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Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug Options
alkarocky
#1 Posted : Thursday, June 10, 2021 7:38:05 PM

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The New York Times
Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug
Pam Belluck and Rebecca Robbins 26 mins ago
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In a powerful statement of disagreement with the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, three scientists have resigned from the independent committee that advised the agency on the treatment.

a man wearing a suit and tie: Dr. Aaron Kesselheim, who resigned this week from an F.D.A. advisory committee, speaking at a panel in 2018. “This might be the worst approval decision that the F.D.A. has made that I can remember,” he said Thursday.© Scott Eisen/Associated Press Dr. Aaron Kesselheim, who resigned this week from an F.D.A. advisory committee, speaking at a panel in 2018. “This might be the worst approval decision that the F.D.A. has made that I can remember,” he said Thursday.
“This might be the worst approval decision that the F.D.A. has made that I can remember,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, who submitted his resignation Thursday after six years on the committee.


He said the agency’s approval of the drug, aducanumab, which is being marketed as Aduhelm, a monthly intravenous infusion that Biogen has priced at $56,000 per year, was wrong “because of so many different factors, starting from the fact that there’s no good evidence that the drug works.”

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Two other members of the committee resigned earlier this week, expressing dismay at the approval of the drug despite the committee’s overwhelming rejection of it after reviewing clinical trial data in November.

The committee had found that the evidence did not convincingly show that Aduhelm could slow cognitive decline in people in the early stages of the disease — and that the drug could cause potentially serious side effects of brain swelling and brain bleeding. None of the 11 members of the committee considered the drug ready for approval: Ten voted against and one was uncertain.

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