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3 experts resign from FDA over drug approval debacle
Posted on 6/12/21 at 7:05 am
Posted on 6/12/21 at 7:05 am
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?
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?
Posted on 6/12/21 at 7:12 am to BeNotDeceivedGal6_7
They probably voted for Trump
Posted on 6/12/21 at 7:13 am to BeNotDeceivedGal6_7
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.
The FDA has been corrupt for a long time. I work in Pharmacy and lost respect for FDA long ago. Same for big Pharma.
Posted on 6/12/21 at 7:15 am to BHS78
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.
Posted on 6/12/21 at 7:16 am to IslandBuckeye
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.
Posted on 6/12/21 at 7:21 am to BeNotDeceivedGal6_7
Can you give me an example of a Govt agency
that works for US
that works for US
Posted on 6/12/21 at 7:26 am to BeNotDeceivedGal6_7
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...
See Fauci, Brennan, Comey, Obama, Hillary, Pelosi, Schiff, Schumer, etc...
Posted on 6/12/21 at 7:28 am to BHS78
quote:
Can you give me an example of a Govt agency
that works for US
I cannot
Posted on 6/12/21 at 7:29 am to BeNotDeceivedGal6_7
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??
Posted on 6/12/21 at 7:31 am to TOSOV
Treatment @ $57k per year with a 22% effective rate sounds about right in this clown world
Posted on 6/12/21 at 7:33 am to BeNotDeceivedGal6_7
quote:
pprove Biogen’s Alzheimer’s drug Aduhelm (aducanumab)
Racing for a cure just in time????
Posted on 6/12/21 at 7:36 am to BeNotDeceivedGal6_7
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.
Posted on 6/12/21 at 7:38 am to BeNotDeceivedGal6_7
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 6/12/21 at 11:01 am
Posted on 6/12/21 at 7:41 am to BeNotDeceivedGal6_7
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
These aholes must have been lobbied. It’s all about improving their selfish lives again
This post was edited on 6/12/21 at 7:42 am
Posted on 6/12/21 at 8:33 am to BeNotDeceivedGal6_7
Trust the science!!!!
Posted on 6/12/21 at 8:51 am to BeNotDeceivedGal6_7
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.
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.
Posted on 6/12/21 at 8:56 am to TOSOV
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.
Posted on 6/12/21 at 8:56 am to BeNotDeceivedGal6_7
FDA and CDC peddle a lot of snake oil.
That's my medical opinion.
That's my medical opinion.
Posted on 6/12/21 at 8:58 am to BeNotDeceivedGal6_7
quote:
despite a lack of efficacy data.
Trust the science!
Posted on 6/12/21 at 9:05 am to BeNotDeceivedGal6_7
Translation: Laying the foundation to speed the COVID vaccines through for final approval for general use.
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