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【drug-news】研究者国会听证透露受药厂胁迫

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Study by researcher tied drug to heart ills

波士顿球报
By Diedtra Henderson, Globe Staff | June 7, 2007

WASHINGTON -- An executive of the company that makes the diabetes drug Avandia said a researcher who was among the first to link it to heart problems would be held liable for the $4 billion GlaxoSmithKline PLC lost in stock value as a result of his findings, Dr. John B. Buse testified before congressional investigators yesterday.

Buse told the House Committee on Oversight and Government Reform that he raised concerns about Avandia's connection to heart problems in 1999 , the year the Food and Drug Administration approved it for sale. He said the Glaxo executive, Dr. Tadataka Yamada, made the "disturbing" comment during a meeting Yamada had with Buse's department chair at the University of North Carolina. Afterward, Buse said, he faxed a letter to Yamada asking him to "please call off the dogs " because he feared he could no longer remain civil "under this kind of heat ." Buse, a UNC researcher, is incoming president of medicine and science for the American Diabetes Association's board.

The former Glaxo executive was "passionate about his work," Moncef Slaoui , Glaxo's chairman of research and development, said of Yamada, when questioned by the committee chairman, Representative Henry Waxman . "We regret that Dr. Buse felt pressured."

Yamada, who now works for the Bill & Melinda Gates Foundation , was participating in an all-day retreat, according to a foundation spokesman, and could not be reached for comment.

Buse's testimony capped a day marked by allegations of witness intimidation and an admission from the FDA that Avandia and Actos , a similar diabetes drug made by Takeda Pharmaceuticals North America Inc. , deserve the agency's strongest warnings for increasing the risk of congestive heart failure .

Avandia, the world's top-selling oral diabetes drug, has been under increasing scrutiny since May 21 when Dr. Steven Nissen , a Cleveland Clinic cardiologist, reported in the New England Journal of Medicine that patients in trials who took it had a 43 percent higher risk of suffering a heart attack , compared with people who took other diabetes drugs or sugar pills. Glaxo's own analysis of nearly four dozen studies found similar heart risks, as did a statistical analysis that the FDA conducted.

The "black box" warnings the FDA is requesting from Glaxo and Takeda would replace less prominent warnings the drugs already carry. Takeda yesterday committed to strengthen its warnings. Glaxo's Slaoui declined to comment because the firm is negotiating the change with the FDA.

The FDA's willingness to add a black box warning to Avandia is a sharp reversal that comes after the Senate and House launched inquiries into its handling of Avandia's heart risks and followed, by two days, Nissen's paper highlighting those risks. A supervisor who signed off on a February 2006 internal FDA memo suggesting such a label change for Avandia was rebuked by the agency, according to Senator Charles Grassley , Republican of Iowa.

The same day Nissen's study was published, Waxman, Democrat of California , called for a hearing before the oversight committee. He is trying to galvanize House support for an FDA reform bill he co sponsored. It would give the FDA authority that could have sped its actions on Avandia, including power to force changes to drug labels, greater power to require completion of postmarketing studies , and wider dissemination of clinical trial results.

Some 21 million Americans have diabetes, an ailment marked by the body's inability to properly use or produce insulin. Avandia, which generated more than $3 billion in revenue last year, is taken by 1 million Americans.

The public health impact of Avandia's cardiovascular side effects should have prompted faster action by regulators and the company, Waxman said.

Instead, Glaxo waited 11 months before telling federal regulators about clinical trial results linking Avandia to heart risks, and government officials ignored years of earlier warnings about the treatment, Waxman said. "Avandia is a case study of the need for reform of our drug safety laws," he said. "FDA needs the will, the resources, and the authority to be a more effective watchdog."

At the time of Avandia's approval, the FDA was more concerned about the drug's potential to cause heart failure , as well as the liver toxicity that forced a similar drug from the market.

"In retrospect," Avandia's link to heart attacks has evolved into an equally important cardiovascular side effect, FDA commissioner Andrew von Eschenbach testified. But the postmarketing study that Glaxo conducted, at the behest of the FDA, is not large enough to definitively address the drug's heart attack risks, officials said.

http://www.boston.com/business/technology/biotechnology/articles/2007/06/07/scientist_says_executive_of_avandia_firm_tried_to_bully/

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2007-06-11 13:25 浏览 : 730 回复 : 3

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• 「考研树洞」第二弹：女生考研选什么科室比较好？

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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.

