Two members of an FDA advisory committee have resigned following the agency's approval of aducanumab, a controversial new drug to treat Alzheimer's disease. Mayo Clinic neurologist Dr. David Knopman and Washington University neurologist Dr. Joel Perlmutter both resigned this week, citing the approval of the drug which the committee had recommended against. Knopman was recused from the meeting and did not participate in the vote on aducanumab, branded as Aduhelm, because he had been an investigator in clinical trials run by Biogen, which manufactures the drug.
- Knopman told Reuters he was "disappointed" at how the FDA responded to the advisory committee's recommendation. "I don't wish to be put in a position like this again."
- The FDA approved the drug earlier this week, confusing many neurological researchers who say there is not enough evidence that it is effective in patients in the early stages of Alzheimer's.
- Aduhelm is the first drug approved to treat what some believe is the "root cause of Alzheimer's," plaques that develop and clump in the brain.
- One geriatrician and memory specialist told Nature that the evidence that clearing out these proteins can improve Alzheimer's symptoms is "thin, at best."