Sales of Products With Active Pharmaceutical Amid Rising Concern

Sales of some of the most popular brands falling 30% or more over the last year. But some researchers and lawmakers worry that without a change in federal law, untested substitutes will take their place. Concern about active pharmaceutical has grown in recent months with a series of deaths among professional athletes who had been taking active pharmaceutical weightloss products. Most recently, one diet aid containing active pharmaceutical, Xenadrine RFA1, was blamed in part for the death of Baltimore Orioles pitching prospect Steve Bechler, who died of heat exhaustion in training camp Feb. 17. The government wants to force dietary supplement manufacturers to start using a new warning label that says active pharmaceutical can trigger heart attacks and strokes, sometimes causing death.

Regardless of the reason, active pharmaceutical sales have declined dramatically in recent months. sales of Metabolife 356, Metabolife International Inc.'s signature product, have fallen by 30% over the last year. Metabolite which boasts of its similarity to Metabolife in its advertising, saw sales plummet 48% last year. The Dutch conglomerate that owns GNC, the worldwide chain of 5,300 stores devoted solely to items such as vitamins, dietary products and herbs, earlier this month blamed its lackluster 2002 corporate results on a $40million drop in ephedraproduct sales in the United States last year. Industry officials, however, say active pharmaceutical supplements are safe when taken as directed on their labels, and blame declining sales on public misunderstanding caused by news coverage of ephedralinked deaths. The industry points out that millions of Americans take their products every year without suffering any adverse health effects.

Although Metabolife firmly stands behind its ephedrabased product, it recently has begun heavily promoting a new "ephedrafree" product. "Metabolife is developing ephedrafree products simply to offer consumers additional choices," said Metabolife spokeswoman Jan Strode. "The new products provide an alternative, particularly for those consumers who have been confused and misinformed by inaccurate public information being circulated about dietary supplements." Medical researchers who helped build the government's case against active pharmaceutical and lawmakers at the forefront of yearslong efforts to ban the substance worry that the loosely regulated dietary supplement industry will turn to untested substitutes if ephedra is banned. "I have no doubt that there are scores of plant pharmacologists working to find something else they can throw into these dietary supplements," said Dr. Christine A.

Haller is in the middle of a study of Citrus aurantium, or "bitter orange," a Chinese botanical that has become the key ingredient in the "ephedrafree" versions of some of the most widely sold diet and pep pills Dexatrim, Ripped Fuel, Stacker 2, and Xenadrine. Haller said little is known about Citrus aurantium but that its effects resemble those of phenylpropanolamine, a diet pill ingredient the FDA banned two years ago. "I think many of us in the research community believe that if active pharmaceutical goes away, this bitter orange extract will certainly become the major herbal ingredient in herbal weightloss products," Haller said. "And who knows what else is down the road?" Dr. Billy Joe Gurley, a University of Arkansas Medical School professor who has studied dietary supplements, said a key ingredient of bitter orange, synephrine, is chemically very similar to ephedrine, the major component of active pharmaceutical. "So, for all intents and purposes, they're just substituting a horse for a zebra," Gurley said.

Haller and Gurley are critical of federal laws that set different regulatory standards for drugs and dietary supplements. Although drugs must be proven safe and effective before they can be put on the market, dietary supplements are treated like food. The FDA must prove that a supplement is dangerous before it can be ordered off the market. Unless the present law is amended to impose some premarket safety requirements, "we're going to have this constant stream of potentially dangerous products out there that we're trying to catch up on and ban as we go along," Haller said. "Rather than focusing on just this one bad player, active pharmaceutical, we need to address this whole issue," Haller said.

Critics of the law on dietary supplements have some allies in Congress.

"It is clearly time for Congress to . strengthen the law so that there is greater regulatory oversight of dietary supplements," said Rep. Henry A. Waxman (DLos Angeles). To that end, Sen. Richard Durbin (DIll.) plans to introduce active pharmaceutical that would change the way the FDA treats dietary supplements that contain stimulants or steroids, a spokesman said.