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Biowatch

07/23/13 12:49 AM

#164346 RE: ilpapa #164048

NYT: Drug Research in China Falls Under a Cloud
http://www.nytimes.com/2013/07/23/business/global/drug-research-in-china-falls-under-a-cloud.html

They are concerned that GSK didn't oversee their research facilities in China as they expanded quickly, hence data-handling got sloppy. They paid people to recruit patients who did or maybe didn't (?) meet criteria.

By KATIE THOMAS
Published: July 22, 2013

Executives at the British drug maker GlaxoSmithKline were warned nearly two years ago about critical problems with the way the company conducted research at its drug development center in China, exposing it to potential financial risk and regulatory action, an internal audit found.

The confidential document from November 2011, obtained by The New York Times, suggests that Glaxo’s problems may go beyond the sales practices that are currently at the center of a bribery and corruption scandal in China. They may extend to its Shanghai research and development center, which develops neurology drugs for Glaxo...

...Auditors found that researchers did not report the results of animal studies in a drug that was already being tested in humans, a breach that one medical ethicist described as a “mortal sin” in the world of drug research. They also concluded that workers at the research center did not properly monitor clinical trials and paid hospitals in ways that could be seen as bribery.