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Joe Giffels, MAS, has written extensively on the regulation and practice of clinical research and is here to offer information. Here he shares information and advice on what you should know before, and how to decide if you should volunteer to participate in a clinical trial.

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WebMD Health News

Tuesday, July 24, 2007

China's FDA Troubles
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Let's say a high-ranking US official, perhaps the commissioner of the US Food and Drug Administration (FDA), was found to have accepted bribes from pharmaceutical companies to give the FDA's stamp of approval on drugs that had not been sufficiently tested for safety and efficacy in humans. What's the worst that would happen to him (yes, it would probably be a him)? Perhaps he would be fired or asked to resign. He would likely be assessed fines. And he might even be sentenced to some prison time (although it's not inconceivable such a sentence would be commuted). Then he goes on the lecture circuit and eventually accepts a very highly compensated consulting position in industry. After all, he is an expert.

That is essentially the scenario that recently unfolded in China. Zheng Xiaoyu, the former head of China's State Food and Drug Administration, was convicted of taking bribes to give approval to market untested products, including drugs. As might be expected, problems were attributed to some of drugs, including a number of deaths.

Because China is concerned about establishing a global market position in the drug industry (as well as many, many other industries), it considers it critical to project an image as a reliable source of safe drugs. So what did it do?

It sentenced Zheng Xiaoyu to death. Zheng was executed on Tuesday, July 10.

~Joe

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Posted by: Joe Giffels_ WebMD at 8:08 PM

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