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September 20, 1971

The University Group Diabetes Program: A Further Statistical Analysis of the Mortality Findings

Author Affiliations

From the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh.

JAMA. 1971;217(12):1676-1687. doi:10.1001/jama.1971.03190120044009

The basic conclusion of the University Group Diabetes Program on tolbutamide is: "the findings of this study indicate that the combination of diet and tolbutamide therapy is no more effective than diet alone in prolonging life. Moreover, the findings suggest that tolbutamide and diet may be less effective than diet alone or than diet and insulin at least in so far as cardiovascular mortality is concerned."1 With no evidence of efficacy and a definite possibility of toxicity the investigators concluded that the safety of the patients still receiving tolbutamide therapy required its discontinuance and that the factual basis for this decision needed to be communicated to the biomedical scientific community. This prudent decision and moderately worded conclusion has been received by some critics with a hostility which has no discernible scientific basis. The following analysis is largely confined to Dr. Schor's analysis (see page 1671).

In general, independent repetition

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