Washington,
DC (April 5, 2000)---How valid are the reports of adverse
reactions from people using popular dietary supplements containing
Ephedra? The U.S. Food and Drug Administration, which has
been severely criticized for using these reports previously
to propose limiting consumption of Ephedra, released a new
set of reports on Friday.
Dr. John
N. Hathcock, Vice President, Nutritional and Regulatory Science,
Council for Responsible Nutrition, said today that all new
adverse event reports need to be carefully analyzed before
any conclusions about the safety of Ephedra should be reached
by FDA or the public. Hathcock pointed to four key questions
that should be asked by the media and others who review the
new AERs:
- How
many reports contain sufficient evidence to be scientifically
valid and useful?
- How
many of the events relate to persons who followed label
instructions for use and complied with label warnings?
- After
the AERs are screened for scientific completeness, validity,
and proper use, how do the remaining incidences compare
with the amount of Ephedra consumed in this country?
- What
is the incidence of each serious health problem among users
of Ephedra compared with non-users?
Scientific
experts who reviewed the previous reports, released in 1997,
found that they were too incomplete or flawed to connect the
health problems reported with consumption of Ephedra used
according to directions. Moreover, these reports, they said,
were insufficient as a matter of scientific methodology to
recommend specific dosage levels. The General Accounting Office
and the Small Business Administration agreed, which led FDA
to take the unprecedented step of withdrawing major portions
of a proposed rule.
Based
upon extensive analysis of previous AERs and a preliminary
evaluation of the new AERs, scientific experts continue to
conclude that Ephedra is safe when used according to label
directions. Moreover, these limited number of adverse reactions
must be evaluated against the millions of consumers who have
taken billions of servings of Ephedra safely and appropriately.
In FDA's
assessment of the new adverse event reports for Ephedra, FDA's
Center for Food Safety and Applied Nutrition appears to have
once again conducted a risk assessment with insufficient data.
FDA has failed to consider two essential pieces of information
-- the number of consumers of Ephedra, and the direct relationship
between Ephedra consumption and alleged health concerns, as
compared with non-Ephedra consumers.
FDA's
own Center for Drug Evaluation and Research, which is expert
at assessing adverse events, reviewed the same reports as
FDA's Center for Food Safety and Applied Nutrition, and in
a memorandum dated March 28, 2000, reached a very different
conclusion:
"[I]t
is possible that the reported serious adverse events are
reflective of coincidental background spontaneous occurrences
in the population and are not necessarily causally related
to [Ephedra] product uses. The availability of additional
information, including product market or usage data, would
be useful to further characterize the potential risks associated
with the use of these products."
The missing
information is available, but FDA's Center for Food Safety
and Applied Nutrition has not collected it. FDA's actions
have led reasonable experts to question why FDA has again
tried to reach a conclusion about the safety of Ephedra without
collecting the data.
The Ephedra
Education Council (EEC) provides factual information to the
media and public about dietary supplements containing Ephedra.
The EEC is supported by members of the Ephedra Committee of
the American Herbal Products Association.
For more
information on Ephedra, logon to www.EphedraFacts.com.
