Astral Codex Ten

aducanumab

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aducanumab

Article

aducanumab is a recurring brand in the Astral Codex Ten archive, appearing 5 times across 5 issues between August 05, 2021 and August 14, 2025. The archive places it in contexts such as “While I acknowledge that aducanumab probably sucks”; “the FDA approving aducanumab”; “approve aducanumab based on the flimsy efficacy data from the trials”. It most often appears alongside Biogen, FDA, aducanumab.

Metadata

  • Category: Brands
  • Mention count: 5
  • Issue count: 5
  • First seen: August 05, 2021
  • Last seen: August 14, 2025

Appears In

Source Context

Recovered passages from the original issue text. When the raw archive preserved outbound links inside the source passage, they are listed directly under the quote.

Adumbrations Of Aducanumab
August 05, 2021 · Original source
Lots of people have been writing about aducanumab, but this Atlantic article in particular bothers me.
Inline links: this
Backing up: aducanumab, aka Aduhelm, is a new “Alzheimers drug” recently approved by the FDA. I use the scare quotes because it’s pretty unclear whether it actually treats Alzheimers. It definitely treats beta-amyloid plaques, and beta-amyloid plaques are kind of nasty-looking brain structures that seem to be related to Alzheimers somehow. But we’re not sure exactly how they’re related, they might not be related in a way where removing them treats Alzheimers, and the best studies don’t find that the drug helps patients feel better or remember things more. Aducanumab doesn’t meet normal FDA standards for approval, but the FDA approved it anyway under one of their many “fast track” programs for promising drugs. This has been pretty roundly criticized, because although aducanumab might or might not work, it definitely costs $50,000/year/patient. Even if it worked great, that would be a hard pill to swallow (no pun intended, Aduheim is an IV infusion), but it’s especially galling since it might not work at all. Doctors will probably prescribe it despite its questionable value, and someone will end up paying the extraordinary price tag.
While I acknowledge that aducanumab probably sucks, I think the Atlantic article and its global warming metaphor are totally off base. Nobody in the “FDA is too strict” camp has written a rebuttal yet, so I want to try my hand at this.
Highlights From The Comments On Aducanumab
August 20, 2021 · Original source
These are highlights from the comments of Adumbrations Of Aducanumab, Details Of The Infant Fish Oil Story, and discussion of those posts elsewhere.
Inline links: Adumbrations Of Aducanumab, Details Of The Infant Fish Oil Story
C_B writes:
Inline links: writes
I agree with this post's overall point that the FDA is not, on average, too lax, and that the Atlantic article's take that the aducanumab approval is a sign of them being too lax is a bad take.
When Will The FDA Approve Paxlovid?
November 23, 2021 · Original source
(big pharma companies do often try to sneak mediocre drugs past the FDA, but that doesn’t look like falsely claiming 90% mortality reductions. It looks like aducamumab: a drug whose early trials showed mediocre results on secondary endpoints, but which Biogen somehow got the FDA to approve anyway)
Inline links: looks like aducamumab
Your Review: Of Mice, Mechanisms, and Dementia
July 11, 2025 · Original source
However, cracks are showing in this façade. In 2021, the FDA granted accelerated approval to aducanumab (Aduhelm), an anti-amyloid drug developed by Biogen, despite scant evidence that it meaningfully altered the course of cognitive decline. The decision to approve, made over near-unanimous opposition from the agency’s advisory panel, exposed growing tensions between regulatory optimism and scientific rigor. Medicare’s subsequent decision to restrict coverage to clinical trials, and Biogen’s quiet withdrawal of the drug from broader marketing efforts in 2024, made the disconnect impossible to ignore.
Inline links: the FDA granted accelerated approval, made over near-unanimous opposition, Biogen’s quiet withdrawal
And yet, the story held for decades. In many places, the amyloid cascade hypothesis remains entrenched to this day. Its staunchest defenders still occupy some of the most influential positions in research institutes, scientific societies, and grant review panels. Under their influence, evidentiary standards were shifted. Assumptions, and even the diagnostic criteria (!), were revised to accommodate half-satisfactory results, rather than to face falsification. Correlations were elevated to causes. And over time, the elegant machinery of scientific inference began to slip its gears. The field can sometimes feel like it’s circling endlessly round a well-funded cul-de-sac—exhausting resources while alternative ideas remain unfunded, unpursued, or unheard.
Inline links: the amyloid cascade hypothesis remains entrenched, diagnostic criteria
In Defense Of The Amyloid Hypothesis
August 14, 2025 · Original source
Aducanumab in phase 1b [77] (19% on my average across cognitive endpoints for the highest two doses) and one of two phase 3 trials [78] (22%, but negative 2% in the other trial, which also gave a lower dose on average).
But biology is messy, and we need to have comfort with complexity. Yes, there’s evidence that tau is responsible for the neurodegeneration in Alzheimer’s disease; no, this doesn’t contradict the amyloid hypothesis. Yes, Biogen screwed up in conducting the aducanumab phase 3 trials and this made the results harder to interpret; no, that doesn’t mean amyloid therapies have completely failed. Yes, it’s taken way too long to get even to this intermediate point of 30% efficacy, due to a combination of overregulation and biology just being damned hard; no, that doesn’t mean we’re on the wrong track with the underlying science.
[77] J. Sevigny et al., “The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease,” Nature, vol. 537, no. 7618, pp. 50–56, Sep. 2016, doi: 10.1038/nature19323.
Inline links: 10.1038/nature19323