2007-06-11 13:53

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• # 妇儿联动 # 启动期，作为妇产科/儿科医生，你有哪些问题，想请教对方？

ericwang

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Study by researcher tied drug to heart ills
研究证实药物与心脏病相关

By Diedtra Henderson, Globe Staff | June 7, 2007

WASHINGTON -- An executive of the company that makes the diabetes drug Avandia said a researcher who was among the first to link it to heart problems would be held liable for the $4 billion GlaxoSmithKline PLC lost in stock value as a result of his findings, Dr. John B. Buse testified before congressional investigators yesterday.
华盛顿——“生产糖尿病药物文迪雅的制药公司总裁声称，一名首先将他们的产品与心脏疾病相关联的研究者应当为GlaxoSmithKline PLC在股票市场损失近四十亿美元负责。”昨天John B. Buse博士在国会调查人员面前作证说。
Buse told the House Committee on Oversight and Government Reform that he raised concerns about Avandia's connection to heart problems in 1999 , the year the Food and Drug Administration approved it for sale. He said the Glaxo executive, Dr. Tadataka Yamada, made the "disturbing" comment during a meeting Yamada had with Buse's department chair at the University of North Carolina. Afterward, Buse said, he faxed a letter to Yamada asking him to "please call off the dogs " because he feared he could no longer remain civil "under this kind of heat ." Buse, a UNC researcher, is incoming president of medicine and science for the American Diabetes Association's board.
Buse在众议院政府改革委员会宣称，其早在1999年，也就是药品食品管理局批准该药上市时，就对该药物的心脏病风险引起重视。葛兰素公司总裁山田孝利博士在与北卡罗来纳大学Buse博士所在部门主席会面时，发表了干扰性的评论。此后Buse发传真给山田，要求他“停止进一步攻击”。因为Buse害怕在这种压力之下无法保证研究的公正性。Buse 是UNC的研究者，时任美国糖尿病学会医学和科学委员会主席。
The former Glaxo executive was "passionate about his work," Moncef Slaoui , Glaxo's chairman of research and development, said of Yamada, when questioned by the committee chairman, Representative Henry Waxman . "We regret that Dr. Buse felt pressured."
葛兰素研发部门主席Moncef Slaoui称公司前总裁Yamada “对事业充满热情”。而接受委员会主席质询时，公司代表 Henry Waxman声称“Buse感受到了一定的压力，他们对此深表遗憾。”
Yamada, who now works for the Bill & Melinda Gates Foundation , was participating in an all-day retreat, according to a foundation spokesman, and could not be reached for comment.
山田目前就职于Bill & Melinda Gates基金会，基金会发言人称目前他本人正在休假顾无法就此发表评论。
Buse's testimony capped a day marked by allegations of witness intimidation and an admission from the FDA that Avandia and Actos , a similar diabetes drug made by Takeda Pharmaceuticals North America Inc. , deserve the agency's strongest warnings for increasing the risk of congestive heart failure .
Buse 在国会的作证持续了一整天。其主要内容为宣称受到药厂的恫吓以及FDA承认文迪雅和艾可拓（由武田制药厂北美公司制造的类似药物）增加了充血性心衰的风险，应当接受该机构最高级别的警告。

Avandia, the world's top-selling oral diabetes drug, has been under increasing scrutiny since May 21 when Dr. Steven Nissen , a Cleveland Clinic cardiologist, reported in the New England Journal of Medicine that patients in trials who took it had a 43 percent higher risk of suffering a heart attack , compared with people who took other diabetes drugs or sugar pills. Glaxo's own analysis of nearly four dozen studies found similar heart risks, as did a statistical analysis that the FDA conducted.
克利夫兰诊所的心脏病学家Dr. Steven Nissen在5月21日的新英格兰医学杂志上报道服用文迪雅的患者比服用其他降糖药或者安慰剂患者的心肌梗塞发生率增加43%。这种目前最畅销的口服抗糖尿病药物正接受越来越多的安全监控。葛兰素自身对于近40多个研究进行分析后也发现的相似的心脏风险。而FDA进行的统计分析的结论也类似。
The "black box" warnings the FDA is requesting from Glaxo and Takeda would replace less prominent warnings the drugs already carry. Takeda yesterday committed to strengthen its warnings. Glaxo's Slaoui declined to comment because the firm is negotiating the change with the FDA.
FDA要求葛兰素和武田将以往的安全警告更换为更高级别的“黑盒”警告。武田昨日已经对警告升级发表评论。而葛兰素的Slaoui则以公司正在与FDA谈判更改事宜为由拒绝发表评论。
The FDA's willingness to add a black box warning to Avandia is a sharp reversal that comes after the Senate and House launched inquiries into its handling of Avandia's heart risks and followed, by two days, Nissen's paper highlighting those risks. A supervisor who signed off on a February 2006 internal FDA memo suggesting such a label change for Avandia was rebuked by the agency, according to Senator Charles Grassley , Republican of Iowa.
参众两院启动对文迪雅心脏风险处理的质询以及两天后Nissen 发表的文章强调了这种风险以后，FDA对于给文迪雅增加黑盒警告的态度出现了急剧转变。Iowa州共和党参议员Charles Grassley称，2006年2月FDA的一位主管在内部的备忘录中建议更改文迪雅的标签，随后被该机构否决。

