FDA chief - Settling ephedra risks high priority

By Lauren Neergaard ~ The Associated Press

WASHINGTON -- Food and Drug Administration investigators are looking into the death of Baltimore Orioles pitcher Steve Bechler as they try to decide just how dangerous the herbal stimulant ephedra might be and whether to ban it, the FDA's new chief said Wednesday.

Ephedra may prove particularly risky for athletes, and settling the long-simmering controversy about the herb's safety is a high priority, FDA Commissioner Mark McClellan said in an interview with The Associated Press.

Ephedra, an herb commonly used for weight loss and body building, increases metabolic rate and speeds the heart, he noted. Add strenuous activity, and "sports use is one area where I have got some particular concerns," McClellan said.

McClellan's boss, Health and Human Services Secretary Tommy Thompson, convened a meeting of health officials to discuss ephedra later Wednesday. Asked what he thought of the herb, Thompson told reporters: "I wouldn't use it, would you?"

The comments came after a Florida medical examiner said Monday's heatstroke death of Bechler may have been linked to an ephedra-containing supplement found in the 23-year-old pitcher's locker at the Orioles' spring training camp.

Toxicology tests to prove if ephedrine, the herb's active ingredient, was in Bechler's body won't be available for at least two weeks. But Broward County medical examiner Dr. Joshua Perper, who interviewed the player's family and Orioles officials, said he was told Bechler took three pills each morning of Xenadrine RFA-1.

Perper urged baseball officials to ban use of the supplement, as football, college athletics and Olympics officials have.

Xenadrine's maker, Cytodine Technologies, said in a statement that two capsules a day is the recommended dose, and that studies show the product is safe when used as directed.

But ephedra has long been linked to heart attacks, strokes and other serious side effects -- even at recommended doses, particularly if users have underlying heart trouble or certain other ailments. The FDA has reports of at least 100 deaths linked to use of the herbal supplements. A study published earlier this month found U.S. poison control centers reported 1,178 side effects among ephedra users last year alone, and critics have urged FDA to ban the pills.

Now Bechler's death is focusing public attention on ephedra again.

Within a month, the FDA expects to receive a review of ephedra's risks from the Rand Corp., hired to take an independent look at the controversy.

Also, FDA investigators are talking with the Florida medical examiner and will scrutinize Bechler's toxicology tests, as another piece of evidence, FDA chief McClellan said.

"We are going to get the reports, look at all this evidence and take appropriate action quickly," McClellan said Wednesday. "If there is a health risk, we need to be on top of it," he said, adding that sports use may ultimately prove the area of most concern.

Is a ban possible? "That's something we definitely are considering," he said.

Because ephedra is an herb, federal law lets it sell over-the-counter with little oversight to ensure safety. Only if the FDA proves a clear danger to public health can it curb sales; manufacturers blocked an FDA attempt to restrict sales of certain doses four years ago by arguing the agency didn't have enough proof.

The Ephedra Education Council, an industry funded group, did not return calls seeking comment. Calling ephedra an important way to battle obesity, some manufacturers have been lobbying HHS' Thompson to settle the controversy by ordering labels on ephedra that set dose limits and urge consumers to consult a doctor before taking it.

Ephedra is one of the trickiest issues facing McClellan as FDA commissioner. Among other priorities he noted Wednesday as he outlined his plans for the consumer-protection agency:

--Increasing education to consumers on how to improve their health. He wants more clear nutrition advice on food labels, and is hunting ways to advise consumers on how to avoid useless dietary supplements.

"I'd rather the limited money people have to spend on their health go to something that really works," he said.

--Improving patient safety, by better tracking and warning about risks of prescription drugs.

--Improving anti-terrorism initiatives, including increased food security and encouraging wary drug companies to invest in better antidotes for chemical or biological attacks.