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The FDA is bleeding out Covid contrarians. Marty Makary, Vinay Prasad, Tracy Beth Høeg—all gone. Jonathan Howard returns to discuss why so many RFK Jr's friends have reached the end of their bureaucratic road. Show Notes FDA Swaps Top Drug and Vaccine Regulators in Staff Overhaul F.D.A. Commissioner Marty Makary Resigns After Weeks of Pressure No One Should Care About or Trust Anything Dr. Marty Makary Says Ever Again My Sincere Message to Dr. Jay Bhattacharya: Welcome Aboard and Good Luck. We Are Rooting for Your Success. Learn more about your ad choices. Visit megaphone.fm/adchoices
This week on We Want Them Infected, Jonathan Howard and Wendy Orent take a step back from the headlines to examine the academics, journalists, physicians, and commentators who helped legitimize and elevate the MAHA movement. They revisit articles, endorsements, and public statements that portrayed figures like Jay Bhattacharya, Marty Makary, and Vinay Prasad as reformers poised to restore trust in science and public health. With the benefit of hindsight, they explore how those predictions have aged, what has happened inside major health agencies, and why accountability matters when influential voices help shape public opinion.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the dynamic landscape of the pharmaceutical and biotech sectors, a domain experiencing profound changes marked by leadership transitions, regulatory challenges, and groundbreaking scientific advancements. Recent developments within the FDA highlight significant shifts as the agency finds itself at a critical juncture following the departure of Commissioner Marty Makary. This leadership vacuum presents an unprecedented challenge for the FDA, with analysts predicting a prolonged period of uncertainty. Such transitions hold considerable implications for the regulatory framework, potentially influencing drug approval processes and the strategic direction of the agency at large. Amidst this backdrop, industry insiders have proposed Richard Pazdur, a former cancer regulator renowned for his impactful tenure, as a potential successor. His appointment could introduce stability and renewed focus on regulatory frameworks that encourage innovation while upholding stringent safety standards. The recent spate of exits at the FDA, including Vinay Prasad's departure, underscores an urgent need for steady leadership capable of navigating the intricacies of modern drug regulation effectively. In response to these leadership changes, the stock market has shown some volatility, with shares of companies such as uniQure and Replimune experiencing a surge following Makary's exit. However, analysts caution against premature optimism, emphasizing that substantial regulatory relief is unlikely without broader systemic changes. The industry must advocate for policies that sustainably support innovation in light of these shifts. Turning to scientific developments, Lilly's next-generation obesity drug has emerged as a beacon of hope for metabolic disorder treatments. This triple agonist has demonstrated impressive weight loss results in clinical trials, comparable to those achieved through bariatric surgery. Such breakthroughs underscore the critical importance of investing in novel therapeutics that address significant health challenges with high unmet needs. Meanwhile, Amgen's rare disease drug Tavneos is witnessing regulatory progression in Japan after overcoming initial safety concerns. The decision to allow new patient access following a reversal reflects evolving attitudes toward risk-benefit analysis in rare disease treatments. This trend aligns with broader movements in personalized medicine where targeted therapies are gaining precedence despite complex regulatory landscapes. However, beneath these advancements lie economic pressures starkly illustrated by CEO compensation ratios in relation to median employee wages. These disparities raise pertinent questions about resource allocation and investment priorities within pharmaceutical organizations. Such financial dynamics could significantly influence both the pace and direction of future innovations. In oncology, efforts to tackle challenging indications continue with emerging treatments like Revolution's pancreatic cancer drug making headlines. Companies such as Immuneering and Actuate are at the forefront of striving to surpass existing breakthroughs, underscoring competitive innovation as a defining trait of today's biotech landscape. As we reflect on these transformative times within the pharmaceutical and biotech industries, it becomes evident that they are navigating a complex interplay between regulatory upheavals and scientific milestones. The potential appointment of leaders like Richard Pazdur at the FDA may well shape future regulatory directions. Simultaneously, pioneering drugs such as Lilly's obesity treatment exemplify therapeutic advancements poised to redefine patient care paradigms. Nevertheless, financial pressures coupled with market dynamics continue to present formidable obstacles requiring strategic foresight and collaboration among stakeholders to maintain innovation momentum. As these sectors evolve, striking a delicate balance between rigorous regulation and scientific progress will be paramount for advancing public health goals effectively. Thank you for tuning into Pharma Daily. Stay informed and stay ahead with us as we continue to explore these pivotal developments in the world of pharmaceuticals and biotechnology.Support the show
Dr. Marty Makary out as FDA Commissioner—was he the victim of a BigPharma purge? Are “liquid biopsies” useful for predicting recurrences, as well as guiding therapy, for cancer? Nighttime smartphone by adolescents surges, eroding kids' sleep needs; Persistent itch may require an “all of the above” approach to break its vicious cycle—could topical vitamin B12 provide an answer? Study critiques research methods that fast-tracked new Alzheimer's drugs.
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 demanded couldn't actually be enrolled. Tracy Beth Hoeg, the leaked pediatric deaths memo, and the Maryanne Demasi interview Hoeg's insistence she was fired, not resigned, and her interview with Brownstone Institute–adjacent journalist Maryanne Demasi. Her claim that the chaos at the FDA was "created by the media" rather than real. The memo alleging 10 pediatric deaths from the COVID vaccine that career FDA staff would not sign off on — and Howard's contrast with the J&J/thrombosis response, where nine deaths produced immediate, transparent action. Hoeg's role in the Denmark-style vaccine schedule rollback memo alongside Makary. The Makary–Prasad ZDoggMD clip on FDA "vindictiveness" — and the irony Audio pulled from a pre-appointment Prasad/Makary appearance describing the FDA as "erratic," "capricious," and politically pressured. Howard's read: every criticism they leveled at the Biden-era FDA describes their own tenure — political pressure from Trump, demoted career staff, inconsistent standards. The Peter Marks / Marion Gruber / Phil Krause booster episode reframed in light of what followed. John Mandrola, Adam Cifu, and the cost of vouching Mandrola's "Can We Give the New FDA's Leadership a Chance?" piece a year earlier — and the line about Prasad and Makary inducing companies to run proper RCTs, set against Pfizer's halted trial. Howard's account of an email exchange with Cifu following Cifu's visit to NYU — Howard's offer of a serious content-level conversation, and Cifu's decline. The broader "medical conservatives" project and what the hosts argue has happened to its credibility. Jay Bhattacharya, NIH, and the resignation letter from departing staff The letter from a senior NIH scientist on Bhattacharya's leadership — political termination of grants, deals institutions are making to recover funding, and Bhattacharya's silence. Howard and Orent's read on Bhattacharya's visible deterioration and his retreat into Great Barrington nostalgia. Kennedy's behind-the-scenes vaccine review and Martin Kulldorff The New York Times reporting (Christina Jewett and Sheryl Gay Stolberg) on Kennedy's vaccine inquiry being led by Kulldorff. Howard's pushback on the framing of Kulldorff as merely "a critic of restrictions and mandates" — and the 2020 record of his herd-immunity-through-infection advocacy, including his Stockholm "almost at herd immunity" claim in April 2020. The hosts' concern that the COVID amnesia project lets pandemic-era pro-infection figures re-enter regulatory power with their record sanitized. Casey Means, Surgeon General nomination withdrawal, and MAHA fracturing The withdrawn Surgeon General nomination and what it signals. The Robert Malone vs. Makary public falling-out over the unreleased pediatric deaths data. Why the MAHA coalition — held together by shared COVID grievance — is coming apart now that COVID has receded from headlines. Notable Moments On Cassidy: "He betrayed his oath as a physician, he betrayed the American people, and he's going down into the ignominious dust." — Wendy Orent On the Makary–Prasad–Hoeg trio: "The same skill sets that catapulted these guys to power — essentially being excellent podcasters — do not translate into leading a government agency of tens of thousands of employees that regulates 20 percent of the US economy." — Jonathan Howard On the legacy: "These guys are now cautionary tales for medical students. I would love to teach a course called 'Be the Opposite of Bill Cassidy, Marty Makary, Vinay Prasad, and Tracy Beth Hoeg.'" — Jonathan Howard On Bhattacharya: "His soul has been totally corrupted by the people who he teamed up with. You also see it in his face. He's not the same person that took the position." — Jonathan Howard References Mentioned in the Episode Stat News — "Why Marty Makary Was the Worst FDA Commissioner in 25 Years" Vinay Prasad's 2016 Stat News rebuttal of Makary's "medical error" claim David Gorski (Science-Based Medicine, 2016) — rebuttal of the medical-error-as-third-leading-cause-of-death claim Jonathan Howard, Science-Based Medicine — recent piece compiling Makary's COVID-era statements New York Times — Christina Jewett and Sheryl Gay Stolberg on Kennedy's vaccine inquiry Washington Post — "Ouster of RFK's Allies Tests MAHA-Trump Alliance" Ben Mazer, The Atlantic — on whether Makary and Prasad enacted lasting change Francis Lee — In COVID's Wake Alfred Crosby — America's Forgotten Pandemic Maryanne Demasi interview with Tracy Beth Hoeg MedPage Today — Makary and Prasad, "The Importance of Humility in Medicine" People Referenced Marty Makary — outgoing FDA Commissioner Vinay Prasad — former CBER Director Tracy Beth Hoeg — fired FDA official Senator Bill Cassidy (R-LA) — lost primary Robert F. Kennedy Jr. — HHS Secretary Jay Bhattacharya — NIH Director Martin Kulldorff — leading Kennedy's vaccine review Peter Marks — former CBER Director, Operation Warp Speed Bob Kadlec — Operation Warp Speed David Kessler — former FDA Commissioner (referenced) Marion Gruber and Phil Krause — former FDA vaccine reviewers John Mandrola and Adam Cifu — "medical conservative" commentators Robert Malone — anti-vaccine activist Casey Means — withdrawn Surgeon General nominee Senator Ron Johnson (R-WI) Representative Jake Auchincloss — opened FDA whistleblower line Art Caplan — bioethicist (retirement) Erica Schwartz — CDC Director nominee, unconfirmed
