quinta-feira, 5 de abril de 2007

Um caso de corrupção na China: exceção ou regra na aprovação de medicamentos?

The Wall Street Journal relata um caso de corrupção na China relacionado à regulamentação de medicamentos. A empresa local estava para aprovar o sal da claritromicina, um antibiótico, no equivalente da ANVISA. Ao invés de enviar o próprio sal, remeteu a formulação original da Abbott americana para o órgão fiscalizador. A empresa teve seu pedido aprovado e, desde então continua vendendo o seu sal (que não foi testado de fato). Recentemente, investigação do partido comunista confirmou o pagamento de propinas por parte da empresa.
Casos como esse abalam a credibilidade de tudo que foi e continua sendo feito na China e seu órgão regulador.
Abaixo, trecho da matéria.
In 1995, a Chinese drug maker was developing a version of clarithromycin, a popular antibiotic used mainly to treat respiratory infections. But to begin selling the medication, the company, Zhongxiang Kangshen Medicine Co., needed approval from China's drug regulator. So Luo Yongqing, director of Zhongxiang's research department, called his top employees to a meeting. According to Gao Chun, a research scientist who attended, Mr. Luo tossed a box of antibiotics made by Abbott Laboratories on the table and told the scientists to use the American drug maker's pills in their application for approval from the country's drug watchdog. Zhongxiang's own drug wasn't ready yet, Mr. Gao says, but the company didn't think that should get in the way. Some of the researchers agreed to substitute the pills, Mr. Gao says, but he refused. "I thought it was immoral and against the law," he says. A short time later, Mr. Gao stopped working for Zhongxiang and launched a decade-long fight against the drug and against government regulators, whom he accuses of taking bribes from his former employer to look the other way. The company won approval for the drug and has been selling it ever since. Mr. Gao's case failed in the courts, but the picture he painted of a system gone wrong has received surprising vindication. A major corruption probe has targeted China's former top drug regulator, a man with whom Mr. Gao had an angry confrontation as he pursued his case. The Central Commission for Discipline Inspection, the Communist Party's anticorruption watchdog, began investigating the regulator, Zheng Xiaoyu, in December and announced his expulsion from the party on March 1, alleging that he abused his power by taking bribes from drug companies. It is unclear whether he will face criminal prosecution. Mr. Zheng couldn't be reached for comment.

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