Kennedy Institute of Ethics



Ethics and the Ebola Outbreak Margaret Dunne Since ancient times, the existence of infectious diseases has been accompanied by a number of ethical concerns. Even in Leviticus, the instructions about how a diseased person should act show an understanding that certain diseases have the potential to spread from person to person, and also raise a number of ethical questions, "The person with such an infectious disease must wear torn clothes, let his hair be unkempt, cover the lower part of his face and cry out, 'Unclean! Unclean!' As long as he has the infection he remains unclean. He must live alone; he must live outside the camp” (Leviticus 13:45-46). In this short passage referring to how a person infected with leprosy should act, many ethical dilemmas are raised such as: where should infected people live? Should they be separated, or forcefully separated, from society? And whose duty is it to treat those afflicted? In recent history, the Ebola outbreak in West Africa has raised a number of ethical questions due to the number of people infected, the place where the epidemic occurred, and how long the epidemic has lasted.Background of the West African Ebola EpidemicOn March 22nd, 2014, armed with laboratory confirmation of samples that had been sent to Europe, Guinea’s Ministry of Health declared that there was an outbreak of Ebola in the country. Although the outbreak was reported in late March, the virus had been spreading undetected for three months, misdiagnosed as Cholera and Lassa Fever. One week later, on March 29th, 2014, Liberia’s Ministry of Health confirmed its first cases of Ebola. Two days after that, because of the geographic spread of the outbreak, Médecins Sans Frontières (MSF) declared the outbreak to be “unprecedented,” an analysis that at the time was considered hyperbolic my many, including the World Health Organization (WHO). At the end of May, less than two months after Ebola was detected in Liberia, Sierra Leone declared its first case of the virus. By the end of June, MSF teams identified “that the virus was actively transmitting in more than 60 locations in Guinea, Liberia, and Sierra Leone.” Because of the large number of locations that were actively transmitting the virus, MSF declared the outbreak “out of control” on June 21st, 2014 and “called for qualified medical staff to be deployed, for trainings to be organized, and for contact-tracing and awareness-raising activities to be stepped up.” Unfortunately, lack of leadership, capacity, and coordination meant that these calls went largely unanswered, and MSF was again accused of alarmism. Meanwhile, across Guinea, Liberia, and Sierra Leone thousands of people were infected and dying at about a 50% case fatality rate, including dozens of healthcare workers. Finally, on August 6th the Director-General of the World Health Organization (WHO) Dr. Margaret Chan convened the first meeting of the Emergency Committee under the International Health Regulations (IHR), and on August 8th Dr. Chan declared a Public Health Emergency of International Concern (PHEIC). In all, as of November 12th, 2015 there were 28,599 total cases in Guinea, Liberia, and Sierra Leone and 11,299 deaths in the three countries combined (Table 1). Table 1: This table compiles data on the total number of cases and total number of deaths from Ebola Virus Disease in Guinea, Liberia, and Sierra Leone by country and combined until November 12, 2015. Although having a world that is safe from the global health threat of infectious diseases would be ideal, unfortunately the measures that are currently in place failed during the West African Ebola epidemic to prevent, detect early, and rapidly respond to the epidemic. The virus was spreading in Guinea for three months before it was detected, and due to the incredibly slow response of the global community, far from preventing an outbreak, an epidemic of unprecedented proportions took place. If there is anything that the global community has learned, or should learn from this outbreak, is that it is not prepared to effectively respond to an outbreak of this size. Due to the failure of public health surveillance systems, rapid laboratory support, and health information systems to identify cases at the beginning of an outbreak, and later due to the slow response of the international community once the virus had spread, the transmission of the Ebola virus spiraled out of control and resulted in the largest Ebola epidemic in history. Because of the infectious nature of the virus, and because of its rapid spread in West Africa, the most recent Ebola epidemic raises many ethical questions. The number of people infected and killed by the virus, the location in which the epidemic occurred, and the slow response of the global community all contribute to the number of ethical questions put forth by the epidemic. This paper will focus on the many ethical issues that arose in the wake of the Ebola outbreak due to the location, duration, and magnitude of the epidemic. While this is by