HHS: Congress Should Rewrite Ephedra Law
Congress Should Rewrite Law Hampering Ability to Regulate Herbal Supplements, Health Chief SaysJul 23, 2003 | AP
Congress should rewrite a law that rolled back dietary-supplement regulations and require manufacturers to acknowledge potential side effects, Health and Human Services Secretary Tommy Thompson said Wednesday.
Thompson's comments came as the House Energy and Commerce oversight subcommittee opened two days of hearings on the supplements, with a particular focus on ephedra, often promoted as a weight-loss product. Ephedra has been linked to as many as 100 deaths.
Ernie and Pat Bechler, the parents of Baltimore Orioles pitcher Steve Bechler, were among those who testified. Their son died during spring training last February. He had been trying to lose weight, and toxicology tests after his death showed ephedra in his system.
Kevin Riggins, whose 16-year-old son, Sean, died of a heart attack while taking ephedra, also testified.
"How many Steve Bechlers or Sean Rigginses have to die to prove that these are not safe?" Mrs. Bechler said, sitting behind a framed picture of her son in his Orioles uniform, her voice cracking. "We need to get this off the market. We need to help our children."
In a statement submitted to the subcommittee, San Diego-based nutritional supplement-maker Metabolife International said it "strongly believes in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed."
But several scientists said that it was impossible to prove whether ephedra was safe because studies screen out participants who have health problems the people most likely to be hurt by the product.
The General Accounting Office, Congress' investigative arm, looked into the issue and found many people who reported problems had followed the label's instructions.
Marcia Crosse, the GAO's acting director of health care-public health and science issues, said the health problems reported to Metabolife included heart attacks, strokes and seizures. Five deaths also were reported.
Crosse said the problems reported to Metabolife "are consistent with the types of adverse events reported to FDA and with the documented physiological effects of ephedra." The records of calls to Metabolife, she said, "contain reports of serious adverse effects in consumers who were young and among those who used the product within the recommended guidelines."
Crosse also noted the Food and Drug Administration has received more reports of problems from ephedra than from any other supplement.
A 1994 law left dietary supplements largely unregulated. The FDA has said the statute prevents it from banning such products.
Thompson said makers of dietary supplements should have to tell the FDA about potential side effects, just as drug makers do. He urged Congress to revise the 1994 law.
"FDA is somewhat hampered," Thompson said. "We are unable to really do as effective a job as possible."
A subcommittee member, Rep. Greg Walden, R-Ore., has co-sponsored legislation to amend the law.
"I don't think that the FDA is properly equipped to quickly deal with an issue of this magnitude," Walden said. "While somebody does a study to figure out if something is safe or not, we let people get injured before we decide to act. The burden of proof should be on the manufacturer, not the consumers who suffer stroke, heart attacks and death, all of which is associated with these ephedra-based products."
Rep. Henry Waxman, D-Calif., a member of the subcommittee, said he favors changing the law.
"They claim they don't have sufficient legal authority," Waxman said of the FDA. "That may be an excuse, and I don't want them to have the excuse."