Introduction - CFI: Center for Inquiry

EXECUTIVE OFFICES 1012 14th Street NW, Suite 205

Washington, DC 20005

Joint Commission of Pharmacy Practitioners1 by email

February 16, 2021

Re: Pharmacists' role in protecting patients from the harms of homeopathy

Dear healthcare professional:

As pharmacists and pharmacy staff rally to support the deployment of COVID-19 vaccines, the importance of the profession is at the top of so many thankful minds. For this reason, on behalf of the Center for Inquiry, Inc., we urge the Joint Commission of Pharmacy Practitioners (JCPP) to remind its member organizations, and their respective membership, that homeopathy is never an appropriate component of the patient care process. While medical advances continue to help make and keep us healthy, the importance of science-based treatments must not be set aside for unproven, unsafe snake oil.

Introduction

The Center for Inquiry, Inc. (CFI), a national nonprofit organization dedicated to the promotion of science, reason, freedom of inquiry, and humanist values, has long worked to battle the ills of pseudoscience, quackery, and all forms of confidence schemes that defraud the unknowing and unwitting.2 CFI's goal is to protect consumers from the ills of these schemes. Homeopathy, and the myriad products that fall under the term, typifies the deceit and dangers of magical thinking.

Pharmacists possess unique training and expertise in the appropriate use of medications. Patients expect and rely upon this professionalism. It would therefore be difficult to imagine a scenario where an individualized patient-centered care plan--evidence-based and cost-effective-- involves homeopathy. However, pharmacists do not practice in a bubble and are often located in retail stores. The proliferation of homeopathic products, coupled with the easy profit generated by these sham cures, makes it nearly impossible for a patient to visit the pharmacy without being bombarded by signs and labels promising quick cures. Pharmacists have an ethical and moral obligation to ensure that patients are safe, not a profit source.

Homeopathy Harms

Front and center in the JCCP's Pharmacists' Patient Care Process is the notion of "evidence-based practice." The pharmacist undertakes a five-step process: collecting necessary

1 A copy of this letter was sent to each of the thirteen membership organizations that compose the Commission. 2

information; assessing that information; planning, in conjunction with other health care professionals, an individualized patient-centered health plan; implementing that plan; and following up.3

For many patients, pharmacists will be the sole medical professional with whom they interact. In 2019, almost 29 million Americans lacked health insurance coverage.4 Millions more had poor or expensive coverage, often with high co-pays and deductibles. For these, the neighborhood pharmacy, and its qualified, trained pharmacist, provide the only expert medical care available.

When those seeking over-the-counter (OTC) treatment for conditions visit a retail pharmacist such as CVS or the pharmacy section of their chosen supermarket or big box store such as Walmart, they are presented with a vast range of options. The pharmacist there is not solely someone who fills a prescription; they are the gatekeeper to the entire product range, and shoppers frequently turn to that professional for advice.

Market research shows consumers place a great degree of trust in retail pharmacies and pharmacists. Seventy-nine percent of adults trust retail pharmacies to sell OTC drugs that are safe and effective.5 Thirty-three percent of adults report that they ask for advice from the pharmacist before selecting a remedy for a common illness, a number three times that of the 11 percent who call a doctor first to get a recommendation.6

One out of three customers suffering from an illness place themselves in the hands of the pharmacist to recommend treatment. This places a great responsibility on pharmacists to ensure a safe and effective, evidence-based patient care process for those seeking their help. Recommendations should be appropriate for the individual, should be safe, and should be effective in treating the condition or symptoms from which the person suffers.

Homeopathy simply fails to meet any of those requirements.

Why It Matters

The bottom line is homeopathy does not and cannot work.

