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Safety of Ephedra is Still Being Debated

Originally published Sep 2003

Since the February 17 death of Baltimore Orioles pitcher Steve Bechler, the ephedra that may have contributed to his death has been the center of a firestorm of controversy.

Major League Baseball has already banned the additive at the minor league level. MLB Commissioner Bud Selig is considering joining the National Football League, the National Collegiate Athletic Association and the International Olympic Committee to ban all products containing ephedra, but is waiting for the results of Bechler''s autopsy to take the next step. The National Basketball Association and the National Hockey League have not banned ephedra products. Calls for a complete ban of ephedra products have reached the Food and Drug Administration and the U.S. Congress.

"It''s something that needs to be studied," said Dr. David Tan, an emergency physician at Barnes Jewish Hospital in St. Louis. "I''m trying to be fair to both sides. As a physician, sure, I''d like to say, ''Go ahead and just ban it.'' But I''m also aware of the fact that there are a number of ''home remedies'' that once they were actually scientifically studied and put through the rigors, were actually shown to be something beneficial. ... ButI think dietary supplements and herbal supplements should be studied and put under the same regulatory restrictions as drugs -- as pharmaceutical medications are."

Manufacturers of products containing ephedra insist it is safe if the directions are followed.

"When taken as directed, ephedra dietary supplements are safe and have significant weight loss benefits," said Richard Price, a spokesman for the Ephedra Education Council.

Approximately 55 clinical studies confirm the safety and benefits of ephedra, Price said. In the best study to date, he added, researchers from Harvard and Columbia universities reported that overweight, healthy subjects lost 11 to 12 pounds using ephedra without significant adverse events.

A new study by Dr. Stephen Bent and colleagues of the University of California at San Francisco and other institutions, an early release by the journal Annals of Internal Medicine, says the danger of ephedra is so great compared to other herbal supplements its use should be restricted. Dr. Bent''s group studied 2001 data from the Toxic Event Surveillance System, which includes about 96 percent of all poison control centers in the United States.

During 2001, the system received 1,832 reports of adverse events related to herbal products. Almost two-thirds of these -- 1,178 events -- were related to ephedra. Yet ephedra only accounted for an estimated 0.82 percent of the sales of all herbal products in the U.S. during 2001.

Overall, Bent''s group concluded, people taking ephedra were 220 times more likely to have an adverse reaction than people taking any other herbal supplement.

This, Dr. Tan said, is why it''s necessary to enact more stringent regulations for herbal supplements.

"The thing about prescription drugs and pharmaceutical companies and the FDA is that in order to be even released on the market, you have to prove that it''s safe," he said. "The funny thing about herbal supplements and dietary pills is, you have to prove that it''s harmful before you take it off the market. It''s completely opposite. ... Herbal supplements like ephedra ... need to be a little bit more tightly regulated and controlled, and not simply sold as food supplements."

Just like cocaine and amphetamines, Dr. Tan said, ephedra is a stimulant.

Overuse can cause heart attack, stroke and malignant hypertension.

"In most normal, young people who don''t have any medical problems, or at least undiagnosed medical problems, it''s something that can be used relatively safely," Dr. Tan said. "But you say that cautiously because there are people who seem young and otherwise healthy, like the ballplayer, who collapse dead. It''s only 80 degrees outside, and he died from heat stroke.

"Stimulants, like ephedra, can decrease your body''s ability to tolerate heat illness, because it already puts a strain on your body''s system by increasing heart rate and blood pressure. You add on top of that the strain of exercise in heat, it can often overwhelm a body''s compensatory mechanism and induce a heat stroke in someone who otherwise would not have succumbed to that illness."

Dr. Tan said dietary supplements can be misleading because they are frequently marketed as medicine.

"People think it must be safe -- it''s over the counter," he said. "And there are all these health benefits that are being touted in posters and in-store advertisements and even right there on the label. In fine print it says,''These statements have not been evaluated by the FDA.'' But in big, colorful, bold labeling and packaging and posters in the store, you have all kinds of health benefits that are touted as if it were a medication. So it''s being sold as a supplement and is therefore immune from FDA approval and review, but it''s being marketed as a medicine. That sends a mixed message to consumers, and it''s dangerous."


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