U.S. Orders Safety Study of EphedraJun 17, 2002 | AP
The Bush administration is ordering a new safety review of the herbal stimulant ephedra, outraging doctors who say the supplement has been linked to dozens of deaths and should be banned.
Friday's announcement comes two years after federal health officials began working toward warning labels, and means a delay in any tightening of ephedra rules.
"This is a black day in medicine," said Dr. Raymond Woosley, vice president of health sciences at the University of Arizona. Ephedra is clearly linked to heart attacks and strokes, he said.
Supplement makers praised the decision.
Clinical trials done over the years show the products are safe, said Wes Seigner, attorney for the Ephedra Education Council.
Also Friday, the Food and Drug Administration ordered six companies illegally selling synthetic ephedrine in the guise of an herb to stop. The synthetic form of ephedrine has long been outlawed, and the FDA for years has sought to stop such sales, which occur mostly over the Internet.
The FDA ordered a seventh company to stop selling "energizing herbs," including high ephedra doses, as alternatives to LSD, cocaine and other illegal drugs. The Web site advertises "legal speed" and products that "felt like an acid trip," claims that FDA rules prohibit.
More controversial is the legal use of ephedra — the actual herb, not chemical cousins — for weight loss and body building.
At least 54 deaths and about 1,000 reports of complications have been linked to the popular supplement since the mid-1990s, according to an analysis in the New England Journal of Medicine two years ago.
One theory is that the herb, especially when combined with caffeine or exercise, overstimulates the heart.
There now are 100 reported deaths, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.
Federal law forbids most regulation of dietary supplements unless the FDA proves danger. Three years ago, citing death reports, the agency attempted to bar certain high ephedra doses. Industry protests killed the move, and a General Accounting Office report said that while ephedra clearly was risky to some people, the FDA's statistics were sloppy.
So FDA officials reanalyzed and began working toward warning labels. Public Citizen petitioned for a ban.
Instead of deciding on either option, the Department of Health and Human Services hired Rand Corp. to review all scientific reports on ephedra's safety. Results are due this fall, when the National Institutes of Health will determine what additional research is needed.
Canada a year ago warned consumers not to use ephedra, and the National Football League banned it. The U.S. military, citing the deaths of several supplement-using soldiers, has issued cautions. Wolfe provided the FDA with a Fort Hood, Texas, directive last month asking officers "to identify their soldiers using these supplements and strongly discourage their use under any circumstances."
"The world knows these things are toxic. What's wrong in Washington?" asked Woosley, who recalled treating a 30-year-old ephedra user left mute by a stroke. "Her husband looked at me and said, 'Why didn't the FDA tell us?' and I didn't have an answer."
Manufacturers counter that reports of sick patients don't count as proof an herb is risky; the illnesses could be coincidence, they say.
Wolfe said prescription drugs are banned on the basis of such reports and herbs shouldn't be held to a different standard.
The controversy won't dissipate without additional research, said Dr. Neal Benowitz of the University of California, San Francisco. He plans a study comparing ephedra users to people of similar age and background, a common means of proving risk.
The industry group, meanwhile, supports a warning label that cautions certain people, such as children and pregnant women, not to use ephedra.
HHS adds that consumers with high blood pressure, heart or thyroid disease, depression, a seizure disorder, diabetes, prostate enlargement or glaucoma should consult a doctor before taking ephedra.