According to NBC News, multiple doctors on a U.S. Food and Drug Administration (FDA) panel received payments from the company that made a cardiac device it assessed.

The FDA didn’t disclose the payments.

“One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services,” NBC News wrote.

“Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A third member of the committee worked on research supported by more than $180,000 from the company,” the outlet continued.

Per NBC News:

The government database, called “Open Payments,” records financial relationships between doctors and certain other health care providers and the makers of drugs and medical devices. KFF Health News found records of Abbott payments associated with 10 of the 14 voting members of the FDA advisory panel, which was weighing clinical evidence for a heart device called TriClip G4 System. The money, paid from 2016 through 2022 — the most recent year for which the database shows payments — adds up to about $650,000.

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

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.

“This is a problem,” Dr. Joel Perlmutter, a former FDA advisory committee member and a professor of neurology at Washington University School of Medicine in St. Louis, said by email, according to NBC News.

“They should or must disclose this due to bias,” Perlmutter added.

“When a group of FDA advisors recently assessed a heart 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,” NBC News wrote.

“Abbott today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first-of-its-kind TriClip transcatheter edge-to-edge repair (TEER) system that’s specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve. This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of TriClip outweighed the risks,” Abbott stated in a press release.

From Abbott:

“The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues,” said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE™ Pivotal trial. “With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker.”

The tricuspid valve controls blood as it flows from the heart’s right atrium to the right ventricle. TR occurs when the valve doesn’t close properly, causing a leak and allowing blood to flow backward in the heart. TR can force the heart to work harder, causing debilitating symptoms such as fatigue and shortness of breath. When left untreated, TR can lead to atrial fibrillation, heart failure, and ultimately, death. For those who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents an option that can improve a person’s quality of life.

Delivered through a vein in the leg, TriClip’s TEER technology works by clipping together a portion of the leaflets – or flaps of tissue – to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. On average, people who receive TriClip only need one day in the hospital before they recover and can return home.

As part of its approval process, the FDA reviewed findings from the TRILUMINATE Pivotal trial, the world’s first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery. In the study, 90% of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction that was sustained at one year. The trial also demonstrated a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life.

An FDA official reportedly announced at the public meeting to consider the TriClip device that “committee members had been screened for potential financial conflicts of interest and found in compliance with government requirements.”

“The FDA followed all appropriate procedures and regulations in vetting these panel members and stands firmly by the integrity of the disclosure and vetting processes in place. This includes ensuring advisory committee members do not have, or have the appearance of, a conflict of interest,” FDA spokesperson Audra Harrison said via email.

This isn’t the first time the FDA has received criticism for conflicts of interest in the regulatory process.

“The FDA has a history of appointing people to advisory committees who had relationships with manufacturers of the products under review. For example, in 2020, the doctor who chaired an FDA advisory committee reviewing Pfizer’s covid-19 vaccine had been a Pfizer consultant,” NBC News noted.

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