Monday, Jun. 15, 1970
Relief from Parkinson's
A million or more Americans, most of them over 50, suffer from Parkinson's disease, once generally known as "shaking palsy." The mysterious nerve disorder causes tremors, muscle rigidity, involuntary movements, slurred speech and may eventually disable the victim. Until recently it was virtually untreatable. Last week the U.S. Food and Drug Administration cautiously approved L-dopa, the first drug shown to be effective in a majority of cases of Parkinsonism. As a result, L-dopa, although subject to unprecedented safeguards because of its undesirable side effects, now becomes available for general prescription use.
The value of L-dopa (short for levo-dihydroxyphenylalanine) was established by Brookhaven National Laboratory's Dr. George C. Cotzias (TIME, Nov. 28). Earlier investigators had abandoned it after short-term trials, but Cotzias administered it in carefully calibrated, massive doses for weeks and months. 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 and, paradoxically, involuntary muscle movements of a different type. (Suggestions that the medication dangerously increases libido are not taken seriously by responsible medical investigators.)
L-dopa will at first be in short supply, but major manufacturers are stepping up their output, and two have already been licensed to distribute it.
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