Science-based medicine = Big Pharma? You hear it all the time from the peddlers of woo, but it’s rare that they disclose their own profit motives.
Take the fellow who used Greg’s recent post on the FDA and acetaminophen to complain about how the FDA conducts itself.
I think more people need to take a bigger picture approach to this latest FDA news. Who is the FDA ultimately protecting? How long do they wait, how many lives are affected before they take this kind of action on big pharma drugs? Too long. How long do they wait to come down hard on the natural health industry when a few people lose their sense of smell (for example)? Not that long. The makers of Zicam got dragged through the media a few weeks ago after 100 or so people lost their sense of smell temporarily over a ten year period, but it takes 20 years or so for the FDA to say anything about the drug that is the leading cause of liver failure in the U.S.
Set aside the fact that the post quotes an article talking about the years-long educational campaigns conducted by the government to help keep people from using acetaminophen dangerously. Set aside the fact that this is not the first FDA action on acetaminophen. Ben, the commenter, did, after all. Even after this was pointed out to him, he accused the FDA of “purposely staying silent” on the subject.
Ben wanted to “focus…on the priorities of the FDA.” Of course, contrarian that I am, that only makes me look at Ben’s priorities, particularly since I just looked at the FDA’s and he ignored what I said.
Ben was kind enough to provide a link to the blog for his company, Swanson Vitamins. So I took a look at the company, specifically in regard to things he didn’t think the FDA should be focusing on.
Zicam, of course, is the “homeopathic” cold/allergy/wealth remedy, at least one formulation of which actually contains an active ingredient (unlike most homeopathic remedies, which are just water). The FDA recently released a consumer warning that Zicam Cold nasal gels can temporarily or permanently impair users’ sense of smell. That may not sound so awful, but it’s an ugly condition.
Now, as Ben pointed out, his company’s site doesn’t carry the Cold products. Of course, those can’t currently be marketed without FDA approval, so that’s not evidence of care for their customers. They do, however, continue to carry other Zicam products, even after:
There have been 130 cases reported to the FDA of decreased sense of smell following the use of one of these Zicam products – sometimes after a single use, sometimes after repeated use. All of these cases were reported by patients or their doctors; none were reported by the company, Matrixx Initiatives. According to reports, the FDA has asked Matrixx to turn over 800 consumer complaints regarding to Zicam. There is a 2007 law that requires company to report such complaints to the FDA, although the FDA has not said whether Matrixx violated this law.
Swanson Vitamins could choose not to carry any of these Zicam products in order to protect their customers. They don’t. They are instead choosing to ignore a company history of unsafe formulations and failure to report problems with their own products in order to continue to promote a popular brand name of woo.
Ben points to the fact that the other Zicam products haven’t been dunned by the FDA. He links to an article on his own blog that says that the FTC and FDA have regulatory powers over “natural” medicines. What he doesn’t tell you:
While most homeopathic remedies are diluted to the point that they are indistinguishable from water, that is not a requirement. Lesser dilutions may contain small amounts of active ingredient. If a “homeopathic remedy” contains a biological active amount of a drug as an active ingredient, is it not a regular drug?
This is relevant to Zicam because these products are regulated as homeopathic drugs – which means they were allowed on the market without having to provide any evidence for safety or efficacy.The homeopathic exception allowed the manufacturer to simply bypass the usual requirements, even though Zicam is not really homeopathic but contains biologically active levels of zinc.
Why doesn’t he tell you that? Why doesn’t he tell you the the FTC has only the power to make sure he’s not making direct medical claims for his products? Well, you could ask Ben, or you could just read the title of this post again.
Update: Note that a profit motive can also encourage other unethical behavior. As Jason points out in the comments, the astroturfers from Swansons Vitamins have arrived.