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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。

进行椎体成形术(Vertebroplasty)期间摄制的一张椎骨彩色CT扫描图(如图所示)。椎体成形术是一种用于治疗压缩性骨折的手术。手术时,外科医生向椎骨注入骨水泥(从针头流出的白色物质),以增强骨骼强度,防止未来的损害。

    2011年11月16日,70岁的乔治亚•巴德利,一位居住在盐湖城附近的老太太,收到了一个令人震惊的电话。给她打电话的是美国卫生和公众服务部的一位特殊代理人。这位代理人对她说,政府无意中获悉一个与其母亲之死有关的最新消息。

    巴德利说不出话来。8年前,她时年83岁的老母亲芭芭拉•马塞利诺出人意料地死于脊柱外科手术。当时,巴德利并没有对手术台上发生的一切产生疑问;她那个年龄的老人做外科手术总是有风险的。这位代理人告诉她,外科医生当时向她母亲椎骨注入的骨水泥是一种未经批准的产品,或许正是这种产品导致了她母亲的死亡。这番话让巴德利极度震惊。

    这位代理人解释称,政府已经向这种骨水泥的制造商,一家名为辛迪斯(Synthes)的公司,以及该公司4位高管提出了刑事指控。挂掉电话后,还没有缓过神来的巴德利陷入了长久的沉默之中。她说:“我非常吃惊,我万万没有想到竟然会发生这样的事情。”

    辛迪斯对大多数人来说或许都是一家闻所未闻的公司。但在6月份,强生集团(Johnson & Johnson)斥资近200亿美元,完成了对辛迪斯的购并(这也是强生集团历史上最大的一宗收购案)之后,这家总部位于宾夕法尼亚州西切斯特市的医疗设备制造商顿时成为医疗保健业最知名的公司之一。市场观察人士为这笔交易欢呼雀跃,认为此举有助于进一步丰富强生集团具有高利润率的骨科产品系列。近几年以来,强生集团经历了一系列令其声誉受损的召回事件和诉讼风波。阐述购并动机时,强生集团特别指出,辛迪斯公司的“文化”和“价值观”是吸引其收购的原因之一——尽管几位被控犯有严重不当行为的前辛迪斯公司高管当时正在等候法庭的判决裁定。

    2009年,美国费城检察官指控辛迪斯公司非法进行临床试验(其实就是在人体上做试验)。2002年至2004年,辛迪斯公司多次测试一款名叫Norian XR的产品,在被注入人体骨架之后,这种骨水泥产品具有一种转变为骨骼的独特能力。美国食品和药物管理局(FDA)明确告知辛迪斯公司,不要将Norian XR推广应用于几种特定的脊柱手术之中,但该公司置若罔闻,依然抓紧时间进行试验。至少有5位脊柱被注入Norian骨水泥的病人死在了手术台上,其中就包括芭芭拉•马塞利诺。

    辛迪斯公司及其高管受到的指控震动了美国整个医疗保健业。此事堪称一个经典的公司渎职案例,但它也揭开了一家几乎与世隔绝的公司的神秘面纱。辛迪斯公司的老板是一位深居简出,独断独行的瑞士亿万富豪,他也是哈佛大学(Harvard University)历史上最大一笔个人捐赠的提供者。这起案件提供了一个难得的机会,借此可以观察迷雾重重的医疗器械世界——尽管其中的某些事情或许会让我们感到不安。我们现在知道,外科医生在进行手术期间,有时竟然会向20来岁的销售代表咨询意见。

    On Nov. 16, 2011, Georgia Baddley, a 70-year-old woman living near Salt Lake City, received a shocking call from a special agent at the U.S. Department of Health and Human Services. The agent told her that the government had come across new information about her mother's death.

    Baddley was speechless. Eight years before, her 83-year-old mother, Barbara Marcelino, had unexpectedly died during spine surgery. At the time, Baddley didn't question what had happened; surgery was always risky for a woman of that age. She was horrified when the agent told her that the surgeon had injected bone cement into her mother's spine and that the product -- which was not approved for that use -- may have played a role in her death.

    The agent explained that the government had filed criminal charges against the maker of the cement, a company called Synthes, and four of its executives. After hanging up the phone, Baddley sat in stunned silence. "I was taken aback," she says. "I had no idea that anything like that had happened."

    Most people have never heard of Synthes, a medical device maker headquartered in West Chester, Pa. But the company became part of one of the most recognizable names in health care in June when Johnson & Johnson (JNJ) completed the purchase of it for nearly $20 billion -- the largest acquisition in J&J's history. Market watchers cheered the deal, which will expand the company's stable of high-margin orthopedic products. J&J, which has endured a series ofreputation-sullying recalls and lawsuits in recent years, specifically cited Synthes's "culture" and "values" as evidence of its appeal, even as former Synthes executives awaited sentencing on charges of grievous conduct.

    In 2009 the U.S. attorney in Philadelphia accused the company of running illegal clinical trials -- essentially, experimenting on humans. Between 2002 and 2004, Synthes had tested a product called Norian XR, a cement that has a unique capacity to turn into bone when injected into the human skeleton. The Food and Drug Administration explicitly told Synthes not to promote Norian for certain spine surgeries, but the company pushed forward anyway. At least five patients who had Norian injected into their spines died on the operating-room table. One was Barbara Marcelino.

    The indictment of Synthes and its executives shook the health care industry. What occurred is a classic example of corporate malfeasance, but set inside an insular corporation run by a reclusive and autocratic Swiss multibillionaire, the provider of the largest individual gift in the history of Harvard University. The case offers a rare, sometimes disturbing, glimpse inside the shrouded world of medical devices, where surgeons occasionally turn for advice during operations to twentysomething sales representatives.

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