When the FDA recently convened an advisory committee to evaluate heart devices made by Abbott, the agency found that most of them received payments from the company and conducted research funded by the company. , but that information is readily available in federal databases.

A database maintained by the Department of Health and Human Services shows that one member of the FDA advisory committee was involved in hundreds of payments totaling about $200,000 from Abbott. Another researcher is connected to his 100 payments totaling about $100,000 and conducted research with about $50,000 in support from Abbott. Her third member of the committee worked on research with more than $180,000 in support from her company.

A government database called “Open Payments” records financial relationships between doctors and certain other health care providers and drug and medical device manufacturers. KFF Health News discovered records of payments to Abbott related to 10 of the 14 voting members of an FDA advisory committee that was reviewing clinical evidence for a heart device called the TriClip G4 system. The total amount paid between 2016 and 2022 (the most recent year for which payments are recorded in the database) totals approximately $650,000.

The committee voted almost unanimously that the benefits of the device outweighed the risks. Abbott announced on April 2 that the FDA has approved the TriClip, which is designed to treat leakage from the heart’s tricuspid valve.

The Abbott payment shows the limits of the reach of the medical industry’s money and the limits of FDA’s transparency. They also discussed how the agency is considering the relationships between those who serve on advisory committees and the manufacturers of drugs and medical devices that those committees review as part of the regulatory approval process. has also been made clear.

This payment does not reflect any wrongdoing on the part of the agency, its outside experts, or the equipment manufacturer. The database does not indicate that the payment was directly related to the TriClip device.

But some people familiar with the process, including someone who served on an FDA advisory committee, said the payments should have been disclosed at the Feb. 13 meeting. This is for the sake of transparency, if not as a regulatory requirement. Question the objectivity of committee members.

“This is a problem,” Joel Perlmutter, a former FDA advisory committee member and professor of neurology at Washington University School of Medicine in St. Louis, said in an email. “They should or should disclose this because of the bias.”

The Open Payments database records several types of payments from drug and device manufacturers. One category, called “associated research funding,” supports research in which physicians are named as principal investigators in the database. Another category called “general payments” includes consultation fees, travel expenses, and meals associated with the physicians in the database. Funds may flow from the manufacturer to third parties such as hospitals, universities and other legal entities, but the database explicitly links physician names to payments.

At a public meeting to review the TriClip device, FDA officials announced that committee members were screened for potential financial conflicts of interest and found to be in compliance with government requirements.

FDA spokeswoman Audra Harrison said in an email that the agency does not comment on issues related to individual advisory committee members.

“FDA follows all appropriate procedures and regulations when vetting these panel members and is committed to proper disclosure and the integrity of the vetting process,” she said. “This includes ensuring that advisory committee members do not have, or appear to have, a conflict of interest.”

Company spokesman Brent Tippen said in a statement that Abbott “has no influence over who is selected to serve on FDA advisory committees.”

Diana Zuckerman, director of the National Center for Health Research, a think tank, said the FDA should not have allowed companies that have received funding from Abbott in recent years to sit in judgment on Abbott products. She says the agency has too narrow a view of what should be disqualified.

One of the committee members was Craig Selsman, director of the Department of Cardiothoracic Surgery at the University of Utah. The Open Payments database connects Selzman with approximately $181,000 in related research funding from Abbott to the University of Utah Hospitals and Clinics.

Asked in an interview whether a reasonable person could question the impartiality of committee members based on payments to Abbott, Selzman said, “I think anyone looking in from the outside would probably say yes.” said.

He pointed out that Mr. Abbott’s funds were donated to the university, not to him personally. Participating in industry-funded clinical trials has professional benefits for doctors, he said. He added: “There are probably better ways to provide transparency.”

The FDA has a history of appointing people with ties to the manufacturers of the products it reviews to its advisory committees. For example, the doctor who chaired the FDA advisory committee reviewing Pfizer’s COVID-19 vaccine in 2020 was a consultant to Pfizer.

appearance problem

Candidates for FDA advisory committees are often selected to provide expert advice on complex drug and medical device applications, and are often chosen to You must complete a Confidential Disclosure Report that asks for “things”.

According to a guidance document posted on the agency’s website, the agency has discretion to determine whether a person with a “disfigured appearance” can serve as a commissioner. The document says relationships that are more than a year old usually do not pose a cosmetic problem, unless they imply a close relationship with the company or involvement in the product being reviewed. The key question is whether a reasonable person would question a member’s impartiality because of economic interests, the document says.

