Podcasts about fda commissioner

Each year WNYC hosts a "health convening," with support from the Alfred P. Sloan Foundation, as an opportunity for healthcare experts and practitioners to inform WNYC's health reporting. This year, the topic is ultra-processed foods and how they affect our health.  David Kessler, MD, former FDA Commissioner, breaks down a citizen petition he filed with the Food and Drug Administration last summer which would, among other things, declare that some of the core ingredients in ultra-processed foods were no longer “generally recognized as safe (GRAS)” -- a classification that means ingredients are exempt from strict premarket approval process. Photo: US Food and Drug Administration (FDA) website detail, by MarioGuti.   Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

"The average marketplace deductible grew by about $1,000 per person in 2026. Premium payments increased by an average of 58%... We might be seeing the death throes of the fully insured market."Welcome back to Last Month in Healthcare! This month, Spencer, Nathaniel, and special guest Jonathan Lopez break down the most impactful healthcare headlines and regulatory shifts from May 2026.The episode kicks off with a discussion on the sudden resignation of FDA Commissioner Dr. Marty Makary following reported clashes with the food, tobacco, and pharmaceutical industries. From there, the guys dive into the shocking 58% premium hikes and 37% deductible increases hitting the ACA marketplace as carriers like Cigna exit the space.Finally, Spencer and Jonathan play a World Cup-themed game guessing the cost of medical procedures across different North American cities and answer a listener question about Cost Plus Drugs and the rise of direct-to-consumer pharmacy models.If you'd like your question answered on next month's episode, call/text 469-213-6381 and leave us a voicemail/text.Thank you to our sponsor, Walk On Clinic. This month, we shared a tragic reminder to our listeners on the critical importance of early cancer detection and proactive primary care. To hear Chris's brother-in-law's music, tune in here: https://open.spotify.com/artist/1SKw4DO9FNLjcZDb5Q81q4?si=Dwpuz2wOTRawhMDfR5NIsAEpisode Chapters:(00:00:00) Intro: The Importance of Early Detection & Walk-On Clinic(00:02:30) Dr. Marty Makary Resigns as FDA Commissioner(00:04:37) ACA Marketplace Premiums Skyrocket by 58%(00:07:51) HR 8163: Stopping the Squeeze on Physician Reimbursements(00:12:34) Harvard Study: AI Outperforms Doctors in ER Triage(00:14:53) The FDA's Push for Hospital-at-Home Devices(00:17:18) Game: Guess the Procedure Cost (World Cup Edition)(00:21:22) Ask Spencer Anything: Cost Plus Drugs & D2C Pharmacies

"The average marketplace deductible grew by about $1,000 per person in 2026. Premium payments increased by an average of 58%... We might be seeing the death throes of the fully insured market."Welcome back to Last Month in Healthcare! This month, Spencer, Nathaniel, and special guest Jonathan Lopez break down the most impactful healthcare headlines and regulatory shifts from May 2026.The episode kicks off with a discussion on the sudden resignation of FDA Commissioner Dr. Marty Makary following reported clashes with the food, tobacco, and pharmaceutical industries. From there, the guys dive into the shocking 58% premium hikes and 37% deductible increases hitting the ACA marketplace as carriers like Cigna exit the space.Finally, Spencer and Jonathan play a World Cup-themed game guessing the cost of medical procedures across different North American cities and answer a listener question about Cost Plus Drugs and the rise of direct-to-consumer pharmacy models.If you'd like your question answered on next month's episode, call/text 469-213-6381 and leave us a voicemail/text.Thank you to our sponsor, Walk On Clinic. This month, we shared a tragic reminder to our listeners on the critical importance of early cancer detection and proactive primary care. To hear Chris's brother-in-law's music, tune in here: https://open.spotify.com/artist/1SKw4DO9FNLjcZDb5Q81q4?si=Dwpuz2wOTRawhMDfR5NIsAEpisode Chapters:(00:00:00) Intro: The Importance of Early Detection & Walk-On Clinic(00:02:30) Dr. Marty Makary Resigns as FDA Commissioner(00:04:37) ACA Marketplace Premiums Skyrocket by 58%(00:07:51) HR 8163: Stopping the Squeeze on Physician Reimbursements(00:12:34) Harvard Study: AI Outperforms Doctors in ER Triage(00:14:53) The FDA's Push for Hospital-at-Home Devices(00:17:18) Game: Guess the Procedure Cost (World Cup Edition)(00:21:22) Ask Spencer Anything: Cost Plus Drugs & D2C Pharmacies

Dive into the latest episode of Pharmacy Friends for a discussion of the FDA Commissioner's National Priority Voucher pilot. While accelerated approvals may improve access to innovative therapies, what could a compressed decision-making window mean for evidence review, affordability assessment and implementation planning? Prime experts Angela Sutton and Bob Greer explore the important roles clinical confidence and operational readiness will play in making solid coverage decisions. Hear what they're most focused on, including:Managing drug spendAssessing coverage strategiesDetermining policy risk00:00 Introduction02:10 What's generating all the questions now?04:35 FDA Hearing05:50 Pro's and con's of accelerated drug approvals11:05 Policy uncertainty and impact to payers11:54 Impact of FDA leadership changes12:24 Meeting the moment15:26 Using data to make better decisions that need to be fast18:39 What we would tell the acting FDA leadership that matters23:15 Closing

Bob Harringson and former FDA commissioner Rob Califf discuss medical misinformation, its impact on public and individual health, and how to fight against it. This podcast is intended for healthcare professionals only. To read a transcript or to comment, visit https://www.medscape.com/author/bob-harrington  Is a Long-Simmering Crisis Boiling Over? U.S. Primary Care Today https://doi.org/10.1056/NEJMms2510425 The Global Wellness Economy Hits a Record $6.8 Trillion and Is Forecast to Reach $9.8 Trillion by 2029 https://globalwellnessinstitute.org/press-room/press-releases/the-global-wellness-economy-hits-a-record-6-8-trillion-and-is-forecast-to-reach-9-8-trillion-by-2029/  Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association https://doi.org/10.1161/CIR.0000000000001078  Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)17018-9/abstract  Here's What We Know https://weillcornell.org/heres-what-we-know  Fifth Circuit sides with ivermectin-prescribing doctors in their quarrel with the FDA https://www.courthousenews.com/fifth-circuit-sides-with-ivermectin-prescribing-doctors-in-their-quarrel-with-the-fda/  SNAP Tracker: People Are Losing Food Assistance as the Republican Megabill Is Implemented https://www.cbpp.org/research/food-assistance/snap-tracker-people-are-losing-food-assistance-as-the-republican-megabill  Chronic Conditions and Food Insecurity in US Children https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2839376  As Unregulated Peptides Flood the Market, Clinicians Encouraged to Counsel Patients https://www.medscape.com/viewarticle/unregulated-peptides-flood-market-clinicians-encouraged-2026a1000e63 Coethia https://coethia.com/  You may also like: Hear John Mandrola, MD's summary and perspective on the top cardiology news each week, on This Week in Cardiology https://www.medscape.com/twic  Questions or feedback, please contact news@medscape.net

The CDC has expanded U.S. airport screening for the Ebola virus; former FDA Commissioner Dr. Scott Gottlieb discusses risks of outbreak, as well as the potential uses for GLP-1s in cancer treatments. Author of “The Infinite Machine” Sebastian Mallaby discusses Pope Leo XIV's encyclical on AI, where humanity fits into global innovation, and the risks of unregulated technology. Plus, Uber and Lyft drivers in Massachusetts have formally unionized, Ferrari has released its first fully electric vehicle, and tensions are high in Iran.   Sebastian Mallaby - 14:28 Dr. Scott Gottlieb - 24:09   In this episode: Sebastian Mallaby, @scmallaby Joe Kernen, @JoeSquawk Becky Quick, @BeckyQuick Andrew Ross Sorkin, @andrewrsorkin Katie Kramer, @Kramer_Katie Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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  

It's Tuesday, May 19th, A.D. 2026. 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 and Timothy Reed Another British preacher arrested in London Another British pastor has been arrested for preaching the Gospel of Jesus Christ on the streets of London.   Pastor Steve Maile was singing, preaching the Good News, and calling on Muslims to be saved when he was arrested by the police.  Pastor Steve told Fox News Digital, "It's called inciting religious hatred — which is false. … The cross of Christ is a message of hope, love, mercy, and reconciliation to a fallen world. ... How could that be hate?" Not much has changed since the Prophet Amos spoke these words: “They hate the one who rebukes in the gate, and they abhor the one who speaks uprightly.” (Amos 5:10) Three Christian pastors killed in Manipur, India The Manipur, Indian Baptist Convention is condemning the death of friend and pastor Reverend Dr. Vumthang Sitlhou, who was shot and killed along with Pastors Lhouvum and Paogoulen in an ambush which took place on May 13th. Manipur State is located in Northeast India in a mostly hilly area, where the percentage of Christians has risen from 19% in 1960 to 41% in 2011, equaling the percentage of Hindus which dropped from 62% to 41%. The Baptist group noted “This senseless violence is a grave attack on humanity, peace, and religious harmony. The tragic loss of such devoted leaders who dedicated their lives to serving God, the Church, and society, is not only a loss to the Christian community, but also to the people of Manipur as a whole.”   The Worldview received pictures of the scene from Christians who witnessed the killings. The Baptist Convention is pleading with the government of India to “seriously look into the matter to conduct an immediate and impartial investigation, and ensure that the perpetrators are identified and brought to justice without delay.” Send a 2-sentence letter to Indian Ambassador Vinay Kwatra, asking that he hold the killers accountable. Send it to: Embassy of India, 2107 Massachusetts Avenue, NW, Washington, DC 20008. Or you can email him: psamb.washington@mea.gov.in Ebola virus outbreak claims 80 lives in Uganda Another Ebola virus outbreak has surfaced in Congo, Africa. So far, 80 people died this time. At least two cases of Ebola have been detected in Kampala, Uganda as well, according to the World Health Organization. That's the worst outbreak since 2020. Those who contract the Ebola virus have a 50% chance of dying. Right-wing Vox Party makes gains in Spain The far-right, nationalist Vox Party gained some ground in Spain's election over the weekend.  The conservative party will be forced to build a ruling coalition with the Nationalists to establish a new government for that European nation. At last count, 15 European nations have experienced a surge in anti-immigrant nationalism. However, that's not necessarily a return to Christian values or pro-life values. Death tolls in the U.S.-Iran War and Russ-Ukrainian War Here's an updated list of death tolls for recent wars. * 3,000 deaths in Lebanon as reported by the BBC. * 1,700 Iranian citizens are reported to have been killed in the recent US-Israeli war on Iran. * Thirteen U.S. military personnel also gave up their lives in this war.   * While estimates vary for the Russian-Ukrainian War, the best estimates we can find are 16,000 Ukrainian civilians and about 400 Russian civilians have been killed in that war. Worse yet, anywhere from hundreds of thousands to 3,000,000 Russian and Ukrainian soldiers have given up their lives in this conflict.  Jeremiah 25:32-33 speaks of God giving nations over to the devastation of war: “Thus says the Lord of hosts: “Behold, disaster shall go forth from nation to nation, and a great whirlwind shall be raised up from the farthest parts of the Earth. And, at that day, the slain of the Lord shall be from one end of the Earth even to the other end of the Earth.” Two teens killed three at Islamic Center in San Diego On May 18th, two teenagers killed three adults at the Islamic Center of San Diego including two staff members and a security guard, reports Fox News. San Diego Police Chief Scott Wahl said that the two suspects involved in the shooting, ages 17 and 19, are both dead from self-inflicted gunshot wounds. He also added these additional details. WAHL: “At about 11:43am, we received a call of an active shooter at the Islamic Center. Within four minutes, officers arrived on scene and observed immediately three deceased, what appeared to be deceased, victims out in front. They immediately began to deploy with an active shooter response into the mosque and adjacent school.” Wahl said the security guard “played a pivotal role” in preventing the attack from becoming even worse. GOP Senator Bill Cassidy lost primary in Louisiana Louisiana Republican Senator Bill Cassidy was ousted in Saturday's primary election. The longtime senator came in with a dismal 25% support.  He had served as a Congressman for six years and a Senator for 11 years. Cassidy was known for both his reluctance to support the Trump agenda and challenging Robert F. Kennedy Jr. during his confirmation to be Health and Human Services Secretary.   Plus, Cassidy was one of seven GOP senators to vote to convict President Trump in his second impeachment trial on February 13, 2021 after he had already finished his first term. The vote was 57-43. Louisiana Republicans will now pick between Congresswoman Julia Letlow, whom Trump endorsed, and State Treasurer John Fleming in the upcoming run-off since neither one secure 50-plus percent of the vote. New acting FDA Commissioner worked as Planned Parenthood attorney The new Acting Commissioner for the Food and Drug Administration, Kyle Diamantas, previously worked as an attorney for Planned Parenthood. Now he says he regrets taking on the role. Diamantas told Live Action that he was assigned a case for Planned Parenthood, and, despite his opposition to abortion, he took the case. However, he later regretted his decision and asked to be recused. Diamantas also confirmed that a review of the Abortion Kill Pill is a top priority for the department. Deficits and cost of living in America are up And finally, the U.S. Office of Budget and Management is estimating a national deficit of $2 trillion for this fiscal year. That's up 15% from Fiscal Year 2025 — the last year for which the Biden administration was responsible.   The Core Producer Price Index for this country has topped 5.2% —on a steady increase since last summer. The Producer Price Index stood at 2% in January of 2024, before the 2024 elections.  Food prices are up 32% since 2020. That's an annualized whopping 4.7% per year — a pinch on the average middle class family. Close And that's The Worldview on this Tuesday, May 19th, in the year of our Lord 2026. Subscribe for free by Spotify, Amazon Music, or by iTunes or email to our unique Christian newscast at www.TheWorldview.com.  Plus, you can get the Generations app through Google Play or The App Store. I'm Adam McManus  (Adam@TheWorldview.com). Seize the day for Jesus Christ.

