Expectations are high that Health & Human Services Secretary Tommy G. Thompson will hustle to control the sale of ephedra-laced products, now largely unregulated by the Food & Drug Administration. The agency is evaluating thousands of reports of adverse reactions to ephedra, a Chinese herb also known as ma huang, and is awaiting the results of a government-commissioned Rand Corp. study. "When all that is done, we expect some further appropriate action," new FDA Commissioner Dr. Mark McClellan told BusinessWeek on Feb. 25.
Based on preliminary findings, Bechler's death may have been partly caused by the ephedra supplement he was allegedly taking, Xenadrine RFA-1. Ephedra contains substances known as ephedrines, chemical cousins of amphetamines that are also in FDA-regulated drugs like Sudafed. These supplements elevate heart rates and blood pressure and have been linked to scores of deaths and thousands of injuries. Doctors, public health groups, and some FDA staffers have been pushing for stricter regs for years--only to be blocked by industry friends on Capitol Hill, where companies such as Metabolife have spread around millions in campaign gifts. The stakes are high: Sales of ephedra products are about $3 billion a year.
Hill sources say that Secretary Thompson has complained in the past that he couldn't take action because of White House support for the industry, which insists that ephedra supplements are safe if taken as directed. Now, "If the FDA doesn't do something here, they will look very bad," warns Dr. Stephen Bent of the University of California at San Francisco, co-author of a new study showing that ephedra is 100 times more dangerous than other herbal products.
Ephedra foes hope Bechler's death will give Thompson and the FDA enough political cover to finally crack down. "We are going to take action based on what science has to say about unreasonable risks," Dr. McClellan says. Thompson asks bluntly: "I wouldn't use [ephedra], would you?" Even industry supporter Senator Orrin G. Hatch (R-Utah) concedes that regulation may be necessary if the FDA proves there's a danger.
The supplement industry was able to quash regulations proposed by the FDA in 1997, but in the wake of Bechler's death, legal experts say that it could face mass torts and that agreeing to FDA oversight would help in court. That's another reason why it's likely that the FDA will soon require strong warning labels and dosage limits. Such rules would fall short of the ban many public health advocates want. But they would be the first steps the feds have taken against ephedra--and a sobering reminder that it often takes a high-profile tragedy to get Washington's attention. By John Carey in Washington