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When does patient need outweigh scientific rigor when approving experimental drugs?


Domain: @F
Commit: 6

Status: head
Author: Ender
Date: 25 June 2021, 12:59 (UTC)

is a question related to the recent decision by the FDA to grant approval to an experimental Alzheimer’s drug, Aducanumab, despite significant opposition from the scientific community [Ix4]. When confronted with an intractable, widespread disease, when–if ever–is it acceptable to prematurely grant approval for a questionably effective treatment?

Patient need [edit]

Alzheimer’s is a devastating disease with no known cure, and has had no new medications approved for its treatment since 2003. Consequently, there is a significant amount of despair and hopelessness associated with its diagnosis [Tx4].