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: Continue reading

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

Mozi-Q won't protect against mosquito bites

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: Continue reading

Should you take expiry dates seriously?

Is is safe to take expired drugs? Are they still effective? Consider this scenario:

You’re in good health and take no prescription drugs. You use the following remedies occasionally:

  • Excedrin for the rare migraine
  • Arnica 30CH for bumps and bruises
  • Echinacea capsules, when you feel a cold coming on

Today you look in your cupboard, and notice all three products expired last year. Would you still consider taking any of them? Why or why not?

Your answer is probably influenced by a number of factors, including perceptions of risk and benefit. I’ve encountered patients who believe that drugs are less active as they near the expiration date, and others who see expiry dates solely as marketing ploy from Big Pharma. Few understand  how they’re calculated.

Over the past few months I’ve written several posts on different aspects of drug development and testing, including drug interactions, fillers and excipients in drug products, the equivalence testing of generic drugs, and the management of drug allergies. I’ve done this for two reasons. The first is to develop a resource for common questions and misconceptions about the mechanics of modern medicines. The second, less obvious reason for these posts has been to illustrate the serious credibility gaps with CAM (so-called “complementary” and “alternative”) therapies. Largely because of lax regulatory frameworks in the USA and Canada, the CAM industry has ballooned into a multi-billion dollar market without answering basic questions that should be asked of any supplement or drug, “alternative” or otherwise. What’s not well known to consumers, but is glaringly obvious to science-based health practitioners, is that CAM largely ignores issues of pharmacology: understanding how a chemical substance, once consumed, behaves in the body. It’s critical to scientific medicine, but an unnecessary step for CAM, where there’s no need to determine if a product has a beneficial biological effect before selling it. Fundamental tests in medicine, like the identification and isolation of an active ingredient, or understanding dose-effect relationships, are simply ignored. Science-advocates are regularly accused of being biased, to which I plead guilty. I have a reality bias, and don’t believe that magical thinking and pseudoscience form the basis of credible medicine, or pharmacy practice. And this bias is equally jarring when it comes to considering expiry dates for products: real drugs, and also CAM.

Continue reading

Who’s to Blame for Drug Shortages?

Are more empty vials something to expect?
All the best effort to practice science-based medicine are for naught when the optimal treatment is unavailable. And that’s increasingly the case – even for life-threatening illnesses. Shortages of prescription drugs, including cancer drugs, seem more frequent and more significant than at any time in the past. Just recently manufacturing deficiencies at a large U.S.-based contract drug manufacturer meant that over a dozen drugs stopped being produced. This lead to extensive media coverage, speculating on the causes and implications of what seems like a growing problem. So who’s to blame? Continue reading

Hyland’s Teething Tablets: These sugar pills may be toxic

As has been repeatedly pointed out on this blog, homeopathy is an elaborate placebo system, with most remedies diluted so greatly that not a single molecule of the original material remains. The final product sold to consumers is quite literally, water – drops of which are dried on sucrose or lactose tablets. The fact that homeopathy has not been shown to be more effective than placebo should surprise no-one: it is a placebo, and the positive effects reported are placebo effects.

Because there are no medicinal ingredients, there is no way to take a typical homeopathic remedy and, by testing it, determine which remedy it’s supposed to be. All you would find would be sugar. That’s why Health Canada doesn’t require any post-manufacturing quality testing of the remedies it deems “safe and effective” – there’s nothing that can be objectively measured. So whether it’s lead, rabbit vagina (really), or the liver and heart of a duck, once they’re diluted enough, there’s nothing to distinguish one homeopathic remedy from another. Yet each approved product is granted a unique license number by Health Canada.

Homeopathy’s lack of active ingredients gives the products a reasonable safety profile. After all, a product can’t cause side effects, if it doesn’t cause any effects at all.  So you can take plutonium, dilute it enough, and you won’t get radiation poisoning.  But when a homeopathic remedy isn’t diluted enough, you can be exposed to the initial substance, which can be toxic. Enter Hyland’s Teething Tablets, and a recent warning from Health Canada: Continue reading

Guess The Fake

]I want to highlight a popular new recurring post over at Skeptic North: Health Canada Approves. Each week, Erik Davis describes two remedies:  An actual product reviewed and approved by Health Canada’s Natural Health Products Directorate, and one that is completely made up. Based on his description (no googling!), can you identify which product is approved as “safe and effective”? The results are posted one week later, and Erik reviews the evidence that exists for the approved product. Given these products are found on pharmacy shelves, see if you can guess which is the “real” remedy.

Health Canada Gets Out a Big Rubber Stamp

Canada’s regulatory framework for natural health products (NHPs) has undergone a prolonged, painful, implementation. And it doesn’t seem to be getting any better. The Natural Health Products Regulations were designed to provide Canadians with minimal assurances of product quality, safety, and efficacy, while recognizing that little high quality, objective evidence usually exists to substantiate efficacy claims. The results has been mixed. The regulations offer reasonable assurance of manufacturing quality and product safety, but it’s also led to the licensure of homeopathic remedies, some with specific “Recommended Uses” for what are indistinguishable sugar pills. At a minimum, however, the regulations should assure Canadian consumers that what is on the label is actually in the bottle. That’s a win. Plus, one of most important elements of the NHP regulations is the implementation of pre-marketing registration requirements. That is, 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. Unfortunately, there’s a big backlog in the queue at Health Canada. About 12,000 products haven’t been reviewed yet. Continue reading

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. Continue reading

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? Continue reading

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. Continue reading