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Is it ethical to sell complementary and alternative medicine?

Legal to sell, yes. But ethical to sell?

Legal to sell, yes. But ethical to sell?

Complementary and alternative medicine (CAM) is no longer fringe, and anything but the mom-and-pop image that manufacturers carefully craft. CAM is big business, and most Americans today take some sort of supplement. The impetus for my blogging (and tilting at CAM windmills) emerged from years spent working in a pharmacy with a heavy reliance on CAM sales. If it was unorthodox, this store probably sold it. Conventional drug products (the ones I was familiar with) were hidden off in a corner, and the store was otherwise crowded with herbal remedies, homeopathy, and different forms of detox kits and candida cleanses. All of this was unlike anything I’d ever seen or heard about in pharmacy school – so I started researching.

I looked at CAM from a scientific evidence perspective, the one I was taught in pharmacy school, using the same approach I’d take when assessing a new drug. Did the evidence support the claims made about these products, or not? The answers, as you might expect, were often the same. There was little or no credible evidence to demonstrate CAM had any meaningful benefits. I started blogging my own reviews as a way of documenting my own research, while offering some information to anyone on the Interwebs who might be searching for evidence.

Over time my blogging focus expanded, as I asked myself the inevitable questions: How could implausible products with no scientific backing even be approved for sale at all? I discovered the regulatory double-standard allowed for anything considered a dietary supplement (or in Canada, a “natural health product“) and the history and politics that have made CAM the “Wild West” of health care, with a marketplace that prioritizes a manufacturer’s right to sell over a consumer’s right to purchase a product that is safe and effective. Given the retail marketplace that’s been established by regulators like the FDA and Health Canada, I’ve turned my focus on to health professionals, who have an ethical responsibility to put patient interests above that of commercial interests. From a professional practice and medical ethics perspective, I have argued that health professionals that sell or promote CAM are on ethically shaky ground, and compromise the credibility of the profession.

Despite the lack of evidence that CAM (in general) offers any health benefits at all, it’s been remarkable to watch its popularity grow, to the point where even large pharmacy chains now sell aisles of products that are implausible and often highly questionable. Generally meeting these changes with a collective shrug, the pharmacy profession has even tried to lower its own ethical standards. While I do get the occasional encouragement from some of my peers, most just say “it’s business” or “the customer wants it, and these are legal products.” My argument today is CAM fails even this lower ethical bar. (more…)

Posted in: Ethics, Herbs & Supplements, Homeopathy, Medical Ethics, Politics and Regulation

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The fine line between quality improvement and medical research

Quality

As I’ve mentioned before, the single biggest difference between science-based medicine (SBM) and what I like to call pseudoscience-based medicine, namely the vast majority of what passes for “complementary and alternative medicine” (CAM) or “integrative medicine” is that SBM makes an active effort to improve. It seeks to improve efficacy of care by doing basic and clinical research. Then it seeks to improve the quality of care by applying the results of that research to patient care. Yes, the process is complicated and messy, and it frequently doesn’t progress as fast as we would like it to. Sometimes it goes down blind alleys or takes wrong turns, such as when a treatment is adopted too rapidly and determined later to be ineffective. Overall, however, improvement does occur, and it continues to occur. New treatments that work better are discovered. Old treatments that don’t work as well (or that don’t work at all) are abandoned.

There is, however a blurry line between what constitutes medical research and what constitutes quality improvement (QI). A couple of years ago, in one of those unexpected turns that a career can take, an opportunity presented itself for me to become co-director of a statewide quality improvement consortium for breast cancer care in my state. As I’ve alluded to before, it was a case of unexpectedly being in the right place at the right time, of seeing an opportunity and being willing to take it. How I ended up making quality improvement a large part of my career is unimportant. What is important is that it puts me in a unique position among all the other SBM contributors to discuss the interface between science and quality. (It’s also important that I lay down a disclaimer here that this post represents my opinion and my opinion alone; it does not represent the views of the QI with which I’m affiliated, my cancer center, or my university.) In particular, there are ethical considerations that are not obvious, apparently even to someone as brilliant as Steven Pinker, who Tweeted yesterday:
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Posted in: Clinical Trials, Medical Ethics, Quality Improvement

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Antivaccine activists fund a study to show vaccines cause autism. It backfires spectacularly.

