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 the 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.
Although 80 mention serious disease or death — and a company lawyer said a total of 100 to 200 deal with people hospitalized — Metabolife insists they don’t prove that ephedra is dangerous when used as directed.
Some of the reports probably were received before Ellis’ 1998 statement to the FDA, Metabolife attorney Lanny Davis said. But Ellis did not lie to the FDA, he insisted.
“It is my understanding that Mr. Ellis, as many other people, regard the phrase ‘serious adverse event’ as requiring a show of causation between the reported event and the use of Metabolife,” Davis said. “These records, some of them on the back of envelopes or call slips … do not seem even close to meeting the definition of a serious adverse event caused by Metabolife.”
Metabolife said its reports merely were complaints called in to a consumer hot line for weight-loss advice and thus are suspect. It contended the nation needs a better system to report problems — and promised to donate up to $500,000 to help set up such a system.
Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, who is pushing the government to ban all ephedra sales, praised the FDA’s response to Metabolife.
“The question is: Are they going to follow through and get these dangerous products off the market?” Wolfe said. Metabolife’s about-face on providing the complaint records shows “they are squirming to get out of the dangerous mess they’ve caused,” he said.
Ephedra, a popular herb commonly used for weight loss and body building, has long been controversial. The FDA has reports of 100 deaths among ephedra users, and a report in the New England Journal of Medicine two years ago cited about 1,000 reports of complications linked to the herb since the mid-1990s.
Manufacturers insist that reports of sick patients — instead of a definitive diagnosis from a doctor or a definitive autopsy — don’t count as proof an herb is risky. They contend an industry-commissioned study comparing ephedra to dummy pills shows the herb is safe under the recommended uses with a daily dose of 90 milligrams.
Federal law forbids most regulation of dietary supplements unless the FDA proves danger. Three years ago, the agency attempted to bar certain high doses of the supplement from being sold. Industry protests killed the move, and then a General Accounting Office report, while calling ephedra clearly risky to some people, said the statistics FDA used to back its move partly those voluntary consumer reports were sloppy.
So FDA officials reanalyzed and began pushing for warning labels. But in June, the Department of Health and Human Services put that effort on hold, instead hiring the Rand Corp. to review all scientific evidence of ephedra’s safety. Results are due this fall, when the National Institutes of Health will determine what additional research, if any, is needed to settle the debate.
Canada a year ago warned consumers not to use ephedra, and it has been banned by the International Olympic Committee, the National Football League and the National Collegiate Athletic Association.