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药品巨商面对罪名临床试验
星期五， 2007年6月1日
安德鲁Gumbel 美国巨型制药业Pfizer在它在孩子进行在脑膜炎流行性期间十年前的尼日利亚掴了与罪名在一次臭名远扬的临床试验。 患者变成无心的试验品为死去的新，未经考验的抗生素和大多数或离开以永久伤残。 Pfizer和它的代表在Kano萘及利亚人的状态将叫认为在听证会由于开始下个月，公开愤怒在临床试验-和任何制药公司保证-遗骸的很高地方人口甚而不会信任萘及利亚人的政府使他们的孩子免疫反对小儿麻痹症。 情节，在美国法院已经导致了一套不成功的衣服，是启发为约翰· Le Carre的小说恒定的花匠和频繁地被阻止作为偏差可怕去的科学询问事例。 萘及利亚人的当局认为1996年Pfizer研究员在Kano选择了200个孩子和婴儿从一个拥挤流行性阵营并且给了大约半他们称Trovan的未经考验的抗生素。 诉讼宣称研究员没有获得同意从儿童的家庭，即使他们从他们自己的研究知道Trovan也许有威胁生命的副作用并且是“不合适的为人的使用”。 衣服更加进一步主张研究员给了另外一半Pfizer的竞争者HoffmanLa做的比较药物Roche，但故意地underdosed他们使他们自己的产品看起来更好。 “同意的Pfizer和它的医生做一种违法行为”，衣服说， “有些很轻率和疏忽至于危及人生”。 一旦试验是，衣服继续， Pfizer左区域，去除了所有病历，并且“磨灭了所有证据”的试验。 一个萘及利亚人的政府报告，看上去激励了罪名，早先被发现Pfizer未曾告诉孩子或他们参加试验，并且没有通知他们的他们的父母供选择的治疗是可利用的-最明显地氯胺苯醇，为细菌脑膜炎通常推荐的相对地便宜的抗生素。 政府报告发现死的11个孩子，五采取Trovan，并且六采取比较药物的低药量， ceftriaxone。 An unknown number suffered deafness, blindness, paralysis and other disabilities. The Kano authorities have charged Pfizer on eight counts of criminal conspiracy and voluntarily causing grievous harm. They have also filed a civil suit seeking more than $2.7bn (£1.3bn) in damages. Pfizer has responded to the lawsuit by insisting it did nothing wrong. “Pfizer continues to emphasize - in the strongest terms - that the 1996 Trovan clinical study was conducted with the full knowledge of the Nigerian government and in a responsible and ethical way consistent with the company’s abiding commitment to patient safety,” a company statement said. “Any allegations in these lawsuits to the contrary are simply untrue - they weren’t valid when they were first raised years ago and they’re not valid today.” Back in 1997, when Pfizer faced a US government audit of its records on Trovan, the company produced a letter from a hospital in Kano saying its study had been approved by the hospital’s ethics committee. The company’s accusers contend that the letter was fabricated after the fact, using a forged letterhead. The hospital, according to the suit, has no ethics committee. Nigeria’s decision to prosecute Pfizer marks the first known instance of a Third World country going after a pharmaceutical multinational. Until now, the Nigerians have trod very carefully around the issue - commissioning an investigation but then suppressing the results until they were leaked to The Washington Post a few years ago. But the episode has got in the way of successive public initiatives, including a polio vaccination drive that prompted an 11-month boycott in Kano. Trovan has never been approved for use on US children. It was cleared for adults in 1997, but its use was restricted two years later following reports of liver damage and death. It is banned throughout Europe. Have Your Say: Drugs giant faces criminal charges over clinical trial Please read our posting guidelines before posting. Alternatively you can discuss this report here. Related News
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