US approves first new Alzheimer's drug in 20 years
bbc.com
bbc.com
"A Brief Note About Aducanumab"
https://blogs.sciencemag.org/pipeline/archives/2021/06/03/a-...
"Given the current data, I do not think that aducanumab should be approved. I don’t believe that Biogen’s clinical trials have really demonstrated efficacy against the disease, and the FDA briefing documents show that there are many people in the agency who agree with that position..."
The advisory panel voted 8-1 against approval - as it was not effective.
The US has shown a general lack of care for it's citizens health. I honestly wouldn't be shocked of this was just a way for biogen to have a massive spike in their stock so it's holders can cash out.
The American health system has its problems. But this is an odd accusation to level against the country that played a foundational role in developing, distributing and administering highly-effective and novel Covid vaccines to a world-leading fraction of its population.
These systems have strengths and weaknesses. Broad measures of "good" or "bad" are too lossy.
(I seriously hope this is excessive cynicism on my part, but I vaguely remember reading articles like https://www.mondaq.com/india/patent/768712/pharma-companies-... [have not read this particular one, just the first thing I found googling...])
I wonder how much the FDA increases healthcare costs. Biogen has been trying to get the approved for a very long time. I'm sure they're starting out maybe five to ten billion in the red on this product.
Imagine a world where a pill was made to cure all cancer, but not approved because the price was too high.
If they have thought pricing it at $100,000/year would have brought more profits they would have priced it at $100K, and if they thought pricing it at $25,000/year would have brought more profits they would have priced it at $25K.
Indeed, the expert advisory committee at the FDA itself recommended against approving the drug, since the data on improving actual Alzheimer's progression is at best equivocal, especially given the past history of amyloid blockers. The FDA granted it essentially saying "there's nothing else there that works, and this does clearly clear amyloid plaques" (ignoring prior drugs that clearly cleared amyloid plaques yet still didn't work). And many people, including myself, are now preparing for the country to spend tens of billions on a drug which very probably doesn't work.
This does not paint the FDA in a good light.
Playing devil's advocate, would it be preferable if the FDA just validated the manufacturer's claims were true rather than applied a value judgement on the drug? That way, even if it turns out this (and other similar) drug isn't useful for Alzheimer's in general, but if it turns out amyloid plaque clearing is found to have an actual use, then this drug could be immediately used? In a sense, embracing the "off label" use of medication that's already prevalent throughout medicine.
I don't know whether this would make medicine better or not, but deciding on the risk vs benefit of a particular treatment is something that should be done between a patient and a doctor, provided they have access to all necessary information to make that decision and the claims made by the manufacturer are known to be valid.
The manufacturer's claims here are that the drug treats Alzheimer's. That's the key claim here that everyone cares about; the amyloid plaque-clearing part of it only matters insofar as it's hoped to be the key to Alzheimer's treatment.
There's another factor to point out: strictly speaking, this drug is only approved conditional on a further clinical trial proving efficacy (which will take years because Alzheimer's trials take forever). Now take stock of how many headlines mention that fact, or even hint at the sharp disagreement (what an understatement) about the efficacy of the drug.
I know, it was just a bit of an aside. The reason they presumably claim this is because if they just claimed it cleared amyloid plaques, that wouldn't be approved by the FDA as it's not treating a condition?