Harvard veteran resigns from FDA panel amidst Alzheimer’s drug controversy

One more veteran has resigned from the US Food and Drug Administration advisory panel in the wake of Biogen’s Alzheimer’s drug Aduhelm getting approval from the agency.

Harvard Medical School professor, Aaron Kesselheim, who is the third committee member to depart from the panel, announced his resignation in a letter to FDA Acting Commissioner Janet Woodlock.

The clearance “was probably the worst drug approval decision in recent U.S. history,” Kesselheim said in the letter, reported Bloomberg.

In November, the advisory panel voted 8 to 1, with 2 undecided, claiming that data from a single clinical trial with positive results is not enough to show the efficiency of the drug.

“The agency owes it to the nation to provide a detailed justification” for going against the advice of the panel, Kesselheim said.

“FDA considered the committee’s input, weighed the overall evidence in the application, and considered the dire situation of patients with AD who have few treatment options,” an agency spokeswoman said, reported Bloomberg. “Based upon this, the FDA concluded that an accelerated approval was appropriate.”

Before Kesselheim, Joel Perlmutter from the Washington University School of Medicine and David Knopman from Mayo Clinic resigned from the committee.

Kesselheim also voted against the drug, while Knopman recused himself from the November hearing.

(With inputs from Bloomberg)

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