In the category of potentially dangerous complementary or alternative medicine, I can think of few products worse than ones claimed to relieve asthma, yet don’t actually contain any medicine. Yet these products exist and are widely sold. Just over a year ago I described what might be the most irresponsible homeopathic treatment ever: A homeopathic asthma spray. If there was ever a complementary or alternative product that could cause serious harm, this is it:
Among the different treatments and remedies that are considered “alternative” medicine, homeopathy is the most implausible of all. Homeopathy is an elaborate placebo system, where the “remedies” lack any actual medicine. Based on the idea that “like cures like” (which is sympathetic magic, not science), proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: cancer, boar testicles, crude oil, oxygen, and skim milk are all homeopathic “remedies”. (I think Berlin Wall may be my favorite, though vacuum cleaner dust is a runner-up). The dilution in the case of homeopathy is so significant that there’s mathematically no possibility of even a trace of the original ingredient in the typical remedy – they are chemically indistinguishable from a placebo. To homeopaths, this is a good thing, as dilution is claimed to make the medicine-free “remedy” more potent, not less. As would be expected with inert products, rigorous clinical trials confirm what basic science (and math) predicts: homeopathy’s effects are placebo effects. Recently Steven Novella blogged about the Australian Government’s National Health and Medical Research Council’s (NHMRC) comprehensive report on homeopathy which concluded the following:
- Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.
- Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
- The National Health and Medical Research Council expects that the Australian public will be offered treatments and therapies based on the best available evidence.
Despite the implausibility of homeopathy and the lack of any convincing evidence it is effective, homeopathy continues to enjoy modest popularity as an “alternative” medicine system, and some national health care systems have even funded treatments. In the United States, the Food and Drug Administration is responsible for regulating homeopathy – and it does so, with a very loose hand. If you want to sell a homeopathic remedy in the United States, you are not required to show that your product actually works. Unlike prescription drugs, there are no requirements for clinical trials at all. Yet these products can be legally sold. Thanks to a former US Senator who was a homeopathy fan, any product listed in the US Homeopathic Pharmacopoeia (HPUS) is by definition a drug to the FDA, and therefore falls under its purview. Alec Gaffney, in a nice summary of the regulatory framework, notes that the FDA relies on a Compliance Policy Guide (CPG), Conditions Under Which Homeopathic Drugs May be Marketed, which defines labelling and manufacturing standards for homeopathic products. Those regulatory standards, are in a word, homeopathic themselves. The framework puts the FDA in a difficult situation, such as licensing these products as “drugs” while simultaneously acknowledging that there’s no evidence to show homeopathy works:
FDA is not aware of scientific evidence to support homeopathy as effective.
Do the current FDA standards provide adequate consumer protection, given the marketing of homeopathy for the treatment of very real conditions, like asthma? These products may be labelled “not a rescue inhaler”, but it’s fair to ask why they are sold at all, when they offer no plausible benefit. Last week the FDA issued a warning about homeopathic asthma inhalers:
The U.S. Food and Drug Administration is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.
OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms. In general, consumers can identify such products by looking for the word “HOMEOPATHIC” or “HOMŒOPATHIC” on a product’s label and looking for whether the product’s active ingredient(s) are listed in terms of dilution (e.g., “LM1” “6X” or “30C”).
Now the FDA has announced plans to re-evaluate the homeopathy regulation framework, something I’m sure my American co-bloggers will applaud:
The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.
The event will be held April 20-21 in Silver Spring, Maryland. Registration is free (there will be a webcast) and you can even make an oral presentation. I strongly encourage anyone able to participate and give a science-based perspective to register and do so. It’s clear that the FDA recognizes that homeopathy is ineffective. So what does adequate and appropriate regulation, from an FDA perspective look like? Let’s hope it ensures that products like “homeopathic asthma sprays” will become a thing of the past.