Dr. Jonathan Howard (neurologist and author) and science journalist Wendy Orent return for another sharp, unsparing look at the state of U.S. public health policy. In this episode, the hosts unpack the surprise withdrawal of Casey Means as surgeon general nominee, her replacement by Fox News commentator and MSKCC breast imaging chief Dr. Nicole Saphier, and what the shuffle signals about the fracturing of the MAHA coalition. They dig into Saphier's contradictory record — pro-vaccine statements from 2020 and 2021 set against more recent anti-vaccine messaging, her supplement business (DropRx), and her now-deleted social media posts criticizing Trump and Elon Musk. From there, the conversation turns to the FDA's blocked publication of research showing the COVID and shingles vaccines are safe, the apparent role of former FDA vaccine office chief Dr. Vinay Prasad, and reporting that FDA Commissioner Marty Makary's job is in jeopardy. The episode also covers a small piece of good news — NIH program director Jenna Norton being reinstated after Jay Bhattacharya placed her on administrative leave for organizing the Bethesda Declaration — alongside disturbing developments: RFK Jr. clearing the path for minors to use tanning beds, and the militarized arrest of 78-year-old retired NIH scientist Dr. David Morens. Howard and Orent close on what the Morens arrest reveals about where lab leak conspiracy thinking has led American science and the rule of law. Hosts Dr. Jonathan Howard: Neurologist, professor, and author who writes prolifically on COVID misinformation and public health policy. Wendy Orent: Science journalist and author specializing in infectious disease, evolutionary biology, and public health. Episode Timestamps [00:00] Welcome and Atlanta weather check-in [00:35] Casey Means out, Nicole Saphier in as surgeon general nominee — what it signals about MAHA [01:30] Saphier's role at Memorial Sloan Kettering and her integrative medicine push [02:50] The 2021 WSJ op-ed with Marty Makary: a 10-fold error on pediatric COVID hospitalizations that was never corrected [06:30] Saphier's video opposing COVID vaccines for healthy children — and the framing of myocarditis as a fate worse than death [09:20] Saphier's earlier pro-vaccine statements from 2020 and 2021, and why MAHA now resents her [11:15] DropRx supplements: the surgeon general nominee's tincture business [12:30] Brandy Zadrozny's reporting on Saphier's book and her past criticism of the Plandemic film [13:10] Wendy watches Plandemic so you don't have to: Judy Mikovits and the anti-vaccine machine [14:50] CNN reports Saphier purged posts critical of Trump and Musk before her nomination [15:50] The most disturbing Saphier clip: 'DOGE is one of the greatest things to happen in U.S. history' while telling cancer researchers to 'just pause' [16:50] Harvard's November 2025 finding: hundreds of thousands of deaths from the USAID shutdown [18:20] Good news: Jenna Norton reinstated at NIH after Jay Bhattacharya tried to fire her over the Bethesda Declaration [19:30] Greg Gonsalves on scientists who cooperate with authoritarian science policy [20:10] FDA blocked publication of research showing the COVID and shingles vaccines are safe [21:30] Vinay Prasad: the censorship critic who became a censor [22:30] Why are these people opposed to the shingles vaccine? Howard and Orent on herpes zoster, strokes, and ophthalmic complications [23:50] New evidence: recombinant zoster vaccine linked to reduced dementia risk in adults 65+ [26:10] Marty Makary's FDA in chaos — WSJ, Bloomberg, and Politico reporting on a possible shakeup [28:00] Trump pressures the FDA to approve flavored vapes; ENDS authorization issued the same day [31:00] Makary's interview defending the Replimmune metastatic melanoma rejection — and getting caught in the contradiction [33:30] Who's really driving the FDA shakeup? Biotech investors, not patients [35:30] RFK Jr. clears path for minors to use tanning beds, and what dermatologists are saying [36:30] The arrest of Dr. David Morens: a 78-year-old retired NIH scientist, federal agents, tactical gear, and a strip-search [38:30] Lysenkoism revisited — what the lab leak conspiracy was always going to lead to [40:30] Closing thoughts and sign-off Key Discussion Points The Nicole Saphier Nomination Casey Means was withdrawn as surgeon general nominee and replaced by Dr. Nicole Saphier, head of breast imaging at Memorial Sloan Kettering Cancer Center and a frequent Fox News medical commentator. Howard revisits Saphier's December 2021 Wall Street Journal op-ed with Marty Makary, which understated pediatric COVID-19 hospitalizations by roughly a factor of 10 because the authors did not realize covid.net data only covered about 10 percent of the U.S. population. The error has never been corrected. Saphier's pre-nomination digital footprint included pro-vaccine statements from 2020 and 2021 alongside more recent anti-vaccine content, criticism of Trump and Elon Musk that has since been purged, and a personal supplement line called DropRx. FDA Censorship of Vaccine Safety Research The FDA blocked publication of internal research finding that the COVID-19 and shingles vaccines are safe, with reporting suggesting Dr. Vinay Prasad's office was involved in the decision before he left the agency. Howard points out the irony: Prasad built much of his public profile complaining about scientific censorship, then engaged in censorship the moment he held FDA power. New peer-reviewed research continues to show the recombinant zoster (shingles) vaccine is associated with reduced dementia risk in adults aged 65 and older, even as senior officials downplay or block such findings. Marty Makary on Thin Ice Multiple outlets — the Wall Street Journal, Bloomberg, NOTUS, and a Rachel Bade scoop — report Makary is at risk of being removed as FDA Commissioner over conflicts with the White House and his handling of rare-disease drug approvals. The same day Trump publicly pressured the FDA on flavored vapes, the agency issued a press release authorizing new ENDS (electronic nicotine delivery systems) products. In a 15-minute interview, Makary defended the rejection of Replimmune's metastatic melanoma drug by attributing it to career FDA scientists, but the journalist surfaced earlier indications that the initial review team had recommended approval. A Rare Piece of Good News NIH program director Jenna Norton, a key organizer of the Bethesda Declaration, was reinstated after Dr. Jay Bhattacharya placed her on administrative leave. A judge also reinstated several FEMA employees in the same ruling. The Arrest of Dr. David Morens Federal agents in tactical gear and bulletproof vests arrested Dr. David Morens, a 78-year-old retired NIH influenza researcher and former aide to Dr. Anthony Fauci, at his home over allegations he used a private email account to discuss official business and avoid FOIA disclosure. According to reporting in Science, Morens was strip-searched, handcuffed, and driven roughly 65 kilometers for fingerprinting and booking. Howard and Orent frame the arrest as the predictable endpoint of years of lab leak conspiracy rhetoric, and as a clear case of selective political prosecution. Mentioned in This Episode Wall Street Journal op-ed: 'Should You Vaccinate Your Five-Year-Old?' by Nicole Saphier and Marty Makary, December 3, 2021 Plandemic (2020 anti-vaccine film featuring Judy Mikovits) Make America Healthy Again (book by Nicole Saphier) Harvard study, November 2025, on deaths attributable to the USAID shutdown Greg Gonsalves essay on Vichy scientists Bethesda Declaration Alyssa Finley, Wall Street Journal: 'President Trump's Marty Makary Problem' Bloomberg: 'Paranoia, Turmoil and Backlash Inside Marty Makary's FDA' Rachel Bade: 'Scoop: Makary's Job in Jeopardy as White House Considers FDA Shakeup' Liz Esely White, Wall Street Journal: 'Trump Pressures FDA Commissioner to Approve Flavored Vapes' Los Angeles Times: 'RFK Jr. clears path for minors' use of tanning beds, much to the dismay of dermatologists' Science: 'Guns and bulletproof vests: How federal agents arrested a Fauci aide' Brandy Zadrozny — reporting on Nicole Saphier
First quarter earnings are coming in at a rapid pace, with Sanofi and Novartis defending patents for Dupixent and Lutathera, respectively, and Sanofi welcoming Belén Garijo as CEO. Still to come this week are Eli Lilly, AstraZeneca, Regeneron and many more.Lilly will undoubtedly discuss its recent streak of dealmaking, including a $2.25 billion pact with AI biotech Profluent, plus buyouts of Ajax Therapeutics for up to $2.3 billion and Kelonia Therapeutics for up to $7 billion.Meanwhile, Regeneron earned FDA approval for the highly anticipated gene therapy that will now be known as Otarmeni. The same day the approval came down, Regeneron also struck a deal with the White House.Over at the FDA, the agency has requested—again—that Amgen remove the autoimmune therapy Tavneos from the market. Separately, the FDA has issued three Commissioner's National Priority Vouchers to unnamed psychedelic drug developers. Finally, who will replace Vinay Prasad, the head of the agency's Center for Biologics Evaluation and Research (CBER), who departs at the end of April after one year as the biologics chief?
My Free tools for sites and researchers: https://coordinare.co/ My substack FREE: https://substack.com/@dansfera1?r=27gh4e&utm_medium=ios&utm_source=profile Inato: https://go.inato.com/3VnSro6 CRIO: http://www.clinicalresearch.io My PatientACE recruitment company: https://patientace.com/ Join me at my conference! http://www.saveoursites.com Text Me: (949) 415-6256 Listen on Spotify: https://open.spotify.com/show/7JF6FNvoLnBpfIrLNCcg7a GET THE BOOK! https://www.amazon.com/Comprehensive-Guide-Clinical-Research-Practical/dp/1090349521/ref=sr_1_1?keywords=Dan+Sfera&qid=1691974540&s=audible&sr=1-1-catcorr Text "guru" to 855-942-5288 to join VIP list! My blog: http://www.TheClinicalTrialsGuru.com My CRO and Site Network: http://www.DSCScro.com My CRA Academy: http://www.TheCRAacademy.com My CRC Academy: http://www.TheCRCacademy.com Latinos In Clinical Research: http://www.LatinosinClinicalResearch.com The University Of Clinical Research: https://www.theuniversityofclinicalresearch.com/ My TikTok: DanSfera
Jonathan and Wendy unpack the most surprising political move of Trump's second term: the nomination of Dr. Erica Schwartz — a physician, lawyer, former Coast Guard public health official, and unapologetic architect of military vaccine mandates — to run the CDC. Praised by figures like Jerome Adams, Vin Gupta, and Dorit Reiss, and openly loathed by RFK Jr.'s attack-dog attorney Aaron Siri, Schwartz's selection is read as a signal that the White House is quietly sidelining Kennedy ahead of the midterms and trying to win back the saner corners of the GOP. From there, the hosts dig into the widening fault lines inside MAHA: Marty Makary vs. Robert Malone — the "10 children killed by the COVID vaccine" report Makary promised has never materialized, and Malone is now publicly accusing him of the exact cover-up Makary accused his predecessors of. Vinay Prasad's exit from the FDA — his much-hyped randomized controlled trial of the Pfizer COVID vaccine in healthy 50–64-year-olds failed to recruit, proving (again) that tweeting about RCTs is easier than running them. Jonathan plays Prasad's own year-old promise back against him. The rumored FDA replacement — ophthalmologist and Twitter personality David Hooman, whose COVID-vaccine misinformation record would send exactly the wrong signal. Jay Bhattacharya on the rally circuit — CPAC, Turning Point USA, Kennedy rallies, DeSantis rallies — all while insisting "science shouldn't be political." Plus his role in suppressing a CDC vaccine-safety study and the UCSF faculty petition to block Prasad's return. The peptides free-for-all at the FDA, and why Kennedy still has enough juice to throw bones to his wellness-grifter base. Also: measles in Utah, a Moab travel detour, and a plea to every journalist, clinician, and listener still pushing back. MAHA is on its back foot — the job now is to keep the pressure on.
