Medical Crony Capitalism At It's Finest
Jun 11, 2021 05:57:20 #
Are you aware that the FDA approved Biogen's Aduhelm treatment for Alzheimer's Disease?
It turns out that despite the fact that not one member of the FDA Advisory Committee v**ed to approve Aduhelm, the FDA recently approved this Alzheimer therapy anyway, relying on an alternative measure of activity.
As Statnews reports, since the FDA's decision, three members of that FDA Advisory Panel have quit.
1. Neurologist J.Perlmutter, a member of the FDA’s expert panel said he quit the committee “due to this ruling by FDA without further discuss with our advisory committee.”
2. Neurologist David Knopman of the Mayo Clinic.
3. Dr. Aaron Kesselheim, director of Brigham and Women’s Hospital’s Program on Regulation, Therapeutics, and Law, said Aduhelm’s approval didn’t just set “a dangerous precedent” for what kind of evidence an Alzheimer’s therapy would need to show to get the green light, “but even more broadly for the idea that a company can turn around and at the last minute seek [accelerated approval] when their primary clinical endpoints in their trials don’t reach the level needed for FDA approval,” he told STAT in an email.
In his letter of resignation to the FDA, Kesselheim said Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.”
"But hey, if there's $56,000 per year per customer patient to be made, the "science" can always be adjusted.
Were the Biogen bribes to the FDA paid in bitcoin too?
— zerohedge (@zerohedge) June 10, 2021
So much for science... again!"
Who says the FDA is not a captive to the industry that they are supposed to regulate?
https://www.zerohedge.com/medical/dangerous-precedent-3rd-fda-advisor-quits-after-controversial-alzheimers-drug-approval
It turns out that despite the fact that not one member of the FDA Advisory Committee v**ed to approve Aduhelm, the FDA recently approved this Alzheimer therapy anyway, relying on an alternative measure of activity.
As Statnews reports, since the FDA's decision, three members of that FDA Advisory Panel have quit.
1. Neurologist J.Perlmutter, a member of the FDA’s expert panel said he quit the committee “due to this ruling by FDA without further discuss with our advisory committee.”
2. Neurologist David Knopman of the Mayo Clinic.
3. Dr. Aaron Kesselheim, director of Brigham and Women’s Hospital’s Program on Regulation, Therapeutics, and Law, said Aduhelm’s approval didn’t just set “a dangerous precedent” for what kind of evidence an Alzheimer’s therapy would need to show to get the green light, “but even more broadly for the idea that a company can turn around and at the last minute seek [accelerated approval] when their primary clinical endpoints in their trials don’t reach the level needed for FDA approval,” he told STAT in an email.
In his letter of resignation to the FDA, Kesselheim said Biogen’s Aduhelm “was probably the worst drug approval decision in recent U.S. history.”
"But hey, if there's $56,000 per year per customer patient to be made, the "science" can always be adjusted.
Were the Biogen bribes to the FDA paid in bitcoin too?
— zerohedge (@zerohedge) June 10, 2021
So much for science... again!"
Who says the FDA is not a captive to the industry that they are supposed to regulate?
https://www.zerohedge.com/medical/dangerous-precedent-3rd-fda-advisor-quits-after-controversial-alzheimers-drug-approval
Jun 11, 2021 08:15:50 #
lpnmajor
Loc: Arkansas
ACP45 wrote:
Are you aware that the FDA approved Biogen's Aduhe... (show quote)
Capitalism at it's finest. 
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