- The Washington Times - Wednesday, July 23, 2003


Congress needs to rewrite a 1994 law that has hampered health officials’ ability to deal with herbal supplements such as ephedra, the stimulant linked to numerous deaths and various side effects, Health and Human Services Secretary Tommy Thompson said yesterday.

Makers of dietary supplements should have to file reports with the Food and Drug Administration on side effects possibly linked to their products — just as makers of drugs have to, said Mr. Thompson as, across town, Congress opened two days of hearings into ephedra’s risks.

The 1994 law, which left dietary supplements largely unregulated, precludes revealing side effects that have played a key role in the controversy over ephedra, which was thrust into the spotlight following the February death of Baltimore Orioles minor-league pitcher Steve Bechler. The medical examiner said ephedra in a weight-loss product contributed to the pitcher’s death.

The government is investigating whether one leading manufacturer, Metabolife International, lied about ephedra’s safety by withholding from the FDA until last year 16,000 customer complaints — including dozens of reports of heart attacks and other serious problems.

“FDA is somewhat hampered,” Mr. Thompson said, calling on Congress to revise the law. “We are unable to really do as effective a job as possible.”

Mr. Thompson and FDA Commissioner Mark McClellan wouldn’t say if a ban of ephedra is possible.

The ephedra industry has long claimed that people reporting health problems after taking ephedra didn’t use it properly. But many of those people did follow label instructions — and many complaints came from users under age 30, the General Accounting Office said yesterday in testimony before the House Energy and Commerce oversight subcommittee.

Marcia Crosse, the GAO’s acting director of health-care, public-health and science issues, said the reports of health problems made to drug-maker Metabolife International included heart attacks, strokes and seizures. Five deaths also were reported.

Miss Crosse also noted the FDA has received more reports of problems with ephedra than any other supplement. She said the average age of those who included an age when they called was 38, with ages ranging from 17 to 65. More than one-third were under 30.

In a statement submitted to the subcommittee, Metabolife said the company “strongly believes in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed.”

Testifying before the subcommittee was Kevin Riggins, whose 16-year-old son, Sean, died of a heart attack blamed on ephedra.

“The little packages, which promote weight loss, performance and energy enhancement, were being sold right next to the Twinkies and candy bars,” Mr. Riggins said in his prepared testimony. “The use of these products was so casual, none of the kids believed they were taking a drug.”

The FDA is sifting through 16,000 comments responding to its March proposal to order warning labels on bottles of ephedra. The FDA has not tried to ban the product, despite reports of more than 100 deaths being linked to the herb, citing the 1994 law.

In May, Illinois Gov. Rod Blagojevich signed the nation’s first statewide ban on ephedra.

Kiley Bechler, the pitcher’s widow, filed suit in federal court last week against the manufacturer and distributor of the supplement containing ephedra that was found in her husband’s locker.

Medical Examiner Joshua Perper in Fort Lauderdale, Fla., where Mr. Bechler died, said ephedra in the weight-loss supplement Xenadrine RFA-1 contributed to the heatstroke that killed the pitcher.

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