Today's Headlines: Trump's personal aide Natalie Harp — dubbed the "Human Printer" by the Wall Street Journal — follows the president around with a printer for his Truth Social posts and is responsible for his midnight rage posting, including the Obama monkeys video, because no one else on his comms team has any visibility into what goes out at 2am. Trump returned from China having spent most of his time complimenting Xi Jinping's height, claiming Xi promised to stop arming Iran while continuing to buy their oil, getting nowhere on tariffs, and receiving a firm warning to back off Taiwan — which makes 70% of the world's semiconductors — with the one concrete outcome being China agreeing to buy 200 Boeing jets, which sent Boeing's stock down 4% because the market wanted 500. Kash Patel, meanwhile, used an FBI work trip to Hawaii to do a "VIP snorkel" around the USS Arizona at Pearl Harbor where snorkeling is explicitly prohibited, and is separately being reported to have padded the FBI's arrest statistics by adding people to the Most Wanted List right before they're captured. The FDA commissioner resigned after the administration approved blueberry, mango, and menthol flavored vaping pods over his objections, and RFK Jr.'s chief spokesperson quit the next day for the same reason — flavored vapes being, apparently, everyone's line in the sand. On a darker public health note, ProPublica found that the growing MAHA-driven trend of parents rejecting Vitamin K shots for newborns — not a vaccine, just a blood-clotting intervention — has led to a measurable increase in infant deaths from preventable brain bleeds. Two House members have been missing for weeks and are both running for reelection, PCOS has been renamed PMOS because the old name caused decades of misdiagnosis, Stephen Miller's wife is in talks with Paramount for a podcast deal, and King Charles announced the UK will finally prioritize banning conversion therapy, which several prime ministers have promised and never delivered. Resources/Articles mentioned: NYT: After Xi's Warning on Taiwan, He and Trump Strike Positive Tone: Live Updates on Trump's China Visit WSJ: The Late-Night Truth Social Storms That Offer a Window Into the President's Mind PBS: FBI Director Kash Patel took 'VIP snorkel' at a Pearl Harbor memorial, emails show MS Now: FBI insiders: Kash Patel is ‘padding the stats' to boost his record of arrests Forbes: 2 House Members Have Been Absent For Weeks, Missing Dozens Of Votes NYT: Marty Makary, Trump's F.D.A. Commissioner, Resigns After Weeks of Pressure The Hill: RFK Jr.'s chief HHS spokesperson resigns over flavored vapes ProPublica: Babies Are Bleeding to Death as Parents Reject a Vitamin Shot Given at Birth AP News: The condition PCOS is now called PMOS. What to know about the name change and what it means for care Axios: Scoop: Paramount in talks with Katie Miller for podcast deal as it eyes expansion Them: U.K. Government Pledges for Fifth Time in Eight Years to Ban Conversion Therapy Subscribe to the Betches News Room and join the Morning Announcements group chat. Go to: betchesnews.substack.com Morning Announcements is produced by Sami Sage and edited by Grace Hernandez-Johnson 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. Today, we're diving into some of the latest news shaping the industry, from breakthroughs in cancer therapies to advancements in AI-driven drug discovery. Starting with regulatory updates, the potential appointment of Richard Pazdur, M.D., as the new FDA Commissioner is causing quite a stir. Following Marty Makary's resignation, Pazdur has emerged as a prominent candidate due to his extensive background in oncology drug regulation. Known for his commitment to accelerating cancer therapy approvals, his potential leadership could maintain or even amplify the focus on expediting innovative treatments for cancer patients. In a significant regulatory achievement, Beone Medicines celebrated the FDA's approval of Beqalzi, marking it as the first BCL-2 inhibitor approved for mantle cell lymphoma. This approval challenges AbbVie's Venclexta and underscores a growing trend towards targeted cancer therapies that offer new treatment avenues for patients. The oncology space continues to be fiercely competitive, with companies striving to deliver more precise and effective cancer treatments. Turning to clinical trials, AstraZeneca's Imfinzi has shown promising results in a phase 3 trial focused on bladder cancer patients who are not eligible for cisplatin-based chemotherapy. These findings position Imfinzi as a strong competitor to Merck's Keytruda and reinforce AstraZeneca's strategic focus on expanding its oncology portfolio through novel combinations and indications. In the realm of genetic therapies, Regenxbio has achieved a milestone with its gene therapy for Duchenne muscular dystrophy. This therapy met its primary endpoint in pivotal trials, highlighting the potential of gene therapies to address rare diseases with limited treatment options. Such successes are likely to encourage further investment in gene editing technologies, which hold significant promise for tackling conditions once deemed untreatable. The FDA is also exploring frameworks to repurpose existing drugs for new uses by leveraging existing safety data. This could streamline drug development processes and offer cost-effective solutions for patients with complex conditions. However, this approach will need rigorous validation of efficacy in new indications to ensure patient safety and therapeutic effectiveness. Despite setbacks in its Alzheimer's research, Biogen remains steadfast in its efforts. While their tau-targeting candidate did not meet primary endpoints in a phase 2 trial, reductions in tau pathology and cognitive benefits were observed. This perseverance showcases Biogen's commitment to finding innovative approaches to tackle Alzheimer's disease despite ongoing challenges. On the operational front, Taiwan's Bora Group is acquiring Macrogenics' CDMO operations for up to $127.5 million. This move reflects a broader trend of consolidation within the CDMO space as companies aim to enhance their production capabilities and streamline operations. Quality control remains a critical concern as evidenced by Sun Pharma's recent recall of a chemotherapy batch due to glass particle contamination. Incidents like these underline the importance of stringent quality assurance measures throughout the manufacturing process to ensure patient safety. Moreover, Viz.ai has launched an AI-powered pulmonary care platform aimed at integrating acute and chronic care workflows. This development signals an increasing adoption of artificial intelligence in healthcare, promising improvements in diagnostics and patient management efficiency. AI continues to gain traction as Isomorphic Labs recently secured $2.1 billion in Series B funding aimed at enhancing AI-driven drug design models. Similarly, Charles River has introduced an AI-powered digital pathology platform poised to Support the show

On this week's episode, Sam Fazeli, Josh Schimmer, Eric Schmidt, and Tess Cameron kickoff with deals, highlighting the up to $15.2B Hengrui–BMS partnership and the broader trend of outsourcing early-stage drug development to China. The discussion continues with the co-hosts noting China's edge in speed, quality, and cost-efficiency, while underscoring that the strength of U.S. capital markets remains a key advantage. This week also saw a significant raise, with Isomorphic Labs announcing a $2.1B Series B. In regulatory news, the group described the departure of FDA Commissioner Dr. Marty Makary as creating fresh uncertainty around FDA leadership and direction as they speculated on his exit and who will replace him. On the data front, Regenxbio met the primary endpoint inits Phase 3 trial for Duchenne, though the hosts flagged potential investor skepticism around the side effects, limited data, and FDA uncertainty. Next, they discuss that Biogen and Ionis are advancing their Alzheimer's tau program despite mixed results. The co-hosts also mention Inhibrx's Phase 2 data in head and neck squamous cell carcinoma, as well as Moderna's Hantavirus vaccine research following the recent cruise ship outbreak. The episode concludes with a look ahead to upcoming conferences, including ASCO, ADA, and ATS. *This episode aired on May 15, 2026.

Get the facts, without the spin. UNBIASED offers a clear, impartial recap of US news, including politics, elections, legal news, and more. Hosted by lawyer Jordan Berman, each episode provides a recap of current political events plus breakdowns of complex concepts—like constitutional rights, recent Supreme Court rulings, and new legislation—in an easy-to-understand way. No personal opinions, just the facts you need to stay informed on the daily news that matters. If you miss how journalism used to be, you're in the right place. In today's episode: CIA Whistleblower Testifies Before Senate Committee Alleging Cover Up on COVID Origins (0:37) FDA Commissioner Dr. Marty Makary Resigns (7:16) California Mayor Admits to Acting as Chinese Agent (12:18) South Carolina Supreme Court Overturns Alex Murdaugh's Double Murder Conviction. Here's Why. (~19:38) Quick Hitters (~26:04) Rumor Has It: Are People Really Losing Their Deposits on the Trump T1 Smartphone? Did Mayor Mamdani Really Balance the NYC Budget? (~29:27) Critical Thinking Segment (~32:59) ⁠Watch⁠ this episode on YouTube. Follow Jordan on ⁠Instagram⁠ and ⁠TikTok⁠. All sources for this episode can be found ⁠here.⁠  Learn more about your ad choices. Visit podcastchoices.com/adchoices

In one of the most widely expected departures in recent memory, Marty Makary stepped down as head of the FDA this week. Meanwhile, the Supreme Court is considering blocking telehealth prescriptions for the abortion pill mifepristone. Lauren Weber of The Washington Post, Alice Miranda Ollstein of Politico, and Rachel Cohrs Zhang of Bloomberg News join KFF Health News' Julie Rovner to discuss these stories and more. Also this week, Rovner interviews Sen. Tammy Baldwin (D-Wis.) about health issues before Congress. Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too: Julie Rovner: ProPublica's “A Unique Oregon Law Allows It To Block Healthcare Deals. In Five Years, the State Hasn't Done So Once,” by Rob Davis. Rachel Cohrs Zhang: The Wall Street Journal's “Inside Marty Makary's Downfall at the FDA,” by Liz Essley Whyte and Josh Dawsey.  Alice Miranda Ollstein: Politico's “Lawmakers' Prescription Data at Risk After Data Breach,” by Katherine Tully-McManus.  Lauren Weber: Stat's “Alcohol Is Wreaking Havoc on U.S. Public Health. American Society Looks the Other Way,” by Lev Facher and Isabella Cueto. 

