A new anti-Alzheimer's drug is raising red flags in the medical community around its efficacy, side effects, and even the maker's relationship with the FDA, writes drgdanielgeorge
Aducanumab is an antibody that removes amyloid molecules associated with Alzheimer's disease.
Since the Food and Drug Administration approved Biogen’s drug aducanumab on June 7, it has been quite a bumpy ride on a predominantly downhill slope. We thought we’d do a quick check-in about our concerns over the controversial biologic and speculate as to where things might be going. There is an obvious problem here: amyloid does not equal Alzheimer’s—unless you reductively try to define it that way, as some unfortunately do. Moreover, and most importantly, removing amyloid is not associated with clinical improvement, and this unvalidated biomarker should not have been used to justify accelerated approval. In the scientific community, the amyloid hypothesis was on its way to the graveyard of failed theories at the end of the last decade.
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