U.S. Investigates Metabolife Over Ephedrine Concerns

The Justice Department has opened a criminal investigation to determine whether San Diego-based Metabolife International lied when it told the Food and Drug Administration that it had received no reports of adverse health effects caused by its bestselling weight-loss product, officials said Thursday.

News of the FDA’s request for an investigation prompted the company’s lawyers to announce Thursday that they were immediately and voluntarily releasing records of more than 13,000 health complaints the company had received since 1997 from consumers of Metabolife 356, which contains the herbal stimulant ephedrine.

Washington attorney Lanny Davis said the company also was taking the “unusual step of asking to be regulated, asking for a mandatory reporting system” of health complaints. In addition, Davis said, the company was offering to donate 5 cents per bottle of Metabolife 356 sold--roughly $500,000 a year--to help finance a public education campaign and studies on ephedrine’s health effects.

But Dr. Lester Crawford, FDA deputy commissioner, called the company’s action “disingenuous,” noting that the agency had been trying to get ephedrine side-effect information from the $16.8-billion-a-year dietary supplement industry since 1997.

“Metabolife has refused and resisted us every step of the way,” Crawford said in a statement.

In 1994, the FDA began receiving reports of heart attacks, seizures, strokes and other health problems associated with the use of products from the ephedra plant, also known as the Chinese herb ma huang. The FDA has since collected reports of more than 100 deaths among users of products containing ephedrine, whose molecular structure is very similar to that of amphetamine.

Various sports organizations, including the NFL, the NCAA and the International Olympic Committee, ban ephedrine.

The FDA’s repeated efforts to limit use of the herb in dietary supplements have been blocked by the industry’s high-powered lobbying efforts and by Congress, Crawford noted.

Because ephedra is a plant, products using it can be marketed as an all-natural food supplement rather than a drug. Federal law prohibits regulation of such supplements except in cases where the FDA can prove the products are dangerous.

The public-interest group Public Citizen, which first asked the Department of Health and Human Services to ban ephedra products last year, repeated that call Thursday.

“I urge you to free yourself from the influences that Metabolife and other ephedra makers have had on the Texas Department of Health and their continued massive lobbying in Washington against a ban of these most dangerous ‘food supplements,’ ” wrote Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group, in a letter Thursday to HHS Secretary Tommy G. Thompson.

The Times reported last year that public health officials in Texas had suspended the enforcement of a state regulation that would have required products containing ephedrine to include a label with a toll-free number for consumers to report suspected side effects to the FDA.

The Justice Department investigation of Metabolife is likely to center on the company’s own records and a letter written to the FDA by then-company President Michael Ellis in 1998. Ellis is still on the company’s board.

“Metabolife has never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356,” Ellis told agency officials, adding that the company had received “no serious adverse reports of any sort.”

Davis said Thursday that the company had received a subpoena last week to turn over records related to that 1998 letter.

In 1997, Metabolife began including a toll-free number on the product label, inviting customers to call with questions about weight loss. In five years, the line received more than 400,000 calls, according to the company.

But for the first year or so of the phone line’s operation, the company had “no regular system” to keep track of questions or complaints.

In late 1998, Metabolife hired registered nurses to take the calls, and in 1999 the company devised a form on which to record the callers’ complaints. Last year Metabolife hired three outside experts to analyze the data, Davis said.

In the more than 13,000 calls the firm received over five years containing the word “health,” about 80 callers mentioned seizure, stroke, heart attack or death. About 120 more referred to hospitalization, Davis said.

Although the company instructed the nurses to encourage such callers to see a doctor and to stop taking the supplements, Metabolife did not report the information to the FDA or follow up with its customers. The company was not required by law to do so, and it “didn’t know if what they said was true” or if the health problems were caused by the company’s product, Davis said.

The federal health department in June short-circuited the FDA’s latest anti-ephedrine efforts by hiring the Rand Corp., a think tank, to review scientific data on ephedrine and adverse side effects.

Metabolife International was founded in 1995 by Ellis, a former police officer. The privately held company said in 1999 that annual sales topped $1 billion.

But in 1999 Metabolife recalled its nationally distributed energy bars because of concerns of toxic levels of vitamin A. Last month, the Internal Revenue Service seized documents as part of a tax-evasion inquiry.

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Times staff writers Eric Lichtblau in Washington and Don Lee in Los Angeles contributed to this report.