Jonathan Howard and Wendy Orent dig into the widening fractures inside the MAHA coalition — from Robert Malone's dramatic ACIP exit and UFO tangents, to Vinay Prasad's phantom "10 dead children" claim, Jay Bhattacharya's inability to fix literal broken windows at the CDC, and the ongoing search for anyone willing to run federal health agencies. A sprawling, unscripted conversation about vaccine science, institutional collapse, and the human cost of health misinformation. Connect with us further on https://sciencebasedmedicine.org/author/jonathanhoward/ The Fine Print The content presented in the "We Want Them Infected" Podcast and associated book is intended for informational and educational purposes only. The views and opinions expressed by the speakers, hosts, and guests on the podcast do not necessarily reflect the views of the creators, producers, or distributors. The information provided in this podcast should not be considered as a substitute for professional medical, scientific, or legal advice. Listeners and readers are encouraged to consult with relevant experts and authorities for specific guidance and information. The creators of the podcast and book have made reasonable efforts to ensure that the information provided is accurate and up to date. However, as the field of medical science and the understanding of the COVID-19 pandemic continue to evolve, there may be new developments and insights that are not covered in this content. The creators are not responsible for any errors or omissions in the content or for any actions taken based on the information provided. They disclaim any liability for any loss, injury, or damage incurred by individuals who rely on the content. Listeners and readers are urged to use their judgment and conduct their own research when interpreting the information presented in the "We Want Them Infected" podcast and book. It is essential to stay informed about the latest updates, guidelines, and recommendations related to COVID-19 and vaccination from reputable sources, such as government health agencies and medical professionals. By accessing and using the content, you acknowledge and accept the terms of this disclaimer. Please consult with appropriate experts and authorities for specific guidance on matters related to health, science, and the COVID-19 pandemic.
As one researcher told us: “We've engineered a world where the most distracting device ever made is also the one we use to listen to music in the car." A new study tries to measure the cost. SOURCES: Bapu Jena, economist, physician, and professor at Harvard Medical School. Chris Worsham, pulmonary and critical-care physician at Mass General Hospital, health-policy and public-health researcher at Harvard Medical School. Vishal Patel, surgery resident at Brigham and Women's Hospital, researcher at Harvard Medical School. RESOURCES: "Smartphones, Online Music Streaming, and Traffic Fatalities," by Vishal Patel, Christopher Worsham, Michael Liu, and Bapu Jena (NBER, 2026). Random Acts of Medicine: The Hidden Forces That Sway Doctors, Impact Patients, and Shape Our Health, by Anupam Jena and Christopher Worsham (2023). "Mortality and treatment patterns among patients hospitalized with acute cardiovascular conditions during dates of national cardiology meetings," by Bapu Jena, Vinay Prasad, Dana Goldman, and John Romley (JAMA Internal Medicine, 2015). "Road Crash Fatalities on US Income Tax Days," by Donald Redelmeier and Christopher Yarnell (JAMA, 2012). "Memories of colonoscopy: a randomized trial," by Donald Redelmeier, Joel Katz, and Daniel Kahneman (PAIN, 2003). EXTRAS: "Why Is There So Much Fraud in Academia?" by Freakonomics Radio (2024). "Why Is Flying Safer Than Driving?" by Freakonomics Radio (2023). "Why Is the U.S. So Good at Killing Pedestrians?" by Freakonomics Radio (2023). Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Is the medical establishment trying to shatter the MAHA movement? Jeffrey Tucker, founder of the Brownstone Institute and the man Politico calls the architect of RFK Jr.'s “kitchen cabinet” joins Dr. Drew to expose fake Big Pharma polls and their unrelenting pressure to force Dr. Vinay Prasad out of the FDA. He reveals what Americans really think about medical freedom, vaccine mandates, and health sovereignty. Next, conservative activists Geno Young and Vashon Tuncle (“The Chicago Conservative”) join the show to discuss a viral city council confrontation and the catastrophic collapse of the public education system. Can Chicago be saved? Finally, Paleovalley co-founder Autumn Smith exposes the dark reality of the modern meat industry, the “illusion of choice” at the grocery store, and how to use nutrition to fight chronic inflammation. Jeffrey Tucker is founder and president of the Brownstone Institute, a nonprofit focused on public health, economics, and the philosophical foundations of freedom. He is also Senior Economics Columnist for Epoch Times. Follow at https://x.com/jeffreyatucker Geno Young is a conservative author, South Side of Chicago native, musician, educator, and author of Sex, Drugs, And Illiteracy: The Death of Education in America available at https://amzn.to/4lA6HHz. Follow at https://x.com/Geno4America Vashon Tuncle is The Chicago Conservative on YouTube and a conservative activist based in Chicago. Learn more at https://youtube.com/@TheChicagoConservative Dr. Autumn Smith is the co-founder of Paleovalley, a company focused on nutrient-dense foods. She advocates for rethinking meat consumption and promotes the benefits of bone broth and tallow. Learn more at https://drdrew.com/paleovalley 「 SUPPORT OUR SPONSORS 」 • STRONG CELL – If you want to feel more like your younger self, go to https://strongcell.com/ and use code DREW for 20% off. • AUGUSTA PRECIOUS METALS – Thousands of Americans are moving portions of their retirement into physical gold & silver. Learn more in this 3-minute report from our friends at Augusta Precious Metals: https://drdrew.com/gold or text DREW to 35052 • FATTY15 – The future of essential fatty acids is here! Strengthen your cells against age-related breakdown with Fatty15. Get 15% off a 90-day Starter Kit Subscription at https://drdrew.com/fatty15 • PALEOVALLEY - "Paleovalley has a wide variety of extraordinary products that are both healthful and delicious,” says Dr. Drew. "I am a huge fan of this brand and know you'll love it too!” Get 15% off your first order at https://drdrew.com/paleovalley • THE WELLNESS COMPANY - Counteract harmful spike proteins with TWC's Signature Series Spike Support Formula containing nattokinase and selenium. Learn more about TWC's supplements at https://twc.health/drew 「 ABOUT THE SHOW 」 This show is for entertainment and/or informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment. Executive Producers • Kaleb Nation - https://kalebnation.com • Susan Pinsky - https://x.com/firstladyoflove Content Producer • Emily Barsh - https://x.com/emilytvproducer Hosted By • Dr. Drew Pinsky - https://x.com/drdrew Learn more about your ad choices. Visit megaphone.fm/adchoices
Biopharma's weight loss warriors have led the news this week, with Structure Therapeutics and Rhythm Pharmaceuticals announcing new data. Structure delivered a “competitive profile” for its investigational GLP-1 pill compared to Eli Lilly's orforglipron and Novo Nordisk's oral Wegovy, BMO Capital Markets wrote to investors, after the candidate elicited 16.3% weight loss after 44 weeks in a Phase 2 trial. Rhythm was not as successful, announcing that Imcivree failed in a Phase 3 basket trial of various genetically driven obesities. Meanwhile, Lilly and Novo made headlines outside of the clinical realm, as Lilly warned the public of the potential safety risks of taking compounded versions of tirzepatide—marketed as Zepbound for obesity and Mounjaro for type 2 diabetes. And Novo was hit with an FDA warning letter for failing to investigate reported adverse events—including three deaths—potentially linked to its own diabetes drug Ozempic. The letter only adds to what has been a challenging recent run for Novo, one that led to a 34% drop in total assets under management for its controlling shareholder Novo Holdings. On the regulatory front, Robert F. Kennedy Jr.'s vaccine agenda is stalled after Massachusetts District Court Judge Brian Murphy found that his efforts to overhaul policies in this area were likely unlawful. Murphy specifically cited Kennedy's move last June to empty the CDC's Advisory Committee on Immunization Practices (ACIP). This comes on the heels of a White House crackdown in which officials would like the health secretary to tone down his vaccine skepticism, according to a report by The Wall Street Journal. At the FDA, tensions continue to escalate, with Sen. Ron Johnson (R-WI) launching an investigation into recent rejections of rare disease drugs. And transparency issues have come to light once again regarding the circumstances around biologics chief Vinay Prasad's imminent departure and recent request to remain anonymous during a media briefing about uniQure's gene therapy for Huntington's disease.
In this episode, the hosts unpack the controversial exit of Vinay Prasad from the FDA and what it reveals about fractures inside the MAHA coalition and the broader Trump-era health policy landscape. They examine the disputes surrounding rare-disease drug approvals—particularly Huntington's gene therapy—alongside ongoing battles over COVID vaccines, regulatory standards, and public trust in federal health agencies. The discussion also explores how political alliances, pandemic-era commentary, and conflicts with patient advocacy groups ultimately contributed to Prasad's downfall and what it may signal for the future of vaccine policy and biomedical regulation in the U.S. Connect with us further on https://sciencebasedmedicine.org/author/jonathanhoward/ The Fine Print The content presented in the "We Want Them Infected" Podcast and associated book is intended for informational and educational purposes only. The views and opinions expressed by the speakers, hosts, and guests on the podcast do not necessarily reflect the views of the creators, producers, or distributors. The information provided in this podcast should not be considered as a substitute for professional medical, scientific, or legal advice. Listeners and readers are encouraged to consult with relevant experts and authorities for specific guidance and information. The creators of the podcast and book have made reasonable efforts to ensure that the information provided is accurate and up to date. However, as the field of medical science and the understanding of the COVID-19 pandemic continue to evolve, there may be new developments and insights that are not covered in this content. The creators are not responsible for any errors or omissions in the content or for any actions taken based on the information provided. They disclaim any liability for any loss, injury, or damage incurred by individuals who rely on the content. Listeners and readers are urged to use their judgment and conduct their own research when interpreting the information presented in the "We Want Them Infected" podcast and book. It is essential to stay informed about the latest updates, guidelines, and recommendations related to COVID-19 and vaccination from reputable sources, such as government health agencies and medical professionals. By accessing and using the content, you acknowledge and accept the terms of this disclaimer. Please consult with appropriate experts and authorities for specific guidance on matters related to health, science, and the COVID-19 pandemic.
Health Affairs' Jeff Byers welcomes Deputy Editor Leslie Erdelack back to the pod to break down recent turbulence at the FDA following the departure of Vinay Prasad, whose decisions around rare‑disease gene therapies courted controversy. They explore the fast‑growing rare disease therapeutics market, why traditional clinical trials often don't work for ultra‑rare genetic conditions, and the new FDA draft guidance for rare disease drug development. On March 24th, join us for our upcoming Insider exclusive event focusing on pharmacy benefit manager reform with Harvard Medical School's Benjamin Rome.Become an Insider to get access to this event, trend reports, cheat sheets, and exclusive newsletters.Related Articles:FDA vaccines chief who ran afoul of pharma to depart (Politico)Rare Disease Therapeutics Market to Surpass US$ 495.27 Billion by 2033 as Gene Therapy, RNA-based Drugs, and Biologics Transform Patient Care (PR Newswire)FDA NEWS RELEASE: FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases FDA illuminates new approval pathway for bespoke gene editing therapies (Fierce Biotech)One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma (The New England Journal of Medicine)
Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs discuss potential directions for the US Food and Drug Administration's Center for Biologics Evaluation and Research after the departure of Director Vinay Prasad (:32), including similarities between the center's leadership issues and the staffing problems in the Harry Potter saga's Hogwarts School of Witchcraft and Wizardry (7:48), as well as the potential policy implications (10:11). They also discuss the contributions of the agency's Real-Time Oncology Review (RTOR) pilot program to the quick reviews of two Commissioner's National Priority Voucher (CNPV) awardees (17:19). More On These Topics From The Pink Sheet US FDA's Vinay Prasad, Controversial CBER Director, Leaving In April: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-vinay-prasad-controversial-cber-director-leaving-in-april-DJO7ACE73RCNTLZKQWCN2S26LM/ US FDA's CNPV Approvals Ride RTOR Pilot's Coattails: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fdas-cnpv-approvals-ride-rtor-pilots-coattails-3HEGU5MDWJEG7OYHSZQR6TE5NM/
On this week's episode, Sam Fazeli, Josh Schimmer, Paul Matteis, and Graig Suvannavejh kick off with a discussion on the impact of current geopolitics on biotech investor sentiment, noting that biotech is fundamentally insulated from oil prices and emphasizing that the sector is becoming cash‑flow positive at a pace not previously seen. Shifting to regulatory news, the group discusses Vinay Prasad's departure from the FDA and highlights that upcoming rare disease readouts will serve as a test of the FDA's flexibility. They also cover the FDA's new Adverse Event Monitoring System, which consolidates multiple adverse event reporting databases into a single platform. Next, the co-hosts highlight John Crowley's opinion piece in STAT News on Biotech's 50th anniversary (marked by the founding of Genentech), emphasizing the importance of protecting U.S. biotech and pharmaceutical pricing to sustain innovation. On the deal front, the group discusses Servier's $2.5B cash acquisition of Day One Biopharmaceuticals' oncology asset, as well as the recurring rumor of an Abivax takeover. The episode closes with a review of recent clinical data and company updates from IDEAYA Biosciences, Roche, Benitec Biopharma, RenovoRx, Vertex, Xenon, and Dianthus, along with broader commentary on FDA decision‑making following the approval of leucovorin. *This episode aired on March 13, 2025.
