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:

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.

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:

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.

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:

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.

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:

AVAILABLE IN PHARMACIES AND HEALTH FOOD STORES.

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.

Homeopathy: The Comic Treatment

From the same cartoonist that brought you The Facts in the Case of Andrew Wakefield, Darryl Cunningham now brings you The Story of Homeopathy. If you don’t want to read all the prior SBP posts on homeopathy, Darryl’s comic pretty much sums it up.

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.

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?