July 23, 2003
House panel puts ephedra studies under microscope
Metabolife executives may be called to testify
By TOBY ECKERT
COPLEY NEWS SERVICE
WASHINGTON – Members of a House panel are expected to sharply question studies that tout the safety of ephedra when they open hearings today into the herbal stimulant made by companies including San Diego's Metabolife International.
One study widely cited by the ephedra industry as evidence of the herb's safety was reviewed by three experts who found shortcomings, indicating that the diet supplements should only be used under the supervision of a doctor or other "learned intermediary," they said in a memo released by the House Energy and Commerce Committee.
The memo to Food and Drug Administration Commissioner Mark B. McClellan concerned a six-month study of a generic ephedra formula that was funded by the ephedra industry. The FDA is weighing stricter regulation of the popular diet aids.
In a series of memos, Charles W. Prettyman of the FDA's Center for Food Safety and Applied Nutrition said the study was "not sufficient to address the safety of these products as they are used in the marketplace by the population at large."
Ephedra critics have said such studies, conducted on small numbers of patients who are carefully screened to weed out any potential health problem, don't reflect the real-world consumers who buy ephedra products. The diet pills are aimed primarily at overweight people, who may have underlying or undiagnosed medical conditions, such as high blood pressure, that make them vulnerable to potentially lethal side effects linked to ephedra, such as stroke and heart attack.
Prettyman also noted that one reviewer was concerned about the validity of the study results because of a potential mix-up in the bottles of the ephedra formula and the placebo given to test-group patients.
In testimony submitted to the committee, Carol Boozer, a Columbia University scientist who led the study, said the results were subjected to peer review and published in a reputable scientific journal.
She also said more research would be needed to determine ephedra's effects in people who "are not healthy," who take higher doses or use the herb for more than six months.
"But, at present, there is no scientific data proving that consumption of ephedra/caffeine combinations for weight loss are unsafe" when used as directed, Boozer said.
Committee spokesman Ken Johnson said, "The industry has touted this study as its Good Housekeeping Seal of Approval. But based on the evidence we have seen, it does not adequately address the safety of ephedra-based dietary products."
A spokesman for the Ephedra Education Council, an industry group, could not be reached for comment. The industry has consistently said that its products are safe and effective if used as directed.
More than a dozen witnesses, including Metabolife executives and the parents of two athletes whose deaths were linked to ephedra products made by other companies, are expected to testify before the House committee's oversight and investigations subcommittee. Committee Chairman Billy Tauzin, R-La., and subcommittee Chairman James C. Greenwood, R-Pa., have raised safety concerns about ephedra, which is largely unregulated.
Documents released by the committee this week indicate that ephedra-free products have played a larger role in Metabolife's marketing strategy as controversy and legal problems surrounding ephedra mount.
A weekly sales report in August 2002 to David Brown, who at the time was Metabolife's chief executive officer, discussed whether to introduce an ephedra-free product sooner than planned. The memo was prepared amid falling sales after disclosures that the Justice Department was investigating whether company founder Michael Ellis had lied to the FDA regarding consumer complaints about Metabolife 356, its ephedra-containing flagship product.
The memo concluded that an early introduction of the ephedra-free product might lead retailers to conclude Metabolife was in serious trouble and start removing the company's ephedra supplements from store shelves.
Retailers "believe if 356 gets pulled it will bankrupt the company and they want to protect themselves and not get caught holding inventory that we cannot reimburse them for," wrote Eric Larsen, vice president for sales and marketing. "The other issue is we don't know how much we could be scaring the consumer by having it changed out so quickly."
A June 12 memo to Brown from business consultants concludes that "Ephedra is done in the perception of the consumer (and ultimately will be killed by legal and insurance costs) and that all efforts should be to develop a scenario that is Ephedra-free and develops a better product and formula with "all the good and none of the bad.' "
Johnson said, "Publicly, Metabolife talks a lot about safety, but privately the operative word seems to be sales. The committee is deeply concerned that consumers may not be getting all the facts they need to make informed decisions."
A company representative could not be reached for comment.
The subcommittee subpoenaed Ellis, Brown and Daniel Rodriguez, described as a nurse who oversees Metabolife's call-complaint office, after they refused to appear voluntarily.
"They will be given every opportunity to tell their side of the story," Johnson said. "If they choose to plead the Fifth (Amendment) that's certainly their right, but no one is getting a free pass from this committee."
Metabolife CEO Russell Schreck and Vice President Robert Hermann are listed on the subcommittee's witness list. Also on the list is Michael Vasquez, a nurse and former Metabolife employee who has outlined in court depositions how the company handled adverse reaction reports from consumers and emergency room physicians.
Among those slated to appear are the parents of two athletes whose deaths have been linked to ephedra: 23-year-old Baltimore Orioles pitcher Steve Bechler and Sean Riggins, a 16-year-old high school football player from Illinois.
Reuters contributed to this report.