Duke Investigates Professor Over Sanofi Contoversy

The Duke University researcher who consulted for Sanofi at the same he implored the FDA not to approve a med from a rival drugmaker is now being investigated for failing to disclose his financial ties. Last March, thrombosis expertVictor Tapson wrote the agency to argue that generic versions of Lovenox may not be as safe as the brand-name med, but he did not mention his relationship to Sanofi.

His work on behalf of Sanofi was disclosed yesterday in a US Senate Finance Committee report that detailed how Sanofi also engaged two medical societies to encourage the FDA to delay approval of a rival med the drugmaker feared would undercut its blockbuster Lovenox bloodthinner. Sanofi paid more than $5 million to the two medical societies, including $260,600 to Duke’s Tapson (back story). And now, Duke is also investigating Tapson.

“An investigation of the...report related to Dr. Tapson has been initiated by the Duke University School of Medicine Conflict of Interest committee,” Ross McKinney, committee chair and director of the Trent Center for Bioethics, wrote in a statement to The Duke Chronicle. “At the conclusion of this process, we will be providing a report of our findings to the dean (of the School of Medicine).”

This is not the first time that a major university has taken a hard look at faculty for undisclosed pharma ties. Earlier this month, Stanford University disciplined five faculty members at its medical school for violating school policy by giving paid promotional speeches for drugmakers. The moves come amid growing scrutiny of relationships between drugmakers and academic researchers over concerns that the practice of medicine will be unduly influenced.

For his part, Tapson told the school paper that various claims in the Senate report are inaccurate, but he continues to believe the FDA should have considered further clinical data before approving a drug from Momenta Pharmaceuticals. And he maintains that he was invited by the FDA in March 2010 to offer his thoughts on the generic version of Lovenox.

“During that visit...I disclosed my relationship with Sanofi and indicated that I had done research funded by them, served on international steering committees for clinical trials funded by Sanofi and that I had received consulting fees and honoraria from Sanofi,” Tapson tells the school paper, adding that his visit to the FDA was neither prompted nor funded by Sanofi.

He adds that the amount of money he was paid by Sanofi was incorrectly reported by the committee. "The figure in the report...does not match my 1099 forms, which I carefully reviewed and which totaled less than half of that amount,” he tells the paper. “I am continuing to research the source of the disparity, which perhaps includes funds allotted for research.” However, he acknowledged that his ties to Sanofi were not mentioned in the letter to the FDA (here is the letter).