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: Continue reading

What’s with the new cough and cold products?

One of my earliest lessons as a pharmacist working in the “real world” was that customers didn’t always act the way I expected. Parents of sick children frequently fell into this category — and the typical vignette went like this for me:

  1. Parent has determined that their child is sick, and needs some sort of over-the-counter medicine.
  2. Parent asks pharmacist for advice selecting a product from the dozens on the shelves.
  3. Pharmacist uses the opportunity to provide science-based advice, and assures parent that no drug therapy is necessary.
  4. Parent directly questions the validity of this advice, and may ask about the merits of a specific product they have already identified.
  5. Pharmacist explains efficacy and risk of the product, and provides general non-drug symptom management suggestions.
  6. Parent thanks pharmacist, selects product despite advice, and walks to the front of the store to pay.

In many ways, a pharmacy purchase mirrors the patient-physician interaction that ends with a prescription being written — it’s what feels like the logical end to the consultation, and without it, feels incomplete. It’s something that I’m observing more and more frequently when advising parents about cough and cold products for children.

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

Safe and Effective? A Consumer’s Guide to Natural Health Products

How far have we come from the Patent Medicine era?

The following is a summary of my Skepticamp Toronto 2010 presentation. Apologies to international readers for the Canadian-centric content.

I’ve been practicing pharmacy for over 15 years, and it didn’t take me long to realize after I started working that there was a completely different standard for safety and efficacy for herbal preparations and other supplements. That is, they were largely unregulated. Compared to Health Canada’s internationally-respected approval process for drug products, there was no process in place to regulate the supplement marketplace. To ensure consumers fully understood the potential risks of these products, I started to give two warnings to anyone that asked for my advice about these 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 had any medical conditions, or were taking other drugs or supplements I would add:

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

Until just a few years ago, Canada’s regulatory framework was not equipped to deal with non-drug supplements. Products were either drugs, and were registered as such, or they were food products, and drug regulatory requirements did not apply. A grey area existed and and all kinds of supplements appeared – with no specific regulatory oversight, no defined quality or content standards, and no objective evaluation of the efficacy claims. Continue reading

Don’t ask your pharmacist about Nervoheel N or Neurexan

Magic beans

I can across a strange full-page ad in yesterday’s Globe and Mail. The headline was huge:

Reclaim your inner peace. Homeopathic Preparations. Scientifically proven effective.

Proven effective? Large comprehensive reviews have concluded that homeopathy is not efficacious (that is, it does not work beyond the placebo effect) and that explanations for why homeopathy would work are scientifically implausible. Consequently, it seems quite a stretch to say any homeopathic remedy is “Scientifically proven effective”.  This particular ad was for two homeopathic products from Heel.  Both Nervoheel N (“calms stressful moments, eases nervousness”) and Neurexan (“restores your natural sleep patterns, improves sleep quality”) are approved by Health Canada as safe and effective. Kim Hebert over at Skeptic North went looking for the published clinical evidence to support these efficacy claims:

  • For Nervoheel N there was one open-label, non-randomized cohort study that stated “The differences between the treatment groups [Nervoheel and lorazepam] were not significant.” The paper concluded that Nervoheel N is non-inferior to lorazepam. No placebo group was included.
  • For Neurexan there were two studies. Both non-random studies compared Neurexan with another unproven treatment, valerian, in the absence of a placebo group. There is no objective way to separate these results from unintentional researcher/patient bias or the placebo effect. Therefore, the results of both are clinically meaningless.

This data was presumably adequate for Health Canada (search their database for products 80007796 and 80004914 here) unless there’s unpublished data that was supplied.  The ad continues:

Both products are suitable for the whole family, for short or long-term use, as they are clinically proven effective, non-addictive, and non-sedative. They have no known side effects, medicinal interactions, or contraindications.

In order to have side effects, first a product has to have effects. So no surprise there.  The strangest statement, however, is at the bottom of the ad:


Ask your chiropractor or naturopath for more infomation.

Presumably they don’t want you to ask your pharmacist for more information. What kind of response might a pharmacist give about the scientific evidence supporting this, or any other homeopathic remedy? Hopefully, a science-based one.

Pharmacists, Pharmacies, Homeopathy, and Ethics

Is it ethical for a pharmacist to knowingly sell a mislabeled product – one that contains no active ingredient, and has been demonstrated to be no more effective than a placebo? That’s the question being asked by Dr. Chris MacDonald over at the Business Ethics blog today:

If someone selling something believes that it doesn’t work, should they tell you so? Does it matter if the person doing the selling is a licensed professional, someone with advanced training and a sworn duty to promote the public good?

Dr. MacDonald is referring to the fallout from the UK Parliament’s Science and Technology Committee Evidence Check on Homeopathy, which I’ve blogged about previously. As I pointed out in yesterday’s post, the regulatory body for pharmacists in Northern Ireland is acting on this report, and has proposed that patients be told that homeopathic products do not work, other than having a placebo effect. 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

Homeopathy and Consumer Protection

Editor’s Note: It’s World Homeopathy Awareness Week.

Today’s guest post is from Dr. Chris MacDonald, PhD. Dr. MacDonald is Associate Professor, Department of Philosophy, Saint Mary’s University, and a Nonresident Senior Fellow at Duke University’s Kenan Institute for Ethics. Dr. MacDonald blogs at the Business Ethics Blog.

