Will wonders never cease? A recent story about how “homeopathic” Zicam managed to slide through a loophole in which the FDA doesn’t require evidence of efficacy or safety for medicines labeled as homeopathic has been percolating through the blogosphere based on a recent warning that the FDA issued. It turns out that the zinc in Zicam can mess up your sense of smell, causing a loss of the sense called anosmia. Steve Novella has already done an excellent job of discussing the issues involved with this loophole, which is big enough to pilot the proverbial Death Star through.
However, a followup story on the AP shows that the problem is likely more widespread than Zicam:
CAMBRIDGE, Mass. – The unsettling little secret of Zicam Cold Remedy finally spilled out this week. Though widely sold for years as a drug for colds, it was never tested by federal regulators for safety like other drugs. And that was perfectly legal — until scores of consumers lost their sense of smell. One little word on Zicam’s label explains all this: “homeopathic.”
Zicam and hundreds of other homeopathic remedies — highly diluted drugs made from natural ingredients — are legally sold as treatments with explicit claims of medical benefit. Yet they don’t require federal checks for safety, effectiveness or even the right ingredients.
They’re somewhat similar to dietary supplements, which use many of the same natural ingredients and also aren’t federally tested for safety or benefit.
Many scientists view homeopathic remedies as modern snake oil — ineffective but mostly harmless because the drugs in them are present in such tiny amounts.
But an Associated Press analysis of the Food and Drug Administration’s side effect reports found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.
The reason, it turns out, is because these “homeopathic” remedies have actual–gasp!–medicine in them:
In its review of homeopathy, the AP also found that:
- Active homeopathic ingredients are typically diluted down to 1 part per million or less, but some are present in much higher concentrations. The active ingredient in Zicam is 2 parts per 100.
- The FDA has set strict limits for alcohol in medicine, especially for small children, but they don’t apply to homeopathic remedies. The American Academy of Pediatrics has said no medicine should carry more than 5 percent alcohol. The FDA has acknowledged that some homeopathic syrups far surpass 10 percent alcohol.
- The National Institutes of Health’s alternative medicine center spent $3.8 million on homeopathic research from 2002 to 2007 but is now abandoning studies on homeopathic drugs. “The evidence is not there at this point,” says the center’s director, Dr. Josephine Briggs.
- At least 20 ingredients used in conventional prescription drugs, like digitalis for heart trouble and morphine for pain, are also used in homeopathic remedies. Other homeopathic medicines are derived from cancerous or other diseased tissues. Many are formulated from powerful poisons like strychnine, arsenic or snake venom.
All of this is mostly correct, except that true homeopathic remedies are diluted to far, far below 1 ppm. In fact, even a 12C homeopathic dilution represents approximately a 1024-fold dilution. Get up to 20C or 30C, and there is, to a very good approximation, zero chance of even a single molecule of the active remedy remaining. It’s true that some homeopathic remedies have detectable compound in them (for instance, 6C potency), but the vast majority do not. However, thanks to an old law, homeopathic remedies can be marketed without having to demonstrate safety or efficacy to the FDA:
To this day, homeopaths put forth mystical-sounding explanations involving “vital force” and “healing energy.” And with arcane ingredients like “nux vomica” and “arsenicum album,” many homeopathic medicines sound like something brewed in a druid’s kettle.
In 1938, Congress passed a law granting homeopathic remedies the same legal status as regular pharmaceuticals. The law’s principal author was Sen. Royal Copeland of New York, a trained homeopath. “He did it in such a sneaky way that nobody really noticed or paid attention,” says medical author Natalie Robins.
And that law has remained in force ever since.
Basically, this law results in automatic approval of drugs that appear in the Homeopathic Pharmacopoeia are given automatic FDA approval, no science, evidence, or messy clinical trials needed. Talk about a double standard! True, most homeopathic remedies are mostly water or alcohol, but a lot of them are adulterated with real drugs–like Zicam, which contained enough zinc to fry the smell receptors of a number of people to the point where they lost their sense of smell.
Perhaps the revelation in this story that interested me the most was the news that NCCAM is no longer funding trials of homeopathy. You may recall that I went absolutely ballistic when I learned about clinical trials of homeopathy funded by NCCAM. If there were ever a bigger waste of money by the NIH than that, I’m not aware of it. It is good to see that a spark of rationality has pervaded NCCAM, at least for the moment. I don’t expect it to last (eventually the homeopaths will convince the powers that be at NCCAM that homeopathy deserves to be studied), but for now I’m glad to see no more money going for trials of homeopathy.
Of course, right now the homoepaths are–surprise! surprise!–claiming that Zicam is not “homeopathy”:
Dr. Iris R. Bell, a psychiatrist and homeopathy researcher at the University of Arizona, Tucson, says the suspended Zicam products deliver the homeopathic ingredient right into the nose — not an accepted homeopathic method. She says the FDA should act against such products.
She also acknowledged that “there are people preparing things homeopathically to try to get around FDA regulations of over-the-counter drugs.” But she says most homeopathic remedies are much safer than conventional pharmaceuticals, so no major regulatory changes are needed.
There’s no doubt that true homeopathic remedies are safer than conventional pharmaceuticals. They are, after all, water. Unfortunately, they are as effective as water against the diseases and conditions for which homeopaths recommend them; that is, not effective at all. Continuing Homeopathy Awareness Week, perhaps the most important “awareness” of homeopathy is that it is nothing more than pseudoscience. That fact can’t be emphasized or repeated enough.