Novartis Whistleblower: His Lawyer Chats
1 CommentBy Ed Silverman // July 20th, 2007 // 1:57 pm
Yesterday, we wrote how David Olagunju, a former Novartis global director of biostatistics, filed a lawsuit in which he alleges he uncovered numerous violations of the drugmaker’s safety reporting system, which is used to process safety data from clinical trials, in particular the Tasigna cancer med trials. He reported the problems internally, but claims to have suffered only retaliation, such as negative performance reports and was ‘terminated’ in January. Novartis declined to comment.
This afternoon, his attorney, Bill Courtney, returned our telephone call and chatted briefly about the case which, in part, hinges on rather complicated statistical processes for tracking and analyzing clinical trials. But as far as corporate behavior is concerned, he says Novartis “didn’t seem to know what to do with him. He tried to go by the books (when reporting violations), but they didn’t seem to want to pursue the matter. And it’s a shame. He made every effort.”
As to the June 28 meeting with the FDA, which the agency wouldn’t confirm or deny, Courtney says that three FDA people showed up at his office - two from Washington and one from New Jersey. Much of the lengthy meeting - he couldn’t recall exactly how long - centered on statistics. They gave no indication of their intent but, like us, Courtney notes that Novartis disclosed just three weeks later that the Tasigna approval was unexpectedly delayed so data can be reviewed.
“Could be a connection,” says Courtney.
Hypocrisy rules
Please see what one of your members is doing internationally. What are dong in Canada with our weak laws against the misconduct of big pharma?