, it means that there is no "standard" of care. (Macklin 2001)
As we see it is interesting that the reasons raised by two groups, are the same but their different interpretations have divided them into two groups of opponents and defenders.
However Robert Veatch argues that the controversy has erupted over placebo-controlled trials because opponents of such trials fail to acknowledge that subjects should be permitted to take small risks for the benefit of science, while defenders of such controls often fail to emphasize adequately that their claims only apply to small-risk cases. (Veatch 2002).
Local conditions argument
This argument based on the following facts intends to show that in some critical conditions PCTs can be ethically justifiable.
1- Current situation on the ground in poor resource countries. Devastated health infrastructure in many developing countries, and lack of expertise along with economical crisis do not allow them to deal with an emerged health problem like AIDS and they can not resolve their health problems alone.
2- Urgent and desperate need to receive treatment. Not to be forgotten that AIDS kills many patients in Africa every day and only in Sub-Saharan between 25 and 28 million people are living with HIV/AIDS (UNAIDS 2003).
3- Unavailability of the new therapy despite its existence somewhere else.
Regarding PCTs. there are two ethical judgments so far: First, PCTs are ethically sound if no proven effective therapy exists and the second is that PCTs are unethical if proven effective therapy exists. Therefore our ethical judgment depends on the existence and nonexistence of an approved effective therapy. Let us focus on this word “existence”: No doubt that the rationale behind this judgment which makes it unethical to have a placebo arm in clinical research is the existence as well as availability/affordability (which means a therapy not only exist but also patients have an access and can purchase it) and not just the existence of the drug somewhere else in the world. However the supporters of placebo controls should emphasize on the local availability/affordability instead of a mere existence of the therapy somewhere else in the world. For example since the 076 regime cannot be implemented in developing countries ( De Zulueta 2001), the relevant research question is whether another regime (appropriate to the needs and resources of the host country) is better than nothing, that is only answerable through a placebo controlled trial.
Therefore if the existence of a therapy is not evacuated in terms of its availability/affordability, its existence makes no sense and its mere existence has no credibility. For example, we may not have a food shortage in the world in general, but because of unjust distribution, people are suffering from famine in some regions, while, of course, an excess food exist in other regions. The question is: Does the existence of food somewhere, makes sense for those people who are dying of famine?
Conclusion
There is no consensus on the use of placebo arm in clinical trials when an effective therapy exists. The local argument allows us to establish our ethical judgment based on availability/affordability of a therapy instead of the mere existence of it. Therefore if we establish the ethical standard and our moral reasoning based on availability/affordability instead of the mere existence of a therapy in the world, conducting a PCT to find a new treatment which surely can be available for poor people, would be an ethically sound practice. It should be stressed that this approach should not be generalized and a case by case evaluation is needed and precautionary measures should be taken to avoid exploitation.
References
Cohen Peter J., 2002, Failure to Conduct a Placebo-Controlled Trial May Be Unethical, The American Journal of Bioethics Vol. 2, No. 2. p:24.
Connor E.M. et all, 1994, of Maternal-infant Transmission of Human Immuno-deficience Virus Type 1 With Zidovudine Treatment, New England Journal of Medicine. 331, pp: 1173-1180.
Freedman B., 1987, Equipoise and the Ethical of Clinical Research, New England Journal of Medicine 317, pp: 141-45
Freedman B, K.C. Glass, and Weijer C., 1996 a and b , Placebo Orthodoxy in Clinical Research I and II: Empirical and Methodological Myths, Journal of Law, Medicine and Ethics, 24:243-59.
Levine, Robert. 1998, Placebo and HIV: Lessons Learned. Hastings Center Reports 28 (6), pp: 33-48.
Lurie P., and Wolfe S M., 1997, Unethical Trials of Interventions to Reduce Prenatal Transmission of the Human Immunodeficiency Virus in Developing Countries, New England Journal of Medicine 337, pp: 853-856.
Macklin, Ruth. 2001. After Helsinki: Unresolved Issues in International Research. Kennedy Institute Ethics Journal Vol.11 No.1, 17-36.
Miller Franklin G, Brody H., 2002, What Makes Placebo-Controlled Trials Unethical? The American Journal of Bioethics Vol. 2, No. 2. pp 3-9.
Paquita De Zulueta 2001, Randomized Placebo Controlled Trials and HIV- Infected Pregnant Women in Developing Countries. Ethical Imperialism or Unethical exploitation? Bioethics Vol.15, No. 4, 289-311
Rothman K., Michels K. B., 1994, The Continuing Unethical Use of Placebo Controls, New England Journal of Medicine 331, 394-98.
Shapiro Harold T. and Meslin Eric M. 2001. Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries.N. Engl J Med, Vol. 345, No.2, 139-142.
The World Medical Association, 2000, The Declaration of Helsinki, , 52nd General Assembly, Edinburgh, Scotland, Available at:
UNAIDS/WHO – Joint United Nations Programme on HIV/AIDS
AIDS epidemic update: December 2003, Geneva – Switzerland, 2003.
Veatch Robert M, 2002, Subject indifference and the Justification of Placebo-Controlled Trials, The American Journal of Bioethics Vol. 2, No. 2. pp :12-13.
Weijer Charles, 2002, When Argument Fails. The American Journal of Bioethics Vol. 2, No. 2. pp: 10-11.
Similarity and Difference Between Japan and Korea in the Debate on Bioethics
- Lee Sung Kyu.
Inha University, SOUTH KOREA
Email: seiryu@
Korea and Japan show considerable difference in their process of discussion and legislation of bioethics. Compared with the Japanese situation, for example, the rivalry between governmental ministries to take the initiative in providing legislation, the fierce confrontation among scientific, religious and civil circles, and the consequent delay to enact the legislation bill on bioethics are Korean characteristics. In Japan, the government is taking the initiative in dealing with bioethical problems.
However, these two countries are eventually arriving at almost the same conclusions in the most important aspects of bioethics. On various aspects in bioethical argument, like human cloning, human embryonic cloning by means of somatic cell nuclear transfer[therapeutic cloning], human stem cell research, cross-species nuclear transfer (or transplantation), organ transplantation, and brain death, etc., the two countries have arrived at the strikingly similar conclusions.
First I will investigate mainly the process toward establishing the bill of the Basic Law on Bioethics and its content, which had been sent to National Assembly to be soon enacted as a law. Centering on the legislation endeavor, I will analyze the Korean present situation and characteristics in the debates of bioethics. Next I will identify the National Bioethics Committee of Japan. To know the characteristics of bioethical debate and the consequent legal enactment in Japan, I believe, it is important to understand first of all the structure and power of the Committee. In this paper, I will concentrate on the endeavors toward legislation of bioethics both in Japan and Korea.
Euthanasia is Under Discussion in Korea
- Park So Young, Jee Young Hyun and Choi Hee Son.
Student, Bioethic course MA, Catholic University of Korea, SOUTH KOREA
1. Introduction: Necessity and objective of the study and a method of the study
Recently in Korea, one father (J) turned off the switch of the artificial respiratory machine attached to his daughter on purpose because he couldn’t afford to pay for her hospital bill. For eight years, he (J) had been taking care of his paralyzed 20-year old daughter who suffered from Cervical Dislocation Syndrome. J’s daughter was conscious but couldn’t breathe by herself, and she depended on the artificial respiratory machine. She had to be hospitalized for nearly the entire year except for two months of family care. She was under the worst circumstances but never lost her hope for her life. However, J’s financial problems led him to take his daughter’s life.
The development of medicine is contributed to many parts of human life from birth to death. This contributed to human life can be divided two parts - a participation in the beginning of a life and a participation in the end of a life. Brain death and heart attack belong to the participation in the end of a life. In Korea, this kind of participation has been avoided although it was already a clinical reality which can't be avoided. Through putting a law of a transplant of organs in operation, brain death is approved passively, but a study about euthanasia has not performed actively. As the quality of life and the right of patients become more and more important, this study this kind of study and discussion should be settled without delay.
But in Korea, there is little study and discussion about euthanasia and it is hard to find examples of euthanasia. In a body, we will keep these points about euthanasia in view.
1) To analyze some 'passive by euthanasia' cases and study an ethical significance in those cases.
2) To find out an understanding on euthanasia of Korean.
3) The opinion of Catholic Church on euthanasia.
2. Case study Example) A father turned off an artificial respiratory machine of a daughter
This case is an example of non-voluntary and involuntary euthanasia. It reveals some problems of the reality of medical care, an absence of social morality and a poor social medicare system. Through this case, we will try to approach some discussions of euthanasia in Korea, not for the purpose of theoretical problem solving but to look for solutions to complicated ethical problems and decision-making that we might face in the realities of life.
In October of 2003, Jeon (Age of 49) switched off an artificial respiratory machine of his daughter which was the only lifeline for the daughter who was an invalid for life. An arrest of warrant was issued for Jeon's arrest.
Jeon's daughter had 'Cervical Dislocation Syndrome' (Neck pain is common in the general population and even more common in a chronic pain management practice)
It started to show some signs when she was 5th grade of elementary school and broke out when she became 15 years old. And her family's economic distress had begun. She remained conscious although she couldn't move by herself and she could communicate with other people by opening her mouth slightly also she could chew and eat her food by herself. She had to live with an artificial respiratory machine after she had Pulmonary embolism as a complication but she had a strong will to live. Her family could buy an artificial respiratory machine from a donation from the TV audience of a broadcasting station and doctors from 'S' hospital.
Jeon visited many hospitals and hospitals of Chinese medicine through all areas of Korea with his daughter when the disease started to attack to cure the daughter. And he got huge bills from hospitals. Finally he was indebted for about 200 million won because of bills of hospitals. He made a living by a taxi driver but recently he lost his job.
Analysis of the case and ethical examination
This case is a 'passive and compulsive by euthanasia' that a patient was killed regardless of her own opinion. This was not euthanasia which was performed by a doctor or medical experts but a guardian of a patient switched off an artificial respiratory machine of the patient by compulsion to kill the patient, therefore it is 'passive euthanasia'.
The reason why this case is important is because the patient remained conscious, she could express her own thoughts even though it was very slight and she had a will to live. But a father who had to be a protector of the patient committed a 'murder by euthanasia' by reason of financial difficulties without thinking of the dignity of the patient's life.
This case went to the Court as a name of a 'crime by a murder' and it was focused on a judgement by criminal law but there was no medical and ethical judgement first. Although the patient had little possibility to be healed, she wanted to live very strongly. Therefore it runs counter to the autonomy of the patient and the dignity of the life. In other words, it is passive and compulsive euthanasia, which is unacceptable by ethical, legal, and medical point.
Table 1: Demographic features
Q1) The question about the range of euthanasia (Classified by sex, age, Religion, Educational level, financial ability (economic power), and occupation)
3. Understanding about Euthanasia of Korean (People)
In Korea, many cases of 'passive by euthanasia' due to shortage of social and medical system occur. Furthermore many people perform 'passive euthanasia' without showing to the public. Therefore we will find out the understanding about euthanasia of Korean people and find reasons and solutions to these euthanasia cases in Korea. We surveyed 479 persons more than high-school students who live in Seoul and Kyeong-ki area, from May to July of 2000.
There was no special consistency in the result for the question about factors which can affect the understanding about euthanasia. But some factors which influenced highly were age, financial ability and educational level (Table 1).
The questions about 'legislation of euthanasia' and 'the range of approval' used the definitions:
*Active euthanasia : Intentionally causing a person's death by performing an action such as by giving a lethal injection.
*Passive euthanasia : Intentionally causing death by not providing necessary and ordinary medical cardiopulmonary resuscitation(CPR), care such as Endotracheal intubation, Antineoplastic drug therapy.
Overall, 304 people (74%) answered that they thought the legislation of euthanasia is necessary, and for the range of approval, 156 people (38%) answered active euthanasia can be approved and 234 people (57%) answered that passive euthanasia can be approved. The most common reason why people supported euthanasia was pain and the most common reason why people objected euthanasia was the dignity of human life (Table 2).
Table 2: Q3) The question about a reason to support or to object to euthanasia.
According to the data, over 70% of respondents answered the legislation of euthanasia is necessary. And according to a survey to medical specialists in Korea, 76% of respondents answered the legislation of euthanasia is necessary. And in medical reality doctors make negative positions to meaningless medical examination and treatment. For the range of approval of euthanasia, more people supported 'passive euthanasia' other than 'active euthanasia'. There was no special consistency in the result for the question about factors which can affect the understanding about euthanasia. But some factors which influenced highly were age, financial ability and educational level.
The most common reason why people supported euthanasia was pain and the most common reason why people objected euthanasia was the dignity of human life.
In addition to these results, there was another survey whose result said that the doctors and the guardians of patients should take the most important roles in a decision whether the patient should get medical examination and treatment continuously or not. This can be because of the absence of expressing their own opinions for patients but basically it shows that doctors respect opinions of patients' guardians who are responsible for the bill of hospital. This means Korean medical reality is still remaining undeveloped in ethical point.
Euthanasia problems cannot be concluded just positively or negatively but people tend to think about euthanasia positively. And we should study legislation and systems of euthanasia fairly.
3. The opinion of Catholic Church over Euthanasia
In Catholic church, we think that a life of a human being is a gift from God and we believe that human being is called by God to preserve one's life well. Therefore, taking a person's life is committing a serious crime and it is an invasion of constitutional rights which is against God's will with no exception. And all men have duties to live as God had planned. That life only can be completed in an eternal life from God but it is already given to individual as a gift which should be fruited on earth. Also leading oneself to the death on purpose or committing a suicide is unjust as a murder. Because these actions by people are obviously against to God's sovereignty and plan of love.
Also, providing a food and water which is basic for maintaining a life always should be done, even to a long-term human vegetable patient. Providing a food and water is obviously differ from medical care. Medical care is for healing of illness but providing a food and water is concerned with a maintenance of life and the dignity of a patient. Therefore quitting to provide a basic food and water to a patient is always wrong morally. Because that led a patient to the death consequently.
In modern society, there are some people who think euthanasia which can be a request to die from a patient who is suffer from a severe pain for a long time is good for patient himself or herself and also good for other people around the patient and it also coincide with the dignity of human life. But in catholic church, murder of any people - who is old, young, suffering from a severe pain or dying- can't be accepted without exception. Furthermore no one can request an action of murder and no one can agree on that kind of action. That is a violation of God's law, an insult to the dignity of human life, a crime contrary to human life and an attack to human nature. Some people talk about 'the right to die' but that doesn't mean a right to obtain a death by oneself or by other people. That does mean a right to die peacefully with dignity as a Christian.
In a teaching from Catholic church, pain especially pain at the very last moment of life takes special part in God's plan for salvation. Death can't be avoided but is an existing and at the same time death opens a door to an eternal life. Therefore, without advancing the time of death, we should accept a death with a responsibility and a dignity.
Reflections on the Rights of Nature in Humankind in Public Health Decisions in Developing Countries
- Jayapaul Azariah, Ph.D..
Founder President, All India Bioethics Association,
New No 4, 8th Lane, Indiranagar, Chennai 600 020, INDIA
Email:jazariah@
There are two main sectors that can contribute to social development. They are the education sector and the health sector. Education and health are the two wings of the constitutional guarantee for the right to life. Emphasis has been given to the concepts of “Education for all” and “Health for all”. Deprivation of these two basic sectors will result in poverty of all kinds. Recently, the Supreme Court of India emphasized the need to develop and to introduce, in centers of higher education, curricula in environment sciences so as to create awareness on environmental problems. Poverty leads to environmental degradation and vise versa. Three case studies on the poverty of the environment have been presented: namely (i) the death of the river Cooum; development of the Metropolitan Rapid Transit System (MRTS) in the very heart of the Buckingham Canal system (ii) deprivation of the livelihood of Tirupur, the Manchester of India and (iii) the decadence of the Pulicat Lake ecosystem and the fisherman community.
The paper outlines the harmful effects to health due to environmental pollution and denying the rights of nature. An emphasis is placed on achieving an eco-ethical balance between the pace of development and harmony in nature. The life style of Indians is changing. The two business sectors that are growing very fast are the “Fast Food’ hotel industry and the hospitals managed by the private sector. The paper lists the current concerns on disease resurgence and lists the shortcomings in the containment of diseases. Any imbalance between anthropocentric development and the health of nature is a hot bed of crisis.
Earth Our One Home
A biosphere is understood to be the globe (sphere) in which there is life and consequently the presence of water. It there is no water then there could be no life and this sphere could not sustain life. Therefore, a biosphere is one, which can sustain life by utilizing water. In this very vast universe there is only one biosphere, which is our planet earth. Our home earth is the first. The moon is very beautiful to look at. But it is a dead sphere. There is no water in it, which could support life. If there is only one planet, which could support life then it is our human responsibility to keep it from dying or from destruction. This biosphere, which is the Earth, is our only one home; if we loose it or make it inhabitable then we do not have another home to move in. ‘Earth First’ emphasizes that the life and health of the biosphere should be maintained at any cost.
As early as 1802 a German physician Gottfried Reinhold considered differently of the earth, our biosphere. He construed the biosphere as a living entity, a concept reiterated by the early Vedic culture in India as well as by the modern concept of GAIA by Prof. James Lovelock. In 1869, a German biologist Ernest Haeckel coined the word Ecology, deriving the word from a Greek word “OIKOS ”, meaning a dwelling place. From this Greek root word the disciplines like Ecology, Economic, and Ecumenism were derived (Azariah, 2002). The results of the industrial revolution were felt in the 18th century. A materialistic view of life was ushered in as a way of life. The traditional God believing mindset of western civilization was questioned in the year 1859 by the publication of the “Origin of Species” by Charles Darwin. The birth of Darwinism brought in the divide of the concept of “fit” and the “unfit” organism of the biosphere. The latter has not “right” to live on this earth and the fittest could only populate the earth! In my opinion the synergic effect of the onset of materialism and a lifestyle loosing the spiritual value of the biosphere strengthen the view of Aristotle who said “ Plants exist to give food to animals and animals to give food to man – domestic animals for their use and food, wild ones, in most cases, if not in all, furnish food and other conveniences, such as clothing and various tools. Since nature makes nothing purposeless or in vain, all animals much have been made by nature, for the sake of men” (Aristotle, Politics. 1256). The view of Darwin denies the “rights” of unfit-organisms any place in the unfolding of life. At the same time, the materialistic view of western civilization denied the “rights” of mother (living) earth. This was reflected in the significant change in the usage of phrases like “living beings” to “living things”, 1994). What our forefathers safeguarded for 4000 years, namely the living nature of nature was set on the road to exploitation.
Right vs. Rights
At this juncture, the early prophet of ecology, Aldo Leopold used the life giving words such as “ conservation ethics” (1933) and “land ethics”(1949). He used the words “right” and “wrong”. His usage was on the basis of a moral position. He said “a thing is right when it tends to preserve the integrity, stability and beauty of the biotic community”. He also said that a thing is wrong when it tends otherwise. Leopold’s concept of right and wrong indicated the moral position of human beings and his concept of conservation ethics and land ethics stood for the legal position of the earth – the rights of the earth i.e. its legitimate privilege to enjoy the freedom to live and free from human oppression. As bioethicists, we stand for the position “Right and Rights” and not “Rights Vs Rights. The later is a confrontationist position.
Three approaches
How do we maintain the right position which safe guards of the rights of the helpless plants and animals (nature). The ancient Indian forefathers developed a cosmocentric view of life in which the life of plants and animals were given a very important position in their social life and they were viewed as very important component of nature – though not equal to human life. In the current knowledge-society such a position would be termed as a biocentric view of life. Respect to the laws of ecology and implementation of human based ecological regulation is ecocentric view of the biosphere. All these two positions in a cosmocentric approach is non-anthropocentric view of life. The third approach is purely human centered and hence it is anthropocentric, which does not give the legitimate rights to non-human organisms. It subscribes to the Aristotle’s view of life – nature for the sake of men”.
The Vedic Conflict and Catholic Rights
In the Vedic culture, the legitimate rights of plants and animals were maintained. But they had to resolve the conflict of interests if they wanted to restore one hundred per cent rights to non-human organisms, which could be seen in the following extract`. The Vedic culture extends far back in history to about 3000-4000 BC. They followed a principle of liberal bioethics and conferred catholic rights to plants. “The special group of Vedic mantras dealing with the plants are known as oshadi or vanspati suktra or hymn pertaining to plants. These are chanted by the Vedic seers for the health and well being of plants. The enlightened seers looked towards the plants with great love, awe and respect. The plants are regarded as having divine, curative and healing powers. The seers seek humble permission of a plant before harvesting or cutting even a leaf from it fro reemployment in herbal combinations…. According to the Vedic method of farming, all agricultural operations, like sowing, tilling and ploughing are ordained to be either commenced or accompanied by Uajnja or chanting of Mantras. The harvesting of fields is accompanied by Yajna in which the first farm produce is offered into five…The Rishies express their feeling of Ahimsa towards the plants and pray ‘ Oh! Ye plants, shoot forth in hundredfold leaves as I cut your leaf for curing human diseases. If you prosper, we men will grow in thousand fold “. (Rajimwale, 1994, p.1).
Such a practice may appear to be ‘biocentric’, giving one hundred percent rights to plants. But the catch is found in ascribing benefits to plants and human beings. For the former it is only ‘hundred fold’ and for the latter it is one thousand fold’. Although on the periphery it may look like biocentric but in the core it is essentially anthropocentric. The bioethical dilemma is resolved by providing a balance in their consideration.
The Tamil culture which also dates back to Vedic period has numerous instances where kings have given off their personal comforts for the benefit of plants and animals. King Pari left his chariot as a support for a plant-climber. King Chivi Chakravarthi was willing to give equal amount of his flesh for the release of a captive bird! All these instances recognize the legitimate rights of plants and animals. Their heritage culture recognized both intrinsic and instrumental values. Rolston (1989) enumerated about 10 different values in nature, which indicates their individual biotic rights as well as instrumental rights. The biotic value that predominates the list is the economic rights. If a natural substance is of value to human life support system that it has economic as well as human life support value. Such a position is anthropocentric and leads to exploitation, which denies their biotic rights.
As early as 1973, the concern to implement the rights of nature started with a Norwegian Philosopher, Dr. Arne Naess, who distinguished two types of ecological thought. Dr. Naess defined ‘Shallow Ecology’ as “fight against pollution and resource depletion, with the central objective: The health and affluence of people in the developed countries”. Whereas “Deep Ecology’ denotes the normative, ecophilosophical insight that formed the motivating inner power that is inspired and fortified in part by our experience as humans in nature and is part by ecological knowledge. It is essentially ecocentric (centered around ecological principles) in its objectives that are based on the self-realization of humans as one of myriad self-realizing beings as well as self-identification.
Experiential knowledge, as human beings in Nature, with self –identification and self-realization is Ecosophy. We want to live in tune with nature! Drengson (1990) paraphrased “´ecosophy’ for humans means ecological wisdom, which is not just discursive knowledge, but a state of harmonious relationship with Nature. The Earth has wisdom, and each species has a wisdom peculiar to it, which is exemplified in continued flourishing, beyond bare survival. “Flourish” means in optimal state of self-fulfillment and self-raliza5tion… Ecosophy is the wisdom of dwelling in a place and it is also the wisdom to dwell in a place harmoniously” (pp 101-102). Such a philosophical perspective implies that the very presence of all the ecological components, by itself, is value laden. But all components are natural elements, with no value based on their usefulness to human beings. They become useful when humans create a need of/for them! The irony of the situation is that human beings are not needed at all for the well being and continued existence of non-human life in this biosphere. Even if no human is present in this biosphere then the biodiversity will still continue to flourish and sustain itself. On the other hand if the microorganisms are absent from this biosphere then human life will die off in the course of time. Because the waste products and human and non-human excreta will continue to pile up since there will be no microbial decomposition of the waste products and dead bodies. Nevertheless, human beings occupy a dominant position in the ecosystem. It is we, the human beings, who pollute the biosphere and hence we should learn to manage the actions of human beings.
In the opinion of the author of this paper, all anthropocentric developmental activities are destructive to the biotic rights of non-human organisms, including the land and the habitats. Since no ecosystem is found in ‘a ready to use stage’ a given ecosystem has to be developed i.e. it should be made better. Once a given biotic entity assumes human life support value it becomes a economic commodity. One action leads to another. Commodifiction of a natural resource provides economic rights to a section of humanity where the resource is found. Then the question of ownership rights and use rights emerge. Hence anthropocentric development has many facets. In this context, it is worth mentioning that in 1974 in the Sixth Special Session of the UN General Assembly a declaration on the concept of New International Economic Order (NIEO) was proclaimed together with a detailed Program of Action on the Establishment of NIEO. The dream of NIEO is the fulfillment of social development. This concept was sponsored by the USA in 1990 and paved the way for the consolidation of Multi National Corporations. International Monetary Institutions provided the needed finance for developmental activities in developed countries. Not all developmental activities curtail the rights of nature. But some do.
The constitution of India provides a guarantee for the rights to life. Human social life is developed through education. Education for the sustainability of the environment as well as to upgrade the quality of life through improved health services. Recently, the Supreme Court of India emphasized the need to develop and introduce curricula in Environment Sciences in centers of higher education so as to create awareness on environmental problems. Emphasis has been given to the concepts of “Education for all” and “Health of all”. In India, the Kerala State has achieved one hundred per cent education and the health status of the people is of higher dimension. Deprivation of these two basic sectors will result in poverty of all kinds. Poverty leads to environmental degradation and vise versa
In this paper three case studies on the poverty of the environment have been presented in order to emphasize that environmental poverty breeds human misery and poverty and vise versa. The first case deals with the degradation of the River Cooum in Chennai. Any decline in the biodiversity is an index of sustainability. The urban ecosystem of Chennai is an example of an unplanned city. Sewage is freely let into the waterways; as a result, the dissolved oxygen content of the water is reduced. Hydrological work in the river system indicated that except in the river mouth area where it is connected to the open coast, appreciable oxygen levels were recorded. In all other places in the river system there was no dissolved oxygen. Such an a condition has an impact on the fauna of the present system. It has been documented that the fish population showed a steady decline over the past sixty years. During the year 1949 there were 49 different species of fishes in the river, In 1975-79 the biotic number was reduced by half (21 species of fishes). Currently there is no fish at all (Azariah and Azariah 1987). On the other hand the bacterial Most Probable Number (MPN) index was very high. It was 24, million bacteria in 100 ml of water, which showed an increase to 34 million in 100 ml during 1995. Even if we purify the river water with 99.9% of technological efficiency even then there will be a MPN index of 34,200 bacteria per 100 ml of water. The river for all practical purposes is dead. Such a condition is ideal for the entry of Multi National Company with a load from an International Monetary Funding Agency. In this connection mention must be made of the recent anthropocentic developmental activity in another water ways of Chennai, namely the Buckingham Canal were a Metropolitan Rapid Transit System (MRTS) is being built. The MRTS concrete structures are placed right on the very heart of the Buckingham Canal system. When knowledge able engineers are asked about the reason, it was said that an International Bank gives the needed money as a loan and there is no other place to build such a transport system. This waterway is the main conduit for draining the storm water during the monsoon days. Roughly once in every ten years there is flooding of water in the city due to heavy monsoon rains. The wisdom of such an anthropocentric activity will be tested in the next flooding season.
The town of Tiruppur has been nick named as the Manchester of India due to its cotton knitwear and T-shirt industry. The first hosiery industry was established in Tiruppur in 1930. It supplies 90% of Indian Cotton knit wear and earns about 4000 crores of rupees. It had about 713 water intensive textile complexes with 526 dyeing industries and 187 bleaching complexes. It uses about 240 liters of water to produce about a kilogram of cloth. The total water consumption is about 93 million liters per day (mld), of which only 1.4 mld is used for domestic purposes. About 33 mld of water is drawn from the River Bhavani and about 60 mld is mined from the ground water resources. It has been estimated that about 700,000 tons of dye effluent is let into the environment, which has rendered agricultural practices impractical. Farmers have lost their livelihood and flora has been affected severely. It should be emphasized that agricultural loss willnot be compensated by the industrial growth. Recently, a stretch of Bhavani River has been sold to Coimbatore based Annapoorna Hotels which will draw 1,000,000 litres a day to supply to Kinley – a Coca Cola’s bottle-water unit. A consortium of three international companies and one India company (Mahindra & Mahindra, United International, West Waters and Bechtel work on the philosophy of Build, Own, Operate and Transfer (BOOT) has been formed. New Tiruppur Development Corporation Ltd (NTDCL) awarded 1273 Crores rupees (Crore = 10 million 10,000,000 ) Water Privatization Project to Mahindra Consortium for 30 years. Such shortsighted activities will lead to water–mining to dryness of the river and the ground water. (Azariah, 2004).
The Pulicat Lake is situated about 60 Kms North of Chennai in the State of Tamil Nadu The Pulicat village assumes ecological significance due the Pulicat Lake (13o24' and 13o47' N latitude and 80o2' and 80o16' E longitude), which has a water-spread area of 460 Km2. The Pulicat lake is the second largest brackish-water eco-system on the East Coast of India, It is approximately 59 km North to South and 18 km from East to West and possess an average depth of 1.5 m which is ideal for shrimp growth. Three small rivers, Swarnamukhi, Kalangi and Arni flow into the lake and the lake empties into the Bay of Bengal at its southern end through a shallow narrow bar mouth about 20 meters wide. The Pulicat Ecosystem is known for its fishery resources.
Although the International Union for the Conservation of Nature and Natural Resources (IUCN) has declared the Pulicat Lagoon system as a Ramsar site of international importance and the World Wide Fund has declared the lake as a protected area due to
the liberalization policy, there has been rapid industrialization in the region. There are two thermal power plants in the neighborhood and a new seaport, The Ennore Port, has been commissioned. The area is considered as a special Economic Zone. There is also a proposal to build a Petro-Chemical Part much against the wishes of the local community. This, coupled with population increases and the cultural habits has threatened the eco-system of Pulicat Lake thus and endangering about 1,10,000 people who depend upon the lake and the sea for their livelihood. Fly ash released from the coal based thermal power plants pose a serious problem. Fly ash has been either let into the open sea or stored in massive isolation inland ponds, which are currently filled to the brim. Moreover, heat charged industrial effluent-water (40 degree C) is let into the Buckingham Canal that runs through the Pulicat Lake. As a result Pulicat Lake ecosystem is sick. The decadence of the Pulicat Lake ecosystem and of the fisherman community has been switched on. Some major efforts on an integrated basis should be undertaken soon.
Such health impacts due to environmental pollution are the indications that deny the rights of nature. Therefore, an emphasis must be placed on achieving a eco ethical balance between the pace of development and harmony in nature. One of the major characteristic features of natural resources such as rivers and lake ecosystem is that once these resources are lost, such changes are irreversible! No short-term remedial measures will restore them to humanity. The possibility exits that they can never be regained (Azariah, 1994). It is known that, during 1600s, there were four rivers in the city of Chennai. Now there are only two rivers – namely the Cooum River and the Adyar River. Rivers such as the North River (Ellumbore River) and the Uttra Vadani Rivers have been extinct. Ethically, all the natural resources must be kept in the: milk-stage”. If they are let to change over the “curd-stage” (Yogurd) then it is a very serious ethical lapse on the part of humanity (Azariah, 1994).
Values carried by nature are many. Some are intrinsic while others are instrumental, An exhaustive account of values in nature and our duty to nature have been outlined by Rolston (1989, 1997 a, 1997 b, 1999). Water in rivers have a life support value, recreational value, scientific value, aesthetic value, historical value, cultural symbolization value, Character building value, esthetic value and religious value. If these values are lost humanity will not be sustainable. It is possible to attain a ‘win-win’ situation if humans do the right policy with respect to the sustainability of the environment (Rolston, 1994, Azariah, 1998). Living with polluted waters has major health impacts. Polluted waters can sweep into ground water and residential areas. Already the ground water quality in the neighborhood of Cooum River and Buckingham Canal is poor with bad odor and unpleasant color. What is lacking is the public participation in the decision of developmental activities and a holistic approach keeping the ecobalance of the total system at the central position. We need to develop suitable environmental polices as well as switch over to environment friendly life styles that will save us from the impending danger and live harmoniously with Nature.
References
Azariah, J and Azariah H. 1987 Let the Fishes Live in Cooum. Blackbuck 3:12-18.
Azariah, J 1994 Global Bioethics and Common Hope: Parts 1, 2 & 3 IN (Ed ) Macer, D.R. J Bioethics for the People by the Peoples. Eubios Ethics Institute Japan. Pp 98-124.
Azariah, J. 1998 Bioethics in India. Eds. J. Azariah. H. Azariah, D. Macer. University of Madras. Pp 403.
Azariah, 2002 Food in/security in Genesis. Eubios Ethics Institute, Japan. pp 48.
Azariah J 2004 Ecospiritual Theosophy in Water Resource Management: Damage and Social Cost of Mismanagement. Paper presented at the III World Conference on Bioethics, Cuenca, Spain. Sep. 26-Oct.1, 2004.
Drengson, A., 1990 In Praise of Ecosophy. Trumpeter 7: 101-103.
Rajimwale, S.G. 1994 Agnihotra Farming Method. Institute for Studies of Vedic Sciences. Slapur. India. pp 16.
Rolston, Holmes III 1989 Philosophy Gone Wild: Environmental Ethics. Prometheus Books. New York USA. . pp.269.
Rolston, H, 1994 Winning and Losing in Environmental Ethics IN Eds. Ferre, F and Hartel, P., Ethics and Environmental Policy. The University of Georgia Press. Athens. London. Pp 217-234.
Rolston, Holmes III 1997 a, Science and Religion: A Critical Survey. Harcourt Brace Custom Publishers. USA. pp.357.
Rolston, Holmes III 1997 b, Environmental Ethics Duties to and Values in The Natural World. Temple University Press USA. pp.391.
Rolston, Holmes III 1999 Genes, Genesis and God: Values and their Orgins in Natural and Human History. Cambridge University Press USA. pp.391.
Discussion.
Macer: Thank you to Vice-Director of the Institute of Advanced Studies, United Nations University, Mr. Watanabe, for your message on behalf of Dr. Zakri. Mihaela Serbulea outlined our initiative at UNU-IAS for bioethics, are there any questions?
Leavitt: In the first place, with respect to traditional medicine, I disagree with you. There is no such thing as traditional medicine. There are many, many kinds of medicine in different parts of the world. An Ayurvedic doctor once said to me that Ayurveda was not traditional medicine. Traditional medicine was superstition. Ayurveda is scientific.
They have a 6 year medical program where a lot of their basic classes are similar to Western Medicine. Chinese medicine is a whole different thing. Tibetan medicine is somewhat similar to Chinese, and somewhat similar to Ayurveda. And I think it is very misleading to generalize. I think everyone should be treated individually and personally and like in your last slide, respectfully.
Serbulea: Thank you very much for your comment. I respect individuality and I think everything must be taken individually.
Serdult: You said that the distribution of results will be uploaded unto the internet. I would just like to raise a point on access to the internet. Developing countries, especially may have problems with access.
Serbulea: I wanted to emphasize open access. We don’t want to sell the information and there will be free access to everyone. Those who don’t have access to the internet will get hard copies.
Sivakami: I would like to know whether you would like to collaborate, like Frank said, and Frank has visited India many times, besides Ayurveda we have lots of different kinds of systems. These are time tested but don’t have clear formulas. People of India have used this before and are still using it. I think that unlike Chinese medicine, which has been accepted overseas; these Indian systems of medicine have not been accepted outside India. Those who follow one tradition only follow one. Some would collaborate with you. If you want I can introduce some to you. Some may be reluctant but I will try to rope them in, and that would be a start of a good network for you.
Serbulea: As I mentioned, one of our long term objectives, like in the behaviorome is to integrate all types of alternative medicine into the national health system, which is mostly composed of allopathy and Western medicine.
Tanida: I am very, very suspicious about the project. As you may know, the government of the United States has been spending a lot, there is a huge budget, to study alternative medicine as a part of NIH since 1998 or like that. But nothing after that. So what do you expect from your project?
Serbulea: Probably methods are different. We don’t have money to invest. We would hope that invested money, results and methods need to be directly proportional. So probably from networking at the basic level, specially for those who have access to their patients and can design scientific studies in their field and they can share their data can benefit more than elevated studies done with a lot of money.
Leavitt: One thing with respect to Prof. Tanida’s remarks. Controlled clinical trials in the Western sense of Asian medicine are not always appropriate. In acupuncture, for example, doctors don’t just stick needles into you. They look at all sorts of factors such as lifestyle , diet, etc.. This is different from a controlled clinical trial where one aspect is looked at. Also in terms of this general project, there are a lot of duplication of efforts around the world. For example, Prof. Hans Martin Sass in Germany has a very similar project on health literacy. I think it is very important to know what other people are doing so we don’t do the same work twice.
Serbulea: Thank you very much.
Macer: Are there any questions on the paper by Yang I Ching?
Sivakami: In previous conferences, we have talked about making drugs available and cheaper for AIDS patients. Drugs are made available and cheaper not because of WTO and TRIPS alone. Manufacturers and distributors are important in this process too. People also have the guts to fight when they are signing the agreement.
Tomas: In a state of emergency, is it possible to make these drugs available? Who decides there is a state of emergency? Government? International commissions? Is there a special law for this?
Yang: Because time is limited, I didn’t have enough time to show the entire declaration. It says that if there is a public health crisis in your country, if it is to be considered a national emergency, then you can use this mechanism.
Tanida: I think the important thing is how to deliver drugs from the doctor to the patient. If you have read the news from Lancet, you can find news about fake HIV drugs in the market. And the other thing is that the HIV virus will become resistant due to incorrect use of the drug. For example even if the patient gets the drug from the doctor, the virus can become easily resistant to the drugs if the patient doesn’t take the drug correctly. The doctor needs to give very strict instructions to patients. But the situation is very difficult in Africa and Asia.
Yang: How does the patient accept the legal obstacles? A lot of people get drugs from the black market. But there have been no considerable actions taken against this. In the general counsel’s behavior, it is the duty of the government. There is a question of implementation in WTO.
Sivakami: Why is it always that research is done on Asian and African countries? In previous conferences that I have attended, there were no papers presented about white people. In one of these conferences, I had the guts to ask the question about why this was so, and this was met with applause from the audience.
Macer: We look forward to more discussion. Are there any questions for Sahin Aksoy?
Wu: Can you clarify your first statement? It seems like there is a conspiracy between patient and doctors.
Aksoy: People hold green cards, which allow government funded health insurance, but go to the health center in Mercedes--- there are a lot of false statements.
Wu: But if people who hold green cards consist of 25% of the population, it’s not very serious?
Aksoy: That’s 20 million people.
Wu: It would still be easy to monitor. For example if people are required to show proof of low income. Professionals like you can serve as gatekeepers. The medical profession should do something to stop them.
Weisburd: Thank you. It was very impressive to see the gains in coverage in the Turkish system. You mentioned that public insurance of many types covers almost all procedures. In modern medicine there are some procedures with marginal health benefits, minimal effect at great expense. On the other hand you have basic medical needs that are not being met. How does the system balance these two?
Aksoy: It’s a problem of the organization of the government. We have people dying from diarrhea which is a simple disease. At the same time there are people with cancer in the same hospital. People are turned away from the hospital when they are without health coverage. It is a failure of the government in organizing these things.
Shinagawa: Your health system in 1940 was similar to the old Russian system. How many health centers exist?
Aksoy: It’s hard to say
Shinagawa: Your country is very old. Tell me more about traditional Turkish medicine.
Aksoy: We can’t define traditional Turkish medicine, but we can talk of traditional Islamic medicine with influences from Indian medicine. Islamic medicine also has a long tradition from the Ottoman empire.
Leavitt: Looking at the last slide, I feel myself looking forward to ABC6 in Turkey.
Aksoy: On the 15th February Cultural Evening, we’ll have a 9-10 minute information on Ulfa and his prophetic vision of Turkey. People who plan to go to Turkey should come.
Macer: We look forward to the Turkish ABC. Regarding the paper from Frank Leavitt let me ask, were the participants happy? Did they learn something?
Leavitt: People who participated, the health ambassadors, Yes, I noticed they learned a lot. On the other hand, they were very disappointed when they stopped receiving the stipend.
Konrad: It would be terribly important to do a follow-up study to document what has happened after the project. Also to inform health projects and how this impacted on communities.
Leavitt: We interviewed over half of the women. We have detailed informal interviews which I still haven’t analysed. Now, I think I have the retrospect and perspective to analyze it. But yes there shouldn’t be more...
Konrad: How about funding?
Leavitt: Our major funding came from the Ministry of Foreign Affairs of Israel whose policy is not to fund the same project twice.
Konrad: How about the Indian end?
Azariah: An Indian philantropist donated 100,000 rupees.
Leavitt: The Murogovand foundation paid for the stipend at the start. But what happened was that he retired.
Wen: Did women’s role in the project change their roles in the community? Have you also thought about bringing men into the project?
Leavitt: I was actually thinking about that. But I didn’t have time to bring that up, so thank you for asking. When we teach something about gynecology there should only be women room. But after 2 weeks, the women were much more relaxed, and during the final review meeting, the men were there. And one of the women asked the woman, how do you know that you have a suspected sexually transmitted disease? One answered, that the sign was the discharge. Then the woman asked, what should you do? The other woman answered, go to the doctor. Then when she was asked about who should go to the doctor, she answered, my husband. The point I wanted to make here is that they were more relaxed. We also invited men to meetings and talked with men of the village less informally. One discussion with the men was on condoms. One man stands up, and angrily says, my wife’s body is my property and I will do whatever I want, and he walked out. But the next time, he brought his wife to the meeting. We don’t really understand people well.
Hsin: My background as a nurse makes me interested in one of the nurses with you, who was also a lawyer with background in human rights. Did you teach people about human rights?
Leavitt: That was my part of it. Ester taught about sexually transmitted diseases and family planning. I taught bioethics, once Aruna was my translator. My personal opinion is that in medically deprived developing countries nurses are more important than doctors.
Macer: The next paper is by Rev. Santhosham, and also looks at Dalit people. Are there any questions?
Santhosham: To identify the oppressor is hard to do so. But Brahminical concepts perpetuate injustice for 200 million Dalits.
Gupta: In Bengal, in Assam there is no Dalit problem , reform movements are strong among Hindu people. We don’t have this system, and most people are Hindu. I think this Dalit problem is prevalent in Northern and Southern India. We need to sensitize the majority of the community to this problem, to avoid more infighting and to go to steps for integration. We have to look for lasting solutions and be careful of politicians who use the Dalit issue for their own interests.
Santhosam: You may not face conflicts, but I ask you how many Dalits are educated? How many Dalits hold government posts? How many are leaders? How many own land? Do you have any data on Bengal? The rage against Dalits is increasing ( reads from his paper). Do you have any data?
Pollard: My comment is very much the same. The caste system is political. It is a convenience rather than religion. Buddhism is from Hinduism and it did away with the caste system.
Santhosham: True. That’s why there is no place for Buddhists in India.
Sivakami: That’s not true.
Leavitt: I’m pro-Dalit. And I think we should pay attention to what Abnik Gupta is saying. I love India—it is so big and complicated. My contacts in India include Dalits from Tamil Nadu, Brahmins in Puna. Puna is a non-caste society. There is a Brahmin organization in Puna who does health projects and works for poor people. In fact, Brahmins are threathened, for example due to the reverse admissions policies in universities. I’m not saying that you’re wrong. I just think that the truth is much bigger, India is bigger and that we should look for a balanced view.
Bhardwaj: Well, my comment is similar to what Aruna was saying. You were referring to, if I was hearing your talk correctly, all Hindu people. I think this was a very disappointing way of presenting the situation. Hindu fundamentalists exist. In Hindu religion, the majority are Hindus that are against caste. A crucial distinction should be made.
Santhosham: I did not say everybody. But the oppression does exist. I’m not accusing anyone. But wasn’t it the Hindu people who introduced the caste system? Who cultivated? We need to identify. Someone is responsible. I’m not accusing the Brahminical community. We need to identify who are the oppressors.
Mi Jung Koo: As a Christian Pastor, what is your Ministry? What is your priority? To liberate not from the Christian perspective but through bioethics?
Santhosham: India is a big nation. I have my own approach and own identity as a Christian priest. This is my third time in rural parishes. In my church in Chennai there are a lot of castes. I minister to 5,000 unemployed, uneducated Dalits. I need to educate, that is my problem, my mission, thank you.
Azariah: Three things. First, Who perpetuated this system? In Tamilian 300 BC, the golden age of Tamil, there was a similar conference but no caste system. Second, an Italian came and Brahmins became Christians. This created communities but they made one slight mistake, so now its in the caste system, it is a social taboo to marry outside one’s caste. Third, Education is a liberation of the mind. The Dalit problem is a reality in Southern India.
Sivakami: India is a multicultural society. There are many different problems. Mainly, the Dalit problem is in South India. It is a fact that the caste system was introduced by Hindus, the Brahmins. Who are the Brahmins? Only 3%. In fact, the government has to protect the Brahmins. Oppresion doesn’t come from Brahmins. No one comes to protect the Brahmin community. The problem of Dalit is not the Brahmin. But the Manias who demand a separate group from Tamil Nadu. The Dalit problem has nothing to do with Brahmins. There are many rich Dalits. In Article 17 of the constitution of India, there is no untouchability. Some problems persist, and these are exploited by local politicians. Buddhism, Christianity, Hinduism is able to absorb all traditions. Buddhism is not dead in India. Temples are there. Jains exist as well in India. Dalits became Christian, not because of religious fate for conversion. Most were lured by money, not lured by faith. Many Dalits are very rich and are employees of the World Bank.
Santhosham: Thank you, but I am very sorry to hear from you. You have no evidence at all. Do you have any evidence? Not at all. You speak like the chief minister of Tamil Nadu.
Sivakami: Just because a civil servant writes it, it doesn’t make it a document.
Su: I’m confused with your discussion. This is a silly question. How many castes are there? How do you classify them?
Santhosham: A new born child follows the father’s castes. There are more than 2,000 castes in India. I am happy that I have kindled many minds about the plight of the Dalits. Thank you very much.
Macer: This fundamental problem can be viewed from different perspectives. But it is a fact, during my visit in India, I have seen in one area, two villages---one untouchable and the other not. It is like apartheid. The next paper is by Huei-Chih Niu, are there any questions?
Bagheri: The principle of minimizing risks, should benefits be management is missing in your analysis. How to minimize this? In providing help in terms of new drugs and new technology, this should be addressed. For proper usage, it should be mentioned how a new method, new drug should be approved. The law addresses the first part. The public uses it properly, but there is harm.
Niu: I totally agree with your first point. The government should minimize the risk. Reality must be faced in order to minimize risk. For example in the case of how the government in Taiwan looks at GM, the first priority is to manage it safely and then there is talk about minimizing risks. About your second point, in this drug relief act, it does define the meaning of proper use.
Miller: What’s the burden of proof of causation? Tribunal? Judicial or what?
Niu: There are two stages. One is monitoring. And then the review committee has to investigate whether it’s true or not.
Wawrzyniak: Who is being monitored? The medical practioners themselves or people working in the medical laboratories, those doing research?
Niu: Two thirds are medical experts, for example, in advisory committees, they ask experts from the country. I don’t think I understand you truly.
Wawrzyniak: I would like to know about the degree of independence of the committees.
Hsin: My husband is a doctor in a medical center. They do a lot of clinical trials that they do for pharmaceutical companies. They have a contract with the company. They are independent but try to cooperate with one another. The rules are strict and the data is very clear.
Wawrzyniak: Is it institutional?
Hsin: It is not the same, but they have a contract.
Su: Risk assessment and risk management are very important. I am aware that the funding comes from the safety review. Where does the funding for the work of the committee come from?
Niu: It is a budget, not a funding. For the court to operate, this comes from the government.
Macer: The next paper will be from Yangguang Wang, who will talk about the Ethical Issues in the International HapMap Project in China. You may remember last year we introduced about the HapMap Project in Japan. I am one of the people responsible for collecting samples for the HapMap Project. I invited the two other people in the Ethical team in Japan, but they both could not come at this time. I think it is a very interesting topic and you will find the use of the term community engagement in different countries is difficult.
Sivakami: How informed was your informed consent form?
Wang: The donors were students. Before getting the blood sample we had informed consent. We went to the university and gave them a report. We also had community engagement and worked with committees.
Wen: You said that your donors are university students. The products are anonymous. But now we know they are students. So they can be easily identified. The ethics committee process sounds interesting.
Wang: As a way of keeping privacy, out of the 150 samples only 50% were used. We didn’t code whose blood sample was added to the database. In China, there was no code. We only know the gender and that they are Han Chinese. It is difficult to identify beyond this.
Davis: This is a basic question you mentioned that all the samples were Han Chinese, how many different groups are there?
Wang: Only one group from Beijing Normal University.
Davis: How many non-Han groups in China.
Wang: 56
Davis: One follow up question, how did you know that they were Han?
Wang: If they can trace up to 3 generations of Han lineage.
Macer: As a representative of the ELSI group of the Hap Map Project in Japan, I would say that in the case of Japan, partly from my insistence to not to identify the groups that are made, there was strong protection of the privacy of donors. Even in the e-mails of the international coordinators to the United States, I insisted that no one should ever mention the name of any of these groups and the site of collection. So the international coordinators do not know the name of these groups. The names of the groups are known only by 7 or 8 experts, including myself and those who gave. In Japan, it was very complicated, actually sampling happened twice, because the result of 140 donors, randomized and were taken, they were all apparently contaminated by Mycoplasma and rejected by Corriell Repository. Then it was insisted that within a few weeks we try again another random sample or else the Japanese section might be dropped from the project. So, some people worked very hard and got a few sets of another 140 donors and these were the ones that were used to select 45 cell lines for the actual analysis. It was very unfortunate, the contamination, the cell lines were made in Japan, it was a big embarrassment to the Japanese researchers who insisted that we should make the cell lines first in Japan, and then it got contaminated. So the second time around, the blood samples were sent directly to USA to make the cell lines there. And there is no record of the cells, the DNA donor's etc. The cell lines are not kept in Japan. The results have been written up, and there is a paper on HapMap, the scientific aspects, in Nature in December 2003. And the paper on the ethical aspects will be published in Nature Reviews – Genetics in June 2004. We will write up more details on the lessons in a paper with Eiko Suda, Ichiro Matsuda and myself.
We must move on to the paper by Abnik Gupta, are there any questions?
Pollard: In Australia, there’s a wealth of indigenous information. The Australian aboriginal population has been in Australia for 60,000 years. And they have a huge pharmacopecia of plants.
Gupta: So, there are similar social problems.
Pollard: Very similar, with patenting. And even finding out what it is and what the active principles are.
Song: Are you familiar with any comparative studies between traditional Indian and Chinese medicine. I’m asking you because in China, traditional medicine is recognized in the field of science and technology. What about in India, what is the official status of traditional medicine?
