U.S. Food and Drug Administration–s (FDA) approval of aducanumab (Aduhelm® in the US) as a treatment for mild cognitive impairment of the Alzheimer type and Alzheimer–s disease has raised such major concerns about efficacy, safety, FDA processes, and regulatory capture that Biogen–s license to market this biologic should be immediately withdrawn. Aducanumab has not demonstrated benefit to patients, failed to meet regulatory guidelines, and is likely to cause both individual and societal harm.
AlexanderGC, EmersonS, KesselheimAS (2021) Evaluation of Aducanumab for Alzheimer disease: Scientific evidence and regulatory review involving efficacy, safety, and futility. JAMA325, 1717–1718.
3.
AckleySF, ZimmermanSC, BrenowitzWD, Tchetgen TchetgenEJ, GoldAL, ManlyJJ, MayedaER, FilshteinTJ, PowerMC, ElahiFM, BrickmanAM, GlymourMM (2021) Effect of reductions in amyloid levels on cognitive change in randomized trials: Instrumental variable meta-analysis. BMJ372, n156.
4.
RichardE, den BrokMGHE, van GoolWA (2021) Bayes analysis supports null hypothesis of anti-amyloid beta therapy in Alzheimer’s disease. Alzheimers Dement17, 1051–1055.
5.
BattS, ButlerJ, ShannonO, Fugh-BermanA (2020) Pharmaceutical ethics and grassroots activism in the United States: A social history perspective. J Bioeth Inq17, 49–60.
6.
LenzerJ, BrownleeS (2020) Should regulatory authorities approve drugs based on surrogate endpoints?BMJ374, 2059.
7.
GeorgeD, WhitehouseP (2021) American Dementia: Brain Health in an Unhealthy Society. Johns Hopkins Press, Baltimore.
