- The Washington Times - Wednesday, June 19, 2002

An herbal supplement commonly used to aid weight loss but linked to heart attacks and strokes is headed to the lab for scrutiny.
The Department of Health and Human Services has commissioned a safety review of the herbal stimulant ephedra, which is popular among dieters as well as truckers, college students and professional athletes because it can increase energy and help stave off sleep.
"By increasing our breadth of knowledge about these supplements, we can give consumers the information they need to make informed decisions about these products," HHS Secretary Tommy G. Thompson said in announcing the review Friday.
Ephedra, also called ma huang, speeds the heart rate by stimulating the central nervous system soon after entering the bloodstream. It has been linked to heart attack, stroke, tachycardia (speeding heart rate) and palpitations, especially when combined with caffeine or exercise.
It is found in diet pills, illegal recreational drugs and legitimate over-the-counter medications used to treat congestion and asthma. The Rand Corp. will perform the study.
The activist group Public Citizen, which in September petitioned for a ban on all dietary supplements containing ephedra, denounced the decision to revisit its safety and said the Food and Drug Administration and HHS were "responsible for this dangerous cowardice."
Public Citizen claims the number of ephedra-related deaths, most of which have been cardiovascular-related, has risen to 100 from the 54 reported two years ago in the New England Journal of Medicine.
Those in favor of keeping ephedra available say the research clearly shows some people can use the supplement safely.
"HHS says whatever decision we make needs to be science-based. We applaud that philosophy," said John Cordaro, president and chief executive of the Council for Responsible Nutrition, which commissioned a comprehensive study of ephedra in 2001. "I applaud the regulators and everyone involved that's been looking at the quality of the science."
So long as product labels inform consumers that ephedra is not for everyone, point out the subpopulation that should not be using ephedra, including anyone younger than 18, and identify daily dose and duration of use, Mr. Cordaro said, ephedra need not be banned.
The Food and Drug Administration says anecdotal claims of ephedra's dangers are not enough to warrant federal regulation of the herb. Under the Dietary Supplement Health & Education Act of 1994, the FDA must screen all supplements for safety, but it cannot regulate a dietary supplement unless it is proven harmful.
To those who believe ephedra is a drug and must be regulated as such, this arrangement is dangerous for a vulnerable public.
"Ephedra should be strongly regulated or taken off the market," said Dr. Stephen Sinatra, a cardiologist based in Manchester, Conn. Because "people on the street don't have a physician talking in their ear," many of them may be part of the at-risk group who have other conditions or take other medications that could mix with ephedra for a deadly result."
Others in the anti-ephedra camp, who are vocal on the Internet, say it has killed and hurt enough people to prove it is unsafe.
"Have you been injured by ephedra? Click here," reads www.ephedraattorney.com, Web site of New Jersey-based lawyer Joseph R. Santoli. On www.ephedrainjury.com, a section is dedicated to the case studies of those who have suffered permanent injury to the heart and brain after taking ephedra.
Among those against a ban on the supplement is the Ephedra Education Council, a group backed by the American Herbal Products Association, which is in favor of "the safe and responsible marketing of dietary supplements." Its Web site, ephedrafacts.com, asserts the herb is safe when taken as directed.
Wes Seigner of the ephedra council called ephedra a "convenient fall guy" for the National Football League and other organizations blaming the herb for recent reports of athlete deaths linked to the use of ephedra-boosted sports supplements.
The council said that while no solid numbers are available, retail sales of ephedra bring in an estimated $1 billion to $3 billion annually.


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