I assume that by now a number of people on TiPS as well as their students will have heard about the New England Journal of Medicine's (NEJM) review of studies using antidepressant medications for depression. Below is the abstract of the article, a link to the abstract at the NEJM website (on this page is a link to the article but your access to it may dependent upon whether your institution subscribes to the journal), and, at the very bottom, an email address to the senior author for reprint requests.
One of the most disturbing aspects of this review is that, given that science depends upon the open and free discussion of research, how can we even begin such a discussion if critical pieces of information, such as negative results for medication effects, are withheld from public scrutiny? As the concluding statements below indicate, the reasons why this occurred cannot be readily identified but, regardless of the reasons, the net effect is that everyone listed including teachers who disseminate the research results in their classes (e.g., clinical psychology, drugs and behavior, psychophamacology, etc.) can have various adverse consequences. I have not done so yet but I think that a thorough reading of the article would probably be time well spent, if for no other reason to correct the inevitable misrepresentations of the article that will appear in the media. -Mike Palij New York University [EMAIL PROTECTED] http://content.nejm.org/cgi/content/short/358/3/252 Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy Erick H. Turner, M.D., Annette M. Matthews, M.D., Eftihia Linardatos, B.S., Robert A. Tell, L.C.S.W., and Robert Rosenthal, Ph.D. ABSTRACT Background Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased. Selective publication of clinical trials - and the outcomes within those trials - can lead to unrealistic estimates of drug effectiveness and alter the apparent risk-benefit ratio. Methods We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. We conducted a systematic literature search to identify matching publications. For trials that were reported in the literature, we compared the published outcomes with the FDA outcomes. We also compared the effect size derived from the published reports with the effect size derived from the entire FDA data set. Results Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall. Conclusions We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both. Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients. Source Information >From the Departments of Psychiatry (E.H.T., A.M.M.) and Pharmacology (E.H.T.), Oregon Health and Science University; and the Behavioral Health and Neurosciences Division, Portland Veterans Affairs Medical Center (E.H.T., A.M.M., R.A.T.) - both in Portland, OR; the Department of Psychology, Kent State University, Kent, OH (E.L.); the Department of Psychology, University of California-Riverside, Riverside (R.R.); and Harvard University, Cambridge, MA (R.R.). Address reprint requests to Dr. Turner at Portland VA Medical Center, P3MHDC, 3710 SW US Veterans Hospital Rd., Portland, OR 97239, or at [EMAIL PROTECTED] --- To make changes to your subscription contact: Bill Southerly ([EMAIL PROTECTED])
