CDER/CBER medical reviwer. Left during trump1. Everything is insane now, but the head of CDER, Tidmarsh, rambling on social media, and doing a smear job on Aurinia's voclosporin is malignantly unhinged, and NOT HOW THINGS HAVE EVER HAPPENED.
Dr Angela please don't take offense to my possible parody of your treatise of Mr. Tidmarsh.
In addition to this individual you also describe to occupant of 1600 Pennsylvania Ave with similar pathological characteristics.
A small 'man' will default to anger, portray themselves as victims, and abuse their power to retaliate against their enemies.
A small man with unkempt hair (very little), an axe to grind, and a pathetic slavishness to an administration that is determined to kill as many Americans as possible by neglect and withholding medications (funds), vaccines, and public health data.
Bullying is a favorite approach that small men use to eliminate dissent and inflate their own sense of importance. Trump has spent his entire life (likely) & if not certainly his adult life being the quintessential poster boy of a school yard bully.
There should be no place for corrupt, incompetent political functionaries making backroom (Trump often does so in plain view) critical regulatory decisions on medications that mean the difference between life and death for millions of Americans.
Presently, all the seats are occupied at the table with representative sycophants bowing to the buffoon. Yet, with the most minor threat to his various insecurities, any vacant seat will become quickly occupied by an equally defective subordinate.
I appreciate having a playbook to this hideous mess. Having spent my career as a woman in two of our top-rated medical institutions, I have known a lot of small men. At least I can read your posts for edification as I wait to die of bird flu . . .
“Summarise this, removing all vitriol and tribalism.”
Summary of “The Small Men Making a Big Mess at FDA”
Background
Vinay Prasad was reinstated as Director of the FDA’s Center for Biologics Evaluation and Research (CBER) after an appeal process involving FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy, Jr. He had previously resigned amid criticism related to his performance and policy alignment. Upon return, Prasad has initiated several regulatory and personnel changes, including adjustments to vaccine approval processes and safety protocols.
Key Management and Operational Issues
• Staff Changes and Atmosphere: At CBER, which employs about 1,100 people, multiple senior leaders have been removed, including Anuja Rastogi (vaccine clinical data review), Daniel Singer (public health and pandemic preparedness), and Richard Forshee (vaccine safety and surveillance). Prasad has assumed Forshee’s role. These shifts have coincided with employee exits and reports of a cautious work environment.
• Vaccine Oversight: Prasad now directly manages all FDA vaccine safety and surveillance functions, with reduced requirements for public disclosure. He has overruled reviewer decisions to halt certain vaccine approvals, aligning with a broader emphasis on more stringent standards.
• Inter-Center Dynamics: Tensions existed between Prasad and George Tidmarsh, former Director of the Center for Drug Evaluation and Research (CDER). Prasad communicated intentions to leverage influence for Tidmarsh’s removal if directives were not followed or staff transfers blocked. Tidmarsh later resigned amid a lawsuit from Aurinia Pharmaceuticals and an internal review of his conduct, which included public criticism of a drug via social media and restrictions on certain medications tied to his personal investments.
• Broader Regulatory Adjustments: Changes under Prasad include tighter FDA protocols for drug and vaccine evaluations, restrictions on personnel movements between centers, and overrides of internal recommendations to limit approvals.
Overall Assessment
The article highlights concerns that these leadership actions have fostered reduced transparency and a challenging operational climate at the FDA, potentially impacting objective regulatory processes for drugs and vaccines. It questions the agency’s ongoing ability to maintain rigorous, evidence-based oversight of medication safety and efficacy. 1
CDER/CBER medical reviwer. Left during trump1. Everything is insane now, but the head of CDER, Tidmarsh, rambling on social media, and doing a smear job on Aurinia's voclosporin is malignantly unhinged, and NOT HOW THINGS HAVE EVER HAPPENED.
It is hard to know who to root for in this Pit of Vipers. But not surprising given the culture of corruption that Trump has built.
