10 doctors on FDA panel reviewing Abbott heart device had financial ties with company

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Payments Notícia

Conflict Of Interest,University Of Utah,Craig Selzman

Craig Selzman, chief of the Division of Cardiothoracic Surgery at the University of Utah, said the payments went to the university, not to him, but added, “There’s probably a better way to provide transparency.”

A U. of Utah doctor was among those who received payments, though he said the money went to the university, not him.| April 13, 2024, 12:00 p.m.

The Abbott payments illustrate the reach of medical industry money and the limits of transparency at the FDA. They also shed light on how the agency weighs relationships between people who serve on its advisory panels and the makers of drugs and medical devices that those committees review as part of the regulatory approval process.

FDA spokesperson Audra Harrison said by email that the agency doesn’t comment on matters related to individual advisory committee members. One committee member was Craig Selzman, chief of the Division of Cardiothoracic Surgery at the University of Utah. The Open Payments database connects to Selzman about $181,000 in associated research funding from Abbott to the University of Utah Hospitals & Clinics.

The FDA draws a distinction between appearance issues and financial conflicts of interest. Conflicts of interest occur when someone chosen to serve on an advisory committee has financial interests that “may be impacted” by their work on the committee, The committee voted 14-0 that TriClip was safe for its intended use. The panel voted 12-2 that the device was effective, and it voted 13-1 that the benefits of TriClip outweighed the risks.

 

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