Vinay Prasad

Jonathan Howard and Wendy Orent call this week their "Red Wedding": within days, FDA Commissioner Marty Makary resigned, Vinay Prasad was pushed out of CBER, Tracy Beth Hoeg was fired, and Senator Bill Cassidy lost his Louisiana primary. The hosts argue this is not a tragedy but a long-foretold collapse — a group of physicians who built careers as COVID-era contrarian podcasters discovering that running a regulatory agency is fundamentally different from posting about one. Howard works through the wreckage: Makary's reported approval of flavored nicotine products days before his ouster, the FDA's treatment of the rare disease community, the leaked memo claiming pediatric COVID vaccine deaths that career staff refused to sign off on, and the broader pattern of "regulatory whiplash" that drove the agency into dysfunction. The episode then turns to who is still standing — Jay Bhattacharya at NIH, Robert F. Kennedy Jr. at HHS — and what Kennedy is reportedly doing to vaccines from behind the scenes via Martin Kulldorff's review effort. Throughout, the hosts return to a single thesis: the skills that made Makary, Prasad, Hoeg, and Cassidy famous during COVID — opinion, tweeting, posturing — do not translate into running institutions, and the medical commentators who vouched for them (John Mandrola, Adam Cifu) have lost any remaining credibility. Key Topics Discussed Bill Cassidy's primary loss and the cost of the Kennedy confirmation vote Cassidy's earlier vote to convict Trump after January 6 followed by his decisive vote advancing RFK Jr. as HHS Secretary. Howard and Orent's view that Cassidy's promise to "keep Kennedy in line" was hollow from the start. What Cassidy's defeat signals about Trump's grip on the Republican base in Louisiana — and the hosts' read that his lame-duck status may give him cover to block the next round of HHS nominees. Marty Makary's resignation and the "worst FDA Commissioner in 25 years" framing The Stat News piece characterizing Makary's tenure, and the reporting that flavored nicotine was the precipitating issue with Trump's tobacco-industry donors. Howard's counterpoint: Makary reportedly approved a batch of electronic nicotine delivery systems (ENDS) on May 5, 2026 — the weekend before he resigned — undercutting the "principled stand" narrative. The pattern of selfie videos, public-facing performance, and what former FDA staff describe as hostile management of career scientists. Makary's pre-FDA record: the "medical error is the third leading cause of death" claim, Omicron as "nature's vaccine," "Omicold," herd immunity calls in May 2021, and the Nazi-bioweapon Lyme disease theory amplification. Vinay Prasad, regulatory whiplash, and the rare disease community How Prasad's stated preference for randomized controlled trials translated into rejection of rare disease therapies — and the disconnect between calling for RCTs on Twitter and the practical impossibility of running them for small patient populations. Right-to-try advocates, the libertarian wing of MAHA (Senator Ron Johnson), and why they turned on Prasad. Howard's point: Pfizer's halted COVID vaccine RCT in 50–65-year-olds is the case study — the trials Prasad

FDA’s Center for Biologics Evaluation and Research Director Vinay Prasad is set to leave the agency for a second time amid controversy. In a March 6 post on X, FDA Commissioner Marty Makary suggested that Prasad’s presence at FDA was a “sabbatical” from his academic career and that he would be returning to his job at the University of California, San Francisco. “Under Richard Pazdur's leadership, FDA was heading in the direction of behaving rationally in the same way as the mainstream of oncology,” Paul Goldberg, editor and publisher of The Cancer Letter, said. “So, then they take someone who is really an outlier in oncology. He really is like an N-of-1, Vinay Prasad, and basically try to integrate him or make him the chief scientific and chief medical officer over a regulatory agency, and that's like sticking a finger in the eye.” On this week’s episode, Paul and Claire Marie Porter, reporter with The Cancer Letter, talk about Vinay Prasad’s unusual year at FDA, and what led to his second departure from the agency. He’s officially out at the end of the month, following weeks of controversy, specifically criticisms around drug approvals. “Right now drug companies are mad [at Prasad], rare disease patients and advocates are mad, and now Congress people are mad, which is a lot of mad people,” Claire said. “And I think when you've united pharma, Congress, and patients, that's almost impressive.” Drug companies and rare disease advocates are frustrated with Prasad because of seemingly arbitrary rejections of some of those drugs that were among the few options patients had. Representative Jake Aushinschloss (D-MA) has called for Makary’s resignation and accused the agency of crossing legal lines by revealing trade secrets after a very public fight over a gene therapy for Huntington’s disease. At the same time, the agency’s actions seem to be contradictory—rejecting rare drug approvals while simultaneously publicizing a new push to smooth the approval process for sponsors focused on rare diseases. Stories mentioned in this podcast include: Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again) Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology As more people are surviving cancer, we must continue funding bold science The murder of Alexei Navalny is part of Russia’s macabre fascination with poisons HHS postpones third USPSTF meeting in a row FDA approves leucovorin for cerebral folate deficiency A transcript of this podcast is available: https://cancerletter.com/podcastc/20260315-vinay-prasad/

