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?
The Intent of Regulation
Health Canada sets the regulatory standards that determine which health and food products can be sold in Canada. Until several years ago, Canadian natural health products (NHPs) 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 1998, a report was tabled in the House of Commons: Natural Health Products: A New Vision. It gave 53 recommendations, which included the following (emphasis added):
- #19. NHPs be allowed to make health claims, including structure-function claims, risk-reduction claims and treatment claims.
- #20. Claims be assessed to ensure that there is reasonable evidence supporting the claim.
- #21. The evidence not be limited to double blind clinical trials but also include other types of evidence such as generally accepted and traditional references, professional consensus, other types of clinical trials and other clinical or scientific evidence.
- #22. The evidence required vary depending on the type of claim being made, with different evidence being required for structure-function claims and risk-reduction claims for minor self-limiting conditions than for therapeutic or treatment claims.
- #23. The label indicates clearly the type of evidence used to support the claim.
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. The NHP regulations include products such as nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy. It’s less clear why homeopathy was included, because homeopathy, at typical dilutions, don’t contain a single molecule of the original substance. In addition, homeopathy can involve “dilution” of substances that are not natural. For example, a piece of the Great Wall of China, a shred of plastic wrap, gunpowder, or even prescription drugs like pregabalin can be converted into homeopathic “remedies” and are claimed to treat different symptoms.
The Current Day
The Natural Health Products Directorate has now been established for several years. It has published detailed guidelines for the manufacturing, labeling and marketing claims for the different categories of NHPs. Staff at the Directorate evaluate and approve new license applications. Approved products are licensed into two categories, and given unique identification numbers:
- DIN-HM (homeopathic remedy number) – all homeopathy
- NPN (natural health product number) – all other natural products, including vitamins, probiotics, etc.
On this basis, Health Canada’s granting of a DIN-HM means a review of safety and efficacy of a particular homeopathy remedy has been conducted, and a specific recommendation for use has been formally approved for the label.
So on what basis is Health Canada determining these remedies to be effective? It all comes down to the evidence standard.
What is Homeopathic “Evidence”?
Health Canada’s Evidence for Homeopathic Medicines: Guidance Document states that applications for licenses for homeopathic products must include evidence to support the “safety, efficacy, and quality” of a homeopathic medication. All “homeopathic medicine” must be from substances referred to in the following:
- Homeopathic Pharmacopeia of the United States (HPUS)
- HomÃ¶opathisches ArzneiBuch (HAB)
- PharmacopÃ©e franÃ§aise (PhF)
- European Pharmacopoeia (Ph.Eur.)
- Encyclopedia of Homeopathic Pharmacopoeia (EHP)
There are two categories of remedies: those that include a recommended use, and those that do not. If the manufacturer wants to include a recommended use for the product, “evidence” must be provided. Health Canada accepts different levels of evidence, from clinical trials, down to what it calls “traditional use”. The two most common types of traditional use claims are provings, and references to homeopathic materia medica:
Provings: A homeopathic “proving” has nothing to do with proof – it’s simply the exposure of an undiluted remedy to one or more healthy people, who document anything they experience. The symptoms that are noted during a proving are believed to be the symptoms that the diluted remedy will cure – “like cures like”. For a sample proving, check out the light reflecting off Saturn, and here are a few excerpts from a proving of a piece of the Berlin Wall:
- I am in a new room, a stranger, nobody wants to have anything to do with me. German language is spoken. The room is a kind of cellar, half underground. They cannot see me really, there is something with their eyes. I want to touch people all the time I detest that in myself.
- Immediately when touching the remedy I feel more at ease, I feel a separation between my energy and the energy of the other/the outside.
- Holding the remedy for a while gives a tremendous rise of grief and sadness, so huge you would drown in it.
Materia Medica: Homeopathic manufacturers can use materia medica, which are essentially compilations of information derived from provings. Again, there is no objective evaluation of efficacy in materia medica. Health Canada offers a list of 59 references it will accept, but indicates that the list is “not intended to be all inclusive.” Here’s a few references deemed acceptable, in bold, along with other notable dates to illustrate the parallel process in medical and other sciences.
- 1834- Publication of homeopathic reference:Traité de matière médicale ou de l’action pure des médicaments homéopathiques.
- 1846 — Publication of homeopathic reference: Doctrine et traitement des maladies chroniques
- 1854 – Publication of homeopathic reference: Codex des medicaments homeopathiques.
