Became a paid subscriber in support of Vinays most appreciated sharp dialogues, teachings and critical appraisal. Awesome trio. Hope he'll join you again
Very sad and shocking news This says it all... :Other changes under Prasad, who was also the agency's chief medical and science officer, included a new policy limiting the approval for COVID-19 vaccines, and his FDA division also rejected therapies from Replimmune (REPL.O), opens new tab and Capricor Therapeutics (CAPR.O), opens new tab:
"Shares of Replimmune nearly doubled in value, while those of Sarepta and Capricor gained 11% and 18%, respectively on Wednesday."
Endpoints and STAT news first reported Prasad's departure.
Dr. Cifu, like the others here who appreciate Dr. Prasad's brutal honesty and character, I am very sad to see him leaving his post. It bodes very badly for the of future of facts in policy-making. However, I have to have you look again at the history he has, and particularly your statement that this is to be expected with the current administration. Are you saying that the Biden administration listened more closely to his advice? I certainly got the impression that he disagreed vigorously with the previous administration, and with the place that politics and pharma had at that point. I question if any independent thinker could find a place in government at this point, whoever is in power. I hope that Marty Makary, MD has better luck.
As much as i admire Dr Prasad, regardless of his good intentions, he became part of a corrupt and rotten administration where no one is safe from becoming a political target. I sense naivete in thinking that he could be part of an oasis of common sense and decency. Being associated with Trump's presidency is a risky undertaking that often backfires.
When I read about the about-face with Sarepta, followed by Dr. Prasad’s short shrift from the FDA, I was really saddened and angered.
The FDA learned a hard lesson in the late 80’s when AIDS activists, frustrated by the slow pace of drug development and approvals, forced the accelerated approval of DDI. Though by no means rare like DMD, HIV/AIDS was devastating and decimating and new drugs were needed ‘yesterday’. However, once approved, DDI’s severe toxicities became apparent, causing (notably) liver toxicity and pancreatitis, and fatality in some cases.
The DDI experience changed how the FDA approached accelerated approval programs, and became a lesson in balancing patient advocacy with scientific rigor.
Dr. Prasad was correct in his initial decision with Sarepta. Shame on this administration. Shame.
I’m so angry! We knew Vinay would do his job and demand that new therapeutics be safe and effective. God forbid he maintain his standards in this very important post. I’m sorry Loony Loomer went after him. A huge loss for science.
I was bewildered when Dr. Prasad accepted the position given the current administration — I thought he would have known better than to waste his incredible talent in the currently toxic political-business regulatory environment. Perhaps the way he left will get the attention of some people who have thus far been dormant about the governance crisis we are living.
It was nice of Vinay to try to change the system. Glad that Marty Makary is at the FDA fighting the fight, but I think he is better at politics. I do not like that the internet says these crazy MAGA podcasters have so much power. I hope that is not so. I am conservative and all my friends are MAGA but everything in moderation. Finally, Vinary was directly fighting the Administrative State and big Pharma and they will not give up its power without a fight.
Thanks for this update and commentary. I didn’t know him well, but he seemed like a very smart, welcome addition to the broader conversation.. Seems like these times call for a new type of institution: a loose network of highly responsive, informed, non-partisan systems advocates, who can rally around high leverage activities quickly to strengthen the system over overtime. Maybe your groio is already a part of this? Could we magnify it 100 times? https://substack.com/@drchadswanson/note/c-139628801?
Dr. Cifu, with kindness, captures what I would describe as Dr. Prasad's Jekyl-and-Hyde quality. It is a distressing paradox.
On the one hand Dr. Prasad has argued with fervor that we should shun hyped claims, and attend scrupulously to evidence and what it shows. It's hard to find fault with that..
On the other, he has been careless and brutal on social media, sometimes admitting he does not need even need to read what he criticizes. He can tell from the title (or the inclusion of a single word) that it must be garbage, sight unseen.
I don't really know why Dr. Prasad was taken down. But to the extent it may have involved him being subject to dishonorable social media attacks, that would mirror Dr Prasad's mistreatment of others, including some dear to me.
As a physician who cares for and researches the care of people who have been homeless, I chafed at how Dr. Prasad baldly mischaracterized a paper on navigation for lung cancer screening in persons with past or current homelessness (he did so repeatedly, again and again).
It was obvious he failed to read the paper with care. He did not even notice who was in the study (mostly, formerly homeless persons, who have high rates of medical disease). It was also plain to see that he lacked scholarly grounding in the health concerns of people who are currently or formerly homeless.
But more distressing to me was that he couldn’t just make his argument.
