Barely a month goes by that we don't hear another story about a physician taking handouts from the pharmaceutical industry. The companies typically respond that these payments are for legitimate services, or education, or for consulting. And the doctors usually protest that the money doesn’t influence their behavior.
Well, let’s take a closer look by drilling down into a report released this morning (.pdf) by the Senate Finance Committee. Investigators working for Senator Max Baucus (D-MT) detailed how drug-maker Sanofi-Aventis lobbied the FDA to delay the approval of a generic drug that would cut into profits from the company’s blockbuster blood-thinner Lovenox, which had $4 billion in global sales in 2009.
Part of this lobbying campaign involved letters sent from the Society of Hospital Medicine, the North American Thrombosis Forum, and Duke University researcher Dr. Victor Tapson. The Senate Report said that Sanofi enlisted experts, like Dr. Tapson, to conduct “independent interaction” with the FDA. Specifically, Dr. Tapson sent multiple letters to FDA warning that generic versions of Lovenox may not be as safe as Sanofi’s brand version.
Why might Dr. Tapson take time away from his busy practice at Duke University to lobby the FDA about Sanofi’s drug? Perhaps because the company paid him over $260,000 between 2007 and 2010.
And what exactly did Sanofi get from Dr. Tapson?
According to the Senate report, Dr. Tapson sent a letter to the FDA on behalf of the American College of Chest Physicians (ACCP) in 2008. The letter advised the FDA to “learn more about the findings and recommendations” of roundtable on blood thinners held at Huntington Beach, California.
Executives at Sanofi discussed the letter eagerly when Dr. Tapson was drafting it. “I understand Vic was going to share his letter with Larry,” one Sanofi executive wrote to his colleague in an email.
Oh, the Senate report notes that Sanofi sponsored the roundtable for $190,000.
Sanofi executives later sent the draft of Dr. Tapson’s letter to the Society of Hospital Medicine (SHM) to seek their support with the FDA.
In May 2009, Sanofi executives discussed their ongoing FDA strategy and the importance of Dr. Tapson and the North American Thrombosis Forum (NATF). “We need to keep Vic and especially NATF on task for the FDA communication,” an executive at Sanofi wrote in an email.
But how does Dr. Tapson describe the Senate Finance Report? In an email to the Wall Street Journal, Dr. Tapson wrote that some of the report’s statements were “very incorrect.” The Journal adds that he “didn’t explain why.”
Bonus Discovery: We dug around and found this letter that Dr. Tapson sent the FDA on Duke University letterhead. Once again, Dr. Tapson pleads with the FDA to delay approving cheaper generics to compete with Sanofi’s Lovenox.
Paul Thacker is a POGO Investigator.
Image: Mr. Skinner