7.01.2021

Reading while I sip my coffee on break.... The advisory committee for new Alzheimer's disease drug says "NO" but the FDA says, "Eh, let's approve it"

https://science.sciencemag.org/content/sci/372/6549/1371.full.pdf

 


 



 




 

 


 

".......Despite these bad odds, a drug targeting amyloid-β was presented for approval to the FDA. On 6 November 2020, our FDA advisory committee reviewed Biogen's application for aducanumab, primarily on the basis of a two-part study that had been stopped early because of futility—the chances of clinical benefit were very small if the study continued to the planned conclusion.

But then, the data were reanalyzed and Biogen proposed that because one part of the study was positive, though the other was not, that was sufficient for FDA approval. Never mind that the side effects of the proposed dose included localized brain swelling in 35% of clinical trial participants and microhemorrhages in 20%.

When all this was put to a vote by the advisory committee, 10 voted no, 1 voted uncertain, and no one voted yes.

And yet, the FDA granted accelerated approval of aducanumab for treatment of AD, merely requiring Biogen to do a prospective study over the next 9 years to confirm if there is some clinical benefit. Even worse, the FDA changed the standard for determining this benefit from clinical evidence that the drug actually helps to evidence that the drug simply reduced brain amyloid-β.

Although all of this may be well and good for Biogen with a potential $56 billion dollars for the first year of treatment in 1 million people with AD......."

 

SCREEEEECH!

Yes.  A screeching halt.

Read that again.

The advisory committee overwhelming said NO... absolutely not.
The FDA however, pressured by Biogen and the public says "sure... hell, why not?"
And the biggest flag... Biogen is set to make a potential 56 BILLION DOLLARS in the FIRST YEAR...

I've never been a fan of the FDA or the CDC because they are in bed with too many people that do NOT have our best interest at heart.  It's about who you know and how much money someone's making.  The buddy system and dollars far outweigh honesty and integrity in both.  

So I wasn't surprised when I read this... but once again, I was let down.  Huge kudo's to the researches sounding the alarm about this and other drugs being approved when frankly... they should not be.


 

 

 



 

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Thanks for sharing morning coffee with me!