The following is an abstract of a paper which will appear shortly in the New
England Journal of Medicine on the efficacy of anti-depressants.
Click Here to Read: Abstract and Full Article: Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy By 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
turnere@ohsu.edu .