Aduhelm (Aducanumab) Governance Autopsy: Independent Evidence Integrity Unit

Aduhelm (aducanumab) was approved by the FDA in June 2021 via accelerated approval, despite both Phase III trials failing their primary clinical endpoints and the advisory committee voting 10-to-1 against approval. This document is a structural autopsy of that governance failure, not a scientific critique of the drug, but an operational analysis of how independent evidence evaluation was systematically dismantled through sponsor-regulator collaboration. The intervention proposes an Independent Evidence Integrity Unit (IEIU): a firewalled governance function protecting interpretive independence through DMC authority locks, mandatory independent biostatistical audits, and transparent sponsor-regulator interaction logging. Anchored in ICH E6(R2), ICH E9, and the 2022 House Committee on Oversight and Reform investigation record.