The Case for Ephedra Rests

The FDA has apparently still not been able to come up with any valid information in its second case against the thermogenic herb Ephedra. Back in 1997, the FDA published a proposed rule to regulate Ephedra that would have placed severe limits on its manufacture and use. The rule would have been a death knell, because it declared Ephedra products to be useless for their intended purposes. It included a prohibition of the claim that these products are useful for weight loss.

When the data put forth by the FDA were carefully analyzed, however, it became clear that at least 85 percent of the reports of adverse events associated with the use of Ephedra products - the reports on which the FDA had based its case - were deficient. The data were so lacking in the essential information necessary to arrive at a scientific assessment of their relationship to the consumption of Ephedra that they were essentially worthless.

Moreover, the FDA had relied on a mere 13 such reports as a basis for its proposed dose limits - a dose schedule that would have prevented any meaningful benefits - despite the agency's failure to review these reports carefully enough to determine if the adverse events were actually caused by the consumption of Ephedra. To put the number 13 into perspective, it is estimated that last year there were 3 billion servings of Ephedra used in the United States.

Because of these problems with the FDA's proposed rule, the General Accounting Office (GAO) conducted a critical review of the issue. This led to the eventual, unprecedented withdrawal of the key portions of the proposed rule.

THE VAMPIRE RETURNS
Like the vampire that pulls the partially driven stake out of its heart, however, the FDA returned from its well-deserved grave to revisit its victims in another round, with new data and more testimony by new "experts."

Yet even their best attempts failed. The evidence presented by other medical and scientific experts who testified at public hearings in Washington in August confirmed the safety and efficacy of Ephedra. This evidence failed to show an association between the FDA's newly reported adverse events and the products when they are taken as directed. The expert panel found that these reports are inconsistent with the published medical literature.

The renowned Danish researcher Arne Astrup, M.D., Ph.D., whose studies of ephedrine and caffeine showed that a combination of the two is indeed effective for weight loss, testified that an FDA report on the published literature misrepresented his data on the safety of the two ingredients and that these misrepresentations were used to support the FDA's allegations concerning Ephedra. Said Dr. Astrup, "I think our data and results are mischaracterized, and the presentation is flawed and distorted . . . giving a very negative picture of the safety profile of the combination of ephedrine/caffeine, which is not supported by our research."

SAFE WHEN USED AS DIRECTED
It is scandalous that the FDA has attempted to stigmatize Ephedra by publicizing its "concern" and the shoddy data on adverse events. It is the height of irresponsibility that, in an effort to cling to its scientifically unsupportable position, the FDA rigorously supports the banning of Ephedra for its most common use as an aid to weight loss.

Shockingly, the FDA's own press releases and related news programs were the direct cause of many, if not most, of the reports the FDA received, as shown by the dates of those reports. If these were the deeds of a private organization, the press would dub it a conspiracy and call for prosecution.

The conclusion of objective experts is that the herbal tonic and thermogenic agent Ephedra is a safe and efficacious dietary supplement when used as directed. It hardly takes an expert, however, to perceive that 13 adverse events out of 3 billion possibilities (0.00000043%) is not exactly a major threat to public health.

PROSPECTS FOR THE FUTURE
As a result of the August hearings, there has been a precipitous drop in interest in the Ephedra regulation issue, and it has ceased, for now, to be tabloid news. Yet before the FDA cries uncle and gives Ephedra its due, Hell will have to freeze over. Regulatory agencies need emergencies to sustain themselves, even if they have to play a principal role in their creation.

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