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into the dynamic shifts and breakthroughs shaping this ever-evolving industry. In a significant regulatory update, the resignation of FDA Commissioner Marty Makary has stirred discussions across the pharmaceutical landscape. Over his 13-month tenure, Makary faced considerable scrutiny for his controversial decisions, including the rejection of several rare disease drugs. This leadership change at the FDA may herald a period of uncertainty as the agency searches for new direction amidst criticisms and operational challenges. The implications are vast, potentially affecting drug approval processes and public health policies, making it crucial for stakeholders to watch closely how the agency adapts to this transition. Simultaneously, Takeda's announcement to lay off 4,500 employees marks a strategic move to streamline operations and focus on core competencies. This decision reflects a broader industry trend where companies are optimizing their structures to enhance financial health in a highly competitive market. The cost savings from this restructuring are expected to be substantial, allowing Takeda to pivot towards more sustainable business models and focus on areas that promise future growth. Eli Lilly and Novo Nordisk continue to lead in drug development with their GLP-1 receptor agonists. Both companies have reported promising data on early response and long-term weight loss maintenance in patients, positioning their therapies as pivotal in treating obesity. Eli Lilly's obesity treatments Foundayo (orforglipron) and Zepbound (tirzepatide) have shown sustained weight-loss maintenance in Phase 3 trials, reinforcing their efficacy in metabolic health interventions. These developments not only highlight the intense competition in the GLP-1 space but also underscore the potential impact on addressing global obesity challenges effectively. The strategic landscape of mergers and acquisitions is also evolving with Merck KGaA's announcement to bolster its pipeline through strategic M&A activities. This move is emblematic of an industry-wide strategy where companies seek external innovation to fill pipeline gaps, ensuring sustained growth and competitiveness. In a related vein, BioMarin's $4.8 billion acquisition of Amicus Therapeutics signifies a firm commitment to addressing unmet needs in rare diseases, illustrating how consolidation can enhance capabilities in niche markets with significant potential. In vaccine development, Valneva's decision to reduce its workforce by up to 15% highlights ongoing challenges in the sector, particularly for travel-related vaccines affected by global market trends. This restructuring is indicative of the volatility faced by companies as they adapt strategies for long-term sustainability amidst shifting consumer behaviors. Pfizer's expansion into Europe with its hemophilia treatment Hympavzi marks a critical regulatory milestone, broadening its market presence and offering expanded therapeutic options for patients. This approval not only strengthens Pfizer's foothold in the hemophilia market but also exemplifies the global reach of innovative treatments. Technological integration continues to revolutionize R&D processes, as evidenced by AstraZeneca's licensing agreement with Owkin for AI capabilities. This partnership aims to harness AI-driven insights for drug discovery, showcasing how technology is reshaping traditional research methodologies and enhancing efficiency. Similarly, advancements in AI-powered diagnostics are evidenced by Boehringer Ingelheim's collaboration with Brainomix in pulmonary fibrosis imaging, reflecting broader trends towards personalized medicine through precise disease characterization. Kyverna Therapeutics is advancing in cell therapy with Support the show

President Trump is in Beijing today meeting Chinese President Xi Jinping, with American manufacturers hoping for tariff relief even as the war in Iran looms over the high-stakes summit.The Pentagon told Congress they estimate the war in Iran has cost $29 billion dollars so far. Defense Secretary Pete Hegseth asked for $1.5 trillion dollars for next year's Pentagon budget.FDA Commissioner Dr. Marty Makary has resigned after thirteen months on the job, with the final straw being White House pressure to approve flavored vapes, something he refused to do.Want more analysis of the most important news of the day, plus a little fun? Subscribe to the Up First newsletter.Today's episode of Up First was edited by Miguel Macias, Jason Breslow, Kris Husted, Mohamad El-Bardicy and John Stolnis.It was produced by Ziad Buchh and Nia Dumas Our director is Christopher Thomas.We get engineering support from Neisha Heinis. And our Supervising Producer is Michael Lipkin.(0:00) Introduction(01:57) Trump In China(05:40) Hegseth Requests Wartime Budget(09:26) FDA Commissioner ResignsSee pcm.adswizz.com for information about our collection and use of personal data for sponsorship and to manage your podcast sponsorship preferences.NPR Privacy Policy

This is The Briefing, a daily analysis of news and events from a Christian worldview.On today's edition of The Briefing, Dr. Mohler discusses what to watch for as President Trump goes to Beijing, Chinese spies in U.S. political offices, the theater of international diplomacy, and the end of Dr. Marty Makary's tenure as FDA Commissioner.Part I (00:13 – 12:57)Statecraft on the World Stage: What to Watch For as President Trump Goes to BeijingPart II (12:57 – 18:19)Chinese Spies in U.S. Political Offices: China is Seeking to Subvert the American System, Which Includes Infiltrating America With Its Own AgentsCalifornia Mayor Will Plead Guilty to Working as Agent of China by The New York Times (Pooja Salhotra)He Offered a Lawmaker's Aide Quick Cash. Was He Spying for China? by The New York Times (Dustin Volz)Part III (18:19 – 22:27)Diplomatic Security and President Trump's Visit to China: Honor, Dignity, and the Deeply Serious (and Sometimes Absurd) Theater of International DiplomacyHow to Avoid Fistfights and Poisonings at a World Leaders Summit by The Wall Street Journal (Lingling Wei)Part IV (22:27 – 25:43)Dr. Marty Makary Spends His Ninth Political Life: Dr. Makary is Out as FDA Commissioner – This Could Be a Big Win for the Pro-Life MovementHawley Statement on Resignation of FDA Commissioner Makary by U.S. Senator for Missouri (Sen. Joshua Hawley)Sign up to receive The Briefing in your inbox every weekday morning.Follow Dr. Mohler:X | Instagram | Facebook | YouTubeFor more information on The Southern Baptist Theological Seminary, go to sbts.edu.For more information on Boyce College, just go to BoyceCollege.com.To write Dr. Mohler or submit a question for The Mailbox, go here.

FDA Commissioner Marty Makary resigned today. Guest: Rep. Brad Knott (R-NC) breaks down the ongoing FISA debate. // LongForm: GUEST: NewsNation host Katie Pavlich on the midterms and the latest developments in Iran. // Quick Hit: Part 2 with Katie Pavlich.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of significant shifts and advancements shaping our industry. Kicking off with a notable change in leadership, the resignation of FDA Commissioner Marty Makary signals an important realignment within the U.S. regulatory landscape. As the FDA grapples with complex challenges in drug approval and public health policy, this transition may influence future regulatory strategies. Makary's departure follows speculation about political tensions, with reports suggesting former President Trump considered his dismissal. Taking over as interim leader is Deputy Commissioner for Food Kyle Diamantas, whose expertise in food regulation might redirect the agency's approach toward drug approvals. This shift comes at a pivotal time as the FDA emphasizes real-world evidence and adaptive trial designs to enhance clinical efficiency. The leadership change not only reflects internal dynamics but also underscores how policy directions can impact drug development and patient access to new therapies. Meanwhile, strategic partnerships and market movements are reshaping industry dynamics. Pfizer and Arvinas have teamed up with Rigel Pharmaceuticals in a deal spotlighting targeted breast cancer therapies. With an upfront payment of $85 million for licensing Veppanu and potential milestone payments up to $320 million, this alliance strengthens Pfizer's oncology portfolio amid a growing focus on precision medicine. In contrast, Bayer's Eylea faces a 24% sales decline due to biosimilar competition, illustrating a broader challenge for companies dependent on established biologics. This trend highlights the necessity for innovation within ophthalmic treatments to maintain market position. Alkermes marks a significant milestone as its drug Lumryz successfully meets phase 3 trial endpoints for a rare sleep disorder. Following its acquisition of Avadel Pharmaceuticals, Alkermes is poised to expand its sleep disorder treatment offerings, providing new options where few alternatives exist. Cross-border collaborations are also gaining traction. Bristol Myers Squibb's $15 billion partnership with Hengrui Pharma leverages China's rapid R&D capabilities to advance 13 early-stage programs. Such alliances exemplify how global pharmaceutical giants are tapping into emerging markets to accelerate development timelines and enrich research pipelines. Regulatory efforts are evolving too, with the European Union pushing initiatives to enhance manufacturing autonomy and mitigate drug shortages within member states. This move addresses supply chain vulnerabilities exposed by recent global disruptions, aiming to secure critical medicine supplies through increased local production. AstraZeneca's challenges with immunogenicity issues in their endocrine disorder treatment underscore ongoing hurdles in biologics development. Despite significant investment, the molecule fell short against competitors like Ascendis Pharma's Yorvipath, highlighting the complexities of overcoming immune responses in therapeutic efficacy. Roche has achieved European approval for its second Alzheimer's disease test in collaboration with Eli Lilly, advancing diagnostic capabilities for this challenging condition. Earlier diagnosis can significantly impact treatment outcomes, marking a step forward in managing Alzheimer's disease effectively. Boehringer Ingelheim's €407 million investment in Immunitas Therapeutics demonstrates commitment to chronic inflammatory and autoimmune diseases. The focus on first-in-class biologics aligns with broader trends targeting unmet medical needs through innovative approaches. As we delve deeper into scientific advancements, Inhibrx Biosciences' phase 2 trial results offer promising developments in oncology treatment. Their combSupport the show

Labor Department says inflation in April was 3.8 percent year over year, highest in three years, with the Iran war driving up energy and food prices; Senate leaders weigh in on President Trump's proposal to suspend the federal gas tax as the average for a gallon hits $4.50; Pentagon Comptroller Jay Hurst testifies to House & Senate Appropriations subcommittees that the war with Iran has cost so far $29 billion.  Defense Secretary Pete Hegseth & Gen. Dan Caine, chair of the Joint Chiefs of Staff also testify about the Trump Administration's war strategy; President Trump heads to China for a visit with President Xi Jinping on the war with Iran, trade, AI and Taiwan, among other issues; $1 billion added for security upgrades to President Trump's White House ballroom reportedly gets a chilly reception from Senate Republicans; FBI Director Kash Patel is questioned at a Senate subcommittee hearing about news reports alleging  a pattern of unexplained absences and excessive drinking; Criminal indictments are announced against the companies that operated the ship that crashed into and collapsed the Francis Scott Key Bridge in Baltimore in 2024, killing six workers; FDA Commissioner Dr. Martin Makary says he is resigning; Sen. Ted Cruz (R-TX) does an impersonation of the late President John F. Kennedy setting the goal of going to the moon, complete with a Boston accent, to celebrate the recent Artemis II mission. Learn more about your ad choices. Visit megaphone.fm/adchoices

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

Multiple outlets are reporting that Trump is set to fire Food and Drug Administration Commissioner Marty Makary. The news comes after a tumultuous tenure since his installment as FDA head last year. Stephanie Sy speaks with Liz Whyte, health policy reporter at the Wall Street Journal, for more. PBS News is supported by - https://www.pbs.org/newshour/about/funders. Hosted on Acast. See acast.com/privacy

Escalating tensions in the Strait of Hormuz moving yields and markets... Carl Quintanilla, David Faber, and Sara Eisen kicked off the hour with a contrarian take from investors at the Milken Global Conference - before the team got the latest out from Washington and more on how to navigate the tech trade with one of the street's best, following new numbers from Palantir. Plus: chip stocks in focus after a few key results and a report Apple's contemplating new suppliers... Hear the CEO of On Semi breakdown the demand picture, along with more on some huge moves in the options market.    Elsewhere this hour: a deep-dive with the current Commissioner of the FDA - as he pushes back on growing criticism tied to drug approvals.    Squawk on the Street Disclaimer Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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

FDA Commissioner Dr. Marty Makary discusses President Trump's Executive Order aimed at faster research and access to psychedelics, citing promising research and calling this an 'historic moment.' He talks with Romaine Bostick and Katie Greifeld on "The Close."See omnystudio.com/listener for privacy information.

On this week's episode, Greg Suvannavejh, Josh Schimmer, Yaron Werber, Sam Fazeli, and special guest Financial Times journalist Oliver Barnes kick off by highlighting the strength of the biotech sector from a public markets perspective, noting the XBI has outperformed the S&P 500 so far this year. The group agrees biotech is in a solid position overall. In policy news, the co‑hosts discuss the latest on the Trump administration's proposed 100% pharma tariffs, Most Favored Nation drug pricing, and deals between big pharma and the administration. The conversation shifts to regulatory news, including changes to the CDC's ACIP charter, vaccine oversight concerns, and FDA Commissioner Dr. Marty Makary's press conference highlighting progress under his leadership. The group then highlights major deals, including Merck's $6.7 billion acquisition of Terns and details of the SEC filings, Gilead's $3.15 billion upfront deal for Tubulis, Neurocrine's $2.9 billion purchase of Soleno, and Garda Therapeutics' $125 million acquisition of Assertio. In breaking news, the co-hosts discuss Replimune's second CRL for its melanoma therapy. In data, the group highlights Ascendis' encouraging week‑52 achondroplasia data and Insmed's Phase 2 hidradenitis suppurativa results. The episode concludes with an update on the obesity landscape, including Lilly's newly approved oral GLP‑1, Novo's high‑dose Wegovy, and a Nature paper on GLP‑1 response variability. *This episode aired on April 10.

