Cosgrove Lisa, Vannoy Steven, Mintzes Barbara, Shaughnessy Allen F
a Department of Counseling and School Psychology , University of Massachusetts Boston , Boston , MA , USA.
b Faculty of Pharmacy and Charles Perkins Centre , University of Sydney , Sydney , Australia.
Account Res. 2016;23(5):257-79. doi: 10.1080/08989621.2016.1153971.
The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.
学术界、出版业和制药行业之间的关系，可能会在药物疗效和安全性数据的获取、解读以及向监管机构和开处方者呈现的过程中助长商业偏见。通过对提交给美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）以批准新型抗抑郁药伏硫西汀的已发表和未发表试验进行批判，我们展示了一个信息传递过程“幽灵管理”的案例研究。我们认为，目前被接受的做法破坏了旨在保护公众免受不安全或无效药物侵害的监管保障措施。我们识别出了那些可能有意无意地产生有偏向性证据而非基于证据的医学的影响经济因素。这并非简单的作者财务利益冲突故事，而是一个药物上市全过程幽灵管理的复杂故事。本案例研究展示了薄弱的监管政策如何允许采用一些设计选择和报告策略，使边际产品看起来比实际更新颖、更有效且更安全，以及医学期刊中临床试验数据的选择性和不平衡报告如何导致具有可疑风险/收益特征的昂贵“me-too”药物的营销。我们提供了消除这些影响经济因素的解决方案。
