Dr. Adams
01-17-2008, 06:03 PM
"A study of Food and Drug Administration (FDA)–registered clinical trials of 12 antidepressants found a bias toward publication of positive results. Almost all studies viewed by the FDA as positive were published. The clinical trials that the FDA deemed negative or questionable were largely not published or, in some cases, were published as positive outcomes.
For each of the 12 drugs, at least 1 study was not published or was reported in the literature as positive despite a conflicting judgment by the FDA.
The overall effect size of the antidepressants (vs placebo) that was reported in the published literature was nearly one-third larger than the effect size for these agents that was derived from FDA data.
The outcome of this study is that they are effective, but inconsistently so.
Evidence-based medicine is valuable to the extent that the evidence is complete and unbiased, selective publication of clinical trials can alter the apparent risk/benefit ratio of drugs, which can affect prescribing decisions.
This is one of the first efforts to actually quantify the impact of publication bias in terms of reported efficacy, by medication efficacy or understate the risks of specific medications or interventions, this is clearly a significant problem for physicians, researchers, and the general public.
N Engl J Med. 2008;358:252-60.
For each of the 12 drugs, at least 1 study was not published or was reported in the literature as positive despite a conflicting judgment by the FDA.
The overall effect size of the antidepressants (vs placebo) that was reported in the published literature was nearly one-third larger than the effect size for these agents that was derived from FDA data.
The outcome of this study is that they are effective, but inconsistently so.
Evidence-based medicine is valuable to the extent that the evidence is complete and unbiased, selective publication of clinical trials can alter the apparent risk/benefit ratio of drugs, which can affect prescribing decisions.
This is one of the first efforts to actually quantify the impact of publication bias in terms of reported efficacy, by medication efficacy or understate the risks of specific medications or interventions, this is clearly a significant problem for physicians, researchers, and the general public.
N Engl J Med. 2008;358:252-60.