Culture Apothecary with Alex Clark - How Deep Does the Corruption Go? | FDA Director Dr. Marty Makary Tells All

Episode Date: November 25, 2025

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👗 Get Alex’s freshest fashion picks and exclusive guest recommendations—delivered straight to your inbox!Sign up for the newsletter HERE:  ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠WEEKLY NEWSLETTER SIGNUP⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠FOLLOW ALEX:Instagram |⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ @realalexclark⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Instagram |⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ @cultureapothecary⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Facebook |⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ @realalexclark⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠X |⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ @yoalexrapz⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠YouTube |⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ @RealAlexClark⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Spotify |⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Culture Apothecary with Alex Clark ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Apple Podcast |⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Culture Apothecary with Alex Clark⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Join the Cuteservatives Facebook group to connect with likeminded friends who love America and all things health and wellness!⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Join the CUTEservative Facebook Group!⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Subscribe to ‘Culture Apothecary’ on ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Apple Podcasts⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ and ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Spotify⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. New episodes drop 6pm PST/ 9pm EST every Monday and Thursday.

What has been something that you discovered taking over the FDA and you had to call the president and say, you're not going to believe what I've uncovered? I found out that in the previous administration, they had approved cancer patients in the United States having their cells sent to China to have Chinese labs gene edit the cells of Americans. The last commissioner, I think his number one stated goal was fighting misinformation. I don't even know what he was talking about. Probably people like me. What if the FDA has been quietly operating with its hands tied until now?

What if those safe and effective labels that you trusted were more political than scientific? Today's guest walked into the chaos of that agency and decided to rewire it from the inside. Dr. Marty McCarrie is the newly confirmed commissioner of the Food and Drug Administration, a surgical oncologist and public health researcher with over 300 peer-reviewed publications and three New York Times best-selling books, including blind spots, which is my favorite. Before the FDA, he oversaw novel surgical programs, co-developed the Global Surgical Safety Checklist, and held tenured roles at Johns Hopkins. In this episode, we pull back the curtain on what Dr. McCarrie discovered when he walked

into the FDA, what's gotten him angry, why safe and effective has often been more a slogan than science, the hidden conflicts, the internal pressure, and when dissent was punished, what he and President Trump and RFK Jr. are doing to overhaul regulatory practice, rethink food, drugs, vaccines, and transparency, his take on controversial topics like Tylenol and pregnancy, hormone therapy misinformation, over-vaccination, and what true accountability looks like. This is a fantastic episode to watch. We filmed it at the actual FDA in Washington, D.C. That was like one of the coolest moments of my life. And also, shout out to the FDA. You guys have a beautiful podcast set up. Like, that was stunning.

One of my favorite sets I've ever filmed on. Watch this with the entire family. You can find it on the real Alex Clark YouTube channel or Culture Apothecary on Spotify. Pause. Before we get started, leave a five-star review for this podcast. We are going where nobody in the conservative movement has gone before in terms of health and wellness. Discuss this episode in the conservative's Facebook group and share it all over social media. This was a big deal to interview Dr. Marty.

Please welcome FDA director Dr. Marty McCarrie to Culture Apothecary. You are President Trump and Bobby Kennedy's newly appointed FDA director. What is the most egregious thing that you discovered about how the FDA was allowed to operate before you took over? Well, first of all, it's a huge privilege to be able to have this job. The FDA's an amazing place. But it was a fiefdom culture here. It was a series of centers that were functioning on their own, as if there was no accountability to Congress, accountability to the White House.

