Guest guest Posted January 18, 2008 Report Share Posted January 18, 2008 From Binstock Perhaps NEJM will publish a similar article about vaccinations and the sweeping under the rug of adverse effects? - - - - *Antidepressants' benefits may be exaggerated* * 17 January 2008 * From New Scientist http://www.newscientist.com/article/mg19726393.300-antidepressants-benefits- may-be-exaggerated.html It's called the " file-drawer problem " . A study fails to produce interesting results, so is filed away and forgotten - a practice that might mean antidepressants don't work as well as doctors think. To get approval for the 12 antidepressants that went on the market between 1987 and 2004, drug firms registered over 70 clinical trials with the US Food and Drug Administration (FDA). But when k of Oregon Health and Science University in Portland and his colleagues combed through medical journals, they found that 23 of these studies never made it into a journal. All but one of the unpublished studies concluded that the effect of the drugs was negative or questionable (The New England Journal of Medicine, vol 358, p 252). Consider all 70 studies and antidepressants still emerge as helpful drugs. Publication bias has exaggerated their effectiveness, says, but it's impossible to know if journals refused to publish the studies or didn't get them in the first place. !+!+!+! * Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy* k H. , M.D., Annette M. s, M.D., Eftihia Linardatos, B.S., A. Tell, L.C.S.W., and Rosenthal, Ph.D. http://content.nejm.org/cgi/content/short/358/3/252 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. at Portland VA Medical Center, P3MHDC, 3710 SW US Veterans Hospital Rd., Portland, OR 97239, or at turnere{at}ohsu.edu. - **Full Text <http://content.nejm.org/cgi/content/full/358/3/252> ** - * PDF <http://content.nejm.org/cgi/reprint/358/3/252.pdf>* - *PDA Full Text <http://content.nejm.org/cgi/external_ref?link_type=pda_mms & doi=10.1056%2FNE JMsa065779>* - *PowerPoint Slide Set <http://content.nejm.org/cgi/slideshow/358/3/252>* - *Supplementary Material <http://content.nejm.org/cgi/content/full/358/3/252/DC1>* -------------------------------------------------------- Sheri Nakken, former R.N., MA, Hahnemannian Homeopath Vaccination Information & Choice Network, Nevada City CA & Wales UK $$ Donations to help in the work - accepted by Paypal account Voicemail US 530-740-0561 Vaccines - http://www.nccn.net/~wwithin/vaccine.htm or http://www.wellwithin1.com/vaccine.htm Vaccine Dangers On-Line courses - http://www.wellwithin1.com/vaccineclass.htm Reality of the Diseases & Treatment - http://www.nccn.net/~wwithin/vaccineclass.htm Homeopathy On-Line courses - http://www.wellwithin1.com/homeo.htm NEXT CLASSES start by email January 9 & 10 Quote Link to comment Share on other sites More sharing options...
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