Anturane Reinfarction Trial

Abstract

To the Editor: The FDA's critique¹ of the Anturane (sulfinpyrazone) reinfarction trial^{2 , 3} and the accompanying editorial⁴ contain important lessons for the conduct and reporting of clinical trials.In the first place, it is clear that after a finding of possible bias in exclusions from analysis, the FDA had no choice but to withhold judgment on the study results. However, few clinical trials could withstand comparable review without evidence of blemish. Allocation of deaths to various causes and application of inevitably diffuse exclusion criteria are notoriously subject to error and unintended bias. For this reason most critical observers urge documentation and . . .