美國奪命骨水泥黑幕曝光（節選）

????2011年11月16日，70歲的喬治亞?巴德利，一位居住在鹽湖城附近的老太太，收到了一個令人震驚的電話。給她打電話的是美國衛生和公眾服務部的一位特殊代理人。這位代理人對她說，政府無意中獲悉一個與其母親之死有關的最新消息。

????巴德利說不出話來。8年前，她時年83歲的老母親芭芭拉?馬塞利諾出人意料地死于脊柱外科手術。當時，巴德利并沒有對手術臺上發生的一切產生疑問；她那個年齡的老人做外科手術總是有風險的。這位代理人告訴她，外科醫生當時向她母親椎骨注入的骨水泥是一種未經批準的產品，或許正是這種產品導致了她母親的死亡。這番話讓巴德利極度震驚。

????這位代理人解釋稱，政府已經向這種骨水泥的制造商，一家名為辛迪斯（Synthes）的公司，以及該公司4位高管提出了刑事指控。掛掉電話后，還沒有緩過神來的巴德利陷入了長久的沉默之中。她說：“我非常吃驚，我萬萬沒有想到竟然會發生這樣的事情?！?/p>

????辛迪斯對大多數人來說或許都是一家聞所未聞的公司。但在6月份，強生集團（Johnson & Johnson）斥資近200億美元，完成了對辛迪斯的購并（這也是強生集團歷史上最大的一宗收購案）之后，這家總部位于賓夕法尼亞州西切斯特市的醫療設備制造商頓時成為醫療保健業最知名的公司之一。市場觀察人士為這筆交易歡呼雀躍，認為此舉有助于進一步豐富強生集團具有高利潤率的骨科產品系列。近幾年以來，強生集團經歷了一系列令其聲譽受損的召回事件和訴訟風波。闡述購并動機時，強生集團特別指出，辛迪斯公司的“文化”和“價值觀”是吸引其收購的原因之一——盡管幾位被控犯有嚴重不當行為的前辛迪斯公司高管當時正在等候法庭的判決裁定。

????2009年，美國費城檢察官指控辛迪斯公司非法進行臨床試驗（其實就是在人體上做試驗）。2002年至2004年，辛迪斯公司多次測試一款名叫Norian XR的產品，在被注入人體骨架之后，這種骨水泥產品具有一種轉變為骨骼的獨特能力。美國食品和藥物管理局（FDA）明確告知辛迪斯公司，不要將Norian XR推廣應用于幾種特定的脊柱手術之中，但該公司置若罔聞，依然抓緊時間進行試驗。至少有5位脊柱被注入Norian骨水泥的病人死在了手術臺上，其中就包括芭芭拉?馬塞利諾。

????辛迪斯公司及其高管受到的指控震動了美國整個醫療保健業。此事堪稱一個經典的公司瀆職案例，但它也揭開了一家幾乎與世隔絕的公司的神秘面紗。辛迪斯公司的老板是一位深居簡出，獨斷獨行的瑞士億萬富豪，他也是哈佛大學（Harvard University）歷史上最大一筆個人捐贈的提供者。這起案件提供了一個難得的機會，借此可以觀察迷霧重重的醫療器械世界——盡管其中的某些事情或許會讓我們感到不安。我們現在知道，外科醫生在進行手術期間，有時竟然會向20來歲的銷售代表咨詢意見。

????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.