FDA Censorship Threatens Patient Medical Care

By Samp, Richard A.; Slobodin, Alan M. | Consumers' Research Magazine, December 1994 | Go to article overview

FDA Censorship Threatens Patient Medical Care


Samp, Richard A., Slobodin, Alan M., Consumers' Research Magazine


Aspirin prevents heart attacks.

That medical fact is widely acknowledged among medical experts. Emerging research shows that regular aspirin consumption could prevent about 20% of all heart attacks among middle-aged men. Yet one government organization is fighting desperately to keep that life-saving information away from you: the U.S. Food and Drug Administration (FDA).

But at least the FDA doesn't discriminate on the basis of sex. It works just as assiduously to prevent women from obtaining life-saving medical information. For example, authoritative medical research shows that estrogen helps to prevent ovarian cancer among post-menopausal women. FDA bureaucrats are working overtime to make sure that this research is hidden from the American people.

Luckily, the FDA has not yet found a way to punish doctors who discuss new, effective uses for drugs like aspirin and estrogen, since the FDA has no regulatory authority over the practice of medicine. But the FDA can and has severely punished manufacturers who get involved in any way in disseminating information about new uses of their drugs.

Doctors can write freely in authoritative medical textbooks on aspirin's effectiveness in preventing heart attacks, but an aspirin manufacturer cannot so much as reproduce a copy of such a textbook or provide financial support for a medical symposium at which aspirin's benefits are discussed--even if the manufacturer had no advance warning that such discussions would occur. Similarly, although we are free to discuss the benefits of aspirin, no manufacturer of any of the drugs or medical devices mentioned here would dare risk the wrath of the FDA by having anything to do with the publication or distribution of this article.

The FDA claims to be protecting public health in its suppression of medically-accepted information about drugs and medical devices. The FDA contends that until it has given its official approval to particular uses of therapeutic products, the public is best served by minimizing discussion of such uses.

The fallacy of the FDA's approach is that the medical community's knowledge regarding the safety and efficacy of FDA-approved drugs and devices inevitably outpaces FDA-approved labeling. Physicians who regularly work with such drugs and devices learn of safe and effective uses for the drugs and devices that aren't included within the labeling (generally referred to as "off-label" uses). In some fields, such as oncology, the great majority of treatments involve off-label uses of FDA-approved drugs and medical devices.

Moreover, the medical community already has in place effective mechanisms for differentiating medically-accepted uses of therapeutic products from totally unproven uses. Three standard reference works are generally regarded as the medical bibles when it comes to off-label drug uses: 1) The American Hospital Formulary Service Drug Information, 2) The American Medical Association Drug Evaluations, and 3) The United States Pharmacopoeia Drug Information. These three works list acceptable usages for FDA-approved drugs without regard to whether the FDA has approved those usages for labeling purposes.

It bears repeating that no negative connotations should be attached to the phrase "off-label use." After the FDA has determined that a therapeutic product is safe, it reviews the manufactuer's proposed product labeling. The label should indicate those uses for which the product has been shown (through extensive clinical testing) to be effective. Once the product is on the market, doctors quickly discover other effective uses for the product (e.g., different dosage levels or use in combination with other drugs). Yet, due to the tremendous expense of conducting the clinical trials necessary to obtain FDA approval for those other uses (with a separate trial required for each new usage), manufactuers often determine that such expenditures are economically unjustified. …

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