In 2015, the FDA held a public hearing to evaluate its enforcement policies for homeopathic drug products, indicating that an attack against homeopathy may be imminent. The Federal Trade Commission had previously recommended that the FDA reconsider its framework for regulating homeopathic products, so this move was not unexpected.
Whatever their efficacy, and there is much debate about that (we discuss some of the science of homeopathy below), nothing could be safer than homeopathic preparations. Still, it has rankled the FDA not to have authority over this class of medicine, which they would certainly use to remove homeopathic remedies from the shelves. In the eyes of the FDA, it seems that the besetting sin of homeopathic preparations, as with supplements, is that they can under certain circumstances compete with FDA-approved Big Pharma drugs—the very drugs that pay the FDA’s bills, including staff salaries.
Are homeopathic preparations unregulated, then? No. While they do not need to go through the New Drug approval process, they must undergo pre-market approval with a monograph from the Homeopathic Pharmacopoeia of the United States (HPUS), which involves some clinical verification of the efficacy of the substance.
The science behind homeopathy
A number of scientific studies from the past ten years showing that homeopathy can indeed be effective—far more effective than placebo. These studies, which range from random controlled trials (RCTs, the supposed “gold standard”) to observational studies to meta-analyses, often look at homeopathy as an adjunct to conventional medicine. Here is just a sampling:
- Acute otitis media (when the middle ear gets blocked with fluid and infected with bacteria): a 2012 RCT showed that symptomatic improvement was quicker in the homeopathy group than conventional therapy group, with a much lower antibiotic requirement
- Allergies: a 2012 observational study revealed that homeopathy substantially improved allergy symptoms and conventional medicine dosage could be substantially reduced; a 2013 study listed the effectiveness of different homeopathic treatments for allergies based on the type of allergy
- Asthma: In a study of individualized homeopathic treatment for asthma, there was evidence that it decreased the severity of asthma in children
Other studies show effectiveness of homeopathy for conditions ranging from chicken pox, diarrhea, and in a multi-center observational study, chronic sinusitis. Homeopathy could be an effective treatment for low-grade chronic inflammation, which is the root of many diseases, and as a complement to conventional anti-tubercular treatment (a finding that is especially important as patients are becoming resistant to TB drugs).
Conventional medicine’s hostility
Practitioners of conventional medicine are often hostile toward homeopathy: one commentator called homeopathy “a fraud perpetrated on the public with the government’s blessing.” This kind of response is understandable considering that homeopathic medicine is often so diluted that the original ingredient is virtually undetectable. The mechanism of action is therefore uncertain. But there is scientific support for efficacy, in addition to anecdotal evidence from centuries of use.
Much more research is needed on homeopathy, despite the abysmal lack of funding for it. At the very least there is promising evidence supporting it—which is why the FDA’s move to shut it down now is so troubling and wrongheaded.