Government Will Study Ephedra Risks
Washington DC, 14 June 2002

The federal government has hired the RAND Corporation, a Washington-based think tank, to perform a comprehensive review of studies of ephedra (also known as ma huang). The National Institutes of Health will use their report, due this fall, to decide how to pursue further research.

Roughly 100 deaths and 1000 other adverse events among people using ephedra have been reported to the Food and Drug Administration (FDA). As the industry has been quick to point out, however, these adverse events may be coincidental because of the large numbers of people using ephdra in weight-loss aids or energy-boosting supplements.

The Ephedra Education Council says ephedra is safe when used as directed (see industry guidelines). However, the Mayo Clinic published a report in January 2002 that found some of the adverse events occurred at recommended dosage levels. Their analysis of the FDA adverse event database found 11 sudden deaths, 16 strokes and 10 heart attacks in patients who took products with ephedrine between 1995 and 1997.

Public Citizen, a consumer advocacy group, which has sought for years to have ephedra banned by the FDA, was angered by the government's action. Dr. Sidney Wolfe, head of Public Citizen's research department, said everyone involved should be fired for "dangerous cowardice."

The Ephedra Education Council said, "[Health and Human Services] Secretary Thompson's call for a science-based initiative to study Ephedra is a common-sense regulatory approach that will lead to a policy ultimately based on science rather than speculation. Recent clinical research and long- term usage supports the safety of ephedra, but the industry is as interested as HHS in having more definitive data. The Secretary's message to consumers is exactly right: Be responsible, read the label, review the science, and make a decision that is right for you."

The FDA is also pursuing companies that sell synthetic ephedrine in the guise of dietary supplements over the Internet. Such sales are illegal because synthetic ephedrine is a drug, and cannot be marketed as a supplement. Deputy FDA Commissioner Dr. Lester Crawford stated that it looked as if many of the health problems stemming from use of ephedra were due to these synthetic products rather than the actual herb.

Whether the adverse events associated with ephedra are coincidental or due to ephedra use is not yet scientifically known, since both sides of the debate cite reputable scientific evidence to support their position. However, ephedra is definitely a potent herb with cardiovascular effects. Those who chose to use it are well advised to be closely monitored by their physician.

Sources

AOL news, 14 June 2002.

Ephedra Education Council via PR Newswire, 14 June 2002.

Yahoo news, 17 June 2002.