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BeNotDeceivedGal6_7
Georgia Fan
Member since May 2019
5616 posts

3 experts resign from FDA over drug approval debacle
Fallout continues from the Food and Drug Administration’s contentious decision this week to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab) despite a lack of efficacy data.

Three experts who sat on an advisory committee for the FDA have now resigned over the decision.

The advisory committee reviewed the data behind Aduhelm last November and voted overwhelmingly against approval. Of the 11 advisors on the committee, 10 voted “no” on the question of whether Biogen had collected enough evidence to indicate that the drug is effective. The remaining advisor voted “uncertain.”

Nevertheless, the FDA approved the drug on Monday. Though the regulator acknowledged that there are “residual uncertainties regarding [the] clinical benefit” of Aduhelm, the FDA said it decided to lower the requirements for approval after the advisory committee voted.

The approval and explanation riled advisory committee member Aaron Kesselheim, a professor at Harvard Medical School who is also director of the Program On Regulation, Therapeutics, and Law at Brigham and Women's Hospital. In a searing resignation letter sent to acting FDA Commissioner Janet Woodcock on Thursday, Kesselheim called the FDA’s decision "probably the worst drug approval decision in recent US history."

He noted that the surrogate endpoint was not discussed by the advisory committee—in fact, he notes, the FDA told the committee specifically that it would not use amyloid beta plaque clearing as a surrogate for efficacy.

Slanted wording
Kesselheim also criticized other aspects of how the FDA oversaw the committee meeting, writing:

At our public meeting, concerns about trial data from one of the FDA’s own reviewers were not given adequate time for discussion, and some of the questions FDA asked the Committee to answer were worded in a way that seemed slanted to yield responses that would favor the drug’s approval.

Overall, he described the decision as a debacle and wrote that “it is clear to me that FDA is not presently capable of adequately integrating the Committee's scientific recommendations into its approval decisions." As such, he resigned from the committee, on which he had served since 2015.

In resigning, he joins neurologists David Knopman of the Mayo Clinic in Minnesota and Joel Perlmutter of Washington University in St. Louis, both of whom also announced resignations this week.

article


Now, why would the FDA go against their expert reviewers to approve a drug? $$$$$$$$$$$$$

Is this shite starting to sink in yet, people?


BHS78
LSU Fan
Member since May 2017
756 posts

re: 3 experts resign from FDA over drug approval debacle
They probably voted for Trump


IslandBuckeye
Ohio State Fan
St. Thomas, USVI
Member since Apr 2018
9240 posts

re: 3 experts resign from FDA over drug approval debacle
Saw the news of approval earlier this week when it was discussed that the company's stock had dramatically gone up. Shortly after there was a commercial for the drug.

The FDA has been corrupt for a long time. I work in Pharmacy and lost respect for FDA long ago. Same for big Pharma.


BeNotDeceivedGal6_7
Georgia Fan
Member since May 2019
5616 posts

re: 3 experts resign from FDA over drug approval debacle
quote:

They probably voted for Trump


Well, it sounds like they actually care about doing what's right, not what puts money in their own pockets, so yeah, they probably did vote Trump.


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BeNotDeceivedGal6_7
Georgia Fan
Member since May 2019
5616 posts

re: 3 experts resign from FDA over drug approval debacle
quote:

The FDA has been corrupt for a long time. I work in Pharmacy and lost respect for FDA long ago. Same for big Pharma.


It's pretty sad that we can't trust any of the government agencies that are supposed to be looking out for us.


BHS78
LSU Fan
Member since May 2017
756 posts

re: 3 experts resign from FDA over drug approval debacle
Can you give me an example of a Govt agency
that works for US


AURaptor
US Space Force Fan
South
Member since Aug 2018
10702 posts
 Online 

re: 3 experts resign from FDA over drug approval debacle
It has become impossible to decipher the motives of anyone working in government anymore. Thanks in great part to the overt lying that went on by 'top men' in the bureaucracies , who all vowed to uphold the Constitution, but instead did one thing while telling the public the exact opposite. And then putting on a show of indignant defiance after they were revealed to be liars.