You want to inject me with vaccines and then dissect my brain? Why? We already know vaccines don't cause autism!

You want to inject me with vaccines and then dissect my brain? Why? We already know vaccines don’t cause autism!

Having written about pseudoscience and quackery continuously for over a decade and having engaged in conversations about it online for over 15 years, I’ve come to recognize a number of traits that are virtually the sine qua non of quacks and pseudoscientists and their believers. Obviously, one of them is a severe case of the Dunning-Kruger effect, a tendency of those with low expertise in a topic to overestimate their expertise and express far more confidence in their conclusions than warranted while those with high expertise know enough to know how much they don’t know about a topic and thus tend to express more uncertainty and caveats. Basically, the Dunning-Kruger effect describes how unskilled individuals express an illusory superiority, mistakenly believing their knowledge, competence, and ability to be much higher than it really is.

As a result of the Dunning-Kruger effect, coupled with other cognitive shortcomings suffered by all human beings (but seemingly amplified in believers in quackery and pseudoscience) that lead them to believe in pseudoscience, such as confusing correlation with causation, motivated reasoning, and the like, believers in pseudoscience are often so absolutely rock-solid in their beliefs that they are virtually impossible to reason with. It is incredibly difficult to change their minds, and disconfirming evidence often causes them to dig in all the more deeply to defend their beliefs. Not uncommonly, this leads them to commission studies designed to support their beliefs. But what happens when such a study does not actually support their belief? What happens when such a study backfires spectacularly and not only fails to support their belief, but emphatically so? Skeptics were re-treated to just such a spectacle last week when SafeMinds and other antivaccinationists were burned by a study they funded (subscription required):

Between 2003 and 2013, SafeMinds provided scientists from the University of Texas Southwestern School of Medicine, the University of Washington, the Johnson Center for Child Health & Development and other research institutions with approximately $250,000 to conduct a long-term investigation evaluating behavioral and brain changes of baby rhesus macaques that were administered a standard course of childhood vaccines. (The National Autism Association, another organization that has questioned vaccine safety, also provided financial support for this research.) The latest paper in the multiyear project was published Monday in the Proceedings of the National Academy of Sciences (PNAS). In it, the researchers concluded that vaccines did not cause any brain or behavioral changes in the primates.

Astute readers will recognize that I’ve written about similar papers before reporting that pediatric vaccines cause changes in behavior and/or brain structure in macaque monkeys. Specifically, way back in 2008, I noted the initial report of this ongoing study, first when preliminary results were reported as a poster presentation and then later another publication from the same group published in 2009. Steve Novella and a certain well-known friend of the blog have also described how poor experiments published from these studies in 2010 were, the latter of whom cited several other major criticisms of the study, not the least of which was some reporting of changes in the size of a part of the brain known as the amygdala that were…hard to believe. There were also a lot of issues with the control group chosen.

Basically, these abstracts and papers reported the results of an ongoing study looking at infant vaccines in macaque monkeys to see if there was an effect on socialization or changes in brain anatomy, the key hypothesis seeming to be that thimerosal-containing vaccines cause autism. (The investigators even added thimerosal to some of the vaccines because they weren’t being made with thimerosal anymore!) You can read the links I cited just now if you want the gory details; suffice to say that these were not good studies and not particularly good evidence that vaccines cause autism, as shown by the fact that homeopaths loved the study, and ultimately the paper examining hepatitis B specifically was withdrawn. Yet these reports were flogged for quite a while by the antivaccine movement as proof positive primate data that vaccines are Evil.

Fast forward to 2015. Now we have a much larger, much better study. It’s even by the same people. And guess what? It’s as negative as negative can be. No wonder SafeMinds and other antivaccinationists are unhappy. Let’s take a look. (more…)

Posted in: Science and Medicine

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It’s time for pharmacies to stop selling sugar pills

Some of these products contain no medicine at all.

Some of these products contain no medicine at all.

