Homeopathy, Zicam & the FDA – The Dangers of Unregulated Drugs

June 18, 2009

By Terry Smiljanich:

With the FDA announcement that Zicam, a homeopathic cold remedy,  was shown to have potentially dangerous side effects (how would you like to lose your sense of smell?), the whole issue of homeopathy and the FDA has come back to the forefront. Are homeopathic medicines any good? Should they be required to back up their claims just like any other drug?

Homeopathy and the FDA

Homeopathy is an “alternative medicine” invention of the late 18th century which claims that a highly diluted dose of a substance that normally produces symptoms in a healthy person can actually extract its “vital essences” and makes it more potent in curing the same disease or condition. Indeed, the highly diluted dose somehow carries the “molecular memory” of the original substance. “Like cures like” is the calling card of homeopaths.

The American Institute of Homeopathy (AIH), a nongovernmental trade association, publishes the “Homeopathic Pharmacoepia of the United States,” and will help you find a “licensed homeopathic practitioner.” The homeopathic industry has grown recently into a billion dollar market in which more than 4 million Americans take some form of unprescribed homeopathic medicine.

Since 1938, the FDA has classified homeopathic remedies as over-the-counter drugs that do not need prescriptions and do not have to undergo thorough testing and review by the FDA to ensure safety and effectiveness. That’s right – a homeopathic “remedy” doesn’t have to be backed up with any scientific testing to determine whether it really does what it claims to do.

Scientific Testing?

What about any such scientific testing? A few years ago, the respected medical journal The Lancet reviewed the available data on homeopathic testing and concluded that homeopathic products were no more effective than placebos (fake drugs composed of inert substances such as salt or starch). In fact, the very claims of homeopaths (molecular memory?) completely lack any valid scientific theory to back them up. The AIH was, of course, outraged, but hasn’t followed up with any comparably respected scientific testing by other neutral arbiters.

Skeptics such as James Randi have exposed homeopathic claims in the past. Randi himself has challenged the homeopathic claimants to prove their claims and win his $1 million challenge (for proof of claims of the paranormal). So far, no takers.

Zicam Cold Remedy

So, a company such as Matrixx Initiatives, the manufacturer of Zicam Cold Remedy Nasal Gel (which contains a highly diluted form of the mineral zinc), could market its product without any FDA approval. After several complaints of nasal injuries came to light, however, the FDA did step in and “advise consumers” not to use the potentially dangerous product, and issued a warning letter against further marketing. Matrixx complied.

Why doesn’t the FDA exercise more authority over homeopathic claims? Compare the regulation of “supplements” such as saw palmetto, B-12 vitamins, etc. The FDA doesn’t test these products for effectiveness either, but does prohibit them from making specific medical claims on their packaging.

It’s time that the FDA cracks down on the homeopathic industry and requires it to put up or shut up. Before a diluted product can claim that it can cure a cold, help depression, or cure migraines, it should be required to reveal the vigorous testing by medical professionals (not paid for or employed by the company itself, of course) that both proves it can do what it claims and doesn’t produce unacceptable side effects. Why should homeopathic drugs be treaed any differently?