HHS To Investigate Ephedra Safety, Efficacy
WASHINGTON--On June 14, Secretary of Health and
Human Services (HHS) Tommy Thompson reported the department will expand its
research efforts on ephedrine alkaloids while aggressively pursuing the illegal
marketing of non-herbal synthetic ephedrine products.
"It is crucial that we have a full understanding of these
dietary supplements," Thompson said. "By increasing our breadth of
knowledge about these supplements, we can give consumers the information they
need to make informed decisions about these products."
The Food and Drug Administration reportedly advised HHS (www.hhs.gov)
that adverse event reports (AERs) would not provide a good enough scientific
basis for assessing the safety of ephedra products, and there is a need for
further research. HHS announced it recently contracted the RAND Corp., based in
Santa Monica, Calif., to conduct a comprehensive review of the existing science
behind ephedra, especially in dietary supplements. The meta-analysis is expected
to be completed by early fall, according to HHS, at which point the National
Institutes of Health will use this information to expand its research efforts in
better understanding ephedra.
In mid-May, acting deputy director of the HHS, Yvonne Maddox,
submitted an HHS 2002 fiscal budget request to President Bush asking for $232.1
million, part of which was earmarked for the Office of Dietary Supplements and
other federal centers to conduct an evidence-based review on the safety and
efficacy of ephedra. HHS also reported that it planned to nominate ephedra be
studied by the National Toxicology Program at the National Institute of
Environmental Health Sciences.
One surprising comment made by HHS was that FDA had begun a
major effort to strengthen its AER system by incorporating existing reporting
systems into a new, unified one to better monitor the safety of all dietary
supplements, including ephedra.
"This is interesting news and the first I've heard about
it," said Michael McGuffin, president of the American Herbal Products
Association (AHPA) (www.ahpa.org). He added
that the present system for reporting AERs--the Special Nutritionals Adverse
Event Monitoring System, also known as SN/AEMS--does not work, especially since
the system allows for nothing more than entering AERs. It does not allow
re-entry into the system if the wrong company or even ingredient is attributed
to an AER.
In his statement, Thompson not only encouraged FDA to continue
with its plans to improve the current AER system, but also for manufacturers to
label ephedra products in a way that would better protect consumer health.
"I urge manufacturers to include FDA's 800-MEDWATCH telephone number on
their product labels," he advised, adding that this number is an
opportunity to support FDA's AER system.
"The general consensus is why should supplements that have
a low incidence of AERs compared to drugs receive an 800-number when drugs
aren't required to have one?" asked John Cardellina, vice president of
botanical science and regulatory affairs at the Washington-based Council for
Responsible Nutrition (CRN) (www.crnusa.org).
"If the government requires them for supplements, shouldn't they also
require them for drugs?"
All in all, the move by HHS to better understand ephedra
supplements was seen as a positive action. "Sec. Thompson's statement is
... commendable for moving the policy discussion on ephedra's safety to a more
advanced level," said Wes Siegner, general counsel and spokesperson for
Washington's Ephedra Education Council (www.ephedrafacts.com).
"For too long, this important public safety issue has been stuck in first
gear and has looked only at the collected AERs."
According to San Diego-based Metabolife, a manufacturer of
weight-loss products containing ephedra, Thompson's words were a positive
message for the industry. "We are pleased the HHS is conducting additional
scientific research of herbal ephedra-based products ... to add to those studies
that have been done, showing that when taken as directed, these products are
safe and effective for weight loss."
AHPA commended HHS's announcement as a positive and informed
response to the current issues surrounding ephedra. "It's satisfying to see
the government is essentially saying that the stand the industry has taken is
sound," McGuffin said.
However, not everyone was enthused with HHS' plans.
Washington-based Public Citizen (www.citizen.org)
deemed the HHS announcement as a failure to ban ephedra dietary supplements and
also a failure to seriously warn against the use of these products, and should
"result in the firing of all officials in HHS and the FDA who are
responsible for this dangerous cowardice."
Cardellina added, "Advocates for an alternative point of
view are entitled to their opinions. However, ephedra is getting a very thorough
look at by the government."
According to CRN, the Agency for Healthcare Research and Quality
will begin circulating the agency's Safety Report on Ephedra on July 1, which
will have a 30-day technical comment period when industry members such as CRN
will review the report. The final report is slated to be released in September.