Clinical Briefs: Metabolife® and Safety

With Comments from John La Puma, MD, FACP

Sources: Adams C. Senate Committee Criticizes Metabolife Over Ephedra (Wall Street Journal Oct. 9, 2002); Adams C. Officials Open Criminal Probe On Metabolife International (Wall Street Journal Aug. 15, 2002); Parker-Pope T. Despite Evidence of Success, Ephedra Comes With Risks (Wall Street Journal April 6, 2002).

This trifecta of popular press articles summarizes Metabolife’s and ephedra’s current circumstances. Ephedra, they note, "is chemically similar to phenylpropanolamine, or PPA, a cold-medicine and diet-pill ingredient recently banned by the FDA after research found an increased risk of hemorrhagic stroke in young women who used PPA products."

The Justice Department’s criminal investigation of Metabolife for allegedly lying about the existence of side effect reports may be beginning to bear fruit: The Wall Street Journal reported that more than 13,000 reports had been received by the company between 1997 and 2002. And the company president is reported by the paper to have said he had no knowledge of such reports.

What brought down Big Tobacco may bring down Big Ephedra. Lying to doctors and patients is never a good idea. What is a good idea is to give the FDA some jurisdiction—even with the tangibility of the Samenuk et al data, and the FDA’s own adverse event report database, the FDA is powerless. The American Medical Association has called on the FDA to ban ephedra, and Metabolife’s argument that people who were harmed may not be using the product properly simply proves the point that it ought to be available, if it is safe, by prescription only. Adams reports in the Wall Street Journal (Oct. 9, 2002) that "The Senate panel was told that more than 30 military personnel using ephedra had died, which led to ephedra’s ban at some commissaries."

Recommendation

Although the issue is not completely settled, ephedra-caffeine is not the answer for weight loss. Recommend that patients avoid it.