The same day Nissen's study was published, Waxman, Democrat of California , called for a hearing before the oversight committee. He is trying to galvanize House support for an FDA reform bill he co sponsored. It would give the FDA authority that could have sped its actions on Avandia, including power to force changes to drug labels, greater power to require completion of postmarketing studies , and wider dissemination of clinical trial results.
在Nissen的研究发表的同一天，加州民主党人Waxman要求政府改革委员会举行听证会。他极力促使众议院支持他作为发起人之一的FDA改革法案。它将赋予FDA足够的权力对文迪雅采取行动，包括要求厂家更改药物标签，完成上市后研究，对临床研究的结果进行更广泛传播等更大权力。
Some 21 million Americans have diabetes, an ailment marked by the body's inability to properly use or produce insulin. Avandia, which generated more than $3 billion in revenue last year, is taken by 1 million Americans.
糖尿病的主要特点为人体无法正常分泌和利用胰岛素。目前大约有2千1百万美国人罹患此疾病。有大约1百万美国人正在使用文迪雅，去年该药共产生约3亿美元的利润。
The public health impact of Avandia's cardiovascular side effects should have prompted faster action by regulators and the company, Waxman said.
Waxman认为：对于文迪雅的心血管副作用对公众健康带来的影响，监管部门和制药企业应当采取更为措施。
Instead, Glaxo waited 11 months before telling federal regulators about clinical trial results linking Avandia to heart risks, and government officials ignored years of earlier warnings about the treatment, Waxman said. "Avandia is a case study of the need for reform of our drug safety laws," he said. "FDA needs the will, the resources, and the authority to be a more effective watchdog."
但是格兰素公司拖延了11个月，才将文迪雅增加心脏病风险的临床试验结果通知联邦政府的监管部门。而政府官员却对于几年前对于该药物的警告置若罔闻。“文迪雅可作为药物安全法律改革的一个案例。FDA必须有更大的决心，充分的资源以及足够的权威，才能成为一个更有效的监管部门。
At the time of Avandia's approval, the FDA was more concerned about the drug's potential to cause heart failure , as well as the liver toxicity that forced a similar drug from the market.
在文迪雅批准上市时，FDA更关心药物导致心衰的潜在风险，以及药物的肝脏毒性，此前已经有一个药物因此被迫撤市。
"In retrospect," Avandia's link to heart attacks has evolved into an equally important cardiovascular side effect, FDA commissioner Andrew von Eschenbach testified. But the postmarketing study that Glaxo conducted, at the behest of the FDA, is not large enough to definitively address the drug's heart attack risks, officials said.
FDA委员Andrew von Eschenbach在作证时说，回顾性的研究发现，文迪雅导致心肌梗死的风险已经成为一个相当重要的心血管副作用，。但是Glaxo在FDA要求下进行的上市后研究规模太小，无法阐明该药物与心肌梗死风险的联系。

研究者国会听证透露受药厂胁迫，议员要求赋予FDA更大权力

波士顿球报报道：美国糖尿病学会医学和科学委员会主席John B. Buse博士在国会调查人员面前作证说，文迪雅的制药公司总裁声称他应当为GSK在股票市场损失近四十亿美元负责。Buse早在1999年药品食品管理局批准文迪雅上市时，就对该药物的心脏病风险引起重视。而时任葛兰素公司总裁Tadataka Yamada在与研究者的部门主席会面时，对其发表了干扰性的评论。此后Dr. Buse发传真给山田，要求他“停止进一步人身攻击”。Yamada则以休假为由拒绝对此发表评论。
克利夫兰诊所的心脏病学家Dr. Steven Nissen在5月21日的新英格兰医学杂志上报道服用文迪雅的患者比服用其他降糖药或者安慰剂患者的心肌梗塞发生率增加43%。FDA要求葛兰素和武田将以往的安全警告升级为更高级别的“黑盒”警告。2006年2月FDA的一位主管在内部的备忘录中建议更改文迪雅的标签，随后被该机构否决。参众两院启动对文迪雅心脏风险处理的质询以及两天后Nissen 发表的文章强调了这种风险以后，FDA的态度迅速发生转变。加州民主党人Waxman等发起FDA改革法案，要求赋予FDA包括要求厂家更改药物标签，完成上市后研究，对临床研究的结果进行更广泛传播等更大权力。
文迪雅是目前最畅销的口服抗糖尿病药物，去年该药共产生约3亿美元的利润。格兰素公司拖延了11个月，才将文迪雅增加心脏病风险的临床试验结果通知联邦政府的监管部门。而政府官员却对于几年前对于该药物的警告置若罔闻。Waxman声称，FDA必须有更大的决心，充分的资源以及足够的权威，其监管才更为有效。
文迪雅批准上市时，FDA更关心药物导致心衰的潜在风险，以及药物的肝脏毒性。FDA委员Andrew von Eschenbach在作证时说：回顾性的研究发现，文迪雅导致心肌梗死的风险已经成为一个相当重要的心血管副作用。但是Glaxo在FDA要求下进行的上市后研究规模太小，无法阐明该药物与心肌梗死风险的联系。

2007-06-11 17:15

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ericwang 编辑于 2007-06-11 17:39

• #医生的昵称有多好笑#这是你们热爱工作的表现吗？哈哈哈哈

freelane

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John B. Buse 是下届主席,非本届
Tadataka Yamada 不是GSK总裁,而是项目主管,
去年该药共产生约3亿美元的利润。是销售30亿,没有披露利润

2007-06-11 21:57

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