Word: fda
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...Many of his patients made remarkable recoveries. Since then, 6,000 patients have taken L-dopa in tests at other medical centers, two-thirds of them with good results. As a result, Congressmen, prodded by physicians and officials of Parkinson's disease organizations, put tremendous pressure on the FDA to make L-dopa generally available. Commissioner Charles C. Edwards indicated that the FDA had yielded somewhat to that pressure "while bearing in mind our duty under the law to make certain to the best of our ability that the drug is safe and effective...
Side Effects. Said Edwards: "For the first time in FDA history, manufacturers will be required to conduct long-term studies of the drug's effects." They will have to compile data on the reported effects of patients under treatment, and on the results of post-mortem examinations of those who die of Parkinson's disease. There is good reason for this caution. Nearly all patients treated with L-dopa suffer some side effects, among which loss of appetite, nausea and vomiting are considered minor. More serious are changes in blood pressure and the white-blood-cell system...
Well aware of the report's general contents for several weeks, the FDA made a swift response. Just two days after its release, the agency announced plans to revoke thousands of food additives previously declared safe under its old sanctioning procedures...
...often as those receiving other drugs. But lithium carbonate posed a problem for the drug industry. A common chemical, it could not be patented, so there could be little profit in its manufacture. Any schoolboy could buy it from a chemical supply house for his basement laboratory; the FDA insisted that only research psychiatrists could use it clinically, under rigid rules...
...FDA was promptly attacked by the American Medical Association, which charged it with interfering in doctor-patient relationships, and by the pharmaceutical companies, which saw their sales slipping. White House pressure made the FDA back down...