It was sort of a series of empires that made their own rules. They had had its own revenue stream from the user fees, that is the posted stamps, essentially they would sell for applications. So they were autonomous with their funding, communications, lawyers. And so a lot of commissioners would come through and realize, hey, the place kind of runs itself. there's a lot broken. I might make suggestions to change some things. And we took an entirely different approach. So it's been a wild ride, but the place is much better. The culture is great. The FDA is strong. And there's teamwork that you'll see here that you've never seen before. Now that the FDA,

the NIH, and CMS are finally aligned under Trump and Kennedy, what are you guys specifically doing behind the scenes to kind of unwind that damage from the old regime? Well, the most important thing is we talk every day. We talk every day about how to make health care better because the problem with health care is it's so fragmented. And the government says the same way. And so what we do is we talk about a massive public health need, a problem that's not being addressed right now in health care. And we talk about how we could have NIH fund studies that are different from the typical studies. We're not talking about modifying a chemo a little bit, and then maybe you live a week longer, but we can argue about whether or not it's even statistically significant and if we should approve that new chemo.

No, we're talking big ideas. We're talking, can we study environmental exposures that cause cancer? Wow. We study why young people are getting cancer at an increasing rate when other rates of cancer are going down. Can we talk about how a new therapy that's been a generic where there's not an incentive to go back and do big studies to get a new approval for some new indication, how we go into the pipeline and say, hey, research shows that this existing treatment that's been around might actually be effective.

And then we talked to Center for Medicare and Medicaid Services to say, hey, we think this is a meaningful treatment. will you pay for it if we announce we're going to approve it? And things happen in weeks where it normally takes years. So that's exciting. And speaking of cancer, you guys just announced that there's going to be this new focus on pediatric cancer, right? Can you tell us a little bit about that? Yeah, this is personal for me because I'm a cancer surgeon from Johns Hopkins and gastrointestinal surgery.

That's been my background. And so we're going to use AI to try to research cancer differently when it comes to cancer that affects children. Now, it's going to apply to all cancers, but it's one of those new approaches. We have to try something new. We can't just keep going down this road we're going on when the population is getting sicker. We're not seeing major breakthroughs with a lot of the giant debilitating and terminal conditions that affect the country. And what I love about the FDA is we go deep into the pipeline of medications that are being proposed. early animal studies, pre-clinical, phase one studies, not after they've had their big giant

randomized trials in phase three, but the early. And we ask our reviewers and our scientists, are you seeing anything that looks amazing? And if so, bring it to our desk. Yeah. And so we're getting away from the receive-only mode. Are they used to that? Are they like, oh my gosh, wait, this is so fun. My job is fun now. before maybe it wasn't? A lot of them love it. We're moving fast. We do need more scientists and we're actively hiring because there's a normal turnover where 5% of our scientists leave every year. Normally, that's just the turnover. We're in a growth mode on the science side here. But yeah, people come up to me all the time. Hey, I heard about that new program. I've got a drug that I'm

reviewing that might be a good fit. And so we can't just be a stingy librarian as a regulator. Our goal is not to, you know, have everybody go through our application process properly. Our goal is more cures and meaningful treatments for the American people and healthier food for children. That's very clear. The last commissioner, I think, his number one stated goal was fighting misinformation. I don't even know what he was talking about. Probably people like me. Well, I saw Chelsea Clinton today and now she's coming up with the.

podcast that's going to be dedicated to fact-checking, I don't know, health and science coming out of this administration or something. What do you think about that? Oh, right. Yeah. So we're going to, the government's going to tell you what's correct and not correct with your health information. Look at our track record. Look at the medical establishment's track record when it senses and silences people that disagree. And you're seeing it now with child mutilation and puberty blockers. You're seeing it with holistic medical care. You're basic things that. It makes sense. You're seeing it with a mom comes along and says, hey, I don't, I don't want to follow the entire U.S. vaccine schedule. I'm looking at the UK vaccine schedule, and that one seems

a little more reasonable to me. Can we use that vaccine schedule? And the reaction has been no bad disobedient. We're going to kick you out of our pediatric's practice. Or instead, we can listen to people and say, what are your concerns? Oh, aluminum, the lower aluminum content with a European vaccine schedule. We can listen. We just had a baby, my wife and I. And, congrats. Thanks. And of course, they're out there, you know, with the needle ready to, you know, vaccinate them with hepatitis B at birth. And I was a pain in the butt, you know, as a. I would have been nervous being a nurse with you. I would have been like, oh my gosh, this is the FDA director's baby, I cannot make a mistake. Well, the vast majority of the clinicians were amazing and the nurses

were amazing. Nurses are always amazing. I've learned that in the hospital. But, you know, it's like, no, we don't need hepatitis B at birth. My wife was hep B negative when she tested. So what are we doing? We have to listen to people, not just treat them like they're a fugitive. And so we're taking a whole new approach to health. The F&FDA stands for food. It's been ignored. People think it's just a drug center. Well, it kind of has become that. I mean, before you. Dominates, it's become dominated. Yeah. Yeah.

