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FDA Approval of Alzheimer’s drug prompts advisors to resign


WHAT YOU NEED TO KNOW:

  • Three members of the FDA’s advisory panel have resigned in protest against the agency’s decision to approve Biogen Inc’s Alzheimer’s treatment.
  • Dr. Joel Perlmutter, Dr. David Knopman, and Aaron Kesselheim recently resigned after the agency seemed to ignore the advisors’ “firm recommendations” against the drug’s approval.
  • The 11-member committee cited inconclusive evidence of the drug’s effectiveness when they voted nearly unanimously against its approval in November.

The U.S. Food and Drug Administration (FDA) has approved Biogen Inc’s treatment for Alzheimer’s disease despite the advisory committee‘s recommendation against it, prompting three advisors to resign in protest.

Professor of Medicine Aaron Kesselheim of Harvard Medical School had been a part of the FDA’s advisory committee for nervous system drugs since 2015. On Thursday, he informed Reuters of his resignation.

Kesselheim stated in an email, “The FDA needs to re-evaluate how it solicits and uses the advisory committees.” He stated that the advisors’ “firm recommendations” against the approval didn’t seem to be “appropriately integrated into the decision-making process.”

His resignation from the panel was first reported by Stat News.

According to Kesselheim, the agency has previously approved a drug against the advisors’ recommendations. He referred to the approval of Sarepta Therapeutic Inc’s drug, eteplirsen, for Duchenne muscular dystrophy in 2016.

Washington University neurologist Dr. Joel Perlmutter was the first to resign on Tuesday. He cited the agency’s approval of Aduhelm. The resignation of Mayo Clinic neurologist Dr. David Knopman followed on Wednesday.

The 11-member advisory panel cited inconclusive evidence of the drug’s effectiveness when they voted nearly unanimously against the approval of Biogen’s drug in November.

But the FDA allowed “accelerated approval” for the Biogen treatment on Monday. The agency cited evidence that the drug can reduce a potential contributor to Alzheimer’s disease, which is far from definite proof of a clear benefit against the illness.

 

Source: NBC News

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