WASHINGTON (BLOOMBERG) – A prominent Harvard Medical School professor has resigned from a US Food and Drug Administration advisory panel in protest over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm.
The doctor, Aaron Kesselheim, announced his departure in a letter to FDA Acting Commissioner Janet Woodcock. He is the third committee member to quit in the wake of the highly controversial approval.
Two big trials of the drug produced conflicting results on whether it could slow cognitive decline. The advisory panel voted almost unanimously in November that a single trial wasn’t enough to conclude that the drug works.
But the FDA granted conditional approval to the drug on Monday (June 7), on the basis that it could remove a bad protein called amyloid from the brain.
The decision “was probably the worst drug approval decision in recent US history,” Dr Kesselheim said in the letter. “The agency owes it to the nation to provide a detailed justification” for going against the advice of the panel, he said.
During the November advisory committee meeting, concerns about the data “were not given adequate time for discussion” and the crucial question of whether an Alzheimer’s drug should be approved based on amyloid lowering alone “was specifically excluded from discussion,” Dr Kesselheim wrote.
The doctor also made broader criticisms of the agency, saying it needed to reassess its decision-making process.
Dr Kesselheim is the third member to quit the committee, following Joel Perlmutter from the Washington University School of Medicine and David Knopman from the Mayo Clinic. Both Dr Perlmutter and Dr Kesselheim voted against the drug, while Dr Knopman was recused from the November hearing as he had already staked out a public position critical of the drug’s trial results.
Dr Perlmutter resigned “due to the FDA approval of aducanumab without further discussion with the advisory panel,” a spokeswoman for Washington University said in an e-mail.
Dr Knopman’s resignation was confirmed by the Mayo Clinic.