Retail pharmacies have a sugar pill problem. Homeopathic “remedies” may look like conventional medicine when they’re stocked on pharmacy shelves, like the photo above. But unlike conventional medicine, homeopathic products don’t contain any “medicine” at all. They are effectively sugar pills – placebos. Not surprisingly, there is convincing evidence to show that homeopathy is useless as a medical treatment, and fundamentally incompatible with a scientific understanding of medicine, biochemistry and even physics. Questions have been raised about the ethics of selling homeopathy in pharmacies to consumers who may not realize what they’re buying. This growing practice is attracting sharp criticism from other health professions. So why do pharmacies sell them? And what will it take for pharmacies to change? (more…)

Posted in: Ethics, Homeopathy, Politics and Regulation, Public Health

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Selling complementary and alternative medicine: An business ethics perspective

I joined Professor Chris MacDonald at Ryerson University earlier this week to participate in Ryerson’s business ethics speaker series. The topic was CAM:

Is it ethical to market complementary and alternative medicines? Complementary and alternative medicines (CAM) are medical products and services outside the mainstream of medical practice. But they are not just medicines (or supposed medicines) offered and provided for the prevention and treatment of illness. They are also products and services – things offered for sale in the marketplace. Most discussion of the ethics of CAM has focused on bioethical issues – issues having to do with therapeutic value, and the relationship between patients and those purveyors of CAM. This presentation — by a philosopher and a pharmacist — aims instead to consider CAM from the perspective of commercial ethics. That is, we consider the ethics not of prescribing or administering CAM (activities most closely associated with health professionals) but the ethics of selling CAM.

If it’s not embedded above, you can watch the whole presentation on CAM and business ethics with this link.

It was great to see so many public members attend and participate. There was an extended Q&A afterwards, with some very thoughtful audience questions. Outside of blogs like this, and those of CAM critics like Edzard Ernst, the practical ethics of CAM provision are rarely discussed.  Watch for more on this topic in the future.

 

Posted in: Announcements, Homeopathy, Medical Ethics, Politics and Regulation

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Beware the Integrative Pharmacy

pharmacy window

Imagine a retail pharmacy where some of the medicines on the shelves have been replaced with similar-looking packages that contain no active ingredients at all. There is no easy way to distinguish between the real and the fake.

Another section of the store offers a number of remedies with fantastic claims, such as “boosting” the immune system, “detoxifying” the body, or “cleansing” you of microscopic Candida. They look sciencey, unless you realize that they treat imaginary medical conditions.

A corner of the store offers unpurified drugs supplied as tinctures and teas. The active ingredients aren’t known, and the batch-to-batch consistency of the product is unclear. The store will suggest products for you based on your symptoms.

Walk past the enormous wall of vitamins and other supplements and you’ll find a nutritionist who will tell you what products you should be taking. You’ll also find a weight loss section. From a science-based perspective, this shouldn’t even exist, given no product has been shown to offer any meaningful benefit. But there are dozens of products for sale.

At the back of the store you’ll finally find the pharmacist. A sign on the counter offers blood- and saliva-based tests for food “intolerance” and adrenal “fatigue”, claiming to test for medical conditions that actually don’t exist or lack an evidence base. The pharmacy also offers a large compounding practice, advertising what it calls “personalized” approaches to hormone replacement with “bioidentical” hormones.

Welcome to the “integrative” pharmacy.

You may not see all these features in your local drug store, but they’re coming: claims of a new “integrative” way to provide health care that is changing the face of retail pharmacy. Unfortunately, it’s harkening back to the era of patent medicines and snake oil. It’s not good for the pharmacists and the profession of pharmacy, and it’s even worse for patients. (more…)

Posted in: Homeopathy, Medical Ethics, Politics and Regulation, Science and Medicine

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Philosophy Meets Medicine

Note: This was written as a book review for Skeptical Inquirer magazine and will be published in its Jan/Feb 2014 issue.

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Medicine is chock-full of philosophy and doesn’t know it.  Mario Bunge, a philosopher, physicist, and CSI (Center for Skeptical Inquiry) fellow, wants to bring philosophy and medicine together for mutual benefit. He has written a book full of insight and wisdom, Medical Philosophy: Conceptual Issues in Medicine.