no means an exhaustive undertaking of all of the ethical dilemmas presented by the most recent Ebola outbreak, it is a survey of many of the ones that have been addressed by the media in the public discourse and by bioethicists in academic settings. It aims to address these ethical issues that when taken together ask questions about the responsibility we as human beings have to one another before, during, and after we are drawn closer by a deadly virus. A Survey of the Ethical Issues Raised by this Ebola Outbreak This paper will discuss the ethical issues surrounding the response to the outbreak and the treatment of patients during the epidemic. Discussion of the response will center around the length of time it took for Dr. Margaret Chan, Director-General of the WHO, to convene an Emergency Committee, and to subsequently declare a Public Health Emergency of International Concern (PHEIC). This delay had very real consequences as there were far too few healthcare workers, medical supplies, and treatment units available to treat patients with Ebola, and not enough resources to adequately track the number of cases and stop chains of transmission until five months after the outbreak began. At the height of the outbreak doctors were forced to choose which patients to let into the Ebola Treatment Units (ETUs) as there was not enough capacity to treat everyone. Had the mechanisms in place been better utilized to prevent, detect, and respond, the outbreak likely would not have spiraled out of control to this extent. There are also ethical concerns regarding the treatment of patients with the Ebola virus. Even before this outbreak, there was no research and development for vaccines or treatments for Ebola by pharmaceutical companies. This led to the responders playing a game of catch up and wondering how they should perform randomized control trials in the midst of an epidemic, if at all. The Response:As was previously mentioned, Dr. Chan took five months before convening an emergency committee under the IHR, the first step towards declaring a Public Health Emergency of International Concern (PHEIC). Two days after the committee was convened via teleconference, a PHEIC was established. Between the first WHO reporting date of the number of cases on March 25th, 2014 until the date that a PHEIC Was declared on August 8th, 2014, 1,680 new cases were identified and 900 people died (Table 2). Table 2: This table compiles data on the total number of cases and total number of deaths from Ebola Virus Disease in Guinea, Liberia, and Sierra Leone by country, and combined, from March 25th 2014 until August 8th 2014. About two weeks before Dr. Chan declared a PHEIC, Samaritan’s Purse, a missionary group working in West Africa to contain the epidemic, reported that two of their American staff members had tested positive for Ebola. Shortly after the two Samaritan’s Purse staff were infected, a man who had recently returned from West Africa became the first person to be diagnosed with the virus outside of Africa when he tested positive for Ebola in a Dallas hospital. Next there was the first instance of human-to-human transmission of the virus outside of Africa when a Spanish nurse who was treating a citizen of Spain with Ebola tested positive for the virus. MSF’s international president eloquently noted that, “The lack of international political will was no longer an option when the realization dawned that Ebola could cross the ocean. When Ebola became an international security threat, and no longer a humanitarian crisis affecting a handful of poor countries in west Africa, finally the world began to wake up.” Although the WHO’s Director General needs to balance the many different concerns of countries affected by an outbreak with the concerns of countries that that have not yet been affected, and take into consideration the impact of her decision on trade and travel between countries, the Ebola Interim Assessment Panel found that the “independent and courageous decision-making by the Director-General and the WHO Secretariat” was “absent in the early months of the Ebola crisis.” It further found that there were “significant and unjustifiable delays” in the declaration of a PHEIC. The WHO “plays a leading role in protecting international public health” and as such has a duty to protect the health of the citizens of all nations. The fact that a PHEIC was only established in the weeks following the spread of the disease outside of the African Continent sets a dangerous precendent and implies that only when developed countries are affected by a virus does the situation become a PHEIC. From an ethical perspective, the WHO must value the health and lives of all of the citizens of the world, and not just the lives of those living in developed and more powerful countries. Although it is likely that the affected countries themselves did not want a declaration of a PHEIC from the WHO as it would seem like an acknowledgement that the countries could not handle the outbreak effectively on its own, the WHO’s