This story is massive because it will have massive implications.
Story starts out with a treatment from a company called Biogen. The FDA just approved this treatment called Aduhelm which is supposed to be used to slow down Alzheimer’s disease. The treatment consists of injecting a live antibodies into the patient on a monthly basis. But the truth is, in short:
The drug failed to produce any benefit in its double blind placebo studies.
The treatment produced very painful brain swelling in over 40% of the people.
The independent advisory panel (not the FDA panel) said the treatment simply does not work and further studies are not justified.
Biogen shelves the treatment and comes back and says we have looked at the data and it does appear to work by increasing the dosage.
So the FDA approves the treatment using Accelerated Approval which is usually done for cancer treatments. The conditions for the approval that it must do another study and it gave the company 9 fucking years to report back.
Meanwhile the treatment has been fully approved and Biogen set the price tag at 56K per patient per year or nearly $4,700.00 per injection while they do yet another study. You can bet your ass they will take all 9 years to do that study. There is no benefit to the company to do it in less time.
Ok so here we are. Now 3 FDA panel members have resigned saying this was the absolute worst decision the FDA has made.
That means the FDA is compromised and is being shaken up. That also means that the FDA will be getting 3 new members.
There are no coincidences and this sets a distubing precedent. Anyone who doesn’t think they wont approve this covid vaccine is a fucking moron, its coming. What are you going to do?
blogs.sciencemag.org/pipeline/archives/2021/06/08/the-aducanumab-approval
h/t Save America From Politicians