A Duke medical researcher has been involved in a report issued by the U.S. Senate Finance Committee.
Dr. Victor Tapson, thrombosis specialist and faculty member in the Pulmonary, Allergy and Critical Care Medicine division of Duke Medicine, encouraged the Federal Drug Administration to delay approval of generic versions of the bloodthinner Lovenox, The Wall Street Journal reported early Wednesday morning. According to The Wall Street Journal, Tapson did not disclose the fact that he received more than $260,000 from Sanofi SA, the company that manufactures the drug Lovenox.
Tapson wrote letters to the FDA that claimed generic versions of the anti-clotting medication may not be as safe as the brand-name drug. Nowhere in these letters did Tapson disclose his financial connection to the company.
According to The Wall Street Journal, this information was part of the Senate committee report titled “Sanofi’s Strategic Use of Third Parties to Influence the FDA.” The report states that Sanofi recruited and paid medical specialists to conduct “independent interaction” with the FDA in order to secure Lovenox’s market.
The report also states that two other medical societies—the Society of Hospital Medicine and the North American Thrombosis Forum—submitted letters to the FDA while also receiving a combined $4.9 million between 2007 and 2010.
Tapson wrote in an email to The Wall Street Journal that some statements in the report were “very incorrect” but provided no further explanation as to why.
In 2009 Lovenox sales exceeded $4 billion internationally. After the first generic version of the drug was approved in July 2010, though, sales in the U.S. declined sharply.