The U.S. Food and Drug Administration (FDA) recently convened a committee of independent advisors to review a cardiac device made by Abbott but failed to disclose that most of them had financial ties to the company.
According to the Open Payments database, 10 of the 14 voting members on the FDA’s advisory panel tasked with reviewing the clinical data for Abbott’s heart device and voting on information related to its premarket approval application received a total of roughly $650,000 between 2016 and 2022.
The panel, during its Feb. 13 meeting, voted almost unanimously, 13 to 1 that the benefits of Abbott’s TriClip G4 System used to treat tricuspid regurgitation outweigh the risks, The panel also voted 14 to zero that TriClip is safe for its intended use, and 12 to 2 that the device is effective, despite concerning clinical trial results provided to the panel in an FDA briefing document.
Yet Abbott announced on April 2 that its product had received full FDA approval following the panel’s recommendation.
According to the FDA, it uses “committees and panels to obtain independent expert advice on scientific, technical, and policy matters.” At the public meeting to consider TriClip, an FDA official said committee members had been screened for potential financial conflicts of interest and found in compliance with the “federal ethics and compliance of interest laws.”
Conflicts of interest may include “investments, consulting, expert witness testimony, contracts, grants, CRADAs [Cooperative Research and Development Agreements], teaching, speaking, writing, patents and royalties, and primary employment.” An FDA explainer says a conflict of interest occurs when someone on an advisory committee has a financial interest that “may be impacted” by their work on the committee. Additionally, a member may have a conflict of interest if they have financial ties to a competing company affected by the outcome of the meeting.
When there is a potential conflict of interest, Congress has authorized the FDA to grant waivers to “special government employees and regular federal employees” when “it is determined that agency needs for the particular individual’s services outweigh his or her potential conflict of interest.” However, none of the committee members with financial ties to the company who voted on TriClip received a waiver.
Advisors Received Payments From Manufacturer
The Open Payments database is a federal transparency program established in 2013 by the Department of Health and Human Services. It was established amid growing concern that financial relationships between physicians and the industry were unduly influencing healthcare decision-making and costs.
According to Open Payments data, voting member Dr. Paul Hauptman, dean and professor of Medicine at the University of Nevada, Reno School of Medicine, has received nearly $200,000 in general payments from Abbott.
“General payments” are payments made to a physician not associated with any research study, whereas “associated research funding” includes payments for a research project where the physician is designated as the principal investigator.
Dr. Paul Hauptman cast one vote in favor of TriClip’s safety, one vote against the device on effectiveness, and the only vote against the device on whether the benefits outweigh the risks.
“I voted yes on safety. I think that was very, very clear,” Dr. Hauptman said during the meeting. “I just felt the need to pull back a little bit on unbridled enthusiasm. Because I think we have a responsibility to better understand who’s going to benefit, and that needs better definition.”
Dr. Hauptman told KFF Health News in an email that he followed FDA guidance and added, “My impartiality speaks for itself based on my vote and critical comments.”
However, other voting members who had received funding from Abbott voted for the device despite concerns presented during the meeting. For example, voting committee member Dr. Marc Katz, chief of the Division of Cardiothoracic Surgery at the Medical University of South Carolina, has received 77 general payments totaling more than $53,000 and almost $11,000 in associated research funding from Abbott.
“I voted yes for safety, no for effectiveness, but then caved and voted yes for the benefits outweighing the risks,” Dr. Katz said during the meeting.
Another voting member, cardiologist Dr. Mitchell Krucoff at Duke University School of Medicine, has received over $105,000 in general payments from Abbott and almost $52,000 in associated research funding. He voted in favor of all three questions during the meeting and said TriClip is a “breakthrough technology” that doctors will learn more about once it’s on the market.
“Do we set people up for catastrophes later by putting a clip in now?” Dr. Krucoff asked. “That’s what the breakthrough technology process is for,” he added.
Voting member and cardiologist Mladen Vidovich received $14,000 in general payments from Abbott, while another voting committee member received $6,000 for consulting services.
Dr. Craig Selzman, committee member and chief of the Division of Cardiothoracic Surgery at the University of Utah, received 59 payments totaling more than $181,000 in associated research funding from Abbott and 24 payments totaling nearly $41,000 in 2022 alone. He has also received over $46,000 from competitor Edward Lifesciences Corporation for associated research funding.
Edward Lifesciences and Abbott were involved in global litigation related to transcatheter mitral and tricuspid repair products. The company agreed to pay Abbott $368 million upfront to settle patent disputes and roughly $100 million in royalties through mid-2024.
In the FDA’s briefing document provided to committee members before the meeting, FDA staff noted that some of Abbott’s clinical trial data didn’t favor TriClip. For example, all-cause mortality and heart failure were “numerically higher” in the TriClip group compared to the control group.
Dr. Selzman, who voted “yes” on all three questions despite “some of the less strong evidence of efficacy,” was asked in a KFF Health News interview whether a reasonable person could question the impartiality of committee members based on payments received by Abbott.
“People from the outside looking in would probably say yes,” responded Dr. Selzman, who said Abbott’s money went to the university, not to him personally. Dr. Selzman also said doctors benefit professionally from industry-funded clinical trials, but there’s “probably a better way to provide transparency.”
FDA Has History of Not Disclosing Financial Ties
This is not the first time the FDA has appointed people to its advisory committees with financial ties to the manufacturers of the products under review. For example, epidemiologist Dr. Arnold Monto, who previously consulted for Pfizer, chaired the FDA’s Vaccines and Related Biological Products Advisory Committee meetings, which led to the Emergency Use Authorization of the Pfizer/BioNTech and Moderna vaccines.
According to the Project on Government Oversight, Dr. Monto “curbed and corralled” the discussion on Pfizer’s COVID-19 vaccine, “cutting off questions, limiting debate, and forcing committee members to cast an up-or-down vote without giving them a chance to vote on any refinement to the authorization.”
In a 2018 analysis published by Science using Open Payments Data, researchers found that many FDA committee members received payments or other financial support from the drugmaker or its competitors for consulting, travel, lectures, or research during or leading up to the year of FDA advisory meetings.
Additionally, of 107 physicians who advised the FDA on 28 drugs approved from 2008 to 2014, a majority later received money for travel or consulting or received research subsidies from the manufacturers of the drugs they voted on or from competing firms.
Science found that the highest earners, and many others, received funds from the same companies during the year before their advisory service—payments disclosed in scholarly journals but not by the FDA.
The Epoch Times contacted the FDA for comment but has not received a response.