This week, three members of an 11 member FDA advisory committee of experts resigned in protest over the FDA’s approval of Aduhelm (aducanumab) for the treatment of Alzheimer’s disease. These resignations are extremely unusual, but in this case, understandable.Aduhelm was approved by the agency despite the fact that both pivotal trials were stopped early because they were judged to be futile, the FDA’s own statistical reviewer did not support approval, and the FDA advisory committee reviewing the application voted it down overwhelmingly. Additionally, in a survey conducted by Endpoint News, whose readership is heavily weighted to biopharmaceutical industry staffers and...
