Opinion: Patient advocacy organizations and FDA drug approval: lessons from Aduhelm
In the wake of last month’s controversial Food and Drug Administration approval of Biogen’s Aduhelm, Alzheimer’s Association CEO Harry Johns condemned the “negative voices” concentrating on the flaws in the FDA’s approval as “not pro-patient.”
The Alzheimer’s Association wasn’t the only patient advocacy organization applauding the FDA’s questionable decision, which was based on changes in a surrogate endpoint for Alzheimer’s disease — reduction of amyloid in the brain, an outcome the FDA had previously rejected and that dozens of previous studies had failed to associate with better dementia outcomes.
