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美国夺命骨水泥黑幕曝光(节选)

美国夺命骨水泥黑幕曝光(节选)

Mina Kimes 2012年09月21日
医疗器械制造商辛迪斯公司决定非法在人体上试验一种骨水泥产品,造成了灾难性的后果。这是一个令人不安的讲述公司罪与罚的故事。

    最重要的是,此事涉及的公司是一家再三忽视潜在致命后果证据的公司。对20多位参与Norian骨水泥计划的前员工和外科医生的采访实录,数百页法庭记录,以及提交给法庭的公司文件显示,辛迪斯公司不仅无视关于其藐视规则的多次警告,而且还对科学家的劝告(这种骨水泥可能会导致致命的血液凝块)置若罔闻。

    美国司法部将矛头对准了4名位居高位的高级管理人员。按照一个名叫《公司主管責任律例》 (Responsible Corporate Officer Doctrine)的医疗保健法案一款不同寻常的条文,他们均承认自己犯有一项轻罪。他们承认对公司从事未经授权的临床试验,以及参与药品核准标示外营销(off-label marketing,即推广产品应用于未经授权的领域)等罪行负责,但并不承认自己参与了犯罪。当时,没有哪位高管因为这项指控被判入狱(4位高管的律师拒绝让其当事人接受本文作者的采访,也不愿就这起案件的事实发表评论)。

    药品核准标示外营销是一种非常普遍的现象,以至于在一些药品和医疗器械制造商看来,这种行为与轻微超速行驶没什么两样。过去10年间,默克(Merck)、辉瑞(Pfizer)、雅培(Abbott Labs)和葛兰素史克(GlaxoSmithKline)这样一些医药大鳄已经支付了数十亿美元的罚金,用来摆平它们因参与药品核准标示外营销所受到的指控。但此类案件依然持续发生,部分原因在于潜在的利润往往超过罚金。

    但这并不是一起典型的药品核准标示外营销案例,也不是典型的医疗设备或药物试验。在诸如此类的临床试验中,病人有时会死亡——但这种实验只有在告知病人潜在的风险,并征得其同意之后才会进行。检察官声称,辛迪斯公司掩盖了其骨水泥产品未经授权这一事实,进而剥夺了病人选择是否愿意成为试验品的权利。

    辛迪斯案例为司法部门提供了一个前所未有的机会。它终于可以要求相关的公司高管为其行为承担责任。作为这起诉讼的主要发起人,美国助理检察官玛丽•克劳利敦促法庭将这些犯有“腐败罪行”的高管关进监狱。她说:“这种悍然无视病人安全的行径理应受到法律允许范围内所能作出的最高刑罚。”

    点击此处阅读英文全文>>

    译者:任文科

    Most of all, this is a story about a company that repeatedly ignored evidence of potential lethal consequences. Interviews with more than 20 former employees and surgeons involved in the Norian project, hundreds of pages of court transcripts, and company documents submitted in the case reveal that Synthes not only disregarded multiple warnings that it was flouting the rules, but also brushed off scientists' cautions that the cement could cause fatal blood clots.

    The Department of Justice targeted four high-ranking executives, all of whom pleaded guilty to a misdemeanor under an unusual provision of health care law called the Responsible Corporate Officer Doctrine. They accepted responsibility for the company's crime of running unauthorized clinical trials and for engaging in off-label marketing, or promoting products for unapproved uses, without conceding that they were involved in the crime. At the time, no executive had ever gone to prison for such a charge. (Lawyers for the four executives declined to make their clients available for interviews or to comment on the facts of the case.)

    Off-label marketing is so common among drug and device makers that it's often dismissed as the equivalent of driving slightly over the speed limit. During the past decade, pharmaceutical behemoths such as Merck (MRK), Pfizer (PFE), Abbott Labs (ABT), and GlaxoSmithKline (GSK) have paid billions in fines to settle charges that they engaged in off-label drug promotion. Yet cases continue to happen, in part because the potential profits often exceed the fines.

    But this wasn't the typical off-label marketing case. Nor was it typical of trials for medical devices or drugs. Patients sometimes die during such clinical trials -- but only after being advised of the risks and then granting their consent. In hiding the unapproved status of the cement, prosecutors argued, Synthes denied patients the right to choose whether they wanted to be test subjects.

    For the Justice Department, the Synthes case posed an unprecedented opportunity. It could finally hold individual businessmen accountable for their actions. Mary Crawley, the assistant U.S. attorney who led the prosecution, urged the court to send the executives to jail for their "venal crime." The "callous disregard of patient safety," she argued, "warrants the highest sentence the law will allow."

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