FRANKFURT, Aug 17 (Reuters) - Bayer's BAYG.DE failure to supply U.S. regulators with risk data for heart-surgery drug Trasylol was the result of misjudgement, not a cover-up, an independent counsel hired by the German drugmaker said.
“This failure was not motivated by any intent to conceal the existence of the study but was regrettable human error,” said William Taylor, a partner at Zuckerman Spaeder LLP, in a report released by Bayer.
The U.S. Food and Drug Administration began reviewing the drug last year after two 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 advisers ruled that 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 may increase the chances of death, serious kidney damage, congestive heart failure and stroke.
At the time, the drugmaker 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 has since suspended two senior staff over what it described as a “serious error in judgement” by failing to disclose the preliminary results from the Trasylol study.
“These two individuals did not immediately disclose this information, because they had significant questions about the study’s methodology and analyses,” Taylor said in the report.
The report also said no other Bayer employees or any of the external consultants who supported Bayer at the panel meeting knew that the preliminary report had been received.
Bayer shares were down 2.5 percent at 52.38 euros at 0947 GMT, compared with a 0.35 percent fall in the German blue-chip index .GDAXI.
Bayer, which bought rival Schering last year to boost its healthcare business, said it had strengthened structures and processes over its drug safety and monitoring procedures.
“Bayer is confident that errors of this sort will not again occur,” it said in a statement.
Early this year, Bayer stopped three studies to expand the use of Trasylol, approved in 1993. Also known as aprotinin bovine, it aims to reduce bleeding and the need for blood transfusions in heart surgery patients.
The drug was once predicted to be able to reach peak annual sales of more than 500 million euros ($633 million).
Taylor started work on the report in February after Fred Fielding of the law firm Wiley Rein & Fielding LLP, whom Bayer first hired to conduct the probe, was appointed chief White House counsel.
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