Two months ago, we wrote that David Olagunju, a former Novartis global director of biostatistics,filed a lawsuit in which he alleges he uncovered numerous violations of the drugmakerâ€™s safety reporting system. This is an important system, because it 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 â€˜terminatedâ€™ in January.
The case hinges, in part, on complicated statistical processes for tracking and analyzing clinical trials, which can be found, as one might imagine, in reams of paperwork. To build his case, of course, Olagunju relied on documents, which Novartis claims the former exec should not have, and should return, according to a counterclaim the drugmaker filed in state court in New Jersey (we have the complaint, but cannot yet provide a link, so you will have to take us at our word. We hope you will). And the drugmaker is seeking unspecified damages. Olagunju's attorney, Bill Courtney, pooh-poohs the charge.
"We offered to discuss the issues with Novartis and they refused to meet with us," Courtney tells Pharmalot this morning. "Any documentation he had was provided to the FDA. Mr. Olagunju hasn't disclosed any information to anyone other than the FDA. And whatever information he has, Novartis already has, and will be discoverable in our lawsuit. And he's not disclosing anything to anyone who shouldn't have it, which is the FDA."
The FDA? Yes, last June, Courtney reminds us, three FDA people showed up at his office...
- two from Washington and one from New Jersey - to review the documentation. Incidentally, Novartis disclosed just three weeks later that the Tasigna approval was unexpectedly delayed so data can be reviewed. Meanwhile, Courtney now says that the FDA is conducting a guided audit. Novartis spokesman John Gilardi just phoned to say that he can't comment on litigation or the FDA audit. But he did say the drugmaker expects "key regulatory decisions by the end of the year." We continue to await a response from the FDA.
pic thx to katerha on flickr