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Bayer Execs Blamed for Withheld Data

October 14, 2006|From Reuters

WASHINGTON — German drug maker Bayer said Friday that it had suspended two senior employees over the company's failure to provide U.S. regulators with data on its heart-surgery drug Trasylol.

Bayer also said it had hired an independent counsel to investigate its actions regarding the disclosure of the preliminary results from the Trasylol study.

"Based on our investigation so far, we believe this was a serious error in judgment by two individuals," the company said in a statement.

The Food and Drug Administration began reviewing the drug this year after two other studies published in medical journals linked its use to kidney problems. One of the studies also said the drug could increase the risk of heart attacks and strokes.

The FDA sought advice from a panel of outside experts on Sept. 21 over how to address the potential safety concerns. The advisors ruled Trasylol was acceptable for preventing blood loss in certain patients undergoing heart bypass surgery.

Days later, Bayer said it had mistakenly withheld another study based on 67,000 hospital patient records that suggested the drug could increase the chances of death, serious kidney damage, congestive heart failure and stroke.

At the time, the drug maker said it did not share the data with the FDA because the findings were preliminary and there were questions about the study's methods.

Bayer spokeswoman Staci Gouveia on Friday said the suspended employees, two senior members in Bayer's Global Drug Safety Group in Germany, had been notified of the third study's initial results on Sept. 14.

The two employees sent the investigators questions on Sept. 18, but it was not clear when others at the company were made aware of the filings, she said. Bayer sent the study to the FDA on Sept. 27, she said.

The company will make public the final results of the investigation by the outside counsel when it is completed, Gouveia said.

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