Novartis: Whistleblower Stole Our Documents
5 CommentsBy Ed Silverman // September 20th, 2007 // 12:47 pm
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 drugmaker’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 ‘terminated’ 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.
Someone
Thanks for this.
I have been giving some thought to this. We all can only hope that when this case is over and if Novartis has been found at fault then those who created this mess be the most severely punished. Patients and indeed humanity must be able to trust and rely on the integrity of the data from clinical trials. Not only for our own health but for the future of research. So, this really needs to be investigated at all levels. Questions need to be asked that will help us to discern if this was the rogue actions of employees who might have misinterpreted their role and objectives? Were they being coerced into these actions from management and if so why? As much as the system is set up to fine the whistleblower in the event that this is a “red herring” of sorts, then I certainly hope that everyone who had a hand in illegitimating the process and corrupting the clinical trial data (if this turns out to be the case) should be severely and personally fined, not just the company. Fines to the company only serve to add further costs to the process of drug making. Now, if the company is heavily fined and not allowed to raised any drug prices for a period of lets say five years, that might be interesting…
Additionally, if I were a patient I would be very concerned about this drug. I would probably avoid it more than the plague. Why? Well based on the above comments from the Novartis spokesperson, Novartis is expecting to probably still have this drug on the market before the end of the year. Sounds to me that there is some big pharma lobbying going on somewhere…
Hope the FDA leaves no stone unturned. This isn’t just about Tasigna, this is about the entire clinical trial review process and the protection of humanity. Seems to me that cancer patients do not need anymore trouble then they already have….
Kannan Natarajan
Kannan Natarajan’s firing David costed Novartis at least over 300 millions. Kannan did similar thing in BMS and costed BMS big money. He is considered un ethical by a lot of his coworkers. If they put him on stand I think David has a lot to win.
Roland
I’ve met and talked to David a few times while he was in Novartis employ. He seemed like a nice guy to me. What is behind this is all speculation and only he and his boss know the full story. What I would say is that programmers there are treated like disposable assets so the manner of David’s departure does not surprise me in the least and I would sympathize with David, lacking further information.
AReviewer
I carefully read the case filed by David and his attorney. There are several questions to raise about this lawsuit. Why did David wait so long before blowing the whistle if he was disgruntled with Novartis? Why is he requesting for reinstatement at Novartis that he seeks to destroy? Why are there no concrete evidence in the case other than the questionable “hear-say?” To label the statistician and programmers at Novartis as incompetent in his lawsuit seems arrogant. In his interview posted online with Dr. P, are the credentials of his academic degrees accurate? In his interview with Dr. P, why was he erroneously invoking God’s name? Has David been fired by other companies and why? Has he ever threatened other companies with lawsuits? How credible are his claims? I hope that the truth will emerge if this lawsuit, or the counter suit makes it to trial. It appears that David lawsuit is a revenge for being fired
BP MD
In almost all of these cases involving Big Pharma, the employee has been wronged. Typically, the company seeks to ruin the employee’s career, lying about them and humiliating them in front of their coworkers. As with many who are wronged, David probably didn’t know what to do. He wants to work and Novartis can make it impossible for him to find another job. His last resort is to try and take them on in court. Novartis will no doubt investigate him, intimidate him, spy on him, and eventually try to completely destroy him. very strong is the individual who can make it through this type of character assasination.
Reviewer must be a Big Pharma lawyer, a highly-paid Big Pharma consultant lawyer, or a naive Big Pharma employee who has not been paying attention to the news. I’m sure David is not the first and we already know he’s not the last as another former Novartis employee was in the news this week, filing another lawsuit against them.
Wake up FDA, OIG and OAG. Give Big Pharma some of its’ just rewards.