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. Continue reading
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.
You can watch it here here.
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. Watch for more on this topic from us in the future.
While I’m now two full decades out of pharmacy school, I am occasionally invited to return to give a lecture or facilitate a workshop. Pharmacy education has changed a lot since the 1990’s. For me, pharmacy was a Bachelor’s degree program you started right out of high school. Today, students must have a few years of university completed before they can apply (some already have one degree), and the more common degree granted is doctorate-level, the Pharm.D. The clinical training has been bulked up and the practical training is much more rigorous. I see all this as positive change, as the practice of pharmacy has changed along with the education standard. The era of the “count, pour, lick and stick” pharmacist is disappearing as these tasks are automated or delegated to others. Today’s pharmacist has the opportunity to deliver care in different ways, including new roles like vaccine provider, and medication review/drug therapy optimizer. Many find positions that allow them to leverage their drug-related expertise to other areas of the healthcare system.
With pharmacists’ knowledge of drug products it should not be a surprise that they are consulted widely for advice by patients as well as other health professionals. Public surveys on trust show pharmacists lead other health professionals on this measure. It should also not be a surprise that pharmacists can be quite influential in shaping drug use, particularly when it comes to advice about complementary and alternative medicine (CAM), especially when it is used with conventional, science-based drug treatments. After all, drug stores are becoming (to my professional embarrassment) purveyors of all forms of CAM, ranging from homeopathic “treatments” through aisles of herbal remedies, vitamins, and other supplements. One pharmacy I used to work at sold copper bracelets, magnets, salt lamps, ear candles, homeopathic “first aid” kits, and detox packages that were purported to “balance” your pH. If there was a plausibility limit to what this pharmacy would sell, I never saw it reached. I gave the best science-based advice I could, but eventually left due to my concerns about what was on the shelves. But my time in that setting showed me the opportunity to improve care: the pharmacist is well positioned to advise on the evidence for or against any particular treatment, as well as explain the potential risks with combining CAM with evidence-based treatment approaches.
The SBP post on “pH Balancing” is one of the most popular, with over 43,000 views views since it was posted in 2009. The topic seems to come up again and again because alternative practitioners promote ideas that are not reality-based. Unfortunately, some pharmacies sell products that are marketed based on this falsehood. If you see these products for sale, think about taking your business to a pharmacy that puts a higher priority on selling credible products.
Just a short update today. Here’s some link and clips from the past week: Continue reading
Medicine is a collaborative practice. Hospitals are the best example, where dozens of different health professionals work cooperatively, sharing responsibilities for patient care. Teamwork is essential, and that’s why health professionals obtain a large part of their education on the job, in teaching (academic) hospitals. The only way that all of these different professions are able to work together effectively is that their foundations are based on an important, yet simple, principle. All of us have education and training grounded in basic scientific principles of medicine. Biochemistry, pharmacology, physiology – we all work from within the same framework. As a pharmacist, my role might include working with physicians and nurses to manage and monitor medication use. A team approach is only possible when you’re working from the same playbook, and with the same aim. And in medicine, that playbook is science.
That’s why “integrative” medicine frightens me so much. Integrative medicine is a tactic embedding complementary and alternative medical practices into conventional medical care. Imagine “integrating” a practitioner into the health system that doesn’t accept germ theory. Or basic disease definitions. Or the effectiveness of vaccines. Or even basic biochemistry – perhaps they believe in treatments that restore the body’s “vital force” or manipulate some sort of “energy fields”. Instead of relying on objective signs and symptoms, they base treatments on pre-scientific beliefs, long discarded from medicine. There may be entirely different treatment goals, which are potentially antagonistic to the scientific standard. Imagine a hospital or academic setting where this occurs, and the potential impact on the quality of care that is delivered. Continue reading
Vitamins are magic. Especially when they’re injected. Roll up the sleeve, find a vein, insert a needle and watch that colourful concoction flow directly into the bloodstream. It may sound somewhat illicit, but that person infusing it is wearing a white coat, and you’re sitting in a chic clinic. There must be something to it, right? Intravenous vitamin injections are popular with celebrities and have even been described by Dr. Oz as “cutting edge”. Advocates claim vitamin injections can benefit serious conditions like cancer, Parkinson’s disease, macular degeneration, fibromyalgia, depression, and that modern-day obsession, “detoxification”. And vitamin infusions aren’t just for the ill. They’re also touted as helpful for preventing illness, too. A search for vitamin injections brings up millions of hits and dozens of advertisements. There is no question that vitamin injections are popular. But despite all the hype and all the endorsements, there is no credible evidence to suggest that routine vitamin infusions are necessary or offer any meaningful health benefit. Vitamin infusions are a marketing creation, giving the illusion you’re doing something for your health, but lacking any demonstrable efficacy. What’s more concerning, providers of vitamin therapies target their marketing at those fighting life-threatening illnesses like cancer, selling unproven treatments in the absence of good scientific evidence that they are beneficial.
The intravenous vitamin industry is a sideshow to science-based health care. Yes, there is an established medical role for injectable vitamins, though it’s no energy-boosting cure-all – they’re used to replace what we should obtain in our diet. As a hospital-based pharmacist I used to prepare sterile bags of total parenteral nutrition (TPN), a mixture of vitamins, carbohydrate, protein and fat that completely replaced the requirement to eat. TPN is effective, but not without risks, and far less preferable than getting your nutrients the old fashioned way – by eating them. There’s also the routine use of injectable vitamins like B12, or iron, all of which can be science-based when used to address true deficiencies, or to manage specific drug toxicities. IV vitamins (particularly thiamine) are also used in the emergency room, given to alcohol-dependent patients in order to prevent Wernicke’s encephalopathy. And there is the therapeutic use of high-dose minerals like intravenous magnesium for acute asthma attacks. But there is no medical justification to infuse vitamins into a vein when you can more appropriately obtain those nutrients in your diet.
