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Editorials

Ephedra—Lightning Rod For Controversy
24 February 2003
by Peter Everett, Co-Founder of the Dietary Supplement Quality Initiative

Ephedra 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.

Bechler 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.

A 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 herb—is certain to be misleading.

Also, 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.

Because 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®).

The 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?

While 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 weight—and perhaps most importantly the extraordinary demands of professional athletes to push themselves to the limit—cannot 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.

Whenever 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.

Many 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.

Therefore, 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 ephedrine-containing products.

First, what are the limits to its safety—including interactions with other stimulants, medications, and conditions—and 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.

Second, 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 recommended—the "health opportunity cost" of a regulatory withdrawal.

Finally, 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?

While 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.

Dr. 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."

We 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.end-of-story

 

 

 

   
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