Experts, Senator Criticize Ephedra; FDA Cracks Down on Illegally Promoted Ephedra Product
By Paul Recer The Associated Press
Published: Oct 8, 2002
WASHINGTON (AP) - The numerous reports of death and illness among users of dietary supplements containing the herb ephedra show the government must ban the unrestricted sales of such products, a panel of experts testified Tuesday before Congress.
Ephedra, the experts told a Senate subcommittee, has been linked to heart attacks and strokes and has not been proven to have any valid medical purpose. They urged the Food and Drug Administration to remove the products from the market.
“It is beyond dispute that ephedra has triggered heart attacks and death,” said Bill Jeffery of the Centre for Science in Public Interest in Ottawa, Canada. He said supplements with ephedra are banned in Canada, which classifies the herb as a “class 1 health risk.”
Ephedra supplements are promoted as useful in losing weight and increasing athletic performance, but Dr. Ronald M. Davis of the American Medical Association said his organization believes the claimed benefits “do not outweigh the risks.”
"The weight of the available clinical evidence supports the removal of dietary supplement products containing (ephedra) from the market," Davis told the Senate Government Operations oversight panel.
But a lawyer representing Metabolife International Inc., an ephedra supplement maker, disputed the criticism, saying that product is safe and effective when used as directed by adults.
Testimony indicated the U.S. armed services have already banned ephedra products from being sold on military posts. The National Collegiate Athletic Association has banned its use by student athletes and the National Football League has banned its use by the pros. Canada, the United Kingdom and Germany all prohibit sales of the drug.
And, yet, said Sen. Dick Durbin, D-Ill., ephedra-laced supplements continue to be readily available in the United States and are frequently used by young people.
Durbin, who chaired the hearings, said one of his constituents, 16-year-old Sean Riggins, a football player in Lincoln, Ill., died of a heart attack last month after taking an ephedra-laced supplement called Yellow Jackets.
He said there have been thousands of other adverse health reports linked to ephedra, along with studies in the New England Journal of Medicine and at the Mayo Clinic connecting ephedra with heart attacks, strokes and high blood pressure.
Durbin said Metabolife claimed it had received no reports of adverse health effects from its products, but last month the company gave the FDA copies of more than 13,000 adverse event reports, including three deaths, 20 heart attacks and 24 strokes.
But Lanny Davis, a Washington lawyer representing Metabolife, said conclusions about the adverse health events from the company product are based on “unverified telephone calls.” Scientific studies show that “when used as directed by adults,” the Metabolife ephedra supplement is “safe and effective,” he said.
Davis said Metabolife favors FDA regulations that would ban promoting ephedra products as “street drug” alternatives, limit the sales to adults, mandate warning labels and require reporting of adverse health events.
He said there was no requirement for his company to report the adverse events and said that some of the reports are clearly not related to the safety of ephedra. Furthermore, he said there have been no studies that scientifically prove that ephedra causes harm.
"We need science," said Davis, "not junk science."
Young people, particularly athletes, buy the supplements because they are promoted to improve performance or to control weight. Ephedra is known to constrict blood vessels, raising blood pressure and pulse rates. Among some young people, the drug is used to stay alert after long study sessions or to sharpen reflexes on the ball field, witnesses said.
“We have mountains of evidence that this drug is not safe and these manufacturers are being irresponsible about their marketing practices,” said Durbin. “Ephedra is not safe and should be taken off the market.”
He said the FDA and Health and Human Services Secretary Tommy Thompson should “use their authority to suspend sales of the product in the U.S. until we can ensure that it is safe.”
Durbin said he suggested that in a letter to Thompson in August.
“When I sent that letter, Sean Riggins was still alive,” Durbin told Lester M. Crawford, FDA’s deputy commissioner. “Why hasn’t there been a good faith effort to order suspension (of sales of the supplement)? The clear and prudent thing is to take this off the shelf. This is a killer.”
“The burden is on us,” replied Crawford. “Once we take an action, we have to be able to sustain it.”
He said the agency has “stepped up our efforts,” but it needs to complete a study before it can take action that might lead to a suspension.
The FDA on Monday did stop imports of Yellow Jackets, which was blamed for Riggins’ death. The agency said a Dutch organization was touting the pills on a Web site as a substitute for street drugs. The FDA said it is illegal to market dietary supplements as alternatives to cocaine and other street drugs.
The agency took action against Yellow Jackets based on illegal marketing, not ephedra safety, he said.
Crawford testified that agency inspectors were denied admission when they tried to inspect a New Jersey plant where Yellow Jackets are made, so the agency is seeking a court order to gain access.
Under a 1994 federal law, the FDA cannot regulate dietary supplements the same way as it does pharmaceuticals. The agency requires drug manufacturers to prove their products are safe and effective. But the burden of proof is reversed for dietary supplements. Before a dietary supplement can removed from the market, the FDA must prove it is not safe.
Crawford said the FDA is still working on rules that would regulate the diet supplement industry, but it could take four more years before they are in force.