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

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Cardiothoracic Surgery,Drugs,Health And Human Services

When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn't disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database.

Apr 8 2024KFF Health News When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn't disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database.

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.

The Open Payments database records several kinds of payments from drug and device makers. One category, called "associated research funding," supports research in which a physician is named a principal investigator in the database. Another category, called "general payments," includes consulting fees, travel expenses and meals connected to physicians in the database.

Abbott "has no influence over who is selected to participate in FDA advisory committees," a spokesperson for the company, Brent Tippen, said in a statement. He noted that Abbott's money went to the university, not to him personally. Participating in industry-funded clinical trials benefits doctors professionally, he said. He added: "There's probably a better way to provide transparency."

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, an FDA explainer says. ‘Unbridled enthusiasm' The FDA has designated TriClip a "breakthrough" device with "the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease" compared with current treatments, an agency official, Megan Naber, told the advisory committee.

The committee member to whom the database attributes the most money from Abbott, Paul Hauptman, cast one of the votes against the device on effectiveness and the sole vote against the device on the bottom-line question of its risks versus benefits. "I voted yes for safety, no for effectiveness, but then caved and voted yes for the benefits outweighing the risks," he said in the meeting.

 

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