FDA, Metabolife at Odds Over Ephedra AERsFDA, Metabolife at Odds Over Ephedra AERs

WASHINGTON--The Food and Drug Administration (FDA) has taken off the gloves with Metabolife International Inc. FDA, which was charged with rounding up information for Health and Human Services (HHS) to conduct an extensive scientific review on ephedra, issued a public statement that San Diego-based Metabolife has been repeatedly uncooperative in providing the agency with its adverse event reports (AERs). Metabolife sent a letter to HHS 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 Deputy Commissioner Lester Crawford called Metabolife's belated letter "disingenuous."

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

"Since 1997, FDA has tried to get these AERs from industry," Crawford said. "Metabolife has refused and resisted us every step of the way. We are greatly disturbed that Metabolife has repeatedly refused to cooperate with FDA, and news that so many reports exist greatly heightens our concern." He added that once the agency receives a list of these reports, a special task force will review them. In the meantime, Crawford suggested consumers may wish to consult with their physicians before using Metabolife products.

In response to FDA's allegations, Metabolife stated it has not made any false statements to FDA. "Metabolife has repeatedly sought to work with FDA and government officials to establish a science-based regulation for ephedra-containing dietary supplements," stated David Brown, president and chief executive officer of Metabolife (www.metabolife.com), in a statement. "[I]t is surprising that FDA would criticize the one company, to our knowledge, in the dietary supplement industry who has ever voluntarily provided this type of information to FDA." Brown added that anecdotal reports are not helpful in determining causation, and the company believes scientific studies should form the benchmark for any FDA action on ephedra.

According to Metabolife, the AERs gathered by its 800-number service are not well-documented. Reportedly, many involved people vaguely mentioning they had certain adverse reactions while taking the product, but they did not say how much they had taken or if they had mixed it with caffeine or cough medicine (which is warned against on the label). In an attempt to create a better AER system, the company began using registered nurses to document these AERs two years ago.

Lanny Davis, an attorney for Metabolife, stated in a release dated Aug.15 that Metabolife has called on FDA to create a mandatory reporting system for companies that manufacture and market dietary supplements containing ephedra. However, it was only this past June that HHS reported FDA had begun a major effort to strengthen its AER system by incorporating existing reporting systems into a new, unified one to better monitor the safety of all dietary supplements, including ephedra. [For more on this story, visit www.naturalproductsinsider.com/hotnews/26h1416643.html.]

Davis stated when Metabolife asked FDA for this mandatory reporting system--which was, coincidentally, on the same day that news of FDA's allegations against Metabolife broke--the company offered to provide the following: 1) help lead and fund a public awareness campaign to warn against abusing ephedra products, especially by minors; 2) help fund a commission, to be established by HHS or the National Institutes of Health, to supervise studies on the 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, consumer groups and regulators, and for attention to fact and science," Davis stated. "It is not the time for politics and unfounded allegations. We are hopeful that in cooperation with FDA, consumer groups and scientists, a responsible, science-based regulation will finally be adopted."

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

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

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