The FDA recently formed a committee of specialists to examine an Abbott cardiac device, but it didn't reveal that most of them had received commercial money or funded research, which is public in a federal database.
A HHS database linked one FDA advisory committee member to hundreds of Abbott payments totaling $200,000. Another received $100,000 in 100 payments and $50,000 from Abbott for research. Company-funded research by a third committee member cost almost $180,000.
“Open Payments” analyzes financial transactions between doctors, other health care providers, and medication and medical device manufacturers. Abbott paid 10 of the 14 FDA advisory panel members analyzing TriClip G4 System heart device clinical evidence, according to KFF Health News. The information shows $650,000 paid from 2016 to 2022.
The panel virtually unanimously declared the device's benefits greater than its risks. Abbott announced April 2 that TriClip, a tricuspid valve leak therapy, was FDA-approved.Abbott payments reveal FDA transparency issues and medical industry influence. They also demonstrate how the government evaluates advisory panel member-pharmaceutical and medical device industry relationships during regulatory approval.
Payments do not show agency, outside expert, or device manufacturer wrongdoing. TriClip device payments were not in the database. Some FDA advisory committee members claimed the contributions should have been reported at the Feb. 13 meeting, if not for regulatory reasons, then for transparency because the money could cast doubt on committee members' neutrality.
By email, former FDA advisory committee member and St. Louis Washington University School of Medicine neurology professor Joel Perlmutter remarked, “This is a problem.” This must be disclosed due to bias.”Many forms of drug and device manufacturer payments are captured via Open Payments.
She stated that the FDA followed all the protocols and rules in vetting these panel members and stands behind the disclosure and vetting processes. Conflicts of interest should not appear in advisory committees.
Director of the University of Utah Cardiothoracic Surgery Division Dr. Craig Selzman was present. The Open Payments database links Selzman to $181,000 in Abbott research funding to Utah Hospitals & Clinics.Selzman stated in an interview, “People from the outside looking in would probably say yes.” Abbott payments may throw doubt on committee members' objectivity.
Abbott's money went to the university. Medical professionals profit from industry-funded clinical trials, he said. He remarked, “There’s probably a better way to provide transparency.”FDA advisory committee members often have product manufacturer links. In 2020, a Pfizer consultant led an FDA advisory committee reviewing its covid-19 vaccine.
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