Should regulators treat the supplement industry like the tobacco industry?

The supplement industry fights any regulation that might limit sales or improve safety or quality. A new paper suggests that governments should look to tobacco control tactics to make this industry safer for consumers.

The idea that “natural” products are safe and effective has been so effectively marketed to us that many don’t recognize it as a fallacy. Much of the supplement industry is built around an appeal to nature. Supplements are described as natural, gentle, and “holistic”. Medicine, especially prescription drugs, is the opposite. They’re “chemicals”. They’re risky and dangerous – just look at that list of side effects! Supplements are packaged beautifully, have impressive claims, and at health food stores and increasingly, taking space in pharmacies. Drugs are hazardous: They may come in a plain vial, with warning labels, detailed information sheets, and cautious statements about their effectiveness. Is it any wonder that many consumers, when faced with health concerns or medical issues, instinctively think of supplements as a safer alternative? Purveyors of supplements and alternative medicine have leveraged this fallacy so effectively that it’s even guided the regulations that allow their sale. Regrettably, the result is a marketplace that puts consumers’ interests last. The supplement industry has completely stacked the odds against the consumer, challenging their ability to make informed decisions about their health. Most supplements on the market have never been properly tested for safety or effectiveness. And those that have been tested have largely been shown to be ineffective – or in the case of products like vitamins, often unnecessary. And while there are undoubtedly some ethical companies out there, the industry is regularly revealed to resemble a wretched hive of scum and villainy. Despite this, the industry has gone from success to success – in terms of sales, at least. In 1994, supplement sales were about $4 billion in the US. It’s now a $37 billion industry that is remains only lightly regulated – or largely unregulated. With recent action taken against fraudulent products, there are more questions than ever about how to force the supplement industry to make consumer protection a priority. A new paper in Drug Testing and Analysis makes a provocative suggestion: Local and state governments already regulate another hazardous product: tobacco. Can lessons learned from the tobacco wars improve the safety of supplements?

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?

Bogus Children’s Remedy Invented by CBC Marketplace Approved by Health Canada

Nothing is better than Nighton

Like many Canadians who saw last week’s news article “Health Canada licensing of natural remedies ‘a joke,’ doctor says” in the lead-up to Friday’s Marketplace episode on CBC, I was very interested in learning the story behind it. Unlike many Canadians, I wasn’t at all shocked or surprised by the outcome. This blog (and others) have been critical for years about the lack of oversight where the Natural Health Products Directorate (NHPD) is concerned. (The NHPD recently changed its name to the Natural and Non-prescription Health Products Directorate. (NNHPD))  See “Do the Natural Health Products Regulations Benefit Canadians?”, “Health Canada Gets Out a Big Rubber Stamp”   & “Safe and Effective? A Consumer’s Guide to Natural Health Products” for some background. For those who haven’t had a chance to view the episode, it can be viewed here:

THIEVES Essential Oil – Crimes against public health

As discussed in one of my previous posts, the promotion of quackery is so ubiquitous in my town it’s become white noise for me. I mostly tune it out unless I’m personally asked my opinion. Often this promotion comes in the weekly newspaper, in the advertising-disguised-as-advice page “Ask the Expert.” Occasionally there are columns by financial advisors and home improvement experts, but by far the majority of “expert advice” comes from chiropractors, naturopaths, Chinese Medicine practitioners, and holistic nutritionists. One regular advertiser is a local who calls herself a “Divine Healer”. She has some initials after her name, none of which I can trace back to any actual licenced health profession, degree or diploma. Her services include reflexology, mediumship, craniosacral therapy, aromatherapy and card-reading. She also offers a special massage called “vibrational raindrop technique” which apparently involves the use of essential oils and tuning forks or singing bowls. This actually sounds like it might be kind of relaxing and entertaining. Something I would personally never pay the money for, but harmless, right? Earlier this year, however, a local public health nurse who I consider a kindred spirit based on our views of alternative medicine contacted me about the weekly claim.

How weak regulation leads to fake and contaminated herbal supplements

If there is one aspect of “alternative” medicine that both critics and fans should agree on, it’s that products should be manufactured to high standards. What’s on the label should accurately describe what’s in the bottle. Product quality standards are essential, whether you’re using herbs or drugs. And when it comes to ensuring the products we buy are of high quality, we’re all effectively reliant on regulation to protect us. As a pharmacist, I can’t personally verify that each tablet in your prescription contains the active ingredient on the label. I am dependent on a supply chain that may stretch around the world. While the product manufacturer may be reputable, it’s only a regulator that can realistically verify and enforce production to strict quality standards. The same cannot be said for products like supplements and herbs which are regulated differently than drugs, and held to different, and in some cases, weaker standards. A weak regulatory framework, which doesn’t hold manufacturers to account, would be expected to result in a product of lower quality. And that’s exactly what you see when you look at supplements on the market today.

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:

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.