Combined C3b and Factor B Autoantibodies and MPGN Type II

To the Editor: The decision by the Food and Drug Administration (FDA) not to approve the use of 5αreductase inhibitors as a means of prevent ing 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 and by 0.5% with dutasteride. 1 However, there is no evidence of increased mor tality attributable to the use of 5αreductase in hibitors.When the FDA said that reducing the incidence of lowgrade cancer was "unlikely to be clinically significant," 1 it did not consider the fact that such a diagnosis leads most men to elect some intervention, often with lifealtering complica tions.4 We believe that the FDA's emphasis on the theoretical risk of accelerated progression rather than on the benefits of reduced detection of low grade prostate cancer will risk converting suc cess into failure, stymie the development of pre vention strategies, and interfere with the progress being made in the clinical management of this complex but prevalent disease.