Gupta: Ayurveda and yunani are recognized by the Indian government. These principles have been codified, there is some amount of codification and protection. As you can see, Ayurveda uses about 1,800 plants and totally these systems amount to about 2,500. But actually another 4,500 to 5,000 plants are being used by the different folk practitioners. Over 8,000 plants are included, but most have been lost in areas where the oral form of language is not spoken anymore by people. Knowledge is lost because no one wants to take it up anymore. Also there is a lack of plants. So there are very various problems reserve forests where access is denied, this knowledge is not officially recognized. It is a big problem.
Sivakami: Why hasn’t ayurveda, yunani and other systems come up with a drug for AIDS?
Gupta: Perhaps when you think about the traditional medicine, these systems are founded based on felt need. So when these systems developed it wasn’t an immediate need. So individually, some Ayurveda person might be doing something. So I think it is the felt need of the community. Because these systems arose in response the community.
Macer: The next paper is by Lee Sung Kyu, are there any questions?
Mi Jung Koo: Concerning the Japanese situation…the language “law and creation of human by techniques”, is it an official translation or yours?
Lee: It was translated into English from Japanese.
Mi Jung Koo: Because the word creation has a religious background, but when used in the cloning issue, it means production. My point is that creation has a religious background.
Lee: Creation is used in the Bible. But I refer to “created”, this does not have a biblical nuance. But I understand what you are saying.
Leavitt: I was a little bit startled that Korea and Japan are following Western logic. Japan and Korea have lots of things to contribute to the world, so do you like that conclusion? Korea and Japan should be more creative and independent.
Lee: In Prof. Shinagawa’s paper, the conclusion of idea of society in relation to East Asian countries has a strong lasting influence of Confucian idealism in the concept of informed consent. This kind of terminology has bioethical problems. The problem will be solved with informed consent by each person themselves, it is an expression of individualism. Every individual makes a decision. The premise of the foundation for the concept of informed consent is based on the individual differences in mental ability. Therefore a person can not make his own decision, according to Confucian ideology. More competent person can help less competent. More bad sides to informed consent. A weak person will be sacrificed to deal with medical and ethical problems. It does not rely too much on information, this is the dark side of informed consent. Personally, I think it is the age of globalization. Globalized ideas on bioethics. I don’t oppose that Western logic is dominant, it has its weaker side too.
Macer: The next paper is by Minakshi Bhardwaj, are there any questions?
Yasuoka: You mentioned about the gift of life in organ transplantation. In Japan, the concept of gift is not suitable. Is it suitable for English people?
Bhardwaj: There are many conceptions of gift. Well, I can’t claim to whom it would be suitable because I think it is an individual choice that you can make. I can’t tell you why, some individuals recognize, some societies more, some very less. Of course in England, it is not considered as a conception of gift. Maybe Monica can explain more as a native there. It is considered a good for society, not a gift.
Konrad: Can I ask you back the question, the rhetoric…
Yasuoka: The concept of gift, in Japan it is not suitable. How about in England?
Konrad: Ok, the gift is a particular rhetoric actually that perhaps has been used in the medical context. In England, in the UK, the gift has a particular legacy from a certain social theory. It’s loaded rhetoric, so there’s a lot of debate on the feasibility of really thinking of giving gifts altruistically or whether there is a commercial commodification pressure attached to so called gift giving, it is not clear cut. In Japan, in medical or hospital settings, do practitioners use to patients the term gift for organ donation or blood donation?
Yasuoka: It is used but it is not so suitable. The word gift in Japanese is not the same as English gift. In Japanese gift is the same as present. Gift and present are the same word. It sounds like something to be used for things and not for human beings.
Macer: The next paper is by Alireza Bagheri, followed by Park So Young and colleagues. Are there any questions?
Wawrzyniak: I have certain doubt of your classification of the case. Why do you call it passive euthanasia. It is active turning off of a machine. From a utilitarian view, passive and active euthanasia are indistinshable. But here, we deal with a case were the father wanted to kill his daughter, the daughter didn’t want to be killed, it is regular murder in my opinion. Why did you classify dignity of life under objection. Euthanasia can be interpreted, even in the form of assisted suicide as a confirmation of human dignity.
Kim: In terms of the difference between active and passive euthanasia, active euthanasia is killing by poison, for example killing people with poison. Doctors can kill with poison.
Wawrzyniak: OK, the supporting the life of girl is an act of diseuthanasia.
Kim: To stop supporting all therapy, the patient may or may not die. But in Korean criminal law, it must be criminal, so he has a suspended sentence.
Macer: The next paper is by Jayapaul Azariah, are there any questions?
Niu: In your presentation you mentioned about the right of nature. My question is who has the entitlement to claim such a right? My second question, is the right of nature based on a human centered or nature centered approach?
Azariah: On the right of nature. I was told that in Gujarat, the earthquake that they experienced was based on over use of water. Every year they dig deeper and deeper. In 1922, DDT was invented, and the man who invented it got a Noble Prize, now it is banned. So the problem of rights of nature can be restored. The second point, it is obviously anthropocentric. It is always human centered. All development is human centered. The picture I showed you is the curd state, the yogurt state. We want to keep it in milk state. Once it has been transformed to yogurt it cannot go back to milk. Unless we speak for nature, no one is going to speak. Don’t take anything nature from granted. Nature is a precious gift we have to conserve for the continuance of human survival.
Macer: The last paper of the day is by Konstantin Khroutski, who was delayed because of a flight cancellation. Unfortunately we will have to have questions at dinner.
Regulating Assisted Reproductive Technology and Genetically Modified Organisms: a Comparative Perspective on Japan
- Uwe Serdült, Ph.D..
University of Zurich, SWITZERLAND
Email: serduelt@pwi.unizh.ch
Japan, as one of the leading industrial nations, takes part in the international competition between the USA, Europe and rising powers in science, such as China and India, in developing future technologies. Globalising markets and the notion of science as key to economic success set the conditions under which Japan’s domestic institutions are supposed to regulate in the fields of Assisted Reproductive Technology (ART) and Genetically Modified Organisms (GMOs).
ART is nowadays well established in Japan. Its application is embedded into a fragmented health care system without much interference of the state. However, besides a ban on reproductive cloning, so far there is no comprehensive legislation limiting the autonomy of medical doctors or clinics practising ART.
GMOs, especially in the food sector, became a political issue in Japan during the 1990s because of consumer concerns about the safety of genetically modified foods. Until 1998, for reasons of international competition, Japan regulated research on GMOs and the assessment of food safety with the help of frequently updated but flexible ministerial guidelines. By June 2003, both houses of parliament approved the draft law on the assurance of bio-safety through regulations of GMOs .
In this paper, I isolate the factors leading to a non-design or very late design in the case of the “red’ ART; and a consumer protectionist but research friendly policy design in the case of the “green” GMOs. Furthermore, it is interesting to compare Japan as a non-Western and culturally different country with European and North American countries regarding their policy design in ethically and morally debated fields of technology.
The Classifications of Bioethics From My Lecture-Notes of Introduction to Bioethics and Medical Ethics in Hirosaki University School Of Medicine
- Shinryo N. Shinagawa, M.D..
Emeritus Professor, Hirosaki University, 036-8223 Fujimi-cho 32-3, Hirosaki, JAPAN
E-mail: shinryo@smile.ocn.ne.jp
There have been a variety of classifications of bioethics. These include the following: Western and Eastern; Euro-American and Asian; Religious and Secular; Christian, Islamic, Buddhistic, Confucian, and Shintoistic; Normative, Theoretical and Practical; Post-Modern and Communitarian; Democratic, Non-Democratic and Totalitarian; Capitalistic, Socialistic and Communist; Theo-, Anthropo-, Bio- and Cosmocentric.
Besides the ones mentioned above, I have used two other classifications in my lectures. One is based on distinguishing personal, individual and social levels wherein, intrapersonal and interpersonal issues are studied. The other one is based on a distinction between biological and cosmo-global levels. Such levels of life can be further discussed into the following: In-organic, pre- or infra-cytological, cytological, tissue/organs/body fluid, individual, social, national, international, global and cosmo-universal. Moreover, I have recently been teaching and discussing on bioethics of the rich and the poor, and the origin of wealth and poverty of nations.
I. The Aims of Medicine and Health Care
My lecture-Note of Introduction to Bioethics and Medicine starts in citing three proverbs. They are: Always do What’s the Best for the Patient; Always Put the Patient’s Needs Above All; Love Your Patient with All Your Heart, with All Your Soul, and with All Your Mind as You Love Yourself. And the key lines of the First Chapter of my Lecture “The Aims of Medicine and Health Care” (since 1970s) continued to as follows:
1. Improvement of the health of people
2. Achievement of the prevention of preventable diseases
3. Turning of incurable diseases into curable
4. Turning of not-preventable diseases into preventable
5. Minimization of congenital and antenatal abnormalities and handicaps
6. Minimization of unnatural and unwanted deaths of people
7. Improvement of the environment, and natural and human securities
II. Sanctity of Life, Especially of Human Life
In the Second Chapter I discussed on the Sanctity of Life, especially Why Should the Human Life be Respected? And, Why is Killing Wrong? Are discussed. The answers I suggest to the students are:
1. Since human life is intrinsically as well as absolutely sacred.
2. To ignore the sanctity of a man’s life can produce a terrible society where the sanctity of human life and dignity are abandoned widely.
3. When a man is killed or dies, horrors and pains are unavoidable to him.
4. When a man is killed or dies, his parents, wife, children or friends may be saddened.
5. To kill a man is strictly prohibited by laws, habits, ethics, and religions traditionally.
Furthermore in this chapter, why should the life of animals, and plants also be respected? And, the limits to respect the life of animals and plants when they endanger or threaten us are discussed.
III. Main Differences between Medical Ethics (in narrower sense) and Bioethics (in wider sense)
While medical ethics (in narrower sense) discusses on relationship and interaction between patients and their families and health care workers and health practice, bioethics related to whole people of the society and of the world. As far as I understand and believe, the persons most closely related to and should have the interests and obligations to bioethics are not health care workers but politicians, economists, law-makers, mass-media, and bureaucrats.
In other words, bioethics is a wider category than the medical ethics and covers very widely a variety of social problems such as 1. Population, 2. Environment, and Natural Resources and Eco-System, 3. Poverty and Wealth, 4. Genes, Germ Cells, and Embryo, Fetus/Future Generations, and 5. Peace and War.
IV. Changings in Category of Human Life
With an advance in biological technology, category of human life is now greatly changing. Human life can and should be considered in 7 or 8 levels or dimensions. They are:
1. Preconceptional human life in the level of genes, DNA, and chromosomes
2. Cytological level human life in the stage of ovum and sperm
3. Tissue/organ level human life in such as of organs for transplantation and in cultivated cell levels
4. Human life in individual level
5. Human life as a member of family, society, folk, race, and nation
6. Human life as a member of whole mankind
7. Human life as one of the key players in the eco-sphere of the globe
8. The life of the universe
V. Intrapersonal Bioethics and Interpersonal Bioethics
Today’s bioethics is usually discussing on interpersonal, and individual- surrounding relations, and emphasizing the importance of 1. Love, 2. Justice, 3. Autonomy, 4. Beneficence, 5. Non-Maleficence, 6. Reverence of Life, 7. Continuation and Succession of Life, and so on.
Besides them, I am talking about and emphasizing another classification of bioethics to my students. That is to classify bioethics into Intrapersonal and Interpersonal. Intrapersonal bioethics means the self-control of body and health, mind and life-style of her/his own.
VI. Doctor-Patient-Relationship in Wider Sense
Today’s doctor and patient are not isolated and independent, but surrounded, influenced, and supported by and dependent on her/his family, friends, society and community, social habits and laws. Some of them threatening and endangering both doctors and patients. Today in social healthcare system countries, Health Insurance-Patient Relationship is sometimes more important than traditional doctor-patient-relationship.
Main factors threatening and endangering us in health care are as follows.
1. Doctor-Patient’s Family and Surroundings Relationship
2. Doctor-other Health Care Workers Relationships
3. Doctor-Pharmacy and Co-Medical Industries Relationship
4. Doctor-Bureaucracy and –Politicians Relationship
5. Doctor-Health Insurance and Social Security System Relationship
6. Doctor-New Technology (such as new biotechnology and nano-technology) Relationship
7. Doctor-Mass Media Relationship
8. Doctor-Traditional and New Religions, including Cults, Relationship
9. Doctor-Political Powers Relationship
10. Doctor-Fashionable Schools, Thinkings and Trends (such as Darwinism, Marx-Leninism, Maoism, Fascism, Totalitarianism Stalinism, Neo-Conservatism) Relationship
VII. Health Care Workers’ Professional New Responsibility
With a changing human mind and needs, and with an advancement of medical and health care technology, health care workers’ professional responsibility is now greatly changing. Key words of my last lecture in 2003 were as follows.
1. Fundamental Principles
1. Primacy of patient welfare
2. Respect of patient autonomy
3. Respect of Social justice
2. A set of Professional Responsibilities: Commitment to
1. Professional competence
2. Honesty with patients
3. Patient’s confidentiality
4. Maintaining appropriate relations with patients
5. Improving quality of care
6. Improving access to care
7. Maintaining trust by managing conflicts of interest
VIII. “Unethicalities” Latent in Modern Health Care and Medical Science
Finally, I am talking about and explaining the Unethicalities Latent in Health Care and Medicine. Modern medicine is strongly requested to be “ethical”. However, when we check the medical practice impartially, we are surprised at its “unethicalities”. Most modern medical practice are not “ethical” but “unethical” when evaluated from a viewpoint of so-called Gute Sitte (good habits), without some unethical doings no medical practice has been present since Hippocrates.
“Unethicalities” inherent in modern medical practice I am mentioning are as follows.
1. Secrets and privacy of others/patients should be asked, recorded and precisely memorized for a long period.
2. The body of others are observed, palpated, photographed, modern-technologically imaged and described.
3. For the diagnosis and treatment, the body of others/patients, especially their skins, subcutaneous blood vessels, and superficial tissues are very often injured.
4. A small piece of organs/tissues and body fluids of others/patients are obtained to obtain an exact diagnosis.
5. Unusual substances and energies which humans in nature do not experience, such as radiation, are very widely used for the medical diagnosis and treatment.
6. For the surgical treatment, very often in modern medical practice, human body is incised, excised, surgically corrected, and sometimes artificial foreign materials implanted and other person’s organ is transplanted.
7. Whole blood or a partial component of other person’s blood are very often transfused for the life-saving and symptom-relieving of others/patients in spite of not a few religions have prohibited to accept other persons’ blood.
8. Fee for medical examination and treatment are billed to the patient and her/his family regardless whether they can pay or not, and whether health insurance service covers or not.
9. Autopsy, animal experiment, and sometimes human experiment are all performed in practice although they are all unethical. They are all sometimes necessary for the respect of human life and humanity in wider sense.
10. Progress of health care and of medical service is likely to resulted in the overpopulation, and may threaten the survival of the humankind on the globe.
IX. Wealth and Poverty, and Bioethics and Medical Ethics
As probably you readers have already noticed, in my Lecture-Note of Introduction to Bioethics and Medical Ethics, too little or almost nothing is dealt with and discussed on such contemporary, sensational or curiosity-seeking topics produced by modern bi-technology such as human cloning. Half-intentionally, I have avoided to talk about such topics as of brain death/organ transplant and artificial reproductive technology.
Furthermore, I am of an opinion that there are good science and bad science, good technology and bad technology, good medicine and bad medicine, medicine for all and not for all, and technology for the richman’s society and for the poor people.
And, one of my lecture’s conclusion is that origin of poverty and wealth, not only of individual but also of society and nations, should be taught and let students to consider deeply and widely, including bioethical and medico-ethical viewpoints since such medical virtues as justice, autonomy, respect and reverence of human life are all greatly influenced by wealthy or poor of the individual and of the society.
References
1. Shinagawa, S. (1972): Foundations and Safety of Modern Medical Care.
Asian Medical Journal 20: 16-52
2. Shinagawa, S. (1983): Medical Care and Human Right, Especially on Triage. Journal of Japanese Medical Association 90:1136-1142.
3. Shinagawa, S. (1986): An Introduction to Medical Ethics. The Hisosaki Medical Journal 38: 195-210
“Medicine is the Art of Perfect Virtue": Its Bright Side and Dark Side in Japan
- Noritoshi Tanida, M.D..
Medical Humanities, Yamaguchi University School of Medicine,
1-1-1 Minami-Kogushi, Ube, 755-8505, JAPAN.
Email tanida@yamaguchi-u.ac.jp
Introduction
The adage "I-wa-Jinjutsu" or "Medicine is the Art of Perfect Virtue" is the core concept of Japanese medical ethics. "Jin" means benevolence, humanity, and Perfect Virtue "to subdue one's self and return to propriety" in Confucianism. "Jutsu" means art in Japanese. So, "Jinjutsu" means a benevolent act or a humanitarian act. This catchword, "Jinjutsu" means devotion to patients without reward in medicine. Thus, "Jinjutsu" was a perfect medical morality for patients. However, doctors could earn nothing because of "Jinjutsu." Japanese doctors managed this problem by selling drugs; that is, they earned from the surplus balance between the cost price and the selling price of drugs. Secular doctors have used the catchword "I-wa-Jinjutsu" to disguise the actual practice of ""I-wa-Sanjutu" or "Medicine as the Art of Moneymaking." Here, how originally perfect medical morality affected past and current medical practice so badly is described.
Catchwords Expressing Japanese Medical Morality
The catchword showing medical morality was started with Buddhist idea of "Jihi," that is, benevolence or mercy (Tanida, 2003). At the tenth century, medical morality of Sun Simiao (581-682) was introduced from China into Japan, namely "to appreciate the value of life, to rescue the dying and wounded, to show concern to the sufferer, to practice medicine with honesty, to study medicine hard, to oppose careless styles of work, to comfort oneself in a dignified manner, to respect local customs and to be polite, to acknowledge that all patients are equal before the physician, and to respect the academic achievements of others (Guo, 1995). Thereafter, the Buddhist idea and Confucius idea unified, and the resulted catchwords "TaijiSokuin" and "Jijin," meaning of merciful benevolence, were used in medicine during the following few centuries in Japan.
The catchword, "I-wa-Jinjutsu" or "Medicine is the Art of Perfect Virtue" was introduced from China in the late sixteenth century at the dawn of the Edo-Tokugawa-Shogunate era. A direct reference source is said to be a textbook written by Xu Chunfu (1520-1596) in the Ming Dynasty. He wrote that "medicine means devotion for human, hence medicine is the art of Perfect Virtue." The idea itself was already mentioned by Sun Simiao in the Tang Dynasty.
Japan gained stability under the rule of Tokugawa-Shogun at the Edo era (1603-1867). "Perfect Virtue" from Confucianism fitted well into the feudal society of Japan for ruling people. At the same time, the catchword "Jinjutsu" has spread widely, presumably because the paternalistic nature of Confucius ideology also fitted well into the medical society as well.
Bright Side of "Jinjutsu"
A famous moral advocator, Kaibara Ekiken (1630-1714) described "Jinjutsu" in his book "Yojokun (Instructions for Health)" with almost exactly the same words by Sun Simiao and Xu Chunfu, as devotion for patients without reward. Nagata Tokuhon (1513-1603) was one of the doctors who practiced "Jinjutsu." He received only 18 mons (money at the Edo era) for his medical practice including drugs from patients, even from the second Tokugawa-Shogun, Hidetada. At that time, the price of one bowl of soba noodle for one person was 16 to 20 mons. He travelled one place to another shouting "Tokuhon, charge 18 mons" on the back of a cow. "Jinjutsu" was really a humanitarian act, devotion for patients without discrimination.
Problems of "Jinjutsu"
Doctors who practiced "Jinjutsu" received a minimum charge from patients. On the other hand, some high ranking doctors received 4,000,000 to 6,000,000 mons from such rich patients as feudal loads. It was written in a number of literature in the Edo era that doctors were arrogant, idle, superficial, greed, deceptive, seeking promotion and hastening patients' death," which suggests that doctors like Tokuhon were exceptional. In reality, the sarcastic catchword "I-wa-Sanjutsu" or "Medicine as Art of Moneymaking" was used to describe the situation properly. It was quite usual for patients to sell their daughters to make money for doctors.
How did "Perfect Virtue" become "Moneymaking"? "Jinjutsu" meant doctors' consultation was free but service to patients. Thus, doctors could earn none or little out of "Jinjutsu." Old days in China, doctors who came from nonworking class did not have to earn. On the other hand, Japanese secular doctors had to get money for living without charging of their practice. Japanese doctors managed this problem by selling drugs, that is they got a surplus balance between cost price and selling price of drugs.
They kept saying "Jinjutsu, medical consultation was free, they only charged for expenses of drugs." In reality, selling price of drugs was determined freely by doctors who always handed out drugs to patients. Thus, the catchword "Jinjutsu" has been used to disguise the actual practice of "Sanjutsu" or "Moneymaking" by secular doctors.
Dark Side of "Jinjutsu"
Since the concept of "Jinjutsu" is still the core of medical morality in Japan, the problems of "Jinjutsu" have continued from the Edo era to present days. First, in the current national medical insurance system, consultation fees for physicians and surgical fees for surgeons are kept low. Because of the idea of medicine being devotion, discussion on an appropriate fee for medical practice has never become a sincere issue in the Japanese society.
Second, in order to earn enough from a surplus balance between the cost price and selling price, doctors have to prescribe more drugs, to use more medical materials, and to order more clinical examinations. Such practices have lead over-prescription of drugs, over-use of materials and clinical examinations. These unnecessary uses of those medical activities are not only futile, but also harmful to patients. It may be one of the reasons why so many patients have been harmed with drugs repeatedly in Japan (Woodall, 1997).
Third, the problem is that doctors cannot earn enough when they practice properly. If doctors fail treatment or surgery, they will be able to sern more under the fee-for-service system (Ikegami, 1991). Thus, there is no motivation toward improving quality of medicine among Japanese doctors. Patients have been suffered from such negligent attitudes and low level of clinical practice of Japanese doctors (Nakata, 1998).
Fourth, everybody knows the existence of the surplus balance between the cost price and selling price nowadays. It is an essential part of doctors earnings, however it is a kind of deception or fraud. This "surface income of doctors" further exaggerates notoriety of doctors among the general public, although situation has been changing for improvement gradually with the introduction of diagnosis-related-group/prospective payment system in large hospitals.
The situations between private clinic doctors and employed doctors are somewhat different. The former have to work for their own, whereas the latter work for employers, although doctors are urged to earn more in both situations. The compelling pressure is harder toward doctors in private owned clinics and hospitals. They are the strongest faction in the Japan Medical Association who are keen to maintain the current fee-for-service payment system (Ikegami, 1991). Considering the link between the Japan Medical Association and "Jinjutsu," it is highly unlikely that the dark side of "Jinjutsu" is to be improved in the near future.
Future of "Jinjutsu"
"Jinjutsu" has certainly the bright side, and it had its role in old days. However, the effects of the dark side of this ideology are far greater than those of the bright side. "Jinjutsu" has not been functionless; but it is actually harmful to patients and deeply damaging to the medical system in Japan. Is it possible to maintain the bright side while amending the dark side of "I-wa-Jinjutsu" in Japan? The answer lies in the fact that the Japan Medical Association keep saying that Japanese medical ethics does not need the concept of informed consent, because they have "Jinjutsu." The concept in the Hippocratic Oath is almost extinct (Robin, 1995). So the ideology of "Jinjutsu" had its role in the feudal society, but not in this era of democracy.
References
Guo Z. Chinese Confucian culture and the medical ethical tradition. J Med Ethics 1995;21:239-246.
Ikegami N. Japanese health care: low cost through regulated fees. Health Aff 1991;10:87-109.
Nakata Y, Goto T, Morita S. Serving the emperor without asking: critical care ethics in Japan. J Med Philos 1998;23:601-615.
Robin ED, McCauley RF. Cultural lag and the Hippocratic Oath. Lancet 1995;345:1422-1424
Tanida N. "Bioethics" in Japanese medical history. J Health Care Med Community 2002;(N0. 22):45-63
Woodall B, Yoshikawa A. Japan's Failure in Pharmaceuticals: Why Is the World Saying "No" to Japanese Drugs? (accessed Feb 22, 2004).
Analysis of Informed Consent in Chinese Medical Practice
- Li Zhongli , Zhao Shanming, and Neng Changhua.
Educational College , Zhengzhou University, 40 Daxue road, Zhengzhou , Henan 450052 CHINA
Email: lzhl@zzu.
In this paper, nearly ten years of medical literature on informed consent in China were retrieved from the Chinese Biological Medical Literature Disc, and medical conditions on informed consent in China were analyzed by age, period, district, subject and content district of the literature. Some representative viewpoints were elucidated and some attitudes involving use and progress of medical Informed Consent in China were made known. It was suggested that exchange of ideas between doctors and patients, establishing a sense of civil rights and clearing relative articles of law were necessary conditions in actualizing medical intimacy and agreement.
Informed Consent Documents for Medical Interventions in 15th to 19th Century Ottoman State
- M. Alpertunga KARA, M.D*.; Ali Haydar BAYAT, Prof. M.D.*; Sahin AKSOY, M.D., Ph.D **.
* Ege University Medical School, Department of History of Medicine and Deontology, Izmir-Turkey
** Harran University Faculty of Medicine, Department of Medical Ethics and History of Medicine, Sanliurfa-Turkey
Email: atunga@med.ege.edu.tr
Introduction
Information of patients on medical applications is one of the fundamental principles in modern medicine. It is possible to see this practice in the past in one way or another. It has been always discussed whether seeking informed consent is a legal or ethical issue. In this study we looked at this issue in the Ottoman State from the 15th to the 19th century.
Since they contain data about four centuries –from XVth to XIXth- of Ottoman social, economical and political life Sicils (record books) are among the main sources of Ottoman history. They can be compared to Church records of Western World in terms of their importance. (Uzuncarsili, 1939)
The main administrative part of Ottoman State was kaza (kadi-ship), which is ruled by kadi (judge). This was a system that Ottoman State had inherited from the previous Islamic States. Kadis performed duty of judgement in the name of Sultan, and also maintained some other duties. (Gunay, 1997)
Some of the responsibilities of kadis were; to hear civil and criminal cases, to inspect artisans and tradesmen, to inspect vakifs (foundations), to approve contracts, to divide inheritances, to supervise public security affairs with ‘subasi’ (sheriff). (Aygan, 1998)
Kadis kept different data regularly in sicils (record books). These were obligatory records. Sicils include records about lawsuits, written copies of court decisions, notarial documents, copies of imperial edicts (ferman) etc. Kadis worked as a notary public also. (Ilgar, 1991; Ulucay, 1953; Yilmaz, 1991). There are two groups of records in a sicil book. First group is the copies of the documents come from central government (i.e. fermans). Second group is the kadis’ personal records (written copies of court decisions, notarial documents for example). Approved contracts are in this category. (Ulucay, 1953; Yimazcelik, 1994)
Punishment of Murder in Islamic Law
The term ‘kisas’ of Islamic law is a word derived from the word ‘kass’, which means ‘to follow’, ‘to tell’ or ‘to cut’.. As a term, kisas means a punishment because of a murder or hurting someone. In Islamic Law a murderer shall be executed, and if someone wounded another he must be punished with an equal wound (“eye for eye, tooth for tooth”). Kisas can be accepted as a reflection of individual right to life. Murder is a crime against God as well as the violation of a fundamental individual human right. Therefore if the family of the deceased forgives the murderer, there will not be an execution, and murderer will have to pay a ‘diyet’ (blood money) to the family of the murdered person. Diyet is a kind of indemnity. Kisas and diyet are also referred in the Qur’an (El-Bakara 2/178-179; El-Isra 17/34; El-Maide 4/45). (Karaman, 1996)
According to Islamic law, medical operations and medications are accepted as professional services with payment. Because of the importance of human health, responsibility of health personnel is primarily important. Responsibility comes from acts is a general rule in Islamic law, but controlling the results may be very hard in some medical interventions. Therefore the avoidance of health care professionals from intervention by worrying from the result is not a good for human health. For that, additional criteria are available for health care professional in Islamic Law. Health care professionals can be conditionally excused from the responsibility of the results of their acts. First of all physician (or any other health care professional) must be competent in his field. If any person applies a medical intervention in spite of not being a qualified professional, he should be punished and pay for the damage. Incompetent persons are prevented from health care services by the government. Knowledge and competency must be evaluated for every case separately; since they may vary case to case (i.e. one may be competent for one application, but incompetent for another). Medical intervention must be acceptable according to contemporary medical knowledge and common sense. Consent of the patient must also be obtained. Any possible contract before the intervention must be favourable according to the principles of Islamic Law. Riza Senedi (Consent Document) is an application of these principles. (Bardakoglu, 1982; Ibn Kayyim, 1991; Bayat, 1992)
The application of arranging a contract indicating that physician will not be responsible for the result of the life threatening surgical operation had continued during Ottoman era. (Trompoukis, 2002)
“The texts have a standard form. The patient is identified by name, profession, or residential address. The patient declares that because he suffers from a hernia or from any other operable illness that he is “handing himself over” for treatment to the particular therapist. If, by the will of God, he is to die, then no legal action will be brought against the therapist. In some cases a reference to “the blood tax” is made. It is worth noting that in all the cases any negative results arising from the operation are attributed to the will of God” (Trompoukis, 2002)
According to records in sicil books, if the patient dies after the operation, relatives of the patient can apply to the court with a demand of punishment. If there is a riza senedi (consent document) prior to the operation, judge refuses the case. But if there is a doubt the competency of the surgeon may be questioned. Judge also may demand a testimony from witnesses, if it is needed. (Elbasi, 1989; Guzelbey, 1970)
Apparently the major aim of this application is to protect physicians from blood money. (Trompoukis, 2002) But it also protects the rights of patients.
Is a riza senedi an informed consent document?
In this section we take ‘the Convention on Human Rights and Biomedicine of Council of Europe’ as a reference text for informed consent process and compare this with Ottoman Riza Senets. According to the Convention on Human Rights and Biomedicine of Council of Europe, ‘an intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks’. If we look Ottoman Riza Senets, we cannot find any clear statement about informing the patient. But the possibility of death as a consequence of the medical intervention is always mentioned, so patient is aware of the risks of the operation. From that, it is possible to consider this as a kind of informing process.
The European Convention on Human Rights and Biomedicine says: ‘the person concerned may freely withdraw consent at any time’. Riza Senets do not contain anything about free withdrawal. According to the Convention, ‘a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law’. It can be seen in Riza Senets, consent for minors is obtained from parents.
The Convention says ‘an adult does not have the capacity to consent to an intervention because of a mental disability, a disease or for similar reasons, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law’. There is not much clear information about an adult does not have the capacity to consent in the Riza Senets we could reach. (Convention on Human Rights and Biomedicine, Council of Europe European Treaties ETS No. 164, Oviedo, 04.IV.1997)
Conclusion
Islamic law leaves the choice if a murderer will be executed or not to the family of the deceased. The family can forgive the guilty person with a blood money (diyet). Results of medical interventions are not a matter of responsibility, if the person providing health care is competent and the application is acceptable by science. A riza senedi (consent document) is a confirmation of this principle with a contract, and also a document by which the physician can defend himself against a murder case or paying blood money. These contracts can also be considered as an indication of patient’s consent. Apparently this application benefits physician rather than patient. There are similar points between riza senedi and modern concept of informed consent, as well as some differences that we intend to discuss these in detail in another paper.
References
Aygan, H. “Osmanli Toplumunda Sosyal Hayat”, Turk Dunyasi Arastirmalari, Issue 117, December 1998, pp.89-109.
Bardakoglu, A. “Islam Hukukunda Doktor ve Diger Saglik Personelinin Hukuki Mesuliyeti”, Kayseri Gevher Nesibe Bilim Haftasi ve Tip Gunleri, 11-13 March 1982, Kayseri, pp. 527-530.
Bayat, A.H. “Ser’iye Sicilleri ve Tip Tarihimiz 1 - Riza Senetleri”, Turk Dunyasi Arastirmalari, Issue 79, 1992, pp.9-19.
Convention on Human Rights and Biomedicine, Council of Europe European Treaties ETS No. 164, Oviedo, 04.IV.1997.
Elbasi, N. “Bir Ameliyat-i Cerrahiye – Muallim Ismail Hakki”, Tip Tarihi Arastirmalari, Issue 3, Istanbul 1989, pp.166-167.
Gunay, V. “Balkanlara Ait Siciller ve Karaferye Kazasi Ser’iye Sicilleri Katalogu”, Turk Dunyasi Incelemeleri Dergisi, Issue 2, Izmir 1997, pp.103-113.
Guzelbey, C.C. and Yetkin, H. Gaziantep Ser’i Mahkeme Sicillerinden Ornekler, (Volume 81-141) Miladi 1729-1825), Yeni Matbaa, Gaziantep, 1970, p.80.
Ibn Kayyim El-Cevziyye, Zadu’l-Mead, (tr. Akyuz, V., Kurt, A.V., Ogut, S.), Volume 4, Istanbul 1991, pp. 361-363.
Ilgar, Y. “Karahisar-i Sahip Sancaginda Ser’i Mahkeme Sicilleri ve Sicillerden Secmeler”, II. Afyonkarahisar Araştırmaları Sempozyumu Bildirileri (3-4.05.1991), Ed. Mehmet Sarlik, pp.133-149.
Karaman, H., Mukayeseli Islam Hukuku, Vol. 1, Istanbul 1996, pp.189-191.
Trompoukis, C. and Lascaratos, J. “Surgical Operations During the Ottoman Period. Informed Consent According to Documents of the Ottoman Archives of Crete”, Turkiye Klinikleri Tip Etigi-Hukuku-Tarihi, Volume X, Issue 3, 2002, pp.163-167.
Ulucay, M.C. “Manisa Ser’iyye Sicillerine Dair Bir Arastirma”, Turkiyat Mecmuasi, Volume 10, 1951-1953, pp.285-293.
Uzuncarsili, I.H. “Ser’i Mahkeme Sicilleri”, Ulku, Volume 5, Issue 29, 1939, pp.365-368.
Yilmaz, N. “Ser’iyye Sicilleri”, Ilim ve Sanat, Issue 29, 1991, pp.24-27.
Yilmazcelik, I. “Ser’iyye Sicillerinin Toplu Kataloguna Dogru Diyarbakir Ser’iyye Sicilleri”, Turk Dunyasi Arastirmalari, Issue 90, June 1994, pp.41-62.
The issue of trust in the doctor-patient relationship in Japan
- Atsushi Asai M.D., MBioeth., Ph.D., Motoki Ohnishi, Etsuyo Nishigaki, and Tsuguya Fukui.
Department of Biomedical Ethics, School of Public Health, Kyoto University Graduate School of Medicine, Konoe-cho, Yoshida, Sakyo-ku, Kyoto 606-8501, JAPAN
Email: aasai@pbh.med.kyoto-u.ac.jp
Introduction
Patient trust in the doctor is essential to achieve good medical care. Without trust, a doctor could not expect patients to reveal the full extent of their medically relevant history, expose themselves to the physical examination, or act on recommendations for tests or treatments (Goold, 2002). Trust is also fundamental to bring about effective interpersonal relationships in the clinical setting. The absence of trust engenders the need for constant vigilance, anxiety or necessitates reclusiveness (Mechanic & Meyer, 2000). A recent study based upon interviews of elderly Japanese patients showed that reliability on the part of the medical practitioner is one of the most important factors of good health care. A cross-sectional survey done in the US also revealed that confidence and trust in providers were closely associated with patients overall positive evaluation of their hospitals, and was considered to be more important than patient involvement in decision making (Sebata, Sugisawa, & Fetters, Maezawa, 2002, Joffe, Manocchia, & Weeks, Cleary, 2003). Thus, there is evidence that strong doctor-patient relationships form the foundation of good medical care (Keating, Green, Kao, Gazmararian, & Wu, Cleary, 2002).
Recently in Japan, distrust of healthcare professionals has become a pervasive problem. The media regularly reports medical mistakes and accidents, a high incidence of nasocomical infection, the problematic attitudes and behaviour of doctors, and ethically questionable medical research. The media also criticises Japanese doctors for their lack of adequate disclosure of medical information and unacceptable attitudes towards their patients. A recent public-opinion poll conducted by one newspaper demonstrated that only about 60% of the general public trusted doctors and approximately 30% actually distrusted medical practitioners; the most significant reason was the inadequate disclosure of medical information (Asahi Newspaper, 1996, Nakamura, 2000).
Papers and discussions in medical journals often examine the issue of distrust of the medical profession. Many such commentaries suggest that the inadequate process of informed consent, the absence of humane qualities in the doctor, a lack of kindness, an inability to listen to the patient, the low quality of health care, and secrecy within the medical profession have caused distrust (Becker, 2000, Fukushima & Kato, 1993, Hoshino, 1999). Pellegrino has pointed out that patient distrust of medical practitioners is not a new phenomenon at all and argued that venal, greedy, incompetent, dishonest, and insensitive professionals have never been a rarity. Pellegrino has claimed that the recent commercialisation of healthcare, the high incomes of medical practitioners, hospitals that have a policy of upfront payment, the increase in the number of doctors who want nine-to five jobs and time off, and specialisation have all had their part to play (Pellegrino, 1991).
There has been some thorough analysis of the problem of patient trust and distrust in medicine, especially regarding medical practitioners. Mechanic and Meyer interviewed patients with serious illness and their work demonstrated that practitioners’ ability to communicate caring, concern and compassion as well as his or her medical competence were important factors in establishing patient trust. The study also indicated that maintaining confidentiality and the doctor’s role in protecting the patient’s interests within the health care system contributed to building trusting relationships (Mechanic & Meyer, 2000). Thom, et al. identified factors such as clinical competency and respecting and understanding patients as people (Thom & Campbell, 1997). Keating et al, showed that a patient’s intension to change practitioner was directly related to a breakdown in communication, the features of which were that the doctor did not explain issues in an understandable way, did not take sufficient time with the patient, and did not give him or her the full story. (Keating, Green, et al, 2002). Laine et al also suggested that patients thought that, in clinical practice, clinical competence, disclosure of medical information, and the caring attitude of the doctor were of equal importance (Laine, Davidoff, Lewis, Nelson, Nelson, & Kessler, Delbanco, T., L, 1996). Furthermore, Kao et al. suggest that practitioners who were payed on a fee-for-service bases tended to be trusted by their patients more than those who were paid through a managed care plan, salary, or through a capitated health care system (Kao, Green, Zaslavsky, & Koplan, Cleary, 1998). It also emerged that that the quality of paramedical staff, facilities of medical institutions, and knowledge of past unethical clinical research were also influential when considering the issue of patient trust (Anderson, 1990, Kao, Green, et al, 1998, Keating, Green, et al, 2002, Laine, Davidoff, et al, 1996, Matthews & Feinstein, 1988, Mechanic, 1998, Pearson & Raeke, 2000, Thom & Campbell, 1997, Thorne & Robinson, 1988, Thorne & Robinson, 1 1989). Based on these findings, various educational interventions have been implemented in order to enhance patient trust (Matthews & Feinstein, 1988, Mechanic, 1998, Thom, 2000).
In Japan, however, there have been no studies that examine this issue. Little is known about what actually affects trust in relationships between Japanese doctors and patients. Although there is anecdotal evidence from many sources, we do not have reliable data to consider the determinants that affect patient trust in our country. In addition, there is no research that compares western countries and Japan. Therefore, we conducted a qualitative study using in-depth exploratory interviews with Japanese people who have had experience with the health care system, with the aim of revealing the real state of patient trust in Japan. We also wanted to identifying relevant factors affecting trust between Japanese patients and doctors. We hope that the outcome of our study can demonstrate some ways in which patient trust can be enhanced.
2. Methods and Subjects
The study employed in-depth interviews employing the constant comparative method used in grounded theory (Chenitz & Swanson, 1986, Strauss & Corbin, 1990). Semi-structured, individual interviews were conducted between December 2001 and November 2002 in the Kansai Area, mainly in Kyoto. Inclusion criteria for our participants were 1) that they were between 20 and 70 years old, 2) could communicate using Japanese, 3) either the interviewee or his or her family member had been an outpatient had stayed in hospital that had lasted longer than a month, and 4) neither the interviewee nor his or her family member or close relatives were health care professionals. We used these criteria because we thought such people were likely to have sufficient interaction with the medical profession, and would be able to provide us with realistic information and reliable insights into the issue of patient trust.
Three researchers (AA, MO, and EN) conducted the interviews. Each interviewer interviewed one participant and we conducted on average three interviews a day. All interviews were recorded with the permission of the participants and transcribed. The transcribed results were then independently analysed and coded based on grounded theory. The participants’ statements were labelled by the three interviewers and classified. The process was repeated until the final interview was completed. Using the concept of theoretical sampling, we chose each interviewee’s characteristics (gender, age, place of residence, and kind of disease) for the next interviews.
All interview participants were recruited by the Japan Research Center whose main professional activity is conducting both public-opinion polls and market research. The investigators in charge of the Kansai Area conduct approximately 30 public-opinion polls and market research surveys a year. We asked the investigators to find people whose personal backgrounds were compatible with our target subjects. Informed consent was obtained twice. That is, when the investigators from the recruiting centre asked respondents to participate and when we actually started interviewing. An honorarium was paid to all participants. We concluded this part of the study when we judged that we had confirmed theoretical saturation.
In the interviews, we began by asking the participants about their personal backgrounds, present state of health, past medical history, and family history. Subsequently, our participants were asked to describe a doctor who he or she thought was trustworthy, describe a medical practitioner who the participant thought was unworthy of trust, describe the experiences that led them to trust doctors, and tell us about the events that had led them to be distrustful of the medical practitioners. In addition, we asked our participants about other factors related to the establishment or destruction of trust in the doctor- patient relationship.
Unlike previous research regarding patient trust, our interview sessions were exclusively conducted outside of the hospital setting, and our recruitment method was completely independent of the researchers or researchers’ university. We decided to utilise this method because we thought that if the participants were recruited through the hospital system where the researchers were working, or from the hospitals where the researchers had acquaintances, the participants would be unwilling to describe any doctors who the participant thought was untrustworthy, and the experiences that had led them to such a conclusion. In addition, we preferred to interview residents from diverse districts in the Kansai area. This study, interview protocol, recruitment method, and consent process were reviewed and approved by the research ethics committee at the Kyoto University School of Medicine.
In the process of developing categories and subcategories, research team meetings and electronic communication were utilised to discuss the accuracy of the lists of codes, subcategories, and categories during the interview period and the subsequent writing of the paper. Research team discussions were also used to select interviewees' representative statements. We repeated these processes until we reached complete consensus.
3. Results
Between the months of December 2001 and November 2002, we conducted a total of 25 semi-structured interviews. Participants were non-medical professionals between the ages of 42 and 68 with an average age of 54; 92 percent of participants had visited a medical institution and 64 percent of participants had a past medical history (Table 1). The average length of each interview was just over an hour. All interviews were transcribed. Results of this qualitative investigation go some way to explain why patients either trust or do not trust their medical practitioners. Sample categories and subcategories of trust and distrust within the context of healthcare are shown in Table 2.
The doctor’s competency
1-1: The outcome of medical treatment
The outcome of medical treatment was a crucial factor in determining whether or not a trusting relationship could be established. Whether the medical care given was successful, or whether the patient was satisfied with its consequences, had a significant correlation to the establishment and maintenance of a trusting relationship. Events that made our participants distrustful of their doctors included a mistaken diagnosis, delay in making a diagnosis, prolonged pain and suffering, unsuccessful interventions, witnessing deterioration of the medical condition of family members, incompetence when performing basic medical procedures, and the aimless continuation of ineffective treatment. The fact that different doctors gave the participant different explanations about a medical condition also undermined the development of trust. Some respondent stated: “My doctor, who was a young resident, failed to diagnose my pneumonia.”, “The best doctor is the one who effects a cure.”
Patient trust could not be nurtured when a medical practitioner did provide good medical care or conduct procedures that the patient considered to be necessary. Physical examinations or laboratory tests that the participants thought were essential that were not carried out, long waits between appointments, and delays in referrals to specialists also brought about a lack of trust in the doctor. Incompetence, or a feeling that the doctor was not up to date with new knowledge also undermined the growth of a trusting relationship. By contrast, spending enough time with patients and examining them thoroughly was found to be the cornerstone of a trusting relationship. Participants stated: “Even a general practitioner in a private clinic should study more. If this is not possible, then he or she should refer his patients to specialists in a bigger hospital immediately.”, “Nowadays, few doctors look patients in the eye. Why is that?”
Table 1: Participant’s characteristics
|Participant |Age |Sex |Present Illness |Past History |
|#1 |53 |female |asthma |subarachnoid hemorridge, pneumonia |
|#2 |65 |female |hyperlipidemia |gastric ulcer |
|#3 |68 |male |hypertension |primary aldosteronism |
|#4 |58 |male |hypertension |myocardial infarction |
|#5 |61 |female |diabetes milletus |gastric cancer, acute pancreatitis |
|#6 |66 |female |gastric ulcer |ovarian cysts |
|#7 |57 |female |diabetes milletus |myoma uteri |
|#8 |42 |male |hypertension, chronic pancreatitis |acute hepatitis |
|#9 |48 |female |post operation of duodenal cancer |duodenal cancer |
|#10 |46 |female |none |none |
|#11 |46 |female |myoma uteri |none |
|#12 |49 |male |rheumatoid arthritis |none |
|#13 |48 |male |gastric ulcer |none |
|#14 |44 |male |diabetes milletus |acute glomerulonephritis |
|#15 |47 |female |hypertension |myoma uteri |
|#16 |49 |female |ulcerative colitis |none |
|#17 |56 |female |diabetes milletus |duodenal ulcer, iron deficiency anaemia |
|#18 |65 |female |diabetes milletus |none |
|#19 |55 |female |diabetes milletus, hyperlipidemia, |none |
| | | |hypertension | |
|#20 |53 |male |post renal transplantation |renal failure |
|#21 |56 |male |hypertension |appendicitis |
|#22 |52 |male |hypertension |leg fracture |
|#23 |64 |male |hyperlipidemia, hypertension |none |
|#24 |42 |female |mastpathy |none |
|#25 |54 |female |none |liver hemangioma |
1-2:The doctor’s personal and social background
Our participants suggested that the patient gave special attention not only to a doctor’s medical competency, but also his or her personal and social background in determining whether he or she was trustworthy. Characteristics that contributed to patient trust included a high rank in the hospital system, age, adequate clinical experience, being male, and good personal connections. The participants were likely to put trust in a practitioner from a famous university, who had also studied or worked abroad, and who was also able to practice in a Western country. Some participants make comments like the following: “My doctor does not usually explain my condition to me in detail, but I trust him because he is very famous. ”, “When I had surgery my anaesthetist was a young woman. I wondered if she was reliable.”
Patient trust in healthcare institutions had similar features. Our participants tended to find famous institutions, bigger hospitals, and university-affiliated hospitals more trustworthy. Conversely, doctors working at small clinic were often called “Machi-isha ”(doctor in private practice) with a note of scorn and the patient’s use of the name implied that the practitioner in private practice was, in general, inferior to one who worked in a big, famous, university-affiliated medical institution. Remarks like “You can count on K University hospital. Nothing will go wrong there, ” were typical.
However, our participants’ trust in a practitioner that had its basis in the personal or social background of the doctor, or the institution was sometimes changed because of experience as a patient. For example, trust in a renowned medical institution deteriorated when it turned out that a participant’s family member had care as an outpatient that was of a very low standard. He remarked: “I have no trust in that hospital. I thought that I could trust the doctors there because the hospital is the most advanced and biggest centre for heart disease in Japan. But, my wife, who had seen a doctor regularly at the hospital for her heart problem, gradually became worse and even when she complained to her doctor about her condition, no new interventions were attempted, and her drug therapy remained unchanged. I took her to a different hospital - a smaller community one - and the doctor told us that an urgent operation was needed. This series of events caused me to distrust that the first hospital. ”
Table 2: Categories and subcategories of trust and distrust within the context of healthcare in Japan
|Category |Subcategory |
|１. Doctor’s competency |１－１. Outcome of medical treatment |
| |１－２. Doctor’s personal and social background |
| |１－３. Issues of reputation |
|２. Doctor’s appropriate responses |２－１. Doctor’s manner and attitude |
| |２－２. Communication of medical information |
| |２－３. Priority of patient interests |
| |２－４. Limit of care and supererogation |
|3. Emotional aspects in doctor-patient relationships |３－１. Patient’s emotions |
| |３－２. Doctor’s negative feelings toward patients |
| |３－３. Care |
| |３－４. Friendship |
1-3: The issue of reputation
A series of interviews with our participants revealed that they tried to gather information to judge which medical practitioner or medical institution was trustworthy. Before actual contact was made, assumptions regarding trust were often formed, based upon the doctor’s reputation. Our participants were also influenced by media reports of medical error and misdemeanours. Personal communication regarding a doctor’s competence and reputation in a community also affected participant judgment.
Our participants were likely to place their trust in practitioners whom their friends or close relatives regularly saw, and they suggested that consulting a doctor about whom nothing was known made them uneasy. One person stated: “I have never visited a new doctor without any information about him or her. It makes me feel uneasy.”
Our interviews also found there was absolute trust in doctors before medical mistakes were made public. One respondent stated: “In the past I had the feeling that a doctor was infallible. ”
2 The doctor’s approach
2-1: The doctor’s manner and attitude
The doctor’s manner and attitude towards his or her patients was found to be of great significance in the establishment of patient trust. Factors that diminished trust included not listening to the patient, lack of dialogue, not answering the patient’s questions, silent contempt, refusal to disclose information, preaching at patients, and giving offhand answers. Such a lack of communication raised patients’ anxiety about medical conditions. Thoughtless remarks also distressed our participants. As one respondent stated: “I want my doctor to answer my questions more completely. My anxiety level rises if I am left uninformed and ignorant.”, “My doctor told me that I was a very healthy patient. But, how could he call a patient healthy who required an abdominal operation in a week’s time?”
On the other hand, factors positively influencing the development of patient trust included apologising for mistakes, kindness and courtesy, openness, as well as a dignified attitudes towards and appropriate meticulousness with patients. However, pandering to the patient on the one hand, or being excessively dictatorial on the other, had quite the opposite effect on trust. As well, simply giving the patient whatever treatment he or she wanted did not inspire confidence. As one respondent remarked: “A doctor should not be a yes-man.”
A medical practitioner's fairness was also a key point in constructing a trusting relationship. It was essential for our participants to feel that they were treated justly. Our interviews revealed that some of our participants felt that they had been discriminated against. Personal connections with medical practitioners or other health care staff, powerful connections with an influential community member, a letter of introduction, gifts to the medical practitioner, and the social standing of patients or their relatives, our participants reported, changed responses to the patients. One person stated: “My father, who suffered from lung cancer, could have been admitted to the hospital earlier if he had been rich and had had a personal connection with someone powerful in his town.”
Finally, patient trust could not grow without the development of a stable relationship between doctor and patient. Trust did not develop in situations where there was no personal doctor. A shortage of practitioners in charge of patients in hospitals, no available appointments for consultation for outpatients, and patients irregular visits to medical institutions made the establishment of a stable doctor-patient relationship difficult or sometimes impossible. One participant reported that: “I did not have a regular doctor in charge of my care when I was admitted. So I did not know with whom I could consult about my condition or treatment plan.”
