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O criminoso gigante das caras das drogas carrega a experimentação clínica excedente
Sexta-feira, junho 1o, 2007
Andrew Gumbel Os E.U. Pfizer gigante pharmaceutical foram golpeados com cargas criminal em Nigéria sobre uma experimentação que clínica notorious conduziu em crianças durante uma epidemia do meningitis uma década há. Os pacientes transformaram-se cobaias unwitting para um novo, o antibiótico untested e muitos dele morreram ou foram saidos com as inabilidades permanentes. Pfizer e seus representantes serão chamados para explicar nos hearings devidos começar mês seguinte no estado Nigerian de Kano, onde raiva pública sobre a experimentação clínica - e as garantias de alguma companhia pharmaceutical - remains assim elevado que a população local não confiará mesmo no governo Nigerian para immunise suas crianças de encontro à poliomielite. O episode, que tem conduzido já a um terno mal sucedido nas cortes dos E.U., era a inspiração para a novela de John Le Carre o Gardener constante e é prendido freqüentemente acima como de um exemplo do inquérito científico ido shockingly awry. As autoridades Nigerian dizem que investigadores de Pfizer selecionou 200 crianças e infantes de um acampamento epidémico aglomerado em Kano em 1996 e deu sobre a metade deles um antibiótico untested chamado Trovan. O lawsuit alega que os investigadores não obtiveram o consentimento das famílias das crianças mesmo que saibam de sua própria pesquisa que Trovan pôde ter efeitos laterais life-threatening e foi “inadequado para o uso humano”. O terno mais adicional contends que os investigadores deram a outra metade de uma droga da comparação feita pelo Hoffman-La Roche do concorrente de Pfizer, mas underdosed deliberadamente os para fazer seu próprio olhar do produto melhor. Pfizer e seus doutores “concordados fazer um ato ilegal,” o terno dizem, “em uma maneira assim rash e negligent a respeito de ponha em perigo a vida humana”. Uma vez que a experimentação sobre, o terno continua, Pfizer à esquerda a área, removeu todos os registros médicos e “obliterated toda a evidência” da experimentação. Um relatório Nigerian do governo, que parecesse spurred as cargas criminal, encontradas previamente que Pfizer nunca disse as crianças ou seus pais que participavam em uma experimentação e não os informaram que os tratamentos alternativos estavam disponíveis - o mais obviamente chloramphenicol, um antibiótico relativamente barato recomendado geralmente para o meningitis bacteriano. O relatório do governo encontrou que das 11 crianças que morreram, cinco faziam exame de Trovan e seis faziam exame de doses baixos da droga da comparação, 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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