What should we think about homeopathy, from the point of view of Business Ethics? We can begin by asking the same questions about homeopathy as we would ask about any other product. Those questions fall under two main headings:

  1. Is it generally ethically OK to sell this product? Is it a product that should be on the market at all?
  2. If it’s generally ok to sell this product, what are the obligations of companies selling them? Are there any ethical limits on how or to whom they are marketed?

In a free society, there’s a general presumption in favour of free commerce. If Party A has a product and says to Party B, “Hey, you might like this,” and if Party B says, “Hey, I think I’d like some of that, here’s some money!” then they should generally be free to make the transaction. But there are limits. Some things cannot ethically be bought or sold (children or votes, for example). Other things can be sold, but only under special circumstances (cigarettes and alcohol, for example). And more generally, there is a very broad requirement that all transactions must be carried out without force, fraud, or deception.

Now, discussions over alternative therapies like homeopathy tend to be combative, rather than constructive, particularly on the Internet. That’s unfortunate, because a lot is at stake. Finding ways to have a constructive discussion is essential, but few make that effort. But there is common ground in the debate, and we should make good use of it. Both sides of the debate agree, for example — indeed they ethically have to agree — on the importance of consumer protection, though they may disagree on the right way of achieving it. Health is complex, and important, and the average consumer typically needs to be able to turn to experts to get good advice. There are plenty of unscrupulous individuals and companies out there willing to try to make a fast buck by preying on the gullible or the uninformed. Anyone who truly cares about health has to recognize that that’s a serious problem.

So, let’s look at homeopathy through the lens of consumer protection. Most generally, consumer protection means, first, making sure that products are safe (or “safe enough”, since almost all products carry at least some risk), and, secondly, making sure that products do what the manufacturer or seller says they’ll do.

Although I happen believe that homeopathy (like most other alternative therapies) does not in fact work, I want to have a constructive discussion about consumer protection with those who think it does. So I’m going to assume, for the sake of argument, two things that many skeptics are likely to deny.

  1. First, I’m going to assume that homeopaths (and supporters) genuinely believe in the power of homeopathy. That is, I’m going to assume that most homeopaths are not outright frauds. (Actually, that’s not just for the sake of argument. I strongly believe that to be a justified assumption. I strongly suspect that the vast majority of homeopaths and homeopathic pharmacies are 100% well-intentioned, and seek only to promote the health of their patients and customers.)
  2. Secondly, I’m even going to assume — again for the sake of constructive argument — that homeopathy works. I’ll assume that the anecdotes of homeopaths and their patients confirms the positive effects that Randomized Controlled Trials have thus far been unable to detect.

Next, given these assumptions, I’m going to pose two questions for homeopaths to answer, questions that I would likewise pose to any other kind of reputable business, especially any other reputable business in the field of health.

  1. How do we detect phoney homeopathic preparations? In order to protect consumers, we need to be able to detect fake remedies — fake versions (sold by counterfeiters) that are really just inert look-alike copies of genuine remedies. In an age of international trade and Internet-based pharmacies, phoney pills are a big problem. So, is there any way to test a homeopathic preparation to verify that it is genuine? If I buy homeopathic tablets, is there any test that can be done to see if they’re real or counterfeit? If authorities suspect a criminal organization of selling fake homeopathic tablets, how can they tell the difference between the criminal organization’s tablets and those manufactured by an honest homeopathic pharmacy?
  2. What advice would you give a potential patient/customer who is trying to choose among various alternative therapies? How should a potential customer/patient choose between homeopathy, Therapeutic Touch, acupuncture, Angel Therapy, and so on? In other words, how can consumers know that they’re about to buy something good, rather than something bogus? “Trust me” won’t do as an answer. Trust, in itself, is neither a good nor a bad thing; what we value is justified trust. What is it that justifies consumers in trusting you, rather than someone else? “Try it” also isn’t a good answer. When health is on the line, we shouldn’t have to experiment on ourselves. We should have some assurance ahead of time. Consumers deserve that. One alternative, of course, is to deny that this is an important question at all, by claiming that literally all alternative therapies work. But that would make little sense. There surely are fraudsters out there, offering stuff they know can’t work. And even ignoring outright fraud, the homeopathic philosophy claims to have identified the true nature of disease; other philosophies, it seems then, must have it wrong. Which ones? Consumers deserve your input on this important issue.

These are questions I expect any reputable business to be able to answer. They are also questions to which I have not yet heard homeopaths give good answers. (In fact, I asked a version of the 2nd question on my blog, with depressing results.) I’m honestly interested to hear any an answer.

In the end, what I’m really looking for here are reasonably generalizable standards of consumer protection across various categories of health products. What standard of evidence and safety should be applied to products offered for sale, quite generally? If homeopathic preparations are not expected to stand up to the rigours of Randomized Controlled Trials, why, in all fairness, should the products of the major pharmaceutical companies be forced to meet that standard? Surely Merck and GlaxoSmithKline would love to avoid having to jump through those hoops. Surely Big Pharma would love to be able to give vague answers to my questions above. But we don’t let them. And we’re right not to let them. The question is, can the Homeopathic industry demonstrate its commitment to ethics by giving clear answers, too?

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