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【原创】问题药“万络”全球性撤回 FDA受指控压
美国参议院财政委员会主席格拉斯利（Grassley）透露，在默克公司由于副作用问题突然撤回重磅炸弹药物万络（Vioxx）数星期前，美国FDA(食品和药品监督管理局)曾压制药物专家大卫.格兰汉姆（David J. Graham，FDA药物中心药物安全办公室科学主任助理）博士对万络提出的安全性警告。
10月7日，在财政委员会调查官与格兰汉姆接触后，格拉斯利在声明中说，“格兰汉姆博士描述了一个他遭到‘排斥’和‘隐性威胁’的境况。”
格来汉姆是一份研究报告的首席作者，该研究分析了美国最大私人医疗保健中心Kaiser Permanente的139 万病人的医疗报告，其中40,405例接受了辉瑞西乐葆（Celebrex）的治疗，26,748例接受了万络的治疗。研究发现，高剂量的万络即罗非昔布能使心脏[梗塞]发作和突发心肌梗死的几率增加三倍。结论是高剂量的万络不得被处方和使用。
格来汉姆原计划于8月底在法国一次流行病学会议上报告这些发现，但是，在FDA 审查文摘后被阻拦。
FDA 药物安全办公室副主任Anne E. Trontell在8月12日的一封电子邮件中写道：我认为有关高剂量罗非昔布的建议没有必要而且特别有问题，建议格来汉姆推迟这项报告。还提出，默克在这些发现公布前应当受到警告“以便他们有准备来应付由此可能带来的媒体的广泛关注。”
FDA的其他人则暗示，格来汉姆的结论言过其实，因为FDA以前并没有在万络的标签中加入这一警告语。
格拉斯利评论道：我们所看到的是一个只见树木不见森林的机构。默克有了麻烦主动采取行动，而FDA 不但没有担任好公众的监察者，反而在忙于对付自己的专家”。
此前，国会的调查机构审计办公室被授命调查FDA是否曾经钳制另一雇员有关抗抑郁药增加儿童自杀倾向的言论。
在联邦顾问强烈要求对这些药物提出尖锐警告之前，FDA 流行病学家Andrew Mosholder曾警告服用抗抑郁药的儿童，自杀想法和行为都会增加。
在9月中旬的一次国会作证上， Mosholder承认自己的上司要求他用柔和的建议来评价抗抑郁药。告诉他只能建议使用这些药物时要“谨慎”。
FDA则对自己的行为辩护。
在一份准备好的声明中， FDA 表示自己“非常重视有关科学和医学问题的公开讨论和坦诚交流”。
FDA 药物安全办公室代理主任Paul Seligman博士表示，该机构并没有施压给Mosholder去改变他的结论。
审计办公室在9月30日默克主动从市场上撤下万络时把FDA处理该争议的方式列入了调查的内容。作为国会中三个委员会之一的财政委员会，也已开始细查FDA 的有关行为。
预计调查报告将在数月后完成。
FDA accused of silencing scientist's early Vioxx warnings
By DIEDTRA HENDERSON
AP Science Writer
October 7, 2004, 9:33 PM EDT
WASHINGTON -- The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday.
Dr. David J. Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, told Senate investigators he faced stiff resistance within the regulatory agency to his findings.
"Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,"' Sen. Chuck Grassley, R-Iowa, said in a statement after Finance Committee investigators interviewed the researcher Thursday.
Graham told The Associated Press that Grassley's characterization was accurate. Raising safety concerns within the agency is "extremely difficult," the 20-year employee said, declining further comment.
In a prepared statement, the FDA said it "values open discussion and frank exchange about scientific and medical issues" and subjects its scientists to "more rigorous" scrutiny than typical scientific peer reviews.
The Government Accountability Office, an investigative arm of Congress, already has been asked to look into whether the FDA muzzled another staffer who linked antidepressants to raising the odds of children suffering suicidal tendencies. When Merck voluntarily pulled Vioxx from the market on Sept. 30, the GAO was asked to roll the FDA's handling of that controversy into its inquiry.
That report is not expected for months. Grassley's committee is one of three in Congress also scrutinizing the FDA's actions.
A "picture is emerging of an agency that can't see the forest for the trees," Grassley said. "Merck knew it had trouble on its hands and took action. At the same time, instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert and calling his work 'scientific rumor."'
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作者:admin@医学,生命科学 2010-12-18 17:11
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