Lexchin Joel
School of Health Policy and Management, York University, 4700 Keele St,, Toronto M3J 1P3, Ontario, Canada.
BMC Med. 2015 Feb 5;13:27. doi: 10.1186/s12916-015-0270-2.
Some drugs eventually have to be removed from the market because of a negative benefit-to-harm ratio, including an excess of mortality. Drug safety is the result of multiple factors, commencing with how clinical trials are designed, the information generated by and/or hidden through these trials, trial analysis by drug regulatory authorities (DRAs) and the amount of information that DRAs choose to release, the amount of published information regarding drug safety, the effectiveness of postmarket surveillance systems in recognizing and reporting adverse drug reactions, and the structure of DRAs such as the United States Food and Drug Administration and its equivalent in other countries. This commentary will look at each of these issues in order to highlight the problems in the current approach to drug safety and finally indicate how some of these deficiencies should be addressed.
一些药物最终不得不因有害大于有益的比例，包括过高的死亡率而退出市场。药物安全性是多种因素的结果，首先是临床试验的设计方式、这些试验产生和/或隐藏的信息、药品监管机构（DRA）的试验分析以及DRA选择发布的信息量、已发表的药物安全性信息量、上市后监测系统识别和报告药物不良反应的有效性，以及诸如美国食品药品监督管理局及其在其他国家的对等机构等DRA的结构。本评论将审视这些问题中的每一个，以突出当前药物安全方法中存在的问题，并最终指出应如何解决其中一些不足之处。
