Through the Looking Glass at Health Canada, Part II

Posted By Richard Maundrell, Associate Professor, Lakehead University

In 1994 changes to the Food and Drugs Act made Health Canada responsible for the regulation of natural health products and homeopathic medicines (NHP’s). Since then, thousands of NHP’s have been approved by Health Canada as safe and effective. I argue that Health Canada’s criteria for efficacy in relation to NHP’s in particular are inadequate and that its certification of NHP’s is a betrayal of the trust that health care consumers have placed in a bureaucracy that is responsible for the regulation of prescription medicines. In Part One of this two-part blog series, I explained what homeopathic medicine is and why it is pharmacologically implausible. In Part Two, I look at Health Canada’s certification process and the problems with its criteria for efficacy in application to NHP’s.

Part II

As I explained in Part I, there is no scientific reason for believing that preparations at homeopathic levels of dilution can be chemically or biologically active, and the best clinical evidence to date supports the conclusion that homeopathic medicines are nothing more than placebo treatments. Nevertheless, Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) has approved thousands of homeopathic products as safe and “effective” since it assumed responsibility for the regulation of natural health products, including homeopathic medications, in 2004. .

Many of these medicines are manufactured by major corporate entities such as Boiron that specialize in homeopathic medicines. Boiron, which reported worldwide sales of CAD $831 million dollars in 2014, produces the flu medication Oscillococcinum. It is listed in Health Canada’s Licensed Natural Health Products Database as a 200C medication consisting of hyper-diluted liver and heart tissue from the Muscovy duck (i.e. 200C=1 part active ingredient to 10400 parts diluent). Oscillococcinum is sold in Canadian pharmacies under Health Canada’s Homeopathic Medicine Number DIN-HM #80009268. The safety of such a product is beyond question because, pharmacologically speaking, there is nothing in it. But how can Health Canada certify it effective?

Through the Looking Glass…

The NNHPD requires those applying for approval of natural health products to submit evidence of efficacy. According to the application guidelines, five levels of evidence are accepted as proof of efficacy:

  1. Well-designed systematic reviews and meta-analyses of randomized controlled trials or other clinical trials, OR At least one well-designed randomized controlled trial (preferably multi-centred)
    II. Well-designed clinical trials without randomization and/or control groups
    III. Well-designed descriptive and observational studies, such as correlational studies, cohort studies and case-control studies
    IV. Peer-reviewed published articles, conclusions of other reputable regulatory agencies, previous marketing experience, expert opinion reports, textbooks, homeopathic materia medica, homeopathic pharmacopoeias, homeopathic provings, homeopathic repertories
    V. References to a traditional use

This list reflects a descending order of methodological rigour, with the gold standard randomized clinical trial at the top and the appeal to traditional practice at the bottom. Applicants are advised that the use of Levels I-III type evidence is “encouraged,” although the guidelines recognise that “homeopathic materia medica and homeopathic provings are the most commonly available evidence”.

Homeopathic materia medica is the body of collective knowledge available on homeopathic medicine. It dates back to the 19th century and substantially relies on provings, a form of clinical experimentation unique to homeopathy, which involves testing medicinal substances on healthy subjects. As was discussed in Part I, homeopathy’s central tenet, the “law of similars,” holds that a substance which produces the symptoms of a disease in a healthy person will be effective in treating a disease which causes those same symptoms. Even proponents of homeopathy acknowledge that this proposition conflicts with the basic laws of physics, chemistry and pharmacology. Consequently the materia medica cannot contain any credible evidence of efficacy. Nevertheless, traditional use (Level V) is sufficient for NNHPD approval. This is a regulatory example of the logical fallacy known as the argumentum ad antiquitatem: the inference from the age of an idea or practice to the conclusion that it is good, reasonable or useful. If tradition were a reliable indicator of medicinal value, bleeding patients according to the four humours theory of disease would still be a viable treatment option.

