Towards more effective supplement regulation in Canada

Unsubstantiated claims for natural health products could be a thing of the past in Canada.

I suppose I owe Health Canada some thanks. It was Health Canada’s lackadaisical  regulation of dietary supplements and natural health products that turned me from a “shruggie” pharmacist into one that started advocating, publicly, for putting consumers’ interests ahead of those of supplement manufacturers. While health regulations are seemingly created to protect consumers, Health Canada has  consistently given manufacturers the upper hand, prioritizing a company’s desire to sell a product over a consumer’s right to a properly regulated marketplace with safe, effective products. It’s now very clear that the Natural Health Products Regulations have led to an industry boom and massive sales, but also a confusing marketplace for consumers and no persuasive evidence that all those supplements have any meaningful effects on our health. Canadian drug store shelves in 2016 are packed with hundreds of products with unsubstantiated claims and untested products, and little credible information to guide selection.  Yet all of these products have been reviewed and deemed to be “safe and effective” by Health Canada.

A Homeopathic Win for Consumers

Medical history is full of strange practices and beliefs. As scientific principles have become the framework for determining what works (and what doesn’t) in medicine, we’ve seen a steady progression towards more science-based, evidence-based care. Yet some unscientific practices still exist, even when we know they don’t work. It might surprise you to learn that some people believe sugar pills can prevent and heal disease. This belief system, called homeopathy, is a multi-billion dollar industry worldwide, and it’s growing. While there is no convincing evidence to demonstrate that homeopathic treatments are more effective than a placebo, many consumers and even some health professionals accept homeopathy as a legitimate health treatment, and its providers as legitimate health professionals.

Responding to the perceived consumer demand for these products, government regulators have had a difficult decision to make: They could ignore homeopathy as a health practice, treating it like we might think of astrology: firmly outside of medicine, and for entertainment purposes only. Or they could choose some form of regulation, targeting the providers (homeopaths) or the product (homeopathy), possibly with the goal of managing its use, or perhaps limiting harms to consumers. The risk of regulating nonsense is the perceived legitimacy that recognition and regulation implies. Regrettably, regulation in many countries has had that exact effect. What’s worse, regulation often seems to have prioritized the commercial interests of homeopaths (and manufacturers) over the public interest, leaving consumers with little understanding that homeopathy lacks any scientific credibility.

Given the lack of scientific credibility and the evidence it offers no medical benefit, homeopathy has attracted increasing criticism from health professionals, scientists, and science journalists over the years. This advocacy appears to be having an effect. Regular readers at the Science-Based Medicine blog will recall several posts over the past few weeks, describing the possibility of new regulation of homeopathy by the US Food and Drug Administration (FDA). And just recently, Health Canada announced two important changes to its homeopathy regulation, which may signal a new direction that prioritizes the consumer interest and public health. Are we witnessing the beginning of more sensible regulation of this prescientific practice?

Unrepentant Homeopaths Still Selling Sugar Pills to Prevent Infectious Disease

Alternative medicine is ascendant in Canada. From the dubious remedies that are now stocked by nearly every pharmacy, to the questionable “integrative” medicine at universities, there’s a serious move to embrace treatments and practices that are not backed by credible evidence. Canada’s support for alternative medicine, and for its “integration” into conventional health care is arguably is worse than many other countries. Canada’s drugs regulator, Health Canada, has approved hundreds of varieties of sugar pills and declared them to be “safe and effective” homeopathic remedies. Some provinces are even moving to regulate homeopaths as health professionals, just like physicians, nurses and pharmacists. Given the regulatory and legislative “veneer of legitimacy” that homeopathy is being granted, you can see how consumers might be led to believe that homeopathic remedies are effective, or that homeopaths are capable of providing a form of health care. The reality is far uglier, and the consequences may be tragic. Canadian homeopaths are putting the most vulnerable in society at risk by selling sugar pills to consumers, while telling them that they’re getting protection from communicable diseases.

