Harvard Expert Quits
FDA Panel as Biogen Drug Furor Grows
By Robert Langreth
June 10, 2021, 4:52 PM EDT Updated on June 10, 2021, 8:54 PM EDT
Exodus of experts
follows controversial Alzheimer’s clearance
Advisory committee
had said trial data didn’t back treatment
L
A prominent Harvard Medical School professor has resigned
from a U.S. Food and Drug Administration advisory panel in protest over the
agency’s decision to approve Biogen Inc.’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.
The clearance “was probably the worst drug approval decision in recent U.S. history,” Kesselheim
said in the letter.
Evidence that the
drug works is mixed. Two big clinical trials produced conflicting results on whether it could
slow cognitive decline, leading the advisory panel Kesselheim served on to urge
the FDA not to let it on the market without further study.
The agency elected to give the treatment a conditional
approval on the basis that it could remove a bad protein called amyloid from
the brain. Biogen must conduct an additional trial to confirm the drug’s
effectiveness, the FDA said.
The drug’s clearance was celebrated as a landmark by
Alzheimer’s patients and many doctors. It was the first therapy for the
brain-wasting disease to be approved in roughly two decades, and it is
likely to be a blockbuster for Biogen and its partner, Tokyo-based Eisai Co.
At a
meeting in November, the advisory panel voted 8 to 1, with 2 undecided, that
data from a single clinical trial with positive results was insufficient to
show Biogen’s drug works. They also voted 10 to 0, with 1 undecided, that the
positive study shouldn’t be considered primary proof the drug works in light of
conflicting evidence from a different trial.
“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 in an
email. “Based upon this, the FDA concluded that an accelerated approval was
appropriate.”
The agency doesn’t comment on matters related to individual
advisory committee members, she 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,” Kesselheim wrote.
The doctor also made broader criticisms of the agency,
saying it needed to reassess its decision-making process.
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 Perlmutter and Kesselheim voted
against the drug, while Knopman was recused from the November hearing as he had
already staked out a public position critical of the trial results.
Perlmutter resigned “due to the FDA approval of aducanumab
without further discussion with the advisory panel,” a spokeswoman for
Washington University said in an email.
“I am extraordinarily disappointed that our unbiased
advisory committee review was not valued,” Perlmutter said in an email.
Approving a drug that may not be effective “has serious potential to impair
future research into new treatments.”
Knopman’s resignation was confirmed by the Mayo Clinic.
— With assistance by Anna Edney
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