3rd FDA Panelist Resigns Over Approval Of Alzheimer’s Drug

Another member of the Food and Drug Administration’s advisory panel resigned and called this week’s approval of an Alzheimer’s drug “probably the worst drug approval decision in recent U.S. history.”

Harvard’s Aaron Kesselheim made the claim as the third expert advisory panelist to resign in a letter to acting FDA Commissioner Janet Woodcock on Thursday, The Hill reported.

Mayo Clinic neurologist David Knopman and Washington University in St. Louis neurologist Joel Perlmutter have also resigned.

The FDA panel was nearly unanimous last November in advising against approval of Biogen’s Alzheimer’s drug Aduhelm, with 10 voting no and one voting uncertain, citing a lack of evidence the drug is effective.

“At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease, but this pivotal question was not discussed at the Advisory Committee meeting, and its premise was specifically excluded from discussion,” Kesselheim wrote.

Read more at NEWSMAX. 

{Matzav.com}