A prominent Harvard Medical School professor has resigned from a U.S. Food and Drug Administration advisory panel in protest over the agency’s decision to approve Biogen Inc.’s Alzheimer’s drug Aduhelm.
The doctor, Aaron Kesselheim, announced his departure in a letter to FDA Acting Commissioner Janet Woodcock. He is the third committee member to quit in the wake of the highly controversial approval.
The clearance “was probably the worst drug approval decision in recent U.S. history,” Kesselheim said in the letter.
Evidence that the drug works is mixed. Two big clinical trials produced conflicting results on whether it ...