Whether doctors recognize it or not, medicine is firmly based on the philosophical principles of materialism, systemism, realism, scientism, and humanism. Bunge explains that:

Without materialism, both diseases and therapies would be taken to be purely spiritual.

Without systemism, every disease would be attributed to an independent module.

Without realism, diseases would be viewed as either imaginary or as social flaws.

Without scientism, either nihilism or dogmatism would prevail, and all the achievements of biomedical research of the last 500 years would be consigned to oblivion.

Without humanism, all medical practice would be mercenary, and there would be no public health care. (more…)

Posted in: Book & movie reviews

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Followup: Benedetti on Placebo Ethics

A few months ago I wrote about Fabrizio Benedetti’s research on the neurobiology of the placebo response, and a discussion about placebos and ethics ensued in the comments. Now Dr. Benedetti has written about that issue in a “Perspective” article in the journal World Psychiatry, “The placebo response: science versus ethics and the vulnerability of the patient.” 

We have learned that verbal suggestions can activate neurotransmitters and modulate pain perceptions, and positive expectations can activate endogenous opioid and cannabinoid systems. A complex mental activity has objective effects on body physiology. Words and drugs can activate the same mechanisms. Drugs are less effective without therapeutic rituals. We are delving deep into human foibles and vulnerable traits at the center of human interactions. What implications do these insights into mind-body interactions have for patient care?

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Posted in: Medical Ethics

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Placebos as Medicine: The Ethics of Homeopathy

Is it ever ethical to provide a placebo treatment? What about when that placebo is homeopathy? Last month I blogged about the frequency of placebo prescribing by physicians.  I admitted my personal discomfort, stating I’d refuse to dispense any prescription that would require me to deceive the patient. The discussion continued in the comments, where opinions seemed to range from (I’m paraphrasing)  “autonomy, shmatonomy, placebos works” to the more critical who likened placebo use to “treating adults like children.”  Harriet Hall noted,  “We should have rules but we should be willing to break them when it would be kinder to the patient, and would do no harm.” And on reflection, Harriet’s perspective was one that I could see myself accepting should I be in a situation like the one  she described. It’s far easier to be dogmatic when you don’t have a patient standing in front of you. But the comments led me to consider possible situations where a placebo might actually be the most desirable treatment option. If I find some, should I be as dogmatic about homeopathy as I am about other placebos?

Nicely, Kevin Smith, writing in the journal Bioethics, examines the ethics of placebos, based on an analysis of homeopathy. Homeopathy is the ultimate placebo in routine use — most remedies contain only sugar and water, lacking a single molecule of any potentially medicinal ingredient. Smith’s paper, Against Homeopathy — A Utilitarian Perspective, is sadly behind a paywall.  So I’ll try to summarize his analysis, and add my perspective as a health care worker who regularly encounters homeopathy.
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Posted in: Homeopathy, Medical Ethics

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What’s with the new cough and cold products?

One of my earliest lessons as a pharmacist working in the “real world” was that customers didn’t always act the way I expected. Parents of sick children frequently fell into this category — and the typical vignette went like this for me:

  1. Parent has determined that their child is sick, and needs some sort of over-the-counter medicine.
  2. Parent asks pharmacist for advice selecting a product from the dozens on the shelves.
  3. Pharmacist uses the opportunity to provide science-based advice, and assures parent that no drug therapy is necessary.
  4. Parent directly questions the validity of this advice, and may ask about the merits of a specific product they have already identified.
  5. Pharmacist explains efficacy and risk of the product, and provides general non-drug symptom management suggestions.
  6. Parent thanks pharmacist, selects product despite advice, and walks to the front of the store to pay.

In many ways, a pharmacy purchase mirrors the patient-physician interaction that ends with a prescription being written — it’s what feels like the logical end to the consultation, and without it, feels incomplete. It’s something that I’m observing more and more frequently when advising parents about cough and cold products for children.

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Posted in: Homeopathy, Legal, Science and Medicine

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