July 24, 2003
Metabolife execs take the Fifth
Other company officials defend safety of ephedra before skeptical House panel
COPLEY NEWS SERVICE
WASHINGTON – A House panel shined a harsh spotlight on the ephedra industry yesterday, with some lawmakers citing reports of deaths, heart attacks and other side effects to call for strictly regulating or even banning the herbal stimulant.
"It kills," Rep. John Dingell, D-Mich., said of the popular dietary supplement, which is marketed as a diet aid and energy booster.
Three executives from Metabolife International, including the founder of the San Diego supplement maker, refused to testify at the hearing, invoking their constitutional right against self-incrimination and citing other pending investigations. The Justice Department and the Internal Revenue Service are investigating the company.
Other Metabolife executives and their counterparts from two different herbal-supplement companies said the reports of ephedra's ill effects were "anecdotal" and that the supplements were safe for most consumers if used as directed. Reports of health problems associated with common over-the-counter drugs like aspirin and other pain relievers number in the hundreds of thousands every year, they said.
"Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products," Metabolife Chief Executive Russell Schreck told the House Energy and Commerce subcommittee on oversight and investigations.
But a congressional investigation of consumer complaints about the company's flagship product, Metabolife 356, found that "most of the reported serious adverse events occurred among consumers who followed the usage guidelines on the ... label."
More than one-third of the reports of serious side effects involved consumers under age 30, the General Accounting Office said. But the GAO also cautioned that only 44 percent of the reports of serious adverse effects provided by Metabolife included information on the consumer's age, 40 percent contained information about dosage, and 55 percent had data about duration of use.
Metabolife Vice President of Operations Robert Herrmann told the subcommittee that the company's consumer information line "was never intended to be a reporting system for adverse health events."
"The information line was merely intended to be a means for our customers to ask general questions about the proper use of our products and assist them in weight-loss questions," he said.
Michael Vasquez, a registered nurse who said he worked at Metabolife's help information call center between August and November 1999, told the subcommittee that he took seven to 10 reports of adverse effects a day, including some from emergency room physicians wanting to know the ingredients of Metabolife products.
The reports "made us wonder whether the product was safe to take or whether the callers were really telling the truth or not," said Vasquez, who acknowledged having a work-injury case pending against Metabolife.
Testifying from San Diego by video hookup, Vasquez said his job seemed more "like a telemarketer" and the staff was told to be on "heightened security alert" in case of calls from federal food and drug authorities, which were to be transferred to Metabolife's legal department.
Herrmann told the subcommittee, "Clinical trials, not call records from consumers, are the only sound method to evaluate the safety and efficacy of dietary supplements containing ephedra. To my knowledge, there is not a single well-controlled clinical study which demonstrates that ephedra supplements are unsafe when taken as directed."
When subcommittee Chairman James Greenwood, R-Pa., sought to question Vasquez's supervisor, Daniel Rodriguez, about whether nurses were instructed "not to obtain critical information about these adverse health effects" from callers, Rodriguez invoked his Fifth Amendment right against self-incrimination.
Metabolife founder Michael Ellis and former Chief Executive David Brown also refused to testify when Greenwood asked whether Metabolife "put sales above safety" and why it took "several years for Metabolife to send in to the (Food and Drug Administration) 14,000 customer complaint call records . . . after years of insisting that Metabolife had received no such reports."
Later in the hearing, Herrmann told the lawmakers, "I can't believe that anybody would intentionally mislead the FDA or anybody else regarding our products."
The daylong hearing delved into virtually every aspect of the ephedra industry, from its marketing and safety claims to the ingredients used in its products. A second hearing is scheduled for today.
The hearings come as the FDA considers whether to impose stricter regulations on ephedra products, which are largely unregulated under a 1994 law that governs dietary supplements. Some lawmakers, including Rep. Susan Davis, D-San Diego, have introduced legislation to impose controls including mandatory reporting of adverse reactions, strong warning labels and a ban on sales to minors.
The February death of Baltimore Orioles pitcher Steve Bechler, whose heat stroke was linked to his use of an ephedra supplement, heightened concerns over the supplement's safety.
The parents of Bechler and high school football player Sean Riggins of Lincoln, Ill., whose 2002 heart attack death also has been linked to ephedra, urged the lawmakers to crack down on the industry.
"How many Steve Bechlers and Sean Riggins have to die to prove that these (products) are not safe?" said Pat Bechler, a picture of her 23-year-old son propped before her.
"Ephedra is dangerous; it kills, and it needs to be off the market," said Kevin Riggins, Sean's father.
While expressing sympathy for Bechler's family, the head of the New Jersey company that made the supplement Bechler took, Xenadrine RFA-1, said it "did not cause or contribute to Steve Bechler's death."
In testimony submitted to the committee, Nutraquest President Robert Chinery cited the conclusions of a medical examiner hired by the company who said Bechler's heat stroke was caused by "morbid obesity, high blood pressure and heart disease, adverse weather conditions" and other physical and medical factors.
Greenwood called the testimony "terribly misleading," saying Bechler was 10 pounds overweight.