Senators again eye TCT's Leon for conflicts of interest, unreported income

Amidst the excitement of the Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco this week comes the news that its co-founder, Martin B. Leon, MD, is once again being investigated for potential conflicts of interest and unreported income from medical device makers.

Cardiovascular Business News obtained a copy of the letter sent to the president of Columbia University in New York on Sept. 18 by Sens. Herb Kohl, D-Wis., and Charles E. Grassley, R-Iowa. Leon is Columbia’s associate director of the Center for Interventional Vascular Therapy.

“We have noticed that Dr. Leon seems to have failed to report millions of dollars that he has received in outside income,” according to the letter.

The senators state that payment disclosures they received from medical companies and from the Cardiovascular Research Foundation (CRF), a Columbia-linked organization with which Leon has long been associated, do not match up with what Leon has reported to the university.

For example, in 2003, Leon failed to report $462,000 – more than $400,000 of which came from CRF. In 2008, some $130,000 in outside income was not reported to the university, coming from sources such as Abbott, Medtronic, Boston Scientific, Volcano, Edwards, Prescient Medical and Cordis. The letter details other unreported income for the intervening years, totaling more than $8 million.

“Dr. Leon’s disclosures do not always match that of the companies,” according to the letter.

The senators admit that Leon amended his reporting to Columbia in December 2008, disclosing information that he had not previously filed, but there are still gaps that need to be accounted for, they said.

The letter concludes: “In light of the information that we have to date, we would appreciate an explanation of these discrepancies as we are certain that you take this issue quite seriously.”

The senators would like the university to respond no later than Oct. 2, 2009.

A statement from Columbia University Medical Center reiterated that the university is “strongly committed to rigorous standards on research conflicts of interest, and expects its standards and conflict of interest disclosure requirements to be followed strictly by all faculty.”

The medical center is “analyzing the comparative information” contained in the letter “to determine if all appropriate disclosures were made in accordance with Columbia University Medical Center's conflict of interest program.”

Officials at the TCT meeting had no comment, referring the matter to the university.

For more background on this story, click here.