Government Will Study Ephedra Risks
DC, 14 June 2002
federal government has hired the RAND Corporation, a Washington-based
think tank, to perform a comprehensive review of studies of ephedra
(also known as ma huang). The National Institutes of Health
will use their report, due this fall, to decide how to pursue further
100 deaths and 1000 other adverse events among people using ephedra
have been reported to the Food and Drug Administration (FDA). As
the industry has been quick to point out, however, these adverse
events may be coincidental because of the large numbers of people
using ephdra in weight-loss aids or energy-boosting supplements.
Ephedra Education Council says ephedra is safe when used as directed
(see industry guidelines).
However, the Mayo Clinic published a report in January 2002 that
found some of the adverse events occurred at recommended dosage
levels. Their analysis of the FDA adverse event database found 11
sudden deaths, 16 strokes and 10 heart attacks in patients who took
products with ephedrine between 1995 and 1997.
Citizen, a consumer advocacy group, which has sought for years to
have ephedra banned by the FDA, was angered by the government's
action. Dr. Sidney Wolfe, head of Public Citizen's research department,
said everyone involved should be fired for "dangerous cowardice."
Ephedra Education Council said, "[Health and Human Services] Secretary
Thompson's call for a science-based initiative to study Ephedra
is a common-sense regulatory approach that will lead to a policy
ultimately based on science rather than speculation. Recent clinical
research and long- term usage supports the safety of ephedra, but
the industry is as interested as HHS in having more definitive data.
The Secretary's message to consumers is exactly right: Be responsible,
read the label, review the science, and make a decision that is
right for you."
FDA is also pursuing companies that sell synthetic ephedrine in
the guise of dietary supplements over the Internet. Such sales are
illegal because synthetic ephedrine is a drug, and cannot be marketed
as a supplement. Deputy FDA Commissioner Dr. Lester Crawford stated
that it looked as if many of the health problems stemming from use
of ephedra were due to these synthetic products rather than the
the adverse events associated with ephedra are coincidental or due
to ephedra use is not yet scientifically known, since both sides
of the debate cite reputable scientific evidence to support their
position. However, ephedra is definitely a potent herb with cardiovascular
effects. Those who chose to use it are well advised to be closely
monitored by their physician.
news, 14 June 2002.
Education Council via PR Newswire, 14 June 2002.
news, 17 June 2002.