responsibility should be to the sick people in the country, not to the governments. Due to the WHO’s lack of leadership during the epidemic, the outbreak spiraled out of control so much so that there came a point when no organization had the capacity or expertise to control the epidemic. When Samaritan’s Purse pulled out of Liberia after two of their staff became infected there was no one to fill the gap. The only organization to pick up the slack was MSF, but the organization was already “operating at 100 percent” and had overstretched its teams in Guinea and Sierra Leone. The organization was concerned that including Liberia in its operational response would put even more stress on the already thinly stretched organization, “what if mistakes were made, staff became infected and the project collapsed?” However, since there was no one else to do the job, MSF decided that they “would have to push beyond [their] threshold of risk, and…send coordinators without experience in Ebola, with only two days of intensive training.” As MSF was getting ready to deploy staff to Liberia, it began construction on the ELWA 3 treatment center in Monrovia. ELWA 3 became the largest Ebola Treatment Unit (ETU), eventually reaching 250 beds. MSF’s task force coordinator Rosa Crestani noted that, “Even though ELWA 3 was the biggest treatment centre in history, we knew it was not enough. We were desperate because we knew that we couldn’t do more, and we knew exactly what those limitations meant. It meant there would be dead bodies in homes and lying in the street.It meant sick people unable to get a bed, spreading the virus to their loved ones.” By late August 2014, the ETU was only able to be open for one-half hour each morning. Although many potentially infected people were seeking entry to the center, there was only capacity to admit a few patients “to fill beds made empty by those who had died overnight.” Staff members were forced to “make the horrendous decision of who we could let into the centre.” They sought a balance between letting in people in the earlier stages of the disease and taking those who were “dying and most infectious.” This is a kind of utilitarian way of making a decision about who gets treated and who does not, as there is an awareness that not everyone can be treated, and unfortunately there are some people who are not going to be treated in order to give those who are receiving treatment the best possible chance of survival. In order to ensure the safety of their staff-members, and to decrease the chance of spread of the virus within the treatment center, MSF “kept its limits,” and “refused to put more than one person in each bed.” MSF’s incredibly difficult position raises two ethical issues. Due to the severe lack of human resources to aid in the treatment of patients with Ebola and containment of the epidemic, whose duty is it to treat these patients and stop the epidemic? The other ethical concern raised relates to the fact that staff members were forced to choose who could enter the facility. Since a doctor’s first duty is to “do no harm,” how can a doctor reconcile his or her primary calling with having to refuse treatment to some patients? In a situation where there are so few healthcare workers in the countries affected by the ebola epidemic, whose duty is it to care for the patients? MSF’s emergency coordinator Lindis Hurum lamented that, “I think it’s fair to say that we are Doctors Without Borders, but we are not without limits. And we’ve reached our limit. It’s very frustrating, because I see the huge needs but I simply don’t have the human resources. We have the money thanks to our donors. We have the will. We certainly have the motivation, but I don’t have enough people to deal with this.” The word Ebola, accurately or not, conjures up images of hemorrhage, chaos, and death. The fear that the virus promotes led to paralysis and inaction. In an attempt to get more human resources for the epidemic, MSF stressed that “not all of the response involves ‘space suits.’ Contact tracing, health promotion and distribution of soap, chlorine and buckets were all urgently needed.” Many of the doctors who treated the patients infected with Ebola went above and beyond their duty to treat, however there was still a huge lack of human resources. For the responses that did not involve being placed in high risk zones, I would argue that it was the duty of any organization that had expertise in contact tracing, health promotion, and/or logistics to help in the response. As MSF noted, “Not all activities are confinedto the high-risk zone, but everything needed to be done by someone –and on a massive scale.”The United States’ Presidential Commission for the Study of Bioethic Issues (Bioethics Commission) issued a report in which it justified US involvement in the response to the outbreak for both “ethical and prudential reasons.” The report highlights the fact that the places that are most susceptible to outbreaks due to lack of sanitation and strong healthcare systems are also least able