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FDA Advisers Quit Over Alzheimer's Drug: 'Sham Process'

They're not happy the agency OK'd Biogen's Aduhelm against panel's recommendation
By Jenn Gidman,  Newser Staff
Posted Jun 10, 2021 9:25 AM CDT

(Newser) – The week kicked off with controversy swirling around aducanumab, the drug being marketed by Biogen as Aduhelm to treat Alzheimer's disease. The drama continues, with two members of an advisory panel to the Food and Drug Administration stepping down over the agency's decision to OK the drug against the panel's recommendation. Nearly all 11 members of the committee had voted in November not to give the green light to Aduhelm as it wasn't clear it offered any real benefits to Alzheimer's patients. "I was very disappointed at how the advisory committee input was treated by the FDA," Mayo Clinic neurologist Dr. David Knopman, who resigned Wednesday, tells Reuters. Per the Washington Post, he adds that a "sham process" led to the drug's approval, and that "the approval of aducanumab appears [to] have been foreordained."

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Washington University neurologist Dr. Joel Perlmutter also quit the panel, telling STAT his resignation was "due to this ruling by the FDA without further discussion with our advisory committee." Perlmutter had voted against the FDA approving Aduhelm, while Knopman had recused himself from the vote, as he'd been an investigator in the clinical trials. The agency gave the drug "accelerated approval" not based on clinical data showing the drug's effectiveness, but on the fact that Aduhelm reduces amyloid beta proteins in the brain—which the FDA said was "reasonably likely" to help patients. The FDA has gone against panel recommendations before, but "this was the first time that nobody voted for approval of this drug—nobody—and they went against that," a University of Washington biostatistician tells STAT. (The price of Aduhelm is raising eyebrows, too.)

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