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Bayer launches investigation into study disclosure failure

Two senior employees suspended for failing to advise FDA of study linking Trasylol to side effects

Bayer is in hot water after admitting that it failed to tell US regulators about a study linking its heart-surgery drug, Trasylol, to deadly side effects because two senior employees did not inform supervisors that the report had been completed.

The German firm said it had appointed an independent investigator to find out exactly why preliminary results from the observational trial on Trasylol were not made known to a US Food and Drug Administration (FDA) advisory committee before it met to assess the safety of the drug on September 21.

The FDA began reviewing Trasylol earlier this year after two earlier studies published in medical journals linked its use to kidney problems. One of the studies also found that the drug could increase the risk of heart attacks and strokes.

After the September 21 meeting, the FDA advisory committee affirmed that Trasylol was safe and effective for patients undergoing coronary artery bypass graft surgery. It was not until a week later that Bayer released the results of the 67,000-patient study, which confirmed the earlier trial linking usage of the drug to an increased risk of kidney failure, heart attacks and strokes.

Bayer's general counsel, Dr Roland Hartwig, said Bayer acknowledged and regretted the error it made in not sharing the information with the FDA before the meeting.

ìBased on our investigation so far, we believe this was a serious error in judgment by two individuals,î he added.

Bayer said it had suspended the two employees with immediate effect while former White House counsel, Fred Fielding, from the law firm Wiley Rein & Fielding, investigates the lapse. It also said it expects that a ìspecific corrective action planî may arise from the independent investigation, adding that it is ìdetermined to take all appropriate steps to ensure that something like this does not happen againî.

Bayer spokeswoman Staci Gouveia said Bayer believes that the two employees, who work in the company's global drug safety group in Germany, were the only company officials who knew the study had been finished. They did not disclose the report because they viewed it as preliminary and had ìsignificantî concerns about the methodology, she added.

The employees received the report on September 14 from i3 Drug Safety, a private clinical research company, and completed a list of questions for the study's authors.

Sidney Wolfe, of the public interest watchdog group, Public Citizen, said Bayer may have violated the law by failing to release the results.

ìThe thing that's most concerning to me is the withholding of data is a criminal offence,î he said in an interview before Bayer announced the investigation. ìThey can say it's a mistake all they want, but it's a fairly big time mistake to make.î

One member of the FDA advisory committee, Steven Findlay, a Consumers Union healthcare analyst, said he doubted whether knowledge of the study's completion was limited to just two Bayer employees.

ìIt just strains credulity that only they would know,î he said.

The findings from the independent investigation will be published when it is completed.

30th September 2008

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