Del returns from Washington, DC with major updates on vaccine injury and autism. Jefferey Jaxen reports on a HHS leadership shakeup, and the growing demand for accountability in public health. Del breaks down the MAHA Institute's landmark conversation on vaccine injury, examines what Vinay Prasad's departure from HHS could mean, and speaks with Tracy Slepcevic of the Interagency Autism Coordinating Committee (IACC) about why having parents at the table matters. Plus, chef Aran Goldstein is cookin'! Chef joins the show to discuss school lunch reform, healthy meals, and practical ways to bring real food home.Guests: Tracy Slepcevic, Aran GoldsteinMarch, 12, 2026Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.
When MM+M set out to hire a new reporter, there were a few characteristics that we were looking for. We wanted a reporter who was able to file clean copy on tight deadlines while also possessing the soft skills to effectively network and participate in our live events. Most of the reporters we interviewed fit the bill, so one of the differentiators would ultimately come down to experience with healthcare reporting and covering our little corner of the world. That's where Bella Czajkowski stood out. Bella joined MM+M with great familiarity of the healthcare industry, both from her time most recently spent as the newsletter editor for Essen Health Care, as well as working at Kaiser Health News' Arm and a Leg podcast and the Global Health Reporting Center. Yet it was her work as the national correspondent for The 340B Report – covering an arcane, opaque federal health program – that stood out most. That's why we're spending this week's episode formally welcoming her on to the podcast, unpacking what she's learned over the first month on the job and what she hopes to achieve as part of the MM+M team going forward. And for our Trends segment, we're talking about the coming end of Vinay Prasad's chaotic tenure at the FDA. Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
The Food and Drug Administration's controversial regulator is set to exit, amid more criticisms that the agency is stifling promising treatments. Meantime, the AI company Anthropic sues the Pentagon, after the Trump administration labels it a "supply chain risk" after a dispute over surveillance and autonomous weapons. Learn more about your ad choices. Visit megaphone.fm/adchoices
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world.We start with a significant personnel change at the FDA, where Vinay Prasad, M.D., is set to depart by the end of April. Known for his contentious interactions with the biopharma industry, particularly concerning vaccines and cell and gene therapies, his departure may signal shifts in regulatory priorities and approaches. Industry stakeholders are closely watching how his exit will affect upcoming decisions and relations between regulatory bodies and biopharma companies.In a strategic collaboration, Novo Nordisk and Hims & Hers have settled their public disputes by agreeing to distribute Novo's Ozempic and Wegovy through Hims' telehealth platform. This partnership highlights the increasing importance of digital health platforms in expanding medication access, particularly for chronic conditions like obesity and diabetes. This trend reflects a broader movement where legacy pharmaceutical companies are turning to digital avenues to enhance patient reach.On the clinical trial front, Ipsen has decided to halt the development of its lymphoma drug Tazverik after safety concerns were raised by an independent data monitoring committee. This decision underscores the rigorous safety standards in place for clinical trials and the ongoing challenge of balancing potential therapeutic benefits against safety risks. Similarly, Roche's oral SERD giredestrant failed to meet its primary endpoint in a phase 3 trial for first-line breast cancer treatment, raising questions about the limits of selective estrogen receptor degraders despite previous successes in adjuvant and second-line settings. The complexity of translating promising mechanisms into consistent clinical outcomes across different stages of treatment is highlighted here.Regulatory challenges remain a significant theme, with Novo Nordisk's Indiana plant facing scrutiny that led to the FDA rejecting Incyte's application for Zynyz as a first-line treatment for non-small cell lung cancer. This incident underscores how manufacturing issues can heavily impact drug approval processes and highlights the critical nature of compliance with regulatory standards.In terms of new drug approvals, Bristol Myers Squibb has received FDA approval for Sotyktu, a first-in-class oral TYK2 inhibitor for treating psoriatic arthritis. This approval not only broadens treatment options for patients but also reinforces the ongoing trend towards developing targeted therapies with novel mechanisms of action. Additionally, Bristol Myers Squibb is gaining momentum with its cereblon E3 ligase modulator (celmod), mezigdomide, achieving statistically significant improvement in progression-free survival among multiple myeloma patients in a Phase 3 trial. This success solidifies BMS's position in hematologic oncology and demonstrates the potential of targeted protein degradation as a therapeutic strategy.The industry is also witnessing significant financial transactions and restructuring efforts. Lonza's decision to sell a majority stake in its capsule business to Lone Star Funds for $3 billion reflects strategic realignments as companies focus on core competencies while leveraging partnerships to optimize business operations.Meanwhile, regulatory scrutiny persists as Democratic lawmakers are investigating 11 pharmaceutical companies regarding their pricing agreements under the previous administration's "most favored nation" clause. This inquiry aims to understand whether these deals have indeed resulted in cost savings for Medicaid, highlighting ongoing concerns about drug pricing transparency and affordability.In another strategic move aimed at bolstering innovation, Regeneron reported promising results from a phase 3 trial conducted by its Chinese partner on a drug mirroring Zepbound's efficacy in obesity treatmenSupport the show
Renue Healthcare https://Renue.Healthcare/ToddYour journey to a better life starts at Renue Healthcare. Visit https://Renue.Healthcare/Todd Bulwark Capital https://KnowYourRiskPodcast.comBe confident in your portfolio with Bulwark! Schedule your free Know Your Risk Portfolio review. Go to KnowYourRiskPodcast.com today. Bonefrog https://BonefrogCoffee.com/ToddGet the new limited release, The Sisterhood, created to honor the extraordinary women behind the heroes. Use code TODD at checkout to receive 10% off your first purchase and 15% on subscriptions.LISTEN and SUBSCRIBE at:The Todd Herman Show - Podcast - Apple PodcastsThe Todd Herman Show | Podcast on SpotifyWATCH and SUBSCRIBE at: Todd Herman - The Todd Herman Show - YouTubeIf you can't practice tough love, you don't really love. Let's practice tough love and examine why Mike Pence, and establishment Republicans like this who I am calling “Trump 2.0”.Episode Links:Mike Pence loves him some war with Iran BREAKING: Senate Leader John Thune confirms HE'S FORCING A VOTE on the SAVE America Act, he will put Democrats ON THE RECORD opposing the 85-15 issue The Republican Party is protecting Ilhan Omar from accountability. Rep Nancy Mace “I tried to subpoena her immigration records, her brother husband's immigration records, and IT WAS REPUBLICANS that killed my motion” It's a Uniparty. One Big Club.URGENT: Big Pharma wins again; Dr. Vinay Prasad is out as the FDA's chief medical's officer. Not coincidentally, stocks of drug companies are soaring.TRUMP: “You gotta lighten up on this, they might have come into our country illegally but they're good people and they're cheap workers. They're working now on farms, in luncheonettes and hotels. We're just focused on getting the murderers out.” So much for mass deportations.Trump: We'll bring in any Iranian refugees that aid the U.S Military! Trump complained about the Afghan INVADERS and now is doing the same thing. This is how we got invaded with people from the Middle East.HOMELAND: Trump's new pick for Secretary of Homeland recently voted to ALLOW "Refugee" Welfare Programs to continue to be funded at Biden-era levels. Mullin also comforted & HUGGED the cop who shot Ashli Babbitt: "He was distraught. I gave him a hug & said 'you did what you had to do.'" He also claimed Republican Senators were too "emotional" over Jan 6 to confirm Trump's pick Ed Martin for DC Prosecutor.Rep. Brian Mast: “Let's talk about Rep. Mace's resolution. Victims deserve protection. Witnesses deserve confidentiality. I voted to ensure survivors aren't forced to deal with the fallout of the public release of their sensitive information. I voted to send the resolution to the Ethics Committee so that it can be amended to adequately protect those who've done the brave thing and come forward.”Rep Anna Paulina Luna comes out and says it. She says the American People hate Congress for how corrupt they are. After both parties blocked disclosing slush funds using tax dollars to pay off their sexual assault charges, she loses it. “That's why the American people hate us”
The second ousting of Vinay Prasad from FDA in the past eight months won't lead to major changes at the agency, other than selecting a successor tasked with keeping FDA out of the news ahead of the coming midterm elections. On the latest BioCentury This Week podcast, Washington editor Steve Usdin lays out why the former CBER director was pushed out at FDA and what's next for the agency following his departure.BioCentury's editors also discuss the next wave of therapies for idiopathic pulmonary fibrosis, including whether new candidates might go beyond slowing disease to halt or even reverse progression, the biological complexity that makes fibrosis so challenging, and what the 20-plus Phase II programs could teach the field about fibrosis biology.Also up for discussion were recent clinical wins — as well as more complicated readouts — from psychedelic therapies; plus the latest data updates from obesity treatments, with a focus on amylin agonists.View full story: https://www.biocentury.com/article/658698#FDA #IdiopathicPulmonaryFibrosis #PsychedelicTherapies #ObesityDrugs #AmylinAgonists00:00 - Introduction01:56 - Prasad's Departure15:27 - Fibrosis Therapies23:35 - Psychedelics Clinical Catalysts28:24 - Obesity UpdatesTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant events and trends shaping the industry landscape, offering insight into the dynamic interplay between scientific innovation, regulatory challenges, and strategic growth.Starting with the recent departure of Vinay Prasad from the U.S. Food and Drug Administration, particularly from his role as director of the Center for Biologics Evaluation and Research (CBER). Prasad's tenure, though brief, left an indelible mark characterized by controversy and debate over regulatory decisions. His leadership coincided with significant advancements