to respond to the outbreaks precisely due to the same factors. The report notes that the ethical calling for a US response to the epidemic is grounded in humanitarian reasons and social-justice. It argues that “on humanitarian grounds, the magnitude of suffering and loss of life in the Ebola epidemic support a moral imperative for providing assistance grounded in common humanity.” From a social justice standpoint, the right to health is a fundamental human right, a right that in many of the countries affected by the Ebola epidemic is nearly impossible to ensure at the moment because of a lack of healthcare workers and the lack of government expenditure on health, making some healthcare services prohibitively expensive. This inability to attain health as a human right has been even more exaggerated during the Ebola epidemic. The Bioethics Commission points out the fact that global health crises are often geopolitical in nature, and can include the “historical control of regions by former colial powers.” Therefore, “theories of global justice support obligations of addressing inequalities and poverty, which are often considered more stringent than notions of humanitarianism or charity, and might be demanded as redress for past or current injustices.” Although the President’s Bioethics Commission sets up the ethical arguments for the US to help in the quelling of the Ebola epidemic, unfortunately a US-led response was effectively non-existent. Because of global inaction and lack of leadership from the WHO, healthcare workers at ETUs were forced to make almost impossible decisions about who to let into the centers, and then once patients were admitted, who to treat. Dr. Daniel Bausch an associate professor at Tulane’s School of Public Health and Tropical Medicine was at one point left with only one other physician in a ward of 55 infected patients in Sierra Leone after nurses walked out over a dispute on extra pay for taking care of patients with Ebola. In a New York Times interview, he made the point that, “even if you wanted to be the hero, you couldn’t take care of 55 people.” He then told the paper how he triaged patients, “We tried to attend to the most important things we could attend to in terms of people who were the sickest. To be honest, it sounds terrible, not really the sickest, but the sickest who you think have chances of surviving.” Choices like these that have to be made in the midst of an out-of-control epidemic are not necessarily out of the ordinary in crisis situations, but having to make decisions about who gets treated and who does not on such a large scale takes a tremendous toll on the healthcare workers whose primary objective is always to care for as many people as possible. Treatment: Even before the Ebola outbreak occurred, the international community was already playing catch-up. This is because there was no research and development of drugs occurring for the vaccination against or treatment for the Ebola virus. In 2001, MSF released a report entitled “Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases.” Although the report focused mainly on neglected tropical diseases like African sleeping sickness and its counterpart in Latin America, Chagas disease, the point was, and remains, that there is a stark “lack of research and development (R&D) into drugs to treat the diseases of the poor.” Director-General Chan, in her address to the Regional Committee for Africa highlighted the lack of treatments for Ebola, saying, “Because Ebola has historically been confined to poor African nations. The R&D incentive is virtually non-existent. A profit-driven industry does not invest in products for markets that cannot pay.” In the case of influenza, if a certain strain of the flu does not become a pandemic, it will likely come back as one of the strains of the seasonal flu. Therefore, pharmaceutical companies have an incentive to create vaccines against potential pandemic flu strains, as they will be able to use their creations as part of the vaccination campaign against seasonal flu in developed countries. Also, in the event of pandemic flu, developed countries would also be strongly affected because flu spreads through the air and people are infectious before they show symptoms of being sick. However, since there is no seasonal ebola that affects the developed world, and the number of people in developed countries who are infected with Ebola is so small, drug companies have very little incentive to make vaccinations and treatments for the Ebola virus. So whose responsibility is it to make sure that vaccines and treatments for a virus like Ebola are manufactured? And what are the implications if they are not? According to a New England Journal of Medicine (NEJM) article, prior to the Ebola outbreak in West Africa, there was not a lack of basic science research into potential Ebola vaccines, there was however, a lack of testing in humans. Seven Ebola vaccines had been tested in monkeys by 2009, but only one had been tested in healthy humans as part of a phase 1 