Duke medical researcher Dr. Victor Tapson has become the focus of a U.S. Senate Finance Committee report issued Wednesday, which is now under investigation by the University.
Tapson, a thrombosis expert and faculty member in the Pulmonary, Allergy and Critical Care Medicine division of Duke Medicine, was named in the committee report as receiving $260,604 for consultant services from the drug company Sanofi-Aventis. Tapson recommended that the Federal Drug Administration delay approval of the generic version of Sanofi’s fast-acting blood thinner Lovenox. The report suggests that Tapson did not specify the nature of his financial connection to the drug company to the FDA at the time of his recommendation.
“An investigation of the... report related to Dr. Tapson has been initiated by the Duke University School of Medicine Conflict of Interest committee,” wrote Dr. Ross McKinney, committee chair and director of the Trent Center for Bioethics, in a statement to The Chronicle Wednesday. “At the conclusion of this process, we will be providing a report of our findings to the dean [of the School of Medicine].”
According to the committee report, Tapson wrote a letter in May 2008 to the FDA asking its members to consider the findings of a scientific roundtable, which was sponsored by Sanofi regarding the potential threats of the generic drug. In May 2010 Tapson spearheaded another letter on Duke Medical Center letterhead similarly arguing for the generic drug’s delay.
The report also named two medical societies—the North American Thrombosis Forum and the Society of Hospital Medicine—as receiving a combined $4.9 million from Sanofi between 2007 and 2010.
Tapson, however, refutes many of the report’s claims, though he stands by his opinion that the FDA should have considered further clinical data before making its decision.
In a statement to The Chronicle Wednesday, Tapson wrote he was invited by the FDA in March 2010 to discuss 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 said, adding that his visit to the FDA was neither prompted nor funded by Sanofi.
Tapson said his primary concern was always patient safety, adding 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 said. “I am continuing to research the source of the disparity, which perhaps includes funds allotted for research.”
Tapson did confirm that his financial connection to Sanofi was not disclosed in his May 2010 letter to the FDA.
The Senate Finance Committee began its investigation into Sanofi after The Wall Street Journal reported in June 2010 that the NATF, SHM and Tapson had financial ties to Sanofi. The investigation was led by Sens. Max Baucus, D-Mont., and Chuck Grassley, R-Iowa. Both senators could not be reached for comment.