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Spielmans, G. I. & Kirsch I, 2014 Drug Approval and Drug Effectiveness

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Annu Rev Clin Psychol. 2014;10:741-66. doi: 10.1146/annurev-clinpsy-050212-185533. Epub 2013 Dec 9.
Drug approval and drug effectiveness.
Spielmans GI1, Kirsch I.
Abstract at http://www.ncbi.nlm.nih.gov/pubmed/24329178
Data on the efficacy and safety of psychiatric medicines should form the foundation of evidence-based treatment practices.
The US Food and Drug Administration (FDA) reviews such data in determining whether to approve new treatments, and the published literature serves as a repository for evidence on treatment benefits and harms.
We describe the FDA review of clinical trials, examining the underlying logic and legal guidelines. Several FDA reviews provide evidence that the agency requires only minimal efficacy for psychiatric drugs. Further, in some instances, the FDA has relied on secondary rather than primary outcomes and has discounted the findings of negative studies in its review of antidepressant and antipsychotic medications.
The published literature provides another lens into the safety and efficacy of treatments. We describe how treatment efficacy is systematically overstated and treatment-related harms are understated in the scientific literature. Suggestions are provided to improve public access to underlying safety and efficacy data and for the FDA to potentially improve its review process.
From the paper

In sum, there is much evidence that the randomized withdrawal method of examining antidepressant maintenance efficacy conflates short-term and protracted antidepressant withdrawal with long-term antidepressant efficacy. As noted in a thorough review of such studies, “researchers must be aware that additional research is required to clarify whether antidepressants are actually preventing future depressive episodes or simply preventing antidepressant withdrawal phenomena” (El-Mallakh & Briscoe 2012, p. 106).


Edited by Altostrata
formatted for Journals

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