Word: fda
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...eight-hour pain-reliever, originally approved by a Cambridge drug-testing firm, has been taken off the market by the Food and Drug Administration. The FDA said the original tests were "irregular," and the manufacturer has been unable to prove the drug effective without those tests...
...FDA rejected the data of Cass Associates, Inc., headed by Leo J. Cass '33, director of the Las School Health Services. FDA notified the manufacturer, cheesebrough-Ponds, that without Cass' studies, which were now void, there was not enough evidence that the drug was effective...
Much more is known about the general incidence of breast cancer; and on statistical evidence, among the thousands of cases, there should have been hundreds among pill-taking women. Yet FDA files showed only one such case. Again, the experts concluded that doctors had simply failed to say whether their breast-cancer victims had been on the pills...
...committee paid no heed to minor side effects such as acne and weight gain. Even on the major effects, the pills cannot be certified as completely safe until after years of detailed study on tens of thousands of patients. But the committee felt confident enough to recommend that the FDA stop forbidding doctors to prescribe the pills for more than four consecutive years. To this the FDA agreed. The rule is unenforceable and penalizes poor patients getting the pills at clinics. Apparently, the committee concluded, the pills cause no major harmful effects within four years...
...FDA charges that one prisoner had a severe reaction to DMSO, but that this was not acknowledged in the Kligman report, that Dr. Kligman al lowed his comparison subjects to take other investigational drugs, instead of a dummy (placebo), thus rendering his conclusions meaningless, and that he reported blood tests on patients who were not even in the hospital at the time he claimed. Dr. Kligman has the right to ask the FDA to review its action...