Inside the FDA: Vinay Prasad’s First Podcast Since Leaving Trump Admin on Drug Approvals & COVID
What this video covers
Prasad’s first long podcast interview since leaving the FDA’s biologics center, on Get the Check, a tech-and-business podcast. It ranges over his path into medicine and his own Plenary Session podcast, a COVID retrospective on school closures, masks, and vaccines, his insider account of FDA decision-making and his transparency fight over rejection letters, oncology’s evidence standards, Kalshi’s clinical-trial prediction markets, and his political evolution toward populism.
Key points
- Prasad says he was a critic of COVID school closures from the start: he argues each year of early schooling is linked to longer, healthier life, that data from German regions that kept schools open showed no difference in community transmission, and that policymakers never quantified the trade-off — citing an estimate of roughly one extra infection per 10,000 people for each extra week schools stayed open.
- On masks, Prasad dissects the Bangladesh cluster-randomized trial published in Science: he credits it with finding a small, statistically significant benefit for surgical masks (about three-quarters of a percentage point) and none for cloth masks, but argues the study was compromised because mask villages enrolled about 110,000 participants to the control villages’ 100,000 — he says people signed up after seeing trucks full of free masks, breaking the randomization’s concealment.
- Prasad says two things about COVID vaccines are true at once: the vaccines reduced severe illness and death, and later variants were intrinsically less deadly. He calls vaccines and youth gender medicine medicine’s two taboo topics; on gender medicine, he says adults should be free to choose, but for adolescents he wants controlled studies proving the claimed suicide-risk benefit — evidence he says proponents have not produced.
- Prasad traces oncology’s standard “response” threshold — 30% tumor shrinkage — to a 1976 Mayo Clinic dinner experiment in which doctors palpated marbles under foam rubber and could only reliably detect a 30% difference by hand; he says the field still uses the cutoff in the scanner era, and that AI could recalibrate response thresholds cancer by cancer, but nobody has done it.
- Prasad recounts that he and FDA Commissioner Marty Makary began publishing the agency’s complete response letters — its drug rejection letters, roughly 300 of them — even though, he says, agency lawyers warned Makary he could be sued personally; he argues manufacturing know-how is a legitimate trade secret, but efficacy and safety data should be public, and says industry lobbyists are fighting the disclosures while investors welcome them.
- On political pressure, Prasad says that across 25 years, Republican and Democratic lobbyists alike have pressed the FDA on behalf of pharma and biotech to lower evidence bars, especially for rare diseases; he describes senators summoning him over pending approvals and says flatly that “the FDA is not independent” — and questions whether an unelected body should hold such decisions rather than officials who are ultimately politically accountable.
- Prasad, who has written about Kalshi (a sponsor of the podcast), endorses its prediction markets on clinical-trial outcomes and says the pushback has come from industry and from what he calls “so-called” patient objections; he says prediction markets are simply a good idea.
- Describing himself as a populist, Prasad says school closures are what moved his politics: he says that in 2016 he would most likely have been on a Democratic administration’s list, but that since Obamacare the Democratic Party has grown close to big pharma and big insurers. He says a universal healthcare system would have to let the public decide what gets funded rather than write blank checks, and criticizes $3-million-a-dose rare-disease therapies that, he argues, don’t work. He also cautions against mRNA cancer-vaccine hype, distinguishing preventive infectious-disease vaccines from therapeutic cancer vaccines, which he notes have failed repeatedly for decades.