The absence of evidence is acknowledged by federal government bodies such as the National Center for Complementary and Integrative Health (NCCIH), a part of the National Institutes of Health that researches alternative medicine, which states "[t]here is little evidence to support homeopathy as an effective treatment for any specific condition."7 An exhaustive metastudy performed by Australia's National Health and Medical Research Council (NHMRC) in 2015 assessed more than 1,800 papers on homeopathy, finding 225 of them to meet the criteria for

3 4 5 6 Id. 7 National Center for Complementary and Integrative Health, Homeopathy (April 2015), available at

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inclusion in the study.8 The study "found no good quality, well-designed studies with enough participants to support the idea that homeopathy works better than a placebo, or causes health improvements equal to those of another treatment."9 Its conclusion was blunt: "There are no health conditions for which there is reliable evidence that homeopathy is effective."10 In the United Kingdom, a 2010 House of Commons Science and Technology Committee report on homeopathy noted that homeopathic remedies performed no better than placebos and concluded that "[t]he [British] Government should stop allowing the funding of homeopathy on the NHS [National Health Service]."11 In July 2017, NHS England, the state provider of health care, announced it would no longer fund homeopathic prescriptions.12

The NCCIH warns people that they should not "use homeopathy as a replacement for proven conventional care or to postpone seeing a health care provider about a medical problem."13 The FDA has issued warnings about the dangers of relying on homeopathic products to deal with serious conditions. For example, in 2015, the FDA warned against over-the-counter homeopathic asthma products.14

By purchasing products that do not work, consumers are harmed. They are paying money for products that do not effectively treat the ailments for which they are being taken. Where those products are marketed as cures for illnesses, either directly or through suggestion, this is perpetrating a fraud on consumers. This is no small financial loss to the American people. According to the Economist in 2014, Americans spend $3 billion annually on homeopathy.15

The harm caused by homeopathy does not end there, however. Homeopathic products may be tainted or contain harmful ingredients. In its 2012 report, the American Association of Poison Control Centers noted that there were 10,311 reported cases of poison exposure related to "homeopathic agents," with 8,788 of those cases attributed to children aged five years old or younger. Of these 10,311 cases, 697 required treatment in a health care facility.16 The FDA requested that Standard Homeopathic Company recall its Hyland's Baby Teething Tablets after

8 National Health and Medical Research Council, NHMRC releases statement and advice on homeopathy (March 11, 2015), available at 9 Id. 10 Id. 11 House of Commons, Science and Technology Committee Fourth Report: Evidence Check 2 ? Homeopathy (Feb 8, 2010), available at 12 Nicola Davis and Denis Campbell, "`A misuse of scarce funds'; NHS to end prescription of homeopathic remedies," The Guardian (July 21, 2017), available at 13 National Center for Complementary and Integrative Health, Homeopathy (April 2015), available at 14 U.S. Food and Drug Administration, Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement ? Consumer Warning About Potential Health Risks (Mar. 19, 2015), available at 15 "Why Homeopathy Is Nonsense," The Economist (Apr. 2, 2014), available at 16 James B Mowry, Daniel A. Spyker, Louis R. Cantilena, Jr., J. Elise Bailey, and Marsha Ford, 2012 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 30th Annual Report (2013), available at

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concluding that the products had "been found to contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products' labels."17 Hundreds of adverse effects were reported.18

Homeopathy also harms consumers even when properly prepared by encouraging them to rely on such products to the exclusion of proven scientific remedies. As the Australian NHMRC study states: "People who chose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness."19

When sick people eschew effective treatment in place of homeopathic products, they unnecessarily suffer symptoms for longer. They may suffer long-term consequences, up to and including death. This is particularly true for children, who, importantly, do not make the decision to use homeopathic products themselves. Most parents have seen the pain that a child suffers with an ear infection; this can often be treated rapidly and safely through the use of antibiotics. When a parent instead relies on homeopathic remedies such as those suggested by the homeopathic industry that include belladonna (also known as deadly nightshade),20 or through use of the commercially sold homeopathic product Similasan Kids Ear Relief Drops, as sold at retail pharmacies,21 not only does the child suffer unnecessarily but the failure to properly treat may also result in long-term hearing damage or deafness.22

