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More depressing news on antidepressants: should we panic?

35 Arecent article appearing in the January issue of the New England Journal of Medicine has created quite a controversy. The paper titled, “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy” has cast a shadow on the efficacy of antidepressant medication in depression. The authors obtained and reviewed the results of all Phase II and Phase III randomized, placebocontrolled studies of drugs for the short-term treatment of depression registered with the US Food and Drug Administration (FDA). They then compared these registered studies with those in the literature and found that only 69 percent of the studies on file with the FDA were published, and the studies deemed to have clearly positive outcomes were much more likely to be published (37/38) compared to those resulting in a negative or equivocal outcome (14/36). Furthermore, many of the published studies that were deemed negative or equivocal were presented in a way that made the outcomes appear positive, according to the authors. Based upon their findings, the authors concluded that there is a strong publication bias against publishing studies on antidepressants with findings that are not positive. In total, 94 percent of the reviewed studies that had a positive outcome were published; whereas, for the entire set of studies (published and unpublished) only 51 percent were actually clearly positive. The authors argued that this produces an inflated perception of the efficacy of antidepressants. When the authors calculated the effect size (a mathematical measure of the magnitude of efficacy) of the entire set of studies versus those that were published, they found that the selective publication bias inflated it by 32 percent and that the effect size for the entire set of studies was a very modest 0.31. Prima facie, this high-profile paper presents some very disheartening and unwelcome news about the main tool psychiatrists use to treat depression. Only 51 percent of short-term, randomized, placebo-controlled studies in depression produce clear evidence of efficacy for the antidepressant, and the overall magnitude of the effect is modest. The media, most notably the New York Times, were quick to pick up on this paper and its obvious implications. However, we should be careful not to over interpret the finding of this paper. Aside from some methodological problems that seem to exaggerate the bias, we should be aware that a similar publication bias has been reported for many other types of medications in other fields of medicine. More important to emphasize, however, is that the analyzed studies were all short-term studies of depression (typically 6–12 weeks). These are the most common Research to Practice