Live with @kevinnbass on @DRsLoungePod
https://x.com/i/broadcasts/1yKAPMaNjbyxb
Jim Carrey joins Roxbury Guys in their most iconic sketch for Season 21 of SNL (1996)
Very nice job by @Bryce_Nickels on editing.
Visually steps through the timeline of Prasad’s time at the FDA
What you see here is called "lying"
It's what happens when someone's anti-competitive protections are under attack
CON laws are insane. Basically:
If you want to open a new medical practice somewhere, you have to get your potential competitors to sign off, saying you're needed
In my latest @SciFrTheFringe podcast, I spoke with @anish_koka about Vinay Prasad's tenure at the FDA and why I am thinking about starting a Vinay Prasad fan club.
(PS - though it would be great if @AndrewNixonHHS let Vinay out of the White Oak basement to do a podcast with me before he departs, I must admit it's probably strategically unwise for him to do so.)
This day in 1993, 12 bombs supplied by Dawood Ibrahim exploded in Mumbai killing 257 and injuring 1408. Dawood escaped but his accomplice Yakub Memon was caught and sentenced to death for aiding & abetting the terror attack.
These were the scenes from his funeral held in Mumbai.
Absolutely unreal moment. Colin Dorgan of Blackstone Valley, whose family members were killed in shooting at Lynch Arena, is OT hero
Suspect Ron Johnson doesn’t really know what he’s talking about on this topic. . .
Oregon: “A state with a total Medicaid enrollment of just over 700,000 children prescribed psychiatric drugs to 37.7% of them. More than one in three children on Oregon Medicaid received a psychiatric drug in a single year. “
This should be the biggest scandal in decades. Foreigners running fake businesses that bill the US government have stolen hundreds of billions of dollars and shipped it abroad.
It’s become obvious, fund the patients not the programs so people who need assistance actually receive it
You can dump as much money as you want in to a fraud riddled program like Medicaid, and you'll just get more Learing Centers.
We spend about $10k a year on non-disabled adults in Medicaid. The problem isn't a lack of funding. It's that the money doesn't reach the patients.
The Marxist marches in a free society to turn it into this 👇🏽
A 69 year old woman hurt herself playing pickle ball. When she sought physical therapy, Medicare denied her coverage saying she was already in hospice care dying.
It was fraud. She didn’t get the health care she needed, the money was stolen instead, and taxpayers like her are on the hook.
It’s insane and outrageous. But California’s only solution is to raise taxes, so there is more money continuing to leak out to fraud.
When I say most journalism would probably be improved if AI did it instead I’m being totally serious.
Incredible investigation today from @CBSNews. Our reporters visited "ground zero" for hospice fraud: Los Angeles, California. One building had 89 registered hospices . . .
Read it here:
https://www.cbsnews.com/projects/2026/hospice-fraud/
And this is just such a stupid line of attack anyway.
Do coders care what portion of code was AI generated?
If you watch a move where either some of the script or the video is AI generated ?
Respond to the substance that’s produced. Spending time trying to sort out if it’s AI created is not a very smart rebuttal.
Well its not.
And I cut and pasted the same text into another AI detector --> 0%. None of this crap is validated well. Which is why I wrote 4k words on why AI coronary plaque validation, and AI CT FFR is probably gibberish as well.
Peter has a reputation as a very smart, deep guy, and I have repeatedly attempted to engage with him on substance. He chooses not to. Sad.
I will say that after following the FDA journalist coverage closely over the last few months, I know quite a few reporters that would have the quality of their writing vastly improved if they replaced what they wrote with "AI slop".
Indeed. Holden Thorp’s compensation approaches seven figures, and he is not even the highest-paid employee at AAAS. Much of the organization’s eight-figure revenue ultimately comes from taxpayer-funded subscriptions funneled through universities.
Yet this non-profit regularly participates in political narratives and attack pieces targeting scientists who challenge prevailing views.
