Posted by If you don’t want to smell, the FDA has a recommendation: use an over-the-counter cold remedy that contains an intranasal zinc solution. You won’t smell. Possibly ever again:
The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent. (FDA Press Release)
Losing your sense of smell is no joke. It is intimately involved with your sense of taste and is a warning sense for dangerous gases. The role of zinc in destroying a sense of smell is not a secret, either. It’s been known for years. The one thing zinc doesn’t seem to do is prevent you from getting a cold. So it can’t pass any FDA test for safety or efficacy. So why was it allowed to be sold over-the-counter? Orac at Respectful Insolence has covered this thoroughly. An especially good AP story by Jeff Donn identifies the culprit as a Trojan Horse clause stuck into the 1938 Food and Drug law by a powerful New York Senator who also was a licensed homeopath. Here’s Orac:
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. (Orac, Respectful Insolence)
As Orac points out, true homeopathic remedies aren’t likely to hurt you in themselves for the simple reason that orthodox homeopathic practice prescribes serial dilutions so large that it is unlikely the patient gets even a single molecule of the intended active ingredient. But regulation because of this clause is so lax that there isn’t even a check to see if the ingredients are as claimed, and many are certainly at levels that aren’t by any stretch of the fertile homeopathic imagination, “homeopathic.”
So if there’s no effective regulation, what remedies are available for someone harmed by the negligence of a manufacturer who ignores abundant evidence that his product is harmful? Essentially the only remedy is a civil suit, a claim for damages as a result of harmful and negligent actions of another. And that’s happened. While the Bush FDA was asleep at the switch, patients sought legal remedies in civil court:
Zicam seller Matrixx Initiatives, of Scottsdale, Ariz., which grew out of a chewing gum company, paid $12 million in 2006 to settle lawsuits with about 340 Zicam patients. It has won a lawsuit in California, and several other federal cases were dismissed.
[snip]
The company, which has sold more than 1 billion doses since the products came to market in 1999, says it settled in the past simply to reduce its legal exposure. The remedy has recently been sold with a redesigned spray nozzle, and the company argues that it is safe, citing academic studies that it funded. Matrixx says some people failed to follow package directions and stuck the nozzle too far up their noses.(Jeff Donan, AP)
As a result of the FDA advisory, Matrixx has stopped selling its product (Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Nasal Swabs) and offered refunds to consumers who request them. But it clearly admits no wrong. AFter all, what could be wrong with selling — legally, it seems — a billion little olfactory nerve grenades. And this is just the tip of the “trust me” homeopathic medicine racket:
Almost reduced to obsolescence in the United States, homeopathic remedies have revived in recent decades with the burst of interest in vitamins, herbs and other unconventional treatments. Since 2002, the U.S. homeopathic remedy market exploded by 89 percent to an estimated $830 million last year, according to market research company Mintel. By 2007, homeopathic remedies were taken by almost 4 million Americans, or 2 percent of adults, federal data show. (Jeff Donan, (Jeff Donan, AP)
What’s in them? Good question. Here are a few answers:
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. (Jeff Donan, again)
I’m not a crusader against unconventional medicine. Other things are more important to me, although I respect (insolently, perhaps) those like Orac who are infuriated by the damage done to those who delay or refuse effective treatment because they are hoodwinked by quacks. Of course I recognize that much of conventional medical treatment can also be extremely harmful, even when done with the best intentions. But I am offended by those who harm negligently and without the best intentions, driven only by the desire to make a buck by taking advantage of gullibility or desperation. There’s a loophole in drug regulation and these bastards have been driving their Hummers and Cadillacs through it at full speed.
Maybe the victims here have lost their sense of smell, but they sure know when something stinks.
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