Rod For Controversy
by Peter Everett, Co-Founder of the Dietary Supplement Quality Initiative
has become a lightning rod for the controversy surrounding the regulations
that govern dietary supplements. Recent news coverage of the death
of an athlete, Steve Bechler of the Baltimore Orioles, calls the
safety of ephedra into question once again.
was under pressure to lose weight rapidly in spring training and
used an ephedra-containing product to assist in that process. He
died of organ failure brought on by heat stroke when his body temperature
reached 108 degrees. Dr. Joshua Perper, the Broward County medical
examiner, said he was told that Bechler was taking three capsules
of Xenadrine® RFA-1 each morning. Cytodine Technologies, the
manufacturer of Xenadrine®, said that two capsules per day is
the recommended dose.
Boston Globe story published on February 19th cites a recently
completed research study that states ephedra is responsible for
a disproportionate share of adverse events within the universe of
dietary supplements. In order for such statistics to be meaningful,
they must be considered in the context of ephedra's widespread popularity
as well as widespread negative reportage. Looking at the "numerator"the
number of reported adverse events alone, without comparing it to
the corresponding "denominator" of the millions of people who take
the herbis certain to be misleading.
adverse reports are self-selected, which automatically creates a
bias towards heavily reported events in the media. A person with
a headache who is dehydrated, hypoglycemic, and has taken caffeine
and ephedra will, after watching the news, report this as an ephedra
reaction, and not a caffeine, dehydration or hypoglycemia reaction.
This is one simple consequence of the sensationalism of ephedra
in the popular press.
of its stimulant properties, similar to both coffee and tobacco,
ephedra has attracted consumers who seek to lose weight or wish
to enhance their athletic performance. It is also used in teas that
relieve the symptoms of cold congestion colds. Ephedrine, the active
component of the ephedra herb, is used in the asthma medication
Primatene®, and is chemically almost identical to the popular
over-the-counter decongestant, pseudoephedrine (Sudafed®).
important questions are: Does this popular herb meet the safety
standards for an over-the-counter (OTC) product? If it does, what
information must be required on the label so that consumers can
use it responsibly? What are the safe amounts, and under what conditions
should individuals avoid it altogether?
the Broward County medical examiner cites ephedrine as a "probable
contributor" to Bechlar's death, the baseball player's pre-existing
high blood pressure, excess weightand perhaps most importantly
the extraordinary demands of professional athletes to push themselves
to the limitcannot be ignored. Bechler is not the first professional
athlete to die during training, and experience suggests that whether
or not ephedra is banned, he will not be the last.
tragedy strikes, the easy reaction is to call for increased regulation
to intercede in the future. But this is an example of the heat,
and not the light that emanates from an isolated incident. Better
answers will come from careful and dispassionate examination of
the larger picture.
adverse reactions, up to and including death, are reported for OTC
products. For example, acetaminophen (Tylenol®) is the leading
cause of acute liver failure in children, and causes about 100 deaths
per year according to the FDA. However, acetaminophen remains on
the market because its proper use is clearly labeled, and because
the risk of Reyes syndrome makes the main alternative of aspirin
more risky for children with fevers.
it is essential to ask two questions about ephedra. The answers
to these questions can only come from large-scale studies, which
should be easy to organize given the millions of consumers who use
what are the limits to its safetyincluding interactions
with other stimulants, medications, and conditionsand are
those limits clearly labeled? There can be no excuse for failing
to provide consumers with reasonable guidance about the proper
use of a product.
in the absence of ephedra, will consumers adopt alternatives that
are less safe, such as OTC decongestants? One also must include
the risk of not losing the weight that a dangerously overweight
person might have lost while using ephedra as recommendedthe
"health opportunity cost" of a regulatory withdrawal.
the potential for injury due to ephedra abuse should not be ignored.
Ephedra can be abused just as caffeine, decongestants, alcohol,
and OTC cough syrups can be abused. As with other products, information
is a better protector of the public than regulation. It is vital
to ask: What are the limits to safe use, and have the manufacturers
fulfilled their duty to inform consumers properly of those limits?
the safety record of herbs and supplements is better than both OTC
pharmaceuticals or even restaurant meals, there are limits to everything.
Consumers have a right to be informed of those limits, as well as
to be assured that products contain active ingredients in amounts
indicated. Regulations already exist to provide these assurances.
What is needed is a dietary supplement industry that compiles a
much better record in informing consumers of the risks associated
with its products.
Gary Wadler, a member of the World Anti-Doping Agency's medical
research committee, urges baseball to leave drug policy to groups
like WADA, saying, "Sound policy has to be based on sound science.
You can't have policies based on crisis."
agree. The supplement industry will harm both itself and consumers
if it promotes the romantic myth of "natural equals safe." When
that idea collides with the popular attitude of "if a little is
good, more is better," the problems that arise should surprise nobody.