by John M. Curtis
(310) 204-8700

Copyright January 4, 2004
All Rights Reserved.

eaching its heavy hand into the nutritional supplement industry, the Food and Drug Administration promised to ban the popular weight loss and performance-enhancing substance ephedra. Used to suppress appetite and increase energy, ephedra is derived from the Chinese herb ma haung, containing ephedrine—a stimulant, like caffeine, that increases blood pressure and heart rate. Despite used safely by millions—accounting for $1.3 billion in annual sales, according to the San Diego-based Nutrition Business Journal—ephedra has been blamed for heart attacks, strokes and 155 deaths. Similar claims were made against Pfizer's Viagra, a popular erectile-enhancing drug approved by the FDA. “Today's action tells consumers that the time to stop using these products is now,” said Health and Human Services Secretary Tommy Thomson, at a Washington press conference.

      Similar claims were made in 1990 against L-Tryptophan, prompting the FDA to recall all products, despite the Center of Disease Control and Prevention linking adverse reactions to tainted products from Japan's leading manufacturer. Despite widely reported benefits, a series of lawsuits claimed 1,500 adverse reactions and 36 deaths, attributed to the popular sleep-enhancing supplement. When 23-year-old Baltimore Orioles' pitcher Steve Bechler died of “heatstroke” Feb. 18, his wife Kiley blamed Xenadrine RFA-1, a popular supplement used by athletes and bodybuilders containing ephedra. Bechler's autopsy found ephedra, fingering RFA-1 as “significant” in Bechler's death. Kiley's $600 million lawsuit prompted the FDA's latest incursion into the supplement industry. While everyone sympathizes with Bechler's widow, blaming ephedra doesn't tell the whole story.

      Occasional cardiovascular mishaps also occur with illicit drugs like cocaine and methamphetamine. When 22-year-old University of Maryland all-America basketball star Len Bias died June 20, 1986 of a cardiac arrest, cocaine was readily blamed for his death. Unfortunately for Bias' family, they couldn't sue Columbia's drug cartel. Millions use cocaine without adverse effects, yet Bias had the misfortune of bad physiology. Cocaine might have triggered Bias' death, but many other factors including his genetics and personal physiology entered the picture. When Minnesota Viking's offensive tackle Korey Stringer died of heatstroke July 31, 2001, an autopsy showed ephedra in his tissues. His widow Kelci promptly sued the Vikings and NFL for supporting policies that permitted ephedra use. Obesity, dehydration or congenital birth defects were not mentioned as alternative explanations.

      No one disputes the physiological effects of ephedra or other cardiovascular stimulants. Used in conjunction with excessive exertion, ambient heat, obesity, dehydration, stress, congenital defects, interactions with other drugs and supplements and miscellaneous factors, stimulants can contribute to potentially fatal reactions. Blaming ephedra alone ignores the multiple factors contributing to adverse events. Powerful stimulants like cocaine and methamphetamines may cause lethal cardiovascular reactions but only rarely. Despite high-profile lawsuits and today's media focus on ephedra, the low incidence of adverse effects attest to the product's overall safety. “Our concern is: What's next for the FDA,” said Jeff McCarrell, chief executive of Nutrex Research Inc., whose company sells products containing ephedra and opposes any knee-jerk reaction on the substance.

      Since banning L-Tryptophan in 1990, the FDA has steered clear of the supplement industry until now. Nutritional supplements are already severely restricted with respect to making product claims by a 10-year-old law. Lawsuits have more to do with deep pockets than factual connections to product liability. Just ask Bridgestone-Firestone whose defective tires were blamed for fatal rollover accidents by Ford, the maker of the popular SUV Explorer. It's easy ignore driver error, excessive speed, adverse driving conditions and high-profile vehicles for lethal accidents. “We have a tremendous burden of proof in order to take supplements off the market,” said Thomson, suggesting that the threshold is easier for FDA approved drugs. Front-page stories about the pernicious influence of publicly traded drug companies suggest that many FDA approved medications are neither safe nor effective.

      Banning ephedra makes good headlines but doesn't protect consumers against the potentially dangerous effects of widely used nutritional supplements. Jumping on the lawsuit bandwagon provides no proof of product liability. While fingering deep-pocket companies, litigators conveniently ignore exculpatory explanations. FDA Commissioner Mark B. McClellan jumps the gun when he says he has the legal grounds “not only to take ephedra products off the market but to keep them off.” Allegations from high-profile lawsuits offer no proof about product liability other than litigators' hopes of a big payday. Only medical experts and the inferences of juries can determine whether there's substance to adverse claims about ephedra. Before the FDA makes the same mistake it did with L-Tryptophan, it should rely on scientific evidence not wild speculation from pending litigation.

About the Author

John M. Curtis writes politically neutral commentary analyzing spin in national and global news. He's editor of OnlineColumnist.com and author of Dodging The Bullet and Operation Charisma.

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