2-2: Communication of medical information
This subcategory mainly concerns the quality and quantity of medical information that doctors provide to their patients. Inadequate disclosure and explanation regarding medical information relevant to the patient engendered distrust. An insensitive disclosure of results and an explanation of the patient’s condition without addressing his or her personal concerns and circumstances was also described as an obstacle to the development of patient trust. Even if a prior explanation about diagnostic procedures or therapeutic intervention had been acceptable, patient trust could not be maintained in cases where the explanation became inconsistent with what actually happened. For, example, one respondent said that: “My mother began kidney dialysis during hospitalisation for renal failure. On discharge, however, we were not told that my mother needed regular dialysis. So my mother stayed home without having dialysis and general edema, ascites, and dyspnoea soon developed.”
Another person reported that they were not told how long a procedure would take: “I was told that the test only took 40 minutes, but it took three hours! ”
Our participants placed their trust in their doctor when he or she provided them with clear and detailed and explanations. Conversely doctors who believed that they should automatically be trusted in general failed to win our participants' trust. As some respondents stated: “I think a doctor who explains to me in a way that I can understand is reliable. ”, “He gave us a 2-hour explanation about my father’s heart condition and explained the process of the operation in detail. We were informed not only of the benefits of the surgery, but also its risks.”
The full disclosure of information, and the clear explanation of conditions and procedures had the power to transform a participant’s negative first impression of a practitioner. Furthermore, good communication of medical information deserved, our participants pointed out, some inconvenience. Respondents stated that: “I felt that I could not trust him because he was very old. But he gave me a clear explanation and I thought that he was good.”, “I would rather travel for one hour and see a doctor who explains things to me properly, and gives me good advice and care, than see a neighbourhood doctor who does not do these things.” However, the relationship between patient trust and good communication was not a simple one.
Our interviews did not suggest that adequate disclosure by itself always developed trust. Our participants sometimes trusted doctors who did not give sufficient information if the practitioner was an authority in the field. It was also pointed out that frank and complete disclosure of medical information did not necessarily mean “good” communication. Although one of our participants was upset when she knew that her doctor had withheld a diagnosis of ovarian cancer from her, other participants were ambivalent about truth telling in regard to the diagnosis of cancer. Some preferred a white lie and thought that it was not necessary for the doctor to disclose all relevant medical information if there was a trusting relationship. As one respondent stated: “Circumstances may justify a lie.”
2-3: The priority of patient interests
Extremely strong patient distrust came about when our participants suspected that the practitioner thought that patient interests were of secondary importance. This lack of trust also arose when participants felt that they were being exploited for reasons other than the promotion of their own health; for example, when the financial interests of the doctor or the hospital took precedence over the patient care. One participant witnessed a case where a homeless person who required urgent residential care was denied hospitalisation, provided with only token treatment, and forced back on the street. In another case, a hospital urged a member of one of our participant’s family to leave as soon as the residential fee got cheaper (in Japan, hospital fees become cheaper after a 3-month stay). In other cases, some doctors ordered excessive laboratory tests in order to make money.
One participant expressed it as follows: “It is completely unacceptable for a doctor not to treat a patient according to his or her needs. It is the doctor who determines whether or not the patient needs care in hospital, and sometimes doctors ignores a patient’s needs and deny necessary admission because the patient has no money.”
There was a feeling amongst the participants that “things were better in the old days”. There was consensus among them that a fine doctor is never calculating and many thought that in the past, doctors were more altruistic. Some participants referred to “Akahige (Red Beard),” a character in a novel written more than 40 years ago, as a great doctor. Akahige was a doctor who provided the poor with free medical care and worked tirelessly as a patient advocate in the Edo ara (Yamamoto, 1962).
Hospital policies also had a part to play in undermining trust between patients and doctors. One respondent stated that: “My doctor said, that this his hospital was designed to care for acutely ill patients and your mother is now in a vegetative state and stable. So, you need to find a new hospital for her.”
Being used as means to an end, or feeling exploited completely undermined trust. One respondent recalled that: “When I underwent angiography for my primary aldosteronism, the radiologist let his resident practice the procedure on me while pretending he had carried out the test.”
In the same way, our participants said that they felt some misgivings about university affiliated hospitals, as they were places where patients were used inappropriately as experimental subjects.
2-3: The limit of care and supererogation
Our participants complained that “outpatient care often resembled an assembly line”. As well, doctors often failed to give adequate time to their patients. However, our participants had a great deal of insight into the limits of medical care that individual doctors could provide. They indicated that they understood that factors like an excessive number of patients in clinics or hospitals, too much overtime, understaffing, and various kinds of restrictions set by national health insurance all had there part to play. Some participants also perceived medical mistakes to be unavoidable because of the limits of human ability. Taking these factors into consideration, they attempted to distinguish between errors that occurred that were unavoidable, and those for which practitioners needed to take some responsibility.
On a more positive note, respondents noted that their doctors often went beyond the call of duty. For example, one participant was able to have her baby in a hospital where there was no obstetric department, because of her doctor’s assistance. Another woman recalled that her husband was allowed to stay all night with her in a small obstetric hospital. Another participant recalled her doctor coming to see her everyday in hospital, although he was not on call, and another woman recalled a doctor being particularly attentive to her daughter when she was ill. One mother recalled that: “No matter where my doctor was and no matter when I called, even in the midnight, he came and treated my daughter.”
3 The emotional aspects of the doctor -patient relationship
3-1: The patient’s emotions
Our interviews suggested that patients sometimes felt that they had no choice but to trust their doctors, as the world of medicine was not fully comprehendible without their assistance. As well, reliable information about whether or not a medical practitioner was trustworthy was often unavailable. At the same time, however, the respondents’ health problems often required resolution, and if there was absolutely no trust, it became impossible to decide whether or not to take drugs prescribed to them, have surgery, or invasive diagnostic procedures. Nevertheless, they felt that patients were sometimes left to their fate. Some of our respondents put it as follows: “When I started my drug therapy, I tried to find out about each drug. But it became too difficult. I felt that I simply had to trust my doctor.” Another said, “If you can’t trust your surgeon, it becomes impossible to even go into the operating theatre, let alone have surgery.”
When there was insufficient evidence to determine whether or not a doctor was competent, patients sometimes based their opinions on the doctor’s character. As well, when the illness was not serious or life threatening, they tended to see a practitioner with whom they had a good personal relationship. When the illness was more critical, they looked for someone with a good professional reputation. Some respondents were simply terrified of any encounter with the health care system, or disliked certain doctors without justification. As well, hospitals were sometimes seen as frightening places: as one participant stated: “I was really terrified when I was brought to the angiography room. It was as if I was being sent to a battle field.”
Our interviews also revealed that patients also had a sense of obligation to certain healthcare providers. For example, families would continue to see a particular doctor out of a sense of gratitude for his work with other family members. This was particularly the case with older patients, and people from rural areas. This sense of duty sometimes prevented our participants and their families from changing from a doctor whom they did not trust, and caused some frustration.
“Some patients cannot change their physician of whom they are distrustful. They cannot do so because they feel indebted to the physician.”
3-2: Doctors’ negative feelings toward patients
An expression of negative feelings toward patients by the doctor had a dramatic effect on trust and intensified the patient’s suffering and discomfort. A medical practitioner’s failure to control his or her temper and expressions of displeasure always had the effect of undermining trust. However, our participants did not believe that doctors should never show emotion. If a doctor became angry out of concern for a patient, and used strong language to educate and improve health, this was often seen as appropriate, and as a mark of care. As one respondent stated: “A doctor I know well is very kind to children and old people in the clinic. However, he is very firm with patients whose noncompliance causes their health to deteriorate.”
3-3: Care
Empathy and compassion for a patient went a long way towards establishing trust. Our participants also thought that caring for the patient’s psychological well being was vital to developing trust, a sense of security and peace of mind. A doctor who was trustworthy was likened to a talisman whose existence lifted a huge burden from the patient. At the same time it was suggested that the human side of medical care was underdeveloped in Japan. As one of participants stated that: “I need humane care, I do not want to be dealt with medically.”
3 – 4: Friendship
The development of friendship between doctor and patient was considered to be of great value by our participants, as they saw it as the best way of achieving good communication. However, they suggested that as things stood, there were considerable barriers between medical practitioners and patients in Japan at the present time. The ideal relationship between doctor and patient was compared to a fraternal bond, or that between a teacher and student by some participants. Some respondents stated that: “It would be the best if I had a brother who is also a doctor.”, “I felt very happy because I could get familiar with my doctor.”
Discussion
The current study gives us important insight into issues associated with trust in as connected to the doctor-patient relationship in Japan. Factors that contributed to patient trust included the doctor’s competence, his or her appropriate responses, and positive emotional behaviour on the doctor’s part. Our participants also placed their trust in the doctor when treatment went well. Issues like the doctor’s age, sex, rank in hospital, and the university from which he or she graduated also affected patient trust. The doctor’s reputation was important, as was appropriate behaviour and the proper disclosure of medical information. When the doctor did not prioritise the patient, trust was destroyed. However, sympathy and compassion promoted trust, as the participants wanted a close and friendly relationship with their doctors. At the same time, however, participants expressed the idea that they sometimes felt they had no choice but to trust the practitioner, regardless of their relationship.
Previous research suggests that factors that influence trust include technical and interpersonal competence, respect for patients, honesty, agency/fiduciary responsibility, maintaining confidentiality, the doctor’s control of care, disclosure of incentive and conflicts of interest, issues related to the constraints imposed by health care plans, and the method of doctor payment ( Kao, Green, et al, 1998,, Mechanic & Meyer, 2000, Thom & Campbell, 1997). The outcomes of our investigation were mostly compatible with these findings and, at the same time, substantiated the aforementioned claims concerning the Japanese media and arguments put forth in other articles (Asahi Newspaper, 1996, Fukushima & Kato, 1993, Hoshino, 1999, Nakamura, 2000).
Furthermore, the current study suggests that patient trust in the Japanese clinical setting took different forms, consistent with other publications regarding trust (Goold SD, 2002, Mechanic & Meyer, 2000、Illingworth, 2002). Trust based on a doctor’s personal and social background or upon his or her reputation for competence can be categorised as social trust, and at the same time, expectant trust. Trust established after the patient actually saw the doctor and communicated over time can be categorised as interpersonal, experiential, and evidence-based trust (Goold SD, 2002, Mechanic & Meyer, 2000, Illingworth, 2002). It can also be said that, as Yamagishi defined, trust based on clinical competence can be classified as a fulfilment of an expectation of competence, while trust that stemmed for a doctor’s appropriate response to patients as well as positive emotional relationship can be categorised as the fulfilment of an expectation of goodwill or good intentions (Yamagishi, 1998).
On the other hand, unlike many prior studies, our participants did not refer directly to confidentiality, control, or disclosure. There are several possible explanations for this omission. Firstly, our respondents may not have had felt that their privacy had been put at risk. Secondly, our participants may not have been overly concerned about this issue because they did not have so-called stigmatised conditions, like HIV, or genetic disorders. Thirdly, it may have been the case that our participants took it for granted that their doctors would simply maintain confidentiality. At this time it is difficult to determine the relationship between confidentiality and patient trust in Japan.
It is most likely that participants did not refer to issues like the doctor’s control of care, disclosure of financial incentive, conflict of interest, and constraint to care resulting from health plans because, currently, the Japanese national health care plan has not introduced managed care. Japanese doctors are either paid on a fee-for-service basis or earn a fixed salary. As well, insurance companies do not have the power to intervene in a medical practitioner’s decision making for each patient, and doctors can send patients to specialists without the risk of incurring any financial loss.
However, our current study suggests that because of the fee-for-service payment method, Japanese patients suspected that their doctors performed needless tests and wrote prescriptions that were unnecessary in order to earn more money. It seems that doctors who are financially calculating are not trusted in any culture. Regardless of place, doctors who put their patients’ interests first, whether in the clinical setting or in training, engender and maintain trusting relationships with them. The current research -consistent with other studies- indicates that the emotional aspects of the doctor-patient relationship such as expressions of caring, sympathy, and compassion were strongly associated with patient trust in the Japanese clinical setting. In our opinion, however, the emotional dimensions we identified were personal and partial rather than reflective of the professional interpersonal competence or impartial benevolent attitudes of the doctor. Our participants expected friendly and personal connections with their doctors, not unlike the kinds of relationships they had with family members. Thus, friendship seems to play a significant role in establishing trust in doctor-patient relationships in the Japanese health care system. Our study suggests that Japanese human relationships, referred to as “amae”, which means dependence on those with whom we have close relationships still has a tremendous impact on relationships in the clinical setting in our culture (Doi, 1995). Furthermore, this cultural factor helps to explain the importance our respondents placed on doctor’s supererogatory action, which can be regarded as personal and partial treatment for a particular patient.
Several issues deserve further attention. Firstly, our interviews showed that patients sometimes felt that they had no choice but to trust their doctors. This finding we gained from the interviews with Japanese participants is consistent with the concept of “unavoidable trust” or “ineradicable trust” that various western moral philosophers also refer to (Illingworth, 2002, Pellegrino, 1991, Zaner, 1991). Such trust without choice may be quite common across diverse cultures and even universal in the relationship between laypersons and professionals. It might then follow that the inevitability of trust in professional makes the ordinary people vulnerable to the limits of the specialist’s good will (Baier, 1986, Illingworth, 2002, Pellegrino, 1991, Zaner, 1991). In certain circumstances, trust may need to be created - even self created-in the minds of those who need help from professionals. Johann Wolfgang Goethe (1749-1832) wrote that we cannot trust medical doctors but cannot survive without them. This remark has some contemporary application.
Secondly, our study indicated that some Japanese medical practitioners held inappropriate attitudes towards patients, and sometimes even behaved unethically. Our interviews provided us with some telling examples. These included forced discharge from hospital and refusal of care for financial reasons, subtle and apparent discrimination against patients, poor communication skills, no disclosure of relevant medical information, and poor hospital care. These reports may indeed be the tip of the iceberg, as these issues are not discussed openly in Japan. Our sampling strategy - completely independent of the researchers - gave us unique insights into the real state of affairs. If we had recruited our participants from one of university hospitals where the researchers were working or through our own network, no participants would have been frank enough to reveal their experiences. Further studies are undoubtedly needed, as are strategies to prevent such issues from arising in the future.
Thirdly, our respondents indicated that a psychological trade-off among different dimensions of trust took place. This trade off seems to work on two levels. Firstly, patients used different criteria to determine doctor’s trustworthiness. If information about competence were unavailable, the patient might decide to rely upon the doctor’s personal attributes. It can be argued that such trade-offs occur because patients need to trust the medical practitioners when they need medical care. This phenomenon substantiates the inevitability of trust in the doctor-patient relationship. Secondly, trade-offs occur between different practitioners on the basis of different characteristics. Our interviews suggested that when patients believed that they had a serious medical condition, they looked for a doctor who was an authority. However, in cases where the condition was less severe, patients chose to see practitioners with whom they had a good personal relationship. It might be the case that a patient might want to see a doctor who is both competent and personable. However, such doctors were a rarity.
It is important to note also that Japanese patients felt a sense of duty to continue their relationships with a family doctor, and this alone could prevent them from leaving a medical practitioner. This particular feature of Japanese doctor-patient relationships might change significantly as globalisation takes hold, and as Japanese patients become more conscious of their rights. It is also possible however, that if patient dependency, that is -“amae”, a sense of indebtedness to others, and respect for social duty rather than individual right might prove an unshakeable feature of Japanese culture. If this is so, then the particular cultural factors we have discussed will not change.
There are limitations to our study. Firstly, our participants were recruited from the Kansai area only and it is possible that regional issues might have influenced their responses. The attitudes and beliefs expressed in our interviews may not be representative of the general public in Japan. Secondly, our qualitative study cannot provide quantitative information. However, our primary aim was to achieve in-depth understanding of patient trust and distrust in the present Japanese clinical setting and this limitation does not devalue our study. Thirdly, we interviewed people aged between 40 and 60. They were mostly outpatients with chronic, but not life-threatening conditions. Different perspectives might be obtained by interviewing Japanese people with other kinds of personal, social, and medical backgrounds. For examples, a recent study suggested that patients’ responses regarding important dimensions of trust varied according to the nature of their illness (Mechanic & Meyer, 2000). Finally, different people may define trust in a number of ways. In this investigation, we did not define the meaning of trust or present a specific definition to the participants. However, in our opinion, all of the participants used it in the way commonly accepted in Japanese. Namely “believe (Shin) and rely on (Rai)”.
Conclusion
The present research suggests that Japanese patient trust in medical practitioners is multi-dimensional and affected by various factors. Patient trust is also psychologically complicated. The outcome of our study suggests that some dimensions of trust we identified share features with those discussed in previous studies conducted in western countries. However, some features may be, we think, unique to our culture.
Trust is essential not only in the doctor-patient relationship, but in all human relationships. When we trust the wrong person, it is possible for serious consequences to ensue. Those who are physically, emotionally, and sometimes financially vulnerable cannot afford to rely on the wrong medical practitioner. Therefore, medical practitioners have the obligation to be trustworthy. This is made all the more important because patients cannot help but trust them (Illingworth, 2002).
Acknowledgments
The authors would like to thank Professor Akira Akabayashi and Professor Mami Kayama at the University of Tokyo School of Medicine for their advice on methodology. This research was supported by the Grand-in-Aid for Scientific Research (C), 2002-2003
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Problems Over Organ Transplantation in Korea
- Heo Yang Hee and Lee Hea Jin.
Catholic University of Korea, SOUTH KOREA
Email: allisa919@
In Korea, the history of organ transplantation operations date back to 1969 when the first successful kidney transplant was performed with an organ from a live related donor. In 1979, the first kidney from a brain dead donor was transplanted into a patient. The next transplanted organ from a brain dead patient was done in 1988. In 1992, pancreas and heart were also successfully transplanted. From this point on certain transplant operations were deemed viable and practical norm.
The Catholic Church has not officially given a position regarding brain death; however, the Pope’s opinion along with Catholic Theologians is to acknowledge brain death. The reason the Catholic Church has decided to acknowledge brain death is to provide hope for those families of patients diagnosed with brain death, in recognition of the love that people share in the belief in God. Another reason is to allow those patients to donate their organs to the many patients who require organ transplant to survive. The Catholic Church views these organ transplant operations as one of the greatest gifts a person of Catholic faith can share with another human being.
Along with the enforcement of laws on organ transplantation in Feb. 2000, which was enacted in 1999, the Korea of Network Organ Sharing was established. The purposes of legal proposals were: 1) Legislation of removal of organ from brain-death-announced patient; 2) Eradication of illegal organ trafficking through effective distribution of donated organ; 3) Systematic management and control of legal, humanitarian organ transplantation.
There have been several post-legislation problems including:
1) Decreased number of donation and judgment of brain-death. The number of confirmations of brain death and donations has been decreased because of government's excessive interference; not only that, laws- in deciding the approval of donation - give priorities to the agreement from patient's family members, not to patient's own will or intention to donate organ.
2) Too complicated brain-death procedures Delayed amount of time results from complicated procedures between confirmation of brain death and transplant operation. The extended amount of time is mainly caused by the Organization of committee to proceed to judge brain-death; Delayed time to summon the required KONOS (Korean Network for Organ Sharing) committee members to run the committee, and Application of more strict criteria than other countries.
3) Illegal organ trafficking. As long as stereo-typed legal safeguard to analyze the purity of intention exists, any donation from living patient is available legally. Incomplete legal systems which prohibit any type of organ transaction donated from living patient, on the contrary, give birth to arguments about organ transplantation and its commercial use after all.
Therefore, better solutions should be considered in the areas of :
(1) appointment of investigator and /or manager to cover and direct organ donation
(2) development of methods to screen documents
(3) contents of written agreement
(4) prohibitive regulations or clauses to protect young adults over 16 from any intention or suggestion to donate organ for commercial purpose
Most of all, there should be no third-person's demand or persuasion about organ donation.
Suggestions
We wish to make several suggestions.
1) Accept "Living Will" system. A living patient registers his/her will to donate organ in the nation-wide web site featuring the lists of organ donors ; this website may offer details about organs to patients in need of organ donation.
2) Simplify procedures for confirmation of brain-death, Simplified, shortened procedures help keep donated organ in best condition after its removal from brain-death patient.
3) New Priorities. In case there are more than 2 waited-recipients for same organ, priorities are given according to present law to: 1) patient who has donated organ before; 2) patient with younger age; 3) First come, first served. To avoid all these complicated procedures above any removed organ should belong to waited-recipient in the hospital where organ removal occurred.
Table 1: Organ Transplants from Brain Death Donors by Year (1991-2002) in South Korea
| |Brain death | | | |Pancreas | |Kidney+Pancr|Heart+ Lung |Total |
|Year | |Kidney |Liver |Heart | |Lung |eas | | |
|1991 |2 |3 | | | | | | |3 |
|1992 |15 |28 |5 |1 |4 | |2 | |40 |
|1993 |20 |36 |6 |1 |2 | | | |45 |
|1994 |45 |66 |26 |25 |5 | |1 | |123 |
|1995 |78 |135 |22 |21 | | | | |178 |
|1996 |66 |112 |29 |20 |2 |2 | | |165 |
|1997 |97 |177 |36 |31 |4 |3 | |3 |254 |
|1999 |125 |238 |61 |30 |8 | |3 | |338 |
|2000 |162 |306 |8 |34 |8 |3 |5 | |440 |
|2001 |64 |125 |42 |14 |10 |1 |5 | |197 |
|2002 |36 |70 |2 |11 |8 |3 |2 | |168 |
|2003 |43 |84 |32 |8 |9 |2 | | |135 |
Table 2: Criteria of the Brain Death in Korea
1. Deep comatous state no response by external stimuli.
2. No spontaneous respiration.
3. Dilation of the pupil and fixed.
4. Disappearance of brain stem reflex (No light reflex; No corneal reflex; No oculo-cephalic reflex; NO vestibular- ocular reflex; No cilio-spinal reflex; No gag reflex; No cough reflex
5. NO spontaneous movement.
6. NO decarbonated, decorticated (spastic and seizure)
A Community Without A Kidney: A Tragedy? Analysis of the Moral and Ethical Aspects of Organ Donation
- Francis Aguilar and Lalaine Siruno.
Department of Philosophy, CSSP, University of the Philippines
Diliman, Quezon City 1101, PHILIPPINES
Email: lhsiruno@
Community Without a Kidney
Throughout the years, Brgy. 649, Zone 68, District V in Port Area, Manila has acquired many names. The sprawling 52 hectares of land, or island more specifically, resulted from the dredging of a portion of Manila Bay as ordered by then First Lady Imelda Marcos in preparation for the coming of Queen Elizabeth II, whose royal ship is to drop anchor at the South Harbor. The first residents of the island were the workers of the adjacent company, NASCO Stevedoring, and consequently, the place was called the Engineering Island of Nasco. That was year 1975. In 1982, Nasco Island was renamed Isla Baseco, quite aptly and ironically. BASECO stands for Bataan Shipyard and Engineering Company, owned by no less than the family of the First Lady. The name was subsequently changed in 1998 to Brgy. Bagong Lupa (1) but it did not become so familiar that the name Baseco stayed. Isla Baseco is classified as an urban poor community, or in everyday language, a depressed or squatter’s area. As of January of 2001, Baseco has a total population of 45, 017 – composed of 5, 515 families living in 3, 499 houses (2). The place has acquired an obvious notoriety for its poorness and desolateness. The residents try hard to make ends meet mostly by stevedoring, fishing and selling. People live in shanties and makeshift houses and children crowd the mud-sputtered streets. Ms. Vida Florendo, a resident and tanod of Baseco, describes their place as the “poorest of the poor”. Nowadays, it has a new label derived from a growing enterprise of kidney donating, or selling. Isla Baseco is now called by the inhabitants themselves Isla Walang Bato.
Such a namesake is not at all surprising (though more aptly, it should be Isla Isang Bato). According to Baseco Brgy. Captain Teresita Lumactud, approximately 3, 000 residents from their barangay, men and women alike, have donated one of their kidneys – for a cause and/or for a cost. These residents decided to meet the demand for kidneys by donating one of theirs. In return, each donor received a sum ranging from PhP70, 000 to PhP120, 000. Their act can be seen as purely profit-oriented and materially motivated for it seems as if they were selling their kidneys. Most donors however would deny this and claim that their act is based primarily on the intention to be of help to those in need, or more particularly, to prolong and save the lives of kidney patients. That they received money in return should not overshadow that fact, they would say. Besides, an act of kindness should beget just the same, and very poor people like them deserve an act of kindness more than anyone else.
Tragedies?
Surely, what can you do when you have no decent and stable job and your child is sick and dying in a hospital ward? What would you do if you do not have a house to call your own and your family is starving? What would you do if you have only a few pesos in your pocket, never had anything more than a few hundreds and suddenly an opportunity comes offering P100, 000 for “simply” donating a kidney? Money can indeed make a big difference when you are hungry and desperate. P100, 000 is definitely a lot of money for poor people like the Baseco dwellers, definitely more than the value it is actually worth to people belonging above the so-called poverty line of our economic strata.
|Name* |
|Ⅰ. The total number of Medical Schools, Medical Research Institutions and National Hospitals |248 |
|(1) Members of the Liaison Association of Medical Schools' Ethics Committees |86 |
|(2) National institutes in medicine governed by the three ministries ( MECSST, MHLW, METI ) public research |68 |
|institutions, etc. | |
|(3) Adjunct institutes of national universities, adjunct institutes of private universities, and Inter-Universities |26 |
|research institutes | |
|(4) National hospitals without their branches |68 |
|Ⅱ. Hospitals (without adjunct hospitals of national medical institutes, national hospitals and sanatoriums, adjunct |2,000 / 8,951 |
|hospitals of medical schools, and general clinics with 19 beds or less) | |
|(1) Hospitals with 20-99 beds 3,815 | |
|(1) Hospitals with 20 - 99 beds 3,815 | |
| | |
|(2) Hospitals with 100 - 199 beds 2,590 |823 (1-3) |
|(3) Hospitals with 200 - 299 beds 1,189 | |
|(4) Hospitals with 300-399 beds 691 |822 (4-5) |
|(4) Hospitals with 300 - 399 beds 691 822 | |
| | |
|(5) Hospitals with 400 - 499 beds 311 | |
|(6) Hospitals with 500 beds or more 355 |355 |
Table 2: Total Number of Delivered Questionnaires, Received Responses and Valid Answers [N (%)]
|Category of Institution |Delivered |Returned |Received |Valid Answers |
|Medical Schools and Medical Institutes |248 |3 |118 (48.2) * |103 |
|Hospitals with 20 - 199 beds |823 |16 |142 (17.6) |146 |
|Hospitals with 200 - 499 beds |822 |3 |169 (20.6) |168 |
|Hospitals with 500 beds or more |355 |0 |109 (30.7) |107 |
|Subtotal |2,248 |22 |538 (24.2) |524 |
|Unknown | | | |3 |
|Total |2,248 |22 |538 (24.2) |527 |
2-2. Characteristics of Respondent Institutions
Table 3 lists the characteristics of respondent institutions. As shown in Table 3, we used 7 categories of institutions for analyzing survey results to indicate the particular situation of the ethics (review) committee in each category of institution.
2-3. State of Establishment of Ethics Committees
Table 4 presents the state of the establishment of an ethics committee. Among the respondent institutions, 32.1% set up one ethics committee, 14.5% had two or more ethics committees with different roles, and 7.1% were preparing to set up an ethics committee. However, 46.6% of respondent institutions had not established any ethics committees, and had no plan to do so. Approximately 90% of small-scale hospitals and 54% of middle-scale hospitals had not established ethics committee at the time of this survey.
Table 3 Characteristics of Respondent Institution [N (%)]
|Category of Respondent Institutions | | |Mode of Foundation | | |
|Medical Schools within a university |31 |( 5.9) * |National |58 |（11.7） |
|Medical College |25 |（ 4.8） |Public |142 |（28.7） |
|Medical Institutes |28 |（ 5.3） |Private |191 |（38.6） |
|Medical Institutes with Hospital |19 |（ 3.6） |Others |104 |（21.0) |
|Hospitals |421 |（80.4） | | | |
|With 20 - 199 beds |146 |（27.9） | | | |
|With 200 - 499 beds |168 |（32.1） | | | |
|With 500 beds or more |107 |（20.4） | | | |
|Region of Japan | | |Respondent | | |
|Hokkaido |38 |（ 7.6） |Chairperson of EC |146 |(30.0) |
|Tohoku |43 |（ 8.6） |Member of EC |35 |( 7.2) |
|Kanto & Ko-Shin-Etsu |143 |（28.5） |Administrator of EC |43 |( 8.8) |
|Tokai & Hokuriku |68 |（13.5） |Others |263 |(54.0) |
|Kinki |63 |（12.5） | | | |
|Chugoku & Shikoku |78 |（15.5） | | | |
|Kyushu & Okinawa |69 |（13.8） | | | |
Table 4 State of Establishment of Ethics Committees [N (%)]
| |Single- type EC |Two or more EC with | Others |Preparing |No plan to establish | Total |
| | |different roles | |establishment of EC |EC | |
|Medical Schools |8 (25.8)* |23 (74.2) | ― | ― | ― |31 (100.0) |
|Medical Colleges |5 (20.0) |20 (80.0) | ― | ― | ― |25 (100.0) |
|Medical Institutes |12 (42.9) |3 (10.7) | ― |4 (14.3) |9 (32.1) |28 (100.0) |
|Inst. with Hospital |12 (63.2) |5 (26.3) |1 (5.3) | ― |1 ( 5.3) |19 (100.0) |
|Hosp. with 20 - 199 beds |5 ( 3.4) | ― | ― |9( 6.2) |132 (90.4) |146 (100.0) |
|Hosp. 200 - 499 beds |54 (32.1) | 4 ( 2.4) | ― |19 (11.3) |91 (54.2) |168 (100.0) |
|Hosp. 500 beds or more |72 (67.3) |21 (19.6) | ― |5 ( 4.7) |9 ( 8.4) |107 (100.0) |
|Total |168 (32.1) |76 (14.5) |1 (2.0) |37 ( 7.1) |242 (46.2) |524 (100.0) |
As shown in Table 4, 76 institutions had two or more ethics committees with different roles. Table 5 presents the configurations of the ethics committees within 76 institutions. A total of 37.3% institutions set up two or more ethics committees as a nested structure, and 57.3% placed them on the same level. This suggests that when several ethics committees with different roles were set up within the same institution, they were placed on the same level. When several committees were established as a nested structure, about 57% tried to adjust reviewing standards relative to each other. However, when several committees were placed on the same level, about 43% tried to adjust reviewing standards relative to the other committee.
2-4. Budget for Operating Ethics Committees
Table 6 presents the yearly budget for operating singled-type ethics committees. More than half of all medical schools and medical research institutes prepared a budget for operating ethics committees. While in the case of hospitals, 41% of large-scale hospitals with 500 beds or more and 28% of middle-scale hospitals with 200-499 beds prepared a yearly budget for operating committees. Respondents suggested that a significant portion of the budget was devoted to remuneration for the external committee members.
2-5. Means and Contents of Public Release
Table 7 presents the means of public release of proceedings and other relevant materials of ethics committees. A total of 28% of medical institutes with a hospital and 20% of small-scale hospitals with 199 beds or less released such information by written documents, and they allowed reading of the materials and making photocopies of them. In the case of medical schools, 29% used their own webpage for public release. Approximately 47% of middle-scale hospitals and large-scale hospitals did not prepare any means of public release concerning information of ethics committees’ activities. As a whole, the content for public release consisted of the title of the research protocol, the name of researcher and a summary of the proceedings of the committees’ meeting.
Table 5 Configuration of Ethics Committees within 76 Institutions [N (%)]
| |Nested Structure |Placed on the Same |Others |Total |
| | |Level | | |
|Medical Schools |8 ( 36.4)* |12 ( 54.5) |2 ( 9.1) |22 (100.0) |
|Medical Colleges |6 ( 30.0) |12 ( 60.0) |2 (10.0) |20 (100.0) |
|Medical Institutes |3 (100.0) |― |― |3 (100.0) |
|Inst. with Hospitals |1 ( 20.0) |4 ( 80.0) |― |5 (100.0) |
|Hosp. with 20 - 199 beds |― |― |― | |
|Hosp. with 200 - 499 beds |3 ( 75.0) |1 ( 25.0) |― |4 (100.0) |
|Hosp. with 500 beds or more |7 ( 33.3) |14 ( 66.7) |― |21 (100.0) |
|Total |28 ( 37.3) |43 ( 57.3) |4 ( 5.3) |75 (100.0) |
Table 6 Budget for Operating Single-type Ethics Committees [N (%)]
| | |Budget Prepared |Budget not |Total Amount of |Min |Max |
| | | |prepared |Budget / Year ( Yen | | |
| | | | |) Mode | | |
|Medical Schools |(n= 5) |3 (60.0)* |2 ( 40.0) |100,000 |100,000 |330,000 |
|Medical Colleges |(n= 4) |2 (50.0) |2 ( 50.0) |500,000 |500,000 |500,000 |
|Medical Institutes |(n= 5) |3 (60.0) |2 ( 40.0) |150,000 |150,000 |3,000,000 |
|Inst. with Hospitals |(n= 7) |6 (85.7) |1 ( 14.3) |40,000 |40,000 |1,500,000 |
|Hosp. with 20 - 199 beds |(n= 3) |0 ( 0.0) |3 (100.0) |- |- |- |
|Hosp. with 200 - 499 beds |(n=29) |8 (27.6) |21 ( 72.4) |26,000 |26,000 |200,000 |
|Hosp. with 500 beds or more |(n=39) |16 (41.0) |23 ( 59.0) |0 |― |1,200,000 |
Table 7 Means of Public Release [N (%)]
| |by written documents, allowed |by written documents, |on a webpage |others |no release |
| |reading/copying |allowed reading | | | |
|Medical Schools |2 ( 6.5)* |0 ( 0.0) |9 (29.0) |16 (51.6) |7 (22.6) |
|Medical Colleges |2 ( 8.0) |1 ( 4.0) |4 (16.0) |13 (52.0) |6 (24.0) |
|Medical Institutes |1 ( 6.7) |1 ( 6.7) |2 (13.3) |6 (40.0) |4 (26.7) |
|Inst. with Hospitals |5 (27.8) |2 (11.1) |0 ( 0.0) |6 (33.3) |4 (22.2) |
|Hosp. with 20 - 199 beds |1 (20.0) |0 ( 0.0) |1 (20.0) |1 (20.2) |1 (20.0) |
|Hosp. with 200 - 499 beds |4 ( 6.9) |5 ( 8.6) |0 ( 0.0) |12 (20.7) |27 (46.6) |
|Hosp. with 500 beds or more |10 (10.8) |3 ( 3.2) |1 ( 1.1) |30 (32.3) |44 (47.3) |
Table 8 State of Implementation of Monitoring the Progress of Researches [N (%)]
| | |implementation |no implementation |Total |
| |Medical Schools |14 (46.7)* |16 ( 53.3) |30（100.0） |
| |Medical Colleges |9 (36.0) |16 ( 64.0) |25（100.0） |
| |Medical Institutes |3 (25.0) |9 ( 75.0) |12（100.0） |
| |Inst. with Hospitals |4 (23.5) |13 ( 76.5) |17（100.0） |
| |Hosp. with 20 - 199 beds |- |4 (100.0) |4（100.0） |
| |Hosp. with 200 - 499 beds |8 (15.4) |44 ( 84.6) |52（100.0） |
| |Hosp. with 500 beds or more |11 (12.6) |76 ( 87.4) |87（100.0） |
| |Total |49 (21.6) |178( 78.4) |227（100.0） |
2-6. Monitoring the Progress of Researches
Table 8 presents the state of implementation of monitoring the progress of research in each institution. Among the respondent institutions, only 22% kept track of the progress of an approved research by, for example, receipt of a research progress report on a regular basis, at least annually. A total of 78.4% had no experience of monitoring the progress of research. Concerning on-site investigations only medical schools and medical research institutes indicated that they implemented it using qualified external persons.
Table 9 Problems and Claims on Operating Ethics Committees [N (%)]
| |Medical |Medical |Medical |Inst.with |Hosp. With |Hosp. With |Hosp. With |
| |Schools |Colleges |Institutes |Hospital |20-199 beds |200-499 beds |500 beds or |
| | | | | | | |more |
|Procedural burdens |23 (85.2) |16 (64.0) |
|% |Yes |No |DK |W0 |W1 |W2 |W3 |
|Computers |
|2003 |82 |4 |14 |34 |50 |11 |4 |
|1993 |85 |3 |12 |57 |34 |7 |2 |
|In vitro fertilization (IVF) |
|2003 |56 |18 |26 |15 |48 |25 |12 |
|1993 |47 |23 |30 |13 |45 |28 |14 |
|1991 |58 |21 |21 |21 |29 |23 |18 |
|Genetic Engineering |
|2003 |60 |8 |32 |13 |45 |31 |11 |
|1993 |57 |10 |33 |22 |39 |24 |15 |
|1991 |76 |7 |17 |19 |29 |21 |20 |
|Pesticides |
|2003 |75 |10 |15 |15 |42 |29 |14 |
|1993 |84 |9 |7 |21 |36 |26 |17 |
|1991 |89 |4 |7 |27 |23 |25 |18 |
|Cloning |
|2003 |28 |27 |45 |7 |24 |27 |41 |
Some scientists think that it’s not good as a scientist to show ordinary people only technical information. They think they can’t fulfill their responsibility. So some scientists try to devise various materials to make people know and think. In a practical manner, were can ask do people recognize the information and understand scientist’s or expert’s information? In which way do they understand? Let us look at a few examples to consider it.
The public survey results were obtained in the 2003 public survey across Japan, and this paper looks at the analysis of open comments given in response to the questions: "Do you personally believe each of these scientific discoveries and developments is a worthwhile area for scientific research? Why?", and "Do you have any worries about the impact of research or its applications of these scientific discoveries and developments? How much? Why?", in the case of four technologies (In vitro fertilization, biotechnology, agricultural pesticides and cloning ). (Table 1, Inaba & Macer, 2003).. The public survey results were obtained in a 2003 public survey across Japan. A random nationwide survey of 377 Japanese citizens was conducted from Nov. 2002-Jan. 2003, via mail response. The results were discussed last year in TRT8, and published in the May 2003 issue of the Eubios Journal of Asian and International Bioethics (Inaba and Macer, 2003).
The respondents gave a range of interesting comments, and some examples will be given which reveal some characters of Japanese mixed feelings about these applications of technology. These will be analyzed in the light of trends in public opinion since 1991 in Japan. For comparison let us consider some quotations from so-called experts. Let us consider some examples topic by topic.
Most people do not see any large risk from the use of computers, and many see them as providing benefits to us. Some example comments are shown here about Computers by the Public:
Q6 Do you think the research is useful?
It is useful as a labor saver. (Yes) Computers are necessities of life and business. (Yes)
Q7 Do you feel uneasy about the research and the application?
It supports not only our life but also spiritual activity. (No worries)
I don't feel any uneasy at all. (Few worries)
It's not problems the research about computer in itself. The problem is human's intention.
Owing to mechanize the human. (Some worries)
People probably make bad use of it; on the other hand, we don't feel very uneasy because computer is not a living thing. (Some worries)
Here are some comments about Computers from Experts:
Dr. Masashi Tsuboi, Research associate, University of Hiroshima said:
"What's the intellectual ownership, and how do we admit this? What does invasion of privacy mean?"; "We need to make the standard clear to prevent people from infringing on other's rights and giving rise to public discussion."
Dr.Shinji Yamane, Tohoku Uni.said;
"If the computer is adopted in the company and linked by network, what issue will we have then?
How effects will SOHO on our lifestyles?"
Hacker Ethic, RFC Statements on Ethics, and Local Rules said: "Making bad use/abuse of computers. The hacker's ethics."
While many people see some benefit from in vitro fertilization, many also see risks. Some example comments are shown here about In-vitro fertilization made by the Public in the survey.
Q6 Do you think the research is useful?
It is available for sterilization. (Yes)
If ethics can be provided, this research has the value of learning. (Yes)
I admit the research if the parents love each other.(not allowed the surrogate mother) (Yes)
It's the earnest problem for the people who can't be childless. (a majority opinion) (Yes)
For people who hope it in the future. (Yes)
People who haven't very parental affection likely increase,bacause the mother will bear a child without the pain of childbirth. (No)
Do people want to bear such a thing? (No)
I don't know because I'm not the person concerned. (Don't know)
Can we clear the mental problem? (for a patient/society) (Don't know)
Q7 Do you feel uneasy about the research and the application?
Profit-making (Few worries) We can't deny of the risk of HIV infection. (Few worries)
The technology and ethics are out of gear. (Some worries)
Can we have parental affection to the baby as human? (Some worries)
The research is too forward and argument is leaving behind. (Many worries)
Comments about In-vitro fertilization by Experts include a Touoh dairy news :2001.8.8 editional "Can we use of human's fertilized egg for research?", "A fertilized egg is beginning to have values as medical resources (sterilization separately) So we need to impose the controls to save fertilized egg." In-vitro fertilization hasn't been known to Japan and we don't have knowledge of this. (general people,doctor,and medical staff...) In addition, not only doctors but also people are very interested in this topic. So this is a sensitive problem and requires careful handing.
The results in Table 1 shows how there was a drop in support in Genetic Engineering seen from 1991, when 76% in Japan said that they thought that genetic engineering would be a worthwhile area in their country, while 20% were extremely worried about it. In 1993, only 57% believed that genetic engineering was a worthwhile area for scientific research, but still only 15% had a lot of worries about it. In 2003 60% saw it as worthwhile, and 11% had a lot of concerns about it. Here are comments about Genetic engineering by the Public:
Q6 Do you think the research is useful?
It's impossible to think about human from a gene. (Yes)
It’s helping to overcome of starvation. (Yes)
To make sure of safety. (Yes)
From the human health point of view, we should expect GE. (Yes)
The gene sphere must not infringe. (No)
Q7 Do you feel uneasy about the research and the application?
I think O.K because the rest is only progressing of technology .without thinking about ethics. So this is a sensitive problem and requires careful handing. (Few worries)
What's "genetic engineering"? (he/she doesn’t know the word.)
How do we handle the results of research? (Many worries)
Can human operate a gene? (Many worries)
Here are comments about Genetic engineering by Experts:
Ms.Junko Ito who is belongs to Life and bioplaza 21 said, "By about 1997, a government office, a cooperative society and a fringe organization give questionnaire considerably. The result says nothing has been left ensued about GMO foods. But people still feel uneasy to GMO food at the questionnaire about foods. Our lives contradict the Japan: a bio-science nation." Unless we talk about our uneasy honestly, we wouldn't solve the issue.
While many people see some benefit from pesticides, many also see risks. Here are some comments from the Public:
Q6 Do you think the research is useful?
I hope Pesticide is not worse for the human body and I need not to use it much. (Yes)
I think Pesticide should be researched about safety for environment. (Yes)
I want to eat natural foods. (No)
It's necessity for developing countries, but can we make really safe pesticide? (Don't know)
Q7 Do you feel uneasy about the research and the application?
Safety/the free access to information (Few worries)
Depends on user's ethics. (Some worries)
We inoculate Pesticide with foods. (Many worries)
I think AC is necessary, but it's hard to understand the completion. (Many worries)
Experts comments include the comment from a representative of an Inspection Station of Agricultural Chemicals who said "An agricultural chemical is used for saving labor and getting specific effects. Exploiting a bio-chemical."
The highest level of concern was shown about cloning. Cloning is of much concern to the Public, but some benefits were also seen.
Q6 Do you think the research is useful?
The sphere of using is wide. (Yes)
It's good for developing medical supply. (Yes)
Mass-producing farm animals which has superior gene. (Yes)
It's good for preserving species and knowing the risk of cloning clearly. (Yes)
Therapeutic cloning includes a possibility of medical regeneration. (Yes)
Ethical arguments are not enough. (No)
The purpose is not clear. (Don't Know)
I don' know "cloning”. I can't understand it.
Q7 Do you feel uneasy about the research and the application?
Because I don't know the details of cloning. (No worries)
If anyone make human's clone, maybe it's trouble. (Few worries)
If copies increase, we don't find natural. (Some worries)
I can't understand the necessity. (Some worries)
Can cloned-man get human rights? (Some worries)
It happens to trouble for spiritual as human, in addition to that the ethics may be lost. (Many worries)
Cloning was also debated by Experts. The law of clone control said: "It is forbidden to produce clones of human by the law. Research of particular embryo, cloning embryo of human e.g. is controlled by the guide based on the law."
The Clone World HP said: "The aim of clone engineering isn't "to produce of cloned livestock" but stable produce livestock much more."
Discussion
Looking at what people say allows us to examine the way that people's views are shaped in society and the interplay between different groups. We can find the sentence “this affair raises ethical problems” in daily news and reports, but they usually don’t refer to any concrete ethics. Therefore people can recognize some topics as ethical problems, but they can’t have concrete proposition and correct knowledge to think about things.
In contemporary Japan, technology and information interplay more, so we shouldn’t neglect these issues. And if the sender and the addressee couldn’t keep a balance, this "collision" will continue in the future.
In conclusion we need to ask for whom or for what do scientists really study? Can this technology contribute to people and/or the environment in the long run? Is it good to propel technology or hesitate? Even if a research purpose is purely a closed inquiry, it is necessary for scientists to act with thinking about it. And more, as to applicable technology, we need to think about the influence in society and in the future.
“Intergenerational ethics” is talked about commonly in environmental ethics. We should apply such ideas to bioethics. At the same time, people who receive information must consider about their own life issue. Unless for some strange reason Japanese people cannot consider these issues, Japanese society should immediately think objectively of the issues, which face other persons. Also if we suddenly face the problem, we may get into a panic. It is better to think beforehand.
Bioethics is requested to bear a part as an interface because of solving the gap between people and scientists. Such thinking activity results from the mind of thoughtfulness for others. We also study philosophically about the influence of thoughtfulness about technology and bioethical issues in society.
Confidentiality and Duty to Warn: Challenges of Genetics Information on the Physician-Patient Relationship in Taiwan
- Shinrou Lin.
Research assistant, the Core project on ELSI Research sponsored by National Science Council,
NRPGM, Taiwan, ROC
Email: rou@.tw
Introduction
Medical professionals have upheld the principle of confidentiality for more than two thousand years since the Hippocratic Oath. They acknowledge medical information is sensitive personal information and appropriate disclosure of patients’ medical information may cause harm to the bonds of trust between physicians and patients may occur without this obligation. Traditionally, a physician’s duty of confidentiality forbids the physician to disclose information about the patient’s case to other parties concerned in order to avoid spillover of the patient’s information out of the physician-patient relationship. However, it has been recognized that physicians may breach confidentiality to protect public health and certain third parties since preserving confidentiality may bring greater harm in such situations.
While genetic research empowers us with better understanding of the blueprint of humans, this scientific progress brings new challenges to the society. One of the most dominant issues is to whom may a patient’s genetic information be disclosed? To answer the question, courts of the United States have applied the duty to warn doctrine that is developed in lines of cases to place a duty on physicians to warn at-risk third parties and applied to genetic cases to protect a patient’s offspring. This complicates physician’s assessment of patient confidentiality. With medical advancement, physicians are facing more and more difficulties to maintain the old ethics and laws of medical confidentiality.
Patient confidentiality is a widely accepted medical ethic in western countries but a foreign concept in Taiwan despite the fact that physicians in Taiwan receive comparable education as doctors in the west. It is not uncommon to see physicians in Taiwan go on TV and talk about patients’ secrets. Last year, when my grandfather was diagnosed with cancer, his physician disclosed this information to all the family members without my grandfather’s knowledge and consent. Clearly, these are violations of patient confidentiality. Therefore, what is the attitude of Taiwanese to patient confidentiality? Additionally, there are few debates centered on the patient’s right to confidentiality versus third party interests in Taiwan while the Code of Physician Ethics and concerning health laws recognize medical confidentiality as a value worth protection. Why? While western doctors are in the dilemma of keep patients’ information private and third parties’ interest of knowing patients’ information, is this a problem in Taiwan? What should be Taiwan’s concern in the conflict of confidentiality and duty to warn?
This paper is divided into four parts. Part one begins with a discussion of physicians' duty to confidentiality and the duty to warn doctrine created by courts in the United States. Part _ I explore the attitude of Taiwan society to medical confidentiality. In Part _, I compare the concerns of the United States and Taiwan on the confidentiality and duty to warn issue based on my analysis in part one and part two. Finally I will conclude that it is impractical for Taiwan to follow the duty to warn doctrine and Taiwan should build its own frameworks for the confidentiality principle to avert current comprehensive disclosure of patients' information to preserve patients' privacy and dignity.
1. Confidentiality－principle and exception
Physicians are obliged to keep their patients’ information secret. Codes of ethics and laws prescribed this duty to provide a foundation for trust in the physician-patient relationship. However, in some circumstances, it is necessary to breach this duty because revealing patients’ information might significantly avert harm to others. Except for requirements in statues, courts of the United States have created a duty to warn doctrine to balance third party’s interests of knowing patients’ information.
A. General principles
Much earlier than the birth of the law of privacy in late 1800s, the principle of confidentiality has been declared an important ethical rule for medical practice for as long as two thousand years since Hippocratic Oath. It declared: “Whatever, in connection with my professional service, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.”[44][45]
The Declaration of Geneva in 1948 also stated: “I will respect the secrets which are confided in me, even after the patient has died.” The general principle of confidentiality forbids the physician to disclose information revealed by a patient or discovered during the course of treatment of a patients to other parties.[46]
The duty of confidentiality forbids the physician to disclose information revealed by a patient or discovered during the course of treatment of a patients to other parties. No body can deny that medical information is one of the most sensitive personal information that require proper rule of disclose to prevent harm to patients and insure the bonds of trust between physicians and patients. Inappropriate disclosure of health information may have harmful impact on the person such as injuring one’s reputation, losing jobs and insurance, being alienated from friends and families, public discrimination and psychological distress. On the other hand, patients are eager to develop close relationship with their doctors in a short time because that they can save lives. However, to develop close relationship with physicians, patients have to reveal private and sensitive information that even cannot be shared with their families. If a patient cannot believe that their physicians will keep the information confidential, the patient may not be willing to provide truthful information. In this context, the duty of confidentiality guarantees patients to feel free to make a complete disclosure.
Healthcare providers have long acknowledged the importance to maintain patient confidences. If a doctor is provided uncompleted or false information, the patient may not be given proper care and physicians’ ability to treat the patient may be impaired. Therefore, the duty of confidentiality enables physicians to make an appropriate diagnosis and give fitting treatment. With the knowledge that physicians will keep their information private, patients will be more willing to seek help and the purpose of medicine can be accomplished.
