Government Launches Criminal Investigation Of Metabolife
by Wyn Snow, Managing Editor
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.
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."
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."
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.
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.
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.
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.
1994, trade organizations in the botanical industry have instructed
their member companies to limit dosages and to place warnings
on the labels of all ephedra products.
Fox. "FDA Seeks U.S. Criminal Investigation of Diet Firm." Yahoo
News (Reuters), 16 August 2002.
International, press releases on PR Newswire, 15 and 16 August 2002.
Neergaard. "FDA Asks For Ephedra Criminal Probe." Yahoo News (AP),
15 August 2002.