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WASHINGTON, June 14 — Two years after federal health officials wanted warning labels on ephedra, the Bush administration instead is ordering a start-from-scratch safety review of the herb that has been linked to dozens of deaths.
THE MOVE prompted outrage from consumer advocates and doctors who want ephedra banned, citing the dietary supplement’s link to heart attacks and strokes.
“This is a black day in medicine,” said Dr. Raymond Woosley, vice president of health sciences at the University of Arizona, who called the risk clear enough that further study would be unethical.
But supplement makers, including leading ephedra marketer Metabolife International, praised the decision.
“Clinical trials that have been 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 ephedra has long been outlawed, and the FDA for years has sought to stop such sales, which occur mostly via the Internet.
The FDA ordered a seventh company to stop selling “energizing herbs,” including high ephedra doses, as alternatives to LSD, cocaine and other street 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 bodybuilding.
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An analysis in the New England Journal of Medicine two years ago said at least 54 deaths and about 1,000 reports of complications have been linked to the popular supplement since the mid-1990s. 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.
INDUSTRY PROTESTS
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, so officials instead began pushing for warning labels — and then Public Citizen petitioned for a ban.
Health and Human Services Secretary Tommy Thompson announced Friday that instead of deciding that petition now, the government had 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 FDA 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?” said 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.
But Wolfe responds that prescription drugs are banned on the basis of such reports and herbs shouldn’t be held to a different standard.
CALL FOR MORE RESEARCH
Still, 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. Consumers or doctors can report ephedra-associated side effects by calling FDA at 1-800-MEDWATCH
THE MOVE prompted outrage from consumer advocates and doctors who want ephedra banned, citing the dietary supplement’s link to heart attacks and strokes.
“This is a black day in medicine,” said Dr. Raymond Woosley, vice president of health sciences at the University of Arizona, who called the risk clear enough that further study would be unethical.
But supplement makers, including leading ephedra marketer Metabolife International, praised the decision.
“Clinical trials that have been 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 ephedra has long been outlawed, and the FDA for years has sought to stop such sales, which occur mostly via the Internet.
The FDA ordered a seventh company to stop selling “energizing herbs,” including high ephedra doses, as alternatives to LSD, cocaine and other street 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 bodybuilding.
Advertisement
An analysis in the New England Journal of Medicine two years ago said at least 54 deaths and about 1,000 reports of complications have been linked to the popular supplement since the mid-1990s. 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.
INDUSTRY PROTESTS
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, so officials instead began pushing for warning labels — and then Public Citizen petitioned for a ban.
Health and Human Services Secretary Tommy Thompson announced Friday that instead of deciding that petition now, the government had 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 FDA 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?” said 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.
But Wolfe responds that prescription drugs are banned on the basis of such reports and herbs shouldn’t be held to a different standard.
CALL FOR MORE RESEARCH
Still, 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. Consumers or doctors can report ephedra-associated side effects by calling FDA at 1-800-MEDWATCH