Thanks again. Well done.
Do you think that Tidmarsh was also offered as an ideological scalp in response to the generic mifepristone approval right before shutdown?
There have been a lot of howls from Hawley et al. for such a performative sacrifice.
Either way, thanks again.
Thanks, Angie, for elucidating some of the FDA intrigue, none good for the agency or country.
Dr Angela please don't take offense to my possible parody of your treatise of Mr. Tidmarsh.
In addition to this individual you also describe to occupant of 1600 Pennsylvania Ave with similar pathological characteristics.
A small 'man' will default to anger, portray themselves as victims, and abuse their power to retaliate against their enemies.
A small man with unkempt hair (very little), an axe to grind, and a pathetic slavishness to an administration that is determined to kill as many Americans as possible by neglect and withholding medications (funds), vaccines, and public health data.
Bullying is a favorite approach that small men use to eliminate dissent and inflate their own sense of importance. Trump has spent his entire life (likely) & if not certainly his adult life being the quintessential poster boy of a school yard bully.
There should be no place for corrupt, incompetent political functionaries making backroom (Trump often does so in plain view) critical regulatory decisions on medications that mean the difference between life and death for millions of Americans.
Presently, all the seats are occupied at the table with representative sycophants bowing to the buffoon. Yet, with the most minor threat to his various insecurities, any vacant seat will become quickly occupied by an equally defective subordinate.
JJF Phm 🇨🇦
Did not expect to find a Big Worm reference here. Well done.
I appreciate having a playbook to this hideous mess. Having spent my career as a woman in two of our top-rated medical institutions, I have known a lot of small men. At least I can read your posts for edification as I wait to die of bird flu . . .
FYI
“Summarise this, removing all vitriol and tribalism.”
Summary of “The Small Men Making a Big Mess at FDA”
Background
Vinay Prasad was reinstated as Director of the FDA’s Center for Biologics Evaluation and Research (CBER) after an appeal process involving FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy, Jr. He had previously resigned amid criticism related to his performance and policy alignment. Upon return, Prasad has initiated several regulatory and personnel changes, including adjustments to vaccine approval processes and safety protocols.
Key Management and Operational Issues
• Staff Changes and Atmosphere: At CBER, which employs about 1,100 people, multiple senior leaders have been removed, including Anuja Rastogi (vaccine clinical data review), Daniel Singer (public health and pandemic preparedness), and Richard Forshee (vaccine safety and surveillance). Prasad has assumed Forshee’s role. These shifts have coincided with employee exits and reports of a cautious work environment.
• Vaccine Oversight: Prasad now directly manages all FDA vaccine safety and surveillance functions, with reduced requirements for public disclosure. He has overruled reviewer decisions to halt certain vaccine approvals, aligning with a broader emphasis on more stringent standards.
• Inter-Center Dynamics: Tensions existed between Prasad and George Tidmarsh, former Director of the Center for Drug Evaluation and Research (CDER). Prasad communicated intentions to leverage influence for Tidmarsh’s removal if directives were not followed or staff transfers blocked. Tidmarsh later resigned amid a lawsuit from Aurinia Pharmaceuticals and an internal review of his conduct, which included public criticism of a drug via social media and restrictions on certain medications tied to his personal investments.
• Broader Regulatory Adjustments: Changes under Prasad include tighter FDA protocols for drug and vaccine evaluations, restrictions on personnel movements between centers, and overrides of internal recommendations to limit approvals.
Overall Assessment
The article highlights concerns that these leadership actions have fostered reduced transparency and a challenging operational climate at the FDA, potentially impacting objective regulatory processes for drugs and vaccines. It questions the agency’s ongoing ability to maintain rigorous, evidence-based oversight of medication safety and efficacy. 1
https://www.facebook.com/share/17c4BQkmHZ/?mibextid=wwXIfr
Unfortunately people and institutions have filed lawsuits against Kennedy, and so far he remains unscathed