The herbal supplement industry uses the same strategies as the pharmaceutical industry - no surprise. 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.

What tactics does he use? I find this difficult to type. He (representing an industry that eschews effectiveness data) argues that the data on harm are not conclusive. This arguement must involve obfuscation.

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.

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In 1997, when the FDA sought to limit dosages of ephedra and require warning labels on products, Siegner helped persuade Congress to order a General Accounting Office audit. The GAO concluded that the FDA's proposed rules were based on only 13 cases of adverse events, and that the data in those reports were too sketchy to blame them on ephedra, scuttling any regulatory action.

Since passage of the Dietary Supplement Health Education Act in 1994, supplement makers have not had to prove that their products--herbal or otherwise--are safe and effective before they put them on the market. The law, in effect, mandates that the FDA assume that supplements are harmless until proven otherwise, according to Christine L. Taylor, director of the FDA's Office of Nutritional Products, Labeling and Dietary Supplements in Rockville, Md. To remove a supplement from the market, the agency must demonstrate that it is dangerous.

Why do we allow politicians to make health decisions? From a patient advocacy perspective (the only perspective I understand) I find this situation deplorable.