He somehow felt obligated to slander the character of the investigator as “putting (his) career ahead of doing right by patients”.
This was a homeless health care physician of immense kindness, someone whose clinical and ethical commitments to people who are homeless were in place for over a decade. That person - who never wanted the limelight, and asked me not to respond- was subject to Dr. Prasad’s social media meat grinder for what, actually? For clicks? For followers? For glory?
Could anyone believe that it advances an evidence-based argument to insult the character of someone who works with homeless patients?
That version of Dr. Prasad (“Mr. Hyde”) sits in striking opposition to the courage and intellectual discipline I observed in a book he cowrote with Dr. Cifu: Ending Medical Reversal.
Dr. Prasad should be thankful that he has amazing friends who can see that this is one and the same man, and who embrace him. That he has friends who will show HIM the grace and the kindness we all deserve.
Became a paid subscriber in support of Vinays most appreciated sharp dialogues, teachings and critical appraisal. Awesome trio. Hope he'll join you again
Very sad and shocking news This says it all... :Other changes under Prasad, who was also the agency's chief medical and science officer, included a new policy limiting the approval for COVID-19 vaccines, and his FDA division also rejected therapies from Replimmune (REPL.O), opens new tab and Capricor Therapeutics (CAPR.O), opens new tab:
"Shares of Replimmune nearly doubled in value, while those of Sarepta and Capricor gained 11% and 18%, respectively on Wednesday."
Endpoints and STAT news first reported Prasad's departure.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fdas-top-vaccine-official-vinay-prasad-leaves-agency-after-3-months-2025-07-30/
Dr. Cifu, like the others here who appreciate Dr. Prasad's brutal honesty and character, I am very sad to see him leaving his post. It bodes very badly for the of future of facts in policy-making. However, I have to have you look again at the history he has, and particularly your statement that this is to be expected with the current administration. Are you saying that the Biden administration listened more closely to his advice? I certainly got the impression that he disagreed vigorously with the previous administration, and with the place that politics and pharma had at that point. I question if any independent thinker could find a place in government at this point, whoever is in power. I hope that Marty Makary, MD has better luck.
As much as i admire Dr Prasad, regardless of his good intentions, he became part of a corrupt and rotten administration where no one is safe from becoming a political target. I sense naivete in thinking that he could be part of an oasis of common sense and decency. Being associated with Trump's presidency is a risky undertaking that often backfires.
When I read about the about-face with Sarepta, followed by Dr. Prasad’s short shrift from the FDA, I was really saddened and angered.
The FDA learned a hard lesson in the late 80’s when AIDS activists, frustrated by the slow pace of drug development and approvals, forced the accelerated approval of DDI. Though by no means rare like DMD, HIV/AIDS was devastating and decimating and new drugs were needed ‘yesterday’. However, once approved, DDI’s severe toxicities became apparent, causing (notably) liver toxicity and pancreatitis, and fatality in some cases.
The DDI experience changed how the FDA approached accelerated approval programs, and became a lesson in balancing patient advocacy with scientific rigor.
Dr. Prasad was correct in his initial decision with Sarepta. Shame on this administration. Shame.
I’m so angry! We knew Vinay would do his job and demand that new therapeutics be safe and effective. God forbid he maintain his standards in this very important post. I’m sorry Loony Loomer went after him. A huge loss for science.
I was bewildered when Dr. Prasad accepted the position given the current administration — I thought he would have known better than to waste his incredible talent in the currently toxic political-business regulatory environment. Perhaps the way he left will get the attention of some people who have thus far been dormant about the governance crisis we are living.
Robert Barnes reposted
Kevin Bass PhD MS
@kevinnbass
·
12h
Why Vinay Prasad was fired from FDA
-> Sarepta spends years making drug
-> drug is really awful, no benefit
-> studies are so cooked and terrible FDA regulators are horrified and say studies are so bad
-> regulators overruled
-> drug gets approved
-> $3.2 million/injection
-> patient advocacy groups criticize drug
-> Sarepta threatens them with lawsuit
-> drug explodes livers
-> drug kills someone every other month
-> Sarepta hides third death from investors
-> FDA's Vinay Prasad strikes with ban hammer
-> Sarepta stock falls to all-time low, down 88%
-> Sarepta burning $1B/yr, about to go bankrupt
-> Sarepta to FDA: f*ck you, we are going to keep selling the drug
-> Sarepta panics privately, hires top former Trump strategist
-> strategist goes to Laura Loomer
-> Laura Loomer smears Prasad, who loves Trump and hates Fauci
-> digs up 5-yo Prasad posts saying he hates Trump and loves Fauci
-> Loomer writes pharma lobby talking points about rare diseases using words she doesn't understand
-> Sarepta pretends to comply with FDA while Loomer works
-> top PhRMA lobbyist copies the smears in Real Clear Health, cites Sarepta
-> online pharma-run sock puppet accounts, probably run by strategist, start smearing Prasad
-> WSJ copies the smears, cites Sarepta
-> RFK Jr. praises Prasad privately
-> FDA commissioner Marty Makary praises Prasad publicly, calls him impeccable scientist
-> strategist gives video to Loomer of Prasad making fun of Trump Derangement Syndrome
-> strategist/Loomer edits the video to make it look like Prasad is the one with Trump Derangement Syndrome
-> Rick Santorum spam dials Trump, screams about innovation and children
-> Ron Johnson spam dials Trump, same thing
-> Trump says why do I have to deal with this sh*t my god why is Indian guy in FDA causing so much trouble
-> Trump asks: does he really have a voodoo doll of me that he stabs?
