The FDA, Unicure, and the Limits of Accelerated Approval

Gaming the System: LTACHs, Guidelines, and the Evidence Problem in American Medicine

Episode Summary Dr. Anil Makam — hospitalist, health services researcher at UCSF, and faculty at Zuckerberg San Francisco General — joins Drs. Koka and DiGiorgio for a wide-ranging conversation on the hidden mechanics of American healthcare. Makam breaks down long-term acute care hospitals (LTACHs): what they're for, how regional variation and perverse payment incentives have distorted their use, and what the 2016 site-neutral payment reforms actually did to the market. The conversation then shifts to Makam's research on clinical practice guidelines — specifically his 2018 study showing that the majority of ATS recommendations were grounded in low-quality evidence, many carrying strong designations anyway — and what that means for how clinicians should read and apply guidelines at the bedside. The episode closes on the FDA, indication creep, the limits of central planning in quality measurement, and what it actually means to be a good doctor in a system where you can't buy your way to better medicine. Chapter Markers 00:00 Introduction — Dr. Anil Makam, UCSF hospitalist and health services researcher 02:09 What is an LTACH? Origins, optimal use cases, and the vent-weaning niche 08:09 How clinical practice led Makam to study LTACH utilization 10:08 Geographic variation in LTACH use — decomposing what drives it 14:16 Post-acute care economics: DRGs, payment systems, and perverse incentives 19:11 Medicare Advantage denial rates and the two-tier access problem 23:06 Market access vs. total closures: what the 100 LTACH closures actually mean 24:04 Short-stay outlier rules and the "magical recovery" at the payment threshold 26:07 Site-neutral payment reform and its effects on the LTACH market 31:51 Moving to guidelines: evidence vs. recommendations 33:38 The ATS guidelines study — what they found and the Twitter fallout 39:34 How to practice when most of what we do lacks strong evidence 43:38 Why guidelines are getting more confident on less evidence 47:10 The generalist vs. specialist lens on evidence appraisal 53:47 How do you measure what makes a doctor good? 56:41 Three buckets of physician quality: technical, relational, cognitive 01:00:06 Running a trial vs. appraising a trial — two different skills 01:05:16 Indication creep and applying trial evidence to the wrong patients 01:09:24 The FDA, Vinay Prasad, Marty McCary, and why reform failed 01:13:45 Wrap-up and where to find Makam Co-Host Handles @anish_koka and @drdigiorgio Show Handle @drsloungepod Subscribe Links Spotify: https://open.spotify.com/show/44vw8eirsKKnjgNIrdDvrR [https://open.spotify.com/show/44vw8eirsKKnjgNIrdDvrR] Apple Podcasts: https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658 [https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658] YouTube: https://www.youtube.com/@TheDoctorsLoungePod [https://www.youtube.com/@TheDoctorsLoungePod]

The FDA, Unicure, and the Limits of Accelerated Approval

Episode Summary Anish sits down with Adu, a med student and biotech investor, to work through the FDA's contested handling of Unicure's AMT-130 — a gene therapy for Huntington's disease delivered via stereotactic brain injection. They debate whether the underlying data justifies approval, why the agency's mid-course reversal has rattled the investor community, and what the Sarepta precedent should have taught everyone involved. The conversation broadens into a bigger question: given that desperate patient populations will always demand access to anything showing a signal, who is actually best positioned to make the call on whether a drug works — the FDA, the clinician, or the market? Chapter Markers 00:00 FDA approval of AMT-130 and investor reaction 01:16 Unmet need and the case for regulatory flexibility 02:37 Sarepta, Duchenne's, and the cost of approving under pressure 05:09 Accelerated approval done right: the Amylyx example 09:14 Debating the AMT-130 data and the historical control problem 13:53 Why stock price matters for trial funding 17:20 How Prasad could have changed FDA culture differently 19:37 The FDA's role from Kefauver-Harris to today 22:26 Competing Huntington's therapies in the pipeline 25:39 Prasad's tenure: what worked, what didn't 28:27 Media coverage of the FDA and science journalism Co-Host Handles @anish_koka and @drdigiorgio Show Handle @drsloungepod

