> <i>The drug in question, Aduhelm, was approved by the agency last month and has caused an uproar in the scientific community. Three of the agency's scientific advisors resigned following the decision.</i><p>Is this sort of thing common? Seems like an investigation is definitely warranted if this type of resignation is a rare as I would imagine it be.
> Recent advances in amyloid imaging have made it possible to observe Aβ amyloid accumulation in the patient's brain. As a result, it has been found that there are many normal patients with amyloid deposits, and also AD patients with very few amyloid deposits (Edison et al., 2007; Li et al., 2008). [0]<p>How long is it going to take for the scientists who have built their career on the amyloid hypothesis to die out so new ideas can be investigated?<p>[0] <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3title" rel="nofollow">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797629/#s3titl...</a>
The problem is obviously a type error (not different from the use of a Social Security Number as a National Identification Number).<p>The government will pay for medication “that works”.<p>It determines that medication is one “that works” by seeing if the FDA approves it.<p>The FDA doesn’t want to always be too slow to approve medication so sometimes it wants to approve medication as “doesn’t hurt”.<p>Ultimately, the problem is that American policy relies on categories rather than spectra. My personal belief is that this is because the bureaucrats and policy makers are taking advantage of common American knowledge of categories vs spectra. So it needs some categorization mechanism and since one exists, they use that one. Presumably, out there is a bureaucrat with the same impulse as the engineer reading your PR who says “We already have a function to calculate radians to degrees. Why don’t we use that?”<p>In comparison, the NHS will measure how much to spend on a treatment based on an adjusted QALY measure (that boosts the value of the last few months). X QALYs are worth Y pounds.<p>Almost all American policy, by comparison, is category-based.<p>Other examples:<p>- immigration: America does categories (so either family or employment or refugee) while other nations use scores (if you both have family and employment you get some boost from both rather than the US max(categories)) system<p>- social security: Thresholds on disability and poverty are cliffs resulting in marginal income improvement resulting in marginal post-support income decrease. These should scale down, not drop off based on in-category/out-category
Unfortunately the link is unavailable in Poland:
<a href="https://imgur.com/a/48MFia6" rel="nofollow">https://imgur.com/a/48MFia6</a>
Link to pdf with prescribing information highlights which includes a small bit of detail about Aduhelm's mechanism of action and other details:<p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf" rel="nofollow">https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76...</a>
Full headline (presumably cut for HN length restrictions) is:<p>> The head of the FDA is calling for an investigation into her agency's controversial decision to approve a new Alzheimer's drug
The baseline reaction I'm seeing from commenters is appalling. This drug has been shown to NOT be particularly dangerous in clinical trials, while having a biochemical effect on amyloid protein buildup, which has strong correlations with degenerative brain diseases. It's another tool in the arsenal. There's no evidence that it cures one of the worst diseases around, but that shouldn't be the requirement for whether the public (only after having it prescribed by a medical doctor, mind you), has access to a drug.<p>How can you be pro-Marijuana and then not trust doctors to have another tool in their arsenal? The FDA should exist to prevent fraud and monitor quality, and nothing else. In this case, it would be highly reasonable to restrict the claims of the drug based on the study. But to ban it? What gives you or them the right to protect people from themselves?
Is the aduhelm company publicly traded? Seems like a lot of fun volatility upcoming on binary outcomes<p>If I was a gambling man, which I am, I would add this to my paid newsletter and call it investing (with contradictory and nullifying disclaimers of course)