I actually think @ashishkjha did excellent work in this series identifying how policy choices created the consolidation and pricing power we see in healthcare today.
But the conclusion is strange.
He correctly identifies that regulation distorted markets and eliminated price signals.
Then proposes… more price fixing.
Medicare prices are not some objective benchmark grounded in economic reality. They are administratively set prices created through a political process.
Using one price fixing system to fix the distortions caused by another is how you get deeper distortions.
The real solution is restoring price signals where markets can function, combined with a generous safety net for those who cannot participate in them.
More administrative pricing will simply produce more lobbying, more consolidation, and more crony capitalism.
First step for Yale healthcare affordability lab is to give back the $250 million Yale got from CMS for making quality metrics.
And then to kill the quality metric program it’s been pushing that drives up the cost of care for everyone.
The average hospital has 7 FTE devoted just to quality metrics and the average independent clinic has 1/2FTE per doctor.
That’s all to meet your arbitrary metrics. Eliminate it all.
To twits like this person, stability means the FDA gives the pharma bros whatever they want. . .
🧵 that’s a deeper dive Into the substance of Cardiologist Dr. Wang’s paper on affirmative action published in 2019 that lead to him being sanctioned and demoted.
The colleague who publicly accused him of racism has since been given a prominent role in the American College of Cardiology.
SCOTUS agreed with Dr. Wang, and ruled affirmative action as practiced by universities to be illegal.
The meticulously prepared paper with oodles of citations was retracted in ~2 days with no process for the author to respond on the basis of quotes that didn’t have a following sentence. Outright fraudulent made up papers take months to investigate and retract.
2 days to retract.
I’ve attached the link to the retraction notice at the end of the thread for those who read papers to see how completely absurd the rationale given was.
Emilia didn’t read the Substack that’s linked that describes the flimsy context for retraction, and the embarrassingly bad rebuttal.
And of course it needed to be retracted.
“The Party told you to reject the evidence of your eyes and ears. It was their final, most essential command”
Next up instead of addressing any substantive issues, someone will start counting em Dashes. Do I have that right?
https://x.com/anish_koka/status/2030851670062637330?s=46
I don’t know why every doctor doesn’t listen to this podcast, it covers all sorts of topics from healthcare economics to actual medicine, practice issues, viral tweets; easy enough to just add to your podcast list
Cool, cool. Nail bombs being tossed in Carl Schultz Park where my wife and I take our kids all the time to play. I’m a decent person so of course I won’t let this affect my good beliefs. Where can I go to vote for more of this?
Great non technical essay on the roots of Vinay’s exit : patients with terrible diseases desperate for hope.
Even better : Maps a way forward from this debacle that doesn’t involve burning everything down.
AP wrote a bizarre story that claimed FDA's Beth Hoeg was a "friend" of physician Adam Urato which is a "conflict of interest. HHS has no legal definition of "friend" and COI forms don't ask you to list friends.
AP also ignores peer reviewed research
Academic medicine circa 2020-2024:
Dr. Anish Koka and Dr. Anthony DiGiorgio open with the little-known medical story behind the death of the Shah of Iran — how Mohammed Reza Pahlavi came to be operated on in Cairo in 1980 by legendary cardiovascular surgeon Michael DeBakey, and how the "comforting explanation" bias may have contributed to his death from a post-operative abscess rather than his underlying cancer. The case, drawn from a piece by Dr. Li Zhao (NYU Langone), launches a broader conversation about anchoring bias in medicine and the cognitive traps all clinicians face. From there, the hosts turn to the quality metric industrial complex — MIPS, the new low back pain ambulatory model threatening a 12% Medicare penalty for spine surgeons, the hospital readmission program's documented mortality spike, and how 2,266 CMS metrics are costing billions while failing patients. They close with a NEJM perspectives piece from Harvard Business School's Leemore Daphne on health insurance consolidation and her surprisingly free-market prescriptions for reform.
