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Firm Glossed Over Complaints About Herb Ephedra, Panel Told

Oct 9, 2002 | San Diego Union Tribune

Metabolife International vastly understated the number of dangerous side effects experienced by consumers who took its controversial diet pills and was "careless" in investigating serious health complaints, according to a government report.

The report, an analysis of about 13,000 Metabolife consumer complaints that the San Diego company turned over to the U.S. Food and Drug Administration in August – was released yesterday at a Senate subcommittee hearing that took aim at the safety of dietary supplements containing the herb ephedra.

A government analysis of the so-called adverse-event reports produced by Metabolife concludes that almost 2,000 of the 13,000 reports documented "significant" side effects.

In stark contrast, Metabolife officials acknowledged just 80 serious incidents.

The nearly 2,000 side effects included three deaths, 20 heart attacks, 24 strokes, 40 seizures, 465 episodes of chest pains and 966 reports of heart rhythm disturbances, according to a report by the special investigations division of the U.S. House of Representatives' Committee on Government Reform.

The congressional hearing comes at a time when the federal government is considering whether to impose tougher restrictions on ephedra products or even ban them outright.

Numerous scientific studies and medical experts have linked the use of ephedra, a herbal stimulant used to promote weight loss and improve athletic performance, to serious health problems.

Metabolife, the largest manufacturer of ephedra diet products, insists that the supplements are safe when used as directed.

The Justice Department in August launched a criminal investigation into whether Metabolife lied to the FDA about the existence of safety complaints about its flagship product, Metabolife 356.

Only after the criminal investigation was made public did Metabolife turn over the 13,000 consumer complaints to the FDA.

The FDA tried unsuccessfully for more than a year to get access to the complaints through the courts.

In a written statement to the Senate subcommittee, Metabolife chief executive David Brown countered critics with numerous studies that he said support the safety and efficacy of ephedra supplements.

He also said that clinical studies favorable to the industry have been "consistently ignored" because of the "inappropriate legitimacy" placed on "anecdotal" consumer complaints.

The congressional report blasted Metabolife about its handling of the adverse-event complaints, saying the company "exhibited indifference to the health of consumers."

One-third of the complaints compiled by Metabolife were done in handwriting, with notes that were often illegible.

In 98 percent of the cases there is no indication that Metabolife tried to obtain medical records needed to evaluate the role its products played in causing the alleged health problems, the report said.

The FDA is conducting its own review of the Metabolife complaints.

A 1994 federal law severely restricts the FDA's ability to regulate dietary supplements, many of which contain potent druglike compounds.

Unlike pharmaceutical companies, which must prove that their drugs are safe and effective before they market them, diet supplement companies don't have to prove the same for their products.

The law also requires the FDA to prove that a supplement poses a health risk before the agency takes action – a task made more difficult because supplement companies, unlike drug companies, don't have to report consumer complaints to the FDA.

Yesterday, Health and Human Services Secretary Tommy Thompson said he has asked the FDA to recommend the "strongest possible mandatory warning label" for ephedra products.

"We will move as aggressively as the law and the science allow us to protect the public from the potential dangers of ephedra and other products," said Thompson. His department is awaiting the findings of a scientific review of ephedra being conducted by the Rand Corp.

Yet medical experts and consumer activists called for stronger action.

Ron Davis, a spokesman for the American Medical Association, called on the FDA to initiate proceedings to remove ephedra products from the marketplace.

"The risk associated with the use of these products outweighs the benefits," said Davis, whose national medical lobby represents about 278,000 doctors.

Sidney Wolfe, director of the health research group for Public Citizen, a consumer watchdog group in Washington, D.C., also renewed his group's call for an ephedra ban.

"This is not and has never been a question of scientific or medical evidence," Wolfe said. "It is a question of politics, and the extraordinarily dangerous political cowardice of the FDA and HHS Secretary Thompson in the face of massive lobbying by ephedra-makers in Washington."

Other testimony at the hearing indicated that the U.S. armed services have already banned ephedra products from being sold on many military posts.

The National Collegiate Athletic Association has banned the use of ephedra by student athletes, and the National Football League has banned its use by the pros.

Canada, the United Kingdom and Germany all prohibit sales of ephedra, while other European countries allow the sale of ephedra products only by prescription.

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