See Fauci, Brennan, Comey, Obama, Hillary, Pelosi, Schiff, Schumer, etc...



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BeNotDeceivedGal6_7
Georgia Fan
Member since May 2019
5616 posts

re: 3 experts resign from FDA over drug approval debacle
quote:

Can you give me an example of a Govt agency
that works for US


I cannot


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161
TOSOV
Member since Jan 2016
7448 posts

re: 3 experts resign from FDA over drug approval debacle
quote:

Now, why would the FDA go against their expert reviewers to approve a drug? $$$$$$$$$$$$$


Curious...does it have to FDA approved to be covered by an insurance policy??....ummm...just as an example of course...say a Presidential insurance policy??


TOSOV
Member since Jan 2016
7448 posts

re: 3 experts resign from FDA over drug approval debacle
Treatment @ $57k per year with a 22% effective rate sounds about right in this clown world


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ChineseBandit58
LSU Fan
west of the pines
Member since Aug 2005
33793 posts

re: 3 experts resign from FDA over drug approval debacle
quote:

pprove Biogen’s Alzheimer’s drug Aduhelm (aducanumab)


Racing for a cure just in time????


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40
NineLineBind
US Space Force Fan
LA....no, the other one
Member since May 2020
3541 posts

re: 3 experts resign from FDA over drug approval debacle
Sounds like we can add FDA to the ever-growing list of politicized alphabet agencies of the federal government. And we have Trump’s predecessors to thank for it.


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50
tiggerthetooth
US Space Force Fan
Big Momma's House
Member since Oct 2010
49792 posts

re: 3 experts resign from FDA over drug approval debacle
Yeah supposedly the drug has very little data to support its use but comes at a high cost to insurance companies and medicare. So the taxpayers will be fronting the cost for a drug that doesn't help them in anyway. The worst kind of drug.
This post was edited on 6/12 at 11:01 am


xxTIMMYxx
Member since Aug 2019
7609 posts

re: 3 experts resign from FDA over drug approval debacle
So everyone votes no, but they go with it anyway by changing the rules. Take them to court. Leaders are no longer listening to the people putting them in these positions. Get rid of them. That’s not democratic

These aholes must have been lobbied. It’s all about improving their selfish lives again
This post was edited on 6/12 at 7:42 am


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Bourre'
New Orleans Saints Fan
Da Parish
Member since Nov 2012
15365 posts
 Online 

re: 3 experts resign from FDA over drug approval debacle
Trust the science!!!!


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thetempleowl
Temple Fan
dallas, tx
Member since Jul 2008
13598 posts

re: 3 experts resign from FDA over drug approval debacle
The fact is a political organization.

The cdc is a political organization.

fricking Obama made almost everything a political organization.

Whatever he missed biden is getting this time around. As in the military.


Wildcat1996
Texas A&M Fan
Lexington, KY
Member since Jul 2020
1491 posts

re: 3 experts resign from FDA over drug approval debacle
quote:

Treatment @ $57k per year with a 22% effective rate sounds about right in this clown world


Immune Checkpoint Inhibitors have a 13% response rate for non-small cell lung cancer, run $100K over the course of treatment, are FDA approved and are considered a "breakthrough" in cancer treatment.


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40
Stingray
LSU Fan
Shreveport
Member since Sep 2007
11934 posts

re: 3 experts resign from FDA over drug approval debacle
FDA and CDC peddle a lot of snake oil.
That's my medical opinion.


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80
Sasquatch Smash
LSU Fan
Member since Nov 2007
16333 posts

re: 3 experts resign from FDA over drug approval debacle
quote:

despite a lack of efficacy data.



Trust the science!


Bard
LSU Fan
Poli Board President-Elect
Member since Oct 2008
40251 posts

re: 3 experts resign from FDA over drug approval debacle
Translation: Laying the foundation to speed the COVID vaccines through for final approval for general use.


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