To appreciate just how cosmetic Health Canada’s efforts at determining the efficacy of NHP’s are, consider a homeopathic medicine manufactured by Boiron with the brand name “Insulin” (DIN-HM #80016478). Certified safe and effective by Health Canada in 2010, homeopathic Insulin is a 12C medication, which means that it contains one part medicinal ingredient to 10-24 parts diluent – less than one molecule per litre. The non-medicinal ingredients in this product are listed as lactose and sucrose, making Boiron’s Insulin essentially a sugar pill. Health Canada’s approval of NHP’s is not contingent on the specification of intended use, and under “Recommended Use or Purpose,” the Health Canada NHP Database entry for Insulin simply states “homeopathic medicine.” However, one might reasonably anticipate confusion on the part of health care consumers confronted by a non-prescription medicine certified safe and effective by Health Canada, which goes by the same name as the hormone used in standard treatment for diabetes, a serious disease for which sugar pills are unlikely to offer an effective remedy. Boiron and other makers of homeopathic Insulin reinforce this confusion by promoting these products as effective treatment for diabetes.

What is Health Canada’s Mission?

Browsing Health Canada’s guidance documents and database of NHP’s is a “through the looking glass” experience. Just as Alice runs into the insurmountable absurdity of Humpty Dumpty’s declaration that words mean whatever he chooses them to mean,[1] one finds that Health Canada uses the word ‘efficacy’ in a way that bears no relation to its meaning in either conventional usage or medical science. Health Canada’s approval process for NHP’s preserves the appearance of evidence-based review, while indulging the magical thinking inherent in homeopathic doctrine. It is not a harmless indulgence, because it lends an aura of evidence-based due diligence to products that consumers may elect to use as alternatives to conventional treatments for serious treatable illnesses.

Even more worrisome is the recent trend toward using homeopathic medicines as alternatives to conventional vaccines for children.

Homeopathic vaccines or “nosodes” are ultra-diluted preparations derived from diseased tissues or excretions from a sick person or animal. Health Canada has approved over 150 nosodes, including Vagininum (DIN-HM #80012308), a product derived from the vaginal tissue of rabbits. Health Canada instituted changes to labelling requirements in September 2013 that required the addition of the following disclaimer to such products: “This product is not intended to be an alternative to vaccination.” This is a step forward, but, as I have demonstrated, the problems with Health Canada’s certification process for NHP’s go much further than labelling requirements.

The NNHPD describes its role as providing Canadians with ready access to natural health products that are “safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.” The problem with that conception of its mission is that the scientific criteria necessary to assessing safety and efficacy of medicinal substances are not necessarily consistent with the values of philosophical and cultural diversity. Many natural health products and traditional medicines claim to have medicinal properties on grounds that are fundamentally incommensurable with modern medical science. As I demonstrated above, this is true of homeopathic medicine.

Canadians pride themselves on having built a multicultural society based on tolerance and respect for diversity, and Health Canada’s policy on NHP’s may in part be a consequence of privileging the social values of inclusion and tolerance over those of scientific merit. Notions of what constitute disease and health are indeed subject to cultural and historical variation in ways that exceed the philosophical and methodological boundaries of modern medical science. But products marketed as effective in the treatment of disease conditions defined by modern medical science should be expected to meet the same criteria for efficacy as those applied to prescription drugs. To do otherwise would be to betray the public trust.

Conclusion

Monitoring the safety and quality of consumer products is an appropriate function for a federal department that defines its role as a provider of “credible information, reliable advice and quality services” to the people of Canada. Consumers have a right to treatment choices just as they have the right to forego medical treatment altogether. What is crucial in regulating the alternative medical industry, however, is ensuring that consumers have the information necessary to make informed choices. Certifying homeopathic products as “effective” in the absence of compelling clinical evidence is misleading and could contribute to dangerous health care decisions. If there is a segment of the market in which the principle of truth in advertising should be assiduously upheld, it is in respect to medicines. A good place to start would be to stop certifying homeopathic medicines as effective and to start labelling them with the same disclaimer found on a website maintained by the British National Health Service: “There has been extensive investigation of the effectiveness of homeopathy. There is no good-quality evidence that homeopathy is effective as a treatment for any health condition.”

[1] Lewis Carroll, Through the Looking Glass (1871). Chapter 7.

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