dxy

　　　　　　　　　　　　——美国食品与药品监督管理局委员会将不会考虑争议性的文迪雅研究

　　7月26日《华尔街杂志》健康版报道，自从五月份《新英格兰医学杂志》网络版刊登了来自克立夫兰临床中心的Steven Nissen博士撰写的荟萃分析报告之后，有关葛兰素史克公司的糖尿病药物文迪雅是否存在诱发心脏病发作风险的争论就日渐白日化。但是FDA7月26日早晨发表的一个简短声明显示，将于下周进行的一个讨论文迪雅现状和FDA应对措施的专家会议不会将Steven Nissen的报告列入讨论项目，而是以FDA自己的一个结论类似的报告作为依据。尽管如此，会议名单显示Steven Nissen还是会以“非决策者的顾问”身份出席会议。

　　在7月26日的声明中，FDA声称：我们是注意到了Nissen博士的荟萃分析引起了相当程度的关注……这项荟萃分析，因为操作时迫不得已只能采用研究水平的数据，将不会作为该次咨询委员会的重点……原因是我们相信葛兰素史克公司和FDA先后在更详细的数据基础上分析得出的结论与Nissen博士的观点并没有显著的区别……更重要的是，我们相信FDA的这份包含了患者数据的分析报告，比仅仅在研究水平数据上得出的结论更有说服力。

　　　　　　　　　　　　　　FDA Committee Won’t Consider Controversial Avandia Study

　　Questions over whether GlaxoSmithKline’s diabetes drug Avandia contributes to heart-attack risk went from simmer to boil in May after the New England Journal of Medicine published online an analysis by the Cleveland Clinic’s Steven Nissen. He concluded that the drug was riskier than many had thought.

　　But an expert committee meeting next week to ponder Avandia and advise the FDA on what to do about the drug won’t consider the Nissen analysis, according to briefing documents the agency released this morning. The committee will rely instead on the FDA’s own work, which reached a similar conclusion as Nissen’s. Still, Nissen (pictured) will be on the committee as a “non-voting consultant,” according to the roster.

　　In a document published this morning, the agency wrote:We should note that while Dr. Nissen’s meta-analysis … engendered considerable public notice and concern … this metaanalysis, performed out of necessity on study level data, will not be a focus of this Advisory Committee meeting. … This is because we believe the results of the analysis performed by GSK and subsequently by the FDA on the more granular individual datasets do not greatly differ from that of Dr. Nissen … Importantly, though, we believe that the FDA analysis of the data, including patient level data, is more robust than would be possible for an analysis utilizing study-level data alone.