Under threat of class action lawsuit, maker of “homeopathic” medicine settles, and exits North America

I’ve written more times that I want to about homeopathy, the elaborate placebo system of “remedies”. It looks like medicine, and pharmacies stock it on shelves alongside products that contain medicine. But with homeopathy the common “strengths” or “potencies” of products are usually so dilute there’s no possibility of a single molecule of the original substance remaining in the remedy. What’s further, the original substance isn’t medicine, either. They can be derived from from substances like Stonehenge (yes, that Stonehenge), shipwrecks, ascending colons, light bulbs, and even vacuum cleaner dirt. While homeopathic products are deemed “safe and effective” by Health Canada’s Natural Health Products Directorate, the awareness that homeopathic products contain no active ingredients and have no medicinal effects has become increasingly well known. In 2011, I noted that manufacturer Boiron had been served by two class action lawsuit, and that this might be the beginning of a trend.

The legal action route seems to be having an effect – which is good, given pharmacies and even regulators have refused to act. Homeopathy manufacturer Heel has decided to exit the North American market completely:

Mozi-Q – “Insect repellent you eat”. But does it work?

Today’s post is a guest contribution from a Canadian pharmacist who is writing under the pseudonym Sara Russell:

Every morning I open up Facebook and expect to see the usual sharing of my friends’ latest adventures in pseudoscience, but it wasn’t until this morning that I felt compelled to write about something.  A friend had posted this video asking for feedback.

Weekend Reading

It’s Family Day weekend in several provinces in Canada, and President’s Day weekend in the United States. Here’s what I’ve been reading:

 

The consequences of legitimizing nonsense

Smarties: As effective as homeopathy

For a blog established to examine the role of science in pharmacy practice, I’ve given a disproportionate amount of attention to homeopathy. Which is frustrating, because homeopathy is not something that pharmacists, or the pharmacy profession, should even need to discuss. Unlike herbal remedies, and some supplements, there isn’t even any science to discuss. As pseudoscience goes, homeopathy is the worst of the worst – it is a belief system, nothing more. If homeopathy actually worked as claimed, it would mean that all we know about biology, biochemistry, pharmacology, and toxicology was wrong. Not a little wrong, but completely wrong. Which would then mean that all we know about science-based medicine is wrong.

In short, homeopathy is an elaborate placebo system, based on the idea that “like cures like” (which is simply a form of magical thinking) involving successive dilutions of products in water, like Berlin Wall, “Mobile Phone (900mHz)“, and even the light reflecting off Saturn. These substances are believed to have medicinal effects, and the dilutions are believed to increase, not decrease, the potency of the final product. But the dilutions in homeopathy are so great you’re not even getting any Berlin Wall. Think of putting one drop of a substance into a container of water. Only that container is 131 light-years in diameter. That’s the “30C” dilution. Homeopaths believe that the water molecules retains a “memory” of the original substance (while conveniently forgetting all the other products it has come in contact with.) The final remedy is diluted so so completely that most products on store shelves don’t contain a single molecule of the ingredient listed on the label. After all that dilution, the water is dripped on tablets of sucrose and lactose: They are, as a final product, sugar pills. Chemically indistinguishable, and as medicinal as a box of Smarties.

Not surprisingly, a review of clinical trials, when you control for biases, confirms what grade-school numeracy and scientific literacy would suggest – homeopathic products are no more effective than a comparable placebo. Yet frustratingly, regulators in Canada and in other countries have given legitimacy to homeopathy by registering both the medication and their purveyors – risking the perception that homeopathy may in fact offer medicinal value. And whether it’s due to ignorance of homeopathy, or indifference to the unfounded ideas of “alternative” health, legitimate health professionals continue to give a pass to homeopathy, taking a “What’s the harm” attitude. Yet harms can result:

When homeopathy is approved as an insect repellent, there’s a serious regulatory problem

