Healthy Skepticism Library item: 11231

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Publication type: news

Perrone M.
Bayer Issues Findings on Trasylol Probe
Associated Press 2007 Aug 16
http://biz.yahoo.com/ap/070816/bayer_trasylol_investigation.html?.v=3

Full text:

Bayer Says Outside Probe Concludes Negative Data on Trasylol Was Not Deliberately Withheld

WASHINGTON (AP) — Drug maker Bayer AG on Thursday said an outside investigator concluded that two company scientists did not try to mislead the government when they withheld data that raised safety questions about the blood-clotting drug Trasylol.

Bayer retained an outside lawyer in October after two employees failed to notify the Food and Drug Administration about a study showing that Trasylol can increase risk of death, kidney damage, heart failure and stroke.

Scientists Ernst Weidmann and Kuno Sprenger of Bayer’s German drug safety group knew of the study’s results on Sept. 14, according to Bayer, but the company did not make the study public until after a Sept. 21 meeting held by FDA to look at the drug’s safety.

According to the report by lawyer William Taylor of Zuckerman Spaeder LLP, Weidmann and Sprenger did not disclose the results because they had questions about how the study was conducted.

Bayer spokeswoman Staci Gouveia said the scientists were suspended and removed from their previous positions.

Employees Michael Rozycki and Joseph Scheeren, who were responsible for communicating the existence of the study to the FDA, failed to do so. Letters of reprimand will be placed in their personnel files, Gouveia said.

“This failure was not motivated by any intent to conceal the existence of the study but was regrettable human error,” Bayer said in a statement. While understandable, Bayer said it viewed the decision as “a serious error in judgment.”

Since the incident, Bayer said it has added additional checks and balances to its system for reviewing drug studies so that company officials are kept abreast of safety issues.

Trasylol is used to reduce blood loss during coronary artery bypass surgery. FDA added additional safety warnings to the drug’s labeling in late 2006.

Annual sales of the drug fell 33 percent to $195 million in 2006 compared with the prior year.

Shares of Bayer AG fell 93 cents Thursday to $72.16 in after hours trading, following an earlier close at $73.09.

(This version CORRECTS names of scientists to Ernst Weidmann and Kuno Sprenger, and that Michael Rozycki and Joseph Scheeren were regulatory employees who were responsible for communicating with the FDA.)