8/11 of the Doctors Who Advised on Kisunla Approval Had Conflicts of Interest

The new monoclonal anti-amyloid Alzheimer’s drugs are a constant source of controversy among doctors, insurers, and regulators worldwide. One of this buzzy new drug class, Aduhelm, was actually already taken off the market as a result of this controversy, leaving just Leqembi and newer “mab” drug Kisunla which received FDA approval in 2024.

In the U.S., the Food and Drug Administration, which regulates prescription drugs, is at the heart of much of this controversy. In 2021, the agency granted accelerated approval to Aduhelm against the recommendations of its advisory committee. Three FDA advisors quit the panel a week after Aduhelm’s approval because they disagreed with the approval decision — and a congressional investigation found that Biogen had held inappropriate closed-door meetings with FDA officials.

Now, an investigation in British medical journal The BMJ reported substantial conflicts of interest among the physicians on the FDA’s advisory committee who recommended the approval of Kisunla.

BMJ reported that advisers on this committee received up to $62,000 in payments for consulting and speaking fees, and held up to $10.5 million in research grants from companies developing anti-amyloid drugs.

The FDA doesn’t consider these conflicts to be show-stoppers. But experts question whether they do have negative influence in the drug approval process — much less in the public’s perception of the drug approval process. Eric Widera, a geriatrician and professor of medicine at UCSF, told Being Patient that these financial conflicts of interest erode the public’s faith in the FDA decisions. After the fallout over Aduhelm, he fears “the FDA has learned that they shouldn’t include non-industry supported committee members as they will stand up to the FDA” when they make “horrendously bad decisions.”

Conflicts of interest on Kinsula’s advisory committee

Though Kisunla performed better in clinical trials than Aduhelm, slowing cognitive decline by a small amount, experts aren’t sure the benefits outweigh the risk of brain swelling and bleeding. Despite this uncertainty, the advisory committee unanimously recommended Kinsula’s approval.

Could conflicts of interest among these experts have influenced their decisions?

Using the OpenPayments database, Jeanne Lenzer and Shannon Brownlee, who authored the investigation, noted the consulting fees committee members received from drug companies. They also found other conflicts by searching through committee members’ CVs, patents, and disclosures listed in their published research articles.

Three of the 11 committee members had financial ties to Kisunla’s drugmaker Eli Lilly, and two to Roche, who is working with Eli Lilly to develop blood tests that may help people find out if they’re eligible for an anti-amyloid drug faster. 

Two committee members had patents on other anti-amyloid drugs, and another received funding from another drugmaker developing anti-amyloid drugs called Janssen. Although these aren’t direct ties to Kisunla’s drugmaker, they are relevant: When one drug fails to receive approval, regulators are more likely to reject future drugs with a similar mechanism.

But, most of these financial conflicts aren’t considered substantial by the FDA.

The FDA can fill out a waiver form for potential committee members who have significant financial conflicts if they believe their expertise outweighs the risk of these financial conflicts. Only two of the committee members were required to fill out these waivers.

A commentary published at the end of September by senior FDA regulators justified the inclusion of committee members with financial conflicts, writing that “experience that yields insights may create a potential COI [conflict of interest].” 

However, small payments still influence experts’ decision-making, whether they admit it or not. “This doesn’t make them bad people,” Widera said. “It makes them human.”  

Widera said that stricter guidelines around financial conflicts of interest could bolster confidence in the agency, which almost one in four Americans already don’t trust.  

Finding doctors who could assess the efficacy and safety of new Alzheimer’s medications without financial ties to drug companies is possible: Half of neurologists don’t have any such ties. 

Doctors who haven’t worked with drug companies aren’t any less capable of advising the FDA. 

“If anything, it gives the FDA and its advisory committees the much-needed and currently lacking public perception that they are not just driven by industry motivations,” said Widera.