The rush to condemn ephedra

Posted: Jul 27, 2003 12:00 AM

Ernie and Pat Bechler, who testified at the recent congressional hearings on ephedra, blame the herbal stimulant for the death of their son, Baltimore Orioles pitcher Steve Bechler, during spring training last February. So does Bechler's widow, who has filed a lawsuit seeking $600 million in damages from the manufacturer and distributor of Xenadrine, an ephedra-based diet aid found in the 23-year-old baseball player's locker.

As one of Bechler's teammates put it, "Someone has to be held responsible for a young kid dying like that." But the rush to condemn ephedra, which the Food and Drug Administration and members of Congress have threatened to ban, is not justified by the evidence.

Bechler, who died of heatstroke, was overweight, had high blood pressure and abnormal liver function, and was exercising hard in hot, humid Florida weather to which he was not acclimated. Broward County Medical Examiner Joshua Perper concluded that "the toxicity of ephedra played a significant role in the death of Mr. Bechler, although it's impossible to define mathematically the contribution of each one of the factors in his unfortunate death due to heatstroke."

Perper added, "I am not saying (ephedra) was the triggering factor, because I cannot identify the triggering factor. You have here a constellation of factors working together."

But if ephedra was not "the triggering factor," it's possible that Bechler would still be dead even if he hadn't consumed the stimulant. That was the conclusion reached by the renowned forensic pathologist Michael Baden, whom Xenadrine's manufacturer asked to review the case.

"The coincidental toxicologic finding of ephedrine, which is not known to produce heat stroke, in my opinion should not have been linked to the death by the medical examiner," Baden wrote in a letter to the House committee that heard testimony from Bechler's parents. "It is my opinion, to a reasonable degree of medical certainty, . . . that Xenadrine did not cause or contribute to Mr. Bechler's death."

The Bechler case illustrates the peril of leaping to conclusions when someone dies after consuming an ephedra product. News reports frequently assert that "more than 100 deaths" have been "linked" to ephedra. Yet a RAND Corporation study of all the "adverse event" reports in the FDA's files and in the medical literature that were available as of September 30 found only two fatalities where there was an attempt to rule out other factors.

RAND also identified "four myocardial infarctions, nine cerebrovascular accidents, one seizure, and three psychiatric cases" that fell into the same category. Even in such cases, the FDA concedes, the reports "may indicate a safety problem but do not prove that ephedra caused the adverse event. . . . Other unmeasured factors may have contributed, and such serious adverse events are likely to happen (albeit at very low rates) among the millions of users of ephedra anyway."

With an estimated 12 million to 17 million Americans taking something like 3 billion doses of ephedra products a year, FDA Administrator Mark McClellan admits, "serious adverse events from ephedra appear to be infrequent." That point is underlined by data from the federal government's Drug Abuse Warning Network (DAWN), which indicate that two deaths, or even 100, over a decade would not make ephedra stand out on a list of drugs mentioned by medical examiners.

In 1999, the last year for which nationwide totals were reported by drug, DAWN counted 811 mentions for Valium, 641 for Benadryl, 427 for Tylenol, 305 for Prozac, and 104 for aspirin. No drug is completely safe, but ephedra seems considerably safer than many popular over-the-counter remedies and prescription drugs.

The ephedra industry is vulnerable partly because it depends on a loophole in federal law that allows "dietary supplements," including "herbs," to be sold without the FDA approval required for pharmaceuticals. Hence manufacturers have to pretend their product is not a drug. This legalistic maneuver gives consumers a bit more freedom to self-medicate, but it also raises unreasonable expectations about safety.

The dietary supplement route is not the only way for a psychoactive substance to escape regulation as a drug. Coffee is considered a food, for example, even though it contains caffeine. Indeed, the manufacturer of NoDoz, which is considered a drug, reassures consumers by telling them the caffeine pill is "safe as coffee."

It's too bad for the ephedra industry that "Mormon tea," an ephedra brew that Mormons used to drink instead of beverages containing caffeine, never really caught on.