Ephedra: once a boon, now a bane.

Those who forget the past are not always fated to repeat it––sometimes the consequences are even worse. The problem of ephedra in the year 2003 arose largely because we have forgotten some excellent pharmacological research of eighty years ago. The sudden death of Steve Bechler, a promising young pitcher for the Baltimore Orioles, during spring training in February 2003, was attributed to his use of an ephedracontaining dietary supplement. This focused attention on a long-simmering question: is ephedra safe, or should it be banned? The question was quickly taken up by sports columnists, thus assuring wide public awareness of the issue. Although the Food and Drug Administration (FDA) already had reports of at least 100 deaths linked to the use of ephedra––not to mention nearly 17,000 nonfatal adverse events––the Agency took no urgent action. However, the FDA commissioned the RAND Corporation to review all studies and data on ephedra and to submit a report by Spring 2003. Spurred by Bechler’s death, the report was rapidly completed and Health and Human Services Secretary, Tommy Thompson, and FDA Commissioner, Mark McClellan, hurriedly released RAND’s findings at a special news conference on February 28, 2003 (1). On March 1, 2003, the news media reported that the FDA was not only issuing a proposal to require ephedra products to carry warning labels stating that they can cause heart attacks, strokes, even death, but also broaching the idea of a possible ban on some ephedra-containing products (1). These media reports were misleading because of what they omitted. The FDA’s announcement in the Federal Register of March 5, 2003 was not a new proposal (2), but rather reopened the comment period of a proposal on ephedra first published on June 4, 1997. In fact, no final ruling has ever been published. While the foregoing seems like an indictment of the FDA, the following must be considered in mitigation. Ephedra, an herb legally sold as a dietary supplement, is widely used to promote weight loss and to provide an energy boost and is reputed to be popular among athletes. The FDA is prevented from acting quickly by the Dietary Supplement Health and Education Act, which Congress passed in 1994. Under this law, dietary supplements, including herbs, may be sold without FDA review, and the FDA must prove them dangerous before it can have them removed from the market. The purveyors of ephedra products, said to enjoy sales of $3 billion a year, mounted a formidable campaign, claiming that fifty-five clinical studies Reflections