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【drug-news】Vytorin 门事件: 国会开始调查公司高层
January 22, 2008, 5:39 pm
Vytoringate: Congress Investigates Exec’s Stock Sale
Posted by Jacob Goldstein
Congress is pressing Merck and Schering-Plough for information on the timing of executive stock sales in the wake of the delayed release of results from the Enhance trial — a long-awaited study whose results became public last week. The findings suggest the cholesterol drug Vytorin doesn’t slow heart disease any better than a generic statin alone. Schering-Plough’s stock has taken a beating since then (see 10-day chart).
“We have … discovered that a Schering-Plough officer, Carrie Smith Cox, sold significant numbers of shares of Schering-Plough in the time between the end of the ENHANCE study and the release of the results on January 14, 2008,” Congressmen Bart Stupak and John Dingell wrote in their latest letter to the companies today.
But Schering-Plough spokesman Steve Galpin told Dow Jones Newswires that Cox followed required company procedures before initiating her stock sales, which he said occurred well before the Enhance data were “unblinded” to company executives this month. The Web was buzzing about Cox’s stock sales last week; BrandweekNRX was the first to report on the sales.
Bonus Letter: Stupak and Dingell can’t get enough of the drug business. Today they also continued their investigation into Pfizer’s use of Robert Jarvik as the Lipitor man, asking the FDA if its Division of Drug Marketing, Advertising, and Communications (DDMAC) has been involved with the Lipitor ads. January 24, 2008, 1:38 pm
Vytoringate! Senate Boards Bandwagon
Posted by Jacob Goldstein
Not content to let the House of Representatives have the Vytorin spotlight to itself, Senator Chuck Grassley today got in on the action with a batch of letters to the SEC, the American Heart Association, the American College of Cardiology and the CEOs of Merck and Schering-Plough.
The letters, which the WSJ’s Anna Wilde Mathews passed along to the Health Blog, come a week and a half after Merck and Schering-Plough, which co-market Vytorin, released data suggesting the drug doesn’t slow the progression of heart disease any more than a generic statin.
Grassley asks the SEC about the timing of drug company executives’ stock sales with respect to the trial. He asks the AHA about their sources of industry funding and, citing the AHA’s statement in response to the Enhance trial, asks specific questions about AHA Web offerings entitled “The Two Sources of Cholesterol” (a phrase similar to one used in Vytorin’s ad campaign) and “What is cholesterol?.”
In a letter to the ACC, Grassley asks about any funding the group receives from industry. He also writes that he is “interested in whether or not the ACC also urged Schering-Plough and Merck to release the ENHANCE results when it was discovered that the companies were delaying the release. Accordingly, please name all individuals involved in drafting the
ACC statement on the ENHANCE trial.”
In the letters to Schering and Merck, he asks a lot of questions about the timing of the Enhance trial and other studies. He also asks about whether the companies have provided funding to the AHA and ACC.
Separately, the AHA changed its Web site to make the sponsorship by the companies of a cholesterol page clearer, the New York Times reported.
Vytoringate Bonus: Reps. John Dingell and Bart Stupak from the House Committee on Energy and Commerce chimed in too. “Given the AHA’s and ACC’s recent statements on Vytorin and the ENHANCE study, our Committee is interested to learn what financial arrangements exist between the marketers of Vytorin and these two organizations,” Dingell said in a statement. “The public places great trust in the official views of the AHA and the ACC, so it is important to verify that these views have not been compromised by a financial relationship with the pharmaceutical industry.” 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 综合以上两篇进行的编译：
Vytorin门事件：美国会调查公司高层出售股票是否涉及内幕交易
Vytorin是一种由两种降脂药组成的复方制剂，由默克和先灵葆雅一同销售。上周，一项名为“Enhance”的临床试验结果揭晓，Vytorin被证实疗效并没有好于单独使用的两种降脂药。先灵葆雅公司股票因此大幅跳水。但是，国会议员调查发现，本该在该项临床试验结束后立即公布的试验结果被延迟公布，而恰好在这段时间里，一名叫先灵葆雅公司的高管趁机抛售了一大笔的公司股票，避免了股价下跌造成的严重损失。随着调查的深入，更多相关人员和机构被牵涉进来。两天后，即2008年1月24日，参议员正式向美国证监会（SEC）、美国心脏病学会（ACC）、美国心脏病协会（AHA）以及默克、先灵葆雅两家公司的CEO提交信函，对于公司高管出售股票的时机、临床试验结果被延迟公布的原因、AHA和ACC的经费来源及近期对于Vytorin过于热情的“鼓吹”等问题提出严重质疑。虽然距离最终结果的出炉还尚待时日，但这一事件对于学术界和工业界之间的过密联系以及制药公司高管可能涉嫌的内幕交易都将是一个明显的警告。
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作者:admin@医学,生命科学 2011-04-16 05:15
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