15 June 2021 - Like many people, I was shocked when the FDA ignored the advice of its neurological drugs advisory panel and broadly approved Biogen’s new drug, Aduhelm, even for populations never included in the clinical trials to assess the drug.
I am not a casual bystander to this controversial decision. I am a physician who has been treating people with Alzheimer’s since 1982; an early researcher into the biology of amyloid, the brain protein that Aduhelm targets; someone with a strong personal family history of dementia — I have shared the responsibility of caring for seven relatives who died from Alzheimer’s disease over the past 40 years; and have personally undergone biomarker assessment for an amyloid-lowering drug trial.