Harvard veteran resigns from FDA panel amidst Alzheimer’s drug controversy
By Shubhangi on Jun 12, 2021 | 04:32 AM IST
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)
Picture
Credits: CNBC