Bayer said a "serious error in judgment" by two senior members of the company's Global Drug Safety Group may be to blame for the firm's failure to disclose preliminary results from an observational study of Trasylol before an FDA advisory committee review.

"Bayer immediately initiated a full investigation into the matter and based on our investigation so far, we believe this was a serious error in judgment by two individuals," Bayer General Counsel Roland Hartwig said Oct. 13.

The two individuals have been suspended effective immediately, the firm added.

Bayer has appointed Fred Fielding, from the law firm Wiley Rein & Fielding, to conduct an investigation into the matter and provide recommendations for the company's future action.

"We are committed to ascertaining how and why this error occurred, and to ensure that such errors are not repeated we have now retained...an attorney of the highest reputation for integrity and independence to carry on this investigation," the company said.

The company plans to publish the findings of the investigation, which it expects could likely result in the development of a corrective action plan.

FDA's Cardiovascular & Renal Drugs Advisory Committee convened Sept. 21 to discuss safety concerns associated with aprotinin injection revealed in the published findings of two observational studies (¹ Also see "Trasylol Not Associated With Renal/Heart Failure, MI, Stroke, Cmte. Says" - Pink Sheet, 21 September, 2006.).

Despite positive committee feedback regarding Bayer's transparency during the review process, the company told FDA Sept. 27 that it had mistakenly failed to share retrospective data from a 67,000-patient observational study with the agency.

"The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. FDA was not aware of these new data when it held the September 21, 2006 advisory committee meeting on Trasylol safety," the agency said Sept. 29.

Bayer has since submitted a preliminary report to the agency.

-Mary Bruce (m.bruce@elsevier.com)

Bayer Suspends Senior Staffers For Failure To Disclose Trasylol Data To FDA

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