A physician’s duty to confidentiality is not only adopted in ethical codes but also prescribed in laws. Further more, to avoid unreasonable enforcement on physicians to reveal patients’ information, evidence rules provide a testimonial privilege to physicians to refuse to testify in a court proceeding.[47]
B. Duty to Warn－patient confidentiality versus third party interest of knowing
While respect for confidentiality is widely accepted, the principle of confidentiality is not absolute. Generally, a patient’s health condition may be disclosed to third parties, including member of the patient’s family, patient’s attorney and other third parties only if the patient has made a valid consent. Without patients’ consent, disclosure of confidential information must be under the requirements of laws. Moreover, disclosure may be appropriate if it is necessary to fulfill the duty to warn to protect specific persons at risk of serious harm, such as a crime.[48]With discovery and better understanding of diseases, courts of the United States have created a duty to warn doctrine in lines of cases involving different kinds of diseases. Under the duty to warn doctrine, if a physician believe that specific third parties are placed in imminent and serious danger depending on the patient’s medical information at hand, the physician owes third parties a duty to warn the impending harm.
1. Contagious Diseases
The first case to burden a physician whose patient has a contagious disease that can be contracted by a third party with a duty to warn was Skillings v. Allen.[49] In Skillings, a physician advised the parents of a minor child, who was in the hospital with scarlet fever, that they could safely visit their daughter or take her home, who was in the hospital with scarlet fever. After the parents acted on the physician’s advice and both of them contracted scarlet fever, the parents asserted a cause of action against the physician. The supreme court of Minnesota held that physician has a duty to use due care in advising a patient's parents about the potential transmission of disease.[50]
2. Violent psychiatric patients
The most famous case concerning a psychiatrist’s duty to warn is Tarasoff v. Regents of the University of California.[51] In Tarasoff, a patient confided his intention to kill another with his psychiatrist and the patient carry out the homicidal plan. The psychiatrist was sued by the victim's parents for failure to warn the imminent danger. The California Supreme Court concluded that psychotherapist's revelation of a patient's communications is not a breach of trust or a violation of professional ethics where “such disclosure is necessary to avert danger to others”;[52] “public policy favoring protection of the confidential character of patient-psychotherapist communications must yield to the extent to which disclosure is essential to avert danger to others”; “the protective privilege ends where the public peril begins.”[53]
Following Tarasoff, nationwide courts have accepted Tarasoff to impose a duty on psychiatrists to warn foreseeable victim of the danger from a patient although the California Supreme Court narrowed the rule to exclude “nonspecific threats of harm at nonspecific victims” in Thompson v. County of Alameda.[54] Many states also codified the psychiatrist’s duty to warn third parties when the psychiatrist’s patient is mentally ill and poses an obviously threat to an identifiable individuals.[55]
3.HIV Cases
More controversial cases involve duty to warn third parties who may be exposed to HIV via the patient. The California Court of Appeals first applied the Tarasoff doctrine to an HIV case.[56] A minor girl received a blood transfusion when undergoing a surgery at a hospital. One day after the surgery, physicians discovered that the blood was contaminated with Human Immuno-Deficiency Virus (HIV) antibodies, but physicians did not pass the information to the patient or her parents. Three years later, the plaintiff began dating the patient and became intimate with her. Two years later, the patient was diagnosed with AIDS and she told the plaintiff. Shortly thereafter, the patient died and the plaintiff discovered he was HIV positive. He sued the patient’s physicians for negligence.[57]
4. Hereditary genetic defects
Two cases have been reported that exactly addressed whether the duty to warn a patient’s relatives of the patient’s genetic disorder should be recognized.
a. Pate v. Threlkel[58]
The Supreme Court of Florida first analyze the issue that "Does a physician owe a duty of care to the children of a patient to warn the patient of the genetically transferable nature of the condition for which the physician is treating the patient?" in Pate v. Threlkel. Patient's adult child brought medical malpractice action alleging: 1) the physicians knew or should have known of the genetic transferability of the disease; 2) the physicians owed the patient a duty to warn her that her children should be tested for the disease; 3) if the patient had been warned, she would have had her children tested; and 4) after being tested, the plaintiff could have taken preventative action which would have made a cure more likely than not.[59]
The Court found that a reasonably prudent physician would give such warning to his or her patient in light of all relevant circumstances.[60] Physicians had duty to warn of genetically transferable nature of condition, and this duty ran to patient's children despite lack of privity. The Court also addressed that since the physician is prohibited from disclosing the patient's medical condition to others except with the patient's permission, warning the patient would discharge such duty and it would not be necessary for physicians to warn children.[61]
b. Safer v. Estate of Pack[62]
Patient’s daughter who suffered from cancerous blockage and multiple polyposis brought a suit against estate of physician who had treated her father for multiple polyposis in 1950s. In 1990, Ms.Safer was diagnosed with cancerous blockage of the colon and multiple polyposis. Thereafter she obtained her father’s medical; records, learning that her father had suffered from multiple polyposis. She filed her complain in 1992, alleging that cancerous polyposis was a hereditary condition and the treating physician knew of such hereditary nature but had breached duty to inform those who were potentially at risk so that they might have opportunities to avoid developing condition.[63] The Superior Court of New Jersey reached a conclusion different from the Florida Supreme Court's conclusion in Pate, holding that a physician owes a duty to warn, not only to the patient itself, but also to members of the patient's immediate family who may be adversely affected by a failure to warn.[64] This duty can not be satisfied by only warning the patient but requires physicians to exercise reasonable care in assuring that information reaches those likely to be affected or that information is made available for their benefit.[65]
From the aforementioned cases concerning duty to warn genetic disorder, it is clear that genetic technology has pushed the conflict of duty to warn and confidentiality to a new stage. In Pate, the court did not require physicians to warn the non-patient third parties as cases of psychiatric patients and contagious diseases did on the ground of the physician’s duty of confidentiality. In contrast, the Safer court’s discussion reflected the doctrine of Tarasoff and rationale in contagious cases though it also noted the problematic issue of the physician's duty of confidentiality. It also remarked a more challenging conflict that court might have to face one day is that “between the physician's broader duty to warn and his fidelity to an expressed preference of the patient that nothing be said to family members about the details of the disease.”[66]
C. Summary－challenges to confidentiality
While courts and the medical profession in the United States acknowledge the value of confidentiality, numerous exceptions have been created to protect third party interests. Under the duty to warn doctrine, the physician seems to take on some responsibility to protect third parties from predictable harm created by the patient by entering into a physician-patient relationship. If physicians have good reason to believe specific individuals are placed in serious danger depending on the medical information at hand, a duty to protect identifiable individuals from any serious threat of harm is more important than the duty to confidentiality. This duty to warn doctrine has been applied to contagious diseases, violent psychiatric patients, HIV patients, and recently genetic disorder risks. Physicians’ duty to protect non-patient has been extended to many circumstances and different at-risk third parties. The imposition of a duty to warn reflects not only more and more concerns for the interested third party but also continuing challenges to confidentiality with discovery and better understanding of diseases.
2. Medical Confidentiality in Taiwan
While western countries preserve confidentiality as a core value of medical practice, it is unclear that what is the attitude of Taiwan society to confidentiality. To analyze professional ethics and concerning laws may give us a picture of the reality of confidentiality in Taiwan.
A. Code of Physician Ethics
The medical society in Taiwan does not have an official ethical policy until the adoption of the “Code of Physician Ethics” by Taiwan Medical Association in 2001. Since then, the Code becomes a source to discover medical professionals’ opinion to medical ethics, including the duty of confidentiality.
Article Eleven of the Code of Physician Ethics clearly states that “Physicians should respect patients’ privacy; physicians may not reveal the information disclosed to a physician during the course of the patient-physician relationship without a good reason unless required by law.”
Nevertheless, Article Eight of the Code says: “Physicians should provide relevant medical information for the patient, explain the condition, treatment and prognosis to the patient or the patient’s family member(s).”
These two articles implicates that physicians have a duty to keep their patients’ confidences while they are permitted or even obliged to reveal patients’ medical information to family members of a patient whatever the patient is incompetent or has consented, or the family member has been appointed the patient’s attorney under a durable power of attorney for health care. Obviously, the Code of Physicians Ethics has deemed patient confidentiality as a “familial confidentiality” that the patient’s medical information is privileged not only between a patient and a physician but also among a patient, family members of the patient and the physician. Obviously, the Code of Physicians Ethics creates a conflict that how a physician respects patients’ privacy as well as fulfill the obligation to inform patients’ families about patients’ health information. Upon further scrutiny, it becomes even more confusing.
B. Statutes
Laws have recognized medical confidentiality as a value worth protection much earlier than the Code of Physician Ethics, which is quite different from the history of confidentiality developed in western countries. So far, no case is reported concerning breaches of the duty of confidentiality although violation of the duty may constitute administrative and criminal offence.
1. Medical Care Act
Article 49 of the Medical Care Act states:“Medical institutions and its personnel may not disclose confidential information obtained in the course of professional practice without good reason.”
Violation of article 49 may prompt more than NT$5000 and less than NT$50,000 penalty according to article 77. Besides, in article 46, it says “Before conducting a surgery, the hospital should obtain a consent form signed by the patient, the patient’s spouse, the patient’s families, or relevant party of the patient. Before signing the consent form, the physician should explain the purpose of the surgery, the percentage of success and occurrence of possible complication disease and danger to the patient or spouse, families or relevant party.”
According to these two articles, medical professionals are required to keep the patient’s information private as well as share the patient’s health information with the patient’s spouse, relatives and even relevant party. Therefore, if a physician discloses patients’ confidences to those prescribed in the article 46, it is not a violation of the article 49 since law allows it. Undoubtedly, although the confidentiality doctrine is accepted in the article 49 of the Medical Care Act, the requirements in article 46 creates an exception. Unlike the Code of Physician Ethics, third parties who can receive patients’ information include not only family members but also “relevant party.” What does “relevant party” mean? Is a patient’s insurance company a relevant party?
2. Physician’s Act
In this act, there is a whole chapter listing obligations of physicians. Provisions concerning the duty of confidentiality are article 22 and 23. In the article 22, it says:
“ Physician enquired of or entrusted for examination by a relevant authority shall not make false statements or reports.”
Following the article 22, the article 23 states:
“A physician shall not disclose without reason the secrets of another known to him (her) though practice except under the provisions of the preceding Article.”
In violation of these two articles shall be fined an amount of not less than NT$20,000 and not more than NT$100,000 according the article 29.
From the plain meaning of article 22 and 23, physicians have a duty of confidentiality but they are obliged to disclose if relevant authorities enquire them. What do “relevant authorities” mean? Based on physician-patient communication privilege, the Criminal Procedure Law and Civil Procedure Law grant physician testimonial privileges to refuse disclosure in a court proceeding. Why do “relevant authorities” have such a great power or justification to enforce disclosure?
Another explanation of these two articles may be that they are not to place an affirmative duty on physicians to reveal confidential information upon request by a relevant authority but only an obligation to tell the truth if physicians choose to answer based on his belief of ethical requirements. If physicians choose to make a statement, it does not constitute an unlawful disclosure followed by administrative liability. However, because there are no guidelines for physicians’ conduct in disclosing patients’ information, it is equal to a comprehensive privilege to disclosure from a legal perspective. Since it is a privilege, if physicians disclose patients’ secrets when enquired by “ relevant authorities,” no liability will arise against him (her).
In addition, article 12-1 of the Physician’s Act requires that “Physicians shall inform patients or their family members the condition, diagnosis, treatment, medicine, prognosis and the occurrence of possible complication.”
As in the Code of Physician Ethics and the Medical Care Act, this article shows oddity in the patient confidentiality perspective. Patient confidentiality can be breached or even should be breached if family members ask how the patient is doing. Therefore, confidentiality principle is not applicable on patients’ family members without any reason.
3. Hospice Palliative Medicine Act
The special role of family members of a patient in the physician-patient relationship is more clearly certified by the article 8 of the Hospice Palliative Medicine Act, which requires that “Physicians shall inform patients or their families of treatment plan in performing hospice medicine or palliative care to terminal patients, but if patients have expressive intention to know their diagnosis, physicians should informed the patients.”
This article apparently tells physicians that patients’ families’ right to know has priority over patients’ rights to confidentiality.
C. An empty duty of confidentiality
Synthesizing what are discussed above, although ethical code and statues preserve confidentiality of medical information, physicians are permitted to breach it in comprehensive situations without causing a criminal charge or disciplinary action. Keeping patients’ information secret is not actually a principle but is deemed exceptional. This attitude toward the duty of confidnetilaity comes from several roots and results in impact on physician-patient relationship as well as to the whole society.
Causes
First, there is not a solid tradition in medical community to emphasize ethics in their practice. Medical professionals do not have an official code of ethics until 2001 where confidentiality is first time noticed. Attentions on confidentiality are not enough to form consensus on the scope of confidentiality. Therefore, no physician was disciplined in the event of breach of confidentiality so far.
Second, with poor knowledge of medical ethics and conventionally putting emphasis on public welfare more than individual rights, legislatives mistake the requirements of confidentiality resulting in broad permission to disclose patients’ information to unlimited and unspecific third parties. This comprehensive disclosure leads to confusion of what is principle and what is exception of confidentiality. Laws have appreciation for confidentiality but more in favor of duty to disclose to the degree that ignoring the fundamental protection of physician-patient communication privilege.
Last and the most influential reason is the prevalence of family over-participation in the course of treatment. It is common that patients’ families go to clinics with patients and take the responsibility of taking care of patients at bedside. It is taken for granted that patients’ family, usually the immediate family, may obtain patient’s medical information. This medical culture is deeply rooted in familial relationship in Taiwan society and at the same time represents distrust on patients’ autonomy. This family over-involvement culture makes personal medical information never confidential in one’s family, nor physicians think it necessary to keep patients’ confidences from their family members. Physicians don’t refuse to answer family members’ questions regarding patients’ health and prognosis, even feel natural to share information with patient’ family members first when patients’ test results come out. It is not uncommon to withhold information to patients. It is fair to say that physician-patient relationship in Taiwan is not a duality but multitude. Family members have a right to access to patient’s information and physicians are not obliged to maintain confidentiality to patient’s families.
2. Consequences
Because the empty confidentiality, invasion of patients’ privacy becomes normal. Disrespect to patient confidentiality also contributes the tension between physicians and patients today in Taiwan. Patients with certain diseases, like AIDS, are deterred from seeking treatment because fearing dissemination of their information and getting discriminated. More significantly, Taiwan is insensible to issues raised by new technology. The most vivid example is the rash introduction of an IC Card system into the National Health Insurance Program in 2003. Now, with the rapid advancement on genetic research, new challenges on medical ethics have occurred. Without a sound base of medical ethics, it will be difficult for Taiwan to find consensus on these issues.
3.Different concerns in the conflict of confidentiality and duty to warn doctrine
Due to different attitude and practice on medical confidentiality, the United States and Taiwan have different concerns in the conflict of confidentiality and duty to warn doctrine. The former places more emphasis on the creation of exceptions to the general principle of confidentiality because necessities to balance third party interests; the later should be alarmed for the frailty of medical ethics.
A. U.S.－prevent interested third party not informed
The Hippocratic Oath and International code of medical ethics in 1949 admitted no exceptions to the duty of confidentiality. However, recent codes allow physicians to breach confidentiality if required by law. For example, American Medical Association Code of Medical Ethics adopted in 1980 and 2001states that “The patient has the right to confidentiality. The physician should not reveal confidential communications or information without the consent of the patient, unless provided for by law or by the need to protect the welfare of the individual or the public interest.” Thus, according to the AMA’s Code of Medical Ethics, patient confidentiality is not as absolute as the old time but has to be balanced with other interests.
Obviously, there is a trend in the medical community that physicians have responsibilities to their patients as well as to the society. The duty to warn doctrine is created under the movement of limiting individual’s rights to prevent harm to others. In the genetic context, confidentiality prohibits physicians from disclosing a patients’ genetic condition to others, including at-risk relatives, without consent of the patient. Although it is reasonable to expect that most patients will inform their relatives of potential risks, problems may arise where the patient doesn’t want to tell or has died before he or she can give any warning but physicians hold the information that might be helpful for at-risk relatives. Imposing a duty to warn on physicians might guarantee the reach of information to at-risk relatives. In brief, duty to warn release American society’s concerns about interested third party not informed to avoid following harm.
B. Taiwan－prevent third party from knowing too much
Compared with the United States, which requires confidentiality be matained apart from more and more exceptions in various situations, Taiwan only recognizes a limited confidentiality and permits comprehensive disclosure of patients’ information. Because of such a empty duty of confidentiality, interested third parties do not have difficulties in accessing to patients’ information.
A physician has shared his experience of treating patient with HIV positive at the first time in a hospital electronic paper.[67] He said that because of continuing fever of the patient, the anxious resident on the night shift decided to take a chance and ordered HIV test without telling the patient. When the test result came out, he was called to treat the patient. To prevent wrong diagnosis, he ordered the test again and the attending physician immediately called patients’ family members who take care of the patient at bedside, including patients’ children and spouse, for a meeting in his office to tell them the diagnosis and following treatment as well as to advice the spouse to undergo the HIV test. This story vividly presents the weak deference of a patient’s privacy by medical professionals and the third party who has interest in knowing patients’ information, such as the spouse in this case, is well informed in the course of medical practice.
Similarly, in the genetic context, patients’ physicians might first inform at-risk relatives. Patients’ family receive information regarding patients’ health condition, treatment and prognosis previous to patients is ordinary. Now, an individual genetic condition, which is personal and simultaneously familial, reveals potential risks of patients’ family of developing genetic disorders, resulting in greater need of family members to the information and more justifiable for physicians in disclosing information to family of the patients. So, in reality, concerns for interested third party not informed are needless in Taiwan; family members’ interest of knowing patients’ genetic condition undoubtedly has been well protected under the current medical practice. Problem is how about patients’ right to confidentiality? If the patient instructs the physician not to disclose information to anyone, may the physician share information with family members?
Therefore, in Taiwan, challenges to confidentiality is not to provide more protection to third parties but to emphasize the importance of patients’ privacy and respect their rights to determine when and how their sensitive information revealed to their families, friends and others.
4. Conclusion
Confidentiality is a long-standing physician’s obligation to maintain the trust of the patient, to prevent deterring patients from seeking help, and to encourage patients to make full disclosures necessary for treatment. In the long run, protecting confidentiality is in fact the effective way to guarantee everybody’s health. Although cultural differences present a striking contrast to the practice of patient confidentiality in Taiwan and the United States, to say or not to say is a serious question for physicians today whatever in which countries. With great progress in science and technology, more issues may arise to challenge the old ethics and laws. Patient confidentiality is doubtless a topic for debating in the future.
Through analysis of Taiwan’s medical ethics and regarding laws as well as by the observation of current medical culture, I find that the duty of confidentiality is not a principle neither upheld by medical professionals nor admitted as core value of medical practice by the legislations. This empty duty of confidentiality represents fragile respect for individuals’ rights which are usually suppressed by wide-range public needs and family rights. Without a clear duty of confidentiality, it becomes difficult to protect patients’ information from dissemination since the physician-patient relationship is the origin of the information. Once the information is out, it is hard prevent downstream flow of the information.
Because of the difference attitude toward the duty of confidentiality, Taiwan should adopt different approach in resolving genetic information protection issues instead of transplanting duty to warn. The task for Taiwan is to discover the value of long-standing ethics and construct a framework to reconcile local values. It should be fist addressed that there is a strong presumption in favor of retaining patient confidentiality because it provides basis for the trust relationship between a physician and a patient. It is also a start point to preserve individuals’ right to information self-determination. With a sound framework for keep patients’ confidences, individuals may be treated with dignity whatever is sick or not.
Human Cloning in Islamic Jurisprudence
- Abbas Ali Soltani, M.D..
Ferdowsi University, IRAN
Email: asoltani40@
Human cloning is an abnormal human product of science and poses a new question. Jurists have three views on human cloning: 1) It is absolutely illegal. 2) It is allowable just in treatments. 3) It is absolutely legal. Most Sunnits accept the first view; and most Shiites agree with the third one. The Shiites hold this view because of some Islamic jurisprudence like the genuineness of being legal (esalat-ol-helliat), the genuineness of being cleared (esalat-ol-bara’at) and the genuineness of being allowable (esalat-ol-ebaha). On the other hand, Sunnits use the verses of the holy Koran that say that the creation of human beings is specific to God; and they also rely on arguments based on moral beliefs and risks or disadvantages to society. This paper describes the opposing arguments of each group and discusses the conditions in which cloning can be legalized.
Cloning science, like other experimental sciences (for example nuclear energy), has positive and also negative sides, and has animating and useful effects or dangerous and harmful effects. The most important profitable affects are:
1. Its use in multiplying and correction of animals and plants.
2. Helping to recreating and multiplying the endangered or extinct animals.
3. Helping to correcting the genes, that children will be saved from hereditary diseases.
4. Helping to discover ways to care for infertility, that couples can enjoy to be parents.
5. Dividing the completed embryo to several embryoes for succeeding each of them instead of another, infront of probable events.
6. Using cloning for producing amputated limbs and multiplying them to be transplanted instead of terminated limbs. Or regenerating organs like liver and heart, to ensure genetic compatibility with the recipient person, whom had been the origin of first cells, is one of its features.
7. Helping to decrease people’s sorrows and pains for absence of favourite persons, by cloning.
8. Cloning is a gate to understanding the important principle of religious principles, the resurrection. According to verses of Koran and other lessons of divine religions, believe in bodily resurrection is incumbent.
The question remains "How can we get an alive and complete somatic cell from the composed body?" There are some narratives among Islamic Sunnites’ and shiits’ texts that can answer this question. In some of them, we read that any body has pieces that will never terminate and will not become a part of another and if takes place in live food, will not be mixed and never misses its original composition.
This science is new and its products cannot be known, yet it has harms and disadvantages. These probable losses sometimes are from the self for cloning operation and sometimes are external harms that may happen to society or cloned person. Internal harms of genetic science include many doubts and worries about probable happenings and problems of cloning including:
1. Cloned living beings probably will face genetic problems and complications over a long time.
The living being resembles people. There will be danger of termination of them. Because there are 3 billion nucleotides in each person’s body and this magnificent variety is the origin of existence, of human generation, we could be faced to a serious problem by a virus or something. Howsoever, decreasing genetical variety of a society- the cloning - increases this probability that they might suffer from some disease.
2. Become into a beast, as suggedted by Viachlav Tarantol, manager of Rusian molecular genetic institute.
3. Biological indispositions. Viachlav Tarantol said "We have been witnesses in our experiences for equalizinq animals; that in most cases there were some defects and illnesses, and cancer is the most famous among them.
External harms include:
1. Harm to beliefs. Some thinkers, the followers of divine religions, believe that the cloning is interfering in creation. Some others think, this operation is changing God’s work in creation.
2. Moral and anthropological harms.
3. Cloning opens a gate to not making families and to not tolerate family problems.
4.Cloning is against divine nature
Jurisprudential problems include:
1. Loss of identification and legal entity of events because of cloning, for, there is doubt to call this person a human, because of his birth through an abnormal manner.
2. Uncertaity about parentage of the cloned person to the owner of first somatic cell, that if they are just one and resemble each other, or whether they are two different persons.
3. Uncertainty about relationship between the cloned person and woman who has the first cell in her womb.
4. Original jurisprudential uncertainty about the self of cloning. Also religious rules like forbbidance of marriage, inheritance, alimony, are other legal and jurisprudential problems.
Since the subject of cloning, is a new subject, there are naturally disputes among Muslim lawers, jurisprudists and Islamic societies. According to offered theories on internet, magazines, books and scientific societies of sunnits, they believe that cloning is an absolutely illegal fact (even for medical cures), while some believe it as a legal operation just for medical cures such as limb cloning). But most shiite thinkers and scientific societies believe it as a lawful fact, absolutely, and just consider it an unlawful manner when it would be used in negative applications (Alazhar, Egyptian council of (efta), council of (efta) of Palestine, saiied muhammad saiied tantavi sheikh – ol- Azhar doctor sheikh mohammad saeid Al- booti, doctor Nasr farid vasel, doctor Abdol moati boyumi. )
For jurisprudists and clergymen, only by studing the subject and conforming with the principles of Islamic law, finding reasons and evidences, can we declare cloning as an illegal operation. The evidences explained below will either declare it as an illegal operation and stop it’s progress, but if there was not any reason for being illegal, we must declare it as a lawful operation, based upon two principles – the Genuineness of permitting and genuineness of lawfulness.
Islamic jurisprudists have three ideas about cloning: 1: It is absolutely unlawful; 2. Its use in medical operations, is legal and lawful, but human cloning is unlawful; 3 It is absolutely lawful.
Explaining the third view: This group use three practical principles to prove their Theory. The genuineness of lawfulness: by studing and knowing the subject and then conforming the matter with principles of Islamic law, we understand that there is no reason for it being illegal. Thus we use practical principles, that are used when there would be some doubts, and according to genuineness of lawfulness. They conclude that because there is no reason to being illegal, thus cloning is a lawful fact. The second principle is the genuineness of permitting, which means when there is a doubt for an act to be permitted or being unlawful, they use this evidence, so, that a doubtful thing is permited.
Explaining the first view (unlawfulness): There are two groups. The first believe it as an absolutely unlawful act. Egyptian jurisprudist, Doctor Nasr Farid Vasel, says: "We declare the human cloning as an unlawful operation even in medical cures and infertility, because it makes doubts in our religious beliefs. The second group argues that they know that the cloning is unlawful, not because of itself, but for its harms. They declare belief, social, ethical and legal harms for it, and according to prevention of unlawful prefaces, they have opposed human cloning.
Explaining and critizising the evidences used by these opposites of human cloning we can summarize below. First evidence: Cloning is creating and producting a human. Even though, in Islam, human creating is only God’s work. For criticizing this Idea, we can say firstly, the cloning is not making a thing from non-existance that can be compared to divine creation and is only another way for human gereration and multiplying. Secondly, according to the direct verse of Koran, that says: The God creates you and your acts, acts of human are also creatures of God, human cloning is a kind of human act as God’s creature, because God has donated this science to him, like in this verse of koran says: "Nobody knows his science until the same rate that He wants." Body, and if soul comes into the cloned child, this is a sign of God, the creator.
Second evidence: It has been said that if cloning is not creation, it would be also changing the manner of God’s creation. And God, according to his words in the koran (Vesa, vers 119), declares the change in creation as ugly act and evil work - the corruption after the correction, and it is unlawful. For answer against this evidence, we say: The verse seems to mean changing the Creation, Confrontation of the evil act versus God’s work, but cloning, actually has contact with God’s work. Cloning multiplies and resembles, and it is not a real change in creation and it is not included in the verse which says: "There is no revolution in creation".
The claim, destruction of humanity values like friendship, kindness, and devotion, is also an imaginary matter and it has no definite reason. Because the cloned person has body and soul and it is possible by correct teachings to put kindness and devotion into him, like in other persons. But this point, wich says that cloning makes recognizaton impossible, is a solvable prcoblem because we can entact some rules. To recognize people, and to recoginzing these people, ID cards with specific codes can be used, for example. The ages may also be different. At last, cloning has not any harm to the human soul to distract spirtual values.
From the legal point of view, normally, until a theory is actually ready to be applied practically in real world, there would be no rule for it (the exceptions are special cases). Because human cloning has not come into the real world completely and has not passed its evolution levels, most countries and owners of cloning techniques do not have any complete rule for it. Conditions under which permission of human cloning operation could be given could include:
1) In cloning, the man and the woman who give the cells must be known, because there is no legal, lawful, and even comnon descent for unknown persons.
2) At the operation levels, there must be not any illegal subject that could cause denial of the legal descent. For example, if the sexual cell is taken from in an adulterous manner, legal descent will not be proved by it, because in Islam religion there is no respect to the descent of adulterer.
3) There must be no junction with another cells and sperms,in the operation of taking somatic and sexual cells and exitation and feritilization levels. Doubt means the legal descent will be unproven.
4) Persons who do the cloning operation must be specialists and be aware of secrets of the operation, for there should not be harms and hurt to the future child or to human society. This is according to the principle that there should be no harms and harmful acts in Islam, which means that a harmful operation, reasonably and traditionally would be illegal.
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./offices/news title.asp.2003-1-8 lang
Hakim,Mohammad Taghi . Alosol alammeh lelfehjhe almogharan .Amir . gom IRAN .1997
Human Cloning: Reflections on the Meaning of Life and Morality
- Xu Zongliang, Ph.D..
Center for Applied Ethics, Fudan University, Shanghai, CHINA
Email: xzllzx@
In this article I discuss mainly on the reproductive cloning (human cloning) rather than the therapeutic cloning. Human cloning remains a perplexed problem staying in controversy for a number of years. Although at present, attitude that argues against human cloning or that appeals some kind of banning of it shows its predominance, the opposite voice should not be overlooked. In fact, the latter sometimes even sounds strong at length. Moreover, given such declaration like the scientists P. Zavos (USA) and S. Antinori (Italy), the relevant experiments have already been running on the way. Whether on earth human cloning should be permitted or not?
Human Dignity
The dignity of human is a principle of ethics that stands as the base of modern society of democracy and nomocracy, the groundwork of its foundation and development, which must never be shaken. According to individuals, dignity originates from the unique personality of each member in society and its biological basis rests with the uncertainty and diversity that comes along with the natural propagation by the intercourse of man and woman, a genetic feature. That is to say, no one can predestine what kind of inherited trait a newborn baby should have and each newborn life is unique. As to the whole human race, dignity exists as well. Just as the French scholar Delmas-Marty indicated, human dignity finds its embodiment in “the integrity of human beings”, which consists of varied individuals with their distinctive characteristics. So any attempt to obliterate or alter the particularity of individuals would give offence to the dignity of human.
The most profound expression of the principle of human dignity proposed by German philosopher Immanuel Kant is “Man is the end”. Kant regarded man as an end not a means at any time. That is to say, firstly, the being of each person means particular dignity; Secondly, no one can be permitted to set others as the means toward his own end; Thirdly, the expression of the “end” does not indicate that only the individual is the end, the whole human race is also the end. Thus action taken in pursuit of individual’s end but do harm to the whole human race, are in fact violate the gist of “man is the end”.
Let “Man is the end” as an idea of value augment the comprehension of human dignity, survey human cloning upon this perspective and it is not difficult to find puzzles. (1) A cloned body, since it is a result of asexual reproduction, thus no longer has the randomicity and contingency of the regroup of genes, which inhere in the sexual reproduction. A cloned body only has the same genetic characteristics as the one to be copied, therefore he (she) lacks of the biological basis of the uniqueness of individual’s life and it loses the deserved dignity at the beginning of its existence. (2) If the technique for human cloning were permitted to put into practice, the diversity of human genes would be impaired. If a great deal of human being s share the same constitution of gene, the existence and development of the whole human would be terribly threatened. (3) In the view of genetics, a cloned body is a new body that comes into being by the copying and differentiating of the sex chromosomes from father or mother under the condition of artificial activation. It is a progress of copying cells and the copying is predestined according to the will of original person. The result inevitably turns that the process of cloning human has no substantial difference of manufacturing a product: designing beforehand and instrument oriented, the right of having distinctive characteristics of life being deprived.
Autonomy and Public Benefit
Start at the point of maintaining the dignity of individual and the whole human race, it is natural to propose corresponding demands in human rights of individual and the public good in human society. Autonomy in giving birth is a significant aspect of human rights. Among the varied excuses to approve human cloning, the one that sounds most reasonable is probably the contention that people have the autonomy of giving birth. However, if we regard the action of helping the relatively few infertile couples to clone their own children as an individual or sheer private matter, there is really no fault on morality and justice. Nevertheless, the crucial problem turns to be that not only infertile couples have the right of having their own children, what about homosexual families, people who passed the age of giving birth, the singles? Why cannot they demand for their own children? The demand does sound quite reasonable, isn’t it? If we only endow the infertile couples with the privilege and put a ban to the others such as homosexual families, then where does the fairness stand by? If such kind of people mentioned above were all allowed to clone children, and the number of those “procreated children” were not to be limited because of the autonomy on giving birth, accompanying with the theoretical feasibility of cloning in batches, thus not only the perennial problem of population control on our earth would occur in a new turn, but also the more sophisticated problem of society and ethics would probably flood and would result in the turbulence in our society.
Here what is necessary to be further pointed out is that the human right (including the right of giving birth) should not be absolute and without any limitation. According to the idea “Man is the end”, when we stress personal right we ought to put things such as other’s right, the interests of society and the future of mankind into consideration as well. Concretely speaking, those who want to clone to get their own children should think over a great deal of matters after the naissance of children: whether they would be hurt, whether they would have to bear the heavy but unnecessary psychological and social burden. For those who put human cloning in practice, they must weigh whether the flooding of cloned offspring would lead to instability of society and decline of the quality of the whole human life.
The Meaning of Life
Since the techniques on reproductive cloning came existence, human cloning has become the most attractive goal. Besides the hope to get their own children for infertile couples and other families, the aims and motivations to clone human are of a rich variety. Two of the most alluring ideas are to reach eugenics and achieve immortality of life.
Evidently, these two ideas are based on the misunderstanding of cloning techniques. Scientists has indicated long before that a cloned person, although he would inherit the genetic feature of the original one, the arrangement and characteristics of the genetic codes would not be possibly same, because the environment of eggs and uteri and the life surrounding for growing years would be definitely different from those of the original one’s. Therefore, although a cloned person is copied by artificial techniques and resembles the original one physically and apparently, he (she) is absolutely not the re-birth of the original one.
Even though it remains uneasy to keep people from longing for cloning human. Under the subconsciousness of some people, including a number of scientists, the idea of optimizing human races has never faded out. Since the naissance of genetics, it seems that there have always been people who correlate genetics and eugenics and wish to propel the optimization of human races by certain new biological techniques. We cannot doubt the goodwill of these motivations, but the problem is, the will leaded to eugenics sets its basis without the consideration of the diversity of human genes, without the consideration of the dignity of individual and human beings. Once these theories of “eugenics” were actualized, the result would not be difficult to imagine, what else would we gain but make mankind suffer another catastrophe as German Nazis had done during Word War Ⅱ?
Perhaps, for the many people with the purpose of narcissism or some others, they are more desirous to clone themselves so as to acquire immortality of their life. Any life is born to die with the flowering and the withering each acts as an essential part. Nonetheless, people are always enchanted to try to eternalize their life.
The meaning of human life resides in the limited course of life. The limit of life and the existence of death put people to cherish their present life more deeply and spur them to work harder within the limited time, take meticulous care of life and enjoy it. In a word, the existence of death gives prominence to the value and meaning of life and dispels shadows covering the meaning our being. The techniques of human cloning, however, play an opposite role encouraging people’s fascination of their revival by cloning. This easily cause people to look down on the value and meaning of life and help to increase the misdeed of trampling life. Cloning human in batches with the inclination of “instrumentalization” would add further fuel to the fire of impairing the meaning of life. This not only challenges the weighty value of humankind, but also makes direct threaten to the being and developing of human society. However, the techniques of cloning should not be blamed for such situation; technique has no fault. The key point is that open the door of human cloning facilely would probably re-arouse the unreal fancy of living eternally and make people follow the same old disastrous road of immortalization. Thus it can be seen that judging whether it is right or wrong to use cloning techniques, one cannot just stay at the technological layer for this is only a surface, instead, one must pay attention to the more extensive and profound layer of the value and meaning of life. This may be favorable for us to reflect the necessity to preserve human dignity.
Two Queries
In the discussion of human cloning, always some specious contentions merit analysis. Below I will deliberate on two questions.
1. Human cloning is mainly a technical Problem
Many scientists confess that the techniques on reproductive cloning are now far from perfection and the success rate is rather low, so it might cause great disaster if the techniques were used upon human hastily. Once the techniques turned mature, there would be no problem for cloning human. Zaros even holds the opinion that a great deal of researches have already showed high success rate of cloning, under some circumstances, the rate is as high as that of the techniques on tube infant or even higher than that. So he contends actively for the advance of the research of human cloning.
In my opinion, confronting the problem of human cloning, the maturity of techniques is doubtless important, but the ethical principle of human dignity is still more important. Even though the techniques turn to be perfect, they must not be put into use unless those who approve of cloning human put forward sufficient proof to make sure this ethical principle is improper.
2. Human Cloning Can Never be Prohibited
Many experts have repeatedly pointed out that whether or not prohibition will be finally decreed against human cloning in different countries and in the United Nations, the research of it will never stop and cloned human will come into this world sooner or later. The zeal of the research of human cloning grows from varied aims and motivations: some people set out from the curiosity or thirst for exploring truth, they want to discover the mystery of the growth and development of human life through this research; experts such as Zavos hope to release the anguish of infertile couples by these relevant techniques, of course there are other different kinds of motivations. Nevertheless, we insist that the fact that the coming of clone human can never be avoided does not serve as the proper excuse for letting go the cloning of human without prohibition.
First of all, we cannot make the logical inversion thinking that all deeds that cannot be thoroughly forbidden should then be allowable. Thus, things with technological possibilities would all have the feasibilities in society and what would the human society be if so!
Next, frankly speaking, we ought not to overlook the latent tendency of the application of cloning techniques and the emergence of cloned human in the future. Objectively, there exists need for human cloning in our society, let alone that activists like Zavos and Antinori have already immersed in the work. Just as some specialists said, people should properly regard the fact that cloned people would come into existence soon. Thus, it seems useless just to put a piece of decree of prohibition. Nevertheless, in the situation that there have not been sufficient reason to approve of cloning human, we should decidedly prohibit it temporary and try our best to control the emergence of cloned human in the most minimal ranges. On the other hand, once the cloned people really came into existence, we must establish the corresponding regulations as fast as possible so as to treat these peculiar beings, avoid them from being hurt and make society stand out of the influence of them.
In a word, around human cloning and many other problems of biological medical technology, scientists, humanists and the public have published many different opinions, which reflect the maturity of reason and the concern of conscience of mankind. In my opinion, scientists, sociologists, moralists and jurists should all be generous enough to listen to different voices of others in earnest and think deeply from this foundation and then set forth their own more persuasive viewpoint. Simplification and emotionality upon which one is inclined to reject opposite’s opinions sharply would not be advised. In modern society, when there is controversy, it is better to take good means such as discussion, debate, and deliberation. Just as what people said, the character of the ethics of 21st Century should be deliberative. Maybe only in this way can we clarify our ideas better and remove the misapprehension between different sides. Also the advisable attitude helps to further our apprehension on the problem of human cloning so as to gain the appropriate solution in the end.
Moral Disputes Over the Emergency Morning After Pill
- Park Young-Hee and Lee Suk-Hee .
Catholic University of Korea, SOUTH KOREA
The Korean Food and Drug Administration made available the sale of post-sex contraceptives on January 2002, following the after pill “NorLevo” as an emergency form of contraception on November 2001. For fear of misuse or abuse, the administration categorized NorLevo as a special drug, which requires medical prescription by a doctor. Developed by HRA Pharma of France, the marketing of NorLevo has raised moral dispute. The Ministry of Health and Welfare, the Committee for the Protection of the Adolescent, the Korea Pharmacists Association and the Planned Parenthood Federation of Korea agree with the use of NorLevo. The pro-choice group argues that NorLevo is an emergency contraception; however the pro-life group argues that it is an abortion pill. NorLevo is an anti-progesterone drug that induces abortion by blocking essential hormones needed to maintain pregnancy.
We can see that the abortion permission standard of the Child-Mother Health Law is due to serious increase in the number of abortions in Korean society. The limits of the application depend on how we analyze it. Released in 1973, the Child-Mother Health Law was passed in order to decrease the rate of population growth. The Government has allowed the sales of emergency contraceptives resulting in over 1,500,000 abortions per annum. Emergency contraceptives have been on the market since September 2001. In 2002, sales reached over 1.8 million won. Even though there were ethical debates about its maleficence when it was first introduced into the market; currently, there are hardly any studies on its side effects.
Cloning Controversies in Korea
- Park Hee-Joo, Ph.D..
Myungji University, SOUTH KOREA
E-mail: hjpsmile@yahoo.co.kr
This study documents the development of cloning controversies in Korea. Philosophers love to invent new concepts. In contrast, historians try to understand events through periodization. So I divided the recent development of cloning controversies in Korea into three periods.
1. Feb. 22, 1997 - Dec. 1998 : Korean Responses to Dolly
2. Dec. 1998 - Aug. 2000 : From Dolly to Yongrongi: Korea getting its own Cloning agenda
3. Sep. 2000 - Present : From Reproductive Cloning to Therapeutic Cloning
Following this framework, I will briefly explain the key episodes in these periods.
1. Feb. 22, 1997 - Dec. 1998 : Korean Responses to Dolly
The first period starts with the birth of a cloned sheep Dolly. Right after the news announcement of Dolly, Korean society hotly debated the ethical and religious implications of this technology. Two weeks after the announcement, Christian fundamentalists and Catholics submitted petitions to the government for cloning ban and rallied against cloning. They cried, "This is direct denial of the God-given order of the created world." A Buddhist claimed, "Even if human cloning is done, we cannot clone one's own karma". (Karma is a Buddhist concept that one's present life is affected by his/her previous life)
A month after Dolly, the Journalists Association of Korea convened the first public debate on cloning and this opened the floodgate of public discussions on cloning. Citizen's Coalition, the largest non-governmental organization in Korea, also actively participated in cloning disputes. It suggested a consensus conference as a means to settle the issue. Actually two years after this suggestion, a consensus conference on cloning was held. We will get back to this later.
2. Dec. 1998 - Aug. 2000 : From Dolly to Yongrongi: Korea has its own Cloning agenda
On 14th Dec. 1998, Lee Boyon, a professor of the infertility clinic at Kyonghee University in Seoul, made a media announcement that his team succeeded in cloning human embryo, using nuclear transfer technology. Even though he stopped the experiment before implanting it in a woman's uterus, this was shocking news. If this was true, it was the world's first case of cloning human embryo.
This happening developed into a sort of an international scandal and New York Times reported that this experiment garnered international accusations rather than admirations. So Korean Medical Association immediately sent an investigation team. As it turns out, this happening was a mixture of misunderstanding and desire for fame. Lee Bo-Yon had wrong information that Roselin Institute of Scotland had already cloned human embryo. In fact, Roselin only planned to do it but didn't do. Lee Boyon was mistaken and that if Roselin did it, why not me. So he did it to show off the scientific capability of his hospital.
In an interview with a news magazine later on, Lee Boyon made a puzzling confession, "I am a Christian. I believe cloning is a God's gift for medical advancement. I even prayed for a successful experiment". He added. "I did cloning out of sincere hope to help infertile couples". Religious, environmental, and citizen's organizations were furious about this happening and launched a Bioethics Coalition against human cloning. Korean Medical Association also issued A Guideline for Cloning.
Three months after this episode, another cloning news burst out. Fortunately, it was a cow this time. Hwang Woo-Suk, a professor of veterinary medicine at Seoul National University, announced his team succeeded in producing a cloned cow, named Yongrongi. With Yongrongi, Korea became the world fifth nation succeeded in animal cloning.
As events surrounding cloning escalated, Korean Bioethics Society issued "A 1999 Bioethics Statement on Cloning". Citizen's Coalition also convened a Consensus Conference on cloning in Sept. 1999. The final report of the conference read, citizen's panel "unanimously agreed on banning human cloning under any circumstances." It is notable that it opposed not only human cloning but also human embryo cloning, which aimed to extract stem cells. So we enterer into the third period, therapeutic cloning in Korea.
3. Sep. 2000 - Present : From Reproductive Cloning to Therapeutic Cloning
Since Gearhart and Thompson’s success of extracting human stem cells in Dec. 1998, therapeutic cloning became the focus of cloning controversy worldwide. Korea was not an exception in this move. Korean researchers were busy to replicate their success.
On 9th, Aug. 2000, Professor Hwang Woo-Suk announced his team succeeded in cloning human embryo and applied patents for this internationally. This experiment aimed to extract stem cells from the cloned embryo but did not reach to that stage this time. He didn't specify what kind of eggs he used but it turned out they were cow's. In fact, he fused a nucleus extracted from a man's ear skin cell to an enucleated cow egg. For the critics, this was the worst kind of cloning scenario, resulting possible creation of half man and half animal, a chimera. Facing vehement opposition, he eventually gave up to pursue this line of experiment any further. But he made a surprising comeback later on.
Where Hwang Woo-suk left, Park Se Pill, director of the Maria Infertility Research Institute, came in. Just three weeks after Prof. Hwang's announcement of human embryo cloning, Dr. Park announced he succeeded in extracting stem cells from human embryos. In order to circumvent ethical condemnations, he used embryos that were stored and would be discarded after IVF in his clinic. Since then he continually produced stem cell lines, three of them were officially registered at the NIH of the U.S.
Even though his fertility clinic was the nation's largest one, human eggs were scarce resource. So Dr. Park also decided to utilize cow eggs in his experiment. In the middle of March 2002, The Wall Street Journal reported Dr. Park's controversial experiment under the title “Fusing Human DNA and a Cow Egg Creates … World-Wide Debate”. (WSJ., March 19, 2002).
Now get back to Hwang Woo-Suk again. Since the happening in Aug. 2000, he focused on animal applications, such as producing a cow that has mad-cow disease resistance. Last December, in an interview with a newspaper, he said, he gave up cross-species cloning or any cloning involving human altogether. But a week before this interview, in fact, he had already finished a cloning experiment that could be one of the landmarks in the history of cloning. He had submitted the result to Science on Dec. 9, 2003. This paper was accepted 4th of this month and was published on line this Thursday. This made headline news worldwide as we all know.
The title of his paper is “Evidence of a Pluripotent Human Embryonic Stem Cell Line Derived from a Cloned Blastocyst.” What he has done was to extract stem cells from a cloned human embryo created by somatic cell nuclear transfer. What are the scientific implications of this work? First, it is the world’s first success in producing cloned human embryos using somatic cell nuclear transfer, which was published in a peer reviewed journal. Second, moreover, it was also world’s first to isolate a stem cell line from a cloned human embryo. The New York Times said, “It’s a landmark paper.” It continues, “Until now, no one had even come close to using cloning to create a human embryo or even a monkey embryo, to say nothing of extracting stem cells from one.”(NYT, Feb. 12, 2004) The, what made the Korean team succeed, where other teams failed?
The key was the abundance of eggs. For instance, the Advanced Cell Technology of the U.S., could only get 19 eggs after they widely advertised and even paid $4,000 per woman. But the Koreans got a whopping 242 eggs for free from 16 volunteer donors (NYT). How was it possible? Hwang Woo Suk explained at the annual meeting of the AAAS recently. “Some young ladies have a lot of curiosity about reproductive cloning and therapeutic cloning, and after searching the Web site they contacted us”, he said. (The Washington Post, Feb. 14, 2004) From the 16 volunteered women, 242 eggs were extracted, of which 176 were selected. With them, the team tried 14 different protocols and ended up with 30 blastcysts. From them, the team was able to extract 20 inner cell masses, from which one grew into a line of stem cells.(NYT)
Now, what are the ethical and practical implications of this success? First, it will reignite the fierce debate over the ethics of human cloning as the work makes the birth of a cloned baby more feasible. The paper explained how to make a cloned embryo in great detail, including description of combination of chemicals used, doses and timing etc., so it could be used as a cook book for a cloned baby.
Second, it will ignite fierce competition in scientific research. For instance, as soon as the news broke out, the Washington Post criticized Bush’s policy and said, “The US appears to have fallen significantly behind in mining the promising field of stem cell research to treat disease.”
In conclusion, with this landmark experiment, we are stepping into a new era in therapeutic cloning.. Ethicists and scientists have been disputing human embryo cloning in terms of ethical burdens and practical benefits. We have to wait and see how the balance of this dispute will tip. Rather, we are all part of this game. Aren’t we? So let’s talk about this.
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Religions in Conundrum : Conflict or Co-existence
- R.N. Sharma.
Pune, INDIA
Email: vibhor1@
The rise and fall of many cultures and civilizations have been attributed to religions. For long, many of these cultural/spiritual movements were confined to small niches in time and space. But with the contraction of the planet into a global village, interactions between major established religions became inevitable. Rather than ushering universal harmony and spiritual transcendence, these have unfortunately resulted in continuing friction which almost invariably degenerates into wholly un-spiritual squabbles, and worse, often aggravate into violent and bloody conflicts. Most modern religious orders are marred by uncompromising rigidity, exclusivity and dogged adherence to archaic, often puerile edicts pronounced in different, no longer tenable contexts. These attitudes and positions taken by many extant major religious movements (which claim to be ennobling spiritual philosophies), are incomprehensible, and incompatible with the march of human civilization in the third millennium of its existence, especially when the species remains a unitary entity at least in biological terms. This modern conundrum of religions, and its lethal consequences as these keep on unfolding in increasing spirals of hate and gore, are discussed. The choice between confrontation and co-existence is highlighted, and the non-negotiability of the latter as a condition of survival for humankind is emphasized. Instead of more than one civilization, and the inevitable clashes there of, the idea, and ideal of one civilization, one world and one transcendental species is projected.
Beyond Informed Consent: A Complex Model For Genetic Information Regulation
- Wen-Chen Chang and Jiunn-Rong Yeh* .
Graduate Institute of National Development, National Taiwan University
* College of Law, National Taiwan University, Taiwan, ROC
Email: wenchenchang@ntu.edu.tw, jr.yeh@msa.
Technological Drive for Genetic Information
As the development of biotechnology accelerates, doctors and scientists are getting a lot more information from our genes. Our genes reveal not just about us, but also about potential risks and relationships between some diseases and their genotypes. As a result, there arises a strong interest in accessing and utilizing our genetic information in order to unveil secrets behind our genes and to enhance our capacity in curing diseases and promoting public health.(1) Various kinds of “bio-banks” or genetic databases are called for research or public health purpose by governments, science communities, or even commercial corporations. The most well known plan is the deCODE Genetics in Iceland.(2)
Similarly, not long ago, the Taiwanese science community, represented by the Biomedicine Institute of the Academia Sinica, was calling for blood sample donation to establish a “super control genomic database” in Taiwan.(3) It was hoped that around 3,000 blood samples, which would then be transformed into cell or DNA samples, of the Taiwanese people across ages could be gathered. Thus far, about 2,700 blood samples were gathered and the science community waited no time announcing that the database was a huge success and stood as rich resources for future biotechnological experimentation. Not only government agencies and research institutes are enthusiastic about genetic information, but also hospitals and private biotechnological companies are racing to creating various kinds of bio-banks or genetic databases by utilizing their access to patients and their files.(4)
Legalistic Response to Genetic Privacy Protection
In contrast to enthusiastic entrepreneurship regarding the potential use of genetic information, the fear of losing our privacy as well as identity has been growing. Lawyers, ethicists and scholars have expressed their concerns about potential disclosures or misuses of our genetic data and any genetic discriminations resulting from them. The protection of “genetic privacy” was advocated, arguing that without informed consent, no one may access to, acquire or store one’s genetic information in various types such as blood sample or body parts or other cell forms.(5)
At the International Level
Internationally, such a normative cry has re-invoked a focus on right of privacy, already pronounced in the multilateral treaty before World War II.(6) A mere pronouncement of privacy right, however, has not yielded sufficient protection in the context of genetic information. A more direct guide was the Declaration of Helsinki and its subsequent revisions, focusing mainly on the regulation of human subject research, but extending its concerns about research involving identifiable, linked, or traceable personal genetic information.(7) The Declaration and its subsequent revisions differentiate clinical and non-clinical research and more importantly, assert the principle of informed consent to be required in non-clinical research settings. Despite the strength, the Declaration remains as a set of guidelines rather than binding legal demands. (Teresa K. Baumann), 2001:686-689) Yet, through international practice and academic circles, other institutional mechanisms such as Institutional Review Boards (IRBs) have been created to provide peer review for researches involving identifiable human genetic data.
