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Recent Articles
Congress Investigates Wyeth Vitamin Claims
As part of its ongoing investigation of direct-to-consumer advertising, the House Energy & Commerce Committee last week sent the CEO of Wyeth Pharmaceuticals a letter concerning advertisements for its Centrum Cardio multivitamin, which Wyeth advertises as the "first and only complete multivitamin that lowers cholesterol."
Although it is unclear whether Wyeth has actually tested Centrum Cardio for its ability to lower cholesterol, the product contains plant sterols (aka phytosterols), and many foods and supplements containing added plant sterols have been shown to lower cholesterol slightly (usually 5 to 15 percent). As previously noted, the FDA has approved a health claim that plant sterol products "may reduce the risk of heart disease." Unfortunately, this claim was approved based solely on the ability of plant sterols to lower LDL ("bad") cholesterol. Plant sterol supplements have never been shown to prevent heart attacks and strokes.
There are several reasons to be cautious about the use of plant sterol supplements. First, although plant sterols lower cholesterol absorption slightly, they themselves are absorbed into the bloodstream, resulting in higher levels in people who consume these supplements. Whether these higher levels of plant sterols are safe is unknown, but some epidemiological studies have linked higher plant sterol levels to an individual or family history of heart disease. In addition, individuals with a rare genetic disease called sitosterolemia (aka phytosterolemia) that causes very high blood levels of plant sterols suffer from premature heart disease.
Plant sterols have been detected in tissue taken from patients who have had surgery for blocked carotid arteries or aortic valve disease. In addition, some recent studies in rodents have shown adverse effects of plant sterols on vascular function. As a result, several researchers have called for clinical trials to test the effect of plant sterol supplements on heart disease in humans (see also here). In the meantime, I'm sticking to plain, old-fashioned food.
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Comments
This issue is highly political. I do not understand why food supplementation is regulated in a different way than drugs. The question to what it all comes down is: When is a food stuff no longer a food stuff, but a drug ? AND WHO is responsible for DANGEROUS food stuffs ? There is a need for a public discussion of this issue !
This whole area of nutritional supplements is an unregulated quagmire that Congress has ignored because powerful congressmen and Senators, and a well financed grassroots army of supplement devotees can smother Capitol Hill with letters and phone calls that prevent any oversight of this wealthy industry. Meanwhile consumers are being overdosed and underdosed with dangerous substances, and pills are being sold at premium prices even if they have absolutely no active ingredients. FDA is prohibited by federal law from regulating the industry unless the agency can prove that a product causes harm. In other words, people have to die before FDA is permitted to step in.