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Errors, Misconduct, and an Alleged Cover-Up Attempt Delayed Pfizer Inc. (PFE), Bristol-Myers Squibb Company (BMY) Medicine


7/9/2013 8:33:32 AM

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Drugmakers have increasingly been turning to China for large clinical trials because they’re cheaper and there’s a bigger population of subjects to draw on. Now U.S. regulators have stepped in, questioning sloppy data and irregularities from the world’s most populous country. Bristol-Myers Squibb Co. (BMY) and Pfizer Inc.’s blood thinner Eliquis, approved in December, was stalled for nine months because of misconduct, errors and an alleged cover-up attempt at a Chinese trial site overseen by Bristol-Myers, according to documents posted by the U.S. Food and Drug Administration. The delay came after the company told the FDA that patients got the wrong medicine, records were secretly changed and “serious adverse events” went unreported, the documents show.

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