in biologics and gene editing technologies, like CRISPR, highlighting the complexities in balancing innovation with safety standards. Under Prasad's guidance, the FDA faced challenges in navigating these rapid advancements while maintaining rigorous oversight to ensure that new therapies are both effective and safe for public use. Prasad's resignation signals potential shifts in regulatory philosophy at CBER. The biotech industry is watching closely to see how new leadership will influence ongoing and future evaluations of biologics. The change presents an opportunity to reassess how regulatory bodies can better adapt to scientific advancements while ensuring that patient safety remains paramount. The issues faced during Prasad's tenure underscore the need for transparent decision-making and open communication with stakeholders, which are vital for maintaining trust in regulatory processes.Meanwhile, Pfizer has made a strategic entry into the Chinese obesity market with the approval of a GLP-1 drug developed alongside Sciwind Biosciences. This approval represents not only a significant step for Pfizer but also underscores a broader global focus on obesity management. The efficacy of GLP-1 receptor agonists in weight regulation has opened up new market opportunities, highlighting the growing importance of metabolic health solutions in addressing public health challenges.In other news, Johnson & Johnson's Tecvayli-Darzalex combination therapy has received its third national priority recognition from the FDA for treating multiple myeloma. This recognition reflects promising Phase 3 trial results and underscores the critical role of innovative combination therapies in improving outcomes for complex hematologic malignancies. The success of such therapies illustrates how targeted approaches can significantly enhance treatment efficacy and patient quality of life.Strategic acquisitions continue to reshape industry dynamics. Servier's $2.5 billion acquisition of Day One Biopharmaceuticals aims to strengthen its rare cancer portfolio, including a promising glioma drug, Ojemda. This move highlights Servier's commitment to addressing unmet needs in pediatric oncology and rare diseases, emphasizing a broader industry trend towards focusing on niche therapeutic areas with high potential impact.Regulatory activities are gaining momentum as well, with the FDA set to end a nine-month hiatus in advisory committee meetings by reviewing AstraZeneca's oral selective estrogen receptor degrader Truqa. As AstraZeneca seeks to enhance its oncology pipeline, this review signals ongoing innovation in hormone-based cancer therapies and reflects a renewed emphasis on bringing novel treatments to market efficiently.Additionally, Glenmark Pharmaceuticals has achieved a significant milestone with FDA approval for its generic version of GSK's asthma inhaler Flovent. This development exemplifies efforts to improve access to respiratory treatments by providing cost-effective alternatives to branded medications, potentially reducing healthcare costs while enhancing patient access.On an international scale, Taiwan has announced a substantial investment plan aimed at bolstering its drugSupport the show
The FDA is dominating the headlines once again thisweek. Days after FDA Commissioner Marty Makary appeared to question uniQure's gene therapy candidate for Huntington's disease, the company revealed that the agency will require it to conduct a randomized, double-blind, sham surgery–controlled Phase 3 study. The FDA also published anothercomplete response letter (CRL), this one for REGENXBIO's gene therapy for Hunter syndrome. The rejection, sustained by the biotech early last month, was driven by issues with the study's population, controls and use of surrogate markers to measure efficacy, according to the document. Meanwhile, regulatory experts have expressed concernsthat the FDA's circle of trust is shrinking, making many decisions feel like “fiat”—both in terms of individual drug applications and policy. The FDA has reportedly initiated a probe into complaints that a toxic workplace is fostered by CBER director Vinay Prasad, who is at the heart of many of these decisions. Finally, the biopharma industry continues to react to the agency's pivot from a requirement of two pivotal trials to one for approval, asking why now, what are the risks and what exactly the FDA expects from this one trial. Still on the gene therapy front, Sarepta Therapeutics CEO Doug Ingram stepped down last week to spend more time with family as the company's muscular dystrophy mission hits home. Also during the company's fourth quarter earnings call, Sarepta projected that sales of its embattled Duchenne muscular dystrophy gene therapy Elevidys will be flat or down as far as 15% in 2026. On the obesity front, Eli Lilly topped Novo Nordisk again in a weight loss trial, this time in a Lilly-sponsored study of patients with type 2 diabetes. But don't count Novo out yet. The company is actively seeking out new obesity assets, according to business development executive Tamara Darsow. Just last week, Novo linked with Boston'sVivtex to advance novel weight loss pills.Finally, check out BioPham Executive this week for a rundown of 2025's top-selling assets—spoiler: Merck's Keytruda held onto its crown as number one—and a story on former2seventy exec Chip Baird's new role as CEO of recently launched Poplar Therapeutics, which secured a $45 million series A extension this week.
Can a strong U.S. biopharma industry be reconciled with the successful emergence of China? And can China be a catalyst of positive change across the global industry, even if this implies some level of rebalancing away from the U.S.? On the latest BioCentury This Week podcast, BioCentury's analysts discuss a Guest Commentary by McKinsey Senior Partner Emeritus Franck Le Deu, who argues that a multipolar biopharma world in which the U.S. continues to thrive even as China becomes meaningfully stronger can emerge.The analysts also discuss BioCentury's latest Rare Disease Spotlight, which focuses on a wave of therapies aiming to activate retinal function in Stargardt disease patients.Turning to FDA, BioCentury Washington Editor Steve Usdin discusses recent public statements by FDA Commissioner Marty Makary, questions about Vinay Prasad's future, and the plausible mechanism pathway.View full story: https://www.biocentury.com/article/658606 #GlobalBiopharma #ChinaBiotech #RareDisease #StargardtDisease #FDAPolicy 00:00 - Introduction02:47 - Multipolar Biopharma World13:39 - Rare Disease Spotlight25:15 - Makary Remarks31:14 - Plausible Mechanism FrameworkTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text
Amazon stock has snapped a nine day losing streak, oil prices have responded to U.S.-Iran talks in Geneva, and “Late Show” host Stephen Colbert is calling out CBS for allegedly blocking the broadcast of his interview with Texas state Rep. James Talarico. The FDA is looking into the safety and supply of baby formula in America with Operation Stork Speed. Former FDA Commissioner Dr. Scott Gottlieb explains the way formula manufacturing and safety protocols work in the U.S., including why reformulation is often a complicated, expensive process. Dr. Gottlieb also weighs in on the impact that Vinay Prasad's leadership is having on investment in health, both for vaccine research and for cell and gene therapies. Plus, NYC Mayor Mamdani has proposed a property tax hike if Governor Hochul does not pass a wealth tax in the state. Partnership for NYC CEO Steven Fulop discusses the proposal and the impact it may have on business leaders based in New York. Steven Fulop 23:29Dr. Scott Gottlieb 33:50 In this episode:Steven Fulop, @StevenFulopJoe Kernen, @JoeSquawkAndrew Ross Sorkin, @andrewrsorkinCameron Costa, @CameronCostaNY Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
As targeted protein degradation gains momentum, oral selective estrogen receptor degraders are emerging as one of its most advanced proving grounds. On the latest BioCentury This Week podcast, BioCentury's Lauren Martz assesses how the oral SERD landscape is evolving.Washington Editor Steve Usdin then discusses setbacks at FDA for an orphan therapy from Disc Medicine and a vaccine from Moderna, and why he is calling on life sciences industry leaders to publicly demand the dismissal of Vinay Prasad, FDA's CSO, CMO, and director of CBER.View full story: https://www.biocentury.com/article/658455#TargetedProteinDegradation #OralSERDs #OncologyDrugDevelopment #FDASetbacks #CBER00:00 - Introduction03:12 - Oral SERD Spotlight11:40 - Setbacks at FDA15:12 - Disc Medicine CRLTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text
Angel Studios https://Angel.com/HermanJoin the Angel Guild today where you can stream Thank You, Dr. Fauci and be part of the conversation demanding truth and accountability. Renue Healthcare https://Renue.Healthcare/ToddYour journey to a better life starts at Renue Healthcare. Visit https://Renue.Healthcare/Todd Bulwark Capital https://KnowYourRiskPodcast.comBe confident in your portfolio with Bulwark! Schedule your free Know Your Risk Portfolio review. Go to KnowYourRiskPodcast.com today. Alan's Soaps https://www.AlansArtisanSoaps.comUse coupon code TODD to save an additional 10% off the bundle price.Bonefrog https://BonefrogCoffee.com/ToddThe new GOLDEN AGE is here! Use code TODD at checkout to receive 10% off your first purchase and 15% on subscriptions.LISTEN and SUBSCRIBE at:The Todd Herman Show - Podcast - Apple PodcastsThe Todd Herman Show | Podcast on SpotifyWATCH and SUBSCRIBE at: Todd Herman - The Todd Herman Show - YouTubeJenner Furst, director of the latest Angel Studios documentary "Thank You Dr. Fauci" joins the show.Episode Links:Thank You Dr. Fauci | Now Streaming | AngelBREAKING/URGENT: mRNA COVID VACCINES KILLED AT LEAST 10 KIDS, THE FDA REPORTS; An FDA review found the shots to blame for the deaths, FDA's new vaccine chief - Dr. Vinay Prasad - told staffers in an email. The agency will tighten standards on new vaccine approval, Prasad wrote.Fauci's Ebola stuntURGENT: mRNA Covid jabs should NEVER have been approved for children or young adults Pfizer, Moderna, the Biden Administration, and everyone in public health who pushed these for kids and teens have blood on their handsUnmask The Truth | Official Clip | Thank You, Dr. Fauci
