Department of Psychology, Metropolitan State University, Saint Paul, Minnesota 55108.
Annu Rev Clin Psychol. 2014;10:741-66. doi: 10.1146/annurev-clinpsy-050212-185533. Epub 2013 Dec 9.
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.
关于精神科药物疗效和安全性的数据应构成循证治疗实践的基础。美国食品和药物管理局（FDA）在决定是否批准新的治疗方法时会审查此类数据，而已发表的文献则是治疗益处和危害证据的存储库。我们描述了 FDA 对临床试验的审查，考察了其背后的逻辑和法律准则。有几项 FDA 审查提供的证据表明，该机构仅对精神药物的最低疗效有要求。此外，在某些情况下，FDA 依赖于次要而非主要结局，并在审查抗抑郁药和抗精神病药物时对阴性研究的结果不予考虑。已发表的文献则为治疗的安全性和疗效提供了另一种视角。我们描述了治疗疗效如何在科学文献中被系统地夸大，以及治疗相关的危害如何被低估。我们提供了一些建议，以改善公众获取基础安全性和疗效数据的途径，并为 FDA 改进其审查过程提供了可能性。