At the National Level: American Example
Short of a forceful international mechanism in guarding genetic privacy, national governments have sought their own solutions. In the United States, for example, the Constitution does not pronounce expressly a constitutional right to privacy. While recognizing such right, the judicial approach to protecting one’s informational privacy tends to be conservative, showing a balance between personal privacy and government interests. (Lawrence O. Gostin, 1995: 320,325) In Whalen v. Roe, the U.S. Supreme Court found no violation of privacy in state’s accumulation of personal medical information so long as adequate standards and procedures have been provided.(8)
In spite of rather passive judicial attitude towards genetic privacy, legislative and administrative efforts have been much more progressively shown. A draft of national genetic privacy act was proposed.(9) Eight states have provisions that prohibit obtaining and/or disclosing genomic information about individuals without their informed consent. Among these states, while a few such as California provides privacy protection across a broad range of genetic information, most states limit their protection mainly to genetic screening programs conducted by state governments. They leave the accessing, acquiring or storing genomic information by private sectors largely unregulated. (Lawrence O. Gostin, 1995: 326)
Much of the regulatory effort displayed by the health agency is known as “the Common Rule.”(10) The Common Rule yields protection for living human subjects involving in research as well as identifiable private information utilized in such a research.(11) When identifiable private information is used in research, IRB review and informed consent must be provided, even if personal sources of the identifiable private information have not direct contact with the researcher.( Henry T. Greely, 1999:738-741) Under the Common Rule, any research conducted or funded by the U.S. government that seeks to access, acquire or store linked, identifiable, or traceable private genetic information must obtain informed consent from source individuals, and its necessity being IRB reviewed. Despite its comprehensive nature, the Common Rule has a limited application to “public” involvement with personal genomic information, thus leaving “private” gathering of such information ruled largely by common law doctrine, which has nevertheless followed largely the principle of respecting one’s autonomy and self-determination.(12)
At the National Level: Taiwanese Example
In Taiwan, the Constitution does not pronounce directly the right to privacy. But the Council of Grand Justices, a functional constitutional court, has admitted such right in a number of cases by way of interpreting the penumbra provision in the rights chapter as well as long-standing statutory recognition.(13) Unlike the U.S. Supreme Court, Grand Justices have not dealt with cases involving more directly with the assessing, acquiring or storing of personal - medical or genetic- information, and therefore judicial attitudes towards genetic privacy remains uncertain.
In contrast with rather weak constitutional protection of privacy, legislative efforts in Taiwan have been more pronounced. Responding to the mounting cry for more privacy protection especially in the age of information technology, the Act on the Protection of Computer-Processing Personal Information was promulgated in 1995. This Act is designed to protect personal information gathered, processed and/or stored in the computer or other similar forms. Without written consent, public or private agencies cannot access, gather or store personal information unless for research purposes, important government interests, or with minimal harms.(14) Given its broader nature, this Act has the effect on the accessing, acquiring or storing of personal genetic information by government or non-government agencies. Its regulatory weakness, however, lies in the fact that the obtainment of “written consent” - rather than “informed consent”- is sufficient in justifying the interference with one’s personal genetic information, much less stringent than conventional practices. Worse yet, as the consequence of not targeting the protection of personal genetic (or health) information, this Act permits freer accessing, acquiring and storing of personal information for research purpose without any peer-review mechanism.
Other than the Act on the Protection of Computer-Processing Personal Information, no legislation was proposed to shield on the protection of genetic privacy in Taiwan. Currently, if one’s genetic information is contained in his or her medical record, the accessing, acquiring or storing of such information is regulated the same way as that of medical record. According to the Medical Care Act, doctors, nurses or staffs in the hospital cannot disclose one’s privacy contained in medical record without due reasons.(15)
In clinical setting, current provisions in the Medical Care Act allow doctors to access patients’ genetic information for diagnostic, therapeutic, or even predictive(16) purposes without acquiring specific informed consent.(17) With strong criticism in the academic circle, the obtainment of informed consent when doctors accessing patients’ genetic information has been argued, and in some cases practiced, on the principle of medical ethics, rather than on the account of law, respecting patients’ autonomy. Notably however, very recently, new provisions concerning human subject research in hospitals were added, requiring informed consent before patient’s participation in clinical trials.(18) Yet, unlike the U.S. Common Rule, new provisions apply only to direct interference with human subject but not to identifiable individual information.
In research setting, a recent regulatory effort was made, the Notice on Accessing Human Biological Samples in Research Context, to require informed consent when accessing to personal genetic information. This regulatory attempt at protecting genetic privacy, however, is not strong in that it allows proxy consent for minors under age of seventeen and has broader exemptions such as difficult contact with sources or non-identifiable, open sources.(19) Compared with detailed rules on individual genetic information, collective bio-banks have not been regulated heavily in Taiwan. A recent effort was the Law on DNA Sampling, which allows mandatory DNA sampling of sexual crime or felony offenders and volunteering sampling in need of DNA testing on their children and more importantly, permits government to store data for ten years.(20)
At the Local Level
Legalistic response to the call for more protection of genetic privacy has not been sufficient at both the international and national levels. Internationally, the Declaration of Helsinki and its subsequent revisions are a set of guidelines, a tiger without teeth. Nationally, to some extent, informed consent principle and institutional mechanism such as IRB review are realized in the accessing, acquiring and storing personal genetic information. But the extent of their realization has been varied from country to country. In Taiwan, informed consent principle has not been a legalized principle in clinical setting when doctor accessing patient’s genetic information for diagnostic or therapeutic purpose. Accessing to identifiable genetic information has not been regulated in the rules concerning human subjects research. Not surprisingly, some local community felt urgent in creating their own rules.
In a northern city of Taiwan, Keelung, its Council recently promulgated a rule concerning accessing and using their citizens blood samples after citywide health check-ups. Accepting a more balanced approach, with the legalized mechanism of informed consent, the city allows the access to and uses of its citizens bio-banks for purposes of research or public health. A city review board including medical, public health experts, bio-ethicists and citizen representatives is established to review the request of accessing the bio-banks. Notably, the city also sets up fees for using the database and its revenue reserved specifically for citizens and to encourage further research oriented to their citizens’ health. As it was a recent initiative, its effectiveness remains to be seen.
Integrated Approach to Genetic Information Regulation
Insufficiency of Informed Consent Principle: Differentiating Context
The principle of informed consent has been the dominant rule governing the accessing, acquiring and storing of one’s information.(21) Dealing with personal genomic data, confidentiality and anonymity, which de-links biological samples to identifiable individuals, are most governing legal rules.( Ross Lainie Friedman,2001) Together, however, they have not displayed a powerful function in protecting personal genetic privacy and respecting one’s autonomy. Various criticisms have been discussed in different contexts.( Ken M. Gatter, 2003: 445-446)
Clinical Context
In the clinical context, for example, doctor accessing to patient’s genetic information for diagnostic or therapeutic purpose is governed by pre-existing ethical principle of informed consent and general legal rules about confidentiality. With one on one and face-to-face context, informed consent principle is much more practiced and obeyed in this situation. However, the superior position of doctors as expertise makes patient’s informed consent merely nominal, as patient often follows what doctors suggest. What’s worse, there is no law governing purely predictive genetic test in the clinical context in Taiwan and other countries such as U.S.A. ( Ken M. Gatter, 2003: 445-446) It is argued that the introduction of predictive genetic test into medical practice does not fundamentally alter the obligation of doctors nor does it introduce new ethical dilemmas.( Michael J. Green, 2003:573) Thus, all tests performed by doctors in the clinical context now are not regulated except by general rules of medical ethics and confidential provisions in the Medical Care Act.
Research Context: Prospective
In the research context, in addition to informed consent, peer review mechanism such as IRB must be incorporated. In Taiwan, however, according to the current rule, accessing to individual biological sample or genomic data requires only informed consent.
Despite required on the book, informed consent in the research context has not been practice effectively. It has been long argued that in the research context, where the relationship between researchers and genetic information holders is less intimate and perhaps more importantly, research result is often less directly linked to information holders, the requirement of informed consent has been proved ingenuous.( Ken M. Gatter, 2003:445-446) Since not until the final result, researchers often have no better understanding of expressions or implications of the relationship between a particular gene and disease. Thus, upon requesting informed consent, what researcher may reveal are often general expectations of research result. What surprises and gives rise to huge impact on the tested individuals is often unknown and unexpected by researchers at the beginning of conducting research.
As a result, peer review mechanism such as IRB stands as a much more powerful institutional safeguard in preventing any misuse or offensive access to individual genomic information.
Research Context: Retrospective & Collective
Also in research context, but in a retrospective fashion, where genetic research is targeting the existing database or bio-banks established or collected in hospitals, academic institutes, governments or even commercial groups, the principle of informed consent has been nearly of no use. ( Ken M. Gatter, 2003:445-446) At the time patients or information holders give consent or authorization in accessing their biological samples or genetic information, little has been known for possible and unspecified research that would be performed on their samples or data. While re-authorization is required when new research is to be performed, often the contact with information holders is lost or the latter finds disturbing. (Ken M. Gatter, 2003:445-446; Lawrence Gostin, 1995: 322).
On one hand, if insisting on the strict obedience of informed consent principle, certain useful medical or public health research might not proceed and public interests are lost. On the other hand, however, to allow retrospective research on individual genomic data or collective bio-banks without reauthorization or re-informed consent ignores unfairly the privacy protection of individuals. To strike a balance, not only peer review mechanism must be incorporated, but also certain human rights groups or advocates, lawyers, and public-interest group must be introduced in the process. ( Ken M. Gatter, 2003:445-446) This institutional mechanism is both designed for safeguarding privacy interests and enlarging democratic base for technological development.
On this point, the recent local response of Keelung city in Taiwan is enlightening. It is allowing the establishment of citizens bio-bank to encourage further public health research on one hand, also on the other creating a review board not limited to experts but extended to public-concerned citizen groups and their representatives.
Insufficiency of Informed Consent Principle: Enlarging Relationship
The other insufficiency of informed consent principle comes from its individualist nature. Emphasizing only individual consent when one’s genetic information being accessed and inquired is not enough. In fact, our genes reveal not only about ourselves, but also – perhaps more importantly – about our family, our identified groups as well as common human traits. Genetic information contains not only personal diary but also embedded relationship and common human traits. To access to one’s genetic information is at the same time to access to the information of one’s family, belonged groups as well as shared human identities.
When one’s genetic information is found associated with incurable syndromes, that would have a significant impact on his or her family, close relatives, and sometimes his or her ethnical groups. To them, legal emphases on the protection of “individual informed consent”, “individual privacy”, or the prevention of “discrimination against individuals” are not adequate. (Henry T. Greely, 1999:756-757)
Moreover, individualistic jurisprudence combined with impersonal genetic technology fails largely to take into account cultural variations. In cultures where family and relatives may occupy influential roles in one’s life, it is almost unthinkable that one could hide the tested result of genetic-trait diseases from one’s family. In some Asian societies such as Taiwan, patients are often the last ones to be informed of their medical situations after doctors and their spouses or close relatives exchange views and reach consensuses.
However, the involvement of families or groups varies from context to context. In the clinical settings, especially in the Asian culture, patient’s family is often involved and closely informed. Admittedly, however, there exists a conflict of interests between patient’s personal privacy and his or her relative’s interests. Since clinical settings have been long governed largely by medical ethics with a due respect of doctor’s expertise and trust relationship with patients, whether or not to acquire informed consent from family or close relatives is left for physicians and must be examined institutionally and periodically in hospitals.
In the research context, however, one’s decisional autonomy in opting in or out of any particular research must be respected fully. Family’s involvement in this setting is neither appropriate nor practical, as it is often difficult for researchers to inform fully to information holders, not to mention his or her family or close relatives. Yet, it is argued that the findings in the research setting are often tailored to larger ethnical or geographical groups, (Henry T. Greely, 1999:756-757) such as genetic investigations of schizophrenia among the Old Order Amish or SARS-free genetics of the Taiwan aboriginal tribes. While genetic findings in the research context often link less directly to each information holders, they nevertheless give rise to certain genetic discrimination against certain groups. Therefore, certain meaningful forms of group participation must be realized in the research context. It is not necessary to acquire group consent in all situations, but an institutional opportunity for concerned groups to be notified before research and express their concerns is required (Henry T. Greely, 1999:756-757).
In the research context with a retrospective and collective way, such as the access and use of bio-banks, an enlarged participatory mechanism must be introduced. As discussed earlier, it is not impossible but nearly impractical for researches performing on the existing biological samples or bio-banks to acquire re-authorization or informed consent. To strike a balance between public interest in health research advancement and personal privacy protection, some more democratic mechanism and participatory process must be realized in this context. Some examples are citizens or layperson boards concerning the examination or authorization of collective biological samples or bio-banks.
Integrated, Contexualized Approach
It is clear that informed consent principle is insufficient in providing full protection of personal genetic privacy and it must be considered from context to context. To summarize the integrated, contexualized, approach argued above, three charts are shown in the following.
Clinical Context:
|Clinical Context |
|Community |Individual Rights |
|(Family) | |
|Expertise |Biotechnological Development |
|(Physicians) | |
In the clinical context, doctor accessing to patient’s genetic information for diagnostic or therapeutic purpose is governed by pre-existing ethical principle of informed consent and general legal rules about confidentiality. Since clinical settings have been long governed largely by medical ethics with a due respect of doctor’s expertise and trust relationship with patients, whether or not to acquire informed consent from family or close relatives is left for physicians and must be examined institutionally and periodically in hospitals.
Research Context: Prospective
|Research Context: Prospective |
|Community |Individual Rights |
|(Group Participation) | |
|Expertise |Biotechnological Development |
|(Peer Review) | |
In the research context, in addition to informed consent, peer review mechanism such as IRB must be incorporated. While genetic findings in the research context often links less directly to each information holders, they nevertheless give rise to certain genetic discrimination against certain groups. Therefore, certain meaningful forms of group participation must be realized in the research context. It is not necessary to acquire group consent in all situations, but an institutional opportunity for concerned groups to be notified before research and express their concerns is required.
Research Context: Retrospective & Collective
|Research Context: Retrospective & Collective |
|Community |Individual Rights |
|(Public Scrutiny) | |
|Expertise |Biotechnological Development |
|(Researchers) | |
In the research context with a retrospective and collective way, such as the access and use of bio-banks, an enlarged participatory mechanism must be introduced. To strike a balance between public interest in health research advancement and personal privacy protection, some more democratic mechanism and participatory process must be realized in this context. Some examples are citizens or layperson boards concerning the examination or authorization of collective biological samples or bio-banks.
Conclusion
This paper examined the complex nature of our genetic information and develops adequate legal mechanisms beyond individual informed consent to address these issues. Group consent or some other institutional or legal mechanisms that are capable of taking into considerations larger groups interests and cultural differences have been discussed and argued. In conclusion, this paper argues for the establishment of a more complex, group-focused, culture-oriented model for genetic information regulation.
Notes
(1)The global trend (or even racing, to some extent) in establishing “bio-banks” has been illustrated. See Henry T. Greely , 1999:737,740-741
(2)For detailed discussion about the Icelandic health database, see Henry T. Greely ; Jurimetrics J. (forthcoming).
(3)Details on the Taiwanese genomic database, available at
(4)Reporting on the number of bio-banks created by hospitals and biotechnological companies, available at
That hospitals utilize their existing access to blood samples or body parts to create bio-banks, however, is not unproblematic. For discussions, see infra note and accompany text. See also Ken M. Gatter,2003:423, 445--447
(5)For further discussion of the concept of genetic privacy and the danger of genetic discrimination, see Graeme Laurie,2002:119--165
(6)Article 18 of the International Covenant on Civil and Political Rights (ICCPR) states that no one shall be subjected to arbitrary or unlawful interference with his privacy.
(7)For more detailed discussion on the Declaration of Helsinki, see Note (Teresa K. Baumann), 2001: 667, 686-689; Jessica W. Berg et al, 2001:253--253
(8)Whalen v. Roe, 429 U.S. 589 (1977).
(9)For details, see George J. Annas, Leonard H. Glantz, Patricia A. Roche, 1995:360, 361
(10)45 C.F.R. pt. 46 (1998). The Common Rule is a set of regulations concerning the treatment of human subjects that has been adopted in identical language by seventeen federal agencies responsible for most federal funding or regulation of such research.
(11)For detailed discussion on the Common Rule, see Henry T. Greely, 1999:738-741.
(12)Note that, however, the principle of informed consent has been an entrenched common law doctrine. The U.S. Supreme Court established the idea of informed consent in Jacobson v. Massachusetts, in which it conveyed that every human being of adult years and sound mind has a right to determine what should be done with his own body. See Jacobson v. Massachusetts, 197 U.S. 11 (1905).
(13)Interpretation No. 293(In that, the Council of Grand Justices held that banks must respect the right to privacy of their customers and cannot disclose such information without due reasons), and Interpretation No. 399 (In that, a broader personal liberty including right to privacy was asserted and confirmed in the Constitution.)
(14)Articles 7, 8, 18, 23 of the Act.
(15)Article 49 of the Medical Care Act.
(16)While predictive genetic tests often occurred in research context, they sometimes take place in clinics. See Michael J. Green & Jeffrey Botkin,2003:571, 572
(17)Articles 47, 48, 49, 59 of the Medical Care Act.
(18)Article 57 of the Medical Care Act.
(19)Rule 10 of the Notice on Accessing Human Biological Samples in Research Context promulgated by the Health Agency.
(20)The Law on DNA Sampling was enacted in 1999 and set in force in 2000.
(21)For details on the history and development of informed consent principle, see Jessica W. Berg et al,2001
References
1. George J. Annas, Leonard H. Glantz, Patricia A. Roche, 1995, Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations, 23 Journal of Law, Medicine & Ethics
2. Graeme Laurie, 2002, Genetic Privacy: A Challenge to Medico-Legal Norms, Cambridge, U.K: Cambridge University Press
3. Henry T. Greely, 1999, Breaking the Stalemate: A Prospective Regulatory Framework for Unforseen Research Uses of Human Tissue Samples and Health Information, 34 Wake Forest L. Rev.
4. Henry T. Greely, 2003, Iceland’s Plan for Genomics Research: Facts and Implications, Jurimetrics J. (forthcoming).
5. Jessica W. Berg et al, 2001, Informed Consent: Legal Theory and Clinical Practice, New York: Oxford University Press, 2ed.
6. Ken M. Gatter, 2003, Genetic Information and the Importance of Context: Implications for the Social Meaning of Genetic Information and Individual Identity, 47 St. Louis L. J.
7. Lawrence O. Gostin, 1995, Genetic Privacy, 23 Journal of Law, Medicine & Ethics.
8. Michael J. Green & Jeffrey Botkin, 2003, “Genetic Exceptionalism” in Medicine: Clarifying the Differences between Genetic and Non-genetic Tests, 138 Annals of Internal Medicine.
9. Teresa K. Baumann, 2001, Proxy Consent and a National DNA Databank: An Unethical and Discriminatory Combination, 86 Iowa L. Rev.
10. Ross Lainie Friedman, 2001, Genetic Exceptionalism VS. Paradigm Shift: Lessons from HIV, Journal of Law, Medicine & Ethics, Vol. 29, No. 2.
How Japanese Companies Face Bioethics
- Makina Kato, Ph.D., and Darryl Macer, Ph.D..
Doctoral Program in Biological Sciences, University of Tsukuba, JAPAN
Email: makincho@, darrylmacer@.au
1. Introduction
Commercial companies and industry have been playing an important role in the recent development of biotechnology. However, there are a variety of bioethical issues and concerns about its application and commercialization. This research aimed at examining the state of affairs of how the companies related to biotechnology are aware of bioethical issues and how they take actions to deal with the issues. Questionnaire surveys were conducted on Japanese companies in 2003 and responses from 304 Japanese companies were obtained, to compare with earlier results of an international survey (Kato and Macer, 2003). Complementary interviews were conducted with 15 companies inside and outside of Japan. The responses from the interviews and the questionnaire were analyzed quantitatively and qualitatively with the KJ method.
2. Sampling of target companies
The first question to address in sampling is what are "companies related to biotechnology". "The companies related to biotechnology" in this survey were defined broadly as the ones concerned with biotechnology directly or indirectly, and because the aim was focused on the collection of the opinions from a wide range of industries and type of operations, multiple company lists which were judged as related to biotechnology. First, the companies which appeared in the "Nikkei Bio Yearbook 2003" (Nikkei Biotech and Nikkei Biobusiness Ed., 2002) were listed. The member lists of some industrial organizations which companies themselves had wanted to be associated with the term "biotechnology" were also searched through internet, making a reference to the "Collection of Web links related to biotechnology" of the Ministry of Economy, Trade and Industry () and to the organizations of the officers and directors of Japan Bioindustry Association Executive. The member lists of the organization used in searching the companies were:
1. 795 companies from "Nikkei Bio Yearbook 2003"
2. 220 companies from Japan Bioindustry Association (JBA)
3. 136 companies from Japan Health Sciences Foundation
4. 91 companies from the Japan Biological Informatics Consortium (JBiC)
5. 55 companies from the Japan Association of Bioindustries Executives (JABEX)
6. 60 companies from the Kinki Bio-industry Development
7. 79 companies from the Japan Pharmaceutical Manufacturers Association (JPMA)
8. 101 companies from the Society for Techno-innovation of Agriculture, Forestry and Fisheries (STAFF)
9. 49 companies from the Biodegradable Plastics Society
As it seemed that the lists above did not include all the companies, indexed websites related to biotechnology business were searched though internet (search engine Google) and the companies related to biotechnology were searched by using these sites. In so doing, the same screening was done. The index sites used in searching the companies were:
1. 94 companies from Bio-Tech Web (Chugai Co.,Ltd.)
2. 131 companies from BIOWEB(R) (DYNACOM Co.,Ltd.)
3. 66 companies from Japan BioBiz Access (Japan Bioindustry Association)
4. 27 companies from Biotechnology Japan (Nikkei Business Publications, Inc.)
5.
6. 280 companies from N.A. gene Homepage (N.A. gene)
7. 50 companies from Searchable Database of Laboratory Animals in Japan (Institute for Animal Experimentation University of Tokushima School of Medicine)
8. 43 companies from Experimental Animal Database Search (National Institute of Genetics)
Further search was conducted to include the companies falling under the subjects by the means as follows:
1. To make a reference to the surveys by industry organizations and contents of the market research report especially in order to include venture companies.
2. To use internet search site with keywords related to biotechnology industry and search the companies from the results. These keywords were selected from the sense index of "Nikkei Bio Yearbook 2003."
Although there must be some companies that were still not included, for example, new venture companies and the companies which did not publish the information very much, we can be confident that most of the Japanese biotechnology companies were in the sample list. The duplications in the results of the search above were excluded and the secondary list was made, which included 1556 companies.
Attempts were made to telephone all the companies. The reasons to decline to answer, which were also interesting in the previous overseas survey (Kato and Macer, 2003), were also examined. The tertiary list was composed of the companies which accepted to receive the sheet and actually to which the sheets were sent. These 769 companies were defined as the population in this survey. Among these, 335 companies did not respond, 130 declined to answer after looking at the sheet, and the rest, 304 companies were the valid responses. The valid response rate was 38.2%.
3. Questionnaire design and distribution
This survey was aimed at examining how Japanese companies related to biotechnology are aware of bioethical issues and how they deal with them. The content of questions included the following items (see also results from International companies in Kato and Macer, 2003).
1. Base items (Company Name, Type of industry, Principal business, Main products, Amount of capital, Volume of sales, Number of employees, Year of establishment, Customers, Most competitive original technology or service in the field of biotechnology)
2. Presence of bioethical problem in the past.
3. Presence of possibility of bioethical problem in the future.
4. Presence of measures to deal with bioethical issues at present.
5. Presence of code of ethics or guidelines concerning bioethics.
6. Presence of systems in R&D stage to deal with bioethical issues at present.
7. Presence of systems in sales and marketing stage to deal with bioethical issues at present.
8. Presence of employee education about bioethics.
9. Presence of consumer communication/education related to biotechnology.
10. Participation in industry organizations related to biotechnology.
11. Presence of code of ethics or guidelines in the organizations above.
12. Problems in using in case that international standard of bioethics were established.
13. Interest in international standard of bioethics.
14. Expectation toward researchers of bioethics.
15. Opinions about bioethics in the companies related to biotechnology.
The same questionnaire format (except for the face sheet) with the ones used in the overseas survey was employed for the purpose of comparison, and only a few results can be presented in this paper. The period of the survey was from 16th January 2003 when the first telephone call to seek the willingness of the company, and the first survey forms were sent, to 17th June, 2003 when the last response was received. The purpose of the telephone contact was to explain to the persons in public relations or general affairs of each company briefly the purpose of the survey, and they decided to accept or decline to receive the questionnaire sheet, and/or to introduce other departments in their companies. E-mails to explain the purpose of the survey were sent to the companies whose telephone numbers were not found. Among 130 companies that declined to answer after looking at the questionnaire sheet, 129 companies mentioned their reasons as shown in Table 1.
Table 1: Reasons for Japanese companies to decline to participate (N=130)
|Reason for declination |Number of companies |
|We do not fall under the subject according to our description of business. |45 |
|We do not fall under the "companies related to biotechnology" or are not concerned with biotechnology very |24 |
|much. | |
|We are not concerned with bioethics and not in a position to answer. |22 |
|We would like to refrain from answering or cannot answer. |13 |
|The questions are too difficult. |5 |
|We are busy. |4 |
|It is difficult to publish such information. |4 |
|It is impossible for an individual to answer and requires company-wide investigation. |3 |
|The purpose of the survey is not clear. |3 |
|Parent company or headquarters deals with such things. |2 |
|It has made us painfully aware of our delay of efforts and lack of awareness about these issues. We would |2 |
|like to consider from now on. | |
|We have made some efforts in compliance which includes bioethics. See the website. |1 |
|We are very young company. |1 |
|No reason given. |1 |
4. Method of analysis
To analyze the data obtained, the following methods were used:
1. Quantitative analysis of Yes/No answers
2. Cross tabulation of Yes/No answer and attributes of the companies (type of industry, main field of biotechnology, amount of capital, volume of sales and number of employees)
3. Cross tabulation between the answers to each question
4. Qualitative analysis of comments by KJ method
5. Secondary analysis of responses received in different questions
Looking at the type of industry of the population, the number of the companies in "R&D, Contract research and Non-clinical tests" was the most (165 companies) and it made up 21.5% of the total. Following this the companies were classified into the other groups: "Pharmaceuticals" 13.8% (106 companies), "Trading & Wholesaling" 13.3% (102 companies) and "Chemical Manufacturing" 12.5% (96 companies). Looking at the type of industry of the valid responses, "R&D, Contract research and Non-clinical tests" was the most common (70 companies) and it made up 23.0% of the total, followed by "Chemical Manufacturing" 14.8% (45 companies) and "Trading & Wholesaling" 12.5% (38 companies). The percentage of "Pharmaceuticals" in the valid responses was 9.9% and was relatively lower than that of the population (13.3%), but other no other significant differences were found between the population and the valid responses using Chi squared test.
Past Experience with Bioethical Issues
In response to question 2, "Have you ever had a bioethical problem related to biotechnology occur in your company? If so, what kind of problem was it?", only 5.6% of the total valid responses (17 companies) said "Yes". This is lower than expected, and lower than answers to latter questions would suggest, and the reasons for this will be discussed in the Discussion chapter.
To question 2, 29 companies made comments besides the Yes/No answers. These comments were resolved into elements irrespective of a Yes or No answer. The elements summed up to 32, as the comments by 3 companies were resolved into two elements. These elements were grouped by the similarity of the contents and classified into 4 groups as follows. The numbers in parentheses indicate the number of elements, and the number of companies
#1. Have had concrete problems. (23,20)
#2. Have not had such problems. (4,4)
#3. Have nothing to do with such problems. (3,3)
#4. The question is not very clear. (2,2)
Among the first three, the first group, "#1. Have had concrete problems" included 23 elements and was the largest. Although 17 companies answered Yes to the YN question, 20 companies mentioned bioethical problems of some kind in their comments. Among these 20 companies, 4 said that they had received inquiries or criticisms from outside. The group #1 was subdivided into 5 sub-groups according to the specific matters. The problems referred the most were those over handling biological samples, followed by those involving the environment.
1-1. Had problems/concerns about handling biological samples. (8,7)
1-2. Had problems/concerns about animal experiment. (4,4)
1-3. Had problems/concerns about genetic modified materials. (3,3)
1-4. Had problems/concerns about influence on environment. (7,6)
1-5. Had problems/concerns about clinical development. (1,1)
The comments in both the other groups, "#2. Have not had such problems" and "#3. Have nothing to do with such problems", said that they had not had such problems, but in the group #3, they mentioned their reason of not having had a problem, for example, their kind of business and their adherence to the guidelines.
The two comments in the group "#4. The question is not very clear" was not the answer to the question but the general criticism that the area covered by bioethics is not clear.
Future Expectations of Bioethical Problems
In answer to question 3, "Do you think in the future you could have a bioethical problem related to biotechnology in your company? What kind of concerns do you have about this?" were as follows. Almost one third (30.6%) of the total valid responses (93 companies) said "Yes" and the ratio of Yes was over five times more than those who said they had experienced a bioethical problem in the past (Q2).
In response to this question, 114 companies made comments besides the YN answers. These comments were resolved into elements irrespective of Yes or No. The elements summed up to 126, as the comments by 9 companies were resolved into plural elements. The answer divided into 4 elements was 1 company, 3 elements 1company, and 2 elements were found in comments from 7 companies. These duplications did not cross over two groups. The elements were grouped by the similarity of the contents and classified into 6 groups as follows. These groups were disposed in order of the level of critical feeling. (The numbers in parentheses indicate number of elements, followed by the number of companies).
#1. Have possibilities/ concerns of facing concrete problems. (96,85)
#2. Have concerns in broad perspective over genetic manipulation. (4,3)
#3. Do not have problem at the moment but have possibilities that problem will occur depending on the future business. (8,8)
#4. Do not have problem at the moment but cannot say that the possibility is zero. (6,6)
#5. Basically will not have problems in the future. (9,9)
#6. Do not know. (3,3)
Among these groups for question three, the first group, "#1. Have possibilities/concerns of facing concrete problems" included 96 elements (85 companies) and was the largest. Some 83% of 102 companies who gave particular comments had concrete concerns of some kind(groups #1-4). The group #1 was subdivided into 5 sub-groups according to the specific issues mentioned. The problems referred the most were those over handling biological samples, followed by those over handling personal/genetic information. In the subgroup 1-1, at least 13 elements clearly referred to human samples. These elements plus the comments from 1-2 to 1-7, which make up to 61 elements, that is, 64% of the group #1 relates to human material. It is also interesting to note that 8 companies expressed their concerns that they could face problems indirectly through customers or users. The 13 elements inside subgroup 1-1 were:
1-1. Have possibilities/concerns of the problems about handling biological samples. (22,19)
1-2. Have possibilities/concerns of the problems about informed consent. (3,3)
1-3. Have possibilities/concerns of the problems about handling personal/genetic information. (14,14)
1-4. Have possibilities/concerns of the problems about security of information. (5,5)
1-5. Have possibilities/concerns of the problems about clinical application of technology/application to human. (7,7)
1-6. Have possibilities/concerns of the problems about adverse event/ clinical accident. (8,8)
1-7. Have possibilities/concerns of the problems about genetic diagnosis. (2,2)
1-8. Have possibilities/concerns of the problems about handling experimental material. (2,2)
1-9. Have possibilities/concerns of the problems about animal experiment. (9,9)
1-10. Have possibilities/concerns of the problems about influence on environment. (6,6)
1-11. Have possibilities/concerns of the problems about social/consumer acceptance. (6,5)
1-12. Have possibilities/concerns of facing the problems in view of social norms or regulation. (4,4)
1-13. Have possibilities/concerns of facing problems indirectly. (8,8)
The comments in group "#2. Have concerns in broad perspective over genetic manipulation" referred to the awareness of the ethical aspects of genetic technology in a broader social sense rather than concerns over the possible problem in one company.
The comments in both groups, "#3. Do not have problem at the moment but have possibilities that problem will occur depending on the future business" and "#4. Do not have problem at the moment but cannot say that the possibility is zero", denied the present problems but indicated that they could not deny completely the future possibility of bioethical issues facing their company.
The comments in the group "#5. Basically will not have problems in the future" showed various reasons not to have the concern. Only one company said that they did not have concern because they had set up the systems to deal with it. That type of concern was answered more in the next question.
Bioethics Education
In response to the question 8, "Do you educate your employees in bioethics? If so, what kind of education program have you adopted?", 19.4% of the total valid responses (59 companies) said "Yes" and most of the rest , 79.3% (241 companies) said "No".
Looking at the distribution by industry of the companies who answered yes, the percentage of the "Pharmaceutical" companies was remarkably higher than that of the total valid responses and this upper difference was the greatest between the groups. Looking at the distribution by company characteristics of the companies who answered yes, the percentage of the companies in the "Medical" field was distinctively higher than that of the total valid responses as also similarly seen in Q6 and Q7. These companies could be regarded as having stronger sensitivity and critical feeling to bioethical issues. Looking at the distribution of capital scale of the companies who answered yes, the percentage of large companies was relatively higher and that of small companies lower.
To this question, 78 companies made comments besides YN answers. These comments were resolved into elements irrespectively of Yes or No. The elements summed up to 82, as the comments by 4 companies were resolved into 2 elements. These duplications were not in the same subgroup. They were grouped by the similarity of the contents and classified into 4 groups as follows. These groups were disposed in order of the concreteness of the measures. The numbers in parentheses indicate the number of elements, followed by the number of companies, as below:
#1. Have an employee education concerned with bioethics. (58,54)
#2. Take bioethical issues into account in individual instruction. (11,11)
#3. Do not have an employee education concerned with bioethics at present. (9,9)
#4. Do not need such an employee education. (4,4)
The first group "#1. Have an employee education concerned with bioethics" was composed of 58 elements by 54 companies and was 70.1% of the total elements. The group was subdivided into 8 subgroups as follows. Looking at the contents, only two companies referred to training especially on bioethics. In 1-2, 12 companies in "Medical" field referred to the education which could involve bioethical issues. Such education could be regarded as necessary in the course of their business. While 4 companies in 1-4 mentioned concrete topics, 10 companies in 1-7 did not clarify the content of education but just implied that they had education in some way. Some companies referred to education which was not only on bioethics but was included in the general training or compliance program, as seen in the comments for example in 1-5 and 1-8.
1-1. Have concrete training on especially bioethics. (2,2)
1-2. Have education concerned with bioethics as a company involved in medicine. (12,12)
1-3. Have education related to R&D. (7,7)
1-4. Have education on a concrete topic concerned with bioethics. (4,4)
1-5. Have education based on internal codes or compliance program. (7,7)
1-6. Have education on compliance with external provisions/ guidelines. (8,8)
1-7. Have a certain education system or tools. (10,10)
1-8. Include in general employee education such as freshmen education. (8,8)
The group "#2. Take bioethical issues into account in individual instruction" composed of 11elements by 11 companies was 13.4% of the total elements. These comments implied on-job-training style education. Three of the nine companies who commented "#3. Do not have an employee education concerned with bioethics at present", mentioned future consideration, as in the subgroups below:
3-1. Do not have such an education at present but will consider in the future. (3,3)
3-2. Do not have such an employee education. (6,6)
International Bioethics Standards
In response to question 12, "If an international bioethics standard is established in the future, what kind of problems do you think you could have, as an individual company, to keep the standard and practice it?", 257 companies made comments. These comments were resolved into elements, which summed up to 288, as the comments by 28 companies were resolved into plural elements. The answers divided into 3 elements were from 2 companies, and there were 2 elements from 26 companies. These duplications were not in the same subgroup. The elements were grouped by the similarity of the contents and classified into 8 groups as follows. These groups were disposed according to the level of positivity or negativity of the idea. The numbers in parentheses indicate (number of elements, number of companies). Granted that the group #1 as positive, #2 and #3 as not clarifying the attitude (or don't-know), and from #4 onward as negative, the ratio of the elements were 142:75:70 , that is, the positive group and the don't-know plus negative group could be compared:
#1. Think there is no problem. (142,142)
#2. Cannot make a judgment at the present moment. (49,48)
#3. Standard should meet a certain condition. (26,26)
#4. Might have problem depending on the content of standard. (11,11)
#5. Would have a certain problem. (52,48)
#6. There would be issues which could not be covered by a standard. (1,1)
#7. There is some doubt of establishing such a standard in the first place. (4,4)
#8. Standards concerned with bioethical issues are not internationally harmonized at present. (2,2)
The comments in group "#1. Think there is no problem" with 142 elements could be further subdivided into 9 subgroups. Among these, 67 companies (47.2% of the group #1) said "1-1. No problem in complying standard or rule". In this subgroup, there were 14 comments like "Nothing special." Although from this phrase it was hard to tell whether it just expressed indifference or really meant "no problem", still 1-1 was the largest subgroup. The second largest subgroup was "1-3. It ought to comply with standard, if it is established" with 33 companies (23.2% of the group #1) followed by "1-6. It depends on the content of standard but probably no problem" with 17 companies. These companies consider the problem in line with their business as similarly seen in the comments of 1-2 and 1-5. Such comments as "1-7. Have no other choice but to comply, if it is a rule" and "1-9. It might change a part of business" implied somewhat negative nuance but they remained as minority. The subgroups were as follows:
1-1. No problem in complying standard or rule. (67,67)
1-2. Would have no problem because the line of business is irrelevant at present. (8,8)
1-3. It ought to comply with standard, if it is established. (33,33)
1-4. It is beneficial if there is such a standard. (4,4)
1-5. Might need to cope with it but basically there is no problem. (5,5)
1-6. It depends on the content of standard but probably no problem. (17,17)
1-7. Have no other choice but to comply, if it is a rule. (3,3)
1-8. No problem in our company but it might cause problem in others. (3,3)
1-9. It might change a part of business. (2,2)
The second major group of comments from Q12 was "#2. Cannot make a judgment at the present moment" with 49 elements by 48 companies. It could be divided into 4 subgroups. Among these, the most commonly expressed idea was the subgroup "2-1. Cannot answer because it depends on the content of standard" with 22 elements (44.9% of the elements in the group #2). The comments in 2-1 and 2-2 clearly avoided prediction and did not clarify the attitude. On the other hand, there were 17 companies which answered "2-3. Do not know." It was not clear whether these comments meant real "don't-know" or not understanding the intent of the question. These comments were counted as "not clarifying the attitude" here. The subgroups to #2 were:
2-1. Cannot answer because it depends on the content of standard. (22,22)
2-2. Cannot answer at present. (8,8)
2-3. Do not know. (17,17)
2-4. It depends on the future line of business whether the company is concerned with standard. (2,2)
The group "#3. Standards should meet a certain condition" was composed of 26 companies. They were in a sense similar to those in the group #2 but showed some interest in the content of standard and concerns about the compatibility of the standard and own business activity. The group was subdivided into 6 subgroups, among which the largest one was "3-4. It would be a matter whether the standard is established from international point of view". Additionally, 6 companies in 3-6 showed concern about the proper operation of the standard. The subgroups were:
3-1. It would be a matter whether the content of the standard is concrete. (3,3)
3-2. It would be a matter whether the standard is established on understanding of our field of business. (2,2)
3-3. It would be a matter whether the content of the standard is fair. (2,2)
3-4. It would be a matter whether the standard is established from an international point of view. (10,10)
3-5. It would be a matter whether the standard does not lead to excessive regulation. (3,3)
3-6. It would be a matter whether the standard is properly operated. (6,6)
The comments from the group #4 onward showed negative opinion in some way. The group "#4. Might have problem depending on the content of standard" was composed of 11 companies which expressed negative but relatively moderate view. In contrast, the group "#5. Would have a certain problem" was composed of 52 elements by 48 companies and was the second largest group. These were 71.4% of the elements expressing a negative idea to Q12. This group included 11 subgroups according to the content of the problem raised in the comment. The largest subgroup was "5-1. It is costly to comply with standard" with 14 elements, followed by "5-2. It might restrict activity" with 11 elements. It could be said that the company or businessmen who answered were concerned the most about cost increase and the restriction of their activity. Additionally, it was noteworthy that some companies were afraid of being involved in the problem indirectly (even they themselves had no problem) as seen in the comments in 5-7 and 5-8. The subgroups were:
5-1. It is costly to comply with standard. (14,14)
5-2. It might restrict activity. (11,11)
5-3. Problems might occur in its operation. (3,3)
5-4. It requires taking steps to meet the situation as a company. (4,4)
5-5. It might bring about disparity among companies. (4,4)
5-6. It might touch some confidential matters. (2,2)
5-7. It is uncertain whether the users or interested party would comply with standard. (6,6)
5-8. Might be affected indirectly. (2,2)
5-9. Might delay in taking action as a company. (1,1)
5-10. Would have concrete bioethical issues. (2,2)
5-11. It is uncertain whether it is possible to be understood by the public or media. (3,3)
Both groups "#6. There would be issues which could not be covered by a standard" and "#7. There is some doubt of establishing such a standard in the first place" showed some doubts over such a standard. Finally, the comments in the group "#8. Standards concerned with bioethical issues are not internationally harmonized at present" criticized the present situation.
ISO for Bioethics
In response to question 13, "If there was a bioethical authorization system in the field of biotechnology, like the ISO, do you think you would use it? Why, or why not?", 59.5% of the total valid responses (181 companies) answered "Don't know". Most of these companies did not clarify their attitudes or were relatively negative or indifference to "a bioethical authorization system like the ISO", as seen in the comment analysis later on. On the other hand, 31.3% of the total valid responses (95 companies) answered "Yes". These companies seemed to understand the intent of the question and consider it beneficial or necessary. In contrast, only 8.6% (26 companies) answered "No".
In response to this question, 204 companies made comments to the sub-question to ask the reason. These comments were resolved into elements irrespectively of Yes or No, if the comment included plural elements of meaning. The elements summed up to 214, as the comments by 10 companies were resolved into 2 elements. These duplications were not in the same subgroup. The elements were grouped by the similarity of the contents and classified into 9 groups as follows. These groups are listed according to the level of positivity or negativity towards the proposal of Q13. The numbers in parentheses indicate the number of elements, and the number of companies, and the groups were as follows:
#1. Would use it because it is beneficial for business. (30,30)
#2. Would positively comply with standard or regulation whatever it is like. (21,21)
#3. Would use it because it must be necessary for company activity. (30,30)
#4. Would use it as the case might be. (22,22)
#5. Do not know at present. (61,61)
#6. Do not need it. (21,20)
#7. Cannot accommodate even if such a standard was established. (2,2)
#8. There is some doubt of such a standard itself. (26,26)
#9. No reason. (1,1)
Among these groups, the comments in the group #1, #2, and #3 were positive reasons given by the companies who answered "Yes" in the YN answer. So there was no company who answered "No" in these groups. On the other hand, the group #4 included the companies which accepted the standards with a certain condition, those which were negative, and those which did not clarify their attitudes. The comments in the group #5 were more like keeping their option open and most of them were by the companies which answered "Don't know". The group #6 and #7 included many companies which answered "No" and "Don't know".
The first group "#1. Would use it because it is beneficial for business" was composed of comments given by 30 companies and was subdivided into 6 subgroups. These comments showed the positive attitude toward such an authorization system or standard and referred to the judgment that such a standard should be beneficial. The main reason was the improvement of corporate image to facilitate business activity. Although the number is small, it was noteworthy that 4 companies said "1-5. It is easy to deal with the issues with such authorization system". These comments meant concern about certain troubles from not having a standard, which shows clear responsibility. The subgroups inside group #1 were:
1-1. Would use it because it brings multiple advantages. (4,4)
1-2. Would use it because it enhances the credibility of the company. (11,11)
1-3. Would use it because it is beneficial in business development. (4,4)
1-4. Would use it because it improves quality of internal activity. (5,5)
1-5. It is easy to deal with the issues with such an authorization system. (4,4)
1-6. It is good to have such an international standard in bioethics. (2,2)
The second group "#2. Would positively comply with standard or regulation whatever it is like" was composed of comments from 21 companies and was subdivided into 4 subgroups. Some of these companies tended to regard standards as almost absolute rules and seemed to say "Compliance is our company's policy." Others mentioned the efforts already made to use ISO and regarded such standard as its extension. The subgroups were:
2-1. The company ought to comply with standard or regulation. (9,9)
2-2. Comply with standard as company policy. (3,3)
2-3. Make positive use of standards such as ISO as a company. (8,8)
2-4. Use it because the ISO is easy to use. (1,1)
The comment group "#3. Would use it because it must be necessary for company activity" was composed of comments from 30 companies, which were also positive to such standards but implied that the company had no other choice. These companies regarded such standard as something that might affect their business if they did not accept it. The group was subdivided into 4 subgroups as below. Among them, 7 companies made it clear that they "3-4. Would have no other choice but to use it whether someone likes or not".
3-1. It is necessary for company activity. (5,5)
3-2. It is necessary externally. (11,11)
3-3. Would naturally use it on account of the characteristic of business. (7,7)
3-4. Would have no other choice but to use it whether someone likes or not. (7,7)
On the contrary, the group "#4. Would use it as the case might be" was composed of comments by 22 companies, which showed the possibility of acceptance of such a standard under certain conditions. They implied that they would not use it if the standard did not connect to the advantage or necessity in their business. The group was subdivided into 3 subgroups as follows:
4-1. Would use it if there is advantage for business. (9,9)
4-2. Would use it if it is evaluated as necessary for business. (6,6)
4-3. Might use it depending on the content or the circumstances. (7,7)
The largest group "#5. Do not know at present" was composed of the comments by 61 companies, which reserved the judgment on such a standard. Most of the comments said that they could not decide without looking at the content of standard, but some companies in 5-4 referred to the consideration about the concern with the future business activity of the company. This group could be subdivided into 4 subgroups as below:
5-1. Would decide according to the content of the standard. (24,24)
5-2. Cannot decide without looking at the concrete content of the standard. (16,16)
5-3. Do not think it is relevant to our business, though cannot decide without looking at the content. (3,3)
5-4. Cannot decide at present because it depends on the future circumstances. (12,12)
5-5. Would decide according to the reaction of those around. (6, 6)
The comments by 20 companies in the group #6 clearly said that they "Do not need" such a standard. The group was composed of 2 subgroups, where most companies had different reasons. One person from a company gave both reasons. Only 3 companies gave their reasons that they had other measures to deal with the issues.
6-1. Do not need it because it seems irrelevant to our business. (18,18)
6-2. Do not need it because there are already other measures to deal with the issues. (3,3)
There were 2 companies which said that they "#7. Cannot accommodate even if such a standard was established". The comments by 26 companies in the group "#8. There is some doubt of such a standard itself" had a variety of reasons. It was remarkable that 8 companies in 8-1 showed doubt of ISO itself with such reasons that ISO was a standard imposed by the West and that the effect of acquirement was unclear. It was also worth noting that the other 8 companies said that "8-3. Bioethical issues are not the matter of ISO". These opinions were deeply related to the comments in 8-4 and 8-5. In 8-5, even some companies that had given a positive answer on the use of the system commented about some difficulties to operate properly such a standard. The subgroups were:
8-1. There is some doubt of ISO itself in the first place. (8,8)
8-2. It is each company's responsibility to deal with the issues, even if the standard exists. (2,2)
8-3. Bioethical issues are not the matter of ISO. (8,8)
8-4. It is difficult to establish such a standard. (4,4)
8-5. Proper operation would be difficult, even if such a standard was established. (4,4)
In addition, one company said, #9. "No reason". (1,1)
Expectations of Bioethicists
In response to question 14, "As a biotechnology company, what do you expect of researchers of bioethics in the future?", 236 companies made comments but the answers included many obscure comments. The reason for this result seems to be that some respondents confused researchers of bioethics with researchers in biotechnology (who might be involved in bioethical issues). This signified an important fact that the recognition of "researchers of bioethics" was not sufficient among business people in the companies related to biotechnology.
These comments were resolved into elements and separated first by target group, for a "message clearly to researchers of bioethics", next a "message which was not clear whether it was for researchers of bioethics or those of biotechnology" and "messages clearly to researchers of biotechnology". The confusion could also be seen in one answer, there were some elements resolved from one answer but were grouped in the different message. The elements summed up to 271, as the comments by 32 companies were resolved into plural elements. The answer divided into 4 elements was from 1 company, into 3 elements from 1 company, and into 2 elements from 30 companies. These duplications were not in the same subgroup. The numbers in parentheses indicate the number of elements, and then the number of companies. The target groups were:
A. Request to researchers of bioethics. (164,139)
B. Request which was not clear whether it was to researchers of bioethics or those of biotechnology. (33,32)
C. Request clearly to researchers of biotechnology. (24,24)
D. Comments in general. (17,17)
E. Other elements including "Nothing special." (33,33)
As described above, 60.1% of the total elements (that is, the elements in the target group A) could be regarded as direct answers to the question. Although the other elements included important information, at least the recognition of "researchers of bioethics" was not certain as the questioner had expected.
The 164 elements in the target group "A. Request to researchers of bioethics" were grouped by the similarity of the contents and classified into 9 groups as below. The largest group was the first group "#1. Expect researchers of bioethics to address the issues with discernment" with 37 elements by 36 companies and was 22.6% of the big group A. They were not the request to researchers of bioethics for concrete work but for acting based on the balanced and wide range of knowledge in science, culture, religion and industry. These opinions had affinity with those of group "#3. Expect researchers of bioethics to act as a mediator of the party concerned" but later expect more concrete action. Cautious mood or uncomfortable feeling towards researchers of bioethics was not apparent in these opinions except a few comments in 1-1.
However, the tone in the 29 elements (17.7% of the big group A) by 27 companies in the group "#2. Expect researchers of bioethics not to impede biotechnology" showed alarm to a certain extent, least researchers in bioethics should have a negative impact on the industry. These opinions implied the fear for researchers' unilateral action with lack of understanding about biotechnology or industry. On the contrary, the opinions in the group "#4. Expect researchers of bioethics to establish rules soon" (24 elements by 24 companies, 14.6% of the target group A) and "#5. Expect researchers of bioethics to provision of information and enlightenment" (36 elements by 35 companies, 22.0% of target group A) positively expected some concrete works of researchers of bioethics. The group #5 was the second largest group where the researcher of bioethics was expected to have a role as an educator or an information provider.
