Government Launches Criminal Investigation Of Metabolife
16 August 2002
by Wyn Snow, Managing Editor

The US Department of Justice launched a criminal investigation yesterday to discover whether officials at Metabolife have lied to the FDA about whether the product has caused deaths or illnesses among its customers. Metabolife makes a controversial ephedra-based diet aid that is marketed as a dietary supplement.

At issue are the details of 13,000 consumer complaints that Metabolife recently released to the FDA. Concerning these reports, Metabolife states, "Three experts reviewed this information and determined that the information does not demonstrate that Metabolife 356 is unsafe or poses any health problems when used as directed."

According to a statement released by the FDA, " Since at least 1997, the FDA has tried to get these adverse event reports from industry. We also unsuccessfully sought these reports through litigation. Metabolife has refused and resisted us every step of the way."

Metabolife indicated that it received roughly 400,000 calls to its consumer hot line between 1997 and 2001. This hot line offers weight loss advice. The 13,000 reports released to the FDA were among those calls. Approximately 80 of the calls mention serious disease or death; an attorney retained by Metabolife says another 100 to 200 deal with hospitalizations.

According to Metabolife, these reports are not proof that its product is dangerous when used as directed. Indeed, the FDA and a congressional investigative report agree that such "anecdotal evidence" does not constitute rigorous or scientific proof of harm.

FDA Acting Commissioner Lester Crawford called Metabolife's actions "disingenuous," and will assign a special task force to examine the reports for evidence of risks. In the pharmaceutical industry, drug manufacturers are required to collect information about adverse events from doctors who prescribe their drugs, and to report these adverse events to the FDA.

In proposals to Tommy Thompson, Secretary of U.S. Health and Human Services, Metabolife has offered to help fund the creation of a "properly constructed FDA mandatory reporting system," as well as to help fund an NIH or HHS blue ribbon commission to supervise long-term clinical studies of the safety and efficacy of ephedrine-caffeine combinations for weight control.

Sources

Maggie Fox. "FDA Seeks U.S. Criminal Investigation of Diet Firm." Yahoo News (Reuters), 16 August 2002.

Metabolife International, press releases on PR Newswire, 15 and 16 August 2002.

Lauran Neergaard. "FDA Asks For Ephedra Criminal Probe." Yahoo News (AP), 15 August 2002.