“Yes, some children may have died from COVID shots,” says The Atlantic, in a startling headline that would have gotten them deplatformed and shunned just 2 years ago. After a leaked memo from FDA vaccine chief Dr. Vinay Prasad alleged that evidence was found showing mRNA COVID shots killed at least 10 children, over a dozen former FDA commissioners pushed back by calling the memo a “threat to evidence-based vaccine policy and public health security.” But finally – and possibly for the first time in its history – the Atlantic admits: “The idea that mRNA-based shots have, tragically, killed a very small number of children is not far-fetched… this insistence that no evidence exists for vaccine-related deaths risks adding to the crisis.” Del Bigtree is an Emmy-winning producer, journalist, and filmmaker. He is the Executive Producer of “An Inconvenient Study,” CEO of the Informed Consent Action Network (ICAN), and host of The HighWire. Bigtree previously produced “Vaxxed” and served as Communications Director for the Kennedy 2024 campaign. Follow at https://x.com/delbigtree Naomi Wolf Ph.D. is an independent journalist, co-founder and CEO of DailyClout.io, and co-editor of The Pfizer Papers with Amy Kelly. She is also the author of Facing the Beast: Courage, Faith and Resistance in a New Dark Age and War Room/DailyClout Pfizer Documents Analysis Volunteers' Reports eBook. Follow at https://x.com/naomirwolf 「 SUPPORT OUR SPONSORS 」 • AUGUSTA PRECIOUS METALS – Thousands of Americans are moving portions of their retirement into physical gold & silver. Learn more in this 3-minute report from our friends at Augusta Precious Metals: https://drdrew.com/gold or text DREW to 35052 • FATTY15 – The future of essential fatty acids is here! Strengthen your cells against age-related breakdown with Fatty15. Get 15% off a 90-day Starter Kit Subscription at https://drdrew.com/fatty15 • PALEOVALLEY - "Paleovalley has a wide variety of extraordinary products that are both healthful and delicious,” says Dr. Drew. "I am a huge fan of this brand and know you'll love it too!” Get 15% off your first order at https://drdrew.com/paleovalley • VSHREDMD – Formulated by Dr. Drew: The Science of Cellular Health + World-Class Training Programs, Premium Content, and 1-1 Training with Certified V Shred Coaches! More at https://drdrew.com/vshredmd • THE WELLNESS COMPANY - Counteract harmful spike proteins with TWC's Signature Series Spike Support Formula containing nattokinase and selenium. Learn more about TWC's supplements at https://twc.health/drew 「 ABOUT THE SHOW 」 Ask Dr. Drew is produced by Kaleb Nation (https://kalebnation.com) and Susan Pinsky (https://twitter.com/firstladyoflove). This show is for entertainment and/or informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment. Executive Producers • Kaleb Nation - https://kalebnation.com • Susan Pinsky - https://x.com/firstladyoflove Content Producer & Booking • Emily Barsh - https://x.com/emilytvproducer Hosted By • Dr. Drew Pinsky - https://x.com/drdrew Learn more about your ad choices. Visit megaphone.fm/adchoices
Jefferey unpacks a leaked FDA memo written by Dr. Vinay Prasad, head of the FDA's Center for Biologics and Research, which revealed at least 10 child deaths linked by internal analysts to the Covid vaccine, an admission the agency has never made publicly. He exposes how career scientists quietly raised alarms, how corporate media scrambled to distort the story, and why this marks a turning point in government transparency on vaccine safety.Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, the landscape of the pharmaceutical and biotech industries is marked by groundbreaking scientific advancements, regulatory shifts, and strategic collaborations that promise to reshape patient care and drug development significantly.A controversy has emerged in the wake of proposed changes to U.S. vaccine regulations by Dr. Vinay Prasad, a senior FDA official. This proposal has sparked considerable opposition from 12 former FDA commissioners who argue that these regulatory overhauls could potentially undermine public trust in vaccines. Former leaders from both the CDC and FDA have expressed concerns over these proposed vaccine policy changes during an ACIP meeting, discussions that could influence future public health strategies and vaccine trust. At a time when vaccine confidence is crucial, maintaining the integrity of regulatory processes is vital to public health efforts.Leadership changes are also afoot within the FDA, as Dr. Tracy Beth Hoeg steps into the role of acting director for the Center for Drug Evaluation and Research. Her appointment signals a shift towards leaders with direct experience in public health crises. This comes amidst further internal restructuring at the FDA, including the transfer of Theresa Michele, long-standing director of the Office of Nonprescription Drugs, indicating dynamic changes within the agency.In the realm of oncology, Eli Lilly's progress with its Bruton's tyrosine kinase inhibitor, Jaypirca, is noteworthy. The drug's expanded label now includes earlier treatment stages for chronic lymphocytic leukemia and small lymphocytic lymphoma. This expansion underscores the therapeutic potential of non-covalent BTK inhibitors and may significantly improve patient outcomes by offering earlier intervention options.Geopolitical challenges are impacting the industry as WuXi AppTec, a major China-based biopharmaceutical contractor, faces scrutiny from the Pentagon amid concerns about its potential ties with the Chinese military. This development highlights the complex interplay between global security concerns and international biotech collaborations. The intersection of global security concerns continues to impact biopharmaceutical supply chains as WuXi AppTec faces increased scrutiny from U.S. authorities.On the manufacturing front, Quvara Medical's emergence as a new contract development and manufacturing organization following Buckland Group's acquisition of a Becton Dickinson facility in the UK reflects industry trends toward consolidating manufacturing capabilities to meet growing biopharmaceutical demand efficiently.AstraZeneca is enhancing its pipeline through a renewed partnership with Neurimmune for an amyloidosis asset. This collaboration, potentially worth up to $780 million, highlights AstraZeneca's strategic focus on rare diseases and underscores their commitment to expanding their therapeutic portfolio through successful alliances.Regulatory updates from the FDA propose reductions in user fees for early-stage clinical trials conducted domestically while considering additional fees for overseas developments. This initiative aims to incentivize research activities within the U.S., potentially accelerating drug discovery timelines and fostering domestic innovation.In surgical technology advancements, Medtronic's Hugo surgical robot has secured FDA clearance for procedures involving prostate, kidney, and bladder removal. This marks a significant advancement in robotic-assisted surgeries and could enhance patient outcomes across approximately 230,000 surgeries annually in the U.S.As we explore more about financial maneuvers within this sector, Royalty Pharma's $275 million financing deal for Denali Therapeutics' Hunter syndrome drug reflects confidence in Denali's pipeline pendinSupport the show
Angel Studios https://Angel.com/HermanJoin the Angel Guild today where you can stream Thank You, Dr. Fauci and be part of the conversation demanding truth and accountability. Renue Healthcare https://Renue.Healthcare/ToddYour journey to a better life starts at Renue Healthcare. Visit https://Renue.Healthcare/Todd Bulwark Capital https://KnowYourRiskPodcast.comBe confident in your portfolio with Bulwark! Schedule your free Know Your Risk Portfolio review. Go to KnowYourRiskPodcast.com today. Alan's Soaps https://www.AlansArtisanSoaps.comUse coupon code TODD to save an additional 10% off the bundle price.Bonefrog https://BonefrogCoffee.com/ToddThe new GOLDEN AGE is here! Use code TODD at checkout to receive 10% off your first purchase and 15% on subscriptions.LISTEN and SUBSCRIBE at:The Todd Herman Show - Podcast - Apple PodcastsThe Todd Herman Show | Podcast on SpotifyWATCH and SUBSCRIBE at: Todd Herman - The Todd Herman Show - YouTubeJenner Furst, director of the latest Angel Studios documentary "Thank You Dr. Fauci" joins the show.Episode Links:Thank You Dr. Fauci | Now Streaming | AngelBREAKING/URGENT: mRNA COVID VACCINES KILLED AT LEAST 10 KIDS, THE FDA REPORTS; An FDA review found the shots to blame for the deaths, FDA's new vaccine chief - Dr. Vinay Prasad - told staffers in an email. The agency will tighten standards on new vaccine approval, Prasad wrote.Fauci's Ebola stuntURGENT: mRNA Covid jabs should NEVER have been approved for children or young adults Pfizer, Moderna, the Biden Administration, and everyone in public health who pushed these for kids and teens have blood on their handsUnmask The Truth | Official Clip | Thank You, Dr. Fauci
Looking 4 Healing Radio with Dr. Benjamin Benulis – The FDA released an internal memo from Dr. Vinay Prasad estimating that at least 10 children died from the COVID vaccine. He notes that this figure is a conservative estimate — implying the real number may be significantly higher. Dr. Ben explores what this means for ongoing pediatric vaccine recommendations, safety oversight, and public trust...
Looking 4 Healing Radio with Dr. Benjamin Benulis – The FDA released an internal memo from Dr. Vinay Prasad estimating that at least 10 children died from the COVID vaccine. He notes that this figure is a conservative estimate — implying the real number may be significantly higher. Dr. Ben explores what this means for ongoing pediatric vaccine recommendations, safety oversight, and public trust...
Howie and Harlan are joined by Sudhakar Nuti to discuss his work improving healthcare for homeless New Yorkers, as a street-medicine doctor and a population-health leader at NYC Health + Hospitals. Harlan reports on a proposed law that would cut off funding for U.S. scientists who collaborate with colleagues in China; Howie provides updates on the measles outbreak and a leaked FDA memo claiming that COVID-19 vaccines have killed 10 children. Show notes: Science Across Borders Subtitle C—SAFE Research Act "U.S. Congress considers sweeping ban on Chinese collaborations" Sudhakar Nuti NYC Health + Hospitals Street Medicine Institute "Health Care beyond Clinic Walls—Sustaining and Scaling Up Street Medicine" NYC Health + Hospitals: Street Health Outreach & Wellness Mobile Units "Graduate and professional students tackle food insecurity" California Depart of Public Health: Xylazine Measles CDC: Measles Cases and Outbreaks "Tracking U.S. Measles Outbreaks" World Health Organization: Weekly Epidemiological Record, 2025, vol. 100, no. 48 "Winning against measles: five charts that tell a remarkable 24-year story" "Measles deaths down 88% since 2000, but cases surge" FDA Leak "Experts say top FDA official's claim that Covid vaccines caused kids' deaths requires more evidence" "FDA's Prasad tells staffers agency plans to get tougher on vaccine regulation, blames child deaths on COVID shots" "Thoughts on Vinay Prasad's Leaked Email" "Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021" "Fulminant Myocarditis and Cardiogenic Shock Following COVID-19 Infection Versus COVID-19 Vaccination: A Systematic Literature Review" In the Yale School of Management's MBA for Executives program, you'll get a full MBA education in 22 months while applying new skills to your organization in real time. Yale's Executive Master of Public Health offers a rigorous public health education for working professionals, with the flexibility of evening online classes alongside three on-campus trainings. Email Howie and Harlan comments or questions.
