Premature Release of Data from Clinical Trials of Ezetimibe

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Abstract
The recent controversy about whether the cholesterol-lowering drug ezetimibe causes cancer raises urgent questions about the systems we use to develop drugs and medical devices and then to evaluate their safety and effectiveness.1-3 There is widespread recognition that large, multinational clinical outcomes trials are essential to understanding the risks and benefits of new treatments. Although such studies are dubbed “simple,” their organizational complexity entails huge investments of money, time, and energy. Given this context, the events surrounding the development and testing of ezetimibe present a useful opportunity for reflection on the future direction of the clinical research enterprise. We discuss the circumstances that led to the unexpected and untimely release of safety data surrounding cancer-associated results from ongoing trials of ezetimibe ( Table 1 ) and present recommendations for addressing such premature release in the future ( Table 2 ).