Selling danger by the bottle

February 28, 2003|By Arthur P. Grollman

STONY BROOK, N.Y. -- Baltimore Orioles pitching prospect Steve Bechler became the latest professional athlete to succumb to the promise that weight loss coupled with enhanced performance could be achieved by taking ephedra.

Before this latest tragedy Feb. 17, other athletes, including Minnesota Vikings star tackle Korey Stringer, Northwestern University football player Rashidi Wheeler and Florida State's Devaughn Darling, died in 2001 after using supplements containing ephedra. No definitive cause of death was found, although exhaustion and dehydration were cited.

How many more deaths of young, apparently healthy athletes will be added to the total before all sports organizations follow the lead of forward-thinking athletic groups such as the National Collegiate Athletic Association, the National Football League and the International Olympic Committee that have banned ephedra-containing supplements? Where are the National Basketball Association and other athletic associations?

Perhaps they take their lead from the inaction of the federal government. Indeed, the time has come for Congress to finally enact legislation to regulate ephedra and other herbal products.

Major League Baseball this week banned the use of ephedrine-based products in the minor leagues. Its commissioner's office is expected to propose extending the ban to the majors, but the players' union is likely to resist it.

All sports organizations -- and, most importantly, the federal government -- should follow the example of the Suffolk County, N.Y., legislature, which courageously resisted pressure by manufacturers and distributors of these products and voted decisively Dec. 5 to outlaw sales of so-called dietary supplements containing ephedra.

Through misleading advertising, many Americans are convinced that products containing ephedra promote long-term weight loss, increase energy and enhance athletic performance. Ephedra, in fact, achieves none of these.

Like its chemical cousins, methamphetamine ("speed") and phenylpropanolamine (PPA), ephedra temporarily suppresses appetite. But sustained weight loss has never been convincingly demonstrated at doses of ephedra generally considered to be safe.

Ephedra is associated with serious adverse reactions, including death. It is estimated that 100,000 Americans have experienced such reactions over the past few years. Products containing ephedra account for 64 percent of adverse reactions to botanical products reported to poison control centers in the United States -- even though they represent only eight-tenths of a percent of sales.

The American Medical Association has recommended banning ephedra, and the Defense Department has halted sales of ephedra products in military commissaries. Remarkably, the federal government has refrained from taking decisive action to protect the public from the dangers of this herbal drug. The reason for its inaction is quite clear: In 1994, Congress removed the power of the Food and Drug Administration to effectively regulate botanical products by passing the Dietary Supplement and Health Education Act (DSHEA).

This fatally flawed legislation declared herbs to be dietary supplements -- which they are not -- and in doing so, Congress shifted the burden for proving safety from the manufacturer to the FDA. Even when overwhelming evidence of serious injury exists -- as for ephedra -- the FDA lacks the resources required to document its case in court. Meanwhile, the public remains exposed to a dangerous over-the-counter product.

Under DSHEA, manufacturers of dietary supplements are not required to report to the FDA serious adverse effects caused by their products. Thus, the manufacturer of Metabolife, a combination of ephedra and caffeine taken by 2.5 million Americans to lose weight, was within its legal rights in withholding the more than 14,000 reports of adverse reactions it received over several years.

Herbal products should be regulated as over-the-counter drugs. Their current designation as dietary supplements by Congress is a legal fiction. Manufacturers of these products are required to take responsibility for the potency and purity of their products, base health claims on scientific evidence, provide appropriate warnings about possible adverse effects and report them immediately to the FDA. Why should manufacturers of herbal products be held to lesser standards than the makers of prescription or over-the-counter drugs?

The American public overwhelmingly supports new regulations that would require the FDA to review the safety of new dietary supplements before their sale and to promptly remove unsafe products from the market.

This urgently needed legislation is likely to be opposed by powerful political and economic forces and by many proponents of alternative medicine.

Nevertheless, congressional action is needed and further delay will cost more lives. The public interest must supersede that of the botanical industry.

Arthur P. Grollman, an alumnus of the Johns Hopkins Medical School and a visiting professor there, is a professor of pharmacological sciences and medicine at the State University of New York, Stony Brook and attending physician at Stony Brook University Hospital.

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