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© Copyright 2023 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.Alzheimer's drug gets FDA panel's backing, setting the stage for broader use
By MATTHEW PERRONE WASHINGTON©2023 GPlusMedia Inc.
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virusrex
This is a huge point to consider, Leqembi is expensive, risky and its effects quite limited, but it is also one of the very few things that have a therapeutic effect agains Alzheimer's, so for many patients it is still much better than no treatment.
It is very difficult to feel satisfied with the drug, but it is a very important step on treating a cruel disease that affects a lot of people and hopefully will lead to better options in the near future.
gcFd1
It makes sense you don't understand the process in the US.
A reading of the article should help:
The decision carries extra significance because insurers have held off on paying for the infused treatment until it has full FDA approval.
virusrex
The process never involves the FDA "fully supporting" companies to research new treatments, their role is to evaluate already developed drugs to approve them or not. The quote you make from the article clearly supports this role, not developing things in the first place.
RKL
How true.
The FDA is an actual authority.
Drugs approved via the accelerated pathway can technically be withdrawn by the FDA if their benefits aren't confirmed, though regulators rarely take that step. Gaining full approval allows medications to stay on the market indefinitely.
virusrex
"Actual authority" do not depend on having legal powers, scientific authorities for example refers to trust in as well as the social power of scientific knowledge and is completely independent of the ability of an institution to force things into others. A doctor would be an actual medical authority, even if he can't force a patient to undergo a treatment.
CPTOMO
Actual authority means an entity gives orders, others have to obey. The WHO has no such authority,
This will help with your understanding of some of the FDA's functions:
The FDA’s initial OK for Leqembi came via the agency’s accelerated approval program, which allows early access to drugs based on laboratory or biological measures suggesting that they might help patients.
virusrex
You have repeatedly failed to present any evidence of this personal and arbitrary definition being supported by anybody but yourself, that means it is just you again trying to force something you believe as if it were fact.
You can never produce any source that says "medical/scientific authority" requires being able to force anybody to do something and it has been very easy to disprove this claim with examples like the ones offered in the previous comment.
Do you believe doctors are not medical authorities? they can't force patients to do anything. Did you not call the CDC a global authority? the CDC can't force countries like China to do anything either.