Deb (00:03.606)Within the next seven months, up to 1.5 million Americans could lose access to a medication that they’ve relied on for decades. Not because it’s dangerous, but because a pharmaceutical giant may have lobbied the FDA to eliminate their competition. And if you’re one of them, your doctor may already have told you about this issue and stopped prescribing it.This isn’t a conspiracy theory. This is documented in federal court filings. This is happening right now. And the company that stands to profit, well, they’re the same ones manufacturing the only product that might survive.Today on Let’s Talk Wellness Now, we’re exposing the desiccated thyroid extract crisis, the corporate manipulation behind it, and what you need to do right now to protect your health. Stay with me because I’m about to share what could save your access to the medication keeping you alive.Welcome back to Let’s Talk Wellness Now, the show where we uncover the root causes of chronic illness, expose regulatory capture in healthcare, and empower you with the tools to advocate for yourself. I’m Dr. Deb, naturopathic doctor, your medical detective, and today we’re diving into one of the most consequential and corrupt healthcare decisions affecting patients right now. If you or someone you love takes Armour thyroid, NP thyroid, or any desiccated thyroid extract,for hypothyroidism or if you’ve struggled to find a thyroid medication that actually works for your body, this episode is absolutely critical. And if you have celiac disease, gluten sensitivity or corn allergies, what I’m about to reveal will make your blood boil. Now grab your cup of coffee, don’t forget your notebook and settle in because what’s happening to this medication right now is a masterclass in how pharmaceutical companies use regular Deb (02:06.544)agencies to eliminate competition, control markets, and price gouge patients. And I have all the receipts. Deb (02:20.982)Let me start with what might surprise you. Desiccated thyroid extract, or DTE as we call it, is actually one of the most oldest thyroid medications in the world. And I mean old. From the 1890s through 1970, this was the standard treatment for hypothyroidism.Now let’s really dive into that. From the 1890s to the 1970s, this was standard hypothyroidism treatment.In 1965 alone, and this is documented in peer-reviewed literature published in the Journal of Clinical Endocrinology and Metabolism, approximately four out of every five prescriptions for thyroid hormone in the United States were of natural desiccated thyroid preparations.The Journal of Clinical Endocrinology and Metabolism is a very high-end journal. Now think about that. This wasn’t some fringe therapy. This was mainstream medicine. Armour Thyroid, the most recognizable brand name, has been manufactured since the early 1900s, well over a century ago.and this is cited again in NIH bookshelf. When the FDA was officially established in 1938, Arbor thyroid was already on the market. And this is important and I want you to understand why. Under the federal Food, Drug and Cosmetic Act, any drug that was already being marketed before 1938 was automatically grandfathered into the system. That means it didn’t have to Deb (04:08.112)go through the formal FDA approval process. And this again is cited under the Federal Food, Drug and Cosmetic Act, grandfathered drugs and exemptions. And this is crucial to understanding what happens next. By the 1970s, synthetic levothyroxine, brand name Synthroid and generics became the preferred treatment. Hmm, wonder why?It was easier to standardize, came into consistent doses, and worked well for most patients, and could be mass manufactured. By the 1980s, levothyroxine had largely replaced desiccated thyroid in clinical practice, according to the American Thyroid Association 2014 guidelines for the treatment of hypothyroidism. But here’s what matters. Some patients…a very significant minority of them, never felt right on levothyroxine alone. Despite their lab work looking normal, they still had fatigue, brain fog, weight gain, cold intolerance, and depression.These patients often found relief when they switched back to their desiccated thyroid, which contains both T4 and T3 hormones, the way human thyroid naturally produces them. And this is not anecdotal. This is documented in randomized double-blind crossover studies published in Endocrine Practice.For decades, that was fine. Their doctors prescribed it, insurance sometimes covered it, patients were getting better, and the system worked really well. Until August 6th of 2025, just a short time ago, everything changed. On that date, the FDA sent letters to manufacturers, importers, and distributors of desiccated thyroid extract products stating that these medications would need an approval. Deb (06:04.654)a biologics licensed application, a BLA, to remain legally on the market. And this is cited in the FDA’s official statement, FDA’s actions to address unapproved thyroid medications. understand it says unapproved thyroid medications. However, desiccated thyroid, specifically Armour, has been approved since 1938. And this was dated August 6th through 7th, 2025.This wasn’t a guideline. This wasn’t a suggestion. It was an endorsement of action. And the timeline they gave them? Well, just 12 months to transition patients to another medication before enforcement action could begin.This was also cited by an FDA notice to the industry, animal derived thyroid products notice to industry, August 6th, 2025. Now do the math, that means August 2026, seven months from now, 1.5 million Americans currently taking this medication. And this number comes from the FDA official statement, citing that it’s an estimation of 1.5 million patients receiving prescriptions for these medications.could potentially lose their thyroid access. Now, here’s where it gets interesting. The FDA didn’t wake up in August of 2025 and decide to regulate desiccated thyroid after a century. This decision has a much longer backstory. And understanding that backstory is critical to understanding what’s really happening in this industry.The shift started in 2022. Back in September of 2022, over three years ago, an FDA branch chief sent a letter to the National Associations of Boards of Pharmacy noting that the agency had decided to designate DTE as a biological product, which would affect its eligibility for compounding. Deb (08:13.972)This also is cited in an FDA letter to the National Association of Boards of Pharmacy September 2022.Then two months later, in November of 2022, the FDA’s Office of Compounding Quality and Compliance sent a softer letter acknowledging that many Americans take medication to treat hypothyroidism and some choose to take DTE products. The letter stated that the FDA would focus enforcement on cases that pose the greatest public health risks, such as serious adverse offense or serious product quality or adulteration.also is cited by an FDA letter from Francis G. Bromel, the director, Office of Compounding Quality and Compliance, November of 2022. Now, let me just think about this for a second. If this drug has been on the market since the 1800s, been FDA approved since 1938, would we not have seen a health crisis long before 2022?I honestly don’t know of any other drug that’s been around this long that’s used by this many people. Now granted, I haven’t done the research on it either, which I can do for you guys, but I’m just thinking if a drug is on the market today and it causes harm, it doesn’t make it three years, five years before you see lawsuits everywhere. Why are there no lawsuits on this drug? Why are there no major reactions that people are seen having?Hmm, just thought. But here’s the pattern. The FDA was already laying the groundwork back in 2022, testing the waters, signaling where this was headed. The August 2025 action. Then this came down. Deb (10:09.806)August 6, 2025, the FDA announced its position publicly and sent formal letters to all DTE manufacturers, importers, and distributors. This was cited by the FDA Enforcement Action August 6, 2025, letters to manufacturers, importers, distributions of DTE products. The agency stated several concerns. First, DTE products have experienced quality and dosing issues.The FDA cited, and I’m quoting directly from their statement, over 500 adverse events reported associated with DTE products from 1968 to 2025. From 1968 to 2025, we had 500 adverse reactions? What is that math equate to?A couple a year? Come on guys, this is insane! With a substantial increase, you, between 2019 and 2020 that the agency suggested was related to voluntary recalls of sub-potent or super-potent products.This was cited in the FDA statement, over 500 adverse events reported associated with ADT products from 1968 through 2025.Second, the agency expressed concern about batch inconsistency. According to the FDA’s official statements, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Okay, this was cited in the FDA statement, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Thirdly, and I want to actually let’s back up. I want you to remember I said that Deb (12:11.216)because further down in this podcast, we’re going to talk about this. This is an important point to remember. Thirdly, the agency raised concerns about potential impurities from animal source material, including potential for viral contamination due to the animal source and supraphysiological levels of T3.the FDA statement on impurities, viral contamination and super physiological T3 levels. Now I will tell you, I’ve been prescribing armarithograde for 20 years. I’ve rarely seen a super physiological dose given of T3 in lab results, unless the patient takes their medication like four or five hours before you do the blood test, then you’ll see a false rise because you’re actually seeing the medication. You’re not seeing people walking aroundsuperphysiological T3 levels. Nobody would like that feeling. So anyway, I digress. Now let me pause here because this is where I need to give you some context that the FDA hasn’t quite emphasized yet. Of course, we have another connection and it is the China connection.So the FDA’s concerns about contaminated drugs and quality issues don’t exist in a vacuum. In 2024, the U.S. over 828,000 metric tons of pharmaceuticals, seven times the level from 2000. And here’s the kicker. China and India supply the majority of active pharmaceutical ingredients. APIs for U.S. generics accounting for 70 to 80 % of the total genericdrug supply. According to Reuters industry report in 2024, they state that China supplies 82 % of the APIs for critical drugs. Deb (14:08.204)Got to question that, right? Why are we giving all of our drug formulas to China and allowing them to import them into our country? In fact, roughly 20 % of the critical drugs have APIs exclusively sourced from China. And China controls 80 to 90 % of the global production for antibiotics and other key compounds. This was also cited by Reuters industry data thatcontrols 80 to 90 percent of the global production for antibiotics and other key compounds. Now just think about this. They control 80 to 90 percent of our medication. They control 20 percent of our critical drugs and we just put what kind of tariff on them? Hmm.In 2025 alone, the FDA issued multiple warning letters to foreign manufacturers for contamination issues and failure to follow good manufacturing practices. This is also cited by the FDA warning letters 2024 through 2025 and multiple citations to foreign manufacturing facilities. This is a systematic problem affecting the entire US drug supply, not just desiccated thyroid.So when the FDA suddenly became concerned about DTE quality and contamination, part of that concern was legitimate. But this is crucial. The same inconsistencies and contamination issues exist across the entire generic drug supply. And the FDA has not taken the same enforcement action against them. Let that sink in.They have not taken the same enforcement action against the other drug companies. So what’s behind all of this? Where is this all coming from? Hmm. Let’s address something directly, because you deserve to know it. And I’m going to cite my sources precisely so that when the medical boards have something to say about this, and they might, I have a documentation for every single word that I am about to speak. Deb (16:24.878)According to the court documents filed in October 2025, in the case ofa urine, a urine. I’m going to say that wrong. Pharmaceuticals versus Dr. George Tidmarsh from ABBV, the multinational pharmaceutical company that manufactures armor thyroid, reportedly petitioned the FDA in 2024, asking the agency to reclassify DTE as a biologic and to prohibit other manufacturers from selling unlicensed DTE products unless they havehad an investigational new drug application, we call this an IND, and a clinical development program aimed at eventual approval. This is cited in the court filing a Urena pharmaceuticals lawsuit versus Dr. George Tidmarsh, October 2025, reported by Fierce Pharma. Now let me explain why this matters and why this is one of the most brazen examples of regulatory capture I’ve ever seen in my career.AbbeVee is one of the world’s largest pharmaceutical companies. In 2024, they reported over $54 billion in revenue. Drop the mic on that one.They have the resources, the regulatory expertise, the legal teams, and the financial capacity to navigate a biologics license application process that costs between $500 million and $1 billion. Let that sink in. Deb (18:07.882)A drug that’s been on the market since the 1800s that was grandfathered in 1938 that’s making plenty of money right now. They’re going to spend 500 million to $1 billion to get a biologics license application. Why would they do that? Well, we’re about to find out. Most otherDTE manufacturers, smaller companies like Acela Pharmaceuticals, which makes NP-thyroid, and RLC Labs, which made WP-thyroid, do not have those same resources. And this is cited in Pharma Voice in 2025. Why a treatment older than the FDA is getting new regulatory scrutiny. So when you petition the FDA to reclassify a drug in a way that requires this type of expensivetime-consuming biological approval, you’re not just asking for safety. You’re asking to eliminate your competitors from the marketplace. Now, I want to be very precise here. These allegations are documented in federal court filings, and it hasn’t been approved in court. It’s also been reported by multiple industry sources, including Fierce Pharma. But I’m telling you,what has been reported in legal proceedings, not stating it as an absolute fact because you deserve to know the difference and because I have to protect my license. Now, what do we know for certain?AbbeVee is working on a biologics license application for Armour thyroid through clinical trials called Avantia. This is cited by the AbbeVee corporate statement 2025 Avantia clinical trial for Armour thyroid. A cell of pharmaceuticals has been pursuing BLA approval for NP thyroid for seven years since 2017 and it completed its phase two trials successfully in 2025. They’re now moving Deb (20:15.448)into Phase 3 trials. This is also cited by the Acela Pharmaceuticals CEO statement 2025 seven-year pursuit for BLA approval completed Phase 2 trials moving to Phase 3.RLC Labs, which manufactured WP thyroid, has made no public announcement about pursuing BLA approval and really probably don’t have a plan to do this since they’ve been off the market for some time now. About five years, I think maybe a little longer. Here’s the market manipulation.If only ABBV is successful and obtains a BLA approval for Armour thyroid, that company would effectively have a monopoly on the DDT market. And in pharmaceutical markets, monopolies historically lead to price increases.We’ve seen this pattern over and over again when turning pharmaceuticals acquired Daraprim and raised their price from $13.50 to $750 per tablet overnight. When Myelin raised EpiPen increased prices by 400 % when insulin manufacturers colluded to raise prices in lockstep. This is the playbook.use regulatory barriers to eliminate your competition and then exploit pricing power. For a drug that’s been on the market since the 1800s, guess corporate greed is everywhere. They’re not making enough money on this product already and they’re taking advantage of the rules that they can manipulate their competition by. And here’s what really makes me furious. The American Thyroid Association, the professional organization Deb (22:06.672)representing endocrinologists sent letters to the FDA commissioner on October 8th of 2025 and September 18th of 2025.advocating for continued patient access to DTEs. This is cited in the American Thyroid Association statement and letter to the FDA commissioner dated October 8th, 2025 and September 18th, 2025. The American Association of Clinical Endocrinologists issued a statement on September 9th of 2025 supporting equitable access and personalized medicine for DTE. This was also cited in the American AssociationAssociation of Clinical Endocrinologists, AACE, statement dated September 9th, 2025. Even the medical establishment, which has historically favored levothyroxine, is saying, wait, this is going too far. Patients need access to this medication. But the FDA is moving forward anyway. Why? Well, where does it always lead us? Follow the money trail.Okay, so I need to explain what a biologics license application actually is because this is where the rubber meets the road for what’s going to happen to pricing and availability. What is a BLA?A BLA is a biologics license application. It’s a formal request submitted to the FDA to market a biologic product in the United States. A biologic is defined under the Public Health Service Act section 351 as a product derived from or made using living material, in this case, animal thyroid glands. And this is cited in the FDA definition for biologic products. So they’re putting armor thyroid right Deb (23:57.377)right up with stem cells and exosomes. Think about that. Stem cells and exosomes cost thousands of dollars per application because of how they have to be harvested, stored, freezed, all of that. But we’re talking about a thyroid gland. Good Lord, people.Unlike regular drug applications for synthetic medications which follow a simpler pathway, the BLA process is designed for complex biological products like monoclonal antibodies, vaccines, and gene therapy products. It’s a much more expensive, much more time-consuming process. The BLA processis what manufacturers have to do. And we’re going to talk about that. So according to Reprocell and Forge Biologics analysis of the FDA’s BLA process, here’s what companies need to submit. First, they need to complete a clinical trial data, phase one, two, and three trials, proving safety and efficacy for desiccated thyroid. Haven’t we done that since it’s been on the market since the 1800s? Just saying.This means they have to conduct large randomized controlled trials comparing it to levothyroxine, measuring safety outcomes, efficacy outcomes, and quality of life metrics. Second,Chemistry, Manufacturing and Controls, CMC’s data. Detailed information about how the product is manufactured, quality control measures, stability testing and specifications that must be met for every batch. Third, preclinical and animal safety data. Fourth, labeling and product information. Now, I think we have labeling and product information. Deb (25:53.717)since the 1800s? But just saying. Fifth, they need Pharma Covigilance Plan, a detailed plan for monitoring safety after the product is on the market. Haven’t they had to do that since the 1800s? And they have to have a timeline. And this is the critical part. The FDA’s standard review time for a BLA is 10 months.That’s after the application is deemed complete and accepted for filing. So this is cited by the FDA standard review timeline, BLA submission, and FDA review.Now, before you even get to filing, you need to conduct the clinical trials and compile all the data that’s typically several years of work. How are you going to prove safety and effectiveness in a large clinical trial long term? What do they consider? What do they deem long term? Three months, six months, a year, two years. These companies had 10 months.Well, maybe 12. They did it a year in advance. But unless you knew this was coming, how are you going to put together a trial, enroll the people, have all the trial components set up and ready to go in less than 12 months unless you knew it was coming beforehand? Even ifhad started all their clinical trials in 2024, completing them, compiling the data, and getting a complete application ready for submission, this would likely take you through mid-2026, then add another 10 months for FDA review. We’re looking at 2027 at the earliest for most of these