May
22, 2001
Julia
Kagan
Editorial Director
Consumers Union
101 Truman Avenue
Yonkers, NY 10703-1057
Dear
Ms. Kagan:
I
am contacting you on behalf of the Ephedra Education Council
(EEC), which provides factual information to the media and
public about dietary supplements that contain Ephedra. We
felt it critical to point out serious inaccuracies and deficiencies
within the Consumer Reports June 2001 article on Sports
Supplements entitled, "Sports-Supplement Dangers: Some Products
Supposedly Increase Muscle or Energy. But They Could Cause
Serious Harm."
Consumer
Reports prides itself on being an objective provider of
information to the public. It has a reputation of providing
well-researched information on the products that it reviews
and providing both the pros and cons of reviewed products.
Thus, it is especially disturbing to see Consumer Reports
fail to provide both sides of an issue that is important to
the health of the American public. Consumer Reports also failed
to provide the most current and accurate information.
First,
your magazine fails to point out the dangers of obesity itself.
According to the Centers for Disease Control, more than 60%
of Americans are obese or overweight, and obesity results
in 300,000 preventable deaths each year in the United States.
As a result, it is important to note that Ephedra is a popular
dietary supplement used both safely and effectively by millions
of Americans as an aid to weight loss - something your magazine
failed to report.
Second,
your magazine failed to report any of the research that has
taken place with respect to Ephedra over the last 2 years.
Research conducted at the prestigious Harvard and Columbia
Universities, and recently published in abstract form in the
FASEB Journal and Obesity Research, showed that dietary supplements
containing Ephedra and caffeine are safe and effective as
an aid to weight loss. The data from the Harvard and Columbia
study also confirm the results of numerous other clinical
studies, including a separate, short-term study conducted
by some of the same Harvard and Columbia researchers and recently
published in the International Journal of Obesity.
Further,
you neglected to report that in December of last year Cantox
Health Sciences International, an internationally known and
respected scientific research organization, reviewed the data
held by Food and Drug Administration (FDA). Cantox analyzed
over 19 clinical studies and numerous scientific articles
about Ephedra and its chemistry, reviewing that data according
to a standard set by the National Academy of Sciences. That
analysis showed that Ephedra products, when consumed according
to voluntary standards set by industry and codified as law
in several states, are safe. Those standards have been submitted
to FDA yet FDA has failed to respond.
One of the most glaring examples of your article's failure
to fully evaluate, or fairly present all of the available
information, is Consumer Reports' reference to a University
of California, San Francisco review by Christine Haller and
Neil Benowitz, published last year. While Consumer Reports
presents the information from this review that supported the
negative tone of the article, Consumer Reports fails
to mention that Haller and Benowitz recently conceded in a
letter to the New England Journal of Medicine that
their report "does not prove causation, nor does it provide
quantitative information with regard to risk."
Moreover,
had Consumer Reports done a thorough job of researching
the facts for this article, it would have discovered that
Haller and Benowitz's findings represent old information that
had already been reviewed and rejected by scientific and medical
experts. The information was rejected because it conflicted
with more relevant and reliable data from clinical studies,
which are regarded as the "gold standard" for establishing
product safety and benefits. In August 2000, a panel of medical
and scientific experts reviewed the same information reviewed
by Haller and Benowitz, as well as the published clinical
and other data that Haller and Benowitz did not consider,
and found that there was no association between Ephedra and
serious adverse events when it is taken as directed. Haller
and Benowitz's findings are based on anecdotal adverse event
reports (AERs) received by FDA. The use of AERs to demonstrate
product risk is not an accepted scientific method. Therefore,
FDA's use of AERs for this very purpose was found to be scientifically
deficient by the United States General Accounting Office,
causing FDA to have to take the embarrassing step of withdrawing
a substantial portion of the proposed regulation.
Finally,
the Consumer Reports article also incorrectly compares
Ephedra to Methamphetamine. Dr. Edgar Adams, an internationally-recognized
expert in addiction and drug abuse data, has reviewed the
available data on Ephedra on two occasions and has submitted
public statements to the FDA and the Department of Health
and Human Services (HHS) establishing that, unlike Methamphetamine
which is highly addictive and widely abused, there is no significant
abuse of Ephedra despite its widespread use.
As
stated above, obesity is an epidemic in this country. Ephedra
products represent a viable alternative for many Americans
looking for products to assist them in losing and managing
their weight. Several national experts in obesity testified
at a HHS public meeting in August 2000 to urge FDA to continue
to allow consumers to have access to ephedra products because
of the promise that these products offer in the fight against
obesity. Your article unfairly creates an unfounded fear of
these products, and does not provide the balance consumers
have a right to expect from your publication.
We
urge you to take another look at the safety and benefits of
Ephedra. Enclosed you will find related EEC materials for
your review, and please logon to www.EphedraFacts.com for
additional information.
Sincerely,
Colburn
Aker
cc:
Joan Tripi, Office of Public Information Enclosure