Salty About Medical Education: Bryan Carmody on What the System Gets Wrong

Episode Summary Pediatric nephrologist, medical educator, and "Sheriff of Sodium" Dr. Bryan Carmody joins Drs. Koka and DiGiorgio to challenge some of the most persistent narratives in American medicine. From the AAMC's physician shortage projections — which Carmody argues serve the interests of medical schools more than patients — to the mechanics of the residency match, application fever, ERAS pricing, and the largely unrealized promise of pass/fail Step 1, Carmody brings his characteristic data-driven skepticism to each topic. The conversation closes on what's arguably the most consequential question: what should residency selection actually be optimizing for, and why are program directors squandering the leverage they have to drive real change in undergraduate medical education? Chapter Markers 00:00 Introduction 02:02 How Carmody became the Sheriff of Sodium 05:03 Why people keep getting medical education wrong 07:46 The physician shortage: skepticism and incentives 09:03 Rebutting the AAMC's 86,000-doctor shortfall projection 11:17 Supply-induced demand and the limits of training more physicians 17:06 Third-party payment, discretionary care, and the real drivers of access problems 20:27 Who benefits from the physician shortage narrative 26:36 GME funding: $45 billion, hospital incentives, and the case for or against it 30:01 The Match explained: history, origins, and why it exists 35:22 ERAS, NRMP, and the financial architecture of residency applications 40:21 Preference signaling: what it is and why it's quietly capping application volume 44:12 Is the Match a monopoly? The congressional report and the anti-competitive argument 51:18 Step 1 pass/fail: the promise, the timing, and why it stalled 55:43 What actually changed — and what didn't — after 2022 58:00 What program directors should be demanding — and aren't 01:08:12 What we're not doing well in resident selection 01:11:59 Using selection systems to elevate the quality of every applicant, win or lose 01:18:45 The neurosurgery combine Co-Host Handles @anish_koka and @drdigiorgio Show Handle @drsloungepod Subscribe Links Spotify: https://open.spotify.com/show/44vw8eirsKKnjgNIrdDvrR [https://open.spotify.com/show/44vw8eirsKKnjgNIrdDvrR] Apple Podcasts: https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658 [https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658] YouTube: https://www.youtube.com/@TheDoctorsLoungePod [https://www.youtube.com/@TheDoctorsLoungePod]

Free Markets, Private Equity, and the Moral Case for Medicine

Episode Summary Jared Rhoads, founder of the Center for Modern Health and senior lecturer in health policy at the Dartmouth Institute, joins Drs. Koka and DiGiorgio for a wide-ranging conversation on the philosophical foundations of healthcare policy. Rhoads — an Objectivist in the tradition of Ayn Rand — argues that physicians have a right to pursue health, not a right to be given it, and walks through what that distinction means for real policy debates: FDA drug approval, prior authorization, the ban on physician-owned hospitals, private equity in medicine, and foreign-trained physician licensure. The episode is a rare attempt to make the moral case for free markets in medicine, not just the efficiency case. Chapter Markers 00:00 Introduction and guest background 01:52 What is the Center for Modern Health? 04:25 Objectivism, Ayn Rand, and rational self-interest 11:19 Healthcare as a private good vs. community good 13:58 Policy mistakes made for edge cases 16:58 You have a right to pursue health — not to be given it 20:14 Does Medicare violate rights? 22:47 Positive vs. negative rights in healthcare 24:47 The FDA, drug approval, and the Prasad/McCary departures 31:08 A two-tier FDA review proposal: private vs. public payers 42:25 Breaking up Big Medicine — the Hawley-Warren bill 49:43 Prior authorization: structural problem or reform target? 55:22 High-deductible plans and why price consciousness hasn't taken hold 57:43 Price transparency laws: do they actually work? 01:02:49 Section 6001 and the de facto ban on physician-owned hospitals 01:06:04 Stark Law, Medicare Advantage, and a possible reform path 01:11:19 Private equity in medicine: where are the actual rights violations? 01:19:02 Free markets and monopolies: the standard objection answered 01:21:12 Foreign-trained physician licensure 01:34:11 Immigration, physician workforce, and the battle of ideas 01:37:40 Center for Modern Health summer fellowship Co-Host Handles @anish_koka and @drdigiorgio Show Handle @drsloungepod Subscribe Links Spotify: https://open.spotify.com/show/44vw8eirsKKnjgNIrdDvrR [https://open.spotify.com/show/44vw8eirsKKnjgNIrdDvrR] Apple Podcasts: https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658 [https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658] YouTube: https://www.youtube.com/@TheDoctorsLoungePod [https://www.youtube.com/@TheDoctorsLoungePod]

