Bayer did not withhold Trasylol safety data

An independent review of the actions of Germany's Bayer AG regarding the surgical clotting agent Trasylol (aprotinin injection) has concluded that the firm did not deliberately withhold negative safety data, derived from a study conducted by US clinical research company i3, from the Food and Drug Administration. The original allegation was that Bayer had not presented the relevant findings at a meeting with the FDA's Advisory Committee, which had been specifically convened to discuss safety issues relating to the product on September 21 last year (Marketletter October 2, 2006).

"Employees made serious error of judgement"

The investigation, which was conducted by lawyer William Taylor of US firm Zuckerman Spaeder LLP, revealed that only two employees from Bayer's Global Drug Safety Office had access to, and were aware of, preliminary results from the i3 safety examination prior to September 21, 2006, and that they had not disclosed this information due to doubts about the methodology of the study.