FDA咨询委员会开会决定文迪雅是否继续上市

2007年，克利夫兰·尼森博士和克利夫兰诊所的Kathy Wolski发表了一种与Avandia（Rosiglitazone）相关的心血管风险分析，这引起了仍然燃烧强大的争议（对于我们对问题的报道，见学习曲线从倾居＃6）。作为提醒，Avandia（由Glaxosmithkline制作）属于噻唑烷二极管（TZD）类药物，用于治疗2型糖尿病药物，目前只有一个涉及Actos（Takeda制造的欧洲的其他TZD）。虽然Nissen的分析博士建议Avandia可能会使心脏病发作的风险增加43％，但一些医生和统计人员担心研究的有效性并质疑其结论。一台FDA小组于2007年7月30日举行审议争议，两周后，一份黑人警告是由Avandia以及actos发出的，强调TZDS可能导致或加剧心力衰竭或骨折，特别是在某些患者群体中。自那次会议以来，已经发表了更多的研究和分析，包括尼森博士（重申他之前的结论）和记录试验的全部结果以来。

In April, 2010, the Senate Finance Committee published a scathing report criticizing both GlaxoSmithKline and FDA for the way that safety concerns about the drug were handled between 2007 and 2010. These events paved the way for yet another meeting of the FDA’s advisory committee this summer from July 13-14, this time to decide if the new evidence suggested Avandia should be taken off of the market and the ongoing safety trial for the drug (dubbed TIDE) be halted. We were at the meeting bright and early (the room was eventually standing-room-only), and after two days of deliberation, the committee voted 20 to 12 to keep Avandia on the market and continue the TIDE trial, with the majority of panelists suggesting further warnings or restrictions be added to Avandia’s label (FDA has since weighed in against the panel to say that no new patients should enroll in TIDE until further notice). While there is ongoing concern, most panelists did not feel there was sufficient evidence to warrant removal of the drug from the market and emphasized it may still be an important option for some patients. For now, we must wait for the FDA’s final decision (the advisory committee’s recommendations are technically only suggestions), but we note it is extremely rare for the FDA to go against the committee’s vote. The vote was complicated as there were actually five choices for panelists across a broad spectrum of agreement – such a wide range may enable FDA to more easily decide its own course, as there was no clear majority. We did find it notable that the panel seems to have little confidence in many doctors’ ability to explain risks to patients adequately. We will continue to follow this issue closely.——JS