trial. The vaccine was then abandoned. None of the other vaccines had made it to a phase 1 trial, and “none was available in sufficient supply to be deployed in an emergency.” The NEJM article advocates for a global fund for vaccine-development that would provide “resources and momentum to carry vaccines from their conception in academic and government laboratories…to development and licensure by industry.” This fund would allow for the vaccine development of infectious diseases such as Ebola, MERS-CoV, and SARS in the hopes that vaccinating people at the beginning of an epidemic would save lives. From an ethical perspective, there exists a human right to health. This fundamental human right should not be available only to people who are affected by diseases that make drug companies money, thus a global fund for vaccine development would help to decrease inequality in treatment and prevention options for diseases that mainly affect poorer nations. Because there were no vaccines that had moved past the first phase of a clinical trial, questions rose in the midst of the epidemic about how to test potential vaccines in a scientifically effective yet ethically sound manner. Questions about “the ethical standards that should be applied to research conducted…in situations where the results of research are intended…to be applied as direct care in the same context in which studies are conducted” led to huge debates within the international community about whether or not randomized control trials were necessary and/or ethical in the midst of the epidemic. Although randomized-control trials are considered the gold-standard in terms of showing causality between an intervention and its impact, there are factors outside of establishing this causal link that need to be taken into consideration in the middle of an outbreak. In a randomized-control trial, some patients receive the intervention in question, while others receive a placebo. During the Ebola epidemic attaining informed consent about an RCT would be extremely difficult because “it is reasonable to assume that [the patients] have expectations of receiving potentially lifesaving treatment, not that they are part of an experiment.” This brings up the idea of a therapeutic misconception, whereby participants in a study “do not understand that the defining purpose of clinical research is to produce generalizable knowledge.” It is likely that in an RCT trial, patients in West Africa with Ebola would be under the assumption that they were receiving life-saving care instead of either no care at all, or care that could have serious, not-yet know, side effects later on. But then the question becomes how are the possible vaccines and treatments for Ebola to be tested during an epidemic, if at all? The WHO “‘concluded unanimously that it would be acceptable on both ethical and evidential grounds’ to use unproven interventions that have been promising (in vitro and in animals) in clinical practice if certain conditions were met.” But this raises ethical questions related to those raised by the usage of RCTs during an epidemic. There is still likely an assumption that the medicines that are being used to combat Ebola will be safe and effective, yet because of the lack of an RCT we cannot say for sure whether that is the case. These ethical questions that are raised in the middle of the Ebola outbreak, highlight the need for support and incentives so that drug manufacturers invest in vaccines and treatments for diseases like Ebola, MERS Co-V, and SARS that do not yield a large return on investment. This would mean the international community would not have to play catch-up when faced with outbreak of Ebola or another infectious disease, and hopefully decrease the chances of the outbreak turning into such a widespread epidemic. Conclusion As the Ebola epidemic winds down after ravaging three countries for 22 months, the international health community keeps mentioning catch-phrases like “lessons learned.” Unfortunately, there are still infectious diseases with the potential to become epidemics like MERS Co-V that lack vaccinations. The number of ethical issues that were raised by the most recent Ebola outbreak would have been diminished had the response to the outbreak been more effective, and had there been more information available about vaccines and treatments. In the middle of an outbreak it is nearly impossible to think about the ethical implications of every action as there are more pressing practical concerns. However as the intensity of the outbreak is decreasing, looking into these ethical issues is important as it will hopefully help to provide a framework for what should happen in a future epidemic. Further, looking at ethical issues is not simply a futile exercise in “should-haves and could-haves” but rather it is a chance to implement changes in organizational structures and increase the capacity of states so that the response to future outbreaks will be more effective. ................
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