Word: fda
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Dates: during 1980-1989
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...combination of a congressional hearing, an erroneous press report that the Arthritis Foundation had urged FDA approval of the drug and a segment on the TV show 60 Minutes have put DMSO back in the spotlight and renewed the controversy over its effectiveness. Is DMSO, as its supporters stubbornly claim, "the aspirin of the 21st century"? Or is it, as its detractors insist, merely a quack drug, "another Laetrile...
...some 100,000 people were using DMSO, primarily to treat sprains, bruises, minor burns and arthritis. The FDA'S concern about such widespread use of an experimental drug grew into alarm when animal studies indicated that DMSO might cause eye damage. That led to a virtual ban on clinical tests of the drug. But only a year later the restrictions were eased to permit experiments in such hard-to-treat illnesses as interstitial cystitis (a painful bladder inflammation), scleroderma (a condition characterized by thickening and hardening of the skin and sometimes internal organs as well) and rheumatoid arthritis...
Though no one is sure of the long-term side effects of human use, DMSO is now generally held, even by the FDA, to be a comparatively safe drug, though it can cause skin rashes and hives, and has been associated with headaches and nausea. Eye damage, reported in laboratory animals, has not been confirmed. The big sticking point in the DMSO debate is efficacy. So far, the drug has won FDA approval for general use only in cystitis. The agency contends that it has received few applications for controlled tests of the drug and that most data supporting...
...hampered approval of the substance. Says he: "DMSO's too good. If I had said it was only of value for sprained ankles, it would have been approved. But when I talked about a huge gamut of usage, it was anathema. It had not been seen before." The FDA disagrees, claiming that it is open-minded about the drug Dr. J. Richard Crout, director of the FDA bureau of drugs, testifying last month at a hearing on DMSO before the House Committee on Aging, insisted that the agency was "willing, indeed anxious" to approve further uses for the drug...
...risk seemed small. Congress responded by putting off the ban for 18 months, then delayed it again while consumers, only slightly concerned, continued their saccharin binge. Last week they heard some sweet news. Two new studies gave saccharin a nearly clean bill of health and probably ensured that the FDA ban would never take effect...