Bush Admin Fails To Turn Over FDA Documents布什政府当局未能交出林业局文件
By由 Justin Blum贾斯汀百隆
The Bush administration failed to comply with a congressional subpoena seeking documents related to Sanofi-Aventis SA’s antibiotic Ketek.布什政府未能遵守美国国会发出传票寻求相关资料赛诺菲安万特公司的抗生素ketek 。
An investigative subcommittee of the House Energy and Commerce Committee sought briefing papers used to prepare Food and Drug Administration Commissioner Andrew von Eschenbach for testimony he gave at a hearing on the drug in March.一个调查小组委员会的众议院能源和商业委员会要求简报文件用于准备食品和药物管理局专员安德鲁冯eschenbach作证他的一个听证会上对毒品三月。 The administration’s response was released today by the panel.政府当局的回应已于今天发布的小组。
The subcommittee last year began investigating whether von Eschenbach gave misleading testimony on Ketek at the hearing.小组委员会在去年开始调查是否冯eschenbach了误导的证词ketek在听证会上。 The commissioner and the FDA are under scrutiny from lawmakers who say the agency hasn’t done enough to ensure the safety of Ketek and other medications.廉政专员与食品及药物管理局正在审核，由国会议员的人说，该机构没有采取足够行动，以确保安全ketek及其他药品。 The subcommittee is holding a hearing today on Ketek, which has been linked to fatal side effects.小组委员会举行的听证会今天就ketek ，一直与致命的副作用。
“The department has serious concerns about providing the kind of materials the committee has subpoenaed,” said officials of the FDA and its parent agency, the Health and Human Services Department, in a letter to the committee. "该署已严重关切提供什么样的材料，该委员会已传唤说： "官员的FDA和其上级机构，卫生与人类服务部，在给该委员会。
Providing “such highly confidential and deliberative materials used to prepare witnesses testifying before Congress risks chilling the open exchange of views that is essential to the effective conduct of agency business,” wrote Vincent J. Ventimiglia Jr. of the health department and Susan C. Winckler of the FDA.提供" ，这种高度机密和议事材料用于制备证人作证之前，国会令人心寒的风险公开交换意见，这是必不可少的有效开展代理业务， "写文森特j.文蒂米利亚小的卫生署和苏珊长winckler根据FDA的。
The agency offered to brief the committee on issues concerning von Eschenbach’s testimony, and the panel hasn’t responded, according to the letter.该机构表示愿意向委员会的有关问题，冯eschenbach的证词，并小组都没有回应，据信。
`Evidence of Perjury?’ `的证据，伪证罪吗？
Representative John D. Dingell, a Michigan Democrat who is chairman of the Energy and Commerce panel, said at today’s hearing that he supports holding the health secretary, Michael Leavitt, in contempt for failing to comply with the subpoena.代表约翰D dingell ，密歇根州民主党人士担任能源和商务委员会说，在今日的聆讯中表示，他支持召开卫生部长迈克尔里维特，在蔑视未能遵守该传票。
“What is in those briefing books that he does not want either my Republican colleagues or our side to see?” Dingell said. "什么是在这些书籍介绍说，他不希望我的共和党同事或我方看到" ？ dingell说。 “Is there evidence of perjury? " ，是有证据的伪证？ Are there statements embarrassing to the administration?”有报表尴尬当局" ？
The panel has been investigating the FDA’s 2004 approval of Ketek.该委员会一直在调查了FDA的批准， 2004年的ketek 。 Lawmakers have said the drug made by Paris-based Sanofi is an example of the FDA’s weak oversight.据路透社报道该药所作的总部设在巴黎的赛诺菲就是一个例子， FDA的弱者监督。 The agency approved the product even after certain data suggested safety risks and agency scientists expressed concern.该机构批准了该产品后，甚至在一定的数据显示，安全方面的风险和机构的科学家也对此表示关切。
The FDA prohibited marketing Ketek for sinusitis and bronchitis last year after it was linked to liver damage and death in some patients.该管理局禁止销售ketek为鼻窦炎和支气管炎去年之后，它是有联系的肝损伤和死亡，在一些病人。 The drug remains on the US market for pneumonia.该药物仍然是对美国市场为肺炎。
Accuracy of Testimony精度的证词
During the March 22 hearing before the investigative subcommittee, lawmakers questioned the accuracy of von Eschenbach’s written testimony about Ketek.在3月22日的听证会前，调查小组委员会，议员们质疑的准确性冯eschenbach的一份书面证词中约ketek 。
People with first-hand knowledge of the FDA’s oversight of Ketek “have also raised questions about whether the commissioner or those who helped prepare his testimony intentionally misled the subcommittee,” wrote Dingell and Representative Bart Stupak, a Democrat from Michigan, in a letter to Leavitt after last year’s hearing.人们第一手的了解FDA的监督ketek "们也提出了疑问，是否专员或那些帮助准备他的证词是否有意在误导小组委员会" ，写dingell和有代表性的巴特斯图帕克一名民主党人，从密歇根州，在一个信里维特经过去年的听证会。 Stupak is chairman of the investigative panel.斯图帕克是主席的调查小组。
The letter from the lawmakers included an article quoting David Ross, a former FDA scientist who worked on Ketek, saying von Eschenbach’s written testimony contained erroneous comments about the agency’s handling of the medication.这封信由国会议员包括一篇文章，引述大卫罗斯，前FDA的科学家都致力于ketek ，说冯eschenbach的一份书面证词中载有错误的意见，是有关该机构的处理用药。 Ross, who detailed his objections to the testimony to reporters at the hearing, took issue with descriptions of what the FDA knew about a falsified clinical trial and what information regulators took into account when approving the drug.罗斯，他详细他反对人士的证词，以记者在听证会上，上台问题说明了什么林业局知道伪造临床试验和什么样的资讯监管机构考虑到在批准该药。
Clinical Trial Scrutinized临床试验审核
Today’s hearing focuses on what Aventis, a predecessor company to Sanofi, knew about falsified results in a clinical trial of Ketek run by Maria “Anne” Kirkman-Campbell, a researcher who pleaded guilty to mail fraud in the case and was sent to prison.今天的听证会的重点是什么Aventis公司，其前身公司向赛诺菲，知道是伪造的成果在临床试验的ketek民办玛丽亚"安妮" kirkman -坎贝尔，研究员，他们承认控罪，邮件欺诈案而被送往监狱。 Sanofi has repeatedly said the company didn’t know about the fraud before submitting the data to the FDA.赛诺菲一再表示，该公司根本不知道有欺诈行为，然后才提交的数据向FDA 。
Aventis failed to supervise properly the researchers in the Ketek trial, the FDA said in an October warning letter to Sanofi. Aventis公司未能妥善监督研究者在ketek审判中， FDA表示，在今年10月发出警告信给该公司。 The company didn’t “adequately investigate” reports that Kirkman-Campbell produced false data and enrolled ineligible patients, the letter said.该公司没有"充分的调查"报告说， kirkman -坎贝尔出具了虚假的数据和入学资格的病人，信中说。
“Aventis was not aware of fraud until after it had submitted the study to the FDA,” Sanofi spokeswoman Emmy Tsui said last month in an e-mailed statement. " Aventis公司并不知悉欺诈后，直到它已提交研究报告，向美国食品药品管理局， "该公司发言人艾美奖翠说，上个月在一份电子邮件声明。 The company has “learned to improve policies and procedures” and is “committed to conducting clinical trials that are rigorous, ethical and compliant,” she said.该公司"的教训，以完善各项政策和工作程序" ，是"致力于进行临床试验是严格的，合乎道德和兼容的， "她说。
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