The Atom Bomb Speaks: Tracy Høeg on COVID, Myocarditis, and the FDA From the Inside

The Atom Bomb Speaks: Tracy Høeg on COVID, Myocarditis, and the FDA From the Inside

EPISODE SUMMARY Dr. Tracy Høeg — physician, epidemiologist, and former Acting Director of the FDA's Center for Drug Evaluation and Research — joins Drs. Koka and DiGiorgio for her first interview since being fired from the agency in May 2025. She traces her unusual path from ophthalmology dropout to professional ultramarathoner to one of the most consequential and contested researchers of the COVID era, walking through her school transmission studies, the myocarditis preprint that detonated on social media, and what she actually found when she got inside the FDA: career scientists who were sharp, collegial, and largely aligned with her — not the entrenched bureaucratic resistance she expected. She also gives the most detailed account yet of how her firing went down, why she refused to resign, and what she thinks it signals about pharmaceutical industry influence over the agency. CHAPTER MARKERS 00:00 Introduction and Tracy's bio 02:19 Origin story: French major, med school, ophthalmology dropout 07:42 Seven years in Denmark: PhD, clinical work, ultra marathon racing 10:55 Back to the US: PM&R, interventional spine, and the start of COVID research 13:43 Funding research outside the NIH pipeline 17:18 How government funding crowds out independent science 20:59 Evidence-based medicine, spine, and the N-of-one problem 25:35 The Wisconsin school transmission study 28:32 If masks were a drug, would they pass FDA approval? 30:04 Testifying before Congress three times 32:46 The myocarditis preprint: origins, backlash, and vindication 38:34 Post-vaccine myocarditis: what the data actually showed 43:01 Regulatory failure, COVID vaccine risk-benefit, and the pediatric question 45:09 How Europe and Scandinavia got it right earlier 47:58 Cancel culture in academia and the chilling effect on scientific questions 51:18 Joining the FDA: how it happened and what she expected 53:50 What the FDA looks like from the inside vs. the outside 56:38 Where real philosophical disagreements lived within the agency 58:58 Reducing animal testing and CNPV pilot: what actually got done 1:01:45 Leaks to the media: where they came from and what they meant 1:05:17 What the FDA's role should be 1:06:23 Pharmaceutical industry influence and the Wall Street Journal editorial board 1:14:48 The firing: why she refused to resign 1:18:53 The chain of command and who is responsible 1:21:08 What the firing signals about FDA reform 1:27:42 Advice for anyone thinking about taking a leadership role in government Co-Host Handles @anish_koka and @drdigiorgio Show Handle @drsloungepod Resource link: Anish's substack: https://open.substack.com/pub/anishkokamd/p/they-were-fixing-the-fda-then-they?r=6chj5&utm_campaign=post-expanded-share&utm_medium=web [https://open.substack.com/pub/anishkokamd/p/they-were-fixing-the-fda-then-they?r=6chj5&utm_campaign=post-expanded-share&utm_medium=web] 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 ER Doc Who Quit the System - and Built His Own

Episode Summary Dr. Noah Kaufman - board-certified emergency physician with 20 years in the ER, seven seasons on American Ninja Warrior, and a new direct acute care practice in Denver - joins Drs. Koka and DiGiorgio to talk about why he walked away from the employed medicine model and built Cough Care, a cash-pay, fully transparent urgent care. The conversation covers the broken economics of emergency billing, why most urgent care is a race to the bottom, how price signals change both patient and physician behavior, and what a parallel direct care system could look like at scale -including the franchise model Kaufman is already planning. Chapter Markers 00:00 Introduction — Meet Dr. Noah Kaufman 02:12 What led to leaving the ER after 20 years 04:53 Becoming the patient — the moment everything clicked 09:33 What is Cough Care and where it sits between urgent care and the ER 13:54 Why he doesn't take insurance 16:30 How ER billing actually works — the 2.6 cm laceration rule 19:49 Can urgent care be shopped? The free market argument 21:17 One month in — what he's actually seeing 41:00 Does cost-consciousness lead to undertreating? 43:39 The culture of over-treatment and the evidence behind it 45:48 Longevity, peptides, and the gray market 54:25 Patient autonomy vs. clinical responsibility 1:01:36 What happens if every burned-out ER doc does this? 1:07:33 The franchise vision — scaling direct acute care nationwide 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 Cholesterol Debate: What the Keto Influencers Get Right (and Wrong)

Episode Summary Dr. Greg Katz, preventive cardiologist at NYU Langone and co-host of Beyond Journal Club, joins Anish to dissect the online cholesterol debate — specifically the claims made by science communicator Nick Norwitz, who has maintained an LDL over 500 mg/dL on a low-carb diet for seven years with no coronary plaque on CTA. Katz takes the data point seriously, walks through the limitations of coronary CTA and the flawed Keto CTA study, and explains why he still believes the burden of proof lies with those arguing diet-induced hypercholesterolemia is safe — while acknowledging where the cardiology establishment, including the new lipid guidelines, overcorrects. The conversation covers the accountability gap between clinicians and content creators, the failure of risk calculators in young patients, and what a well-designed trial to actually answer this question would look like. Chapter Markers 00:00 Introduction — Dr. Greg Katz, NYU Langone cardiologist and Beyond Journal Club co-host 01:40 What prompted the Substack: patients bringing in Nick Norwitz's content 02:51 Who is Nick Norwitz — LDL of 500, low-carb diet, and the clean CTA 05:38 Why Katz takes the question seriously but disagrees with the framing 08:01 Familial hypercholesterolemia outliers: why some FH patients never have events 10:05 The 50/50 problem — half of high-cholesterol patients have heart disease, half don't 12:27 The Jody Plute story: homozygous FH, Thomas Starzl, and the portacaval shunt experiments 17:37 Seven years of LDL 500 — is that long enough to know anything? 18:21 Limitations of coronary CTA: what it can and can't see 21:00 Why LDL gets put on a pedestal — and the cognitive dissonance of a diet that works 22:05 The conflict of interest argument — and why it cuts both ways 25:43 Burden of proof: mechanisms vs. outcomes data 27:16 Statins and GLP-1 levels — why a mechanistic claim isn't the same as a clinical outcome 31:38 Physician accountability vs. content creator accountability 35:24 The Keto CTA study: what it found, what it didn't, and why the blinding controversy matters 44:40 The new lipid guidelines: where they overcomplicate, where they overprescribe 49:38 GLP-1 deficiency framing and the over-medicalization of well people 55:54 Longevity medicine as "over-medicalization of well people" 57:35 What a well-designed trial would actually look like 1:00:01 Why the debate needs real research, not conjecture 1:02:37 How Katz talks to statin-hesitant patients in clinic 1:07:06 Wrap 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]

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