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Paid Eisai consultant Dave Weisman backs out of temporary adcomm role for Leqembi

The FDA’s advisory committees of outside experts are supposed to offer the agency with unbiased reviews of the sponsor’s efficacy and safety data before…

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This article was originally published by Endpoints

The FDA’s advisory committees of outside experts are supposed to offer the agency with unbiased reviews of the sponsor’s efficacy and safety data before them. And while occasionally the FDA will allow certain tangentially paid consultants (e.g. from a competing firm), those relationships must be disclosed ahead of time, and waivers from that COI need to be granted.

In the case of David Weisman, a neurologist with Pennsylvania-based Abington Neurological Associates, the FDA had sought his expertise in Friday’s adcomm that will discuss whether to convert Eisai’s new Alzheimer’s drug Leqembi (lecanemab) into a full approval. The decision is likely to be one in favor of Leqembi, opening the door for wider sales nationwide with CMS coverage.

The only issue with Weisman’s participation in the meeting, as explained in his waiver to participate, is that he’s received tens of thousands of dollars from Eisai and partner Biogen over the last five years, and been vocal about his support for lecanemab, making his impartiality a question mark.

And while the FDA praised how he is “highly respected internationally for his deep insights and broad perspectives, and he has been highly valued as a member of the Peripheral and Central Nervous System Drugs Advisory Committee” as recently as March to discuss Biogen’s tofersen, a treatment of ALS approved in April, others wondered if there were not better options.

Dave Weisman

Weisman announced on Twitter today that he would not participate in the panel. Others recently raised concerns about his past praise for Leqembi, his impartiality and his financial COI.

“They said they no longer needed me,” Weisman told Endpoints in a phone interview, noting the FDA was trying to diffuse any sort of potential conflict with his removal.

Weisman also signed a letter written by the Alzheimer’s Association, which the association sent to the FDA in late May, that offered strong support for the full approval of Leqembi and requested that CMS revisit its policy, which the agency has since said it will do, such that Leqembi “will be accessible to all Alzheimer’s disease patients indicated by the FDA’s prescriber information.”

Prior to his removal, some questioned his involvement given his funding from Eisai and Biogen over the years.

“This is quite troubling that FDA is allowing him to sit on the advisory committee despite having a direct financial conflict of interest,” Reshma Ramachandran, co-director of Yale’s Collaboration for Regulatory Rigor, Integrity, and Transparency, told Endpoints News via email yesterday.

Briefing documents for the Leqembi meeting will be released on Wednesday. Biogen declined to comment on Weisman, and Eisai did not respond to a request to comment.

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