-> Bill Cassidy: wow this guy hates Trump, I saw the edited video from 5 years ago, that proves it
-> Trump, wanting to be left alone, fires Prasad
-> Democrats in FDA post petulant things on FDA office walls celebrating Prasad's firing
-> Republicans: "innovation is saved"
-> Sarepta stock price doubles
-> FDA regulators now terrified of drug companies, will approve anything they want
-> victory for pharma, defeat for America
-> banana Republic sh*t
https://x.com/kevinnbass/status/1951141627076002240
I am so very sad. Dr. Prasad is brilliant, and I was excited to see what he and Marty could do together.
Very, very sad.
It was nice of Vinay to try to change the system. Glad that Marty Makary is at the FDA fighting the fight, but I think he is better at politics. I do not like that the internet says these crazy MAGA podcasters have so much power. I hope that is not so. I am conservative and all my friends are MAGA but everything in moderation. Finally, Vinary was directly fighting the Administrative State and big Pharma and they will not give up its power without a fight.
Well...On a good note, we may start seeing him posting again on sensible medicine!
Thanks for this update and commentary. I didn’t know him well, but he seemed like a very smart, welcome addition to the broader conversation.. Seems like these times call for a new type of institution: a loose network of highly responsive, informed, non-partisan systems advocates, who can rally around high leverage activities quickly to strengthen the system over overtime. Maybe your groio is already a part of this? Could we magnify it 100 times? https://substack.com/@drchadswanson/note/c-139628801?
Dr. Cifu, with kindness, captures what I would describe as Dr. Prasad's Jekyl-and-Hyde quality. It is a distressing paradox.
On the one hand Dr. Prasad has argued with fervor that we should shun hyped claims, and attend scrupulously to evidence and what it shows. It's hard to find fault with that..
On the other, he has been careless and brutal on social media, sometimes admitting he does not need even need to read what he criticizes. He can tell from the title (or the inclusion of a single word) that it must be garbage, sight unseen.
I don't really know why Dr. Prasad was taken down. But to the extent it may have involved him being subject to dishonorable social media attacks, that would mirror Dr Prasad's mistreatment of others, including some dear to me.
As a physician who cares for and researches the care of people who have been homeless, I chafed at how Dr. Prasad baldly mischaracterized a paper on navigation for lung cancer screening in persons with past or current homelessness (he did so repeatedly, again and again).
It was obvious he failed to read the paper with care. He did not even notice who was in the study (mostly, formerly homeless persons, who have high rates of medical disease). It was also plain to see that he lacked scholarly grounding in the health concerns of people who are currently or formerly homeless.
But more distressing to me was that he couldn’t just make his argument.
He somehow felt obligated to slander the character of the investigator as “putting (his) career ahead of doing right by patients”.
This was a homeless health care physician of immense kindness, someone whose clinical and ethical commitments to people who are homeless were in place for over a decade. That person - who never wanted the limelight, and asked me not to respond- was subject to Dr. Prasad’s social media meat grinder for what, actually? For clicks? For followers? For glory?
Could anyone believe that it advances an evidence-based argument to insult the character of someone who works with homeless patients?
That version of Dr. Prasad (“Mr. Hyde”) sits in striking opposition to the courage and intellectual discipline I observed in a book he cowrote with Dr. Cifu: Ending Medical Reversal.
Dr. Prasad should be thankful that he has amazing friends who can see that this is one and the same man, and who embrace him. That he has friends who will show HIM the grace and the kindness we all deserve.
While I am a fan of Dr. Prasad I appreciate criticism in this style. Thank you.
I am furious. I fell for it.
This makes me physically ill.
MAHA is beginning to look like a scam.