Wednesday, October 19, 2005

Supplement Your Mind . . . and Body?

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It is said that there is no such thing as bad publicity, but Dr. Phil might not agree right now. The TV psychologist is in danger of being named in a class action law suit regarding diet products that he has endorsed. The plaintiffs charge that the diet products do not meet the claims that Dr. Phil and the product literature tout, nor were there ever any clinical trials to validate those claims. What most people don’t realize is that dietary supplements, those claiming to aid in weight loss or otherwise, do not need clinical trials before going to market. Dietary supplements are regulated by the 1994 Dietary Supplement Health and Education Act (DSHEA) which allows manufacturers to market dietary supplements without the sort of rigorous testing required for drugs or food additives. The FDA still has the power to control supplements that it can prove are dangerous, but that onus falls on the FDA instead of on the manufacturers to prove that their supplements are safe. What this means is that consumers need to be cautious about what supplements they take as they are not protected from harmful supplements, even though they may think they are. As an example, it took the FDA close to a decade to ban the sale of ephedra – a supplement often used in weight loss efforts which had dire side effects, including many deaths.

The flip side of dietary supplement regulation is that there are many dietary supplements that people have used for thousands of years that are generally regarded as helpful and safe. To require manufacturers of vitamin C, for instance, to produce clinical trials proving its efficacy and safety would effectively mean that no one would be able to produce this supplement because the costs and time associated with testing are beyond what a vitamin manufacturer could afford to invest in product development. Many common herbs and other plants, such as garlic and cilantro, are used as dietary supplements. Dietary supplementation is one way that health conscious people can be proactive about their health. Wide scale regulation and barriers to dietary supplements would be intrusive and even harmful to many people who depend on vitamin and mineral supplementation to support their health. And yet there are serious plans to do just that at both the state and federal levels.

While the regulation of dietary supplements isn’t a particularly sexy issue, it is the sort of meat-and–potatoes issue (or meat-and-veggies for the low-carb dieters) that deserves a lot more public interest than it is currently getting because it promises to affect just about everyone in one way or another. So whether you want to treat your cold with echinacea or are worried that your spouse shouldn’t take gingko biloba with her Coumadin, you might want to follow this issue.

1 comment:

Kevin T. Keith said...

The real problem, I think, is that we treat large parts of the healthcare industry as no different from any other for-profit enterprise. The burden is on the consumer to protect their own interests against the product sellers whose only interest is to make sales. We do regulate the prescription-products manufacturers to a limited degree, and OTC products to an even-more-limited degree, but in the "supplements" industry the watchword is "buyer beware". Historically, this reflects the clout of the supplements makers in demanding a regulatory carve-out for their products, but even more, I think, it reflects the profit-first orientation of our entire policy-making apparatus. Certainly, selling deadly products is no reason for regulating the tobacco, firearms, or fast-food industries; you could hardly expect them to regulate vitamins and herbs, especially within a free-market health system in which policy-makers' chief priority is the supposed "crisis" of lawsuits holding providers liable for patient outcomes. It's simply not profitable to expect manufacturers to produce safe and effective products.