The groups for Q14 target group A were as below:
#1. Expect researchers of bioethics to address the issues with discernment. (37,36)
1-1. Expect judgment on technology with scientific knowledge. (8,8)
1-2. Expect deep insight and broad outlook. (10,10)
1-3. Expect to have a viewpoint to consider the whole living organisms. (2,2)
1-4. Expect to have respect for life. (3,3)
1-5. Expect digging deeply into the issues. (3,3)
1-6. Expect consideration from an international point of view. (5,5)
1-7. Expect to take account of a variety of ethics which may change as time go on. (2,2)
1-8. Expect to have a certain institution of experts in bioethics. (2,2)
1-9. Expect not to be dragged into commercialism. (2,2)
#2. Expect researchers of bioethics not to impede biotechnology. (29,27)
2-1. Expect understanding of the value of the technology. (4,4)
2-2. Expect them not to impede the development of biotechnology. (4,4)
2-3. Expect to consider the issues from a neutral standpoint. (12,12)
2-4. Expect to address the issues by a realistic approach. (6,6)
2-5. Expect not to be excessive, even though ethics is important. (3,3)
#3. Expect researchers of bioethics to act as a mediator of the party concerned. (20,20)
3-1. Expect acting as a mediator. (9,9)
3-2. Expect collecting a broad variety of opinions. (4,4)
3-3. Expect setting up a place for discussion taking account of consensus building. (7,7)
#4. Expect researchers of bioethics to establish rules soon. (24,24)
4-1. Expect establishment of international guidelines. (8,8)
4-2. Expect establishment of guidelines as soon as possible. (7,7)
4-3. Expect establishment of balanced guidelines. (9,9)
#5. Expect researchers of bioethics to provide information and enlightenment. (36,35)
5-1. Expect provision of information and enlightenment. (18,18)
5-2. Expect relief of misunderstanding and fear of the public. (6,6)
5-3. Expect improving the transparency and clearness of content of research. (8,8)
5-4. Expect to introduce bioethics education. (3,3)
5-5. Expect to improve the image of biotechnology. (1,1)
#6. Expect researchers of bioethics to advise and suggest to companies. (4,4)
#7. Expect researchers of bioethics to watch out for the reckless act of scientists or companies. (4,4)
#8. Expect researchers of bioethics to focus on the issues concretely. (6,6)
#9. Expect researchers of bioethics to define clearly what is bioethics. (4,4)
Analysis was also made for the comments directed to other persons. The 33 elements in the target group "B. Request which was not clear whether it was to researchers of bioethics or those of biotechnology" were grouped by the similarity of the contents and classified into 4 groups as follows. The largest group was "#1. Expect researchers to see to it that R&D should be done in proper way" with 15 elements and included 45.5% of the comments in target group B. These elements could be read both as "researchers of bioethics should take care of the issues" and as "researchers of biotechnology should control themselves". In either way, these opinions implied a fear over the deviation of scientists and unfavorable results caused by scientific research, which was also seen in the group #3. The 10 elements in the group "#2. Expect researchers' good sense" could also be read as having a good sense of "researchers of bioethics" or "researchers of biotechnology" but still implied the concern about the deviation of researchers from good practice. In any case, most of the opinions in the big group B were asking questions about the morals of those who engaged in research related to biotechnology or life. The groups were:
#1. Expect researchers to see to it that R&D should be done in proper way. (17,17)
1-1. It is necessary to control deviation of researchers in some way. (4,4)
1-2. Researchers should take account of safety and environmental influence. (6,6)
1-3. Researchers should respect for human dignity. (3,3)
1-4. Human cloning has problems. (4,4)
#2. Expect researchers' good sense. (10,10)
#3. Expect researchers to see it that individual should not be inflicted with disadvantage. (3,3)
#4. Research must be balanced. (3,3)
The target group "C. Request clearly to researchers of biotechnology" included comments with 24 elements by 24 companies, making up 8.9% of the total elements. That is, this many people confused "researchers of bioethics" with "researchers of biotechnology". These elements were grouped by the similarity of the contents and classified into 6 groups as follows. The most of these except for a comment in #5 were opinions of alarm about the possible deviation of researchers similar to those seen in the target group B. The groups were:
#1. Expect researchers to be prudent with respect for life and consideration of nature as a whole. (6,6)
#2. Expect researchers to comply with standard or rule. (5,5)
#3. Expect researchers to consider the issues with their own awareness. (8,8)
#4. Expect researchers to conduct research that is beneficial to humanity. (4,4)
#5. Expect elucidation of pharmacodynamic action of intestinal bacteria. (1,1)
If at all the elements in the target groups B and C (except for C-#5) were simply summed up as similar group, the number of elements were 56, which was 20.6% of the total elements. One out of 5 elements was the opinion that concerned researchers' deviation by neglecting ethics.
The target group "D. Comments in general", were composed of 17 elements by 17 companies. These elements were not a direct answer to the question but grouped by the similarity of the contents and classified into 4 groups as follows. Among these, there were 6 negative opinions towards bioethics itself. It was noteworthy that there were the opinions "#1. Definition of bioethics is obscure". Together with the opinions in A-#9 and Q15-#3-1, and the existence of the big group B and C, it signified the fact that concept of "bioethics" itself was not clearly recognized by business people related to biotechnology. The groups were:
#1. Definition of bioethics is obscure. (3,3)
#2. It is necessary that companies have morality. (7,7)
#3. It is difficult to find solution to problems with bioethics. (6,6)
#4. Let it go at that what is good is good and what is wrong wrong. (1,1)
The target group "E. Other elements including "Nothing special" were composed of 33 elements by 33 companies. These elements were grouped by the similarity of the contents and classified into 6 groups as follows. It should be taken into account that "Nothing special" still composed a part of proper answer to the question and but was only 7% of the total elements. The comments were:
#1. Have already been doing at least what should be done in our company. (1,1)
#2. Companies may not be very relevant to the issues. (2,2)
#3. Would like to watch how researchers of bioethics deal with the issues. (1,1)
#4. Nothing special. (19,19)
#5. Not applicable. (1,1)
#6. Do not know. (9,9)
Discussion and Conclusion
Some companies related to biotechnology actually faced various bioethical issues, but only a portion of them regarded these as their personal issues and took some measures to tackle these issues. The efforts to deal with the issues showed a wide variety of responses. And these differences depended on the type of industry or the field of biotechnology they were engaged in. This difference can be considered as a difference of "sensitivity". In large companies, in terms of number of employees, concerned with biotechnology in medical field; this sensitivity was relatively high. In biotechnology related companies, although the efforts to deal with bioethical issues were in principle based on their own sense of ethics, they tended to be realistically considered as part of risk management.
This research also revealed that the companies related to biotechnology feel the necessity of public education for the proper understanding of biotechnology. However, they are also faced with the dilemma that they cannot talk objectively on bioethical issues because of the fact that they are companies. Bioethicists are expected to act as mediators to fill the gap between the companies and the public or the media. How to build such communications is an important issue in the future.
The result of the surveys illustrated a wide difference between the companies in their awareness of issues and the efforts to deal with them. This could be regarded as the difference in "sensitivity to bioethical issues". This sensitivity is likely to depend on the attributes of companies and the type of business. For instance, large companies in the field of medicine, such as major pharmaceuticals show higher sensitivity. However, it may be also due to the philosophy or climate of a company, or may reflect the awareness of the top management, considering the fact that some small companies also had high awareness and definitely started the actual work. The CEOs of the major multinational pharmaceuticals sometimes mentioned the necessity of ethical consideration in their speeches and they will make decisions to take actions toward bioethical issues. Still, there also should be some bottom-up cases to reconsider company's policy. It will be interesting to have case studies from this point of view.
The company making positive efforts to deal with issues with high sensitivity could be called as "bioethically advanced company". This research shows that such "advanced companies" certainly exist in the world. For these companies, bioethical consideration tends to be a part of their high level management strategy or risk management strategy, with critical feeling that business does not work neglecting bioethics. It is likely that they have some common "bioethical values", such as importance of informed consent, protection of privacy, taking account for influence on environment, and communication with the public. These common values were already shown in the statements of the industrial organizations and could be included in international bioethics standards, though they may be too abstract as discussed below.
Throughout the survey, the companies have sent some serious messages to bioethicists. Some companies were surely negative and severely criticized bioethicists. Others showed their lack of understanding about what is "bioethicist" as described later. However, it seems that the results as a whole suggested the recognition of the roles of bioethicists and expectations.
Companies related to biotechnology expect bioethicists above all to be mediators between the public or media and the industry, and to engage in communication or education for filling the gaps. However, the expectation to play a role of bridge-building requires the condition that bioethicists should be balanced and objective, and on the understanding of the reality of business. It is also noteworthy that some companies showed fears lest the researchers of bioethics would develop an argument or a movement against corporate profitability, considering ethical debates too much. For some people in the companies, bioethicists' knowledge about business or scientific technology may seem insufficient to balance profit and ethics.
The companies' expectation of bioethicists to be objective demands knowledge about biotechnology and business, which may be called as science literacy and business literacy. Science literacy is something fluid but may be related deeply to one's value judgment. History shows that many scientists have become the victims of scientific unintelligence of the people. As shown in many studies on public opinions, people's knowledge about biotechnology influence on their acceptability to the new technology (Macer, 1992; Macer, 1994; Macer & Ng, 2000). In order to seek a better way to cope with new technologies along with considering bioethical aspects, bioethicists are obliged to have science literacy.
At the same time, business literacy is also fluid and influences one's values. Without a right sense of profit and loss (PL), for example, one may easily mistake gross margins for profit, criticize business activity itself, or blame company's valid activity for their self-maintenance as excessive "profit-making". Business literacy here should be some basic knowledge about corporate accounting, a series of minimum knowledge about activities such as R&D, marketing, sales, maintenance, commercial custom and business rules. Although criticizing company's wrongdoing or deviation in bioethical issues may be one of the roles of academy, still it is necessary at least to know to a certain extent how companies work, and what kind of mechanisms they have, before just attacking their behavior from outside. There are ethical implications of economic policy in general that companies need to consider (Macer, 1996; 1999; 2002).
While arguing about the necessity for companies to involve bioethics, Dhanda (2002) points out that there is enough room for bioethicists to understand their system and introduce bioethics. He argues that "The details of this bureaucracy are new to many bioethicists, and it is at this convergence that the ethical dimension must be included", and that "This technocratic model may seem impenetrable as this specific structure is far removed from the academic situation of most bioethicists; however, it represents the perfect opportunity for bioethicists to introduce their concepts to help groups develop self-regulatory systems." Then, it should be bioethicists' part of efforts to have this literacy, if trying to implement bioethics into companies.
Moreover, some pointed out that there are merits for bioethicists as well to involve in the issues of biotechnology companies (Brower, 1999; Atkin, 2001). Magnus (2002) described the benefit of being able to learn more about the nitty gritty of the work and have access to information more timely. The bioethical problems waiting for resolution might be there at the scene of daily operation of companies, which can never be seen just from without at a distance. In order to get into there, trust from companies in bioethicists is necessary.
In the Japanese questionnaire survey, the responses showed the confusion between "researchers of bioethics" and "researchers of biotechnology" and it was clearly revealed that "researchers of bioethics" were not recognized very much in these companies. There were many comments in the answers and also questions asked by respondents asking for the definition of "bioethics" and also questioning whether their own business would have something to do with "bioethics". Although this question was sometimes used in the explanation for asking to exclude their company as the subject of the survey, it may reflect the fact that the existence of the study of "bioethics" itself has not been widely known in the first place. It can be assumed that the notion of bioethics has not yet taken root in Japanese industry, and that bioethicists have not acquired citizenship enough. This may imply insufficient independency of Japanese companies related to biotechnology in the efforts to deal with bioethical issues.
On the contrary, in the United States, bioethicists are exposed to criticisms from the media. Saletan (2001) wrote in his article in online magazine Slate that ethicists address only the superficial procedures. "Corporate ethicists, like corporate lawyers, have reduced their purview to technique." The New York Times ran a story that threw doubts on independency, qualification and arrogance of bioethicists (Stolberg, 2001). The present circumstances where there is no certification of becoming bioethicist often gives grounds for accusation. Christianity Today (Anonymous, 2001a) also carried the story on bioethics, with a title "Wanna buy a bioethicist?" It included a phrase, "Bioethicist has certainly entered the American vocabulary, but its meaning remains murky". The San Francisco Chronicle put more shocking title on the article about bioethicist in general, "The new grim reapers," which called in question about the discussion on personhood in bioethics.
Consequently, the direction of bioethicist is also coming into question. It is now tested whether bioethicists can become a "trusted partner" for the public and also for the companies. It is urgent to consider how to be more objective neither being radical nor corrupt, and also how to disseminate the presence of the studies. If failed, bioethicists might be left out of scheme from society as a bunch of fishy scholars.
References
Anonymous (2001a), "Wanna Buy a Bioethicist?", Christianity Today, October 1 , Vol. 45, No. 12, Page 32.
Anonymous (2001b), "Corporate Bioethics Smoke in Our Eyes", Content Wire - Biotek Newswatch, 17 July,
Atkin, Jennifer Lee (2001), "Educators and Experts", Science & Spirit Magazine, Nov/Dec,.
Brower, Vicki (1999), "Biotechs Embrace Bioethics", BioSpace, Inc. .
Dhanda, Rahul K. (2002), Guiding Icarus: merging bioethics with corporate interests, John Wiley & Sons, Inc. New York.
Kato, M. and Macer, DRJ. (2003) "How companies respond to bioethical issues". Journal of Commercial Biotechnology 9: 153-62.
Macer, Darryl. R. J. (1992), Attitudes to Genetic Engineering: Japanese and International Comparisons , Eubios Ethics Institute.
Macer, Darryl. R. J. (1994), Bioethics for the People by the People, Eubios Ethics Institute.
Macer, Darryl. R. J. (1996), "Biotechnology, International Competition, and its economic, ethical and social implications in developing countries", pp.378-397 in Concepts in Biotechnology, ed. Balasubramanian, D. et al., (Universities Press Pvt. Ltd, Orient LongMan Inc., India, 1996).
Macer, Darryl. R. J. (1999) “Bioethics and sustainable development”, pp. 112-114 in World Development: Aid and Foreign Direct Investment 1999/2000 , AJ. Fairclough, ed., (London: Kensington Publications 1999).
Macer, D. & Chen Ng, M. (2000) "Changing attitudes to biotechnology in Japan", Nature Biotechnology 18: 945-7.
Macer, DRJ. (2002) "Patent or perish? An ethical approach to patenting human genes and proteins." The Pharmacogenomics Journal 2: 361-6.
Magnus, David (2002), "Is there bioethicist in your company? Should there be?", Drug Discovery Today Vol7, No.7 April, p385-387.
Nikkei Biotech and Nikkei Biobusiness Ed. (2002), Nikkei Bio Yearbook 2003, Nikkei BP, Tokyo (in Japanese).
Saletan, William (2001), "The importance of appearing ethical", Aug. 21, Slate, By , .
Bioethics, Industry and Genome-related Business
- Yoshihiro Okada and Darryl Macer.
Graduate School of Integrative Environmental Sciences, University of Tsukuba, JAPAN
Email: pharma-ethics@ams.odn.ne.jp, macer@biol.tsukuba.ac.jp
There is growing recognition of the importance of ethical issues relating to genetic technology and genomics in industry. This research looks at what issues are raised by different sectors of the community, the public, including industry-themselves, and experts in bioethics and government. It then examines how industry is dealing with these issues to resolve them and how they develop genome-related business that are more in harmony with social values.
Literature review of academic and government papers related to ethical issues of genome-related research, especially in the pharmaceutical industry, was made. A survey of newspaper articles about gene therapy was also made in Asahi Shimbun records from 1990 to 2003. Discussions were also made with some genetic interest groups, including disease support groups. A public survey of citizens was conducted in December 2002-February 2003 (N=377), and analysis of open questions relating to gene therapy was made. A pilot survey on “Bioethics and Management in the Pharmaceutical Industry Related to Genome-related Business" was conducted on managers of Business Planning Departments or from the President’s Office of pharmaceutical companies, clinical diagnosis companies, clinical research organizations (CRO), clinical sales organizations, and wholesalers (N=53).
The statements of some organizations on certain issues, for example, the Human Genome Organization (HUGO) 2000 Statement on Benefit Sharing or Gene Therapy were analyzed. The trends and types of articles published in Asahi Shimbun over the use of gene therapy provide one example of how media attention on a high profile example of medical genetics has fallen in the past year. The 2003 public survey followed a similar system to earlier surveys and the response rate was 20% with responses obtained from all 47 prefectures in Japan (conducted with collaborators). There is a mix of different sectors of the Japanese public, education, different occupations, and rural and urban populations. Comparisons to earlier public surveys allowed comparisons from 1991 to 2003 in Japan. The reasons that the respondents gave for their attitudes in the open spaces on the surveys for the open questions were categorized on the basis of the keywords and concepts expressed. There was continued high public support for use of human gene therapy (57% said they agreed to use it themselves if "they were likely to get a serious or fatal genetic disease later in life" and 26% were against). The most common reason given to support was to save human life, and the most common against were fears of harm and concerns that it was unnatural. There was only 7% against gene therapy in the case of treating cancer, but 50% were against using it to improve intelligence children would inherit.
The response rate from the survey of industry was 9%. People in the pharmaceutical industry and the CRO industry tend to hear or use the word “bioethics” more in the situation of research and development, while in the clinical diagnosis industry bioethics is used more in research and sales. In the wholesaler industry, the most frequent is in the sales scenes. Those results reflect the situations of each sub industry; the pharmaceutical industry is still in the R&D stage of the order-made medicines, while in the clinical diagnosis industry genetic diagnosis is already one of the products and raising practical bioethical issues. All the companies thought bioethics was important, and involved serious responsibilities for their companies. Sometimes the law was a burden, but the respondents all agreed they should deal with the issues. The pharmaceutical industry respondents thought that total sales or profit will increase or that committing resources to bioethics will raise their corporate image. On the other hand, the clinical diagnosis industry, the wholesaler industry and the CRO industry more often said that expenses overall will increase by bioethics commitments. More companies expected trade associations to take the initiative in setting the rules for bioethics, than government; though more individual company role was seen in the CRO industry. All sub industries recognized the necessity of bioethics education, and appropriate schools for education were surveyed. Information and public relations was also discussed. All sub industries answered that they should meet needs only for therapeutic purposes.
Trends in the range of ideas that people have about use of genetic technology for human gene therapy, and for use in the pharmaceutical industry were analyzed. The company survey data is useful for research of the company management in the pharmaceutical industry, and how they will deal with issues of bioethics in application of life science technology in industry. In the future a survey of the cosmetic industry could be made to see how the use of know-how of genome research might be used for non-therapeutic purposes. Companies thought new laws on bioethical issues are needed, and policy needs to be examined to see the best form of regulation.
Ethical Aspects of Counselling in Family Planning Services
- 1Fatma Ersin, 1Fatma Gozukara, 2Nurten Aksoy and 2Sahin Aksoy.
Harran University, 1Higher School of Health , 2Faculty of Medicine, Sanliurfa, TURKEY
Email: saksoy@harran.edu.tr
Introduction
In Turkey, reproductive health comprehension is rather new. Before reproductive health comprehension, ‘family planning’ and ‘mother and child health’ terms are used to explain this comprehension. Around ‘family planning’ and ‘mother and child health’ terms, mother and infant mortality is the mostly discussed subject. Although, the causes of mother and infant mortality are preventable, it is thought provoking that the number of mother mortality is higher in Turkey, when Turkey and developed countries are compared. So, in Turkey both the new comprehension that is ‘reproduction health’ should be worked at being appropriated and to be decreased the number of mother and infant mortality should be considered, discussed and solved from ethical point of view.
Family planning is described as family can have infant as desired time and number. Every year, in a great many countries, including Turkey, thousand of infant and mother are died because of insufficient family planning applications. The reasons of mother and infant mortalities are to give birth at too old or too young ages, many frequently intervals and too many delivers (Taskin 1997). Successful family planning applications decrease mother and infant mortality to a great extent. The large part of mother mortality and diseases, threatening health of mother is preventable with becoming pregnant as desired time, number and appropriate intervals (Taskin 1997). Children from becoming unwanted pregnant increase demand to education and health services. So, family planning gives some help to industrial development and life quality of society, and hinder rapid increase of the population (Taskin 1997; Balkan 1995).
One of the important roles of nurses working in mother and child health services is to help women about choosing appropriate method and supporting (Ozvaris 1993;WHO 1989; Akin and Ozvaris 1995). According to research up to this date, it is thought that education and counselling services, concerning family planning given by nurses make women to plan pregnancy consciously and help to solve the problems on mother and child health caused by frequent and excessive number of delivers (Das and Sezgin 2001). The meaning of counselling is that one person helps to other person when they talk face to face. Counselling would rather be informative than making decisions on behalf of her. The decision should be made by the person who is given counselling. Unfortunately researches have indicated that neutral counselling is impossible although neutral counselling is ideal (Aksoy 2001). Counselling in family planning services is a process to be completed with information, education and motivation during face-to-face talk (The Ministry of Health 1997; The Ministry of Health 1995).
Counselling is a crucial part of family planning services but it is usually neglected. Effective counselling services in a comfortable place help persons to understand protection methods and to choose method appropriate for them. At the same time counselling provide to choose the method of contraception consciously, to apply method as truthfully and regularly.
Benefits of Counselling
Counselling provides applicant to choose the most appropriate method of contraception. During counselling services applicant describes personal characteristics, experiences and expectations, so notice her own family planning needs. In this manner applicant choose method appropriate for her. Since applicant has information correctly and completely, counselling provides the correct application of the method. In this way pregnancy and other complications caused by wrong application of method are prevented. Counselling also provides to apply the chosen method in longer period. If applicant chooses the method consciously and informed she applies the method correctly, has knowledge in side effects, knows who to counsel when she has problems, trusts service and the method very much, and consequently applies method in longer period. Counselling provides the staff to use time efficiently. Although in the beginning counselling is thought as a waste of time, when it is used effectively, counselling provide to prevent unwanted pregnancy, complications, unnecessary applications and additional works. Counselling increases quality of services consequently increases applicants’ satisfaction. Since satisfied users advise modern family planning methods to the other persons, counselling increases the number of persons who use modern family planning methods. Counselling provide economical gain to applicant, country and health services. Application of family planning methods prevent unnecessary methods and reduction of additional health risks and expenses due to unwanted deliveries and abortion, provide economical gain to applicant, country and health services in longer term.
Rights of Applicant
In every unit, applicant has the following rights;
To inform: Applicant can have right to have knowledge about family planning herself/himself and her/his family.
To obtain: applicant can obtain the chosen method if there is no significant contradiction.
To choose: Family planning services can be composed of informing, education, counselling. Services can provide applicant to choose convenient method among other methods.
To trust: Applicant can have all information about services correctly
Confidentiality: Speaking during counselling should not be said to another person and it should respect to confidentially of applicant.
Respect: Respect to can never be neglected.
To feel comfortable: Comfortable place should be provided to applicant.
Continuous service: Service and materials should be provided to applicant when necessary.
To declare opinion: Applicant has right to declare his/her opinion about services (The Ministry of Health 1995; The Ministry of Health 1996).
Reproductive health field includes many ethical issues. Among those, there are subjects such as right to give birth, abortion, effective research of birth control methods, prenatal sex determination, and necessity for infertility treatment. As it is known, there are various ethical conflicts in family planning. Different solutions are found relative to different conditions so in this study all policies, applied in Turkey about family planning are examined with basic principles of ethics (Kirimlioglu, N 1998). Counselling services about family planning are given appropriate to principles (Erdemir et all 2001; Beauchamp and Childress 1994) and concepts (Gillon 1985) of ethics. When we mention principles and concepts of ethics which are;
1. Autonomy: Autonomy means that person can decide under any pressure. During family planning counselling service family can decide autonomously. Nurses and midwifes, who give counselling service inform family fully under any psychological pressure and give some help to decide autonomously.
2. Non-maleficence: Family is informed about side effects and effects satisfactorily so family choose harmless and appropriate method.
3. Beneficence: From establishment of world it is believed that to do someone kindness is a mission.
4. Paternalism: Paternalism means that health staff (i.e. nurse, doctor) decides on behalf of patient and applies since they claim that they know the best interest of the patient (Das 2001) but the point that we confirm in counselling service is that counselling gives all information to patient and decision is taken by the patient. Patient can only make right decision by a good counselling service. For example in paternalism women who want to take contraceptive method is given no information and said that the best method for her is Intra Uterine Device (IUD).
5. Justice: This principle is related that service is given all people at same degree. For example to be just, family planning service about prevention unwanted pregnancy become common in countrywide without protecting region, race and language.
6. Informed consent: For application, firstly patient is given all information and then permission is obtained. To get permission is an ethical responsibility. Informed person has right to refuse the application. This principle brings mutually respect and participation.
7. Honestly and loyalty: all information, given during counselling should be true and complete. Loyalty come with respect and trusts to personal autonomy.
8. Confidentiality: When confidentiality is not observed trust is betrayed. In Turkey termination and prevention of pregnancy is considered as a fundamental human right in ‘Population Planning Law’ and ‘Family Planning Program’. (Sehiralti 1994; Family Planning Law No: 2827). To use this right, people should decide freely and responsibly. To decide as responsible provide that person decide consciously (Sehiralti 1994). Until the middle of twentieth century according to traditional model, accepted in medicine ethics, duty of health staff was to be beneficent to the patient if possible, if it was not possible non-maleficence was prima facia obligation. In addition in this model there was paternalism between patient and staff. But with scientific and social developments in 20. century this ethical model became insufficient. Instead of this model, liberal or contemporary approach is developed. With this new approach rights of applicant are endured to autonomy and informed consent. So applicant participates decision making process in the related to service (Sehiralti 1994) Contraception preference is a very important decision. Ineffective method may cause unwanted pregnancies. A wrong method can cause serious side effects. The method that is not appropriate to lifestyle and social values of user usually is not used correctly and continuously. Therefore, who should choose the method? In our country it usually is wrong that health staff decides method on behalf of the patient. But it is a reality that women who use contraception decide by taking their husbands’ views. It is very important that people who chose contraception use the method willingly and continuously. People should inform, educate, suggest but take final decision consciously. By real counselling we help people to choose the most appropriate method, inform about method and motive. As a result, culture and religion can effect to choose the method. Behaviours of counsellor should make individual’s decision easier. Counsellor never says her/ his opinion. It should not forget that person could accept and use her method easily. For effective counselling service, staff should pay attention to principles and concepts of ethics and educate with national education program. If possible, counselling room in that privacy is provided form for applicant surely. To evaluate service, which is given recording system form is necessary that should be continuous and standard.
References
Akin, A.,Ozvarış, ŞB. ‘Aile Planlamasi ve Halk Sagligi’ (Family Planning and Public Health), In Eds Bertan M. Güler C. Sun Bookshop. Ankara 1995;119-155 [in Turkish]
Aksoy, S. ‘Antenatal Screening and Its Possible Meaning from Unborn Baby’s Perspective’. BMC Medical Ethics. 2001;2:3.
Balkan,GE. ‘Dunyada ve Turkiye’de Saglik, Kalkinma ve Cevre Acisindan Nufus Sorunu.’ (Population Problem in Turkey and in the World from Health, Development and Environment Perspective) In Ed. Akin A. Saglik Bakanligi ACS-AP Genel Mudurlugu. Ankara 1995. [in Turkish]
Beauchamp, T.L. and Childress, J.F. Principles of Biomedical Ethics, Oxford University Press, New York, 1994.
Das, Z., Sezgin, A. ‘Kadinlara Dogum Sonu Donemde Verilen Aile Planlamasi Egitiminin Etkili Yontem Kullanmalarina Etkisi’ (Effect of Education Given to Women in Postpartum Period for Family Planning on Using Effective Methods) Health and Society. October-December 2001;11:4:65. [in Turkish]
Erdemir-Demirhan A. Oguz,Y. Elcioglu, O. Dogan, H. ‘Kadin Hastaliklari ve Dogumda Etik, Klinik Etik, Klinik Uygulamalarda Etik Sorunlar’ (Ethics in Delivery and Woman Diseases), Clinic Ethics, , Nobel Medical Bookshops, Istanbul 2001:586-589 [in Turkish]
Gillon, R. Philosophical Medical Ethics, John Wiley & Sons, Chichester, 1985
Kirimlioglu, N. ‘Aile Planlamasi, Gebeligin Sonlandirilmasi ve Turkiye’deki Nufus Politikalari Hakkinda Yasalar ve Etik Yaklasimlar.’ (Family Planning and Medical Abortion in Turkey, in The Light Of Law And Ethics), Turkiye Klinikleri Journal of Medical Ethics, Law and History, 1998;6(1)
Ozvaris, SB. et. al. ‘Antenatal Donemde Verilen Aile Planlamasi Egitiminin Postpartum Donemde Yontem Kullanmaya Etkisi.’ (The Effect of Family Planning Education in Antenatal Period on Using Methods at Postpartum Period) Saglik ve Sosyal Yardim Vakfi Dergisi. 1993;3:8-15. (in Turkish)
Family Planning Law No: 2827, 27 May 1983/18059 Official Gazette. [in Turkish]
Sehiralti, M. ‘Aile Planlamasi Alaninda Saglik Calisanlarindan Beklenebilecek Etik Yeterlilik', (Ethical Competence of Health Care Professionals in Family Planning) Turkiye Klinikleri, Medical Ethics, October 1994; 2(3):115. [in Turkish]
Taskin, L. ‘Aile Planlamasi, Dogum ve Kadin Sagligi Hemsireligi’. (Family Planning, Nursing of Delivery and Women Health, System) Ofset Printing Office, Ankara 1997:413-416. [in Turkish]
Turkish Ministry of Health, Aile Planlamasi Hizmetlerinde Guncel Bilgiler, (Current Information on Family Planning Services) Ankara May 1997;3-10. [in Turkish]
Turkish Ministry of Health, Aile Planlamasi ve Ureme Sagligi. (Family Planning and Reproductive Health), İstanbul 1995;2.Basım,Cilt 1:3-1/3-9. [in Turkish]
Turkish Ministry of Health, Aile Planlamasi Klinik Uygulama El Kitabi, (Handbook for Family Planning Clinical Application) İnsan Kaynagini Geliştirme Vakfi, Ankara 1996. [in Turkey]
WHO. Preventing Maternal Deaths. Geneva 1989:177-180.
Haeckelian Legacy of Popularization - Vertebrate Embryos and the Survival of the Fakest
- Pauli Ojala, M. Sc..
Scientist, BiochemistryResearch and Development, Plasma Products, Finnish Red Cross, Blood Service, Kivihaantie 7, 00310 Helsinki, FINLAND
Email: Pauli.Ojala@Veripalvelu.fi
Introduction: The Haeckelian embryo relics
The art of embryology used to be called Entwicklungsgeschicte, the developmental history of the organism. This history was to be seen repeating itself during the development of every new individual. Until recently, Ernst Haeckel's (1834-1919) drawings of the external morphology of vertebrate embryos remained the most comprehensive comparative data displaying their conserved stage. E.g. Molecular Biology of the Cell (Alberts et al. 1994, p. 33) referred to Haeckel's Anthropogenie from the year 1874 in its 1994 edition (Fig. 1A).
When a group of zoologists from six universities reproduced the old figures (Richardson et al 1997), it lead to a popular claim that the topic is “turning out to be one of the most famous fakes in biology” (commentary in Science 277, p. 1435, 1997).
On the basis of the correct appearance from over 40 different embryos, Stephen Jay Gould (1941-2002) - the last scholar with a type writer and proofreading in the footnotes – wrote before his untimely death: "But we do, I think, have the right to be both astonished and ashamed by the century of mindless recycling that has led to the persistence of these drawings in a large number, if not a majority, of modern textbooks!"(Gould 2000.)
The reductionist paradigm framing the Haeckelian embryos was not a model, but a universal law. Johann Friedrich Meckel the Younger (1781-1833) and Etienne R.A. Serres (1786–1868) had earlier, but more limited statements of the same idea. The "Meckel-Serres law" asserted that the embryo passed stages corresponding to the adults of lower forms. Ernst Haeckel seized upon these generalizations and he is remembered especially due to his Biogenetic Law ("Biogenetische Grundgesetz") aka recapitulation and his Gastraea Theory.
The law of correspondence meant correspondence between fertilized egg and amoeba, the gastrula and the coelenterates, the pharyngula and the fish etc. The law of terminal addition meant evolution by linear addition on terminal stages. The law of truncation meant the recapitulation in normal time of gestation. The main expression of Haeckel declared that organisms retrace their evolution as embryos when they "climb their own family tree”.
Stephen Jay Gould refuted the dogmatic use of the Haeckelian paradigm "ontogeny recapitulates phylogeny" in his first technical book Ontogeny and phylogeny in 1977. In his more popular Ever Since Darwin, Gould wrote: "Recapitulation was Haeckel's favorie argument… He used it to attack nobility's claim to special status - are we not all fish as embryos? - and to ridicule the soul's immortality - for where could the soul be in our embryonic, wormlike condition?" (Gould 1977b, p. 217.)
The breakthrough or at least the most recent round of correspondence over the level of fabrication and "phylotypic stage" of "hour-glass" theory of resemblance has taken place as correspondence to technical journals like TREE 12, pp. 461-3 (1997); TREE 13, p. 158 (1998); Science 279, p. 1288 (1998); Science 280, pp. 983, 985-6 (1998); Science 281, p. 349 (1998); Science 281, p. 1289 (1998); Nature 406, p. 225 (2000); Nature 410, p. 144 (2001) etc.
According to Richardson et al (1997) (see Fig. 1B), the distortions include omissions and insertions of embryo features, which can neither be explained by the quality of the day's microscopes (the Zeiss company was founded in Haeckel’s city of Jena), nor hand motorics (Haeckel published even art books). There is no scale bar to make a judgment on the "gill slits". The difference in size across the species is about 0,7-9,25 mm, and hidden is also the actual age of the embryos. The first of the three embryo lanes the earliest phase of ontogenesis is not, as was originally implied. The differences are most evident earlier than the disputed phylotypic stage.
Of the seven classes of vertebrates, five at most are included (apparently because the taxonomic level of greatest resemblance among vertebrate embryos seems to be below the subphylum). After omissions of common species, even the nomenclature of the selectively chosen ones (salamander instead of a frog) are skewed. The original and the replicas alike typically fail to give scientific names, stages or source of the specimens illustrated. The number of units in repeating series such as spine somites is claimed to be practically invariant, although it ranges from 11 to over 60.
The infamous visceral or pharyngeal pouches (grotesquely: gill slits or functional gills) at the tailbud stage look strikingly different in Richardson's sample of schemes, and range from 1 to 6 in number. Furthermore, there seems to be changes in pattern (allometry) and timing (heterechrony) of growth in limbs or paired fin buds, lens buds, liver tubes, or heart in the mid-stage of the Haeckel's "phylotypic" stage. In reality, the "gills" develop into structures in inner ear, jaw, throat, some glands etc. The first detailed reference to the correct organs I have found in Finnish dates back to the anthropologist Yrjö Kajava (1919, p. 36-38).
Gould described how the predecessor in his chair (Louis Agassiz, 1807-1873) disliked Haeckel for "his haughty dismissal of earlier work which he often shamelessly 'borrowed' without attribution" (2000). Richardson and Keuck wrote in one of the above mentioned prestigious correspondences:
"We can make a persuasive case with Haeckel because we have identified some of his sources… he removed the limbs. The cut was selective, applying only to the young stage. It was also systematic because he did it to other species in the picture… The altered drawings support theories which the originals did not. Therefore, these are not legitimate schematic figures." (Nature 410, 2001, p. 144.)
Haeckel never listed the sources of his simplified pictures. Filling the gaps in the embryonic series by speculation is one thing, but concealing a mere hypothesis from observations is something else. Richardson and Keuck (2002) have compiled the most thorough list I have seen on the possible sources of the drawings, together with the list of detailed charges on the fabricated embryo panels.
The consensus seems to be, that the recapitulationary concept of Haeckel is dead thanks to developmental physiology and genetics. It is hastily added, however, that it has its value as a descriptive statement. Haeckel himself used puzzling phrase "labyrinth of ontogenesis" in his most popular Weltraethsel or Riddle (1899 p. 79).
University-level textbooks elaborate a new concept of "evolvability" and after the "unipolar Haeckel" –model, students still face concepts such as by "bipolar Haeckel", "two-dimensional Haeckel", and "three-dimensional Haeckel" -models. Sound criticism of the deductive Haeckelian reductionism has been rare in the narrative thread of Ariadne.
In a sense the situation resembles the paradigm change from the "tree of life" to the "bush of life" or "agnostic tree of life" at the emergence of the genome projects and popularization of the lateral gene transfer. Likewise, the Biogenetic Law is still supported by several recent studies – if applied to single characters only (like in Richardson & Keuck, 2002). Popperian habits would wellcome not only verification, but also falsification in order to earn the epithet "scientific" for a theory. Biogenetic Law was a straitjacket for a paradigm, and there must be a place for criticism before adopting it as a heuristic principle.
Reflections of the discourse has led to the dismissal of the Haeckelian relics from the most recent editions of major textbooks such as the aforementioned The Molecular Biology of the Cell (Alberts et al 2002) or Developmental Biology (Gilbert 2000). Pro scientia!
Scott Gilbert is the author of the most extensively used book of developmental biology, whose most recent 6th edition (2000) became freely available in PubMed in the autumn 2002. It is somewhat embarrassing, that even Gilbert used the forgery in the 5th edition of the Developmental Biology (1997). Gilbert has been open-minded enough to give attention to his error, although not in the printed version of the book. In an Internet-appendix to the last chapter, he writes:
"However, even though von Baer and others had discredited the recapitulation notion, it became one of the most popular notions in biology. Gould (1977a, b) has shown that while recapitulation has a limited value in looking at in formation of related species, it is not a general phenomenon. However, recapitulationism became one of the central paradigms of biology." ().
As to its causalities for today's research, it is often boldly stated that the Haeckelian embryos are paramount to the importance of clothing of Madonna in a medieval painting to Christian doctrines. I disagree. The relevance and the level of fabrication in the Haeckelian legacy of popularization can be prooved with a historical perspective, apart from hair-splitting.
Was Ernst Haeckel a deliberate propagandist and a fraud? Did the Haeckelian popularization brutalize the western society cross-disciplinary? How did the laymen embrace the rhetorics of the human “gill slits”?
Haeckel on genocide and infanticide
Haeckel considered human thought as a mere physiological process and stressed the physical similarity of humans and animals. Haeckel used his comparative embryology to cheapen human beings from special creation to animal kingdom. In the Wonders of Life (1904), Haeckel declared that the newborn human infant is deaf and without consciousness, from which he reasons that there is no soul or spirit even by birth. Haeckel advocated the destruction of abnormal new born infants and argued that it cannot rationally be classed as murder. Eventually, Haeckel recapitulated convincing statistics to persue "an act of kindness" and "redemption from evil" to liquidate the invalids by a dose of morphia.
Daniel Gasman's pioneering study The Scientific Origins of National Socialism - Social Darwinism in Ernst Haeckel and the German Monist League (1971) was a study long overdue. He challenged earlier portraits of Haeckel as a socialist or a liberal, and argued that Haeckel defended mainly racism and German nationalism.
"It is to be recalled that Haeckel had written: 'Among the Spartans all newly born children were subject to a careful examination and selection. All those that were weak, sickly, or affected with any bodily infirmity, were killed. Only the perfectly healthy and strong children were allowed to live, and they alone afterwards propagated the race.' [The History of Creation, 1883, I, p. 170.]
In the light of the following comments, is Haeckel “guilt by association” to Hitler only? 'Sparta must be regarded as the first folkish state. The exposure of the sick, weak, deformed children, in short their destruction, was more decent and in truth a thousand times more humane than the wretched insanity of our day which preserves the most pathological subject.'[Hitler's Secret Book, p. 18] (1971 p. 164)?
Let us remember that premature infants have been even operated without local anesthesia or analgesic drugs almost until our times. Western countries, generally, have broadly embraced the fact that a new-born child can feel pain only at the late 1980'ies.
Haeckel ascended from infanticide also to genocide: "…the morphological differences between two generally recognized species - for example sheep and goats - are much less important than those… between a Hottentot and a man of the Teutonic race" (The History of Creation 1876, p. 434). He categorized human beings into "Woolly-haired" and "Straight-haired" classes. The Woolly-haired people were "incapable of a true inner culture or of a higher mental development" (The History of Creation, 1876, p. 310).
Only among the Aryans was there that "symmetry of all parts, and that equal development, which we call the type of perfect human beauty" (The History of Creation, 1876, p. 321). "The mental life of savages rises little above that of the higher mammals, especially the apes, with which they are genealogically connected. Their whole interest is restricteed to the physiological functions of nutrition and reproduction, or the satisfaction of hunger and thirst in the crudest animal fashion… one can no more (or no less) speak of their reason than of that of the more intelligent animals." (The wonders of life, 1905, p. 56-7).
Finally, since: "the lower races - such as the Veddahs or Australian Negroes - are psychologically nearer to the mammals - apes and dogs - than to the civilized European, we must, therefore, assign a totally different value to their lives… Their only interest are food and reproduction… many of the higher animals, especially monogamous mammals and birds, have reached a higher stage than the lower savages" (The wonders of life, 1905, p. 390, 393).
See figures 2-3 as reality bites of the Haeckelian legacy of popularization. How come, that the most celebrated embryo figure in modern times has been mongered from books like these? It is intellectually offensive not only to ethicists, but to Forrest Gump!
The life and deeds of Ernst Heinrich Philipp August Haeckel
Ernst Haeckel was not only the professor of Zoology at Jena, Germany, but committed to "social Darwinism" (or Spencerism) as a social, political and de facto religious ideology. Haeckel solved Gordions knots by defining new terms. During his professorship from 1862 to 1909, Haeckel became an institution, who introduced e.g. the terms phylum, phylogeny, ontogeny, palingenesis, cenogenesis, gastrula, blastula and morula. Heterochrony (evolutionary changes in the sequence of developmental events) is Haeckel's term at the culmination point of his biased representation of observations of embryos. When certain lower organism were difficult to categorize both to the animal and plant kingdom, the invention was to christen them protists. Ecology, again, was coined to refer to "the relation of the animal both to its organic as well as to its inorganic environment".
Year 1859 meant not only the spreading of the 24 canines to Australia by the way of Thomas Austin. In the critical years (1859-1866) after the publication of Darwin's The Origin of the Species by Means of Natural Selection or the Preservation of Favoured Races in the Struggle for Life, Ernst Haeckel worked on invertebrate goups such as radiolarians, sponges and segmented worms. Totally, he described more than 3500 radiolarian species (Sander 2002).
It was Haeckel, who is given the honour of drawing the first gnarled phylogenetic tree covering the whole animal kingdom (see figure 4).
It was Haeckel who postulated that an extinct organism Gastraea is the ancestor of all metazoan species with gastrula-stage (Scott Gilbert in ).
It was Haeckel, who gave the Linnaen binomial classification name Pithecanthropus alalus ('ape-man without speech') for the first "forefather" of man - before it was even dug up (Milner 1990, pp. 147-8). The Java-Man was a discovery of Eugene Dubois, a disciple of Haeckel. The connection to Haeckel was covered first by changing the name to Pithecanthropus erectus, and finally to the Homo erectus. Haeckel had another artist, Gabriel Max, to draw the imagined forefather (see figure 4).
It was Haeckel, who left the mystical connotation to biological proteins, a theory based on the amorphous gypsum precipitated in the bottom of seas. This was years after Louis Pasteur (1822-1895) began shaking hands wearing gloaves while coining the "virus" and "bacteria" and emptying the last corner of spontaneous generation in his sterilization experiments in 1859-1862. Haeckel invented and drew a series of miniscule protoplasmic organisms and named them "Moneron/Monera" (see figure 5). These were to be "not composed of any organs at all, but consist entirely of shapeless, simple homogeneous matter… nothing more than a shapeless, mobile, little lump of mucus or slime, consisting of albuminous combination of carbon." (The History of Creation, 3rd ed. in 1883, p. 184.)
Haeckel had presented his Moneron in 1866, and Thomas Henry Huxley from the British Empire confirmed the statement in 1868 and named the discovery Bathybius haeckelii.
Huxley, however, rejected the discovery immediately upon its refutation as silica pasta. As a resounding contrast, Haeckel's reprints of The History of Creation (1876) remained unrevised until the final edition in 1923. Detailed descriptions and elaborate drawings on 'life particles' that were entirely nonexistent is a heinous deceit. The article in 1868 in a medical journal of Jena contained over 70 pages of speculations and 30 drawings alone (Haeckel 1868b). Omne vivum ex ovo (vivo) said William Harvey already back in 1651.
Let us remind, that spontaneous (non-informational) creation was widely accepted even in the case of worms, mice, scorpions etc. until the seventeenth century. Darwin actually abstrahized his "warm, little pond" before Louis Pasteur, who gave the mortal blow to the belief by the way of Redi and Spallanzani. Cellular level, the black box of the time, was the final citadel that had to yield itself.
Or was it? Not, in fact, in the popularization. Only a few students are aware of the link of the original concept of "plastitudes" to the inheritance of acquired characteristics (“lamarckism”, according to Jean-Baptiste Lamarck, 1744-1829). These "molecules of memory" predated the term of "genes" introduced as late as in 1909. Haeckel was not a consistent materialist: for him, the evolutionary process was guided by mystical forces within matter. Likewise, Darwin's pan-genesis was a theory based on the inheritance of acquired characters.
Gregor Mendel (1823-1884; Johann before joining the monastery) was from the continent, too, and I think the dismissal of his over ten thousand experimental repetitions and his "dishonesty" should be discussed in relation to Haeckel rather than to Darwin. New characteristics did not pop up ex nihilo in peas. (The work still could not be reproduced with the asexual and apomictic hawkweed by the exhortion of the referees!) As a striking contrast to Mendel, Haeckel embraced the common "knowledge" that the environment acted directly on organisms, producing new races.
In the supplementary volume to the bestselling Riddle of the Universe (1899) - that is, in The Wonders of Life (1904) – Haeckel considered Lamarck's theory of inheritance of acquired modifications as a presupposition of Darwin's theory of natural selection. He defended this ideology, predating the disastrous Trofim Lysenko and the Soviet ”lysenkoism”, by writing:
"I cannot yet see how heredity can be explained without this assumption! The very word 'reproduction', which is common to both processes, expressed the common character of psychic memory (as a function of the brain). By plastitudes I understand simple molecules; the homogenous nature of the plasm in the monera (both chromacea and bacteria and rhizomonera) and the primitive simplicity of their life-functions do not dispose us to think that special groups of molecules are to be distinguished in these cases… If we do not restrict the term 'life' to organisms properly so-called, and take it only as a function of plasm, we may speak in a broader sense of the life of crystals. This is seen especially in their growth, the phenomenon which Baer regarded as the chief character of all individual development."
Haeckel's last published work was entitled "Die Kristallsehen" (1917). In it, even the last conditionals have been dropped out amongst the terminology such as "descriptive crystallography" or "physiology" of the "psychomatic" crystals. "Atom-souls" meant merely attraction, repulsion and crystallization. Life differed from inorganic matter just in its degree of organization. The "theory" of entropy had been rejected by Haeckel already in the bestseller. The apparent contradiction of evolution and entropy was too difficult a riddle for Haeckel.
Needless to say, there existed no free will for the determinist. Man and nature were one, and survival required conformation to the "ecological" totality (Gasman 2002).
As a mere graduate student of biochemistry, I have to quote historians of science on the impact of the "gill slit" –heritage. I have set a quote depot, whose present status can be viewed in . Currently the site contains nearly 200 quotes on the cross-scientific impact and social impetus of the vulgar Haeckelism. (Unfortunately, my German skills are limited, and I have to lean mainly on English literature.) One of the most important spin-offs from the recapitulation was psychoanalysis and the sexual revolution.
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Figure 1. Arguably the most recycled topic in the textbooks of the 20th century biology, compared to its empirical reproduction. A) Haeckel's view of a conserved state in the embryonic development of (from left to right) a fish, an amphibian (salamander), a reptile (turtle), a bird (chicken), and a selection of mammals (pig, cow, rabbit, human). From Alberts et al. (1994, p.33). Originally from E. Haeckel, Anthropogenie, oder Entwickelungsgeschicte des Menschen, Leipzig, 1874. B) A sample of the actual outlook of the corresponding embryos (the fish, the salamander, the turtle, the chicken, the rabbit and the human embryo). Adapted and modified from the reproduction by Richardson et al. (1997). Copyright Springer-Verlag.
Darwin, Haeckel & Huxley, and the origin of ideas
Prior to Haeckel's mystified doctrines, Charles Darwin (1809-1882) himself acknowledged in his letter to his intimate Asa Gray (1810-1888) and Joseph Hooker (1817–1911), that "by far the strongest single class of facts in favor of" his theory was the similarity of vertebrate embryos in their earliest stages (Churchill 1991 pp. 1-29). Darwin complained that his reviewers and his friends had not paid attention to his embryological arguments despite of this. In the Origin, namey, Darwin had listed five set of facts in embryology, that could not be explained satisfactorily without the idea of descent with modification. "The leading facts in embryology" were "second in importance to none in natural history" (Origin, p. 450; Mayr 1982 p. 470).
|[pic] |[pic] |
|Figure 2. When is a 'schematic' illustration a fraud? Apart from the |Figure 3. The first all-encompassing genealogical/phylogenetic tree. Note |
|embryos, the celebrated Anthropogenie or The Evolution of Man (1874 |the (fabricated) Monera on the roots of the tree. From the 5th ed. of The |
|edition) contained also this Haeckelian illustration of evolution. |Evolution of Man, 1910. |
|[pic] |[pic] |
|Figure 4. The appearance of the Pithecantropus alalus alias |Figure 5. Reproductive cycle of the Monera. "Details" on the spontaneous |
|Pithecantropus erectus alias Homo erectus - before found by Eugene |generation of living organisms from inorganic material – and on the most |
|Dubois, a disciple of Haeckel. Drawn by Gabriel Max, from the 1898 ed. of|evident Haeckelian forgery. Ernst Haeckel (1882) Naturlig Skapelsehistoria, |
|the Natürliche Schöpfungs-Geschicte. |p. 127. Öfversättning från originalets sjunde upplaga af A.F. Åkerberg. |
| |Stocholm. A.W.Björcks Förlag. |
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Figure 6. How tight is the link between the Haeckelian legacy and the psychoanalysis or sexual revolution? The pansexual drawing was planned as an illustration number 100 in Artforms in Nature. When the model declined from the publication, the image was used finally in Wanderbilder in 1904. Frontispiece a’la Haeckel.
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Figure 7. Ears look more different than early embryos in Ernst Haeckel's drawings. Hitler ordered the Ribbentropp's delegation to make observations on the ear of Stalin during their negotiations in Moscow to make the judgement, whether Josef Stalin was a Jew or not. From the 5th ed. of The Evolution of Man, 1910.