In this episode of Science from the Fringe , host Bryce Nickels speaks with cardiologist and medical commentator Dr. Anish Koka about his recent article examining the forces that led to physician-scientist Vinay Prasad’s departure from the U.S. Food and Drug Administration (FDA). They discuss how Prasad’s efforts to strengthen evidentiary standards for drug approvals quickly ran up against powerful political, financial, and institutional interests. The conversation explores how his brief tenure became a case study in the difficulty of reforming institutions where scientific standards, patient desperation, political pressure, and financial incentives collide. As Anish explains, Vinay Prasad is an unusually independent thinker within academic medicine who built a reputation challenging weak evidentiary standards for drug approvals long before entering government. Once at the FDA, he attempted to raise those standards—particularly for vaccines and costly therapies approved on limited or indirect evidence. Those efforts quickly triggered backlash from pharmaceutical companies, investors, patient advocacy groups, biotech media, and political actors with stakes in the approval pipeline. Anish walks through a detailed timeline of the flashpoints that defined Prasad’s short tenure: disputes over gene therapies for rare diseases, conflicts with companies such as Sarepta, Moderna, and UniQure, and broader debates about how regulators should weigh desperate patient demand against uncertain clinical evidence. He explains how controversial trial designs—such as reliance on historical controls or small datasets—can allow extremely expensive treatments to reach the market without clear proof they improve patient outcomes. In his view, Prasad’s push to tighten evidentiary standards exposed deeper structural problems in the drug-approval system. The conversation also explores the political and media dynamics surrounding Prasad’s tenure, including accusations that he created “chaos” at the agency, personal attacks, and media leaks that intensified pressure on FDA leadership. Bryce and Anish argue that Prasad’s willingness to publicly take responsibility for regulatory decisions—and to challenge entrenched interests—made him an unusually rare figure in Washington. The episode concludes with a broader discussion about incentives in drug regulation: the influence of pharmaceutical profits, the vulnerability of rare-disease communities to exploitation, and whether meaningful reform of the FDA’s approval process is possible from within the current system. Despite Prasad’s departure, Anish argues that his brief tenure exposed important weaknesses at the intersection of science, regulation, industry, and media. ( recorded March 8, 2026 ) Timestamps 00:31 – Introducing Anish Koka and the Vinay Prasad story02:12 – Why Prasad’s FDA appointment was surprising03:20 – Prasad’s background and COVID-era break from consensus04:24 – The core issue: declining evidentiary standards at FDA06:41 – Prasad’s integrity and inevitable clash with the system09:57 – Was Prasad set up?12:08 – Why Peter Marks mattered politically13:19 – Prasad’s new vaccine approval framework14:18 – Sarepta and weak evidence in rare disease drugs17:13 – Media leaks and the role of Stat News 19:33 – Marty Makary backs Prasad20:05 – “Bad politics” or principled regulator?21:58 – The Moderna dispute over vaccine evidence23:51 – Accountability and why Prasad stood out27:49 – Personal attacks and mounting pressure28:09 – The UniQure controversy30:53 – What a sham control is33:55 – The problem with historical controls36:00 – Who decides trial matching?38:00 – Media narratives of “chaos” at FDA40:19 – Political pressure from Congress42:39 – The chain of events leading to Prasad’s exit

Lecture on systematic review, given by Vinay Prasad MD MPH to students in the UCSF Training in Clinical Research Program, November 2024.

"Masking Mistakes: Lessons from the Science, Policy, and Coverage of COVID-19", the 2024 Brian Shields Lecture on Institutional Ethics which took place on Monday, October 7, 2024 for the Emory Center for Ethics. A conversation with Carlos Del Rio, MD and Vinay Prasad, MD MPH with moderation by Gerard Vong, DPhil, Director of the MA in Bioethics program.