companies to receive a BLA application. Deb (27:54.319)But the FDA gave the manufacturers until August of 2026. That’s approximately 19 months from when the August 2025 letters were sent. Most companies cannot reasonably complete the BLA approval in that timeframe. And when I’m talking about the 19 months, I’m talking about the information they would have had earlier. Now the cost.This gets me even more frustrated. Why are we spending this kind of money? The BLL process is extraordinarily expensive. The current FDA user fee for a BLA submission is approximately $483,560 just for the filing fee. And this is cited at the FDA user fees prescription drug user fee rates for 2025.The full cost of conducting clinical trials, CMC studies, and all the supporting documentation typically ranges from $500 million to over $1 billion, depending on the scope of the trials and the complexity. And this is cited in JAMA’s network, Open2023. A cell of pharmaceuticals has been pursuing the BLA approval since 2017. That’s eight years. And it’s just now.moving into phase three trials with a planned enrollment of approximately 300 patients. This is cited by the Acela Pharmacies CEO statement of 2025. Now that’s unusual. That’s typical for this process. This is not unusual. This is typical for this process to take seven, 10 years to get approval for this. So if Abby’s the one that requested this,Abby V. And Acela started this in 2017. Was Abby V threatened by Acela that Acela might get this approval and it would be quietly done without anybody seeing it? And maybe Abby V would be left out of the market after a century? Who knows? It’s possible. Deb (30:13.112)But for smaller manufacturers without billions in revenue, this cost is completely prohibitive. And this is why this matters. When you push an old established medication through an extraordinary, expensive approval process with a compromised timeline, one of three things happen. First, only the largest companies can afford it, creating a monopoly. And when that happens, the company that holds the only approved product can set pricing withminimal competitive pressures. Two, smaller manufacturers can’t afford it and their products disappear and the market shrinks and access decreases. Three, we see a combination of both and who pays the price? Literally, patients do. Now here’s whereThere’s something I want you to really think about because this is where the regulatory argument falls apart when you look at it carefully. The FDA’s concern about DTE is that, and I’m quoting their official statement, tablets from the same manufacturing batches may not always provide the same thyroid hormone levels. This is from their FDA statement.And that’s a legitimate quality concern, right? It is. Thyroid medications have a narrow therapeutic window like any other hormone, meaning the difference between an effective dose and the dose that causes problems can be quite small. But here’s what the FDA doesn’t emphasize. Generic drugs have the exact same dosing inconsistency issue, and it’s considered acceptable and has been since we allowed generics on the market.So how does a generic drug dose work anyway? Well, for generic drugs to be approved as bioequivalent to a brand name medication, the FDA requires that the generic drugs bioavailability fall within 80 to 125 % of the brand name product. Isn’t that a dose inconsistency? Deb (32:22.894)from the brand name medication? 800 or sorry, 80 to 125%. According to the pharmacy times analysis of the FDA’s bioequivalent standards, the 80 to 125 % bioequivalence rule means that a generic drug can have 20 to 45 % variability compared to the original brand product.Now, most generics are much closer than that. The FDA study data shows that the mean difference for an AUC value between generic and reference products is about three and a half percent in the two year post-Waxman hatch period, and 80 % of the generics fall within a five percent range. But the FDA’s regulations allow for that much higher variability. And this is cited in an FDA study data mean difference for AUC.Now, let me put this in plain language. A patient could take a generic levothyroxine tablet where one batch provides, say, 75 micrograms of an active thyroid hormone. And the next batch from a different manufacturer, a different generic manufacturer, could provide up to 93.75 micrograms, 125 % of that 75. That’s an 18 microgram difference.in the same prescribed dose. Now, this is considered acceptable and patients tolerate it and this system works.Yet the FDA’s argument against DTE is that batch-to-batch inconsistency is unacceptable and requires this expensive biologic approval? That’s a double standard. So why is batch inconsistency acceptable for generic levothyroxine, but supposedly unacceptable for desiccated thyroid? I’ll give you the regulatory answer. Deb (34:29.366)because DDT is a biological product derived from an animal tissue and the FDA considers biological products to require more rigorous control. That’s the regulatory answer, but I’ll give you the real answer.because there’s no billion dollar pharmaceutical company with a patent pending on generic levothyroxine who petitioned the FDA to regulate their competitors more strictly. The inconsistency argument is legitimate, but it’s selectively applied. And that matters when you’re trying to understand whether this is really about patient safety or whether it’s about market control.Now I want to talk about something that hasn’t gotten nearly enough attention in this discussion and it’s something that makes me absolutely furious. What is Armour Thyroid? According to the official prescribing information published by AbbeV and available through rxabbev.com and the FDA’s daily med database, Armour Thyroid contains the following inactive ingredients. Calcium steroid,dextrose derived from corn, mycocrystalline cellulose,sodium starch glycolate and a opadri white coating. Now let’s talk about dextrose. Dextrose is a sugar derived from corn and while manufacturers claim that the corn derived dextrose in armor thyroid is gluten free, here’s the problem. Cross contamination during corn processing can introduce gluten proteins especially if the corn is processed in facilities that also handle Deb (36:18.808)wheat, barley, or rye. Corn sensitivity is extremely common in patients with celiac disease and non-celiac gluten sensitivity, and studies show that up to 50 % of the celiac patients react to corn proteins due to molecular mimicry, and the corn proteins look similar enough to gluten that the immune system attacks them. And this is cited by RestartMD.com.And here’s what’s documented in peer-reviewed medical literature in a 2023 case report published in Case Reports in Endocrinology. These researchers documented five patients with gluten intolerance or celiac who were taking natural desiccated thyroid. Three of those patients also reported lactose intolerance. Now these patients had to switch from DTE to liquid levothyroxine formulations to avoid the inactiveSo here’s my question. If AbbeV becomes the only manufacturer with an approved DTE product and their formulations contain corn-derived dextrose that triggers reactions in celiac patients, what are those patients supposed to do? They can’t take armor because of the corn. They can’t take compounded DTE because the FDA is banning compounding of these biologics. They can’t take NPKsor WP thyroid because those companies may not survive the BLA process. So they’re left with a synthetic version of levothyroxine which may not work for them.Now the NP thyroid and WP thyroid difference. Now here’s what’s interesting according to drugs.com comparison of inactive ingredients and P thyroid and P thyroid has calcium steroid dextrose also derived from corn, mineral oil, multi-crystalline cellulose. Deb (38:19.31)cross carmelicin sodium and a opadri to white. So NP thyroid also has corn-derived dextrose. WP thyroid on the other hand was specifically formulated to be hypoallergenic according to ROC labs, but it’s no longer available and its ingredients were inulin from chicory root and medium chain triglycerides. No corn, no gluten, no common allergies. So todayWe do not have a glandular thyroid, a DTE, that is not potentially contaminated with gluten. Yet, patients with autoimmune thyroid disease are supposed to avoid gluten.Now, some of these people can handle a DTE and many cannot, so that argument could be a mute point. But at the end of the day, the one product that we had that was designated for patients with multiple chemical sensitivities, celiac disease and coron allergies, has been off the market for a long time already.We have a monopoly problem. So if ABBV becomes the only approved manufacturer, patients with these celiac diseases and corn allergies will either be forced to take a medicine that makes them sick and triggers their immune reaction or switch to a synthetic that doesn’t adequately treat their hypothyroidism or choose to go without treatment. This is not hypothetical. This is real patients with real medical needs who are about to lose accessto the only formulation that works for their body. And the FDA’s response is silence. Deb (40:07.69)Now I want to highlight something that hasn’t gotten nearly enough attention in this discussion. Compounding pharmacies. What is a compounding pharmacy? Compounded medications are custom made by licensed pharmacists to meet a patient’s specific needs. Maybe you need a different strength that was commercially available, but you have an allergy to a filler or a dye in the commercial product. Maybe you need a liquid formulation or instead of a tablet or you need a capsule. That’s when compoundingin. And the FDA’s, this is the FDA’s definition of compounding. And for decades, compounding pharmacies have been making desiccated thyroid extract for patients who needed customization. Some patients couldn’t take the commercial products because of the dyes and the fillers, and some needed strengths that were not available. And these compounding pharmacies filled the gap.But reclassification changes everything. When the FDA reclassified DTE as a biologic in 2022 and reinforced that decision in August of 2025, explicitly stated, and I’m quoting directly from the FDA’s official statement, these unapproved animal-derived thyroid medications are not eligible for compounding because these products are regulated as biologic products under the Public Health Service Act.How can that be? These products have been approved since 1938 and the Biologics Act didn’t go into effect or doesn’t go into effect until August of 2026.So how in 2022 were they able to say that the compounding pharmacies could not make these products? Anyway, what this means is after August 2026, compounding pharmacies will no longer be permitted to compound a desiccated thyroid extract, even for patients with specific medical needs. Now, compounding pharmacies can still compound T4 and T3 separately, synthetic versions of levothyroxine and liothyronine, according to Deb (42:12.728)healing dose compounding pharmacy. These pharmacists can create custom ratios of these two synthetic hormones to approximate what a patient was receiving from a DTE. But that’s not the same thing. Some patients respond better to the whole DTE preparation than to a compounded synthetic combination. And for patients with specific allergies to standard fillers like your celiac patients that I just talked about, losing the ability to get a compounded DTE alternative isreal hardship. This is going to be a ripple effect. For a subset of patients, maybe 5 to 10 percent of those on DTE compounding was their lifeline and it was their way to get a medication formulation that worked for their unique body. When compounding goes away, these patients lose that option as well and for some it will be a significant problem. Now let’s talk about what this likely means for your wallet.The current pricing right now, according to SingleCare and GoodRx, Armour Thyroid costs approximately $150 to $157 for a 90-day supply of 60-milligram tablets, about $1.67 per tablet. With discount cards, some patients can get it down to $101 to $152 for a 90-day supply.Generic levon thyroxine costs about $70 for a 90 day supply, less than half that price. And p-thyroid costs approximately $133 for a 90 day supply of 60 milligrams with a discount card about $83 to $101.What happens after we get BLA approval? Well, here’s the pharmaceuticals pricing model. When a company spends 500 million to $1 billion to bring a product to market, including conducting massive clinical trials, the cost tens of millions of dollars they recoup in that investment through pricing power. And this is cited in the pharmaceutical pricing models. If ABBIEV is the only company with an approved BLA of DTE, Deb (44:18.248)They have pricing power. They don’t have competitors. They can set their price, whatever they want. And historically, when drugs transition from grandfather status, which is basically unregulated to formal formally approved status, prices often increase significantly, not always, but often. And typically they have to get re-approval for insurance. SoTouring Pharmaceuticals acquired DARPM and raised the price again from $1,350 to $750 overnight, a 5,000 % increase. This is the playbook.Let’s talk about insurance coverage. This is the other consideration. Insurance companies sometimes have different coverage policies for approved versions versus unapproved drugs. And right now, many insurance plans cover armor thyroid or NP thyroid, even though they’re technically unapproved because they’ve been on the market for decades and patients are on them. Once a drug becomes formally approved, insurance companies may have new contractual relationships, prior authorization requirements, or preferred drugs.list that could affect your coverage. If 1.5 million people have to get a prior auth for their insurance to cover this new medication, this is going to drive the doctor’s offices crazy. We do not have the staff to man this. We do not have the manpower. We do not have the time. This is going to interrupt people’s ability to get their medications. This is going to create chaos within the system. And some patients might see better coverage, but manymost likely are going to see worse coverage and some might find themselves in a situation where they need to try to get the drug approved first or get an approval for something else like levothyroxine and they’re going to have to document that it didn’t work and the documentation that they had from 20 years ago is probably not going to be enough because it’s not documented anywhere. It’s lost in the system after 10 years. So for patients the practical takeaway is expect Deb (46:25.774)a price increase. I would say possible, but I don’t think that’s true. think you’re going to see a price increase if they get approved. Expect possible insurance complexities, budget accordingly, talk to your insurance company now about what your coverage is going to look like in 2027 if they even know. And if you want my honest assessment of what is likely to happen,I’ll give you a scenario, 30 % likelihood. The FDA enforces the August 26 deadline and DTE products not approved by then are pulled from the market. Patients will have 30 to 90 days to transition to other medications. Some patients suffer significant symptom relapse. Compounding for DTE becomes illegal and this disruptiveness of the system creates a real hardship. Scenario two.which is 50 % likely. This is actually what the FDA commissioner, Marty McCreary suggested on August 13th of 2025 when he posted on social media. The FDA is committed to pursuing the first ever approval of desiccated thyroid access pending results of the ongoing clinical trials. In the meantime, we’ll ensure access for all Americans. Hopefully that continues. What this likely means is the FDA uses enforcement discretion to allow continuedsales while approvals are being pursued and the deadline gets extended. Maybe patients get access for another two to three years while companies work on a BLA approval. This would be the least disruptive scenario, but it’s also legally uncertain because the enforcement letters have been formally rescinded. And scenario three, which is 20 % likelihood, one or two companies get BLA approval. Those products stay on the market at higher product prices and companies, products, other companiescompanies, products are pulled, the market shrinks, availability is limited, prices are higher, but patients can still get something. This is likely if a seller successfully completes phase three trials for NP-thyroid. And my assessment is based on the regulatory language and the enforcement letters that have not been rescinded yet, that the pattern of FDA enforcement, I believe scenario two enforcement discretion with an extended time frame is most likely what we’re going to see. Deb (48:49.488)doesn’t mean patients should sit back and do nothing. It means you should be prepared for change while advocating for access. If you want to keep Arm or Thigh Right on the market, 1.5 million people need to start talking about this publicly and flooding our Congress people, Bobby Kennedy, the FDA, with what you want to see happen. We have the ability to shape this and to change this with our voice. But if we sit back on our laurels and we do absolutelynothing. What is going to happen is what the FDA wants to have happen and ABV wants to have happen because they’re going to simply think people don’t give a shit. And if the American people are going to be lazy and not want to step forward and actually start using their voice for some good and instead of just going to social media and bitching and hoping something is going to happen, well, then we’re going to get what we deserve. But if you start taking someaction and you start advocating for the things that you want. Contacting your representatives, contacting your U.S. tell them the FDA has done this. Many of them may not know this, may not be on their radar. Tell them what you want. Start going after this. Start writing to the FDA Commissioner’s Office. They have a website. They have a Commissioner’s Office at fda.hhs.gov. Be responsible.respectful, but be firm. Explain your scenario. How long you’ve been on DTE. Why levothyroxine doesn’t work. What symptoms you experience when not adequately treated. How this decision will affect your quality of life and your pocketbook. Let’s do something proactive. So let’s consider this. Moving forward, work with your provider who understands the regulatory landscape around DTE. You can discuss the evidence for and against combination therapy.You can monitor for thyroid function with free T3 and free T4 testing, not just TSH. If you’re willing to try individualized approaches, you can do that. If you need help finding a functional medicine provider who understands this issue, come to serenityhealthcarecenter.com or explorethevanari.com. It’s a self-directed functional medicine support group. And right now what is happening is going to shape how history Deb (51:19.024)is made with not just armor thyroid, but many drugs to come. And it is important for you to take action. So I want to thank you for joining me today on Let’s Talk Wellness Now. This episode is about far more than thyroid medication. It’s about your right to personalized medical treatment. It’s about your regulatory capture and corporate influence. And it’s about what happens when billion dollar companies shape healthcare policy in ways that reduce patient choice and increase their profits.this episode resonates with you or you know somebody who’s going to be affected by desiccated thyroid, please share it. Post it on social media, send it to your doctor, email it to your representatives, tag AbbeVee, tag FDA. Make noise because the only way we stop this is if we make it too politically costly for them to continue. Your voice truly matters. Your health truly matters and you deserve access to treatments that work best for your unique body.If you’re ready to explore comprehensive personalized health care that puts you in control, visit us at SerenityHealthCareCenter.com. Learn more about functional medicine approaches to thyroid and beyond and explore my new platform, Venari.com, which is a self-directed functional medicine tool. Thank you for joining me today. Until next time, I’m Dr. Deb reminding you, your health is your responsibility, your choice, and your right. Be well, stay informed, fight back.and I’ll see you in the next episode. And if you’re looking for a full citation list of this episode, you can head over to letstalkwellnessnow.com and I will post all the citations for you so you have them in your arsenal as well. Thank you again.The post Episode 259 – The Desiccated Thyroid Crisis: FDA's Unseen Impact & Corporate Manipulation first appeared on Let's Talk Wellness Now.