In his autobiography, Darwin stated: "Hardly any point gave me so much satisfaction when I was at work on the Origin, as the explanation of the wide difference in many classes between the embryo and the adult animal, and of the close resemblance of the embryos within the same class. No notice of this point was taken, as far as I remember, in the early reviews of the Origin".
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Figure 8. Earliest stages of vertebrate embryos by the way of Jonathan Wells. The fertilized eggs in the upper panel are drawn to scale relative to each other, while the succeeding stages are normalized. The embryos are (left to right): bony fish (zebrafish), amphibian (frog), reptile (turtle), bird (chick), and mammal (human). Reproduced from the most controversial Icons of Evolution by Jonathan Wells, who is maligned for his Moonist ((Monist) denomination. Regnery Publishing, Washington, DC, p. 95. Copyright Jody Sjogren.
Later on, this subject was siezed, indeed. Subsequent editions of the Origin stated:“[Haeckel]…brought his great knowledge and abilities to bear on what he calls phylogeny, or the lines of descent of all organic beings. In drawing up the several series he trusts chiefly to embryological characters.”
Darwin’s references in the short bibliography of the Origin were fixed from Louis Agassiz to Karl Ernst von Baer (1792-1876) on the topic only in the third edition. Jane Oppenheimer considered it "an embryological enigma", that Charles Darwin did not understand the implications of von Baer's comparative embryology, and writes: "In 1881, the year before he died, he still did not even own von Baer's works" (Løvtrup 1987, p. 160).
Recapitulation might be the source of more confusion than anything in evolutionary paradigm. Recapitulation is often totally misattributed to von Baer, or equalized with mere embryonic similarity (Richardson & Keuck, 2002).
Parodically, a common denominator of the Swiss professor of Harvard (Agassiz), and the father of developmental biology and discoverer of mammalian egg cell (von Baer) was the valiant criticism of "Darwins lehre" (Gould 2000; Gould had an access to Agassiz’s handwritten marginals, in the same chair.)
The laws of von Baer (special characters appear only later during the development) should be apprehended in the light of the old opinion prior to him and Caspar Wolff (1733-1794). Not only was a child considered a small-sized adult, but even the germ was considered like a miniatyr individual. Although Agassiz was persuaded to believe technical details even to the level of functioning human embryo gills despite his opposition to evolution, Von Baer was the nestor who protested Darwin for taking his name in vain to his death (Über Darwin's Lehre in 1874[68]).
Darwin did not apply his revolutionary theory to the human beings until his Descent of Man, and Selection in Relation to Sex in 1871. This was after the ambitious Haeckel had firmly stepped in the print, and the old Darwin paid hommage in his introduction:
"The conclusion that man is the co-descendant with other species… is not in any degree new… maintained by several eminent naturalists and philosophers… and especially by Häckel. This last naturalist, besides his great work 'Generelle Morphologie' (1866), has recently (1868, with a second edit. in 1870), published his 'Natürliche Schöpfungsgeschichte,' in which he fully discusses the genealogy of man. If this work had appeared before my essay had been written, I should probably never have completed it. Almost all the conclusions at which I have arrived I find confirmed by this naturalist, whose knowledge on many points is much fuller than mine."
Haeckel's theoretical magnum opus General Morphology (1866) aimed at a systematization of all biology in the light of Darwin's theory. In Jenensian tradition, his famous trees now covered all life forms (protists, mushrooms, plants and animals) and included the human being, explicitly. Taken into account the fact, that the young Haeckel wrote his major work in one year, his writing speed looks like an opposite to the aged and sick Charles Darwin. Darwin wrote three hours a day. Haeckel claimed he hardly slept three hours a day (Ginard 1981).
Both Darwin and Haeckel were married to their cousins. If Emma Darwin hindered Charles' publication of his studies, the death of Anna (Sethe) on Ernst' thirtieth birthday (!) triggered the outbreak of Haeckels publications. Generelle Morphologie was the outburst of a grieve stricken heart that could not even attend the funerals. Haeckel did not suffer from a mental breakdown, like von Baer. He channeled the pain to a publication speed of nearly three pages a day during this year.
After his first wife died, the happiest years of Ernst' life were all but gone. Haeckel stated in one of his very first letters to Charles Darwin (The Darwin Correspondence Online Database, document 4555 from July 1864) that because of this loss, he has grown indifferent to any criticism. The man became ontological naturalist who rejected any dualism having a trace of separation of material and spirit. This is where the ardent desire for the materialistic "Monism" (mono) came from.
And so Darwin elaborated in his Descent of Man (1871, p. 203): "In attempting to trace the genealogy of the Mammalia, and therefore of man, lower down in the series, we become involved in greater and greater obscurity. He who wishes to see what ingenuity and knowledge can effect, may consult Prof. Haeckel's works."
The correspondence between Huxley and Haeckel, where Darwin referred, seems to have been an excellent indication of the differing "zeitgeist" between the British Isles and the continent. The English edition of the Generelle Morphologie did not contain the main arguments on the descent of man or his 'system of monism'. Huxley cancelled entire chapters from Haeckel's main work despite the fact that he was a fervent defender of Darwinism. Huxley remained an adherent of agnosticism – a word that Huxley coined by himself for himself! (Uschman 1979, p. 116).
Haeckel did not have his cousin to advice in the experiences like that of Darwin regarding the two visits in the islands of southern Pacific, John G. Patton, London Missionary Society, and the impact of environment over the heritage. Was the phrase agnostism directed only against the churches? What if it also meant divergence from the more vulgar evolutionary indoctrination in the continent?
I think this great difference in the legacy of popularization in the British Isles and the continent could have contributed to the ideological resistance of the England against the race hygieny and, finally, against the coalition or armistice with the Nazi Germany after it had assumed power by Thulean conspiracies behind democratic elections.
Referring to both Huxley and Haeckel, Darwin wrote in the first chapter of the Descent of Man: “The [human] embryo itself at a very early period can hardly be distinguished from that of other members of the vertebrate kingdom… It may, however, be added that the human embryo likewise resembles in various points of structure certain low forms when adult… os coccyx projects like a true -- we ought frankly to admit their community of descent.” (p. 14-17.)
The academic myth of recapitulation rests on a set of 24 Haeckelian figures first published in 1866 in Generalle Morphologie der Organismen, recycled first and foremost by Haeckel himself. There was only one illustration in the Origin, but many of them in the Descent of Man. Embryos started the cavalcade.
In a later and much minor work Die Natur als Künstlerin (1913), Haeckel had to defend the drawings of even his most highly appreciated empirical observations of even trivial subjects.
Olaf Breidbach, the director of the Haeckel Haus in Jena, underlines the essential methodological differences of Haeckel's typology and Darwinian phylogenesis (Breidbach 2002). Haeckel did not adopt a Darwinian morphological method, but gave a new and inconsistent status to the more categorical orientation of naturalists such as Cuvier. Goethe had coined the term of morphology and Haeckel's creation was a syn-thesis of ahistorical ideas of Goethe and the radical scheme of Darwin. As a contrast to Darwin's gradualism, Haeckel described a preformed 'ontogeny' to uncover the real system of nature. Darwin's was a history of nature, Haeckel's was a natural history.
If T. H. Huxley was the “Bulldog” of Darwinism, then Haeckel was its “Rottweiler” at least. Aldous Huxley catched more of the anxieties of his grandfather than his brother Julian Huxley (the president of Unesco) in the sarcastic Brave New World (1932).
"Politics is applied biology"
Die Weltraethsel (The Riddle of the Universe, 1899) was one of the most incredible publishing successes of all times. During the first year after its appearance, Weltraethsel sold more than a hundred thousand copies in Germany. It went through ten editions by 1919, and was translated into 30 “civilized” languages (Sander 2002). By the 1933, almost half a million copies had been bought in Germany.
No technical details or illustrations were needed in this work, anymore. The book included 20 chapters, and its arrogant extrapolations reached chapters like "The embryology of the soul", or "The phylogeny of the soul" posing as on a factual basis.
Jonathan Wells is a popular writer, whose exposure of the Haeckelian embryos has gotten much attention, although Wells tried to criticize ten of the most recycled pieces of evidences for macroevolution used in US schoolbooks of biology more systematically. Figure 8 displays Wells' alternative for embryo drawings in their earliest stages.
To put it modestly, Wells' Icons of Evolution has been overdriven in the official reviews of scientific books. Titles of the book review -articles are self-explaining: "The creationist abuse of evo-devo" (Rudolf Raff in Evolution & Development 3, 373-4, 2001; the journal was inaugurated at the new millennium), "Fatally flawed iconoclasm" (Eugenie C. Scott, Science 292, 2257-8, 2001), "Creationism by stealth" (Jeery Coyne, Nature, 410, 745-6, 2001), and the most vicious "The talented Mr. Wells" (Padian & Gishlick, The Quarterly Review of Biology 77, 33-7).
Wells belongs to a moralistic “Moonist” denomination known for their mass-weddings. Wells is a pacifist, whose hopes as a teacher were relinquished as he was sentenced to prison for protesting the Vietnam War. Now Wells is rebuked for not telling his commitments plainly in the preface of the book.
The irony is breathtaking. Another group devoted to Haeckelian naturalism were not called "Moonists" but “Monists”. They certainly did tell their goals plainly - and drowned their surroundings in the indoctrination.
Gould (1977a, 2000), Milner (1993), and Gilbert (1997), refer to Daniel Gasman's most admonishing book The Scientific Origins of National Socialism - Social Darwinism in Ernst Haeckel and the German Monist League (1971). I have been granted a permission to reproduce the final chapter of professor Gasman’s Scientific Origins’ as an open access ().
Prior to Hitler, Haeckel proclaimed the gospel fo evolution with evangelistic fervor. His audience was not only the university intelligentsia, but the common people. The working classes could read Haeckel in his popular books or listen to Haeckel in the lectures in rented halls. By 1914 Haeckel had been granted membership in almost a hundred professional and scientific societies all over the world (Gasman 1998, p. 11).
Three years before his retirement, in 1906, Haeckel founded the International Monist League (Monistebund) in Jena. Within five years, it grew to about six thousand members and maintained local group meetings in 42 places of Germany and Austria.
Finally, Haeckel casted his authority on a membership of the Thule Gesellschaft (Gasman 1971, p. 22). Thule was founded as a public cover in Weimar republic for aristocratic Germanenorden, a secret organ of mixed themes of Völkisch-movement and Antisemitism (Kuparinen 1999 p. 215). Occult society is an odd conclusion for an authority who declared extreme materialism throughout his life. I have scanned Phelps' Before Hitler came: Thule Society and Germanen Orden to )
When one faces a fraud, the exposure of its motivation is the most rational approach.Haeckel's phrase "politics is applied biology" ended up being a standard Nazi slogan (Milner 1993, p. 207). World War I was a war of nations. World War II was a war of races. With his book Ewigkeit: Weltkriegsgedanken über Leben und Tot, Religion und Entwicklungslehre (Eternity: World War thoughts on life and death, religion and evolutionary theory, 1915), Haeckel lived one World War ahead of its time.
Other reasons for the Nazi-movement include events such as the First World War, Versailles Treaty and the October Revolution. Nevertheless, the decisive inspiration of the all-embracing Haeckel's Monism seem to have incorporated an omnipresent incitement of science so called.
As an indicator, Haeckel had the authority for the first consistent and total program for the Judenfrage (Gasman 2002). That is: to exclude all of the Jews from their chairs at the universities. My question is, how much did the opposition of the Rudolf Virchow (1821-1902) contribute to the issue? After all, Virchow the critic was a Jew and Haeckel's own mentor. Heil Haeckel!, incognito.
Paradoxically, the idea of man's animality and materialism in the Haeckelian legacy seems to have been absorbed from National Socialism to Marxism, from psychoanalysis to Free-Thought Movement and theosophism. Gasman has released a more recent and extensive "testament" entitled Haeckel's Monism and the Birth of Fascist Ideology (1998). In it, he extends his evidence and ends up in stating that Haeckel’s nature books were crucial inspiration to much of modern art, including symbolist poetry, Art Nouveau and aesthetics of avant-garde modernism. Gasman goes on to argue that a complex, and not necessarily strictly opposing relationship evolved between fascism, modernism and positivism. Haeckel's riddles provided amunition against many values of the conservative Western civilization.
Nazism was also inter-nationalist. Gasman (1998) marches forth overwhelming evidence of Haeckel's equally significant and parallel contribution to the birth of Italian and French Fascism that has, oddly enough, not been recognized by the mainstream scholars.
Haeckel argued that Western culture in general, specifically Christianity with its dogmas of submission and weakness, was an intruder into the operation of nature. As a consequence, it disturbed the evolutionary balance fatally (Gasman 2002).
"Nietzschism" may resound like "Nazism", but I consider Friedrich Nietzsche (1844-1900) only a curiosity. Nietzsches rebellion against Western Civilization has been decorated like frames in the savage painting. But what if Haeckel's tantamount rebellion gave the actual colours? Nietzsche did not kill God. It was not done by belles lettres, but by the popular non-fiction.
Gasman's pioneering mission can be seen in the way Haeckel is omitted in other studies. The rise and fall of the third reich - A history of Nazi Germany by William Shirer (1960, 1964) was widely hailed as the definitive record of the era. In the 60-paged index of the encyclopedia, there is no mention of Haeckel whatsoever. Robert C. Bannister mentions Haeckel in the context of socialism in three pages in his Social Darwinism. Science and Myth in Anglo-American Social Thought (1979). In his The Nature of Fascism (1991), Roger Griffin defines the ideological substance of Fascism as based on a "Palingenetic myth", without associating this key word of Haeckel to his Biogenetic Law. "Häckel" is mentioned in two pages. Harrington specifically neglects Haeckelian Monism in Reenchanted Science: Holism in German Culture from Wilhelm II to Hitler (1996).
Another branch of study that makes no mention of Haeckel at all in this context is Saul Friedländer's Nazi Germany and the Jews (1997). In George L. Mosse's Toward the Final Solution (1985), Haeckel is only mentioned in four pages. Eero Kuparinen is a Finnish historian and neither does he mention Haeckel in his recent and broad, work on the roots of anti-Semitism. Kuparinen does maintain that the Russian pogroms did not yet have a scientific reason to it (1999 p. 198), and does describe the later biologization of the symptomatic antisemitism (my translation from Finnish):
"A Jew was not a human being, but was created as a buffer between a man and an ape. A Jew was a fossil without roots, who could not nourish himself. Therefore he was sentenced to be a social paracite - a sponger living in the flesh of the host nation… Cancer, bloodsucker, fungus…" (1999 p. 112.)
But antisemitism was built-in for the Haeckelian Monism as it argued that the Jews (inventors of the monotheistic God and Christianity, not to forgot Maimonides of the Moslims) were in charge for the introduction of transcendental dualism into the Western society in its accelerating decline. Jews were the explicit scapegoat. Jews were the great symbol of man's rebellion against nature. Jews were the source of the decadence - and so haeckel sought their immediate exclusion from contemporary society.
Haeckel did not speak openly of genocide in the case of the Jews, but justified antisemitism by charging the Jews themselves as overwhelmingly responsible for persecution's eternal return. Gasman shows, how close followers such as the French authors Jules Soury and George Vacher de Lapouge demanded destruction of the Jews. It was all in the name of science, and far more extreme and physically threatening than the the harangues of Houston Stewart Chamberlain with his program of Aryan Christianity (Gasman 1998, 2002).
The trend is to underestimate the influence of the Hackelian legacy as a contributor to pseudoscience. The question was not on the survival of the fittest, but on the survival of the fakest in the struggle for popularization.
The case of Finland
A new "Yearbook of the European Science Culture", contributed by the personnel of the Haeckel-Haus in Jena, will be inaugurated in 2004 in English, French and Germany. Haeckel-Haus will also publish a catalog of the thousands of letters from all over the world to Haeckel in the near future. At least Westermack, Federley, Palmén, Nordenskiöld, Reuter, Schulmann, Luther, Kaulbars, Korvenkontio, Sederholm, and Toikka are noteworthy Finnish correspondents – and I consider this an important source discovery for the Finnish academia.
The reception of Haeckelian legacy has been documented in many countries in continental Europe, but only recently has the first project been launched in Scandinavia (Olsson & Ho(feld 2003). Most of the 39 Swedish correspondents were members of the Royal Swedish Academy of Sciences. Prior to my unpublished study, the reception of the Haeckelian legacy of popularization in Finland has been briefly acknowledged by many Finnish historians of science (e. g. Aro 1907; Höm 1909; Juva 1956; Lappalainen 1956; Leikola 1977, pp. 184-190; Leikola 1982, p. 172; 1984, pp. 203-4).
Finnish concept of evolution is about as old as the Finnish textbooks in biology. My hypothesis is, that Finnish Darwinism was virtually Haeckelism at the level popularized to laymen. Haeckelian legacy was contributed by the workers institutes both in Finland and Sweden. Nevertheless, Finns were maligned on a racist basis in the Haeckelian legacy of popularization.
J.E. Aro wrote in 1907 (before the publication of neither Haeckel's nor Darwin's classics in Finnish): "But even more zealous combatants were his [Darwin's] supporters, especially the aforementioned Huxley from England and Ernst Haeckel from Germany. Particularly the latter one has caused that so quick a spreading of 'darwinism' in the European continent. On the other hand, due to his extravagance, the struggle has been transformed unusually fierce and has often moved outside the main question. Without a doubt, it is explicitly Haeckel, by whom darwinism has been introduced also to our broader public." (Aro 1907, p. 13; translation from Finnish by author.)
In the same vein, Olsson and Ho(feld (2003) conclude by stating:"We never find severe criticism of Haeckel's ideas in the letters. Haeckel corresponded with many leading scientists and cultural figures in Sweden, and it is probably the case that not only the philosophical ideas like monism, but also Darwinism, largely entered Sweden via Haeckel's popular books". The more sophisticated Darwinism as the modus operandi in the early 20th century popularization seems to be an anacronistic myth.
Wilhelm Bölsche, a fervent Nazi adherent later on, wrote the biography of Charles Darwin that was translated and published in Finnish in 1900. Bölsche was one of the founders of the Monistebund in 1906, and his title Descent of Man was published in Finnish at the same year. Among the first dozen Finnish books on natural history, there are 4 by Bölsche.
A Finnish peculiarity is, that severe assaults against Monism and against the person of Haeckel appeared prior to the translation of his actual works (in 1911 and 1912). The critics referred to Rudolf Virchow also in Finland.
A 40-paged booklet on the evolution of man by Haeckel was translated back in 1911 (Ihmisen kehityshistoria). The Finnish translation of the Weltraethsel was published in 1912 - prior to Darwin's Origin (1913-1917, in eight booklets). Other Finnish works by Darwin are the shortened version of the Journey around the world (1924), The next million years (1954), and Autobiography (1987). The name of Darwin might have been the public statute, but the Bible that solved all the riddles was Haeckel's Weltraethsel. I have scanned the Finnish translation (Maailmanarvotukset, 1912) to Kurt Stueber’s online-library in Jena (biolib.de):
.
The recapitulationary relics and the texts associated from Finnish textbooks of biology is browsed and scanned in () The drawings or their drawn replicas are certainly on the Top-3 list of the figures in Finnish school books on biology, most probably the celebrisity number one. The only exceptions seem to be special readings, rare recent books with more accurate photographs, and few books emphasizing the “genetic” era of biology. Basically, the anacronistic recycling is still going on at our postmodern millennium. Textbook authors have the bad habit of recycling each others material, without references to the original data.
In none of the schoolbooks have I found a description of the possibility of a deceit, not to speak of apology. Evoluutio – Kriittinen Analyysi (2000; edited from Evolution - Ein kritisches Lehrbuch written by Scherer and Junker) handles the issue, but has occasionally been dismissed as "creationist", too. The recent Finnish university level textbook by Sariola et al (2003) now uses Richardson’s photographs, fortunately.
Finns as a degenerate Mongolian race
Already in his Natürliche Schöpfungsgeschichte, admired by Darwin in the introduction to his Descent of Man, Haeckel had classified Finns as Mongolians or peoples who resembled them. Finland was a country located at the bloody northern borders of the east and west. Were the Finno-Ugrian people capable of establishing a state? Consult figure 9 for the place of Finns as the degenerate "Mongolian" race in the Europe, in the linear Haeckelian evolution.
In his popular Wonders of Life, Haeckel categorized Finns as "middle civilized race" which had 7 races below them and four races above them. Of the twelve races, these latter four were "higher civilized races", "lower cultured races", "middle cultured races" and "higher cultured races". Above us Finns were the fifteenth century Italians, French, English, and Germans. Haeckel's evolutionary tree of the indoeuropean languages, naturally, did not include the Finns (figure 10).
And Haeckel declared: "The views on the subject of European nations which have large colonies in the tropics, and have been in touch with the natives for centuries, are very realistic, and quite different from the ideas that prevail in Germany. Our idealistic notions, strictly regulated by our academic wisdom and forced by our metaphysicians into the system of their abstract ideal-man, do not at all tally with the facts. Hence we can explain many of the errors of the idealistic philosophy and many of the practical mistakes that have been made in the recently acquired German colonies; these would have been avoided if we had had a better knowledge of the low psychic life of the natives (cf. the writings of Gobineau and Lubbock)." (The wonders of life, 1905, p. 390-1).
Let us quote this Goubineau, recommended by the scientifically more correct Haeckel, on Finns, then: "creatures so incontrovertibly ugly and repulsive as the ordinary specimens of the Mongolian race… These are all people of low stature, with wide faces and prominent cheek-bones, yellowish or dirty brown in colous---The Finns have always been weak, unintelligent, and oppressed---in the south through miscegenation with the Negroes and in the north with the Finns." (Gobineau, Inequality of Races (1853-55, 1967).
[pic]
Figure 9. Haeckelian drawings of faces of "anthropods". Fom the 1898 ed. of the Natürliche Schöpfungs-Geschicte.
[pic]
Figure 10. Haeckelian evolutionary tree of the Indo-Germanic and Aryan languages. It was, originally, the linguist August Schleicher who drew Haeckel's attention to the concept of "monism". From the 5th ed. of The Evolution of Man, 1910.
Gobineau divided mankind in three races: the White, the Black, and the Yellow. In essence, this meant the Good, the Bad - and the Ugly. The Yellow were extremely ugly, and the group included not only Finns, but also Mongols and Tartars. Kemiläinen explains the history of the low self esteem of the Finnish people: "Finns were a primitive aboriginal people in Europe and in Asia. They were short of stature and deformed. Their limbs were feeble and they had protruding cheekbones and slanting eyes. They were more yellow than the Chinese, who had the blood of the White race. How else could the Chinese have created a high culture? Even the Hungarians were 'white Huns'; they had White ancestors… In an Aryan society at the top were Aryans, in the second class were the Celtic and Slavic peoples and men and women of mixed blood. The deformed Finns were lowest." (Kemiläinen 1998 p. 85).
Virchow, the meticulous pathologist, was an adversary of evolution and appears as one of the main opponents in Ernst Haeckel's books. (Haeckel wonders in his correspondences whether Virchow had emotional life at all due to his discipline.) The infamous "Finnenfrage" caused Virchow to travell to Finland in the 1870’s in order to study the Finnish roots: Finns were blond! (Kemiläinen 1998, p. 69.)
Race theories did not start with Haeckel, and did not end with him. What was most unique in Haeckel was the volume and the scientific statute. The former race theories with the syndromatic Nordic admiration had only been formulated largely by men like Joseph Arthur "Comte" de Gobineau (1816-1882) and Houston Stewart Chamberlain (1855-1927) – a Germanophile Frenchman once serving as a diplomat in Stockholm, and an Englishman and son-in-law of Wagner living in Wien, respectively.
Finnenfrage, of course, did not draw the main conclusion. Writes Gasman:“…Haeckel was one of the most vociferous opponents of the jews and his importance for the history of anti-Semitism in Germany is that he did much to bring the Jewish question into the realm of biology." (1971, pp. xxii, 157).
Hitler's formulation of the differences between the human races was affected by the brilliant sky-blue eyed Haeckel (Gasman 1971, p. xxii). At the top of the unilinear progression were usually the "Nordics", a tall race of blue-eyed blonds. Haeckel's position on the Jewish question was assimilation, not yet an open elimination. But was it different only in degree, rather than kind?
Nature or nurture? In Finland, the term was not the anglosaxon "eugenics" a'la Francis Galton (cousin of Charles Darwin), but "race hygieny", as formulated by Alfred Ploetz, a physician. (In 1936 Ploetz was nominated for the Nobel Prize for his work on racial hygiene; Proctor 1988, pp. 15, 28). The first issue of the Archiv für Rassen- und Gesellschaftsbiologie in 1904 was dedicated to August Weismann and Ernst Haeckel, despite their absurd contradiction regarding the inheritance of acquired characteristics. Weismann was also named honorary chairman of the Society for Racial Hygiene, when it was formed in 1905, along with Haeckel (Proctor 1988, p. 33).
Marriage laws were once erected not only in the Nazi Germany but also in the multicultural states of America upon the speculation that the mulatto was a relatively sterile and shortlived hybrid. The absence of blood transfusion between "white" and "colored races" was self evident (Hailer 1963, p. 52).
In 1917 the immigration of "defective" groups was forbidden even in the United States by a law. In 1921 the European immigration was diminished to 3% based on the 1910 census. Eventually, in the strategical year of 1924 the finest hour of eugenics had come and the fatal law was passed by Congress. It diminished immigration to 2% of the foreign-born from each country based on the 1890 census in order to preserve the "nordic" balance in population, and was hold through World War II until 1965 (Hietala 1985, p. 132).
Richard Lewontin writes:“The leading American idealogue of the innate mental inferiority of the working class was, however, H.H. Goddard, a pioneer of the mental testing movement, the discoverer of the Kallikak family, and the administrant of IQ-tests to immigrants that found 83 % of the Jews, 80% of the Hungarians, 79% of the Italians, and 87% of the the Russians to be feebleminded.” (1977, p. 13.)
Finnish emmigrants put the cross on the box reserved for the "yellow" group (Kemiläinen 1993, p. 1930). As Finns, we simply spoke better German than English. As a parodic indication of the German admiral of the Finnish leaders at the emergence of our independence in 1917, Finland chose Herself a German king (Friedrich Karl, Prince of Hessen) the same day that German requested armistice from the allies (Rautkallio 1977). This was a common tradition to European monarchies, though. After a few absurd months of hesitation, Finland did not come up as a monarchy but a republic.
Finland had a brotherhood in arms with Germany in the latter part of both World Wars. In the repercussions of the Civil War in 1918, there was a preliminary annihilation trial of our own. According to the great world history of Otava, a Finnish encyclopedia, it is difficult to come up with any rational explanation for the annihilation carried out by the Nazis, apart from terrible and mad logics (Suuri Maailmanhistoria, 17, 1986, p. 278). I disagree. The Nazi phenomenon was no historical coincidence, but followed a rational course predating the First World War in the Haeckelian legacy.
In the 23th of June, 1941, the raid over the Soviet Union started from the Black Sea to the polar circle almost simultaneously. With the occupied Norway behind it, foreign interests for the Finnish nickel mines, and Soviet bombardments, however, Finland joined the Barbarossa the 25th of June with her national thesis for a "separate war". Finland remained an unoccupied democracy, but the propaganda value of such an ally was appreciated in the Nazi-Germany. The ethymology for the Greek "barbaros" was in their uncomprehensible tongue, the word was onomatopoetic.
Stalin had stated in 1939 that the safety of Leningrad was the main reason for his territorial demands for Finland. Upon the 900 days long siege of Leningrad, the great command for the "struggle for life" (Kampf) to annihilate the whole city together with its 3 million inhabitants did not get a response from the Finnish leaders. They harassed the brotherhood of arms by trying to avoid the responsibility of closing the line of maintenance and supply. Finnish troops did participate in the siege in the north, but were critically reserved.
German officials had to be persuaded to recruite other than Swedish Finns to the battallion of Waffen-SS from Finland (600 men) due to the "mongolid" element. Fennomanic movement had exercised its influence for a century, and I would consider that inhibitory to the sympathy of Nordic or Aryan nationalism. Teutonic superiority akin to Nietzsche's 'super-man' was abhorrent to the commonwealth of Finland.
Finland concluded a separate armistice with the Soviet Union, which led into war operations between Germany and Finland in a few weeks’ time. In Finland this third war is called the Lapland War (1944-1945).
The offensive pangermanic regime was no exclusive and isolated case, but followed the norm in the countries ranking high in the Haeckelian legacy. In Finland, National Socialism was never established. There were societies in that direction, but they did not enjoy large memberships. As a party, the Finnish Patriotic People's Movement (Isänmaallinen Kansanliike IKL) had fascist characteristics, but it had merely 8 representatives in the parliament in 1939.
Scandinavian countries pioneered in the sterilization laws and race-biological institutes, but the ideal of race hygieny was not put to a final action in Finland. There was anthropologist "mismeasure" of Finnish Romanies, Lapps, and the Finns themselves, but the plan to file all of the population was terminated soon.
Conclusions: Current repercussions in the long Hackelian shadow
Rudyard Kipling, the first British Nobel laureate in literature, versified:
Take up the White Man's burden The savage wars of peace
Fill full the mouth of Famine, And bid the sickness cease;
And when your goal is nearest (The end for others sought).
Watch sloth and heathen folly; Bring all your hope to nought.
(McLure's Magazine 12 (Feb. 1899).
Anthropology corrected the Haeckelian legacy of racism in the textbooks over 50 years ago. Embryology has been transformed into “developmental biology”, but this should not distract an analogous responsibility. This is especially true due to the economic interests involved, ever since the methodologies in cultivating embryonic stem cells have abrupted.
I think the Haeckelian legacy should be discussed in the context of the myth of disability of human babies to feel pain upon birth, abortion legislation, psychoanalysis, and sexual revolution. The memory of Ernst Haeckel should not be cherissed anymore upon the stem cell legislation.
It has been said that if the year 1796 is recalled for the discovery of vaccines year 1928 for the discovery of antibiotics, then the year 1998 will be recalled as the year when pluripotent stem cells from embryos were cultured in a controlled way for the first time (Thomson et al).
Stem cells have been observed in adult body even in the case of neurological tissues or muscles. These used to be catechorical examples whose renewal was unheard of, volte face. The breakthroughs have been derived not only from the totipotent (and ethically most problematic) stem cells from embryos, but from progenitor cells from one's own body. The adult body stem cells could bear less risk of transplantic rejection and malignant growth, and also their therapeutic potential has been shown.
To put the human genome project in any historical perspective, it's most important message is this: There are no human races. Negrids, mongolids, euripids, whatever. Allelic variation or SNPs (single nuclear polymorphisms) are only found at a frequency of 1 SNP/0,6-1,9 kb throughout the genome (Sachidanandam et al 2001, ncbi.nlm.SNP/).
Besides, there seems to have been a gross methodological bias even in the popularization of the old human-chimpanzee annealing studies. The sharing was supposed to be 99% in the textbooks, but a reproduction from a 780 kb sample by the original author gave a different figure. Taking not only the 1.4% nucleotide substitution, but also the 3.4% indels into account, the human-chimp divergence is actually 5% (Britten 2002). Genes are like standard bricks, which can be used for different buildings. What is often neglected are the splice variants, and what was discarded as "junk DNA".
The new wave of popularization ("evo-devo") emphasizes that the regulatory genes are extremely conserved. These homeotic domains and transcription factors, however, have also been used to strenghten the argument from the "Cambrian explosion". There were more than two times more Haeckelian "phylas" at the emergence of the Metazoa. The extreme speed of anatomical change and adaptive radiation during this brief time period requires explanations that go beyond those proposed for the evolution of species within the modern biota. Homeoboxes can not function without the existence of the actual genes.
I will recall Stephen Jay Gould for his laconic quote of von Baer quoting his predecossor Agassiz: "Agassiz says that when a new doctrine is presented, it must go through three stages. First, people say that it isn't true, then that it is against religion, and in the third stage, that it has long been known--- But we must beware the dreaded third stage, for when we capitulate and then smugly state that we knew it all along, we easily fall into the greatest danger of all - smug complacency - because we have ceased to question and observe." (Gould 2000).
The full name of Haeckel’s expression was entitled The riddle of the universe at the close of the nineteenth century. Now that the main DNA-riddles are solved - at the close of the whole millennium - there are some more practical opportunities to be taken.
Science is a self-correcting process, but the technical criticism does not seem to reach the social anchorage. The "publish-or-perish" –competition is not a particularly sound framework for ethical discussions. Peer review can turn into a peer pressure process.
The medical endeavours related to embryonic stem cells are pragmatic, yet sincerely noble and respectable in aims. But how significant are the indirect social consequences of the medical competition on this ethical tangent? The enterprise should not be darkened because of economic interests of a small number of people. McGee and Wolpe (2001) have expressed their concern over the level of abstraction in the current ethical discourse. Are the terminology and definitions of the debate narrowed to make the public opposition too complicated to mount?
I am suspicious over the burial of the Kampf (Struggle). It is the opposite view in a 180 degree angle to the Judaeo-Christian ideal of agapee, that I personally cheriss. The latter sees free giving, altruism, benevolence and self-sacrificing love as the beginning, motivation, and sustainer of reality.
The World Medical Association developed a declaration in 1964 as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. It is called the Declaration of Helsinki (library/ethics/helsinki/). That is my justification to postulate that we are the ones who faced the declassification projects from the World War II. I refer now to the repercussions of the Interagency Working Group, appointed by William Clinton. Samuel Bush? George Herbert Walker? Prescott Bush? What if president George Walker Bush tried to be earnest within this particular topic the 9th of August, 2001, in his White House Paper? What if we would also consider judging the present in the past context, before the market forces break loose?
Acknowledgements
My determination was predestinated when my 15-year old grandfather had to dug the frozen solid and fullpacked graveyard of Jokioinen during the Winter War against the Soviet Union, for his friends killed in action. Pecunia non olet? Let the experience of the melt smell of the spring, and the lifelong nightmares symbolize the persistance of my motivation. My grandfather volunteered in the platoon scouting the departure of the last German troops out of the country in the landmark of three nations at the end of the Lappland War. They replied to the "Heil Hitler" of the last officer representing the Third Reich, across the border, and had to search far to find a scrubby-tree tall enough to carry the Finnish flag. My grandfather was another of the two men who delivered the message to the commander after skiing down the no-man's-land. And so the war ended. "Be gone from Finland!" Be gone from the Finnish textbooks of biology.
I have been funded mainly through the Viikki Graduate School in Biosciences in the Institute of Biotechnology, Helsinki University, for experimental biochemistry. I am grateful for the opportunity to defend my thesis' to the Division of Biochemistry, Department of Biosciences. My justification are the original articles on the actin dynamics, which physically acts to form the embryonic expansions, contractions, thickenings, folds, and invaginations. This literature survey was carried out independently during my free time, and I am grateful for the concerned atmosphere at the Finnish Red Cross, Blood Service.
I am grateful for Dr. Pirta Hilpelä, Dr. Kimmo Karhi, professor Aira Kemiläinen, Päiviö Latvus, professor Matti Leisola, professor Hannu Sariola, Dr. Jouko Seppänen, and Dr. Mike Story for a very critical reading of the early manuscript.
I dedicate my endeavour to the memory of the Yrjö Reenpää –prized Stephen Jay Gould (1941-2002). Gould’s Hungarian Jewish papa Joe was notwithstanding in the “mismeasure of man”.
William Shakespeare wrote his Merchant of Venice near the end of the expulsion of Jews from England (1290-1650). I am afraid we are descending to a modern syndrome of Shylock-stereotypology with the selectivity and short memory of the MWWI: Media World War I. Apart from the economical utility of the human embryos, is a new round of Judenfrage rising simultaneously with eugenics, again? Out of all the cases handled by the UN Commission on Human Rights, nearly 1/4 of the judgments have been focused against the single democracy of Israel. Nearly 1/3 of the cases brought up to the Security Counsil have to do with the same nation.
The tragedy of the heritage of the German Monist League was not the mania of a corporal and postcard artist, but the indifference of the whole Europe. Indifference is also the key to understand the recycling of the fraudulent Haeckelian embryo drawings.
Alfred Nobel was a salesman of death, but the prizes were meant to the persons who had helped humankind the most. In the 20th century fog, about 700 persons got the noble prize. Nearly 150 of these had an ethnically Jewish heritage, which means over 20% coverage by a population of 0,25%, numbering less than 20 million people (; science.co.il/Nobel.asp). In the medicine, the portion of laureates is 25%.
Landsteiner developed two different blood categories, whence functioning transfusions began. Von Wasserman tested vaccines or antitoxins against cholera, tuberculosis, syfilis, tetanus, typhoid, and diphteria. Marmorek made discoveries for multiple epidemics. Haffkine succesfully vaccinated against cholera. Schick developed diphteria-diagnostics and vaccines, Ehrlich salvarsan for syphilis. Neisser & Co. found gonococks causing gonorrhea. Digitalis found by Traube used to be the most used medicine at the time, and also Levine alleviated heart attacks. Typhoid fever was treated by the methods of Vidal and Weil. Woronan and Waksman found neomysin and streptomysin (the most used chemotherapeutics of its day), and introduced the phrase “antibiotic“. Chain was one of the three awarded and knighted for penicillin. Funk invented the concept of vitamins and made research until D, whereas Hess concentrated on the C-letter. Reichstein extracted cortison, cocaine used to be one of the first painkillers and tested by Koller to his friend Sigmund Freud (who, consequently, had to go through 33 face surgeries in his lifetime). Minkowski was involved in the story behind diabetes and insulin. DNA contributors include Lederberg, Kornberg, Nirenberg etc. Salk institute recalls the heritage of Sabin and Salk, who granted an inactivated polio vaccine to the mankind for free. No patent - no patient: in the countries that have adopted it to systematic use, the infantile paralysis has been almost eracidated.
“If we're going to have the Shield of David, why would we not have to accept the Swastika?“ gives enough hits in the Internet. The phrase was the main reason, why the Jenin commission of Martti Ahtisaari, former president of Finland, was not established. The cynical tradition of C. S. dates back to the days of F. C., when the commendant of Treblinka (Stangl), Death Angel with his Mengelian genetics, Butcher of Lyon (Barbie), the leader of the Gestapo in Poland (Kutschmann) etc. got the diplomacy passport of the International Red Cross via Ratlines to the South America. The strategic names of the 30,000 fugitive Nazis and SS-officers were recruited by the western espionages - which were thus infiltrated by the KGP and GRU. This single act of opportunism dug the trenches for the Cold War, because de facto every Western agent was executed behind the Iron Curtain. And so the status quo had to be reached by the nukes.
Dear Markku Niskala, You are the former secretary general of the Finnish Red Cross and since 1.1.2004 the secretary general of the International Federation of Red Cross and Red Crescent Societies. What if You would wellcome MDA (Magen David Amon, Red Shield of David) to join Your politically and religiously neutral organization? It is no Swastika. Besides, Finland has been ranked as the least corrupted country every year in the new millennium in the Transparency International's Corruption Perception Index.
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Gene Therapy- A Scientific and Bioethical Challenge
- Oana Iftime.
Department of Genetics, Faculty of Biology, University of Bucharest, Aleea Portocalelor 1-3, sector 5Bucuresti, ROMANIA
Email: oana@botanic.unibuc.ro
Introduction
The aim of gene therapy
Gene therapy intends to cure or at least alleviate inherited and even non-inherited diseases by introducing into the organism foreign genetic material.
The outcome of introducing foreign material into the cells may be:
1. the replacement of missing or defective genes;
2. the enhancement of specific protein production. It is a form of ‘symptomatic’ gene therapy;
3. pro-drug therapy through delivering to the cells of drug sensitivity (drug induced „suicide”) genes;
4. direct killing of tumor cells by viruses able to attack precisely rapidly replicating cells, without affecting normal cells;
5. delivery of ‘anti-sense’ oligonucleotides (ODNs) in order to hamper the expression of specific genes;
6. delivery of major histocompatibility complex (MHC) genes into tumor cells aiming to increase antigen expression and therefore enhance immune responses;
7. other.
Gene therapy employs, in order to deliver genetic material into the cells viral systems - vectors derived from adenovirus, retrovirus, adeno-associated virus, herpes simplex virus, vaccinia virus, poliovirus, BK virus, Sindbis virus, bovine papilloma virus, Epstein- Barr virus, herpes virus, autonomous parvoviruses and nonviral systems- direct injection into the cells of naked or conjugated DNA (Van Craenenbroeck & al, 2000; Agha-Mohammadi & Lotze,2000).
The need to reiterate the precautionary principle
Recently, a serious adverse effect, namely leukemia induction was noted in two children that have undergone gene therapy for an X-linked disease (Hacein-Bey-Abina & al. 2003).
Some authors underline that lack of success in gene therapy trials was a great disappointment and issue the opinion that it is a good thing that some scientists keep working to gene therapy, at more fundamental levels, namely studying the cell and molecular biology of gene therapy (Pilewski, 2002).
“The optimistic projections of success were, somewhat naively, based primarily on in vitro studies and/or model systems that had a limited relationship to the target organs. These projections underestimated the complexity of an intact biological system and the importance of genomic integrity in the cell-specific regulation of gene expression.” (Gruenert & al, 2003).
After so many vain efforts to domesticate genes and vectors some specialists have come to draw attention on a few common scientific sense (to say so) requirements that need to be fulfilled in order to properly evaluate a gene therapy method- “the emphasis of current clinical trials has been on developing individual gene transfer products as therapeutic agents, as opposed to focusing on the core components of gene therapy—namely, gene transfer and transgene expression.” It is mandatory to permanently consider the fact that gene transfer is a system of drug delivery that uses complex and potentially toxic biochemicals. The biodistribution, excretion, and biotransformation of drugs vectors and gene products has to be carefully investigated. Different vectors show different biodistribution and excretion patterns in humans. Interactions with innate proteins have to be considered when the transgene product is concerned. In vivo, the transgene product is submitted to biotransformation which’s outcome may be the increase or on the contrary the lowering of its effectiveness. All types of vectors have the potential of inducing immunologic responses and those have to be seriously investigated prior to applying gene therapy (Pislaru & al, 2002).
We sometimes face the remodeling of concepts that have been regarded as fundamental for decades. The theories concerning immunity make a good example.
The ability of living organisms’ immune system to distinguish between self and non- self used to be a core concept in immunology till Matzinger’s (1994) proposal of “dangerous” and “non- dangerous” as “pointers”.
According to the old theory, the product of a transgene will always be considered as non-self and rejected. According to the new proposal, there are more danger signals that alert the organism resulting in the failure of gene therapy attempts- the vector, the foreign DNA (the transgene), local inflammation due to vector delivery plus other elements consisting in the many cells and molecules that constitute the immune system’s “army “ with all their interactions. Hope for gene therapy may lie in minimizing the danger signals’ number and intensity (Brown & Lilicrap, 2002).
Recognition of the viruses employed as vectors occurs in the case of most of the vectors because of an innate ability that organisms acquired following the long-term natural exposure to these viruses. Organisms seem to detect pathogens rapidly via pattern- recognition receptors. These receptors identify the general structure, the “model” of the vector as belonging to a pathogen and they do it so quickly that rejection phenomena begin to develop in a few hours (e.g. increases in the level of many cytokines, responsible for local inflammation and the amplification of the immune response).
The epigenetic pattern of the transgene (e.g. its methylation pattern) also acts as a recognition signal for the rejection machinery. Cell death due to inflammation also triggers subsequent “stress” events. “Peace” can hypothetically be achieved by using vectors that are not “known” by the organism as pathogens, best candidates being retroviruses and eventually delaying the transgene’s expression in order to surpass the initial “dangerous context”. But even such vectors’ delivery into the organism led to immune responses that seriously hampered the expected therapeutic action of the vector- transgene complex.
As a general principle, danger signals are thought to somehow operate in regulation of the viral promoters, therefore being able to silence the transgene.
Genetically modified stem cells were shown to give better results in gene therapy attempts and even mediate a long-term tolerance that comprises non- rejection of differentiated cells carrying the transgene but the potential of an immune response still exists.
Immunosuppression has been suggested as a method for improving gene therapy success.
The immunosuppressive therapy has its well known disadvantages as confronted while struggling to prevent tissue/organ rejection after transplantation - being non-specific it induces a general lack of immune reactions, the patient being therefore exposed to infections.
Many specialists claim that results obtained using animal models can and should be regarded as suitable for supporting the idea of starting clinical trials on human patients. It is well documented at this moment that animal models employment in studying gene therapy in humans has very poor relevance (as Wilson stated as early as 1996).
2. Delivery Systems Used In Gene Therapy And Their Major Disadvantages
The use of viral vectors
The expression of the transgenes needs the presence of strong constitutive promoters, usually viral but also endogenous. Constitutive (permanent) expression of the genes can cause cellular toxicity and disturb physiological regulation responses (pleiotropic effects).
Many viruses were engineered in order to obtain episomal vectors. The danger of using such vectors consists in the potential for recombination and reactivation of the viruses.
I shall remind that the BK virus may become responsible for respiratory or renal disease, as well as the Epstein- Barr virus that is associated with mononucleosis, nervous system diseases and various forms of cancer (Burkitt's lymphoma, Hodgkin's disease, T-cell lymphomas, nasopharyngeal carcinoma).
Major disadvantages in gene therapy relying upon nonintegrative viral vectors
Major disadvantages in gene therapy relying upon nonintegrative viral vectors consist in:
1. inefficiency due to rapid loss of the transfected sequences;
2. immunogenicity of the viral vectors;
3. variance of the immune response to viral vectors with the genetic program of the host;
4. improper expression of the transferred gene, due to the absence of its specific regulatory elements;
5. possible immunogenicity of the transgene product;
It was proposed that the viral vectors initially deprived of most of their genetic sequence in order to make room for the carried sequence be re-modified in order to mime the natural mechanisms viruses use to escape the organism’s vigilance. Problem is that such vectors will interfere with the cells’ response to other viruses thus allowing unwanted “guests” to enter the organism, remain there and cause diseases. It can also interfere with the detection of incidentally malignant cells by the immune system, hampering important mechanisms that protect the organism from tumor proliferation.
Major disadvantages in gene therapy relying upon integrative viral vectors
Retroviruses are able to integrate into the host genomes with the help of reverstranscriptase, as they need to produce a DNA intermediate in order to replicate. Using them as vectors for vehiculating transgenes puts a series of problems:
1. short half- life of retroviruses particles and the short distance they can travel resulting in their reduced ability to infect cells in culture;
2. reduced multiplication of the virus, the vector is obtained in low titers;
3. nondividing cells accept the vector poorly;
4. little room for the gene insert;
5. the considered viruses are potentially dangerous to humans;
6. gene disruption, because of the random integration of the introduced genetic material, as well as
7. alterations in genomic methylation resulting in epigenetic effects;
8. improper expression of the transferred gene, due to the absence of its specific regulatory elements, that cannot be transferred because they simply exceed in length the capacity of the viral vectors; plus, genes’ expression may always be regulated by unidentified sequences placed far way in the genome
9. immunogenicity of the viral vectors;
10. variance of the immune response to viral vectors with the genetic program of the host, meaning that they might be so many potential reactions as patients;
11. possible immunogenicity of the transgene product.
12. vectors may become integrated into the germ cells of the patient, together with the transgene, which may result in incalculable consequences for the offspring;
13. transgene silencing by the host protective mechanisms
Integration of a retrovirus or retroviral vector near the promoter of a gene (oncogenes included) can stimulate transcription under the influence of viral enhancer elements. Transcription from the viral promoters may also occur leading to aberrant mRNAs containing information from both virus and host (Trono, 2003).
Retroviruses able to integrate into the DNA of non-dividing, terminally differentiated cells and exhibit stable, long-term expression such as lentiviruses were proposed as tools in gene therapy.
Some specialists think that lentiviral vectors might make a better choice (Tischkowitz & Hodgson, 2003) because those vectors could be administered in lower doses and were better tolerated by mice. The problem is that mice also showed good responses to retroviral therapy, which humans did not.
If more horrendous information needs to be added in order to advocate against the use of such viruses, then we may always remind that HIV is a lentivirus. As a matter of fact, nonpathogenic (really?) retroviral vectors based on the HIV virus have already been developed, although the precise mechanism by which lentiviruses infect nondividing cells was yet vaguely known (Buchschacher & Wong-Staal, 2000) which is still true.
Gene therapy experiments made use of modified HIV and HIV relatives, tumor inducing retroviruses isolated from birds or mammals (that were already shown to be able to contaminate humans and elicit malignant transformation, Hu & Pathak, 2000). Among the diseases caused by the viruses that are studied for their potential use in gene therapy we remind a few types of tumors and tissue destruction diseases such as murine leukemia, spleen necrosis, avian leucosis and Rouss sarcoma.
A most monstrous hybrid in my opinion is a vector that has already been put to trial in airway diseases gene therapy, namely a lentivirus (a HIV relative) exhibiting an envelope protein from a filovirus (Ebola is also produced by a filovirus).
Major disadvantages in gene therapy relying upon cationic liposomes
Cationic liposomes are lipid vehicles able to „pack” the DNA and transport it into the cells. Their use faces a few difficulties:
1. the transfer rate of the carried genes is quite poor;
2. the liposomes are toxic to cells;
3. the efficiency of the process, measured in the persistence of gene expression is very low.
Major disadvantages in gene therapy that uses naked DNA
The use of naked DNA exhibits the following problems:
1. low transfection rates;
2. transgene expression is limited to the site of the injection;
3. potential immunogenicity of the gene product, regarded as novel, non-self by the organism, a problem that is after all common for transgenes no matter the delivery method.
Major disadvantages in the use of mobile genetic elements (transposons)
The method makes use of transposon/transposase complexes, the transposons able to integrate at specific AT dinucleotid sequences together with the gene of interest that has been previously introduced into the transposon (Richardson & al, 2002). The risks are:
1. insertional mutagenesis potential, similar to all other techniques. It has been advocated that the risk is low, as compared to other techniques, but experimental data are insufficient whereas the existence of such a risk can be strongly sustained on theoretical basis.
2. transgene silencing by the host’s protective mechanisms (e.g. DNA methylation).
Transposons may have romantic names such as Sleeping Beauty (Richardson et. al, 2002). Under the enjoyable cover of its fairy tale name it still bears the danger of insertional mutagenesis.
3. Various Fine Approaches In Gene Therapy And Their Limitations
Using DNA analogues
The use of DNA analogues as a gene therapy method was proposed years ago. Binding of synthetic molecules such as peptide nucleic acid (PNA), a nucleic acid analog in which the sugar phosphate backbone of natural nucleic acid has been replaced by a synthetic peptide backbone to a chosen target in a gene sequence shows, in some people’s vision, promise for gene therapy (Ray & Norden, 2000). PNA, as well as its hybrid duplex and triplex complexes with DNA and RNA is very stable inside living cells. Such properties enable it to inhibit both transcription and translation of genes.
It is difficult to deliver PNA molecules into the cells, because of its high molecular mass. This may be, however, overpassed. Which remains unsolved is the danger represented by the very properties of PNAs, as listed above. This DNA analogue has an undeniable potential to interefere with other genome sequences than the chosen target and form unwanted hybrids hampering replication and translation where there is no need for this.
