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A Tug of War in a Larger Battle

Ephedra is now under intense scrutiny. Its fate could affect other supplements.


Wes Siegner is trying to save ephedra, the herbal stimulant that is under attack from a chorus of critics who say it is dangerous to your health. Even opponents of the lobbyist marvel at his victories so far, but it is looking more and more as if he is fighting a losing battle.

Siegner's task grew more difficult last month with news of a federal investigation of Metabolife International, a leading seller of ephedra in the United States. The fate of Metabolife, and of ephedra generally, is likely to influence the broader debate over the effectiveness and safety of herbs, sports drinks, diet pills and hundreds of other products for which Americans spend about $4.2 billion annually.

"Siegner's job is to protect the industry, and thus far he's succeeded," says Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, a consumer watchdog group in Washington, D.C., that has called on the Food and Drug Administration to take ephedra off the market. "But time is running out."

The anti-ephedra forces are gaining momentum as government regulators, health officials, scientists and consumer groups push for tougher regulation of the herb or its removal from the market altogether. These critics, including the influential American Medical Assn., say ephedra, the active ingredient in hundreds of energy boosters and diet products, is a health hazard. They cite evidence linking it to heart attacks, strokes, seizures--and more than 100 deaths.

Seven states have already enacted tough new rules regarding the sale of ephedra products. The Canadian government in January issued a national recall of supplements containing ephedra. The National Football League and the National Collegiate Athletic Assn. have outlawed the use of performance-enhancing supplements that contain ephedra, partly due to safety concerns.

The growing number of serious medical problems linked to the herbal stimulant, ranging from dizziness, headaches, heart palpitations and high blood pressure to heart attacks, seizures, strokes and death, threatens not only to derail ephedra but to engulf the entire dietary supplement industry. The FDA alone has received reports of nearly 1,400 incidents since 1993. Poison control centers nationwide collected 9,000 more during the same period.

And then, in last month the Justice Department launched a criminal probe into whether executives at San Diego-based Metabolife International made false statements about the existence of 13,000 consumer complaints of serious health problems, at least 80 of which included deaths, seizures, heart attacks or other medical emergencies.

The FDA has sought unsuccessfully for years to obtain these reports, which Metabolife refused to provide until the government opened its investigation. In the jargon of health regulators, such incidents are commonly referred to as "adverse events."

Siegner, a lanky man with a plaintive face, looks more like the high school biology teacher he once was than an Ivy League-educated lobbyist whose role is to rebut the arguments of scientists and politicians alike. Although he says he has no need to take ephedra, he would do so "in a heartbeat." In conversation, the 50-year-old Buffalo-born lawyer never strays far from his essential--and, clearly, well-practiced--message.

"Adverse events don't prove causality," he says. "These are a random set of events that happened to people who happened to be taking ephedra."

When millions of people use a product--any product--the law of averages dictates that a certain percentage of them will have heart attacks, strokes and seizures, which may or may not be linked to use of the product. Only a rigorous scientific study, say experts, in which one group is taking the supplement and another is using a placebo or dummy pill, can prove a direct connection. Otherwise the evidence is circumstantial.

The Metabolife investigation "makes the situation more difficult," says Siegner, who contends that it diverts attention from the more important issue of ephedra safety. Siegner has led the industry's so-far effective campaign to keep ephedra products on the market by raising doubts about the link between ephedra and medical problems, and by challenging industry critics at every turn. Even though doctors still aren't sure if ephedra is dangerous, the supplement makers that Siegner represents contend that these products are safe when used as directed on the label.

But critics point to the mounting evidence of serious side effects. This has prompted some lawmakers, such as Sen. Richard Durbin (D-Ill.), to push for stricter regulation of dietary supplements, which could hurt the industry by squeezing out smaller companies, driving up prices and curtailing availability of products. "The existing laws simply do not address the current dietary supplement situation," he said at a congressional hearing last month, "and our government shouldn't just stand by as more and more Americans unwittingly risk their health and even their lives."

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