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs and special guest Dave Wallace, executive editor of Generics Bulletin, discuss the generic industry's future direction and priorities (:27) and the impact of recent policy moves on the biosimilar industry (12:28) following their trade association's annual meeting, as well as US Food and Drug Administration Commissioner Martin Makary's comment on compassionate use and the concern it may have caused industry (20:23). More On These Topics From The Pink Sheet The State Of The Off-Patent Union: AAM's Murphy Sets Out US Achievements And Obstacles: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/the-state-of-the-off-patent-union-aams-murphy-sets-out-achievements-and-obstacles-in-us-IHJH2CZBX5GGTI6UJQVE2WO2G4/ ‘Biology Is Dirty': HHS's Principal Deputy Counsel On How Biosimilar Firms Can Help US FDA: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biology-is-dirty-hhss-principal-deputy-counsel-on-how-biosimilar-firms-can-help-us-fda-2GEAUSXNMRCYNIXPS7P6IAYESE/ Makary's Compassionate Use Comments, Later Clarified, Still May Startle Industry: https://insights.citeline.com/pink-sheet/rare-diseases/makarys-compassionate-use-comments-later-clarified-still-may-startle-industry-XPBVZ6MH7FC7JKP2XEL4ZESWSE/

FDA Commissioner Dr. Marty Makary convenes top researchers to confront the surge in food allergies, warning past medical advice to avoid allergens helped fuel today's crisis - and then joins AM Update for an exclusive interview. Dr. Casey Means tells senators America is the world's most chronically ill wealthy nation, arguing public health must target root causes, not just treatment at her confirmation hearing for Surgeon General. Bill Gates admits his relationship with Jeffrey Epstein was a “huge mistake,” saying he saw nothing illegal but acknowledging the association cast a shadow over his foundation. New polling shows Congresswoman Jasmine Crockett surging ahead in the Texas Democrat Senate primary as turnout rises and the race enters its final days.   PureTalk: Tired of big wireless prices? Switch to PureTalk for unlimited talk and text for $25/month—dial #250 and say MEGYN KELLY for 50% off your first month.   Herald Group: Learn more at https://GuardYourCard.com Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

