※ 引述《pyrogen (New Life)》之铭言： : ※ 引述《jaguarccu (坚持 & 品味)》之铭言： : : 国内众多糖尿病患，大多服用过知名的降血糖药物「梵帝雅」， : : 3年前有研究显示，它可能会增加心脏病和中风的风险， : : 现在又有媒体爆料，葛兰素史克药厂的内部文件显示， : : 11年前就知道梵帝雅有问题，却全力对外隐瞒；美国FDA这2天正在召开审查会议， : FDA投票结果： : Twenty FDA advisory panel members on Wednesday voted to recommend that : the agency keep GlaxoSmithKline's Avandia (rosiglitazone) on the US market, : while 12 advisors voted to remove the diabetes drug's marketing authorisation. : 20比12 : GSK可以继续卖Avandia : 相关争议应该可以平息一阵子， : 直到有更直接的结果/证据出现.(e.g. TIDE trial) From New York Times http://ppt.cc/p!ob A majority of the advisory panel of the Food and Drug Administration voted today to restrict the sales of Avandia, a controversial diabetes drug, because of its potential risk for causing heart attacks. The 33-member advisory committee was deeply divided. Twelve voted to remove Avandia from the market altogether; 10 for continued sale but with new label revisions and possible restrictions; 7 to add more warnings and 3 for no change at all. But the votes can also be viewed as a decision by a majority, 21, to continue allowing sales of Avandia, with more restrictions. A final decision will be made by the F.D.A. at a later date. 33位委员的投票其实很分歧。 12位赞成Avandia下市，10位赞成可以继续贩卖但是要加上新的label及使用上的限制； 另为七位是投要加上新的警语(black box warning，最後三位是说甚麽都不用变 :P 不过总结来说，committee是倾向让Avandia继续留在市场上但加上更多的使用限制。 The committee voted 19-to-11 in recommending continuation of the so-called “ Tide” trial, the one intending to compare Avandia and its rival Actos. 不过对於Avandia vs. Actos head-to-head 的safety trial (TIDE trial)，委员会 以19比11通过建议要继续执行。引述其中一位委员的话 : Dr. Marvin Konstam explained that he voted to withdraw the drug but then voted to continue the Tide trial because, if Avandia stays on the market, it needs to be studied. Still, he said that the trial might not be ethical. “I voted yes, but I really don’t understand how you can do it,” he said. 这位委员是投赞成Avandia下市，但是他赞成要继续执行TIDE trial。因为若Avandia想 要继续留在市场上，他就必须被继续研究其安全性。但是执行这个trial有伦理上的问题 ，因为Avanida在diabetes 病患於CV的风险其实已经很清楚了，而在执行trial的时候， 因为要签病患同意书，到底会有多少病人愿意加入这个trial，是很大的问题。 所以这个委员最後说 "我投了赞成票，不过我不知道药厂要如何做这个trial " 到底FDA的决定是如何咧，让我们看下去 XD --

※ 发信站: 批踢踢实业坊(ptt.cc) ◆ From: 140.116.93.100