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Ephedra Issue Displays FDA's IllsBy Thomas J. MooreA stimulant called ephedra appears to be one of the most dangerous herbal ingredients in America, at least as measured by the imperfect tally of the Food and Drug Administration's adverse event reports. But the Bush administration's recent plan to table a citizens' group's petition to ban ephedra - allowing the product to remain on the market during still another safety review - provides a frightening case study in what happens when a system breakdown occurs in a country that normally provides a reasonable umbrella of consumer protection. According to the FDA, ephedra has been associated with heart attack, stroke, seizures, psychosis and death. Ephedra is used in numerous dietary supplements for weight loss, as an "energy booster" and to provide a "lift" in herbal concoctions. By an act of a Congress then bent on deregulation, dietary supplements are exempt from the safety testing required for over-the-counter drugs. The power Congress left to the FDA was the ability to seek withdrawal if it could prove a product was dangerous. Let us see how that limited power fared under both Democratic and Republican administrations. The FDA issued a medical bulletin warning about ephedra in 1994, the same year that Congress exempted all supplements. In 1996, the ephedra safety issue was a front burner issue for FDA Commissioner David Kessler. After two young people in their 20s - who had consumed ephedra - died suddenly, he convened a special advisory panel declaring that "inaction is unacceptable." By 1997, Kessler was gone, but the FDA proposed to limit ephedra products to a low dose and only short-term use. More than 800 adverse event reports were on file at the agency about ephedra products. But the FDA initiative was abandoned in 1999 after the General Accounting Office reported the agency didn't have the proper scientific evidence to prove that a low dose of ephedra would be any safer. There also was political pressure from ephedra product manufacturers. Unfortunately, the GAO had a point. Because these are untested products, little was known about the dose-response curve of ephedra. Establishing the dose that provides the most benefits and fewest side effects is an elementary first step in testing every new prescription drug. But that law does not apply here. Last month, it was the Bush administration's turn to wrestle with ephedra's safety problems. Tommy Thompson, secretary of the Department of Health and Human Services, announced he had asked an outside contractor, RAND Corp., for a "comprehensive review" of ephedra. But in August 2000, the department had just finished such a review, concluding that "information on appropriate dose is not established." Given that the proper studies had not been done, what could RAND possibly find? According to the announcement, this additional report would "guide an expanded research effort." If this is how the existing system handles one of the best-documented health risks of dietary supplements, just imagine how it might respond to important but less obvious dangers. For example, many chemicals injure the liver, including some of herbal origin. However, a simple blood test detects whether liver cells are being damaged or destroyed. It is used routinely in new-drug tests. Scientific literature reveals fragmentary reports claiming possible beneficial effects on the liver for some herbal products and documenting substantial harm from others. Wouldn't it be nice to know which was which? But neither safety nor effectiveness testing has been done - and never will be under the current system. It is time to provide consumers with the basic protections for dietary supplements that they enjoy for other products with potential risks to human health. Dietary supplements should undergo a battery of basic safety tests. We need ingredient standardization and information about doses for products that purport to have a medical effect (such as weight loss or "boosting" the immune system). And we should have quality controls enforced by government inspections to ensure that supplements are free of contamination and contain the ingredients claimed. This testing should be paid for by a tax on this $17-billion-a-year industry. Airlines and their passengers pay the costs of ensuring air safety, and pharmaceutical companies absorb most of the financial burden for drugs. We shouldn't give the supplements industry a free ride at the expense of safety. Achieving all this does not take another study. What it takes is political will and understanding that ephedra demonstrates that what we don't know can and will hurt us. This article appeared on the Newday editorial page on July 15, 2002 | |
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