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Published: Wednesday, 1/7/2004

The trouble with supplements

The U.S. Department of Health and Human Services has banned the sale of ephedra, an adrenaline-like drug derived from the ma huang plant and sold as a diet supplement in health-food stores.

Under its Chinese name, it has had 5,000 years of medical use as a broncho-dilator and decongestant. But in recent years it has been used in body-building and weight-reduction substances, with strokes, heart attacks, and 155 deaths attributed to its use.

The death last year of 23-year-old Steve Bechler, a Boston Orioles pitcher, was blamed in part on ephedra, which the Food and Drug Administration has been trying to ban since 1997 because of its side effects.

Many manufacturers have stopped producing it because of the liability potential. Some even welcome the ban though consumer advocates are upset by the delay in its arrival.

Ephedra is inherently dangerous in the hands of non-medical personnel and because, passing as a food/dietary supplement while people use it for a purpose, its containers bear no warnings of things that could go wrong as a result of ephedra alone - from high blood pressure and heart attack, to systemic stress - or when it is taken in conjunction with coffee, aspirin, and other substances.

The dietary supplement trade pretends that it is not selling remedies. But many of the medicinal substances are part of the health lore of generations of humanity. They have never been subjected to the rigors of clinical trial testing that past, present, and future pharmaceuticals must now face. No manufacturing standards assure that any product bears the same amount, capsule by capsule. Only when bad things happen to users is there a hard look.

In 1994 a law made greater supplement use possible and permitted a ban only if a substance was proven dangerous. It is that provision that led Health and Human Services Secretary Tommy Thompson to issue the ban, to take effect in 60 days, although the inevitable court challenge will delay its implementation.

Given the ephedra experience, and German research on echinacea that found it ineffective as a touted cold remedy, it is perhaps time for Congress to take a fresh look at this industry and hold its products to scientific standards.

When ephedra kills, when the average person doesn t know that he or she is at risk for a stroke or worse, or whether one ephedra caplet or capsule doesn t contain the same amount of product as the next, intervention would seem to be warranted.

Government regulates pharmaceuticals. It should do the same with substances used with a wink and a nod to remedy ills, even if they are called dietary supplements.



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