American Botanical Council Recommends Cooperative Industry/Government Review of Safety and Benefits of Herb Ephedra
(Austin, TX. Dec. 21, 2000) The nonprofit American Botanical Council has called for continued access to ephedra to permit industry and government to cooperate in further review of the potential risks and benefits of the popular but controversial herb ephedra. New research revealed at a press conference on Wednesday in Washington, D.C. provides important additional support for existing clinical data, which suggests that ephedra, widely used in numerous dietary supplements, is safe and effective when used for weight loss. Recent research shows that about half of adult Americans are overweight and about 18 percent are obese.
The results of the Harvard-Columbia study and Cantox report discussed at the press conference differ from the results of a paper published Thursday in the New England Journal of Medicine. In that paper Drs. Christine Haller and Neal Benowitz of the University of California at San Francisco evaluated 140 adverse event reports (AERs) that were reported by FDA to be attributed to the use of ephedra supplements. Haller and Benowitz concluded that 31 percent of these AERs were definitely or probably associated with the herb, while the rest of the 69 percent were either possibly associated or were not associated with ephedra.
Haller and Benowitz's NEJM article failed to mention that theirs was one of six reviews performed for the FDA on these 140 reports. "The differing conclusions from these reports suggest that there is considerable disagreement among qualified scientists about the validity of some of these reports and the safety and benefits of ephedra, even among FDA's hired consultants, said Mark Blumenthal, founder and executive director of ABC in Austin, Texas. The Cantox report discounted the ephedra reports as "not useful" for the purpose of establishing safe serving levels or making public health decisions, choosing instead a quantitative assessment based on controlled clinical studies.
"Because of this lack of consensus among scientists, we urge industry groups, the FDA, and the National Institutes of Health to work together cooperatively to review all the available scientific and medical evidence on the safety and potential benefits of ephedra," said Blumenthal. "This type of private-public partnership is much needed. There is clearly some potential utility for ephedra in weight loss but the safety issue needs further research," he said. In October a coalition of industry trade groups offered to work with FDA and the NIH to support more research in this area.
ABC's policy is that ephedra products should be properly labeled with adequate warnings that offer a full disclosure of potential risks. Herb industry trade associations initiated voluntary label warnings on ephedra in 1994. In October, a coalition of industry associations formally petitioned FDA to accept the industry's label warning as formal policy. The warning says that persons with the following conditions should not use the herb without medical advice: pregnant and nursing women, people with high blood pressure, heart disease, diabetes, thyroid disease, glaucoma, psychiatric conditions, depression, children under 18, and people using various over-the-counter and prescription drugs.
Founded in 1988 in Austin, Texas, the American Botanical Council is the leading independent non-profit research and education organization that educates the public on the responsible and scientific use of medicinal plants. Its quarterly journal HerbalGram has been published since 1983 as a reliable and authoritative source of herb and medicinal plant research, regulatory and market issues, native plant conservation and other general interest aspects of herb use. Information for consumers and healthcare professionals about herbal medicine may be found on the organization's website www.herbalgram.org.