What has historically happened inside the FDA when someone has tried to challenge the consensus? Was dissent punished? I think it's been stifled. So, for example, we are going to the scientific reviewers and the people that work in food and inspections and our law enforcement division. We have about 16,000 employees here. And we ask him, what big ideas have you had? that you've never been able to do. And a couple people might say, you know, I just do my job here.

I evaluate this on the application. But then you meet somebody who says, you know what, the whole process here is broken. We don't need to farm out the application to 12 offices. We can convene the 12 offices. We can create incentives to get the application done ahead of the target date. You hear things like, you know, why do we have a checklist to review an application? that takes us two months to go through, but we don't make the checklist available to the public.

So companies, they can't go through the checklist themselves. So it's like the FDA has your application. Now they're going through the checklist. Nobody knows what's on it. Hopefully you don't get a got-you. Just making the checklist available to the public. There's a million things like that. We're getting rid of regulations.

We're cutting red tape. We're using idle time in the drug development process. We're eliminating animal tests. testing requirements for a lot of situations. We have to use common sense. We were requiring animal testing at the FDA. Even when a drug was already approved in humans in Europe. What?

Yeah, it's insane. It's like if you explain that on a course in logic, you would fail. Of course. No sense. So there's a lot broken and there's a lot. But I think in the past, somebody's been told, well, this is the way we do it here. And now we're saying, give us your big. ideas and go bold because that's the charge I have from President Trump. Do what's right. Go bold and

don't worry about the lobbyists and the corporations. Before when the FDA would say things like, this is safe and effective, was that really a scientific phrase or just a marketing phrase? Well, it's tricky, right? Because our charge from Congress is to approve. drugs that have a substantial amount of evidence that they are safe and effective? Well, what if it's extremely safe but has a very little effect size? That is, the effectiveness is minimal. Well, that's a different situation than a drug that's dangerous, but has a small effect size. So we have to just use our best judgment, common sense. Our biggest thing is, when you're talking about rare diseases, you have to have different stuff. You have to have different

standards than you are for a blood pressure medication. And you can't even do trials sometimes for conditions that are so rare. There's not enough patients to enroll. So we have regulatory flexibility for a lot of those situations. What has been the most fun idea that you've had so far as FDA director that you brought to President Trump and he was just as enthusiastic about it? Gosh, first of all, he pushes us as much as we present ideas to him. He wants lower drug prices for everyday Americans, and he put us on this charge to get the drug companies to agree to cut their prices by 50, 70, 85%. Can I actually stop you right there? Can you speak to AOC, you know, saying President Trump wants kids to die and really he's just making care more affordable. He's lowering drug prices.

He's also expanding the child tax credit. Can you speak to that at all? This is a study from my field in oncology that came out. 37% of cancer patients say that after their cancer care, they would avoid or delay any other cancer care because of the financial toxicity. They get burned so bad. Endless bills. GoFundMe campaigns. Passing the offering plate around. Rescending reminders for people to donate.

