FDA’s decision to conditionally approve Biogen’s Aduhelm (aducanumab) continues to cause controversy.
Three members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have resigned. The most recent include David S. Knopman, a neurologist at the Mayo Clinic (Rochester, Minn.) and Aaron Kesselheim, a professor at Harvard University (Cambridge, Mass.)
Last November, eight committee members disagreed that there was sufficient clinical trial evidence to suggest that the drug was effective against Alzheimer’s. Another was undecided.
The first to resign was Joel Perlmutter, a neurologist at Washington University (St. Louis).
The three have not gone quietly.
In a letter to acting FDA Commissioner Janet Woodcock, Kesselheim called the aducanumab approval the “worst drug approval decision in recent U.S. history.”
Knopman told The Washington Post that he did not “wish to be part of a sham process.”
Perlmutter was mor…