Abstract

To the Editor: The decision by the Food and Drug Administration (FDA) not to approve the use of 5α-reductase inhibitors as a means of preventing prostate cancer, as discussed by Theoret et al. (July 14 issue),1 illustrates the challenges that thwart efforts to develop agents for this purpose. To support its position, the FDA reanalyzed two major trials.2,3 It cited the fact that the incidence of tumors with modified Gleason scores between 7 and 10 was not reduced and that the absolute incidence of tumors with modified Gleason scores between 8 and 10 was increased by 0.7% with finasteride . . .

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