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Three FDA advisory panel members resign over approval of Alzheimer’s drug

BMJ 2021; 373 doi: (Published 11 June 2021) Cite this as: BMJ 2021;373:n1503
  1. Elisabeth Mahase
  1. The BMJ

Three members of a US Food and Drug Administration (FDA) advisory committee, which advised against authorising the Alzheimer’s disease drug aducanumab because of a lack of efficacy, have resigned after the agency went ahead and approved it.1

One of those who resigned, Harvard professor of medicine Aaron Kesselheim, wrote in a letter to acting FDA commissioner Janet Woodcock that the approval of Biogen’s drug was “probably the worst drug approval decision in recent US history.”

Kesselheim was joined in resignation by Mayo Clinic neurologist David Knopman and Washington University neurologist Joel Perlmutter. They were all members of the independent Peripheral and Central Nervous …

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