Given their visibility in the pharmacy, a recurring topic of this blog are the category of products deemed “natural health products”. My philosophy towards their uses has changed over the years, and what was an “evidence-based” approach is now firmly a “science-based” approach. A central principle to science-based medicine or pharmacy is that all health interventions and treatments should be evaluated based on a single, scientific standard. One of the biggest successes of the alternative medicine industry, worldwide, has been the embedding of different regulatory standards for the evaluation and approval of so-called “non-drug” products such as supplements, herbal products, and non-scientific treatment systems like homeopathy or traditional Chinese medicine (TCM). The implications cannot be overstated: this different and lower standard is now so firmly entrenched in most health systems that few seem to question its rationale, or consider the consequences. As a practicing pharmacist I spent the first decade of my career working within this regulatory framework without ever stepping back to question why we regulate some products differently.  Comparing two countries illustrates my point:

What FX? CBC’s Marketplace looks at Cold-fX

I’ve been blogging for over three years and Cold-fX, a popular Canadian ginseng supplement, was one of the first topics I tackled. The omnipresent Canadian advertising, huge pharmacy presence, and impressive-sounding efficacy claims made it an ideal case study. Perhaps not surprisingly, when I reviewed the data, the results didn’t hold up:  I concluded that in a best case scenario, you’d need to take Cold-fX for four cold seasons (about 16 months) to prevent a single cold. And while the manufacturer claimed that Cold-fX could actually stop colds once they’d started, I noted that there was no published evidence to back up that claim. I concluded there was was little rationale to justify supplementing with Cold-fX. The published clinical evidence wasn’t persuasive, and the supplement is not inexpensive. The smarter strategy? Washing your hands regularly is clinically proven, and it’s a lot less expensive.

Since my review, the popularity of Cold-fX has continued unabated. And the manufacturer has branched out into all kinds of supplements: Cell -fX (shark cartilage), Cold Sore fX (bee propolis), Remember-fX (also ginseng), Memory-fX (more ginseng), and Immunity-fX (ginseng again, but with with reishi mushroom). Skeptical yet? So was CBC’s Marketplace, which scrutinized Cold-FX in a episode broadcast earlier this month. (I can’t embed the video, so you’ll need to watch the video at the CBC’s site.) For those of you that haven’t seen Marketplace, it’s a consumer affairs/consumer advocacy show that takes on medical topics from time-to-time. Last year it did an excellent investigation of the elaborate placebo system known as homeopathy. The producers are clearly science and consumer advocates, making natural health products low-hanging fruit. So Cold-fX was a fitting topic. Their investigation focused on several issues:

Oh yeah? Thalidomide! Where’s your science now?

Online discussions on the merits of alternative medicine can get quite heated. And its proponents, given enough time, will inevitably cite the same drug as “evidence” of the failings of science. Call it Gavura’s Law, with apologies to Mike Godwin:

As an online discussion on the effectiveness of alternative medicine grows longer, the probability that thalidomide will be cited approaches one.

A recent commenter  to this blog, regarding the homeopathic product Traumeel, is typical:

If the scientific method is all that separates an accepted claim, ie Thalidomide, Vioxx, Bextra, Darvon, from mere anecdote, of what benefit is the Science?

As a non-scientist consumer, I’ll take the anecdotes and my own experience. Thank you.

If scientists want to be taken seriously, they must stop selling themselves to the highest bidder becoming corporate whores without a shred of decency. To my mind, that’s how the claims for Thalidomide, Vioxx, Bextra, Darvon were accepted, making the scientific method utterly worthless.

To this commenter, “science has been wrong before.” And that invalidates science, and apparently validates homeopathy. It’s a fallacious argument. But does thalidomide actually represent a failing of science-based medicine? No, not even close. It’s so wrong, it’s not even wrong. Thalidomide is good example of the importance of science-based medicine and why allowing alternative medicine to be sold in the absence of good science is a concern.