The debate over the licensing of dubious products by Health Canada heated up over the weekend this week with an article published in the Toronto Star on Friday. The article, by NYU med student Nathan Kunzler and NYU medical ethics professor Dr. Arther Caplan, suggests that Health Canada's continued approval of bogus homeopathic "nosodes" may be adding to the increased incidence of measles in Canada; something Bad Science Watch has been arguing since the spring.
Just for a review, a homeopathic nosode is a sugar pill, or bottle of water or alcohol claiming to be produced from tissue, pus, sputum, or other matter from a person or animal infected with a disease like measles, whooping cough, or tuberculosis. The preparation is offered for several uses by homeopaths but the most worrying is the use of nosodes as a replacement for childhood vaccinations. There are well over 100 such nosodes actually approved for sale by Health Canada but they are not licensed for any specific use; they are only allowed to be sold as a "homepathic medicine" or similar such general indication.
Health Canada has become a bit perturbed by these criticisms, continuing to insist quite rightly, that these products are not approved for sale as vaccine alternatives and should not be sold as such. Homeopaths disagree, as the coming flu season will surely be a witness to when the Influezinum 9C prep will be offered again as protection or treatment for influenza. This begs the question: is the current regulatory structure for homeopathic products doing any good for Canadians at all? I would suggest that it is a dumb show giving legitimacy to products that are not in any way effective, but making a lot of money for homeopaths and producers alike.
The problem lies in the way that these products are approved by Health Canada, who claims that products, when approved, are safe, of high quality, and effective. One look, however, and we see great flaws in this process. To be even considered for approval by Health Canada, a nosode must be in a dilution that ensures that the end product has little or no chance of actually containing the nosode listed on the label. This ensures that, if produced properly, the product does not actually contain the infectious agent. The irony of receiving approval to put a label of "Influenzinum" on a label as long as your product does not contain any influenza must be lost on Health Canada. If these products are being produced to a high standard, which has been called into question in the past, they contain nothing, and this is seen as a requirement for sale.
In order to prove efficacy of any pharmaceutical, you have to ensure there is rigorous scientific evidence that your product is effective. For natural health products, the standard is different. The level of evidence required is based on the risk of the claim you are making: a claim like "dubium 30C will help control blood sugar in diabetes" requires a high level of evidence, while a claim of "supports the endocrine system" does not. The choice for approval is obvious: if you want to ensure your product is approved then lower the specificity of your claim. A general claim like "homeopathic medicine" means you only have to prove the prep is used in homeopathic medicine, not that it is effective for anything, because it is not making any specific claim. If you are at a loss, then there are several firms in Canada what will help you craft your application to make sure that it will get approved.
If I were a company looking to get approval for a product and market it successfully despite the ambiguous general claims, I would get it approved for a general indication above then move the very generous natural health product media, like Vitality Magazine, to print an article making the claims I can't to get the notion of effectiveness into the general population. Then I would direct market to homeopaths and let them do my work for me by blogging and writing editorials in local papers about the wonders of my prep to prevent flu. This is something they are able to do under the law because the practice of homeopaths is regulated provincially and as long as they are not directly selling or marketing a product in their column, they can prescribe and make any claims they like. This kind of off-label use occurs in pharmaceuticals as well, but to get approval, you have to have a legitimate claim of efficacy to get approval in the first place: this reveals the impotence of Health Canada to properly regulate homeopathic products.
This is exactly what has happened with nosodes in Canada. All one has to do is make general claims to get approval, provide no evidence of actual efficacy, and use other word-of-mouth means of marketing to make sure the public knows what your product is really for. Even more, stores are marketing these products with impunity. Despite the indication for a nosode like Influenzinum 9c as a "homeopathic medication", this has not stopped health food stores from marketing these products as flu care and prevention.
There needs to be, as part of the process, an acknowledgement that the indication being applied for by the manufacturer often does not reflect how the product is being used in the marketplace. If Health Canada did do this kind of investigation, it would be obvious that one serious public health danger exists with the approval of nosodes for sale: the use of these products to replace vaccines. Bad Science Watch has laid out this use very clearly at the website stopnosodes.org and I suggest that Health Canada and the new Minister of Health Rona Ambrose take a serious look at this evidence. Homeopathic product manufacturers have pulled the wool over the eyes at Health Canada, and will continue to act with impunity in the climate of lazy permissiveness that currently exists in the Natural Health Products regulatory environment in Canada.
Note: after an Access to Information request to Health Canada, I have confirmed that the evidence for the use of homeopathic nosodes is absent in most of the applications for approval; this will be the subject of a future post, so watch this space.