For what? For a drug that cost 10 times in the United States, what it cost in England or Germany? or France, that is the great American rip-off. And that's what the president asked us to end. And the way to end it is to go to these companies and say, hey, we're the largest purchasers of drugs. We want the best price. We want the lowest price in a developed wealthy country. They're called OECD countries. It's well-defined. We're not asking for the same price as Zimbabwe gets. They can get lower prices for it's a poor country. But that was the charge we got. And so Mehmet Oz led this. effort in Chris Klomp at the Center for Medicare and Medicaid Services. We have our own

set of tools that we can use here at the FDA. And we worked with these companies. And we've got a series of announcements now that we've never heard of before. So the high price of drugs is an access issue. If you believe in bridging access, because remember, the ruling class in the United States forgets that 50% of Americans have less than $500 of cash on hand. And if you're one of those 50% of Americans, life can be brutal. Your car breaks down. You decide maybe I can't pick up my car. I don't have the money to pick it up from the shop. Life can be brutal. There are decisions made every day by single moms about whether or not to buy certain foods, healthier foods or any food at all, versus pay expenses that they have no control over as they work like crazy, two jobs. The ruling

class in America forgets about them. And we are laser focused on improving the life of the forgotten Americans, the everyday Americans. That means when you lower the price of drugs, you're helping them. There's another myth put out there that you'll hear among the sort of political partisans that this administration cut Medicaid. Not true. Medicaid is going up by about $200 billion. Medicare and Medicaid going up by $200 billion. So why? do they have that so wrong? Well, because the rate of growth of Medicaid and Medicare, sorry, I should say, Medicare and Medicaid, the rate of growth is unsustainable. And so we said we're going to cut waste, fraud, and abuse and reduce that rate of growth to about, say, 3% instead of, you know,

letting it just run wild with waste, fraud, and abuse. And so more money will be in next year's budget or Medicare and Medicaid. But you'll hear these false narratives that it was cut. What about cutting cancer research? Same thing. Exactly same thing. You're going to hear the same thing. Oh, the Trump administration cut cancer fund. No, they didn't. The budget is the same. It's more next year. And what we said is that when we all came into office, and I remember we all talk a lot. And the NIH was a mess. They were funding a lab in Wuhan that brewed up a virus that killed 20 to 25 million people. 14% of NIH grants went to descriptive studies on diversity, equity, and inclusion. Descriptive studies are not helping that 50% of Americans that live with $500 of cash or less.

You're not helping them by funneling money to Harvard and then writing a descriptive study, at a high-end conference where the doctors all go out for a steak dinner the night before. We're not making a difference doing these descriptive studies. So we said we're going to move that money to actual research studies that are making a difference to find cures for diabetes and pediatric renal failure and blindness and deafness. And so that's the exciting thing going on at NIH right now. And what we're doing is we're partnering with drug developers and with device makers. And we're saying, what is it game-changing technology that you've got in any stage that you can tell us about?

And, you know, everybody thinks, oh, well, this is going to change the world and that's going to change. But we're scientists. We can see right through a lot of the fluff. And when we see something that's truly mind-boggling, then we start saying, hey, we're going to have constant. communication, we're going to figure out what makes sense and what doesn't in this normal pathway that we have. We're going to get a decision out once everything's all teed up. We at the FDA will get a decision back to you instead of the normal year. We'll do it in weeks. Wow. And so we have this new pilot program to get decisions out in weeks. The FDA had a system

where they would take two months just to tell you whether or not they were going to review an application called a supplemental BLA, which is a sort of a number. indication for a drug that's right. It's a joke. Other countries were laughing at us. I really think, Alex, with this new approach that we're taking, a very proactive approach on cures and meaningful treatments, in the next year or two, you are going to see a cure or meaningful treatment, some powerful treatment for type 1 diabetes, for neurodegenerative disorders, for some forms of pediatric deafness and blindness. For some types of stage one and stage two cancer, where the tumors for qualified individuals, that is, they have a certain genetic composition of the tumor, it's a minority patients, but the tumor we've seen now shrinking to thin air.

You don't even need surgery to remove it. There's nothing to remove. They don't need chemo. They don't need radiation. How are you guys in less than a year of this administration being in the White House? How are you guys able to do this so quickly and be on the trail of all these hot new things when for decades we've not had any of this? Like what was going on? I don't understand.

