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巨大製薬会社は刑事責任の余分の臨床試験に直面する
金曜日、2007年6月1日
アンドリューGumbel 米国の薬剤巨人Pfizerは前に髄膜炎の伝染病の間に子供で十年行なった悪名高い臨床試験上のナイジェリアの刑事責任と強く打たれた。 患者は死んだ新しく、試験されていない抗生物質そのほとんどのための無意識のモルモットになりかまたは永久的な不能と去った。 Pfizerおよび代表がヒアリングでのために来月説明するために始まるKanoのナイジェリアの状態の、臨床試験上の公共の怒り-および薬品会社の保証-小児マヒに対して子供を免疫にするためにローカル人口がナイジェリアの政府を信頼しないほど残物高く呼ばれる。 米国裁判所の1つの不成功なスーツに既に導いてしまったエピソードはジョンLe Carre's小説のためのインスピレーシヨン一定した庭師であって、ゆがんで衝撃的に行った科学的な照会の例として頻繁に遅れる。 ナイジェリアの権限はPfizerが1996年にKanoの混雑させた伝染性キャンプから研究者200人の子供および幼児を選び、それらの半分についてTrovanと呼ばれた試験されていない抗生物質を与えたことを言う。 訴訟はTrovanは生命にかかわる副作用をもたらすかもしれないし、「人間の使用に不適当」だったことを彼らの自身の研究から知っていたのに研究者が子供の家族からの承諾を得なかったことを主張する。 研究者がPfizer'sの競争相手のHoffmanLa Rocheによってなされた比較の薬剤残りの半分のそれ以上のスーツによっては与えたが争ったり自身のプロダクト一見をよりよくさせるために慎重にそれらをことがunderdosed。 違法行為をすることに同意するPfizerおよび医者は「」スーツ言う、「ある意味ではそうに関して無謀そして怠慢人命」を危険にさらしなさい。 試験がある、スーツは、Pfizer区域、取除いたすべての医療記録を残続き、「試験の証拠」を抹消した。 Pfizerが決して代わりとなる処置は利用できた-最も明らかにクロロアムフェニコール、通常細菌の髄膜炎のために推薦された比較的安い抗生物質こと試験に加わって、それらを知らせなかった彼らの親か子供を告げなかったことを刑事責任にようであるナイジェリアの政府のレポート、前に拍車をかける分られる。 政府のレポートは死んだ11人の子供の、5つはTrovanを取って、6つは比較の薬剤の低い線量を取っていたことを、ceftriaxone分った。 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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