Chapters
00:00 Introduction
02:00 The Shah of Iran — Political Background
03:45 The Shah's Leukemia and Michael DeBakey's 1980 Surgery
06:30 A Spleen the Size of a Football
08:00 The Decision Not to Drain — And Its Consequences
10:00 The Comforting Explanation Bias
12:30 Subspecialization Matters — The Most Famous Surgeon Isn't Always the Right One
14:45 Anchoring Bias in Clinical Medicine
17:00 Modern Imaging and Residents as Checks on Bias
18:30 Surgeons, Complications, and the M&M Conference
21:00 Segue: Judging Doctors by Stats
22:30 The Origins of Quality Metrics — Donabedian 1966
24:00 MIPS and How It Actually Works
26:00 The New Back Pain Ambulatory Specialty Model — A 12% Penalty
28:00 Evidence That Metrics Harm Patients: Hospital Readmission Reduction Program
30:30 Obstetrics and the C-Section Penalty
31:30 Press Ganey and the Cafeteria Problem
33:00 Risk Adjustment Gaming — 40% Margin Increase from Coder Rounding
38:00 2,266 Metrics and 108,000 Person-Hours at Johns Hopkins
40:00 Why Doctors Leave Medicare
42:00 What Good Metrics Could Look Like — Dr. DiGiorgio's JAMA Proposal
44:00 Health Insurance Consolidation — NEJM Perspectives
50:30 FDA, Vinay Prasad, and the WSJ Retraction
55:00 Next Week: Kevin Bass
Subscribe to The Doctor's Lounge: Apple Podcasts | Spotify | YouTube Follow the Show: X: @DrsLoungePod Co-hosts: @anish_koka | @drdigiorgio
An excerpt : When you can't rebut the facts, pharma bros count em dashes.
Sarepta and Duchenne Muscular Dystrophy
To understand what Prasad walked into at CBER, you have to understand what his predecessor Peter Marks had already done there — and what Marks’s predecessor Janet Woodcock had done before him. The Sarepta story is not one bad decision. It is a decade-long institutional pattern of FDA leadership overruling its own scientific staff to approve drugs that didn’t work, under pressure from patient advocates that the companies themselves helped organize and fund.
It starts with Exondys 51 (eteplirsen), approved September 19, 2016. Sarepta applied for accelerated approval based on the claim that the drug increased dystrophin expression in boys with a specific Duchenne variant. The FDA scientific advisory committee reviewed the data and found it inadequate — voting 7-3 against full approval and 7-6 against even accelerated approval. Reviewers cited poor quality biopsy data, no adequate controls, no evidence of clinical benefit, and a dystrophin expression assay that was later independently debunked by the FDA’s own analysts. Committee members also noted on the record the “intense and near-incessant pressure from a large public audience” packed with patient advocates, all of whom testified in favor of approval. Janet Woodcock, then Center director, approved the drug anyway. FDA reviewers responded by filing a formal complaint — a virtually unprecedented act — noting this could be “the first time a Center Director has overruled a review team on a question of whether effectiveness has been demonstrated.” FDA Commissioner Robert Califf issued a 126-page report acknowledging the problems but declined to overrule Woodcock, instead mandating a confirmatory dose-finding study using the North Star Ambulatory Assessment as primary endpoint, which he said would settle the question of whether the drug worked.
That study, the MIS51ON trial, was started in 2020 and as of this writing remains active with no results reported — a decade after the drug was approved. But here is the detail that makes the entire exercise even more farcical: MIS51ON has no placebo arm. It compares higher doses of eteplirsen against the already-approved 30mg/kg dose. It cannot, by design, answer whether eteplirsen beats placebo. It cannot confirm clinical benefit. When it eventually concludes, the foundational question Califf said would be settled — does this drug actually work? — will remain exactly as unanswered as the day Woodcock approved it. Exondys and three successor drugs remain on the market, all approved substantially on the basis of dystrophin protein expression levels. Whether any of them meaningfully alter the natural history of Duchenne muscular dystrophy remains, in the precise scientific sense of the word, unknown.
