According to "Efficacy and Effectiveness of Antidepressants: Current Status of Research," published in the journal, Psychotherapy and Psychosomatics, the authors found that "Meta-analyses of FDA trials suggest that antidepressants are only marginally efficacious compared to placebos [sugar pills or other inactive substances] and document profound publication bias that inflates their apparent efficacy."
A meta-analysis is "quantitative statistical analysis that is applied to separate but similar experiments of different and usually independent researchers and that involves pooling the data and using the pooled data to test the effectiveness of the results reported."
FDA More Likely to Publish Favorable Outcomes
The authors found in one study they considered, "New drug application studies with favorable outcomes were almost five times more likely to be published as those with unfavorable ones." They also found, "Of the 43 primary measures not supporting efficacy, 20 (47%) were not included in the published results."
Another analysis examined by the authors found, "In their meta-analysis, antidepressant studies with favorable outcomes were 16 times more likely to be published as those with unfavorable ones."
Another study explored by the authors found "...a 32% inflation of the apparent efficacy of antidepressants."
Companies Ignore Unfavorable Research
Only two "successful" clinical trials are required by the FDA to approve a new antidepressant for the market. This leads to shoddy science according to the authors: "The apparent lack of significant adverse consequences to drug companies from failed trials (other than added costs and delayed time to market) may have fostered a production-oriented mind-set favoring trial quantity over quality (since it takes only two to win, and losses are not counted) too often resulting in flawed science..."
Maintenance Care Questionable
The American Psychiatric Association recommends that patients take a maintenance or ongoing dosage of an antidepressant after an episode of clinical depression. But the study authors say, "These findings call into question continuation phase guideline of APA that ‘following remission, patients who have been treated with antidepressant medications in the acute phase should be maintained on these agents to prevent relapse’ despite this recommendation having received the highest ‘clinical confidence’ rating of the expert panel."
They further state "...the continuation and maintenance phase guidelines of APA which essentially encourage open-ended use of antidepressants at ‘the same full antidepressant medication doses’ as used in acute treatment appear misguided."
Reassessing the Role of Antidepressants
The authors conclude, "As healthcare professionals...we should take notice of what this largest antidepressant effectiveness trial ever conducted is telling us and reassess the role of antidepressant medications...in the evidence-based treatment for depression."
Sources:
"Efficacy and Effectiveness of Antidepressants: Current Status of Research," Psychotherapy and Psychosomatics, Content.Karger.com. Retrieved August 2, 2010.
Dictionary.com. Retrieved August 2, 2010.
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