Word: fda
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...medical establishment has continued to take a hard line on Laetrile. The American Cancer Society and the American Medical Association oppose the drug on the grounds that its efficacy is unproved. So does the FDA, which says: "There is no evidence, either preclinical or clinical, that it would be effective. There is not the slightest hint that it would work...
Modest Fees. The FDA's order, however, did not stifle interest in the drug. Manufacturers in Mexico and Monaco are now producing Laetrile, and California's McNaughton Foundation, which also funds research in diabetes, parapsychology and heart disease, championed its cause. Nor did the FDA warning frighten the desperate. Since 1963, more than 2,500 American cancer sufferers, many of whom had given up on other treatments, have flocked to the Tijuana clinic, which is run by affable Dr. Ernesto Contreras, a graduate of the Mexican Army Medical School...
...complete U.G.D.P. study will, in fact, be published later this month in Diabetes, a journal devoted to the disease. But in the absence of new evidence, the FDA's decision is likely to stand. Its impact has been enormous. The 34 protesters say that they will continue to use tolbutamide. But many other doctors, fearing possible malpractice suits, are refusing to write prescriptions for oral antidiabetes drugs of any kind...
...disagreement began last June when the FDA received a sobering report from the University Group Diabetes Program, an organization of twelve medical schools that had been studying the oral drug. The study, which followed 823 diabetics for eight years, found that the death rate from cardiovascular diseases was twice as high among patients on tolbutamide as it was among those on insulin treatments or placebos. As a result, the FDA recommended that tolbutamide be used only in cases in which the established treatments−dieting and insulin injections−had proved ineffective...
Violent Reaction. The dissident diabetologists accused the FDA of "unprecedented interference with the practice of medicine," and charged it with damaging the welfare of a million diabetics. As for the U.G.D.P. report, they noted that all diabetics are susceptible to cardiovascular disease. The study included unusually sick diabetics, they argued, so it was unfairly weighted against oral drugs. Because the raw data are still unpublished, the protesters added, the findings are almost impossible to refute...