Debate Over Diabetes

The Food and Drug Administration jumped into a medical dispute this fall when it warned doctors to restrict their use of tolbutamide, an orally administered antidiabetes drug. Now the dispute has grown into an angry battle. Meeting recently in Boston, 34 of the nation's leading diabetologists joined forces to denounce the FDA warning and question the study upon which it was based.

The 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 Because the raw data are still unpublished, the protesters added, the findings are almost impossible to refute.

The 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.

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