Word: fda
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...government succeeded in banning a headache remedy containing a toxic acid and bearing the beguiling name of Cuforhedake-Brane-Fude. The Food and Drug Administration, which was formally established in 1931, has stamped out such gross quackery. But now many concerned scientists are beginning to wonder whether the FDA has become so cautious in its repression of quack cures and unsafe medicines that it is in some danger of stamping out or at least slowing the development of new drugs. The latest report is by two pharmacologists from the University of Rochester School of Medicine and Dentistry. The current laws...
...major part of the FDA's problem, say the Rochester researchers, is a set of 1962 amendments to the Food, Drug and Cosmetic Act-passed in response to the thalidomide disaster that produced thousands of deformed babies throughout Europe. These amendments, which aimed at assuring that drugs were effective, and earlier amendments setting standards for safety, were designed to prevent the introduction of any drugs that might be toxic or cause birth defects or cancer. But they have had other, less desirable effects as well...
...countries in the decade beginning in 1962, a mere 21 were first made available only in the U.S. In fact, at the beginning of the decade, 77 drugs, including many that U.S. physicians now consider not only safe but effective (see box), were not authorized by the FDA...
...report has found few supporters at the FDA. The agency's current commissioner, Alexander Schmidt, concedes that there is a drug lag between the U.S. and other countries. But he denies that U.S. patients have suffered as a result. "There have been no significant therapeutic breakthroughs in other countries that this country has gone without," says...
Frei says that academic boards of authorities should be allowed to decide what chemicals can be administered to terminal cancer cases. As he said on the telephone to a colleague two weeks ago, "Many (cancer) centers have much more sophisticated people sitting around a table than the FDA has." Frei's image of a self-contained cancer center where researchers determine the limits on experimentation suggests the type of facility where heady and expert investigators can experiment on human beings with impunity, but he emphasizes the ethical obligation to serve the patient first, above any commitment to research. But Frei...