June 2, 1975


Author Affiliations

The University of Rochester School of Medicine and Dentistry Rochester, NY

JAMA. 1975;232(9):906. doi:10.1001/jama.1975.03250090010003

To the Editor.—  I should like to respond to Goldberg's rebuttal (232:143, 1975) to our commentary, "The FDA, Politics, and the Public" (232:141, 1975). To begin with, Wardell and I are certainly not arguing that the Food and Drug Administration (FDA) should approve labeling for uses of new drugs as soon as these uses gain acceptance in current medical practice and in the literature. As Goldberg recognizes in some of the quotations attributed to me, I do not believe that there is a necessary relationship between actual and optimal clinical usage. Where Goldberg and I disagree, however, is in regard to what is "substantial evidence," who is to decide what is substantial evidence, and whether such substantial evidence exists for the use of propranolol in anginal patients.Distinguished and experienced clinicians all over the world have been impressed not only by the available literature on the use of propranolol in