After reporting a strong quarter, Nvidia CEO Jensen Huang speaks to Becky Quick about his company's future and the future of the AI landscape–including the ongoing standoff between Anthropic and the Pentagon. FDA Commissioner Dr. Marty Makary discusses the agency's push for reforms and expedited drug approvals, particularly for rare disease therapies. Plus, Beast Games Season 2 finale is out on Amazon Prime, and season three is already in preproduction. Beast Industries CEO Jeff Housenbold discusses his ambitions of building another Disney while producing the most-followed person on the internet, Mr. Beast.    Dr. Marty Makary - 17:16 Jeff Housenbold - 33:30   In this episode: Dr. Marty Makary, @DrMakaryFDA Jeff Housenbold, @jtbold Joe Kernen, @JoeSquawk Becky Quick, @BeckyQuick Andrew Ross Sorkin,  @andrewrsorkin Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Wes, Eneasz, and David keep the rationalist community informed about what's going on outside of the rationalist communitySupport us on Substack!News links:Grand jury rejected charges against Congresspeople who made the “you can disobey unlawful orders” videoJim O'Neill fired from HHSBut he's going to lead the National Science Foundation?feds leaving Minnesota for realFormer SK President sentenced to life in prisonNewsLiberation Day is canceled!Trump is definitely going to reinstate the tariffs claiming fake authority under some other statuteOriginally IEEPA had a legislative veto, but SCOTUS killed it in the 80'sNo Republican Senate candidate in NMThe FDA is ruining biotechUpdate: Trump intervened and now the review is back on!EPA overturned finding allowing them to regulate greenhouse emissionsTrump is trying to cancel bridge project between US & CanadaThe Snow Mexicans double-touched the stone!They also lost to the US in the closest thing they have to a source of national prideAlso, the Poutine Beaners announced a plan to reach 2% of their GDP being spent on defense, but only buying exclusively from Canadian defense companies. The problem is that Canada doesn't have any of those.Your AI is not a lawyerSeeDance is making full-ass multi-minute films.Anthropic says they'll pay for 100% of the grid upgrades needed to interconnect our data centersCENTCOM continues to collect American military hardware like its pokemonTrump announced a 10-day deadline for Iran to agree to a nuclear deal or “bad things happen”Big military buildup near IranIn retaliation for a Mexican operation that killed the leader of the CJNG leader “El Mencho”, the cartel erected roadblocks of burning cars, engaged in street violence, and issued threats against American tourists.Netherlands taxing unrealized capital gainsThey've actually been doing this for almost a decade, in an even stupider wayHappy News!FDA Commissioner: “everything should be over the counter” unless a drug is unsafe, addictive or requires monitoringSingapore is successfully eliminating mosquitosSan Francisco is working on eliminating zombies!Chinese researchers have created injectable “bone glue”In ten years, Israel almost got rid of cystic fibrosis among newbornsAella has released her Bink Kink Dataset and a tool to play with it!Tesla FSD has saved many lives. Here's another one.Insurance exists that will give you 50% off your premium when you drive with Self-Driving mode onTroop DeploymentDavid - The Mind Killer Podcast's long overdue Land AcknowledgementEneasz - Is your life better or worse due to your use of social media?Got something to say? Come chat with us on the Bayesian Conspiracy Discord or email us at themindkillerpodcast@gmail.com. Say something smart and we'll mention you on the next show!Follow us!Feedburner RSSPocket CastsApple PodcastsIntro/outro music: On Sale by Golden Duck Orchestra This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit mindkiller.substack.com/subscribe

This week on Face the Nation, mindful of the upcoming midterm elections, the Trump administration moderates its tone on deportations while ramping up efforts to undermine confidence in our election process. With Congressional efforts to agree on reforms tied to DHS funding stalled, we'll talk to a Texas Republican Congressman Tony Gonzales. His district is home to that family detention facility that housed five-year-old Liam Ramos and his father last month. Plus, President Trump prods Republicans to nationalize voting, a move that prompts pushback from Democrats and state election officials. And what's behind the FBI's seizure of 2020 election records from Fulton County, Georgia?  We'll talk to the top Democrat on the Senate Intelligence Committee Mark Warner and elections expert David Becker. Finally, we'll talk to former FDA Commissioner Dr. Scott Gottlieb about the alarming spread of measles around the U.S .and get his take on evolving vaccine protocols. 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

The CDC announced Monday a major overhaul of the U.S. childhood vaccine schedule, reducing the number of routine immunizations recommended for children. In December, President Trump directed Health and Human Services officials to examine how other developed nations schedule vaccines and to reconsider the U.S. approach. FDA Commissioner Dr. Marty Makary said the changes are intended to restore public trust in health institutions that was lost during the pandemic. However, criticism has been fierce. Lawmakers on both sides of the aisle have pushed back, and the American Academy of Pediatrics has called the move dangerous and unnecessary. Vaccine schedules are handled by the states, meaning states may continue to mandate certain vaccines for school attendance. The updated recommendations also do not eliminate insurance coverage for any vaccines. The CDC changes create three categories. The eleven vaccines that remain in the recommended category include measles, mumps, rubella, polio, pertussis, HPV, and chickenpox. A second category recommends vaccines for individuals considered high-risk, including hepatitis A and B and RSV. The third category includes vaccines available by personal choice after consultation with a doctor, including COVID-19, flu, rotavirus, and others. Earlier this week, former CDC Director Dr. Robert Redfield joined FOX News Rundown host Jessica Rosenthal to discuss the new and reduced childhood vaccine schedule recommendations. Dr. Redfield, author of the new book Redfield's Warning: What I Learned (But Couldn't Tell You) Might Save Your Life, explained why he supports the changes, while also emphasizing the importance of doctors clearly explaining the benefits of vaccines. He also discussed why public trust has eroded and why encouraging vaccine choice and transparency could ultimately lead more Americans to get the shots needed to protect themselves from disease. We often have to cut interviews short during the week, but we thought you might like to hear the full conversation. Today on Fox News Rundown Extra, we share our entire interview with former CDC Director Dr. Robert Redfield—and more of his perspective on vaccines. Learn more about your ad choices. Visit podcastchoices.com/adchoices

The CDC announced Monday a major overhaul of the U.S. childhood vaccine schedule, reducing the number of routine immunizations recommended for children. In December, President Trump directed Health and Human Services officials to examine how other developed nations schedule vaccines and to reconsider the U.S. approach. FDA Commissioner Dr. Marty Makary said the changes are intended to restore public trust in health institutions that was lost during the pandemic. However, criticism has been fierce. Lawmakers on both sides of the aisle have pushed back, and the American Academy of Pediatrics has called the move dangerous and unnecessary. Vaccine schedules are handled by the states, meaning states may continue to mandate certain vaccines for school attendance. The updated recommendations also do not eliminate insurance coverage for any vaccines. The CDC changes create three categories. The eleven vaccines that remain in the recommended category include measles, mumps, rubella, polio, pertussis, HPV, and chickenpox. A second category recommends vaccines for individuals considered high-risk, including hepatitis A and B and RSV. The third category includes vaccines available by personal choice after consultation with a doctor, including COVID-19, flu, rotavirus, and others. Earlier this week, former CDC Director Dr. Robert Redfield joined FOX News Rundown host Jessica Rosenthal to discuss the new and reduced childhood vaccine schedule recommendations. Dr. Redfield, author of the new book Redfield's Warning: What I Learned (But Couldn't Tell You) Might Save Your Life, explained why he supports the changes, while also emphasizing the importance of doctors clearly explaining the benefits of vaccines. He also discussed why public trust has eroded and why encouraging vaccine choice and transparency could ultimately lead more Americans to get the shots needed to protect themselves from disease. We often have to cut interviews short during the week, but we thought you might like to hear the full conversation. Today on Fox News Rundown Extra, we share our entire interview with former CDC Director Dr. Robert Redfield—and more of his perspective on vaccines. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Pulitzer Prize-winning NYTimes Opinion columnist Tom Friedman shares his perspective on the United States' indefinite involvement in Venezuela. He warns that without a pathway toward functioning democracy, the country's “mafia leadership” may remain in place. President Trump is speaking out against defense company stock dividends and buybacks. Plus, Becky Quick shares her personal connection to CNBC's newest initiative, CNBC Cures. In a conversation with former FDA Commissioner Dr. Scott Gottlieb, she discusses the scale of rare diseases and the regulatory hurdles that impact treatments for diagnoses like that of her own daughter, Kaylie. Join us in advancing awareness and understanding of rare diseases. Listen to The Path with Becky Quick, and visit CNBC.com/Cures to access clips, resources, or to sign up for our weekly newsletter.  Tom Friedman - 13:05Dr. Scott Gottlieb - 26:06 In this episode:Becky Quick, @BeckyQuickJoe Kernen, @JoeSquawkAndrew Ross Sorkin, @andrewrsorkinKatie Kramer, @Kramer_Katie Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

The people running our federal health agencies have finally pulled back the curtain, and what they're revealing changes everything we thought we knew about how decisions get made at the highest levels of government. In this groundbreaking conversation, FDA Commissioner Dr. Marty Makary discusses the sweeping reforms transforming America's approach to food safety, drug approvals, and medical transparency under the Make America Healthy Again initiative. What would you change first if you had the power to reform our entire healthcare system?  CLICK HERE TO BECOME GARYS VIP!: ⁠https://bit.ly/4ai0Xwg⁠ Get Dr. Marty Makary's book, “Blind Spots“ here: ⁠https://bit.ly/3MIcg9x⁠ Connect with Dr. Marty Makary Website: ⁠https://bit.ly/48JPxCD⁠  YouTube: ⁠https://bit.ly/4j2IBUx⁠  Instagram: ⁠https://bit.ly/4qaIicv⁠  TikTok: ⁠https://bit.ly/48UlOFK⁠  Facebook: ⁠https://bit.ly/4pJ9QG4⁠  X.com: ⁠https://bit.ly/4pIWGcd⁠  Thank you to our partners H2TABS: “ULTIMATE10” FOR 10% OFF: ⁠https://bit.ly/4hMNdgg⁠ BODYHEALTH: “ULTIMATE20” FOR 20% OFF: ⁠http://bit.ly/4e5IjsV⁠ BAJA GOLD: "ULTIMATE10" FOR 10% OFF: ⁠https://bit.ly/3WSBqUa⁠ COLD LIFE: THE ULTIMATE HUMAN PLUNGE: ⁠https://bit.ly/4eULUKp⁠ WHOOP: JOIN AND GET 1 FREE MONTH!: ⁠https://bit.ly/3VQ0nzW⁠ AION: “ULTIMATE10” FOR 10% OFF: ⁠https://bit.ly/4h6KHAD⁠ A-GAME: “ULTIMATE15” FOR 15% OFF: ⁠http://bit.ly/4kek1ij⁠ PEPTUAL: “TUH10” FOR 10% OFF: ⁠https://bit.ly/4mKxgcn⁠ CARAWAY: “ULTIMATE” FOR 10% OFF: ⁠https://bit.ly/3Q1VmkC⁠ HEALF: 10% OFF YOUR ORDER: ⁠https://bit.ly/41HJg6S⁠ RHO NUTRITION: “ULTIMATE15” FOR 15% OFF: ⁠https://bit.ly/44fFza0⁠ GOPUFF: GET YOUR FAVORITE SNACK!: ⁠https://bit.ly/4obIFDC⁠ GENETIC METHYLATION TEST (UK ONLY): ⁠https://bit.ly/48QJJrk⁠ GENETIC TEST (USA ONLY): ⁠⁠https://bit.ly/3Yg1Uk9⁠ Watch  the “Ultimate Human Podcast” every Tuesday & Thursday at 9AM EST: YouTube: ⁠https://bit.ly/3RPQYX8⁠ Podcasts: ⁠https://bit.ly/3RQftU0⁠ Connect with Gary Brecka Instagram: ⁠https://bit.ly/3RPpnFs⁠ TikTok: ⁠https://bit.ly/4coJ8fo⁠ X: ⁠https://bit.ly/3Opc8tf⁠ Facebook: ⁠https://bit.ly/464VA1H⁠ LinkedIn: ⁠https://bit.ly/4hH7Ri2⁠ Website: ⁠https://bit.ly/4eLDbdU⁠ Merch: ⁠https://bit.ly/4aBpOM1⁠ Newsletter: ⁠https://bit.ly/47ejrws⁠ Ask Gary: ⁠https://bit.ly/3PEAJuG⁠ Timestamps 00:00 Intro of Show 03:29 Leading the Food and Drug Administration 07:22 Setting the FDA's Mission and Agenda 12:12 Time to Change the Medical Educational System 17:01 Going through the FDA's Agenda 22:48 Rewriting the Food Dietary Guidelines 27:13 Unveiling the Scientific Data 30:01 The Truth behind Hormone Therapy 37:32 Dr. Marty's Vision for the FDA 39:19 Are Children Over-Vaccinated? 43:21 FDA's Movement on Vaccination 45:48 FDA Belongs to the American People, Not the Big Pharma 46:41 FDA on Peptides, Stem Cells, and Other Unconventional Therapies 48:14 Scientific Data on Gut Microbiome (Addressing Cancer, Diabetes) 1:14:31 FDA's Challenges against Political Bureaucracy  1:17:01 What does it mean to you to be an Ultimate Human? The Ultimate Human with Gary Brecka Podcast is for general informational purposes only and does not constitute the practice of medicine, nursing or other professional health care services, including the giving of medical advice, and no doctor/patient relationship is formed. The use of information on this podcast or materials linked from this podcast is at the user's own risk. The Content of this podcast is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Users should not disregard or delay in obtaining medical advice for any medical condition they may have and should seek the assistance of their health care professionals for any such conditions. Learn more about your ad choices. Visit megaphone.fm/adchoices

