Bush Admin Fails To Turn Over FDA Documents布什政府當局未能交出林業局文件
By由 Justin Blum賈斯汀百隆
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國國會發出傳票尋求相關資料賽諾菲安萬特公司的抗生素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.一個調查小組委員會的眾議院能源和商業委員會要求簡報文件用於準備食品和藥物管理局專員安德魯馮eschenbach作證他的一個聽證會上對毒品三月。 The administration’s response was released today by the panel.政府當局的回應已於今天發布的小組。
The subcommittee last year began investigating whether von Eschenbach gave misleading testimony on Ketek at the hearing.小組委員會在去年開始調查是否馮eschenbach了誤導的證詞ketek在聽證會上。 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.廉政專員與食品及藥物管理局正在審核，由國會議員的人說，該機構沒有採取足夠行動，以確保安全ketek及其他藥品。 The subcommittee is holding a hearing today on Ketek, which has been linked to fatal side effects.小組委員會舉行的聽證會今天就ketek ，一直與致命的副作用。
“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. "該署已嚴重關切提供什麼樣的材料，該委員會已傳喚說： "官員的FDA和其上級機構，衛生與人類服務部，在給該委員會。
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" ，這種高度機密和議事材料用於製備證人作證之前，國會令人心寒的風險公開交換意見，這是必不可少的有效開展代理業務， "寫文森特j.文蒂米利亞小的衛生署和蘇珊長winckler根據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.該機構表示願意向委員會的有關問題，馮eschenbach的證詞，並小組都沒有回應，據信。
`Evidence of Perjury?’ `的證據，偽證罪嗎？
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.代表約翰D dingell ，密歇根州民主黨人士擔任能源和商務委員會說，在今日的聆訊中表示，他支持召開衛生部長邁克爾裡維特，在蔑視未能遵守該傳票。
“What is in those briefing books that he does not want either my Republican colleagues or our side to see?” Dingell said. "什麼是在這些書籍介紹說，他不希望我的共和黨同事或我方看到" ？ dingell說。 “Is there evidence of perjury? " ，是有證據的偽證？ Are there statements embarrassing to the administration?”有報表尷尬當局" ？
The panel has been investigating the FDA’s 2004 approval of Ketek.該委員會一直在調查了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.據路透社報導該藥所作的總部設在巴黎的賽諾菲就是一個例子， FDA的弱者監督。 The agency approved the product even after certain data suggested safety risks and agency scientists expressed concern.該機構批准了該產品後，甚至在一定的數據顯示，安全方面的風險和機構的科學家也對此表示關切。
The FDA prohibited marketing Ketek for sinusitis and bronchitis last year after it was linked to liver damage and death in some patients.該管理局禁止銷售ketek為鼻竇炎和支氣管炎去年之後，它是有聯繫的肝損傷和死亡，在一些病人。 The drug remains on the US market for pneumonia.該藥物仍然是對美國市場為肺炎。
Accuracy of Testimony精度的證詞
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日的聽證會前，調查小組委員會，議員們質疑的準確性馮eschenbach的一份書面證詞中約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.人們第一手的了解FDA的監督ketek "們也提出了疑問，是否專員或那些幫助準備他的證詞是否有意在誤導小組委員會" ，寫dingell和有代表性的巴特斯圖帕克一名民主黨人，從密歇根州，在一個信裡維特經過去年的聽證會。 Stupak is chairman of the investigative panel.斯圖帕克是主席的調查小組。
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.這封信由國會議員包括一篇文章，引述大衛羅斯，前FDA的科學家都致力於ketek ，說馮eschenbach的一份書面證詞中載有錯誤的意見，是有關該機構的處理用藥。 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.羅斯，他詳細他反對人士的證詞，以記者在聽證會上，上台問題說明了什麼林業局知道偽造臨床試驗和什麼樣的資訊監管機構考慮到在批准該藥。
Clinical Trial Scrutinized臨床試驗審核
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.今天的聽證會的重點是什麼Aventis公司，其前身公司向賽諾菲，知道是偽造的成果在臨床試驗的ketek民辦瑪麗亞"安妮" kirkman -坎貝爾，研究員，他們承認控罪，郵件欺詐案而被送往監獄。 Sanofi has repeatedly said the company didn’t know about the fraud before submitting the data to the FDA.賽諾菲一再表示，該公司根本不知道有欺詐行為，然後才提交的數據向FDA 。
Aventis failed to supervise properly the researchers in the Ketek trial, the FDA said in an October warning letter to Sanofi. Aventis公司未能妥善監督研究者在ketek審判中， FDA表示，在今年10月發出警告信給該公司。 The company didn’t “adequately investigate” reports that Kirkman-Campbell produced false data and enrolled ineligible patients, the letter said.該公司沒有"充分的調查"報告說， kirkman -坎貝爾出具了虛假的數據和入學資格的病人，信中說。
“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公司並不知悉欺詐後，直到它已提交研究報告，向美國食品藥品管理局， "該公司發言人艾美獎翠說，上個月在一份電子郵件聲明。 The company has “learned to improve policies and procedures” and is “committed to conducting clinical trials that are rigorous, ethical and compliant,” she said.該公司"的教訓，以完善各項政策和工作程序" ，是"致力於進行臨床試驗是嚴格的，合乎道德和兼容的， "她說。
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