FDA, Metabolife at Odds Over Ephedra AERs 34248

FDA, Metabolife at Odds Over Ephedra AERs

WASHINGTON--The Food and Drug Administration (FDA)has taken off the gloves with Metabolife International Inc. FDA, which wascharged with rounding up information for Health and Human Services (HHS) toconduct an extensive scientific review on ephedra, issued a public statementthat San Diego-based Metabolife has been repeatedly uncooperative in providingthe agency with its adverse event reports (AERs). Metabolife sent a letter toHHS Secretary Tommy Thompson Aug. 15 discussing the company's AERs; however,this came three weeks after FDA requested the Department of Justice (DOJ)criminally investigate Metabolife. In his Aug. 15 statement, an irate FDA DeputyCommissioner Lester Crawford called Metabolife's belated letter"disingenuous."

In the last year, Metabolife has sold 4.5 billion tablets, whichtranslates into 50 million bottles. Once the company put an 800-number on thebottle, it received 400,000 calls between 1997 and 2000. Of those calls, 13,000were for health-related issues, 100 to 200 of which required hospitalization.However, the company maintains there was no cause-and-effect between product useand adverse events.

"Since 1997, FDA has tried to get these AERs fromindustry," Crawford said. "Metabolife has refused and resisted usevery step of the way. We are greatly disturbed that Metabolife has repeatedlyrefused to cooperate with FDA, and news that so many reports exist greatlyheightens our concern." He added that once the agency receives a list ofthese reports, a special task force will review them. In the meantime, Crawfordsuggested consumers may wish to consult with their physicians before usingMetabolife products.

In response to FDA's allegations, Metabolife stated it has notmade any false statements to FDA. "Metabolife has repeatedly sought to workwith FDA and government officials to establish a science-based regulation forephedra-containing dietary supplements," said David Brown, president andchief executive officer of Metabolife (www.metabolife.com),in a statement. "[I]t is surprising that FDA would criticize the onecompany, to our knowledge, in the dietary supplement industry who has evervoluntarily provided this type of information to FDA." Brown added thatanecdotal reports are not helpful in determining causation, and the companybelieves scientific studies should form the benchmark for any FDA action onephedra.

According to Metabolife, the AERs gathered by its 800-numberservice are not well documented. Reportedly, many involve people vaguelymentioning they had certain adverse reactions while taking the product, but theydid not say how much they had taken or if they had mixed it with caffeine orcough medicine (which are warned against on the label). In an attempt to createa better AER system, the company began using registered nurses to document AERstwo years ago.

Lanny Davis, an attorney for Metabolife, stated in a releasedated Aug. 15 that Metabolife had called on FDA to create a mandatory reportingsystem for companies that manufacture and market dietary supplements containingephedra. However, it was only this past June that HHS reported FDA had begun amajor effort to strengthen its AER system by incorporating existing reportingsystems into a new, unified one to better monitor the safety of all dietarysupplements, including ephedra.

Davis stated when Metabolife asked FDA for this mandatoryreporting system--which was, coincidentally, on the same day that news of FDA'sallegations against Metabolife broke--the company offered to provide thefollowing: 1) help lead and fund a public awareness campaign to warn againstabusing ephedra products, especially by minors; 2) help fund a commission, to beestablished by HHS or the National Institutes of Health, to supervise studies onthe safety and efficacy of ephedrine-caffeine combos for weight control; and 3)help fund a "properly constructed" FDA mandatory reporting system.

"Now is the time for cooperation among industry, consumergroups and regulators, and for attention to fact and science," Davisstated. "It is not the time for politics and unfounded allegations. We arehopeful that in cooperation with FDA, consumer groups and scientists, aresponsible, science-based regulation will finally be adopted."

According to Wes Siegner at the Washington-based EphedraEducation Council (www.ephedrafacts.com),"The AER system that even HHS and FDA don't agree about doesn't add up toscience--their system doesn't assess the safety, but it does raise questionsabout the safety of ephedra products." He added, "You will never beable to tell through AERs alone if ephedra is causally related to reportedhealth problems."

Public interest groups have also gotten into the melee betweengovernment and industry. Ralph Nader's Public Citizen (www.publiccitizen.org)wrote a letter dated Aug. 15 to Sec. Thompson urging him to take legal actionagainst Metabolife and its founder, Michael Ellis, who was convicted of a felonyin 1990 for manufacturing and selling methamphetamine. Public Citizen cited aJuly 1, 2002, letter from Eugene Thirolf, director of the Office of ConsumerLitigation at DOJ, in which Thirolf stated Ellis may have made criminally falsestatements in 1998 when FDA asked for public comment regarding ephedrine. Atthat time, Ellis reported, "Metabolife has never received one notice from aconsumer that any serious adverse health event has occurred because of theingestion of Metabolife 356."

Sidney M. Wolfe, M.D., director of Public Citizen's HealthResearch Group and author of the letter, concluded by writing that if HHS'Thompson were not to pursue Ellis or Metabolife, it would "ultimately bringdisgrace to you and your department."