Metabolife International’s controversial herbal diet pill has been linked to 92 serious health complaints, including deaths, heart attacks and strokes, according to a General Accounting Office report released yesterday.
But congressional investigators stressed that the existence of thousands of consumer complaints about the San Diego company’s popular ephedra product, Metabolife 356, doesn’t prove the herbal stimulant caused the health problems.
In a review of 14,684 complaints turned over by Metabolife to the Justice Department, GAO investigators found reports of five deaths, 18 heart attacks, 26 strokes, and 43 seizures. Other problems included significant elevation in blood pressure, abnormal heart rhythm and loss of consciousness.
The GAO, the investigative arm of Congress, noted that the “inherent” limitations of such complaints, combined with Metabolife’s “incomplete” record-keeping, made it difficult to determine cause and effect.
The Food and Drug Administration, which in March announced a proposal to put warning labels on ephedra products, said consumer complaints, known as adverse events, can establish cause when supported by evidence such as medical documents.
“Today’s report does nothing to change FDA’s heightened concern that dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury,” the agency said yesterday.
As with previous studies of Metabolife’s consumer complaints, the GAO report took aim at the company’s record-keeping. While consumer complaints aren’t sufficient on their own to establish that a product causes a problem, GAO investigators said they “signal potential health problems that deserve investigation.”
Metabolife’s records, however, were “difficult to understand, and consumer information was not consistently recorded,” the GAO report said. In some cases, the evidence for a report of an adverse event was limited to a single word on the record, and most call records did not contain complete information about potentially relevant items.
Though the report does not paint a flattering picture of Metabolife’s handling or investigation of consumer health complaints, the company yesterday said it is “pleased” that the GAO said it couldn’t establish that any of the adverse events were caused by Metabolife 356.
“Metabolife reaffirms its position that the 20 years of clinical studies support that ephedrine-containing products such as Metabolife 356 are safe and effective when used as directed,” the company said in a written statement.
Congressman Dan Burton, R-Ind., who requested the GAO report, said the findings show that the government needs to set up a tracking system for consumer complaints of any dietary supplement.
He also construed the GAO report as proof that ephedra products are safe a conclusion the report does not reach.
Burton, a longtime supporter of the dietary supplement industry, has received generous campaign contributions from companies that make ephedra products, including $13,000 from Metabolife; its founder, Michael Ellis; and Ellis’ wife, Monica.
“Individual consumers can assume, according to the findings of this report, that when used properly, according to the product label recommendations, and under the supervision of their physician, dietary supplements containing ephedra are safe for consumer usage,” Burton said.
Ephedra critics, who have called on the FDA to ban ephedra products, said Burton’s remarks indicate a “complete disconnect” from reality.
“Burton is saying there may or may not have been a crime committed because no one was there to see it happen,” said Joe Shoemaker, a spokesman for Sen. Richard Durbin, D-Ill., who has introduced legislation that would require companies to prove their ephedra products are safe before selling them. “We’re saying there are 15,000 clues here that something went seriously wrong.”
Dr. Sidney Wolfe, a spokesman for Public Citizen, a Washington, D.C., consumer watchdog group that has also called for a ban on ephedra, said Burton should “spend as much energy trying to understand what is going on as he does trying to protect Metabolife and the rest of the ephedra industry.
“Ephedra is not safe, and the GAO report doesn’t say it is safe,” Wolfe said. “The main thing that comes out of this report is that Metabolife never tried to follow up on complaints of serious problems, which is why there isn’t more information about them.”