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.

Part Fills for August 30

Links and updates of interest to SBP readers.

Slipping through the Cracks: Health Canada, Traumeel, and Homeopathy

It’s World Homeopathy Awareness Week. Today’s post is a deeper dive into the world of homeopathic “evidence”. Looking at the science, we’ll highlight the implications of regulators applying two sets of standard to health products: One for medicine, and one for homeopathy. Today’s post is a collaboration with Kim Hebert, who blogs at Science-Based Therapy.

The kindest that can be said about most homeopathic products is that they won’t cause adverse effects. After all, most common “strengths” or “potencies” used in homeopathy are so dilute there’s no possibility of a single molecule of the original substance remaining in the remedy. But what if, instead of diluting a product the typical 30 times, it’s only diluted once or twice? Is it still homeopathy? There’s a very good chance of some molecules of the original substance remaining. That’s the case with today’s case study, Traumeel.

Remedy Regulation: Homeopathy in Canada

It’s World Homeopathy Awareness Week. Today’s post examines the Canadian regulatory framework for homeopathic remedies.

Homeopathy is an alternative medicine system that was invented in the 1800’s and involves three main concepts: like-cures-like (what causes a symptom can cure a symptom); individualized treatments (remedy selection considers factors like emotion and mood); and less-is-more (water has memory, and substances that are progressively diluted (and shaken) become stronger, not weaker.) If homeopathy worked, what is known about biochemistry, physics, and pharmacology is wrong. As expected, upon rigorous examination, there is no convincing evidence that effects attributed to homeopathy are anything more than placebo effects. Yet not only are homeopathic products sold in Canada, their sale is regulated by the federal government, through Health Canada’s Natural Health Products Directorate. And we are assured of of the following:

Through the Natural Health Products Directorate, Health Canada ensures that all Canadians have ready access to natural health products that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity. [emphasis added]

So, what gives? Science has established that homeopathy is no more effective than a placebo. How did Health Canada determine otherwise?

Do the Natural Health Products Regulations Benefit Canadians?

How much confidence do you have in natural health products?

Shortly after I started practicing as a pharmacist, I began giving two disclaimers whenever speaking with patients purchasing herbal products:

Compared to drugs, there is little regulation of herbal products. Variation could exist between what it says on the label and what it actually contains.

And if they have medical conditions or are taking prescription drugs, I would add,

Compared to prescription and over-the-counter drugs, the information we have on these products limited. They could have the potential to interact with other medications and medical conditions that we are not aware of. They should be used with caution.

I would give a similar disclaimer for other types of supplements and “alternative” products.

Why a disclaimer, with every patient, every time? Because the Canadian regulatory framework does not give me the confidence that natural health products available for sale in Canada are either safe or effective. Most importantly, I could not even tell patients with confidence that what was on the label was actually in the bottle.

Change is Coming. Slowly.

Until several years ago, Canadian natural health products fell into a regulatory grey zone.  Products were treated either as drugs, or as foods. Consultation began in the late 1990’s on a new framework to provide appropriate levels of  regulation and oversight to these products. In 2004, the Natural Health Product Regulations (NHPR), under Canada’s Food and Drugs Act, became a reality.  Rather than fully regulating these products as drugs, or leaving them virtually unregulated (as is done in the United States), the NHPR were a regulatory compromise: Implementing manufacturing quality and safety standards, while significantly relaxing the standards for product efficacy claims.  If randomized, double-blind, placebo-controlled trials are not conducted, (the standard for drugs), manufacturers can make claims based on “traditional uses” and other sources that are essentially anecdotal in nature. The NHP regulations include products such as nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy.

One of the most important elements of the NHP regulations was the implementation of pre-marketing registration requirements. Only products reviewed and deemed to meet minimal standards of product quality, safety, and the (relaxed) standard for efficacy claims would be permitted to be sold as of 2010. Manufacturers were given six years to meet these requirements.

I was all set to update my disclaimer. Until now.