It's Tuesday, December 2nd, A.D. 2025. This is The Worldview in 5 Minutes heard on 140 radio stations and at www.TheWorldview.com. I'm Adam McManus. (Adam@TheWorldview.com) By Kevin Swanson Trump urges Venezuelan president to leave country U.S. sabers are rattling off the coast of Venezuela. The Miami Herald reported that President Donald Trump offered Venezuelan president Nicolás Maduro an ultimatum over the weekend: He said, “You can save yourself and those closest to you, but you must leave the country now.” For any assistance in leading to Maduro's arrest, the U.S. government has placed a bounty of $50 million on the Venezuelan President. Also, President Trump issued a warning on Saturday via Truth Social. He wrote, “To all Airlines, Pilots, Drug Dealers, and Human Traffickers, please consider THE AIRSPACE ABOVE AND SURROUNDING VENEZUELA TO BE CLOSED IN ITS ENTIRETY.” Trump designates Muslim Brotherhood a terrorist group The President also designated certain chapters of the Muslim Brotherhood organization as a terrorist group, as of Sunday. CounterExtremism.com has counted 48 extremist individuals and groups tied to the Brotherhood. As a Muslim Brotherhood host, the nation of Qatar has transferred $1.8 billion to Gaza since 2012, some of which reportedly has gone to Hamas. That information was revealed through recent audits. 65 people died from Ebola in Congo, Africa The Democratic Republic of the Congo is dealing with another Ebola outbreak — 65 cases confirmed and 45 deaths, reports U.S. News & World Report. The last major Congolese outbreak occurred in 2018. The virus is as dangerous as rabies, the Marburg virus, and the Avian flu. Exodus 4:11 reminds us that God is in control of all health issues: “So the Lord said to him, “Who has made man's mouth? Or who makes the mute, the deaf, the seeing, or the blind? Have not I, the Lord?” Russian-Ukrainian negotiations at stalemate In other world news, the Russo-Ukrainian conflict negotiations are approaching another stalemate. Ukraine announced they will not accept territorial concessions. And French President Emmanuel Macron announced an endorsement of using frozen Russian assets to help fund Ukraine's defense. Japanese court upholds ban on homosexual marriage Japan's Tokyo court upheld the homosexual marriage ban as constitutional, reports the BBC. Of Asian states, only Thailand, Nepal, and Taiwan have legalized the practice thus far. Christian ministries ranked most and least transparent Ministry Watch has released its 2025 ratings of American ministries for financial efficiency, transparency, and donor confidence. Of the largest ministries in the United States, Medicine For All People International, Grand Canyon University, World Relief, Christian Aid Ministries, Fellowship of Christian Athletes, and the Christian Broadcasting Network rate the highest. Lowest ratings go to Samaritan's Purse, Convoy of Hope, Baylor University, Pepperdine University, and Hillsdale College. Some controversy has been brewing recently over the Evangelical Council for Financial Accountability and the Billy Graham Evangelical Association's withdrawal from the organization. Top 3 ministries serving the persecuted Of the six ministries serving the persecuted saints, Ministry Watch rates International Christian Concern, Equipping the Persecuted, and Persecution Project highest for financial efficiency, transparency, and donor confidence. Voice of the Martyrs is rated lowest. Equipping the Persecuted focuses on Nigeria, and Persecution Project has been actively serving the persecuted saints in Sudan, Africa. Folks, think about giving to the poor and the suffering this Christmas season. Proverbs 28:27 says, “He who gives to the poor will not lack, but he who hides his eyes will have many curses.” U.S. government ran a $1.8 trillion deficit The financial numbers are in for the U.S. government's fiscal year 2025, ending in October. The government ran a deficit of $1.8 trillion for the year. That's down $41 billion or 2% compared to the previous year. However, revenues increased by $317 billion due to higher tariffs on imported goods. Spending was up a whopping 4% or $275 billion, driven by welfare and benefit programs, as well as rising interest payments on the public debt. Trump to pick new Federal Reserve Chairman U.S. President Donald Trump will soon announce his next pick for chairman of the Federal Reserve. The new pick is slated to replace Jerome Powell in May of next year. Gold hits $4,230/ounce and silver hits $58/ounce Metals are still on the rise again. Gold hit $4,230 per ounce and silver topped $58.00 per ounce. Bitcoin is still down 31% over two months ago. FDA admits COVID-19 shots killed U.S. kids The U.S. Food and Drug Administration has acknowledged, for the first time, that COVID-19 vaccines have killed American children. According to Politico, Vinay Prasad, the vaccine chief for the FDA, issued a memo in which he revealed that FDA staff “found … at least 10 children have died after and because of receiving COVID-19 vaccination.” This comes from an “initial analysis of 96 deaths (associated with the vaccine taking place) between 2021 and 2024.” TN Democrat opposes Christian prayer in public forum And finally, the Christian faith appears to be at stake -- in a tight election in Tennessee for the 7th District Congressional seat. The Democrat candidate Aftyn Behn has gone on record stating she is opposed to Christian prayer in the public forum. President Donald Trump took to Truth Social yesterday. He warned that Behn “hates Christianity, will take away your guns, wants Open Borders. . . men in women's sports, and openly disdains Country music.” The latest polls show the Republican candidate, Van Epps, is holding a slight lead in today's election. Close And that's The Worldview on this Tuesday, December 2nd, in the year of our Lord 2025. Follow us on X or subscribe for free by Spotify, Amazon Music, or by iTunes or email to our unique Christian newscast at www.TheWorldview.com. I'm Adam McManus (Adam@TheWorldview.com) Seize the day for Jesus Christ.
Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll explore the latest advances and strategic moves shaping the industry, providing you with insights into how these developments might influence drug development and patient care.The pharmaceutical and biotech sectors are currently experiencing a wave of transformative changes. A significant development is the trade agreement between the United States and the United Kingdom, which excludes medicines from import tariffs. This strategic move, orchestrated by the Trump administration, is set to reduce costs and bolster investments in pharma sectors across both nations. By enhancing market accessibility, it aims to stimulate cross-border investment in pharmaceutical research and production.On the clinical front, Eli Lilly is making headlines by joining Novo Nordisk in reducing self-pay prices for its GLP-1 receptor agonist, Zepbound. This reflects a broader industry trend towards patient-centric pricing models aimed at improving affordability. With healthcare costs on the rise, these measures could ease financial burdens for patients requiring long-term medication regimens.Regulatory updates are also making waves, with the FDA planning stricter vaccine regulations under Dr. Vinay Prasad's leadership at the Center for Biologics Evaluation and Research (CBER). These updates come amid concerns over vaccine safety during COVID-19-related incidents, underscoring a commitment to maintaining public trust in vaccines. Regulatory scrutiny continues as Prasad focuses on COVID-19 vaccine safety in children amid reports linking 10 child deaths to vaccines via VAERS—emphasizing challenges interpreting safety data while highlighting the need for robust methodologies ensuring reliable causality conclusions.In corporate restructuring news, Valneva is streamlining its operations by closing a site and eliminating 30 roles. This move highlights an industry focus on optimizing resources to bolster vaccine development pipelines. Meanwhile, Microsize and Schedio's acquisition of Lonza's Swiss micronization plant underscores ongoing investments in advanced manufacturing technologies critical for high-quality pharmaceuticals.In ophthalmology, Belite Bio is advancing with promising Phase 3 results for tinlarebant in treating Stargardt disease—a rare genetic eye disorder. This success positions Belite to file for FDA approval, potentially expanding treatment options for this underserved patient population. Such advancements in targeted therapies emphasize the need for ongoing research in genetic disorders.Regeneron is betting $150 million on Tessera's gene writing technology targeting alpha-1 antitrypsin deficiency (AATD). This collaboration highlights the industry's growing interest in gene therapy as a frontier for treating rare diseases, marking a shift towards precision medicine where tailored genetic interventions offer hope for previously untreatable conditions. Regeneron's strategic move investing $275 million partnering with Tessera exploring gene editing capabilities—focusing on TSRA-196 targeting the SERPINA1 gene linked to AATD showcases potential advancing therapeutic options for genetic disorders through gene editing technologies offering new disease treatment avenues.AI-driven platforms were spotlighted at RSNA 2025 by industry leaders such as GE Healthcare, Philips, and Siemens. These innovations promise to revolutionize radiological workflows by enhancing diagnostic accuracy and operational efficiency through AI integration. As AI continues to permeate healthcare technologies, its potential to transform diagnostic processes marks a significant leap towards personalized medicine.Akebia Therapeutics' acquisition ofSupport the show
The FDA's vaccine chief says the agency plans to tighten approval standards for COVID-19 vaccines, citing concerns about potential risks for children. In a leaked memo, Dr. Vinay Prasad says a review of records links 10 children's deaths to the COVID vaccine. He did not provide data to support the claim. CBS News medical contributor Dr. Celine Gounder explains what to know. At a pretrial hearing in the state case against Luigi Mangione, his lawyers are expected to argue some key evidence against him should not be allowed at trial. Mangione is accused of killing UnitedHealthcare CEO Brian Thompson nearly a year ago. There have been nearly 1.5 million reports of fraud so far this year, which is up from 1.3 million for the same period last year. Ash-har Quraishi got a behind-the-scenes look at VISA's high-tech cyber fusion center in Virginia to see how it's fighting fraud. Actor and comedian Richie Moriarty talks with "CBS Mornings" about the fifth season of the comedy series "Ghosts," what's next for his character and how the cast has bonded. When Marianne Baumgarten was 8 years old she was supposed to be a flower girl in a family wedding, but got sick just before. Decades later, an unexpected friendship that started during the pandemic would lead to her decades-old wish coming true. David Begnaud reports. To learn more about listener data and our privacy practices visit: https://www.audacyinc.com/privacy-policy Learn more about your ad choices. Visit https://podcastchoices.com/adchoices
Broadcast from KSQD on 9-04-2025: Dr. Dawn opens by criticizing new FDA restrictions on simultaneous COVID and flu vaccinations, calling out vaccine regulator Vinay Prasad for creating artificial shortages. She explains that while no formal studies test multiple vaccines together, decades of safe practice demonstrate effectiveness. The FDA's requirement for separate testing ignores practical evidence and threatens vaccine supply chains during critical flu season. She discusses Oregon research suggesting adults may not need tetanus boosters every 10 years, but warns this misses the pertussis component. Dr. Dawn explains that acellular pertussis vaccines only provide 4-year immunity, making adult boosters essential to prevent whooping cough transmission to vulnerable infants. The focus should remain on pertussis prevention rather than tetanus economics. California, Oregon, and Washington announced a West Coast Health Alliance to maintain scientific integrity in public health policy amid federal changes. Dr. Dawn supports this states' rights approach to vaccination recommendations based on trusted medical organizations, expressing concern about potential vaccine shortages if manufacturers reduce production due to uncertain federal demand. An emailer shares an AI-generated analysis comparing tuberculosis and Lyme disease. Dr. Dawn critiques the AI's inaccuracies, noting that while tuberculosis may be present in 25% of people globally s the AI reports (she did not fact check this), the distribution is very uneven and cases in the US are low which we know since accurate latent TB testing is readily available in the US. She warns against AI's tendency to incorporate conspiracy theories due to a bias which favors frequency vs accuracy and emphasizes the importance of fact-checking AI-generated medical content. Dr. Dawn addresses FDA concerns about unregulated GLP-1 drugs, warning about counterfeit semaglutide and tirzepatide from questionable sources. She discusses dosing errors, non-FDA-approved compounds appearing in gray markets, and the rare but serious cancer risk for people with multiple endocrine neoplasia syndromes - affecting 1 in 30,000 people who could develop hormone-producing cancers. A caller asks about genetic testing for GLP-1 cancer risk. Dr. Dawn explains that complete genome testing costs around $1,000 and requires professional interpretation. She discusses the economic challenges of testing 30,000 people to prevent one cancer case, while acknowledging that obesity's health risks generally outweigh the small cancer risk for most patients. She examines FDA challenges in approving MDMA for PTSD treatment, explaining the "Catch-22" of blinding studies when drugs cause obvious consciousness changes. Dr. Dawn describes how psychedelic research faces unique obstacles requiring 8-10 hour supervised sessions with therapists, making traditional double-blind studies nearly impossible to conduct properly. An emailer asks about B vitamin effects on brain and heart health. Dr. Dawn warns about high-dose biotin interfering with thyroid tests and troponin levels used to diagnose heart attacks. She explains how B12 deficiency affects 40% of people over 80, recommending methylmalonic acid testing for accurate assessment rather than standard blood levels. She discusses research showing coastal living extends life expectancy by over a year compared to inland areas, attributed to cleaner air and better recreational opportunities. However, living near inland waterways may slightly decrease lifespan due to flood risks and environmental factors, suggesting ocean proximity specifically provides health benefits.
Nurses Out Loud – Dr. Vinay Prasad resigns from the FDA after fierce backlash fueled by Laura Loomer and mounting pressure from powerful pharmaceutical interests. His short tenure at CBER exposes deep fractures between political agendas, corporate influence, and public health. What begins as a clash with Trump loyalists quickly reveals a larger battle over pharma power and FDA integrity...