Reliance on homeopathic products to the exclusion of science-based medicines can therefore have serious consequences for both children and adults. The website "What's the Harm" details many such cases.23 For example, Isabella Denley, a toddler from Melbourne, Australia, was an epileptic whose neurologist prescribed her anti-convulsant medication; her parents, instead, chose to treat her exclusively with homeopathic products. She died aged thirteen months.24 Lucille Craven of New Hampshire was diagnosed in 1997 with a small, pea-sized carcinomatous breast tumor. Her doctor recommended mastectomy and lymphectomy, but instead Lucille sought homeopathic and other alternative medical treatments. She died within thirty-six months.25

17 U.S. Food and Drug Administration, Standard Homeopathic Company Issues Nationwide Recall of Hyland's Baby Teething Tablets and Hyland's Baby Nighttime Teething Tablets Due to Mislabeling (Apr. 13, 2017), available at 18 Sheila Kaplan, "Hundreds of Babies Harmed by Homeopathic Remedies, Families Say," Scientific American (Feb, 21, 2017), available at 19 National Health and Medical Research Council, NHMRC releases statement and advice on homeopathy (March 11, 2015), available at 20 Homeopathy Plus!, Middle Ear Infection, available at 21 22 American Academy of Otolaryngology-Head and Neck Surgery, Middle Ear Infection (Chronic Otitis Media) and Hearing Loss (2016), available at 23 24 Lucy Atkins, "When there's no real alternative," The Guardian (Dec. 16, 2003), available at 25 Richard Craven, My Wife's Death from Cancer (Feb. 27, 2002), available at

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Reliance on homeopathy therefore risks harming patients in three ways. Patients suffer a financial loss by spending money on a product that does not perform in the way in which they have been led to believe it will. They may suffer damage from adulterated and dangerously manufactured products. And they may suffer longer and from greater harm from diseases that could have been effectively treated or cured by science-based medicine. Homeopathy is far from harmless, and pharmacists have a duty to protect consumers from the fraudulent claims of homeopathy just as they would from harm inflicted by any other form of snake oil sold in a pharmacy.

Homeopathy's dangers are often dismissed as purely financial. As shown, they are not. Patients who replace their conventional medicine with homeopathic products will not, and do not, get better from the product. Nor could they, because homeopathic products, by design, are intended to be diluted a mathematically impossible number of times. There's no way a molecule of the original substance could remain post-dilution. Assuming the "active ingredient" were effective at all, it is not even supposed to be in the product being sold!

Tragically, though, sometimes this under-regulated and under-policed industry gets its sham wrong. Such was the case with homeopathic teething tablets marketed by CVS and Hyland's Inc.:

FDA analysis found the levels of atropine and scopolamine in some of the CVS tablets and the levels of scopolamine in some of the Hyland's tablets far exceeded the amount stated on the products' labels.26

The products were, eventually, recalled. The FDA requested that Standard Homeopathic Company recall its Hyland's Baby Teething Tablets after concluding that the products had "been found to contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products' labels."27 Hundreds of adverse effects were reported.28

Belladonna alkaloids. In teething tablets. To be taken by infants.

Pharmacists Must Protect Patients

CFI's request here is a simple one. The JCPP should remind its membership that, when asked for advice by patients, they should not recommend homeopathy. Indeed, whenever possible, they should inform patients of what homeopathy is and how it just doesn't work. In pharmacies, the shelves are lined with a range of products about which the patient is often uncertain and uneducated and about which they look to the pharmacist to help. A homeopathic product, such as

26 "FDA confirms elevated levels of belladonna in certain homeopathic teething products," FDA News Release, Jan. 27, 2017, available at 27 U.S. Food and Drug Administration, Standard Homeopathic Company Issues Nationwide Recall of Hyland's Baby Teething Tablets and Hyland's Baby Nighttime Teething Tablets Due to Mislabeling (Apr. 13, 2017), available at 28 Sheila Kaplan, "Hundreds of Babies Harmed by Homeopathic Remedies, Families Say," Scientific American (Feb, 21, 2017), available at

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