As President Trump continues his nationwide tour to tout his economic policies, some in his party are concerned that voters won't feel the effects of an improving economy in time for next year's midterm elections, especially with the soon to expire Obamacare subsidies on track to raise insurance premiums for millions of Americans. FOX News Senior White House Correspondent Jacqui Heinrich joins the Rundown to explain what the economic outlook is like on Capitol Hill, and where the big picture numbers differ from everyday reality. Later, FDA Commissioner Dr. Marty Makary joins to give an inside look on what the Administration is doing to lower healthcare costs for Americans. Learn more about your ad choices. Visit podcastchoices.com/adchoices

President Trump delivered a primetime address to the nation from the White House, laying out what he says are his administration's key accomplishments over the past year and his plans for the future. FOX's Jessica Rosenthal and Jared Halpern break down the speech, including his economic claims, messaging on tariffs and inflation, and his administration's efforts to secure the border. The push to make more prescription drugs in the U.S. is accelerating, with new pharmaceutical manufacturing investments now expanding in various states including North Carolina. After years of shortages tied to overseas production, the Trump administration is leaning on incentives, tariffs, and faster approvals to bring drugmaking back home. FDA Commissioner Dr. Marty Makary joins the Rundown to explain how quickly new facilities can come online, and what it could mean for supply stability and drug prices.  Plus, commentary by David Marcus, FOX News Digital columnist. Learn more about your ad choices. Visit podcastchoices.com/adchoices

The 2025 New York Times DealBook Summit has wrapped, and Andrew Ross Sorkin is back on the Squawk Box set to discuss the highlights with Joe Kernen. He shares the best moments from interviews with Israeli Prime Minister Benjamin Netanyahu, Palantir's Alex Karp, Anthropic's Dario Amodei, California Governor Gavin Newsom, Turning Point USA's Erika Kirk, and Treasury Secretary Scott Bessent. Secretary Bessent, separately, is reportedly in consideration to lead the National Economic Council, should current NEC director Kevin Hassett be named the next Federal Reserve Chair. Then, former FDA Commissioner Dr. Scott Gottlieb discusses his concerns about the Trump administration's approach to regulating vaccines. Dr. Scott Gottlieb - 17:27In this episode:Joe 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.

This week, Dr. Marty Makary — the newly confirmed FDA Commissioner, surgeon, researcher, and bestselling author — joins us to pull back the curtain on what he discovered inside the agency and why it made him furious. We get into the internal pressure, the conflicts of interest, how dissent was punished, and what he, Trump, and RFK are doing to overhaul food, drug, and vaccine regulation. He also dives into Tylenol in pregnancy, hormone therapy myths, over-vaccination, and what real accountability should look like.Thank you to our sponsors!GEVITI: Use code ALEX to get 20% off your first purchasePALEOVALLEY: Use code ALEX for 15% off your first orderA'DEL NATURAL COSMETICS: Use code ALEX for 25% off first-time ordersUTZY: Use code ALEX for 20% off, or FIXMYLIFE for an extra 10% off subscriptions (25% off your first subscription order)CROWDHEALTH: Use code CULTURE to get your first three months for only $99/monthCOZY EARTH: Use code ALEX for 40% offOur Guest:FDA Director- Dr. Marty MakaryDr. Marty's Links:X: @MartyMakaryInstagram: @martymakaryTikTok: @marty.makaryBook — Blind Spots: Available on Amazon

Patrick Bet-David sits down with FDA Commissioner Marty Makary for a deep-dive conversation on Tylenol's risks, vaccine safety concerns, the autism debate, and Dr. Anthony Fauci's handling of COVID-19.------

After decades of stagnation and caution, the FDA is radically changing their advice on hormone replacement therapy for menopausal women. We speak to the FDA Commissioner about the new advice for women. Get the facts first with Morning Wire. Chevron: Build a brighter future right here at home. Visit https://Chevron.com/America to discover more. HelloFresh: Go to https://HelloFresh.com/MORNINGWIRE10FM now to Get 10 Free Meals + a Free Item for Life! - - - Wake up with new Morning Wire merch: https://bit.ly/4lIubt3 - - -Privacy Policy: https://www.dailywire.com/privacy Learn more about your ad choices. Visit podcastchoices.com/adchoices

The Senate has approved a funding package for the government, a first step in ending the shutdown. Facebook co-founder Chris Hughes offers his critique of the Trump administration's tariff policy. He discusses the differences between industrial policy and “state capitalism,” and weighs the impacts of these policies on innovation. The FDA is removing a longtime warning for women considering hormone replacement therapy for menopause. FDA Commissioner Dr. Marty Makary addresses critics' concerns about making this radical policy change without a large body of evidence to support it. Italy's biggest pasta exporters are preparing to pull products from U.S. shelves in the new year, a response to President Trump's 107% tariffs on Italian imports. Plus, Warren Buffett shared an update on Berkshire Hathaway and his own health in a Thanksgiving letter.  Chris Hughes - 11:47Dr. Marty Makary - 21:38 In this episode:Joe Kernen, @JoeSquawk Becky Quick, @BeckyQuickAndrew Ross Sorkin, @andrewrsorkinKatie Kramer, @Kramer_Katie Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

The FDA announced it would begin asking drug companies to remove so-called “black box” warnings for hormones prescribed to treat symptoms of menopause. The FDA says the warning has dissuaded generations of women from taking advantage of the medication that could help them. Ali Rogin discussed more with FDA Commissioner Dr. Marty Makary. PBS News is supported by - https://www.pbs.org/newshour/about/funders. Hosted on Acast. See acast.com/privacy

Dr. Sanjay Gupta sits down with Dr. Marty Makary, U.S. FDA Commissioner to dig beyond the headlines of this Administration's latest efforts to “Make America Healthy Again.” This conversation took place on Friday, September 26th, 2025. Our show was produced by Jennifer Lai, with assistance from Leying Tang, Kyra Dahring, Jesse Remedios, and Nadia Kounang. Medical Writer: Andrea KaneShowrunner: Amanda Sealy Senior Producer: Dan BloomTechnical Director: Dan Dzula Learn more about your ad choices. Visit podcastchoices.com/adchoices

The Rich Zeoli Show- Hour 3: 5:05pm- From the White House, President Donald Trump—alongside Health & Human Services Secretary Robert F. Kennedy Jr., FDA Commissioner Dr. Marty Makary, & NIH Director Dr. Jay Bhattacharya—delivered remarks on Autism research which may link between acetaminophen usage during pregnancy to the condition. 5:30pm- Matt Rooney— Founder of SaveJersey.com, State Director of the America First Policy Institute of New Jersey, & host of The Matt Rooney Show on 1210 WPHT (Saturday's 7pm to 10pm)—joins The Rich Zeoli Show to recap Sunday night's NJ gubernatorial debate between Republican Jack Ciattarelli and Democrat Mikie Sherrill. 5:55pm- Tom Azelby hosts the 6pm Hour of The Rich Zeoli Show!

The Rich Zeoli Show- Full Show (09/22/2025): 3:05pm- According to new data from CNN's Harry Enten, despite Donald Trump's personally low approval ratings, Republicans still possess massive polling advantages on three key issues: the economy, immigration, and crime. Enten joked that the Democrats have become the New Orlean Saints of political parties—which bodes poorly for the party's hopes of taking the House of Representatives and/or Senate in 2026. 3:10pm- On Sunday, Republican Jack Ciattarelli and Democrat Mikie Sherrill held their first NJ Gubernatorial debate at Rider University. During one notable moment, Sherrill refused to pledge that she wouldn't raise taxes on New Jersey citizens. One new poll now has Ciattarelli leading by 1-point. 3:30pm- During Sunday's debate, Mikie Sherrill attempted to explain why she voted in favor of a bipartisan House resolution honoring the life and legacy of Charlie Kirk—but publicly denounced Kirk, lying about his past comments and baselessly claiming he wanted to” roll back the rights of women and Black people.” Sherrill was unable to answer when confronted with her inconsistencies and falsehoods. 3:40pm- On Sunday, a memorial service for Charlie Kirk was held in Glendale, Arizona—with 73,000 inside of State Farm Stadium and an estimated 200,000 people in total showing up to the event. In a powerful moment during the ceremony, Erika Kirk said she forgives her husband's accused killer. 3:50pm- During her Monday briefing, White House Press Secretary Karoline Leavitt announced that President Donald Trump plans to sign an Executive Order designating Antifa as a terrorist organization. 4:05pm- Kimmel is Back: Last week, ABC/Disney indefinitely suspended “Jimmy Kimmel Live”—following Kimmel's comments on the killing of Charlie Kirk. The late-night host shamefully accused Republicans of using the death to “score political points.” While the network's move appeared to be a result of Kimmel's comments coupled with poor ratings, FCC Chairman Brendan Carr suggested his department could potentially investigate ABC/Disney over Kimmel's vitriolic remarks—muddying the waters. Many expressed concern that Carr's warning amounted to a First Amendment violation. ABC/Disney is now announcing that the suspension has concluded, and Kimmel will be back on-air Tuesday night. Rich notes that if Carr had not opened his mouth and baselessly threatened ABC/Disney, Kimmel's show would have likely ended permanently. Did Carr inadvertently save Kimmel's career? 4:20pm- Fox News reporter Peter Doocy asked President Trump: “If you could eat only one thing for a week, what would it be?” Trump responded, “probably steak.” 4:40pm- Joe Gruters—Chairman of the Republican National Committee—joins The Rich Zeoli Show for his first interview since becoming RNC Chair last month! He discusses his experience as a Florida State Senator, November's New Jersey gubernatorial election, and more. Chairman Gruters explains, “I'm committed to do whatever it takes to make sure we give the President a full four years [with a Republican-controlled House & Senate]” so “he continues to save the world.” 5:05pm- From the White House, President Donald Trump—alongside Health & Human Services Secretary Robert F. Kennedy Jr., FDA Commissioner Dr. Marty Makary, & NIH Director Dr. Jay Bhattacharya—delivered remarks on Autism research which may link between acetaminophen usage during pregnancy to the condition. 5:30pm- Matt Rooney— Founder of SaveJersey.com, State Director of the America First Policy Institute of New Jersey, & host of The Matt Rooney Show on 1210 WPHT (Saturday's 7pm to 10pm)—joins The Rich Zeoli Show to recap Sunday night's NJ gubernatorial debate between Republican Jack Ciattarelli and Democrat Mikie Sherrill. 5:55pm- Tom Azelby hosts the 6pm Hour of The Rich Zeoli Show!

FDA Commissioner Mary Makary on an unprecedented change in drug advertising, kids killed by Covid vaccine, and more.Order Sharyl's new bestselling book: “Follow the $cience.” Subscribe to my two podcasts: “The Sharyl Attkisson Podcast” and “Full Measure After Hours.” Leave a review, subscribe and share with your friends! Support independent journalism by visiting the new Sharyl Attkisson store.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Food and Drug Administration Commissioner Dr. Marty Makary discusses the recent decision to approve updated Covid-19 vaccines for a smaller population. In an interview with host Ryan Knutson, Makary also discusses his thoughts on restoring confidence in public health policy and explains the agency's new crackdown on pharmaceutical ads and an upcoming report that says that taking Tylenol during pregnancy could be linked to autism, among others. Further Listening:  - The FDA Boss on the Agency's MAHA Makeover - Breakfast Battle: The Cereal Industry vs MAHA Sign up for WSJ's free What's News newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices

In this special bonus episode of The Megyn Kelly Show, Megyn Kelly is joined by FDA Commissioner Dr. Marty Makary to discuss new information on the short- and long-term health benefits of Hormone Replacement Therapy or HRT, how it can actually help reduce heart attacks and dementia as well as sleep, a 2002 flawed study that scared women about the risks of HRT, new data showing the potential dangers for women of taking antidepressants and SSRIs while pregnant, the potential that it could cause birth defects, shocking information about Chinese gene therapy, the truth about what Makary has uncovered at the FDA about COVID, and more.