Article: Novartis Fired Whistleblower Who Then Met With FDA: Cancer Drug Approval Delayed

Novartis Fired Whistleblower Who Then Met With FDA: Cancer Drug Approval Delayed

Related Topic(s): Drugs; FDA

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David Olagunju, 59, is an accomplished man. He has a B.S. degree in Mathematics, a M.S. degree in Statistics and Computer Science from Minnesota State University and he even earned 56 Graduate Credits toward a Ph.D., in Quantitative Business Analysis at the University of Florida. What is unusual about him is that he grew up in Nigeria. Not too many Nigerians get all those degrees. He started his career in the U.S. in 1984 as a senior data analyst and his career ended in January 2007 after twenty years of crunching numbers in the healthcare and drug industry. During those years he dedicated his working life to Searle (now Pfizer), Genentech and Novartis. At Novartis, his most recent job, he was Global Director, Statistical Reporting and Standards, Oncology. He started that job end of 2004. For Olagunju's CV click here. Funny thing is, during those long twenty years in the drug industry, he didn't ever blow the whistle on anything. Until now. According to a lawsuit Olagunju filed in May 2007, Novartis fired Olagunju for "disclosing and refusing to participate in illegal and unethical activities regarding the testing and reporting of human drug study results concerning Tasigna (ANM), Novartis' new cancer drug." The complaint goes on to state, "As Global Director of Oncology Statistical Reporting and Standards Reporting (SRS), plaintiff disclosed to Novartis' senior management the existence of improper statistical data being reported to the United States Food and Drug Administration (FDA), violations of established ethical standards concerning the recording and reporting of data, the failure to follow proper statistical protocols when reporting drug study data and violations of policies and procedures established to safeguard drug study participants and consumers of pharmaceutical products." The complaint also alleges that in response to Olagunju's "complaints and in retaliation for his refusal to take part in Novartis' illegal activities and violations of public policy, he was harassed, threatened and ultimately terminated from his position at Novartis." But here is the whopper: Plaintiff seeks a Court Order, "compelling an audit of all drug study data compiled by Novartis and provided to the FDA concerning Tasigna or any other drug utilizing Novartis' current clinical trial safety reporting system." And before Olagunju was fired he managed to take with him some of the documents that he says proves his case. Novartis' lawyers, of course, have asked to have them returned. Olagunju replied that this wouldn't work, because he had already turned over those documents to the FDA. On June 28, to be specific, FDA sent three officals to meet with Mr. Olagunju and his attorney in NJ. And Olagunju claims the FDA people were shocked and said they would audit not just Tasigna data, but also other products. So what about the FDA? They ain't talking. They're not denying they've talked to Olagunju, they're simply refusing to add any new information. And Mr Olagunju's attorney, William J. Courtney, Esq., was not available for comment. And Novartis didn't get back with their side of the story. So at this point in my research, all I had was Olagunju's allegations. But then something happened. Two days ago, on July 17, 2007, Reuters announced that Novartis had said that U.S. regulators had "extended their review period for cancer drug Tasigna by three months." "The delay in the Tasigna approval will not change our estimates significantly, but further increases the risk profile of Novartis," Kepler Equities analyst Denise Anderson said in a note, according to Reuters. The reason Novartis gave for this delay? The FDA wanted to "review additional data." Novartis also said that "no new studies are required." "It could have been my meeting with the FDA causing this," Olagunju says. To download Olagunju's entire complaint, click here. And what does Olagunju advice other whistleblowers to do? Mr. Olagunju is a deeply religious person. He ends his voicemail recording with "God bless you," and he ends his e-mails with "The Lord is good unto them that wait upon Him. Wait upon the Lord! God bless you." So Mr. Olagunju knows how to "turn the other cheek," as the Scripture requires. And he says he followed every proper company procedure, but he was punished for doing this. He concludes, "if you're young, think twice before doing this, you really shouldn't blow the whistle unless you're wealthy." And he advises anyone else who feels it is necessary to blow the whistle to NOT go to the company. "Go straight to the authorities," he said. As for himself, he says his Faith is what has sustained him through these hard times. "If I had gone straight to authorities my life would've been so much easier right now," Olagunju says. "But if I meet my Maker tomorrow, at least I would have peace in my heart, because I've done the right thing."