This is the context in which Catherine Collins stood up at a 2024 patient conference and confronted a Sarepta representative directly: five drugs on the market under accelerated approval, confirmatory trials years overdue, a $3.2 million-per-injection gene therapy being promoted on the basis of a failed primary endpoint trial. “You don’t think you can do a little more effort, and give us a little bit more information?” she told them. “You’re just... taking money.” The video is worth watching. As I've documented in detail prior Elevidys was rinse and repeat.
The Phase 3 EMBARK trial — the definitive test of whether the gene therapy actually improved motor function — failed its primary endpoint. North Star Ambulatory Assessment scores showed no significant improvement over placebo. FDA staff again recommended against approval. Peter Marks, who had taken over CBER from Woodcock, overruled them, granting accelerated approval in June 2023 based on micro-dystrophin expression as a surrogate. He then expanded the approval in June 2024 to include all patients four and older, ambulatory or not — including older, non-ambulatory teenagers who had been explicitly excluded from the original trial that formed the basis for that approval.
Then boys started dying.
The toxicity should not have come as a surprise. The AAVrh74 adenoviral vector used to deliver the therapy was known to be highly immunogenic, triggering immune responses that caused severe liver injury requiring heavy steroids and immunosuppressive agents. Two of the teens who died were older, non-ambulatory patients — precisely the group Marks had added to the label on the thinnest of evidence, and precisely the group excluded from the trial. A third death, a 51-year-old man in a separate Sarepta trial using the same vector, was reported to the FDA on July 3, 2025. CEO Doug Ingram had known about it before the company’s June 16 earnings call. He made no mention of it. When later asked why, Ingram explained the death was “neither material nor central to the topics at hand.”
Prasad, now running CBER, responded on July 18 by requesting that Sarepta voluntarily halt Elevidys shipments and pause trials. Sarepta refused — publicly, in a letter stating it saw “no new safety signal in the approved population” and attributing the deaths to “unique patient conditions.” They eventually capitulated on July 21. But behind the scenes, the machine was already in motion.
Laura Loomer — the MAGA influencer who had previously claimed the scalps of several Trump administration officials for insufficient political loyalty — published a hit piece painting Prasad as a “progressive leftist” sabotaging the “Make America Healthy Again” agenda. She cited his past public admiration for progressive politicians and accused him of obstructing Right to Try. The piece arrived with suspiciously precise timing and suspiciously detailed FDA process knowledge for someone with no obvious reason to be tracking CBER’s drug review calendar. The fingerprints of biotech interests protecting a $3.2 million-per-injection franchise were not difficult to find.
The irony was almost too rich: the same MAGA ecosystem that had spent years insisting mRNA COVID vaccines were dangerous gene-modifying experiments was now furious that a regulator was asking hard questions about an actual gene therapy linked to multiple deaths in young boys.
Wang's case shows how politicized medicine has become. We need environments where data comes before ideology, ensuring scientific inquiry doesn't cost you your career.
lol.
Remember, its all about the patients.
I do love it when academics who literally will try to end your career for disagreeing with them give lectures about civility and divisiveness on here.
R to @anish_koka: anishkokamd.substack.com/p/a…
In 2019, cardiologist Norman Wang published a peer reviewed paper on affirmative action in medicine. He argued that the institution of medicine was violating civil rights law by discriminating against Asians/Whites/Males.
Wang was a well liked/respected highly published EP fellowship director at the time. Dr. Katie Berlacher, a good friend of Dr. Gulati, and fellowship director of the same cardiology program took to twitter to call him a racist. In the next few days he was demoted from being fellowship director, banned from future contact with trainees, and his paper retracted.
I wonder if Dr. Gulati finds what happened to Dr. Wang.. divisive ?
Link to full story in reply.