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Topic: Metabolife (Read 499 times)

Rhune
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Metabolife
« on: Aug 17^th, 2002, 12:12am »

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WASHINGTON (AP) - After years of reports of deaths linked to ephedra, the Justice Department is conducting a criminal investigation into whether Metabolife International lied about the safety of the dietary supplement.

Metabolife, the nation's leading ephedra seller, is offering to turn over 13,000 consumer health complaints to the government -- but Justice and Food and Drug Administration officials may have run out of patience.

The acting FDA commissioner, Lester Crawford, called the Metabolife offer "disingenuous," and said the agency would have a special task force comb the records for evidence of risks from the herbal stimulant.

The FDA has long sought the records as part of its probe of ephedra. Three weeks ago, the FDA asked the Justice Department to pursue a criminal investigation -- one Justice lawyers themselves had been urging.

"Metabolife has refused and resisted us at every step of the way," Crawford said Thursday. "News that so many reports exist greatly heightens our concern."

Justice Department spokeswoman Barbara Comstock said a criminal investigation of the company is under way.

At issue is a 1998 statement from then-Metabolife President Michael Ellis to the FDA that his company had "never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356," which contains ephedra.

But court records from private lawsuits against the San Diego-based company suggest Metabolife in fact had received reports of serious illnesses among ephedra users before Ellis made that statement, a senior Justice Department official, Eugene Thirolf, wrote the FDA last month.

Those records were kept under court seal, but "my office stands ready" to fight to get them if FDA gives the word, Thirolf wrote FDA chief counsel Dan Troy.

Hours after word of the unusual Justice overture leaked Thursday, Metabolife sought to stem the damage with a surprise announcement that it was giving the FDA 13,000 reports from consumers about health-related issues linked to its ephedra product.

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