The use of decoy ODNs
cis-element double-stranded oligodeoxynucleotides (“decoy” ODNs) have been studied for their potential involvement in the gene therapy of several cardiovascular and renal diseases. When introduced into the cells, such ODNs compete with their models in the genes for transcriptional factors, subsequently modulating gene expression. There are a few major disadvantages in gene therapy relying upon decoy ODNs transfected by liposomes (Morishita, 1998).
1. most of the oligonucleotidic fragments are rapidly degraded in the target cells;
2. their employment in treating systemic disease such as atherosclerosis would need systemic administration;
3. playing with the transcriptional factors is, definitely, dangerous, because of the involvement of each of those factors in the regulation of more than one single gene. Dangerous side effects may occur, such as the decoy ODNs hampering the normal physiological responses by capturing transcriptional factors used by many other genes than their target;
4. decoy ODNs have been reported to elicit many nonspecific responses due to their potential of binding other proteins than the transcriptional factor that they were designed to “trick”;
5. ODNs can also initiate unwanted immune responses;
6. ODNs derivatives are very toxic.
Site- specific gene repair by the use of chimeraplasty, single-stranded or triplex-forming oligonucleotides
”Genetic repair methods are similar to word processors that correct misspelled words within their intended written context, whereas gene add-back approaches are similar to editors who prepare corrected versions of defective sentences and then randomly insert them into the text without amending the original written mistake” (Sullenger).
Site- specific gene repair concerns genes that are affected by punctiform mutations leading to diseases. It uses small oligonucleotidic sequences that align to the target gene and perfectly pair with the DNA strands except for one base pair intended to create a distortion that activates the endogenous DNA repair mechanisms of the cell. The „wrong” bases face precisely the mutated basis within the gene, so that the repair mechanisms correct, in the end, the punctiform mutation responsible for the disease. The advantages of gene repair consist in maintenance of the rescued gene in their native sequence context and low mutagenesis potential as there is no random insertion of genetic material.
Site-specific genetic repair has other advantages over gene augmentation (the delivery of a transgene in order to replace functionally a defective gene). It is said that nonviral delivery systems are less troubling for the immune system and easier to obtain at high standards of purity and uniformity.
Chimeraplasts (RNA/DNA oligonucleotids) may induce site- specific repair when targeted to defective genes. For good results, it has to be very sharply designed and produced. The sequences in the proximity of the chimeraplast binding region affect significantly the outcome.
RNA/DNA oligonucleotides have been used to experimentally induce mutations that were easy to monitor. In rats, the mutations occurred and their phenotypic effects have been observable for almost two years. The chimeraplast induced repair process seems to take place with less efficiency in stem cells (Richardson et. al, 2002).
Single-stranded oligonucleotides were also tested for their ability to induce gene repair. They seem to be more efficient than chimeraplasts. Both types of molecules need to be short in order to determine some positive response. DNA oligonucleotides were suggested for blocking the production of a specific protein by pairing with the mRNA and activating its destruction by RNase H, approach that is thought that will work some day in cancer treatment.
Small interfering RNA duplexes (siRNAs) are designer molecules intended to be used to inactivate mRNAs in order to block the synthesis of definite proteins and their high specificity is a positive trait recommending them for safer gene therapy. (Tuschl & al., 2002; Kurreck, 2003). The still unsolved problem is how to deliver siRNAs efficiently. The proposed methods, namely liposome mediated transfer or delivery via viral vectors encounters their well known specific setbacks.
As RNAs are subjected to many modifications in the cell before being used, perhaps the cells might be challenged to repair their own defective RNAs. The challenge might consist in modulating the splicing through the introduction of decoy oligonucleotidic constructs that will “draw attention” of the cell and determine it to repair RNAs pointed out by the delivered oligonucleotides. Such oligonucleotides must of course not activate RNaseH. A similar approach might be used for DNA in situ repair, appealing the innate DNA repair mechanisms.
Oligonucelotidic strategy has already been tested for the treatment of thalassemia, cystic fibrosis, Duchenne muscular dystrophy, a form of dementia and also in apoptotic signals modification based cancer therapy. Perspectives are considered for using the splicing modulation potential of oligonucleotides in the treatment of diabetes, schizophrenia and alcoholism, psoriasis, polycystic kidney disease, hypertriglyceridemia due to hepatic lipase deficiencies, prostate cancer.
The latter application is quite intriguing as the candidate for splicing correction would be an antigene which’s implication in tumorigenesis was not clearly demonstrated.
Proposed strategies for introducing oligonucleotides into the cells consist in delivering them naked, in oligonucleotide/cationic lipid complexes or conjugated to cell-penetrating peptide fragments. Those that escape from being degraded will passively diffuse into the nucleus, and hybridize to the pre-mRNA. All cited transfection methods are little effective and known to generate unwanted responses in the organism. It is important to underline that experimental results showed an apparent inability of cell culture tests outcome to be considered as predictive for in vivo efficacy. (Sazani & Kole, 2003).
Reprogramming of mRNA
Spliceosomes are macromolecular complexes that catalyze the removal of introns, noninformational sequences that separate informational ones, namely exons in pre-mARN (splicing).
Artificially induced splicing (e.g. via a technique known as SMaRT) is regarded by some authors as a novel valuable method in gene therapy even though the authors admit that there are innate factors oriented to hampering in living cells the very process that represents the basis of this method and that a potential for non- specific reactions has to be considered (Garcia- Blanco, 2003). Such random splicing reactions can produce chimeric toxic and/or immunogenic proteins.
Reprogramming of mRNA by SMaRT requires the participation of a SMaRT effector or pre–trans-splicing molecule represented by an introduced RNA molecule. The RNA effectors’ design need to meet many requirements and, obviously, the effectors must be delivered into the cell.
First, the technique was successful in reprogramming an artificial very simple gene leaving open the question of its effectiveness when large human genes are involved. Correction of a gene responsible for cystic fibrosis was achieved with the use of SMaRT but with very little efficiency (a maximum of 1% reparation phenomena).
The delivery method (via adenoviral vectors) had the usual unpleasant and not correspondingly feeble effects. Modifications of the SMaRT effectors with the aim of reducing non- specific splicing initiation led to peculiar results. In some cases it worked in other it did not.
Small-fragment homologous replacement (SFHR)
It is another method for sequence-specific modification that makes use of single stranded DNA (ssDNA) or double-stranded DNA (dsDNA), contain noncoding sequences which is designed to be homologous to target loci and therefore able to change places with the target sequences. The enzymatic mechanisms involved require further investigations.
In vitro studies once again showed the possibility of repairing genes involved in cystic fibrosis and also of the alleviation of sickle cell anemia. The problem that keeps reappearing is the safe delivery of the therapeutic small fragment in vivo.
Besides, the rate of success was never higher than 2% “repaired” cells. In Duchenne muscular dystrophy therapy huge discrepancies between the in vitro versus in vivo results were observed. The in vitro efficiency of conversion of the mutant gene to the normal form was up to 20% while the in vivo rate was as small as of 0.1%.
There are however a series of disadvantages connected with the employment of all these small artificial nucleic acids:
1. the methods use similar unsafe mechanisms as any other techniques, the small constructs involved being able to bind to non- target sites and induce unnecessary repair processes, thus causing supplementary punctiform mutations and epigenetic changes;
2. there is a need to know the exact sequence of the affected gene in order to fabricate appropriate complements;
3. there are delivery difficulties, the classical liposome mediated transfer being not suitable because of inherent toxicity and loss of transduced material- Liang & al, 2002 proposed a new polysaccharide-based delivery system, conjugating oligonucleotidic effectors to a short peptide with a special function or encapsulating them in novel types of nanoparticles;
4. the repair mechanism may “correct” the introduced oligonucleotidic sequence, instead of the gene, the result being the perpetuation of the punctiform mutation, added the risk of inducing other mutations.
4. Gene Therapy For Some Serious Ilnesses and its Limitations
Gene therapy and cancer
Cancer gene therapy has known many approaches. We shall remind some of them.
Protection of normal cells during therapy through delivery of tumoral resistance genes
Chemotherapy becomes inefficient at some point because of the resistance tumor cells begin to manifest. The transfection of the involved genes into normal cells via retroviral vectors is thought by some specialists to be able to protect them from the adverse effects of chemotherapeutic agents, leaving the tumor cells as the sole targets of the drugs (Licht & al, 1997). The method puts some serious problems.
First, the use of retroviral vectors is unsafe in itself. As it is well known the integration of transcripted retroviral genetic information into the host’s genome cannot be precisely controlled and may lead to unwanted side effects due to disruption of the cell’s genomic coherence. Taking into consideration that the proposed vectors are sarcoma inducing retroviruses isolated from mice, the matter becomes even more serious.
There is strong evidence of the fact that viruses able to generate tumors in one species can show the same completely unpleasant effect into other species, meaning that using a murine virus in humans may not be such a clever option.
Additionally, nobody can guarantee that the descendants of the normal cells that have been equipped with chemoresistance genes will keep being normal and never ever turn into tumor cells, already carrying active chemoresistance genes. Or, the genes may be transferred, by error, to tumor cells that were not properly identified.
Cancer immunotherapy
It would employ vaccination with dendritic cells generated from cancer patients by culturing and pulsed with tumor antigens (Mitchell & Nair, 2000). Tumor antigenes presenting dendritic cells induce protective immunity. The procedure is based on the assumption that the tumor antigenes will be processed by the dendritic cells so that most relevant peptides are presented to the immune system. Dendritic cells are loaded using RNA.
What if the „helpful”, friendly, inoffensive RNA becomes DNA and integrates into the genetic material of sound cells, by retroviral transcription?
Nervous system cancer gene therapy using altered herpex simplex viruses (altered HSV)
A big problem with treating nervous system conditions is that blood–brain barrier (BBB) does not allow any molecule larger than 500Da to enter central nervous system. Transfection efficiencies of neurons in culture using non- viral methods are poor. Even though efficient in this respect, viral vectors trigger immune responses in the brain leading to tissue destruction (Trülzsch & Wood, 2004).
Herpes simplex virus (HSV) is a neurotropic DNA virus able to establish latent infection (fever, stress, sunlight, malignancy, X-ray irradiation, trauma a.s.o. may reactivate the virus) in neurons. It is therefore regarded as suitable for delivering genes them in order to deal with some serious conditions such as tumors, Parkinson’s disease, Huntington’s disease, other neurodegenerative diseases, cerebrovascular diseases, various gene disorders affecting the nervous system, chronic pain, polyneuropathies arising from systemic disease, a.s.o (Kennedy, 1997; Burton & al, 2001).
The use of herpes simplex virus derived vectors is hindered by:
1. the relative inaccessibility of the nervous system, that is protected by physical barriers to invasion,
2. the need for the vector to be internalized not only bound to the cells’ membrane,
3. the heterogeneity of neural populations that may react differently to the viral invasion,
4. the strong potential of tissue damage following viral invasion, given the fact that HSV derived vectors were shown to induce strong inflammatory responses
5. the danger of viral reactivation resulting in encephalitis,
6. the peril for the viral vector to invade adjacent non- neuronal tissue and become latent there
Indeed, using altered herpes simplex viruses hid some surprises. For example, even though theoretically any deletion in the herpes simplex genome should impair virulence in practice only a combination of a few specific deletions has been demonstrated to work, limiting the reversal to the wild dangerous type and the spread of the virus. Preexisting immunity to HSV might impair in time transgene expression, the antitumor activity of specialized HSV constructs, or the longevity of rescued cells (Koelle & Corey, 2003).
Some trials have been cited as successful as four of nine patients survived for 14 to 24 month after inoculation (Whitley & Roizman, 2002). In my opinion, such results are not convincing. The lot was too small. Besides, cancer is a very tricky disease and there is no possible way to evaluate the survival chances of the patients in the absence of gene therapy.
Introduction of suicide genes into the tumoral cells
Tumor cells may artificially become more sensitive to chemotherapeutics or toxins by acquiring “suicide genes” that activate in the presence of a specific drug, leading to apoptosis of the target cells (Springer & Niculescu- Duvaz, 2000; Mesnil & Yamasaky, 2000). The problem is that no matter which the vehicles carrying suicide genes would be they may also enter normal cells.
Generally speaking, introduction of genes encoding for suicide proteins (e.g. gene-therapy strategies are under development to deliver apoptin into tumor cells in vivo, Ferreira, 2002), tumour suppressor proteins or cytokines into tumour cells sound like a promising approach. Cytolytic viruses were also proposed as potential anti-cancer agents (Ring, 2002) However, the “suicide” method faces fundamental problems such as the peril of destroying sound tissue and even activation of oncogenes in previously unaffected tissue due to vector presence.
The issue is sometimes treated in a manner that is quite perplexing. Firstly scientists admit that viral vectors have to be unable to replicate for safety reasons, then they claim that vectors must, however be able to replicate for the transgene delivery to be efficient, noticing at the same time that viral multiplication usually induces cell lysis and that viral vectors do not show specificity for tumoral cells but also infect sound tissue. So, we must construct viruses that propagate only in tumoral cells. Tests were made and their outcome can be, sometimes, perplexing in its turn.
An attenuated virus was developed to replicate only in cells lacking the cell cycle control protein p53 or at least so did its makers think as it has been shown afterwards that specificity of viral replication of the vector was not due to the absence or presence of p53 but to timing of viral replication in tumor cells. Some feel that “although the initial concept of targeting replication to the presence of a functional p53 gene was not realized with this virus, empiric efficacy in tumor treatment has been demonstrated” (Barnes & al., 2002).
What if the future outcome of such a “misconception” will not be as favorable as this one?
For all viral delivery systems it is compelling that inhibitory antibodies in malignant ascites drastically diminish the efficacy of transfection (Barnes & al., 2002).
Gene therapy in hypertension
Many approaches were adopted in order to establish a “genetic” treatment for hypertension.
The results were not so convincing. For example, introduction into the organism via retroviral vectors of antisense oligonucleotides to the angiotensinogen or angiotensin type I receptor and other methods that interfere with the renin- angiotensin system (Gelband & al, 2000) in order to alleviate hypertension leads to an improvement in the patient’s condition improvement that is limited in time. The effect is similar to that obtained with the help of classical drugs. The risks versus benefits ratio do not seem to justify a large-scale acceptance of the procedure.
Anyway, it has been clearly established that many common diseases including hypertension result from very different combinations of genetic variants and gene– environment interactions. The causal genes are responsible for up to 50% of the variation in blood pressure among individuals, the remaining being the result of the influence of other factors (dietary habits, stress, hypercholesterolemia, smoking). Genetic determinism varies from single- gene mendelian forms of hypertension to complex poligenic interactions.
Among the genes implied in the apparition of hypertension have been identified those encoding for nitric oxide synthases, aldosterone synthase and 11(-hydroxylase genes, 11-( hydroxysteroid dehydrogenase, epithelial sodium channels (Takahashi & Smithies, 1999; Channon & al, 2000). Such complex determinism makes hypertension difficult to address through gene therapy (Dominiczak & al, 2000).
Gene therapy for hemophilia and Fanconi anemia
Gene therapy for hemophilia faces the same risks as classical therapy (formation of antibodies against the newly introduced unrecognised by the organism clotting factors), plus the usual vector employment risks. Antibody formation also bears the influence of the vector’s and target tissue type, the capacity of some vectors and tissues to set strong immune responses being well acknowledged.
Given the fact that many patients with hemophilia are also HIV positive retroviral vectors become useless in their cases because of the fact that those patients undergo antiretroviral therapy (High, 2001).
More than 20 cellular abnormalities have been reported to occur in Fanconi anemia- the concept of pronounced sensitivity to mutagens with multiple determinism summarizes those defects). Because of the complexity of the disease cures based on gene therapy fit rather science fiction than biomedical sciences (D’Andrea & Grompe, 1997). Yet, trials have been made in the same spirit of risky playing with living organisms as many other clearly incapable of success approaches.
Gene therapy for muscular dystrophies
The muscular dystrophies (MDs) are caused in their majority by single- gene mutations that can occur in a large number of genes.Gene therapy of MD faces some major problems: the need to deliver a very large transgene to the vast majority of muscles in the body which makes more than 40% of body mass without triggering toxic or immunological reactions harmful to the patient and the need to make the transgene’s expression stable over time (Chamberlain, 2002).
Dystrophic muscles are susceptible to induce strong immune responses even in the absence of vectors and transgenes because of the continuous necrosis and greatly elevated levels of immune effector cells that are present. The gene encoding for dystrophin, the protein which’s mutations are responsible for many MDs, is 2.4 Mb in size. The transgene needs to be placed under muscular gene regulatory regions therefore the full construct would be even larger. Micro-dystrophins that are truncated but still functional forms of dystrophin have been tested on mice. The problem is that muscular destruction due to MD in mice does not happen so rapidly as in humans.
Treatment of Duchenne muscular dystrophy (a lethal disorder characterised by muscle weakness ultimately leading to death due to respiratory failure) was attempted through various gene therapy methods. In order to obtain significant results, the dystrophyn encoding DNA has of course to be introduced in most if not all muscles in the body, which puts big technical and immunological problems. Rudimentary methods, such as intramuscular injections were proposed but how about the heart or the diaphragm? Other implausible delivery methods would employ dangerous vasodilator drugs in order to allow the vectors pass the capillaries and invade muscles.
The supply of encoding DNA would have to be periodically renewed besides being delivered systemically for the effect to perpetuate. The menace of strong immune responses targeting the non-self dystrophyn is quite serious.
The simplest approach consists in injecting into the muscles naked DNA encoding for dystrophin, (Liu & al, 2001). Adenoviral vectors elicit a cellular immune response leading to destruction of the “repaired” tissue. It remains to be shown whether the use of gutted Ad vectors, a new type of vectors can avoid that. A big unpleasant surprise was that while AAV-mediated delivery of many proteins is without obvious immunological consequences, the same vectors elicit drastically immune response in the muscles. It was proposed the use of introducing muscle promoters into the delivered constructs in order to block the immune response but the effect seems to vary with the protein and the vector.
Chimeroplasts’ use led to poor results, no more than 5% of the mutant dystrophin genes in mice muscles being repaired. Naked plasmid DNA displays a remarkable ability to transfer genes to muscle (55,56). Plasmids display minimal immunogenicity and toxicity, and have an extremely large cloning capacity. The primary disadvantage of plasmids is their relatively poor transduction efficiency under typical delivery protocols. Immunogenicity, even “minimal” still remains.
Gene therapy and cystic fibrosis
Using recombinant adenovirus and adeno-associated viruses vectors for pulmonary gene therapy of cystic fibrosis, a well known severe lung condition (it evolves towards respiratory failure, cor pulmonare and, finally, death) led to the following observations: in vivo transgene expression declines rapidly whereas the presence of the adenoviral vector in the organism induces a strong immune response, namely a significant chronic inflammatory manifestation in the lungs resulting in tissue injury (Rubin, 1999).
Nasal and/or lung delivery of therapeutically significant vector doses induce alveolar inflammation that produces fever, hypotension, hypoxemia and chest infiltrate (Rosenfeld & Collins, 1996). Those observations made a few years ago are still valid. The transfected cells are destroyed and the „therapy” finishes by making so much harm as the disease itself if not more. The vectors were also found to disseminate out of the lungs, e.g. in the liver.
Airway epithelium posses inhibitory abilities towards viral vectors invasion such as few receptors secretory products as mucus, antibodies, surfactant, inflammatory mediators and the poor endocytic capacity of the apical membrane- it has an impressive capacity to reject viruses (Pilewski, 2002).
5. Guidelines For Gene Therapy…And Their Limitations
Guidelines for gene therapy issued by various bioethics organisms share a few concerns.
All trials must be approved by ethics committees, based upon carefull evaluation of the following:
Risks versus benefits ratio, which takes into consideration:
1. the availability of other therapeutical approaches than gene therapy;
They are always available, but the gene therapy’s false miracle makes them look obsolete.
2. the vector must be well studied in respect of its properties and potential interactions with the hosting organism;
None of the presently employed vectors has been “well studied”. Most of their properties may constitute the patient’s big (most likely unpleasant) surprise.
3. the existence of solid scientific background for the considered method, including prior experiments in animals;
Experiments in animals have poor relevance for trials conducted in humans.
4. the quantifiability of the results- significant health improvement should be observable;
How significant ?...
Concerns regarding the patient’s emotional comfort:
1. informed consent has to be obtained;
How would informed consent be obtained where there is almost no reliable scientific information regarding the possible outcome of the trial?
2. specialists have to take care not to arise false hopes.
How can this be avoided in patients with severe conditions that inevitably put their hopes in any new medical discovery, not matter how arguable? Added the contemporary fascination for molecular biology, a veritable “false hopes industry” arises.
6. A Few Considerations On Excessive Therapy Methods
Gene therapy seems to gather many traits that would allow me to call it excessive.
Its methods are highly expensive and the results do not pay for the investments, even exhibiting one of the most discouraging costs versus benefits balance among biomedical techniques. Highly qualified personnel, expensive equipment, all these put to work in order to orchestrate what- some exceptionally scientific murder, eventually.
And do not judge me as being harsh, after reading the above exposed scientific information I guess it would seem quite obvious to anyone that even though scientists lack knowledge on many of the factors involved they keep torturing and even killing patients in the refined manners provided by the many gene therapy methods.
Why this desperate acting manner, what make people try to beat the odds even when it is unmistakable clear that the challenge they are facing is a never- to- be- overcome? What makes patients accept to enroll in gene therapy clinical trials? Some of them are heroic, they wish to make their life valuable for the others, they accept to suffer more hoping that their suffering would bring hope to other ill people. Others are desperate and would accept anything, any feeble glimpse of hope no matter how implausible.
In modern secularized times true hope has been taken away from people. Or, to be more precise, they chose to forget about it, as it was part of a system that did not agree with many of their cravings. I will take the example of my own culture and try to show how people can face death and suffering without knowing despair.
Orthodox Christian perspective upon death and suffering
People do not die entirely they do not suffer annihilation, as there is a persistent, immortal element, namely the soul. It is meant to change, during the eternity, to say so, two bodies- the one we know as flesh and blood, that disintegrates after a while and a new one that will be special, superior to the current and the soul will take after resurrection, when Christ will come to judge every human being that ever lived on Earth.
As for the body, death is only a temporary condition. Things are quite subtle, in this respect. It is said that Christ will come again among us, in His glory, at the end of times and that all human beings that have ever lived on Earth will congregate before Him, waiting to be judged and sent to Heaven or left to hell. Orthodoxy states that dead will rise taking new bodies and that even the living will change, their bodies being transformed in the presence of the Lord.
Orthodoxy insists upon the fact that souls will embody again prior to the Final Judgment. The idea is that we will experience the joy of eternal life in Heaven or the pain of eternal suffering in hell not only as souls, but as entire human beings. Embodied you sin, embodied you’ll suffer, embodied you do good, embodied you’ll enjoy heavenly peace.
In conclusion, from the Orthodox perspective, death is not something horrible and scary unless you know that you have unconfessed sins that make you a candidate to hell. Through the holy sacrament of confession accompanied by a sincere desire not to sin again, anyone can receive God’s forgiveness. For a good Christian, death is nothing but an occasion to meet the Creator of the world in a new way, other than the Holy Communion and praise Him. It is, also, a temporary no-body condition that ends with the Second Coming.
We, however, experience consequences of our sin, or even of the sins of our fathers while alive, in the various forms of suffering. We shall review, in the following, the Orthodox attitude towards suffering. Sins drift us away from God and take us in the proximity of evil. Our soul weakens, makes room for the evil to insinuate and spoil, to say so, our nature. A visible consequence of this spoilage is illness.
In Orthodoxy, the ultimate cause of every sickness, every pain and suffering is to be found not in the body, but in the soul. If you really want to be cured, first of all you have to seek forgiveness for your sins. And this is because God Himself is the One that cures our souls and bodies. Orthodox Christians do not refuse medical care, but they see it complementary to spiritual care and as a sign of the mercifulness of our Creator, that guides doctors’ mind and hand to alleviate the pain of the sick person. The doctor alleviates, God cures, and the restored health of the body is a consequence of His forgiveness and mercy towards the soul.
Orthodoxy does not emphasize the punitive aspect of sickness. Sickness is not castigation, it is a consequence of our own behavior, of our choices, and it comes with the evil we choose to be accompanied by when we sin. At the same time, sickness draws us attention that something is wrong, primarily not with our body, but, more important, with our soul.
Last but not least, suffering (including from disease) is a form of redemption. If we accept suffering as a consequence of our faults, understand that we need to repent for our sins and ask God’s forgiveness it becomes a marvelous instrument of redemption. No matter the circumstances, Orthodox Christians accept suffering in their lives and do not challenge God for being unfair or cruel, as some people say when they are in pain, without understanding the real, spiritual dimension of Christian suffering. It is, of course, unpleasant to be ill but it would for sure be much more unpleasant to experience the everlasting pain of being left far away from God, in hell, alone with devils and your own tormented conscience.
7. Conclusions
We can have many doubts over gene therapy at this moment and there is no viable reason for things to change in the future. We must by no means make peace with the idea of expecting people to suffer and die as if they were the toy soldiers of some lunatic generals that ended to conquer not some county but a laboratory. There are too many scientific, objective factors telling us that gene therapy has very feeble chances of success. How many people have to suffer and die for this to become sufficiently palpable?
As an Orthodox Christian bioethician I have to answer a possible question from my reader. Is my opinion founded at some extent on the idea that from a Christian perspective we shall seek healing exclusively for our soul and reject any form of medical treatment? Of course not, or I would be a heretic. Like I have already mentioned above, as Christians we have the right and even the obligation to take good care of our health in the material, medical manner. I mentioned the Orthodox perspective on suffering in order to underline that it is perfectly plausible for people to endure pain with true dignity that consists in living with it and not challenging God for the unpleasant outcome of your own mistakes. The idea of accepting suffering has nothing to do with rejecting medical care.
Generally speaking, the Christian measure stands in rejecting anything that is excessive, never declining a reasonable manner of dealing with an unpleasant condition such as being ill. The problem with gene therapy is that it is not at all reasonable. So, when it comes about such excessive methods we should use common sense and intelligence that God endowed us with, pass judgment over the still undemonstrated advantages and the well-documented disadvantages of such an approach and discard it as highly implausible.
We speak about a procedure (or a set of procedures) that defies common sense by not taking into consideration basic concepts of Biology and medicine and also by inducing pain to people for nothing. It is not about religion after all, it is about common sense and logic at their general level, where things may be regarded as being the same for Christians as well as for any other people from any other culture, where excessive is justifiably regarded as excessive and useless as useless.
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Discussion.
Macer: The first paper in this session is by Jennifer Robertson. I propose that we invite comments from the two persons who were mentioned. Professor Sakamoto? You don’t want? OK. Masahiro Morioka?
Morioka: Thank you very much for your presentation. I think it is very important. As I was listening to your presentation, I remember that Professor Tsuchiya, Professor Sakamoto and me have had this kind of discussion for ten years. I think even during the first and second meetings of TRT, we had this topic. In any case, your presentation about the historization is very important, and I agree, I completely agree with you. And I have a question. For example, in your presentation just now, I used the word feminist bioethics. Feminist bioethics is not monolithic. I don’t know how to say this exactly but it also relies on historization. My point is that your criticism about Japanese bioethics, East Asian Bioethics, must be applied to another kind of such and such bioethics. What do you think about this
Robertson: I think that this ties with your point on feminist bioethics that there is a long history of feminism, and at different junctions in feminist thinking of bioethical problems, different kinds of attitudes and different kinds of issues were taken up and debated. That’s why it’s important to look seriously at the evolution of some these ideas, which you have pointed out, in response to issues that are very salient and of the moment.
Morioka: Probably, one of Professor Sakamoto’s motives is to unite East Asian regions, peoples and countries into one integrated something. In Feminism, one very important motive was to unite women. In this sense there is similarity.
Robertson: I think there is a difference because feminism was a movement that emerged among individuals that were oppressed and repressed. East Asian Bioethics, East Asian is a geographical region, it is a region that has a long history of multiple colonialism. And I think it is much more fated historically on the notion of holistic ethics rather than feminism in this case.
Sivakami: Just a comment. I think by coining the word Asian Bioethics, what Sakamoto feels is an attachment to families, to kinship. For example the concept of India, that there is an Indian group, is not a revival of hegemonic ideas. I find similarities in Indianized states, and state architecture in Cambodia… So the constructions of building, the aim is to try to revive it and not to become hegemonies.
Robertson: I was referring to the historical colonization of Japan. One can make an argument of internationalization but that’s a complicated thing.
Macer: We will discuss more on Asian bioethics on the last day. The next paper is by Momoru Shimoda, are there any questions?
Wang: I think that from the definition itself eugenics is a sensitive word. So whenever we mention this word, we think of its bad history. There is both positive and negative eugenics. The new eugenics is similar to negative genetics. In Asia, there is a different view about eugenics. In China, what is wanted is negative eugenics, high technology---something like this. I think you could make it very clear what is positive eugenics and what is negative eugenics from your presentation because eugenics is a very complex issue.
Shimoda: Because of the limitation of my understanding, I can’t understand the last part of what you said. My evaluation is on the new eugenics. Some new dimension of eugenics has been already implemented in policy making such as prenatal diagnosis. What is important for us now is the negative type of intervention. But we must confront this problem with positive or enhancive intervention. So both sides have serious problems and we should investigate it using ethical component. We must discuss these issues in public and raise points including new eugenic thinking and practices. Evaluation is not so easy for now.
Wen: The use of the terminology new eugenics brings about a bad connotation especially in the context of history after World War II. But upon some discussion and reflection on the use of genetic technologies and its implications on gender, the term genetic enhancement becomes more neutral. So we can avoid bad connotation from past history.
Macer: The next paper is by Yuko Mizugaki and myself, are there any questions?
Gupta: As an outsider in Japan, it appears to me that the general access to technology is sophisticated. While people are using technology they don’t seem to be aware of the implication of the positive and negative sides. What do you propose to do in this situation?
Macer: People have access to technology in Japan. People can give comments about benefits and risks, which are mainly utilitarian. When we look at ordinary people’s comments we can see that some of them don’t even know how to write a sentence but they still express ideas. Ordinary people can give this sort of comment.
Miller: I have some questions on the validity and consistency of the study. First of all, the group of people you’re interviewing presumably have various basis of knowledge. It would be a reasonable assumption that many of them would not understand the concepts of the questions that you are asking. Therefore their answers would be more statements of fates rather than usable variables of fact that you could put into a study. The second, this is the statement that bioethics should bridge the gap between scientists and non-scientists seems to me contradictory. Because if the basis of ethical argument is that you start from a sound knowledge, it’s not bioethics that bridges the gap, it’s knowledge that bridges the gap and that knowledge allows ethical argument. I feel your study is more religious than it is scientific.
Macer: This is a descriptive bioethics study which shows that a range of ordinary people can express this level of reasoning about technology. So these particular groups who are not familiar have a more interesting experience to base their conclusions upon. But still this is a study that describes what people at this level think.
Miller: Yes ,what people believe.
Macer: Yes, what people believe and think. What is interesting is though we find these beliefs continue even though they have a great deal of knowledge. People with PhD’s gave the simplest comments. Knowledge don’t alter much reflections on technology. At this level they perceive both benefits and risks. The next paper is by Osamu Kanamori, are there any questions?
Leavitt: I have no apriori objections against enhancement. However, you mentioned informed choice. The first few hundred times that you try enhancement on an embryo you want to find out how by switching a certain gene you can make a better baseball player, you don’t know the results. You don’t know that by switching a certain gene, this might cause certain diseases or certain disadvantages. So you will have to do a clinical trial. You can get the parent’s informed choice but how about the child? The child is not giving informed consent. This child might have led a perfectly healthy life, a happy life without being a great mathematician or something.
Kanamori: I agree with you. We are trying to propose a total and continued ban on any genetic intervention. We try to intervene in some forms but the protection of the autonomy and liberty of the child is a normative imperative. Intervening in many forms is perhaps not possible. For example we can evaluate some enzymes but not in the case of having a beautiful daughter. Even if we decide to have some experimentation, at this point, only some limited cases can be permitted. Perhaps we can theoretically cannot propose a total ban because, as I said, we depend a great deal on technical intervention, both big and small.
Gupta: You have clearly shown us and expressed the hope that the new eugenics can forget its negative past and have a positive impact on the human race as a whole. However, if some group uses this for their own maniacal interests, who can be the watchdog, who will have some controlling or regulating influence on this technology?
Kanamori: Of course all of this should be done in the open, social sphere. And we purposely present important social norm of not disturbing the liberty, autonomy and integrity of the child. If someone disrupts this, we can stop them.
Macer: The next paper is by Mi Jung Koo and Jae Sub Yang, are there any questions?
Leavitt: Thank you. That’s the best paper I’ve heard in a long time. I agree with almost everything you say but I think you’re too late, we’re too late. You made a dichotomy between sexually created babies and clones. We should have asked this question when they made the first artificial insemination. The first time there was total break from human culture, which is based on the assumption that babies come from sex from the Bible and other texts. I think that’s when the question should have been asked. I think we’re too late but I hope people like you win.
Mi Jung Koo: Thank you. It is true that human beings are begotten from the womb. But nowadays, human beings can be made by biotechnicians from the lab. I think that if we follow the natural or respect nature, we should be cautious. We should ban reproductive cloning. Therapeutic cloning is also dangerous.
Pollard: I also agree it was an excellent paper. However, I think if we think about the human being, human nature is to be curious, to interfere, to play, to want to experiment…I feel there is no stopping our curiosity. Instead of trying to stop technology, perhaps we need to strengthen bioethics, the ethical way of using biotechnology. I mean science itself is ethically neutral, it is the application which is value laden, we should really think how we apply rather than try to stop because it is not our nature to stop.
Mi Jung Koo: I agree. That’s why I say that we are all fallen. I don’t know how many of you are Christian. But in the Christian tradition, the concept of the kingdom of God is central. I always teach my students that we need to remove “G” from the Kingdom of God. G stands for Greed. What we should aim for is a kingdom of god, based on kinship. That is what our society should strive for. We must try to remove greed from our lives since we are human. We can choose because we have freedom.
Macer: The next paper is by Shinrou Lin, are there any questions?
Wang: I think there is a difference between confidentiality and telling the truth. The aim of confidentiality is to provide privacy and to protect the patient from harm for example in the case of HIV/AIDS. In mainland China, if the family does not want to tell, we don’t. So I think this is a different situation.
Lin: Yes, I totally agree with you that these are different concept. But I think the focus is on disclosure of patient information, and this is widely permitted in Taiwan. And telling the truth is another story. I think what you are referring to is when the family wants the doctor to keep the fact about the disease secret from the patient, such as in the case of cancer, then they can require the doctor to keep secrets from the patient. So that is the situation of telling the patient the truth. I totally agree with you, that’s a different concept. But I don’t deal with that.
Su: How about in the case where a patient does not want his family to know about his disease but in the interest of helping the patient the family wants to know about the disease, what is your opinion on this?
Lin: Do avoid my misunderstanding of your question, do you mean that if the physician thinks it is best to tell the family about the patient’s disease, can the physician do so?
Su: Yes
Lin: The general principle of confidentiality is that the doctor cannot reveal about the patient’s disease to other’s without the patient’s permission, this includes family members. In the case where the patient did not merely give consent but rather openly opposed disclosure, the physician can not tell family members.
Macer: The next paper is by Abbas Ali Soltani, are there any questions?
Aksoy: I don’t know how to start really. Some of my friends here know that I have been working on medical ethics for a long time and genetic engineering, stem cell research and cloning are my special interests. Therefore, I have to say, I do not know how to express my objection without being impolite, this is not Islamic Jurisprudence, I guess. And I would like to see your references and full paper for me to be able to express my views really. It is a big generalization that all Sunnis accept this illegally and all Shias accept this legally. This is not a fact because there are many different positions in both thoughts. Thank you.
Soltani: Thank you. According to scientific societies that I interviewed, most Sunnis say this. Who allows human cloning among Sunnis?
Aksoy: Who allows? You ask me?
Soltani: Yes.
Aksoy: I cannot name them all now, but there are many scholars who allow for therapeutic purposes but not for reproductive purposes. I don’t know how you would define scholar. But I’m a medical scholar, I’m a Sunni with a limited knowledge of theology. And I say, it can be acceptable, cloning, even from reproduction, with some reservations.
Soltani: Thank you. My references will be in my full paper.
Macer: The next paper is also on cloning, by Xu Zongliang. Are there any questions?
Cummensky: I guess I want to agree with you that there are very good reasons for cloning. But some of the objections are what a person would say to someone, about genetic determinism and not getting the exact same person or animal. It depends on the environment and the circumstances that they are raised. So you are not going to get a replica of yourself. When you clone, it will be a unique individual, there will be that uniqueness. The basis of our dignity is not because of our biological identity. Twins have the same genetic identity. They both have standing and rights, etc… If they were to be raised in a different time by different people, they will become different. Why would you think that there would be no uniqueness in this new identity?
Xu: Thank you very much. Maybe our views are different.
Macer: The next paper is by Park Hee Joo, are there any questions?
Wang: I am very interested in about what you mentioned about what one scientist said that cloning is good. Because last year, I spent one year in your country, I know you have many religions. Please say a little more about this.
Park: Actually there are a lot of Christians in Korea, the Christian population is close to 10 million. And actually there is a wide spectrum ranging from conservative to liberal. The strongest are fundamentalists and the evangelicals, they are quite conservative and are usually against all sorts of cloning. However, as I said there are also many liberals, and the spectrum is very broad.
Macer: The next paper is by Wen Chen Chang and Jiunn Rong Yeh, are there any questions?
Bagheri: I completely agree with you that community consent is necessary. However one of your slides is inconsistent with the informed consent procedure.
Wen: There is nothing wrong, it is just the process and embodying are difficult. We need to have a practical attitude. There is nothing against it. Institutional mechanism must be added in the principle of informed consent. We’re not arguing group consent, but group participation, ingenuous not real, why bother getting it when it is not real. In a contexttualized situation, it is more important for the group to participate in order to be empowered.
Bagheri: Do you have any practical suggestion on how we can achieve this as a democratic society? Of course, there are a variety of ideas?
Wen: I approached this from the legal perspective. We are aiming for enlarged public participation. And we have talked to some anthropologists about some real cases.
Miller: As somebody who’s been involved in this kind of thing for many years, I must say that two things are happening in the United States. One is the consent form is getting more and more detailed. And including everybody’s views, I agree that it may not represent what it’s meant to represent. But the second thing, which I don’t know if it is happening in Taiwan, is that IRBs have now very broad representation. That representation is meant to reflect the views of as many aspects of society that have interested in research. So I think that people trying to do what you are suggesting they do.
Wen: I’m aware of that new trend. I hope that kind of discourse will move in that direction.
Macer: The next paper is by Shamad Basheer, are there any questions?
Sy: If you said that in theory there is tragedy beyond the commons but in practice there is none. But it seems to me that in fact the evidence that you just presented may suggest that such kind of tragedy that people are dodging access to patents, doing for instance recited proxy experiments with animals and are going to countries where such patents are not observed. It seems to me that this is in fact an evidence of Anti- Common happening through such tragedy.
Basheer: I think once they do that, then you don’t have an anticommons. Because the anticommons principle is where research will be stopped only because of patents. The anticommons principle is based on two counts. One is that you have a number of patents you need to negotiate a license for. Therefore the contacts and the cost become higher, and you ought not to take a license. And the other part is that the patents are so broad that the person who holds the patent doesn’t license anyone downstream. There is no research downstream. But using these circumvention methods, you actually avoid the patent altogether. But research continues so there is an anticommons. Anticommons is a situation where no one is doing research in that particular field by blocking the patent. But in this case, by circumventing the patent, researches will continue. So there can’t be an anticommons.
Miller: Does this also apply to transgenic models? To transgenic animals? I meant that the theory that you are expounding that the price of transgenic models may be placed too high to allow free research to be done on those models. I meant, I don’t think that’s happening but that’s your inference.
Basheer: How much of that research is being done compared to normal genetic research must be a small portion.
Miller: I think Darryl would know.
Basheer: I don’t think as much as the normal portions. As I said, it was a theoretical possibility that there would be blocking. But practically, they didn’t find any evidence of blocking. So even if, I haven’t investigated the industry dealing with transgenic materials, but my investigation is limited to human genes. But even if there were a possibility of blocking in the transgenic field, I think maybe industry has regulated itself or maybe industry has licensed itself widely so researches are taking on in this field.
Macer: The next paper is by Makina Kato, who has just completed her Ph.D. with me. Are there any questions?
Leavitt: Do you think that these companies answered these questions with public relations in mind?
Kato: I was thinking about the possibility of the companies lying or answering questions with their corporate image in mind. But I think these concerns are similar to those questionnaires given to the public. Some people would lie or try to make themselves sound more clever. So it’s not a matter of whether I trust them or I don’t, I just deal with data.
Shinagawa: Do you have any statistics on pharmaceutical companies?
Kato: Yes, I wasn’t able to present that graph today. Actually, the sensitivity towards issues, awareness, behavior towards bioethical issues are more positively seen in a pharmaceutical company.
-----------------------
. p. 170 in Macer, DRJ., ed., "Challenges for Bioethics from Asia" (Eubios Ethics Institute, 2004).
. . pp. 171-173 in Macer, DRJ., ed., "Challenges for Bioethics from Asia" (Eubios Ethics Institute, 2004).
. . pp. 174-177 in Macer, DRJ., ed., "Challenges for Bioethics from Asia" (Eubios Ethics Institute, 2004).
. . pp. 177-188 in Macer, DRJ., ed., "Challenges for Bioethics from Asia" (Eubios Ethics Institute, 2004).
[1] Acquired Immunodeficiency Syndrome (AIDS) was first reported in 1981 and soon became a global health problem affecting all regions, countries and communities. The Human Immunodeficiency Virus (HIV) was identified as the cause of AIDS in 1983. Visited (05/02/2004). AIDS is the late stage of infection with HIV. AIDS can take more than 8-10 years to develop after infection with HIV. HIV-infected people can live symptom-free lives for years; however, most people in developing countries die within three years of being diagnosed with AIDS. Visited (05/02/2004).
[2] Frederick M. Abbott, The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark corner at the WTO, 5(2) Journal of International Economic Law 469, 473 (2002).
[3] Bradly Condon, The Twin Security Challenges of AIDS and Terrorism: Implications for Flows of Trade, Capital, and Knowledge, in The WTO and the Doha Round: The Changing Face of World Trade (Ross P. Buckley ed., Kluwer Law International, 2003), pp. 251.
[4] WT/MIN(01)/DEC/2, 20 November 2001, Ministerial Conference, Fourth Session, Doha, 9-14 November 2001.
[5] World Trade Organization / World Health Organization, WTO Agreements & Public Health: A Joint Study by the WHO and the WTO Secretariat (2002).
[6] WT/L/540, 30 Aug 2003.
[7] The Constitution of World Health Organization, Preamble.
[8] WTO / WHO, supra note 5, pp. 23.
[9] Ibid.
[10] Marrakesh Agreement Establishing the World Trade Organization [hereinafter the WTO Agreement], Preamble, “ Recognizing that their relations in the field of trade and economic endeavour should be conducted with a view to raising standards of living, ensuring full employment and a large and steadily growing volume of real income and effective demand, and expanding the production of and trade in goods and services, while allowing for the optimal use of the world's resources in accordance with the objective of sustainable development…”
[11] These health-related WTO rules and Agreements are included, but not limited The details of the connections between these health issues and these WTO Agreements are explained in WTO Agreements & Public Health: A Joint Study by the WHO and the WTO Secretariat. See WTO / WHO, supra note 5, pp. 23-24, 57-135.
[12] Cigarette smoke would cause higher risk of lung cancer and several other children's health problems, such as sudden infant death syndrome, low birth weight, and respiratory disease. Thailand prohibited the import of foreign tobacco products under 1966 Tobacco Act, and the United States complained that Thailand’s prohibitions were not justified under Article XX (b) of the GATT 1994. Thailand — Restrictions on importation of and internal taxes on cigarettes (BISD 37S/200), adopted November 7, 1990.
[13] WTO/WHO, supra note 5, pp.119.
[14] SPS Agreement, Article 2.3, “Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members. Sanitary and phytosanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade.”
[15] SPS Agreement, Article 2.2, “Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, …”
[16] SPS Agreement, Article 3.3, “Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5.”
[17] TBT Agreement, Article 2.2, “Members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be more trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create. Such legitimate objectives are, inter alia: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment. In assessing such risks, relevant elements of consideration are, inter alia: available scientific and technical information, related processing technology or intended end-uses of products.”
[18] TRIPS Agreement, Article 8.1 (Principles), “Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.”
[19] WHO, “More equitable pricing for essential drugs: What do we mean and what are the issues? ”, background paper for the WHO-WTO Secretariat Workshop on Differential Pricing and Financing of Essential Drugs, Hosbjor, Norway, 8-11 April 2001, p. 9. Cited in Report of the High Commissioner, “ The impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights”, E/CN.4/Sub.2/2001/13, 27June 2001, para. 43.
[20] UNAIDS, AIDS Epidemic Update 2003, Complete set of 11 slides in PowerPoint format, visited (05/02/2004).
[21] UNAIDS, Regional HIV/AIGS Statistics and Features, visited (1/12/2002).
[22] UN Department of Communicable Diseases, Facts about HIV/AIDS- Global, visited (05/02/2004).
[23] Bradly Condon, supra note 3, pp. 274.
[24] UNAIDS, Statement of the Joint United Nations Programme on HIV/AIDS (UNAIDS) at the Third WTO Ministerial Conference, Seattle, 30 November-3 December 1999 . Cited in Report of the High Commissioner, supra note 19, para. 44.
[25] Jayashree Watal, “Workshop on differential pricing and financing of essential drugs”, background note prepared by Jayashree Watal, consultant to the WTO secretariat, p. 14. Cited in Report of the High Commissioner, supra note 19, para. 43.
[26] WHO/EDM/2001.2, op. cit., p. 1. Cited in Report of the High Commissioner, supra note 19, para. 63.
[27] TRIPS Agreement, Article 31, “Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected: …(b) such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable…(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use; …(h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization; …”
[28] TRIPS Agreement, Article 6, “For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.”
[29] F.M. Scherer and Jayashree Watal, Post-TRIPS Options for Access to Patented Medicines in Developing Nations, 5(4) Journal of International Economic Law 913, 938 (2002).
[30] Bradly Condon, NAFTA, WTO and Global Business Strategy: How AIDS, Trade and Terrorism Affect Our Economic Future (Quorum, 2002), pp. 120.
[31] Doha Declaration, Paragraph 4, “We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.
In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.”
[32] Vienna Convention on the Law of Treaties, Article 31(General rule of interpretation), ”1. A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose…”
[33] TRIPS Agreement, Article 8.1, supra note 18.
[34] TRIPS Agreement, Article 31(b), supra note 27.
[35] Doha Declaration, para. 6, “We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002..”
[36] General Council Decision, para. 1, “(a) ‘pharmaceutical product’ means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address the public health problems as recognized in paragraph 1 of the Declaration. It is understood that active ingredients necessary for its manufacture and diagnostic kits needed for its use would be included; (b) ‘eligible importing Member’ means any least-developed country Member, and any other Member that has made a notification to the Council for TRIPS of its intention to use the system as an importer, it being understood that a Member may notify at any time that it will use the system in whole or in a limited way, for example only in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. It is noted that some Members will not use the system set out in this Decision as importing Members (Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, the United Kingdom, and the United States) and that some other Members have stated that, if they use the system, it would be in no more than situations of national emergency or other circumstances of extreme urgency...”
[37] Ibid. para. 3.
[38] Ibid. para. 4.
[39] Ibid. para. 5.
[40] Whether the Doha Declaration has legal binding is still debated, some consider it only with political effects. See Daya Shanker, The Vienna Convention on the Law of Treaties, the Dispute Settelment System of the WTO and the Doha Declaration on the TRIPs, 36(4) Journal of World Trade 721 (2002). And some think its legal status ambiguous. See Carmen Otero Garcia Castrillón, An Approach to the WTO Ministerial Declaration on TRIPS Agreement and Public Health, 5(1) Journal of International Economic Law 212 (March 2002); Steve Charnovitz, The Legal Status of the Doha Declarations, 5(1) Journal of International Economic Law 207-211, (March 2002); Frederic Abbott, supra note 2.
[41] Bradly Condon, supra note 3, pp. 266.
[42] WTO/WHO, supra note 5, pp. 137-138, 144.
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[43] Oath of Hippocrates. In: Harvard Classics, Volume 38. Boston: P.F. Collier and Son, 1910.
[44]
[45] Declaration of Geneva (1948). Adopted by the General Assembly of World Medical Association at Geneva Switzerland, September 1948.
[46] Federal Rules of Evidence Rule 501, 28 U.S.C.A.
[47] See Confidentiality: Ethic Topic in Medicine, University of Washington School of Medicine,ÿ＜＞(visited 2004/1/9); MEDICAL ETHICS TODAY: ITS PRACTICE AND PHILOSOPHY, BMA’s Ethics, Science and Information Division, 1993; American Medical Association, Patient Confidentiality,＜＞(visited 2004/1/9)
[48] Skillings v. Allen, 173 N.W. 663 (1919)
[49] Id. at 664.
[50] Tarasoff v. Regents of the University of California, 551 P.2d 334. (1976)
[51] Id. at 441.
[52] Id. at 442.
[53] Thompson v. County of Alameda, 614 P.2d 728, 735 (Cal. 1980).
[54] La.Rev.Stat.Ann. § 9:2800.2 (West 1998); Minn.Stat. § 148.975 (1998); Mont.Code Ann. §§ 27-1-1102--1103 (1998); N.H.Rev.Stat.Ann. §§ 329:31, 330-A:22 (1998); N.J.Stat.Ann. § 2A:62A-16 (West 1998); Utah Code Ann. § 78-14a-102 (1998); Wash Rev.Code § 71.05.120 (1998).
[55] Reisner v. Regents of the Univ.of Cal.,37 Cal Rptr.2d 518(1995)
[56] Id. at 519.
[57] Pate v. Threlkel, 661 So.2d 278(1995)
[58] Id. at 279.
[59] Id. at 281.
[60] Id. at 282.
[61] Safer v. Estate of Pack,677 A.2d 1188 (1996)
[62] Id. at1190.
[63] Id. at1192.
[64] Id. 1192-1193.
[65] Id.
[66]Jeng Uei Li, shou tsz jie chu ai tz bing huan de jing ien (First meeting with a patient with AIDS) (visited 2004/1/19)
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[67] The ethymology for the word evolution came from the latin evolvere which was synonymous for the greek apocalypsis, to wrap open, as for a book. Charles Darwin took the name only in the third edition of the Origin.
. . pp. 410-424 in Macer, DRJ., ed., "Challenges for Bioethics from Asia" (Eubios Ethics Institute, 2004).
. pp. 425-429 in Macer, DRJ., ed., "Challenges for Bioethics from Asia" (Eubios Ethics Institute, 2004).
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