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Ephedra Industry Insists Herb Is Safe

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Times Staff Writer

The ephedra industry, disputing reports linking the herbal stimulant to the death of Baltimore Oriole pitcher Steve Bechler, insisted Thursday that its product is safe and, as proof, pointed to the lack of government action to restrict its use.

“We take our lead from the government, from [Health and Human Services Secretary] Tommy [G.] Thompson, that ephedra should remain in the hands of consumers,” said Dr. Carlon M. Colker, a physician and nutrition specialist who spoke to reporters at a news conference sponsored by the Ephedra Education Council, an industry group.

U.S. officials, meanwhile, continued to send mixed messages about the weight-loss herb and in their response to thousands of reports of ephedra-related health problems.

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A day after Thompson told reporters he would not use ephedra products, Food and Drug Administration chief Mark McClellan had this warning: “This product does have effects on the metabolic rate, on the heart rate.... It can be a particular problem for people who engage in strenuous activity. People should be cautious.”

Yet McClellan’s “buyer beware” remark may well be the FDA’s last official word on ephedra for awhile, despite renewed calls from longtime critics -- including consumer groups and some lawmakers -- for a government ban on the stimulant, also known as ma huang.

A federal law passed by Congress in 1994 severely limits the government’s power to regulate dietary supplements.

Still, McClellan said he hoped “there are some things we can do quickly” if the government receives more solid scientific evidence of ephedra’s dangers. A government-commissioned report by the Rand Corp., due within weeks, could fill the holes in previous scientific research and perhaps lead the National Institutes of Health to design a more definitive study of the herb, officials said.

In addition, McClellan said, HHS and FDA officials expect to announce “within three to four weeks” stronger warning labels for ephedra products and new regulations to create uniform manufacturing standards for all dietary supplements.

Industry officials, as well as experts speaking on the industry’s behalf, said Thursday that no further regulatory action is warranted.

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“Ephedra is popular because it works,” said Wes Siegner Jr., general counsel of the Ephedra Education Council.

Siegner, Colker and Richard B. Kreider, chairman of Baylor University’s Exercise & Sport Nutrition Laboratory, strongly objected to preliminary reports that Bechler’s death Monday was caused by ephedra.

“At this point, we have no solid evidence that Steve Bechler actually consumed ephedra,” Siegner said. “But even if he did, there is no evidence it contributed to his death.”

Colker and Kreider noted that Bechler was overweight, and they cited other factors that could have caused his heatstroke, including earlier heat-related illnesses, possible dieting and “being pushed too hard” in training. Ephedra, “taken as directed by appropriate individuals, does not lead to heatstroke,” Colker said.

“The impact of ephedra on body temperature is minimal and, in my view, could not have been a factor in this incident,” Kreider said.

The men also blamed “speculation,” “media spin” and “other parties” looking for something to blame for the early reports linking Bechler’s death to ephedra use.

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A bottle of Xenadrine RFA-1 was found in his locker after he collapsed and died in Fort Lauderdale, Fla., where the Orioles are conducting spring training.

Kreider referred to the thousands of reports linking ephedra to heart attack, stroke, high blood pressure and death as “anecdotes that can’t be substantiated.”

Bill Pierce, a spokesman for Thompson, agreed that “adverse event reports don’t tell us everything. They’re just one piece.”

That’s why the administration is putting so much hope in the Rand report, which it commissioned in June 2001.

If the report succeeds in sorting the good science of previous studies from the bad, it could provide the basis for government action, Pierce and McClellan said.

But the regulatory burden on the U.S. is significant, said an FDA official who spoke on condition of anonymity.

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When Congress passed the Dietary Supplement Health and Education Act of 1994, it believed that such supplements, which at the time consisted largely of vitamins, had a history of safe use.

In addition, campaign contributions from the industry doubled that year, and they have increased markedly ever since, according to federal election data collected by the nonpartisan Center for Responsive Politics. In the 2000 election cycle, the last one for which reporting is complete, nutritional and dietary supplement makers made almost $2.3 million in political contributions.

While manufacturers of prescription drugs must prove scientifically that their products are safe to get government approval for marketing, the 1994 law requires the government to prove that dietary supplements are unsafe before imposing any labeling or use restrictions.

Consumer groups and some lawmakers for years have called on the government to take ephedra off the market, and the National Football League, the NCAA and the International Olympic Committee have forbidden its use.

But the government can ban dietary supplements only by proving scientifically that they are an “imminent hazard” or pose a “significant or unreasonable risk to public health and safety,” the FDA official said.

U.S. sales of ephedra products total roughly $3 billion a year, and the Ephedra Education Council reports that 15 million consumers a year take the herb.

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