They weren't dishonest, just incompetent--or so says an outside investigator who's been looking into Bayer's Trasylol snafu [1]. After a study last fall, Bayer scientists failed to tell the FDA that Trasylol can increase the risk of death, heart failure, stroke, and kidney damage. The study data wasn't reported to an advisory panel that met to review the drug's safety record a week after the two men had received the study data. In fact, it wasn't released until a whistleblower alerted the FDA.
But the investigator, a lawyer Bayer hired when the incident went public, concluded that there was no cover-up, just a series of bad decisions. The scientists questioned methods used during the study. (Question: If the scientists didn't like the way the study was conducted, why didn't they say as much to the FDA?)
Two other employees who didn't tell the FDA that the study even existed simply made "a serious error in judgment," according to the company. They didn't know the study had been completed. Since then, the employees have been disciplined and Bayer has instituted new checks-and-balances to make sure study data doesn't fall through the cracks again.
- check out the AP report [2] on the brouhaha
Links:
[1] http://www.fiercebiotech.com/story/bayer-kept-trasylol-safety-study-hidden-from-fda/2006-10-02
[2] http://www.chron.com/disp/story.mpl/ap/fn/5061037.html