- 1870 — Germ theory of disease proposed by Louis Pasteur and Robert Koch
- 1864 — Pasteurization introduced
- 1874 — Incandescent light bulb invented
- 1882 — Organism that causes tuberculosis identified
- 1890 — Publication of homeopathic reference: The Guiding Symptoms of our Materia Medica. (10 vol.)
- 1895 — Discovery of X-Rays
- 1897 — Aspirin invented
- 1899 — Publication of homeopathic reference: Formulaire de Therapeutique positive (Homoepathie).
- 1907 — Vitamin C is isolated and identified
- 1913 — Commercial availability of first vaccine, for diphtheria
- 1935 — Description of first antibiotic, Prontosil, published
- 1953 — Double-helix structure of DNA proposed by Watson and Crick
…and so on
Information from provings or materia medica may be used to support the requested conditions of use, including claim, dose, route of administration, etc. Allowing anecdotes from the 1830′s as evidence of efficacy may be seen to be a generous standard. But to some, the current standards for homeopathic evidence are too stringent. In a 2008 consultation on the regulations Health Canada noted,
For the most part stakeholders agreed that Health Canada’s current definition of homeopathic medicines (HMs) is too restrictive and that pharmacopeias may not be up to date with today’s more advanced or newly developed homeopathic remedies.
It could be because older pharmacopeias likely don’t include entries on the latest homeopathic remedies, like “Mobile Phone 900mHz”, “Vacuum Cleaner Dust”, “MRI Scan”, or “Swimming Pool Water”.
What are the Consequences of a Lowered Bar for Efficacy?
It’s clear that the NHP regulations create a efficacy standard that is significantly weaker than the standard established for medicine. But homeopathic product stands out as particularly problematic from a licensing perspective. Consider the following:
Quality Assessment: With drug products and herbal products, final product testing can validate the active ingredient and amount of medicinal product per unit. This is impossible with homeopathic remedies. There is no way for Health Canada, or anyone else to distinguish between typical remedies. What this means is there is no way for anyone to tell if a homeopathic product is “mislabelled”. There is actually no way to test if a product has been prepared “properly” or not – a manufacturer could simply package bulk lactose tablets in vials, and claim it is any homeopathic remedy. Not surprisingly, Health Canada does not require final product quality tests that verify the original substance.
Expiry Date: Drug products are subject to stability testing to verify the ongoing stability and safety over time. Quantitative analysis is done to understand how quickly a product will deteriorate, and the expiry date is established based on this information. Health Canada says that for homeopathic products, the expiry date is:
the date, expressed at minimum as a year and month, up to and including which a NHP maintains its purity and physical characteristics and its medicinal ingredients maintain their quantity per dosage unit and their potency.
Given there are no medicinal ingredients in most remedies, and the potency cannot be independently verified, it’s not clear how the homeopathic expiry date is established. Furthermore, given the concept that less-is-stronger, it’s not clear why remedies don’t get stronger and stronger over time.
Product Labelling and Marketing: When the Canadian Government began the consultation process for regulating natural health products, an entire chapter of the final report was dedicated to informed choice:
To ensure successful decision-making, we feel that people must have both knowledge and authority.
The committee continued:
From the Committee’s perspective, there is a dual role for the regulator; first, in ensuring that full and accurate information is readily available and second, in facilitating consumers’ ability to make reasonable decisions about product use. These objectives can be achieved in two ways: through research and through information dissemination.
In order for consumers to make good decisions, they need to be fully informed about what they’re purchasing. In the interest of full disclosure, labels should ideally identify to consumers that homeopathic products contain little to no active ingredients, and that homeopathy has not been demonstrated to be effective, beyond a placebo, for any effect.
Let’s look at one particular product that’s been approved in Canada, as well as countries around the world: Oscilliococcinum. This product is prepared by decapitating a duck, taking 35 grams of its liver and 15 grams of its heart and fermenting it for 40 days. The product then undergoes serial dilutions (1 part in 100) 200 times in a row, (i.e., 200C) and then dried on lactose/sucrose tablets. It’s been noted that in order to obtain even a single molecule of the original fermented duck, a volume of tablets greater that the mass of the entire universe would need to be consumed. Therefore it is mathematically impossible that there is any of the original product in final product sold. Consulting Health Canada’s NHP database (Search item 80014156 here) Health Canada has approved the product, with the labelled medicinal ingredient as “Extract of the liver and heart of Annas barbariae: 200C” and the following recommended use (translated from French):
Homeopathic medicine to relieve flu symptoms: fever, chills, body aches, headaches.