Abdul and Katelyn condemn the violence at the CDC headquarters last week, and the startlingly weak response from lawmakers. Then they unpack Trump's newest executive order, which seeks to give his own appointees the power to approve federal grants. They also discuss the future of the FDA as Vinay Prasad makes his return, following his resignation last month. Then Abdul talks to Sherrell Byrd, founder of SOWEGA Rising, which has organized in rural Georgia to bring fresh produce to rural communities that lack grocery stores. They discuss the health implications of food deserts, and how food justice can change lives. Check out our shop at store.americadissected.com for our new America Dissected merch – including logo shirts, hoodies and mugs. And don't miss our “Vaccines Work. Science Matters.” t-shirts! This show would not be possible without the generous support of our sponsors. America Dissected invites you to check them out. This episode was brought to you by: Quince: Go to Quince.com/AD for free shipping on your order and 365-day returns.
Abdul unpacks the week in public health, which includes: Vinay Prasad's exit from FDA Susan Monarez's confirmation to lead CDC New childhood vaccination data The EPA's move to rollback the endangerment finding Why more experts have been ousted from ACIP Then Abdul interviews professor Dr. Brian Willoughby about his research on porn use among young people, and what parents should know about modern porn content. Note: We recorded this episode before RFK Jr announced the cancellation of $500 million in funding for mRNA vaccine development. However, Abdul and Katelyn discussed the threat of mRNA research cuts in our May 7 and June 3 episodes. (their May convo begins at 00:11:00 / their June convo begins at 00:16:00) Check out our shop at store.americadissected.com for our new America Dissected merch – including logo shirts, hoodies and mugs. And don't miss our “Vaccines Work. Science Matters.” t-shirts!
With Susan Monarez in at CDC and Vinay Prasad out at FDA, change is underway at HHS. Meanwhile, Secretary Robert F. Kennedy Jr. is calling out the Vaccine Injury Compensation Program as “a morass of inefficiency, favoritism, and outright corruption,” where injured families are stonewalled instead of supported. Del breaks down how victims face a court with no judge, no jury, and no real science. Could this be the administration that finally fixes it?Become a supporter of this podcast: https://www.spreaker.com/podcast/the-highwire-with-del-bigtree--3620606/support.
We drown in waves of ideological fluidity as the gurusphere continues to crash all around us.Supplementary Material 3400:00 Introduction01:26 Irish Stew and Dog Exercise Report03:45 A new 276 IQ Genius11:47 Fresh and Fit Antisemitism16:51 Are things getting dumber?21:22 Asmongold on the Epstein Files24:53 Epstein Conspiratorial Discourse helps Ghislaine Maxwell29:00 Vinay Prasad resigns from his MAGA position31:17 Eric Weinstein is the Architect of the Great Reset!32:37 Google Eyed Loons vs. Willing Apparatchik36:40 The Young Turks are joined by... Scott Adams38:51 Ana Kasparian sits down with Tucker Carlson44:46 Jimmy the Giant enters the arena46:11 Jimmy the Giant meets Konstantin Kisin57:12 Debating the Middle Class YouTube Grifters01:06:15 The Gurusphere Grift01:08:16 Jimmy the Giant reflects on his performance01:11:16 Discourse standards for Research01:15:05 Jimmy defends his criticisms01:22:27 Jimmy the Giant deletes his videos and apologises to Konstantin01:28:04 The Call to Action to support the Grand Mission01:32:32 Separating Issues from Support of Influencers01:37:13 Jimmy the Giant explains how the Elites created Wokeness01:47:16 Woke Wars and Psyops01:49:33 The Right Wing Media Outrage Ecosystem01:55:26 False Consciousness and the Billionaires02:02:47 AI limitations and Hallucinations02:07:08 Post Hoc-Reasoning in AI and People02:14:22 OutroThe full episode is available for Patreon subscribers (2hrs 16 mins).Join us at: https://www.patreon.com/DecodingTheGurusSourcesYounghoon Kim: World's Highest IQ Score (276) Scientifically Documented in New Academic PreprintFresh and Fit idiots being giggly anti-semitic and praising HitlerJoanne Freeman: The Field of Blood: Violence in Congress and the Road to Civil WarGhislaine Maxwell moved to Federal prison camp in TexasComment on the move from Prison ConsultantPoor Vinay Prasad – The Disgraceful Campaign Against a Top FDA OfficialEric responds to accusations that he is the mastermind behind the Great ReplacementTYT's The Conversation: Scott Adams Reflects on Life after his Terminal Cancer DiagnosisAna Kasparian on the Tucker Carlson showClips from now deleted Triggernometry video: He Called me a Grifter… it didn't go so well
The new U.S.–EU trade deal negotiated between Donald Trump and the EU's Ursula von der Leyen is surprisingly one-sided in favor of the United States. In the end Europe made major concessions, including accepting a 15% tariff on goods and agreeing to purchase $750 billion worth of U.S. energy, while the U.S. gave up virtually nothing in return. Although European leaders were unhappy with the deal, they accepted it to avoid a full-blown trade war, with critics like former Belgian Prime Minister Guy Verhofstadt calling it disastrous and poorly negotiated. Jimmy argues that Europe weakened its own position by severing energy ties with Russia and becoming dependent on U.S. energy and defense, effectively allowing Trump to dictate the terms. He and Americans' Comedian Kurt Metzger conclude that European leaders have sold out their own nations' interests to serve U.S. and transnational elite agendas, leaving their populations economically disadvantaged and politically powerless. Plus segments with Children's Health Defense CEO Mary Holland on the newly confirmed CDC head and the surprise departure of Dr. Vinay Prasad from the FDA, and a closing segment on rocker Dave Matthews' recent statement of support for Palestine. Also featuring Stef Zamorano!
President Trump announced a major trade deal with South Korea, securing $350 billion in U.S.-directed investments, $100 billion in energy purchases, and a 15% tariff on Korean goods, while U.S. exports face zero tariffs. U.S. GDP grew 3% in Q2 2025, surpassing expectations, with inflation dropping to 2.1%, prompting optimism from the White House despite the Federal Reserve holding interest rates steady. Nancy Pelosi endorsed a congressional insider trading ban after Trump accused her of profiting from insider knowledge, while a new Stanford study revised COVID vaccine lives saved to 2.5 million globally, far below WHO's 14.4 million estimate. U.S. fertility rates hit a record low of 1.6 children per woman, with a Georgian church-led initiative cited as a model for reversing declines, and Senator Josh Hawley's $600 tariff rebate proposal sparked debate as a morally questionable gimmick. Trump South Korea trade deal, U.S. GDP growth, inflation rate, Josh Hawley, tariff rebates, Nancy Pelosi, insider trading, COVID vaccine study, U.S. fertility rate, Georgian Orthodox Church, Cincinnati violence, Vinay Prasad, FDA
A top official at the Food and Drug Administration steps down after the agency changes course on a treatment for Duchenne muscular dystrophy. What does this episode say about the Trump Administration's approach toward drug development and innovation? Plus, Robert F. Kennedy Jr. says he plans to overhaul the National Vaccine Injury Compensation Program. Learn more about your ad choices. Visit megaphone.fm/adchoices
A massive 8.8-magnitude earthquake off Russia's Kamchatka Peninsula triggers tsunami warnings for Hawaii, Alaska, and the U.S. West Coast, with Japan's Pacific coast expecting waves up to 3 yards. The quake, the largest since 2011, causes minor damage in Russia. The Senate confirms Trump's DOJ nominee Emil Bove as a federal judge in a 50-49 vote. Dr. Vinay Prasad resigns from the FDA after facing Big Pharma backlash. Trump reflects on sparing Hillary Clinton from prosecution, contrasting it with the Russiagate hoax. Ron DeSantis criticizes H-1B visa abuse, and ICE arrests a Jamaican overstaying his visa, hired as a Maine police officer. Senator Josh Hawley proposes $600 tariff rebates for Americans. Job vacancies drop to 7.4 million. Tsunami warning, Kamchatka earthquake, Shane Tamura, Manhattan shooting, emil Bove, Vinay Prasad, Trump administration, Ron DeSantis, H-1B visas, Josh Hawley, tariff rebates, economy
Today we discuss sex and vaccines, reality and renegades. First: men can no longer compete in women's sports—from Trump's Executive Order, to the NCAA's response, to William “Lia” Thomas having his records rescinded at Penn, reality is prevailing. Other evidence includes the UK Supreme Court declaring that “man” and “woman” refer to biological reality; and the U.S. Supreme Court writing an opinion that forcing LGBTQ+ books on children in public elementary schools is unconstitutional. Men cannot magically turn into women, nor boys into girls, no matter what they believe or are told. Then: from the ACIP (Advisory Committee on Immunization Practices) to Vinay Prasad's latest presentation at the FDA: the federal government is being populated by a combination of true renegades and middle ground scramblers who are dressed like renegades. A good toolkit for understanding how to make sense of the claims being made is necessary, and we all should be rooting for the renegades to win.*****Our sponsors:CrowdHealth: Pay for healthcare with crowdfunding instead of insurance. It's way better. Use code DarkHorse at JoinCrowdHealth.com to get 1st 3 months for $99/month.ARMRA Colostrum is an ancient bioactive whole food that can strengthen your immune system. Go to http://www.tryarmra.com/DARKHORSE to get 15% off your first order.Helix: Excellent, sleep-enhancing, American-made mattresses. Go to www.HelixSleep.com/DarkHorse for 27% Off - an offer exclusive for listeners of DarkHorse!*****Join us on Locals! Get access to our Discord server, exclusive live streams, live chats for all streams, and early access to many podcasts: https://darkhorse.locals.comHeather's newsletter, Natural Selections (subscribe to get free weekly essays in your inbox): https://naturalselections.substack.comOur book, A Hunter-Gatherer's Guide to the 21st Century, is available everywhere books are sold, including from Amazon: https://amzn.to/3AGANGg (commission earned)Check out our store! Epic tabby, digital book burning, saddle up the dire wolves, and more: https://darkhorsestore.org*****Mentioned in this episode:Trump's EO: https://www.whitehouse.gov/presidential-actions/2025/02/keeping-men-out-of-womens-sports/Paula Scanlan speaks about men in women's sports:https://x.com/xx_xyathletics/status/1940381615131332719U.K. Supreme Court: https://www.supremecourt.uk/cases/uksc-2024-0042The Lancet – sex isn't binary! https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00834-7/fulltextU.S. Supreme Court – Mahmoud vs Taylor: https://www.supremecourt.gov/opinions/24pdf/24-297_4f14.pdfWilliam Thomas in the record books: https://www.outkick.com/sports/lia-thomas-upenn-womens-swimming-record-books-updated-acknowledges-transgender-swimmer-noteRFK Jr on Tucker: https://www.youtube.com/watch?v=w_fzlwxJZAAACIP committee with Robert Malone and Retsef Levi: https://x.com/janjekielek/status/1939482343313453423Prasad on myocarditis: https://x.com/US_FDA/status/1940111214497210425Prasad makes full professor: https://x.com/bretweinstein/status/1554849287300792320Earlier clips of ZDogg and Prasad and Makary: https://x.com/alexandrosm/status/1574530850565558272Support the show