A hilarious and scathing examination of the regulatory system for “complementary” medicine in Australia.
One of the key concepts essential to science-based medicine is the placebo: What it is, what it isn’t, and how it complicates our evaluation of the scientific evidence. One my earliest lessons after I started following the Science-Based Medicine blog was that I didn’t understand placebos well enough to even describe them correctly. Importantly, there is no single “placebo effect”. They are “placebo effects”, a range of variables that can include natural variation in the condition being studied, psychological factors and subjective effects reported by patients, as well as observer bias by researchers studying a condition. All of these, when evaluated in clinical trials, produce non-specific background noise that needs to be removed from the analysis. Consequently, we compare between the active treatment and the placebo to determine if there are an incremental benefits, to which we apply statistical tests to determine the likelihood that the differences between the intervention and the placebo groups are different from random chance. Removed from the observational nature of the clinical trial, we can’t expect the observed “placebo effects” to persist, as they’re partially a consequence of the trial itself. A more detailed review of placebos is a post in and of itself, so I’ll refer you to resources that describe why placebo effects are plural, that placebo effects are subjective rather than objective and there is no persuasive evidence to suggest that placebo effects offer any health benefits. What’s most important is the understanding that placebo effects are a measurement artifact, not a therapeutic effect.
Placebo effects are regular topics at this blog, because an understanding of placebo effects is essential to evaluating the evidence supporting (so-called) complementary and alternative medicine, or CAM. As better quality research increasingly confirms that the effects from CAM are largely, if not completely, attributable to placebo effects, we’ve seen the promoters of CAM shifting tactics. No longer able to honestly claim that CAM has therapeutic effects, “treatments” such as acupuncture or homeopathy are increasingly promoted as strategies that”harness the power of placebo” without all the pesky costs or side effects of real medical interventions. But this is simply special pleading from purveyors and promoters. Unable to wish away the well-conducted trials that show them to be indistinguishable from placebos, they instead are spinning placebo effects as meaningful and worthy of pursuit – ideally with your favourite CAM therapy. Again, I’ll refer you to posts by David Gorski and Steven Novella who offer a more detailed description of how negative results can be spun to look positive. Because CAM’s effects are indistinguishable from placebo, we should not invest time and resources into pursuing them – we should instead focus on finding treatments that are demonstrably superior to placebo.
But what if physicians are already using placebos widely in practice? Setting aside the ethical issues for now, widespread placebo usage might suggest that physicians believe that placebos are effective treatments. And that’s the impression you may have had if you skimmed the medical headlines last week:
One of the themes I’ve emphasized in many posts on this blog is that every treatment decision requires an evaluation of risks and benefits. No treatment is without some sort of risk: Even a decision to decline treatment has its own risks. And when a treatment has no demonstrable benefits, the risks factor more significantly into our evaluation. One of my frequent counseling challenges with patients is helping them understand a medication’s expected long-term benefits against the risks and side effects of treatment. This dialogue is most challenging with symptomless conditions like high blood pressure, where patients face the prospect of immediate side effects against the potential for long-term benefit. One’s willingness to accept side effects is influenced, in part, by and understanding of, and belief in, the overall goals of therapy. Side effects from blood-pressure medications can be unpleasant. But weighed against the reduced risk of catastrophic events like strokes, drug therapy may be more acceptable. Willingness to accept these tradeoffs varies dramatically by disease, and are strongly influenced by patient-specific factors. In general, the more serious the illness, the greater the willingness to accept the risks of treatment.
As I’ve described before, consumers may have completely different risk perspectives when it comes to drug therapies and (so-called) complementary and alternative medicine (CAM). For some, there is a clear delineation between the two: drugs are artificial, harsh, and dangerous. Supplements, herbs and anything deemed “alternative”, however, are natural, safe, and effective. When we talk about drugs, we use scientific terms – discussing the probability of effectiveness or harm, and describing both. With CAM, no tentativeness or balance may be used. Specific treatment claims may not be backed up by any supporting evidence at all. On several occasions patients with serious medical conditions have told me that they are refusing all drug treatments, describing them as ineffective or too toxic. Many are attracted to the the simple promises of CAM, instead. Now I’m not arguing that drug treatment is always necessary for ever illness. For some conditions where lifestyle changes can obviate the need for drug treatments, declining treatment this may be a reasonable approach – it’s a kick in the pants to improve one’s lifestyle. Saying “no” may also be reasonable where the benefits from treatment are expected to be modest, yet the adverse effects from treatments are substantial. These scenarios are not uncommon in the palliative care setting. But in some circumstances, there’s a clear medical requirement for drug treatment – yet treatment is declined. This approach is particularly frustrating in situations where patients face very serious illnesses that are potentially curable. This week is the World Cancer Congress in Montreal and on Monday there were calls for patients to beware of fake cancer cures, ranging from laetrile, to coffee enemas, to juicing, and mistletoe. What are the consequences of using alternative treatments, instead of science-based care, for cancer? There are several studies and a recent publication that can help answer that question. Continue reading
Is it ever ethical to provide a placebo treatment? What about when that placebo is homeopathy? Last month at Science-Based Medicine 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.” My SBM co-blogger 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.