Postmarketing surveillance: perspectives of a journal editor.
In the absence of a systematic monitoring program for drugs newly approved by the Food and Drug Administration (FDA), reports in clinical journals provide a legitimate forum for disseminating information about unexpected pharmacologic events. A journal editor bears the responsibility for publishing educated clinical observations that meet standards of scientific rigor while not giving premature credibility to chance and dubious reports of side effects of new drugs. Often this responsibility involves overcoming the fear of bad publicity and withstanding pressures from pharmaceutical companies to print only positive information about new products. Published preliminary observations may contribute to the problem of product liability, but they also generate testable hypotheses and healthy debate. If hypotheses later prove to be incorrect, they can be refuted by systematic studies and clarified in reviews and editorials. Our goal of effective education will be reached not by self-censorship but by scientific openness.
Gelenberg
A J
AJ
Department of Psychiatry, University of Arizona Health Sciences Center, Tucson 85724.
D006801:Humans; D011358:Product Surveillance, Postmarketing; D011643:Publishing; D014481:United States; D014486:United States Food and Drug Administration