Yascha Mounk and Vinay Prasad assess the strengths and weaknesses of America’s public health response. Vinay Prasad MD, MPH is a hematologist-oncologist and Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco. In this week’s episode, Yascha Mounk and Vinay Prasad discuss the impact and efficacy of mask mandates and lockdowns; how the stifling of dissenting views among doctors and scientists harmed decision-making; and how we can improve our readiness for the next pandemic. This transcript has been condensed and lightly edited for clarit y . Please do listen and spread the word about The Good Fight. If you have not yet signed up for our podcast, please do so now by following this link on your phone . Email: podcast@persuasion.community Website: http://www.persuasion.community Podcast production by Jack Shields , and Brendan Ruberry Connect with us! Spotify | Apple | Google Twitter: @Yascha_Mounk & @joinpersuasion Youtube: Yascha Mounk LinkedIn: Persuasion Community Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices

I give Grand Rounds to UCSF Neurosurgery on how to read and interpret Neurosurgery Studies (Video and slides coming soon to YouTube) Also I discuss Bob Califf's Promotion of Paxlovid

“Incompetence,” says Dr. Vinay Prasad, responding to reports of today’s vote by the CDC’s Advisory Committee on Immunization Practices (ACIP) that will decide if COVID-19 vaccines should be added to their childhood vaccine schedule – a list that is often required to attend public school. “It will be a catastrophic error if they add it,” Dr. Prasad continued on Twitter. “They will do more in a single day to erode routine vaccination than 25 years of a devoted, irrational movement.” Dr. Vinay Prasad, MD MPH is a practicing hematologist-oncologist and Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco. He studies cancer drugs, health policy, clinical trials and better decision making. Clinically, Dr. Prasad cares for patients with a wide range of benign hematologic and malignant conditions. Follow Dr. Prasad at https://twitter.com/VPrasadMDMPH Website: https://Vinayakkprasad.com Plenary Session Podcast: https://twitter.com/Plenary_Session 「 SPONSORED BY 」 • BIRCH GOLD - Don’t let your savings lose value. You can own physical gold and silver in a tax-sheltered retirement account, and Birch Gold will help you do it. Claim your free, no obligation info kit from Birch Gold at https://birchgold.com/drew • GENUCEL - Using a proprietary base formulated by a pharmacist, Genucel has created skincare that can dramatically improve the appearance of facial redness and under-eye puffiness. Genucel uses clinical levels of botanical extracts in their cruelty-free, natural, made-in-the-USA line of products. Get 10% off with promo code DREW at https://genucel.com/drew 「 MEDICAL NOTE 」 The CDC states that COVID-19 vaccines are safe, effective, and reduce your risk of severe illness. Hundreds of millions of people have received a COVID-19 vaccine, and serious adverse reactions are uncommon. Dr. Drew is a board-certified physician and Dr. Kelly Victory is a board-certified emergency specialist. Portions of this program will examine countervailing views on important medical issues. You should always consult your personal physician before making any decisions about your health. 「 ABOUT the SHOW 」 Ask Dr. Drew is produced by Kaleb Nation ( https://kalebnation.com ) and Susan Pinsky ( https://twitter.com/firstladyoflov e ). This show is for entertainment and/or informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment. 「 WITH DR. KELLY VICTORY 」 Dr. Kelly Victory MD is a board-certified trauma and emergency specialist with over 30 years of clinical experience. She served as CMO for Whole Health Management, delivering on-site healthcare services for Fortune 500 companies. She holds a BS from Duke University and her MD from the University of North Carolina. Follow her at https://earlycovidcare.org 「 GEAR PROVIDED BY 」 • BLUE MICS - Find your best sound at https://drdrew.com/blue • ELGATO - See how Elgato's lights transformed Dr. Drew's set: https://drdrew.com/sponsors/elgato/ 「 ABOUT DR. DREW 」 For over 30 years, Dr. Drew has answered questions and offered guidance to millions through popular shows like Celebrit

I am joined by Manni Mohyuddin to talk about How I treat frontline transplant eligible myeloma. Vinay Prasad makes the case the entire field of myeloma is corrupt and broken.

Listen in as I give an unscripted lecture to a general audience about COVID-19; What we got right and wrong these last 2+ years.

Kristina Jenei becomes the 4th guest host and flips the tables on me, interviewing me about academic medicine and more...

Today's episode is a lecture our host, Dr. Vinay Prasad of University of California San Francisco, gave recently on censoring patients in Kaplan-Meier plots. Back us on Patreon! www.patreon.com/plenarysession Check out our YouTube channel: www.youtube.com/channel/UCUibd0E2kdF9N9e-EmIbUew