George Tolis: TAVR, Broken Training, and What's Really Wrong With Cardiac Surgery.

Episode Summary Dr. George Tolis, section chief of coronary and general cardiac surgery at Brigham and Women's Hospital, joins Drs. Koka and DiGiorgio for a wide-ranging conversation on the state of cardiac surgery. He makes the case that TAVR — while genuinely transformative for the right patient — is being systematically applied too broadly, driven by industry incentive and the erosion of meaningful surgical consent. He discusses his collaboration with John Ioannidis that found no statistically significant mortality benefit for any new cardiac surgery technique introduced over the past 35 years, the paper's rejection by every major surgical journal, and what he paid out of pocket to make it open access. The conversation moves to the collapse of surgical training — fragmented pathways, work hour restrictions that leave residents unprepared for attending life, an academic promotion system that ignores teaching, and a culture that routes incompetent trainees around rather than out — and closes with a brief on Vasily Kolesov, the Soviet surgeon from Leningrad who performed the world's first documented coronary bypass years before Favaloro, and whose work was buried by the Cold War. Chapter Markers 00:00 Introduction 01:02 Air-cooled VWs, concert piano, and how Dr. Tolis got here 02:40 TAVR: genuine breakthrough or being abused? 08:02 Finding the TAVR threshold — and why informed consent is the real problem 11:46 Collaborating with John Ioannidis: no mortality benefit for 35 years of new techniques 20:02 Why the major surgical journals wouldn't touch the paper 21:52 Minimally invasive surgery: minimal access vs. minimally invasive 26:24 When do CABG survival curves diverge — and what does it mean? 30:05 Surgeons signing off on TAVRs in young patients 33:51 Health system economics and the heart team dynamic 37:50 How to actually pick a good surgeon (ask the scrub nurses) 40:36 Cardiac surgery training: the three pathways problem 44:04 Work hour restrictions and the residency simulation gap 51:16 General surgery is like MTV — they don't operate anymore 53:21 A resident who finished training without ever applying a cross-clamp 56:34 How to evaluate if a program actually trains 59:27 Academic promotion has nothing to do with teaching 01:01:33 Dr. Tolis's resident outcomes database and three papers nobody cared about 01:05:32 The training timeline: finishing at 49, no runway left 01:07:08 One-size-fits-all RRC rules for cardiac surgery and psychiatry 01:09:16 Cardiac surgery as a disposition, not a therapy 01:12:24 When ECMO becomes the final common path 01:13:38 How you become nationally recognized without being a good surgeon 01:17:16 Vasily Kolesov: the Soviet surgeon who did the first bypass Co-Host Handles @anish_koka and @drdigiorgio Show Handle @drsloungepod Subscribe Links Spotify: https://open.spotify.com/show/44vw8eirsKKnjgNIrdDvrR [https://open.spotify.com/show/44vw8eirsKKnjgNIrdDvrR] Apple Podcasts: https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658 [https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658] YouTube: https://www.youtube.com/@TheDoctorsLoungePod [https://www.youtube.com/@TheDoctorsLoungePod]