※ 引述《pyrogen (New Life)》之銘言： : ※ 引述《jaguarccu (堅持 & 品味)》之銘言： : : 國內眾多糖尿病患，大多服用過知名的降血糖藥物「梵帝雅」， : : 3年前有研究顯示，它可能會增加心臟病和中風的風險， : : 現在又有媒體爆料，葛蘭素史克藥廠的內部文件顯示， : : 11年前就知道梵帝雅有問題，卻全力對外隱瞞；美國FDA這2天正在召開審查會議， : FDA投票結果： : 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可以繼續賣Avandia : 相關爭議應該可以平息一陣子， : 直到有更直接的結果/證據出現.(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位委員的投票其實很分歧。 12位贊成Avandia下市，10位贊成可以繼續販賣但是要加上新的label及使用上的限制； 另為七位是投要加上新的警語(black box warning，最後三位是說甚麼都不用變 :P 不過總結來說，committee是傾向讓Avandia繼續留在市場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. 不過對於Avandia vs. Actos head-to-head 的safety trial (TIDE trial)，委員會 以19比11通過建議要繼續執行。引述其中一位委員的話 : 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. 這位委員是投贊成Avandia下市，但是他贊成要繼續執行TIDE trial。因為若Avandia想 要繼續留在市場上，他就必須被繼續研究其安全性。但是執行這個trial有倫理上的問題 ，因為Avanida在diabetes 病患於CV的風險其實已經很清楚了，而在執行trial的時候， 因為要簽病患同意書，到底會有多少病人願意加入這個trial，是很大的問題。 所以這個委員最後說 "我投了贊成票，不過我不知道藥廠要如何做這個trial " 到底FDA的決定是如何咧，讓我們看下去 XD --

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