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.
Martha Wuya Koroma (Mon,) studied this question.