Reader Response: Decisions With Patients and Families Regarding Aducanumab in Alzheimer Disease, With Recommendations for Consent: AAN Position Statement
Robert E.Becker, Psychiatry, clinical pharmacology,, Aristeas Translational Medicine Corporation
Submitted November 23, 2021
The position statement by the AAN examines the ethical concerns of the use of aducanumab in Alzheimer Disease (AD).1 Under statistical assumptions, this drug failed in clinical trials with two studies that stopped prematurely for futility. Post-hoc analyses validly support subsequent clinical trials. They do not suggest efficacy. Scientifically, the high dose aducanumab benefit cannot be generalized.
I find no remarkable clinical importance to the small statistical benefit in the single trial for daily function. The number of statistical tests that must have been done in the post-hoc analyses do not make random positive events likely. Even with two successful clinical trials, the adverse events seem to argue against approval. Here, the problems are even more shameful for medicine.
The AAN understates questioning whether reducing beta-amyloid plaques will have any meaningful benefit. The repeated failures to modify disease course of AD in multiple clinical trials that produced dramatic reductions in amyloid pathologies and ABeta indicate that one cannot assume clinical benefits from aducanumab effects on amyloid. Having researched AD since 1983, I strongly oppose this drug approval, if only to prevent drug companies from resurrecting their clinically failed, but biochemically effective AD drugs. Medicine serves the interests of patients, not providers.
Disclosure
The author reports no relevant disclosures. Contact journal@neurology.org for full disclosures.
References
Chiong W, Tolchin BD, Bonnie RJ, et al. Decisions With Patients and Families Regarding Aducanumab in Alzheimer Disease, With Recommendations for Consent: AAN Position Statement [published online ahead of print, 2021 Nov 17]. Neurology. 2021;10.1212/WNL.0000000000013053.
The position statement by the AAN examines the ethical concerns of the use of aducanumab in Alzheimer Disease (AD).1 Under statistical assumptions, this drug failed in clinical trials with two studies that stopped prematurely for futility. Post-hoc analyses validly support subsequent clinical trials. They do not suggest efficacy. Scientifically, the high dose aducanumab benefit cannot be generalized.
I find no remarkable clinical importance to the small statistical benefit in the single trial for daily function. The number of statistical tests that must have been done in the post-hoc analyses do not make random positive events likely. Even with two successful clinical trials, the adverse events seem to argue against approval. Here, the problems are even more shameful for medicine.
The AAN understates questioning whether reducing beta-amyloid plaques will have any meaningful benefit. The repeated failures to modify disease course of AD in multiple clinical trials that produced dramatic reductions in amyloid pathologies and ABeta indicate that one cannot assume clinical benefits from aducanumab effects on amyloid. Having researched AD since 1983, I strongly oppose this drug approval, if only to prevent drug companies from resurrecting their clinically failed, but biochemically effective AD drugs. Medicine serves the interests of patients, not providers.
Disclosure
The author reports no relevant disclosures. Contact journal@neurology.org for full disclosures.
References