Metabolife Probe May Chill Diet Pill Industry

Metabolife Probe May Chill Diet Pill Industry

BY MARION WEBB



Senior Staff Writer

A federal Justice Department investigation into whether Metabolife International, the nation’s leading seller of ephedra products, lied about the safety of its dietary supplement could have a chilling effect on the industry, according to an industry expert.






In an Aug. 15 statement, Food and Drug Administration Deputy Commissioner Dr. Lester Crawford said the agency had asked the Department of Justice to investigate whether Metabolife “made false statements regarding the existence of adverse event reports” , that is, reports about unfavorable impacts on consumers’ health.






Lester said the FDA had been unsuccessful for years in trying to obtain adverse event reports from the industry.






Charles Miller, a spokesman for the federal Department of Justice, said the criminal investigation into Metabolife is ongoing, but declined to offer any more information.






San Diego-based Metabolife, a closely held company, said in a subsequent statement it would hand over 13,000 such reports relating to its ephedra product. An attorney for Metabolife said the reports were hand-delivered to the FDA on Aug. 16. An FDA official said on Aug. 20 she couldn’t confirm receipt of the records.






Mark Blumenthal, founder and executive director of the American Botanical Council, a nonprofit group located in Austin, Texas that monitors herbal supplements, said people in the industry are concerned about the criminal investigation and allegations that Metabolife’s former president, Michael Ellis, lied to the FDA about serious adverse reactions experienced by some consumers using Metabolife 356.






Lanny Davis, a lawyer for Metabolife, said of the 400,000 consumer calls to the firm’s hotline between 1997 and 2001, 13,000 were complaints: 80 mentioned serious injury or death, and 100 to 200 involved hospitalization.






The remaining 387,000 calls were not related to the safety of the product, he said.






The attorney didn’t have an answer for why Ellis said in a 1998 statement to the FDA that Metabolife “had never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356.”






“There was never any intention to mislead the FDA,” the attorney said. He added that reports of injury or death are anecdotal and unreliable in terms of showing that ephedra caused the health-related problems.






Ephedra, a popular herb often used to lose weight and build muscles, has long been controversial.






Calls For Stricter Regulation






Consumer groups, doctors and pharmacists have called for stricter regulation of ephedra. The Public Citizen Health Research Group in Washington, D.C., went even further by petitioning the FDA to ban ephedra altogether.






In a letter to the FDA and the U.S. Department of Health and Human Services, PCHRG director Dr. Sidney M. Wolfe said “there are more reports of death, stroke, arrhythmia, heart attacks, chest pain, seizures and hypertension for ephedra than for all other dietary supplements combined.”






Wolfe said FDA reports showed 100 deaths related to ephedra use.






Metabolife responded to Public Citizen’s claim by stating “the petition presents no new credible scientific evidence to suggest that ephedrine alkaloids present a hazard, much less one that is imminent.”






The company also dismissed the findings of another report published in the Dec. 21, 2000 New England Journal of Medicine that found 140 adverse reports related to ephedra use between 1997 and 1999, including stroke, seizures and heart problems, and 10 deaths.






Manufacturers have insisted that ephedra is safe and have successfully fought regulators’ attempts to bar the sale of certain high doses of the supplement. But ephedra is still a hot issue.






Rand Study Underway






The FDA said that a Rand think tank is reviewing the scientific evidence of ephedra’s safety, adding “The NIH (National Institutes of Health) will use this information to guide an expanded research effort on the safety of the product.” The report is expected in early 2003.






Under current law, supplements are regulated as foods and do not require herbal makers to disclose possible health hazards.






In a recent letter to U.S. Secretary of Health and Human Services Tommy Thompson, Metabolife officials said the company wants “responsible regulation of dietary supplements.”






In the letter, Metabolife called for a mandatory reporting system on ephedra products. It also proposed to help lead and fund an industry-wide consumer information campaign to warn against ephedra abuse, and to help fund a blue ribbon commission to supervise clinical trials to study the safety and efficacy of ephedrine-caffeine combinations for weight control.






Blumenthal said he wants some stricter controls on the manufacturing process of ephedra products, but did not want to bring it to the same rigid levels of drug manufacturing.






California Gov. Gray Davis also recently sent a letter to the FDA demanding they take action to investigate consumer complaints, the Associated Press reported.






Davis also indicated that he would sign legislation to ban the sale of the dietary supplement to minors.






The Public Citizen group quoted a Washington Post article that said Davis, who earlier had vetoed legislation requiring warning labels on dietary supplements in the state of California, received $100,000 in campaign contributions from Metabolife.

Metabolife Says It Would Welcome State Regulation

BY MARION WEBB



Senior Staff Writer






Metabolife International Inc. said it welcomes Gov. Gray Davis’ proposal to sign legislation that would regulate the use of ephedrine-based products in California and its extended regulation by the federal government.






Officials at Metabolife, the nation’s leading seller of herbal ephedrine, said in an Aug. 22 press conference that they sent a letter to the National Institutes of Health (NIH) in support of a ban to sell herbal ephedrine to minors.






The company also asked the NIH to establish good manufacturing practices to insure product consistency, require warning labels and establish a hotline for consumers to call the Food and Drug Administration with any complaints.






Metabolife officials also want the NIH to review what it described as 15 years of clinical data of its ephedra-based diet product, Metabolife 356, which they say prove the product is safe and effective.






Metabolife is the subject of a federal criminal investigation by the Department of Justice to establish whether it covered up consumer complaints on the safety of its product.






The Public Citizen, a non-profit consumer advocacy group, and many scientists have asked federal regulators to ban the product, citing concerns that its main ingredients , herbal ephedrine and caffeine , caused heart attacks, strokes, and seizures.






Metabolife’s lawyer Lanny Davis vehemently rejected such claims. He told listeners that he would “challenge the FDA or anyone else” to show one trial suggesting Metabolife’s product is unsafe or ineffective.






In 1997, Congressional members rejected a proposed rule by the FDA on the use and labeling of ephedrine, agreeing with diet industry members that reports of adverse reactions to the product weren’t “science-based.”






The FDA now awaits a report by a Rand Corp. think tank which is reviewing scientific evidence on ephedra’s safety.






However, Davis said the Rand study will be “incomplete” because it is based on 13,000 consumer complaints provided by Metabolife and not on the scientific evidence from previous trials.






Metabolife said it wants NIH, which hired Rand, to create a blue-ribbon commission to review the clinical trials on “ephedra-caffeine combinations for weight loss and to confirm their safety.”






Davis said Metabolife would fund new trials and ask industry members to do the same.






During the press conference, a scientist said some of Metabolife’s trials used “pure synthetic ephedrine and synthetic caffeine,” which is not the same as the herbal ephedra-caffeine used in its product.






Davis reiterated the product is safe.