Not surprisingly, there’s no convincing evidence that Oscilliococcinum is anything more than a placebo – and how could it be? The final product is simple lactose and sucrose.
Regulation in Other Countries
The regulation of homeopathic products was recently scrutinized in the United Kingdom, by the parliamentary science and technology committee. The Medicines and Healthcare products Regulatory Agency (MHRA), (their version of Health Canada), was criticized for allowing label claims for the remedy Arnica montana 30C:
…we fail to see why the label test design should be acceptable to the MHRA given that, first, it considers that homeopathic products have no effect beyond placebo and, second, Arnica Montana 30C contains no active ingredient and there is no scientific evidence that it has been demonstrated to be efficacious.
The committee gave specific guidance to the MHRA:
If the MHRA is to continue to regulate the labelling of homeopathic products, which we do not support, we recommend that the tests are redesigned to ensure and demonstrate through user testing that participants clearly understand that the products contain no active ingredients and are unsupported by evidence of efficacy, and the labelling should not mention symptoms, unless the same standard of evidence of efficacy used to assess conventional medicines has been met.
Health Canada’s decision to regulate and allow unproven claims for homeopathic products has had broader consequences. Health Canada’s approval of any product, pharmaceutical, homeopathic or otherwise, is seen as an important and credible quality indicator. Earlier this year, the National Association of Pharmacy Regulatory Authorities (NAPRA) advised pharmacists that only NHPs approved by Health Canada should be sold in pharmacies:
When presented with a product that does not bear a number issued by Health Canada, it leaves the pharmacist and their patient with no confirmation that the product was properly assessed for its safety, efficacy and quality nor granted approval for sale. (emphasis added)
This guidance infers that a homeopathic remedy that has been approved with a DIN-HM is both safe and effective, and pharmacies can accept Health Canada’s evaluation as that evidence.
The Fraser Institute estimates that the NHPD has cost over $9 million per year since it was created in 1999. A sizeable proportion of its efforts have been devoted to homeopathy including guidance documents, defining evidence standards, homeopathic “research priority setting consultation“, licensing homeopathic products, and even putting a homeopath on its Expert Advisory Committee. While certain elements of the NHP regulations are probably worthwhile (particularly the regulation of herbal products), the inclusion of homeopathy is puzzling. Given its pre-scientific methodology, final products without medicinal ingredients, and demonstrable lack of efficacy, the value-for-money of regulation is questionable.
Health Canada has implemented a regulatory system for homeopathy that seeks to adapt a system of sympathetic magic into a structured, scientific process. To do so, it has essentially eliminated the requirement that homeopathy be supported by credible evidence. This regulation has led to a licensing framework that is fundamentally unfair to consumers, as it does not disclose that most homeopathic products don’t contain a single molecule of the product that is named on the label. Further, it allows centuries-old anecdotal evidence as justification for “recommended uses”. Finally, it reinforces homeopathy’s legitimacy by assigning distinct numbers (actually calling them homeopathic “medicine” numbers) to indistinguishable sugar pills.
Health Canada’s current framework for regulating homeopathic products wastes resources and compromises the regulator’s credibility. Why bother regulating homeopathy? There is no more of a need to regulate homeopathy than there is to regulate the tools of psychics, ghost hunters, wizards or astrologists.
An evidence-based, science-based approach would mean Health Canada would forbid all treatment statements (“recommended uses”) with homeopathic remedies, as none have been substantiated. An appropriate regulatory framework would consider the following:
If a remedy is not sufficiently dilute, it can have medicinal effects. These products should therefore be treated as drugs, and subject to the same regulatory standards, where persuasive, objective, clinical trial evidence must be produced before specific “recommended uses” are allowed. Approved products would then be assigned drug identification numbers.
If homeopathy is sufficiently dilute, it contains no active ingredients and is not a health-related product. For these products, Health Canada adds no value by regulating homeopathy, and, in fact, unnecessarily legitimize the products in the process. Regulations and safety standards are already in place for selling table sugar and drinking water – and these are adequate to protect Canadian consumers who elect to use homeopathy.