Allison Parks, a spokeswoman for BiogenKesselheim and two other members of the advisory committee promptly resigned in protest. In his letter of resignation, Kesselheim called the Aduhelm process "probably the worst drug approval decision in recent US history." Indeed, one study found that between 2008 and 2015 the agency rejected advisory committee recommendations 22% of the time. Advanced medical scans reveal that many Alzheimer's patients have what are called amyloid plaques -- toxic nests of proteins -- in their brains. Woodcock, in turn, has asked for the agency's inspector general to review the Aduhelm approval.

Source: CNN September 26, 2021 21:56 UTC