FDA distinguishes between cosmetic issues and financial conflicts of interest. A conflict of interest occurs when someone selected to serve on an advisory committee has a financial interest that “could be affected” by their work on the committee, FDA briefers say.

If FDA finds a conflict of interest but still wants the applicant to serve on the panel, FDA can issue a public exemption. None of the panelists who voted for TriClip received a waiver.

The FDA’s approach to disclosure stands in contrast to the conference’s rules, which allow physicians to earn credits for continuing medical education. For example, at a recent conference in Boston on heart failure treatment technologies, including TriClip, the group hosting the conference instructed the speaker to include her 24-month prior disclosure in her presentation.

These disclosures, as well as the names of companies from which speakers received consulting fees, grant support, travel expenses, etc., were also posted on the conference website.

‘unbridled enthusiasm‘

FDA designates TriClip as a “breakthrough” device with “the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases” compared to current treatments FDA official Megan Neighbor told the advisory committee.

Naber said that for breakthrough devices, “the amount of data still needs to provide reasonable assurance of safety and efficacy,” but that the FDA has “greater uncertainty” about the balance of risks and benefits. “They may be willing to accept sex.”

In a briefing to the advisory committee, FDA staff pointed to clinical trial results that did not reflect well on TriClip. For example, the report said patients treated with TriClip had “numerically higher” mortality and heart failure hospitalization rates during the 12 months following the procedure compared to a control group. Mr. Tippen, an Abbott spokeswoman, did not respond to requests for comment on these findings.

The commission voted 14-0 that TriClip is safe for that use. The committee voted 12-2 that the device is effective and 13-1 that the TriClip’s benefits outweigh the risks.

Paul Hauptmann, a member of the committee whose database is believed to receive the most funding from Abbott, voted against the device on effectiveness and was the only one on the fundamental question of risk and benefit. voted against.

Hauptmann said during the meeting that the safety issue was “very clear,” but added: “We just felt we needed to dial back some of the unbridled enthusiasm.” “We need a clearer definition” of who will benefit from the device, he said.

Hauptmann, dean of the University of Nevada, Reno School of Medicine, is involved in 268 general payments from Abbott totaling approximately $197,000 in the Open Payments Database. He says some of the payments will go to an organization called Keswick Cardiovascular.

Hauptmann said in an email that he followed the FDA’s guidance, adding that “my impartiality speaks for itself based on my votes and critical comments.”

Some commissioners voted in favor of the device despite their concerns.

Mark Katz, chief of cardiothoracic surgery at the Medical University of South Carolina, is involved in 77 general payments totaling about $53,000 from Abbott and received about $10,000 in support from the company, according to Open Payments. In response, he was engaged in research.

“We voted yes on safety and no on effectiveness, but then we succumbed to the benefits outweighing the risks and voted yes,” he said at the meeting.

“All payments to Abbott have been disclosed and reviewed by the FDA,” he said in an email. He said he could “be unbiased” and “expressed his concerns openly about the treatment”.

Mitchell Krukoff, a professor at Duke University School of Medicine, is involved in 100 public payments totaling about $105,000. Some of the work was done by a third party, his HPIC Consulting. He also received about $51,000 in support from Abbott for his research, according to Open Payments.

He said during the meeting that he voted in favor of the device on all three questions, adding that doctors “have a lot to learn” once it becomes commercially available. For example: By using a device to treat patients now, “will I end up wreaking havoc on people later?”

Krukov said in an email that he had completed a “very thorough FDA conflict of interest review of this panel,” and that the review was conducted not only from Abbott but “from other manufacturers with devices in this field. It also focused on “work and payments”.

John Hirschfeld Jr., a professor emeritus of medicine at the University of Pennsylvania, is linked by the database to six general payments from Abbott totaling $6,000. Two of the payments associated with him went to the nonprofit Cardiovascular Research Foundation, according to the database. He voted in favor of all three questions about TriClip, but said at the meeting that he “would have liked to see more rigorous data to support efficacy.”

Hirschfeld said in an email that he disclosed the payments to the FDA. The agency did not consider Mr. Abbott to have a conflict because he had no stake in Mr. Abbott’s success and was no longer associated with the company, he said. He said he had been removed from previous advisory committees through a conflict of interest review process.