Because we're telling the companies, we're not going to have you go through a 10 to 12 year process to bring a new cure to market. That's the average time it takes. Unbelievable. We can run more continuous trials. We can run more combination trials. The most important thing the companies want is some communication with us. instead of, you know, they put a hundred thousand page application. That's not a joke.

That's a real thing. These applications. Thinking, oh, the FDA is going to pull a gotcha. So let's just put the kitchen sink in there. And they spend so much time putting that together. And then they don't know where to go next. So they do all these experiments of just purely guesswork that waste time. And then the phase three trial gets done.

And everyone's twiddling their thumbs waiting and waiting for the results. Well, we can review all the manufacturing stuff and everything. in the application before your clinical trial finishes. And once it reads out, those are pretty simple results. We can get the read out and then the decision out quickly. PTSD is a big thing, too. We got 8,000 veterans a year that die of suicide. That's more than the entire Iraq and Afghan wars combined over their entire spans. So the wars are over, but the men and women are still dying at a high rate. We have a duty. We owe it to them to get a decision out on potentially promising treatments for PTSD. And so that's one of our huge priorities. We're using that streamlined

modernized regulatory pathway for these potentially promising treatments. Could it involve psychedelics by chance? It could. Okay. Yeah. I've heard a lot about that. Do you want to finish, because I interrupted you and took you off track, but do you want to share anything about like a crazy idea you told President Trump and he was really stoked, like a fun, like a funny thing. When we meet with him, first of all, the guy is super high energy. I mean, he will call at 7 in the morning or at 1 a.m. on the same day. Okay. The guy's a phenom. Literally three hours asleep.

I don't know. I have no idea, but I know. Not always he working all the time. And of course, he takes little breaks. You see him on the golf course. But he is constantly managing like 500 ideas and projects by calling his people and his staff and telling people, hey, where are we on this? Where are we on lowering drug prices? So cool. So, yeah, we do talk a lot of ideas with them. It's invigorate. The questions he's asking are the questions the American people are asking.

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Can you share anything like that? Well, we work through a lot of staff. So I don't just pick up the phone and call the president. But I found out that in the previous administration, they had approved cancer patients in the United States having their cells sent to China to have Chinese labs gene edit the cells of Americans, literally change the gene in the cells of American patients, and then send it back to the United States where those genetically modified cells were then re-infused into American patients. In my opinion, I don't understand how anybody would properly give consent to that. That's something like that. But literally we're having the Chinese gene edit American cells.

That's really freaky. That's just like Tuesday. And we're like, what? No, we're shutting this down. But that's the kind of stuff we find all the time. There was lawfare going on here in the last administration. RFK Jr. is one of the most controversial voices in health. Some call him courageous.

Others say he's dangerous. What do you think of him as a leader? He's an amazing leader. Look, he is pushing the field of, health care in a way we've never seen from any Secretary of Health and Human Services. Look at the last Secretary of Health and Human Services. First of all, nobody knows who he is. He presided over one of the greatest increases in health care spending in modern history. We're throwing good money after bad into the broken system. Nobody is talking about the root issue,

and that is the health of the population. They're just talking about different ways to finance the broken health care system. We don't need to just talk about how to finance the broken health care system. We have to talk about how to fix the broken health care system. And the way you do that is by talking about the health of our nation's kids. Who else has done that except our nation's foremost environmental health attorney, and that is RFK Jr. Now, I love meeting with him. He's got a lot of ideas. And what I love the most about him is that he's engaged. His motives are entirely pure. Everything we talk about almost everything comes back to the health of children. And could this help children? And how fast can we help children? And what do you guys think as medical doctors about this potential

thing that could help children? And those are the conversations we have. We have them every few days. I walk into his office. It's nostalgic. You know, he's a part of American history. He'll tell me about how the government was involved in assassinating. his uncle. And I can't believe I'm having these conversations because the man is a treasure trove of wisdom on the American system. And one thing that made him so popular, especially when he sort of teamed up with President Trump, was talking about the undue influence of corporate America. I think there are really two political forces in the United States. And it's not what people think. It's not the left and the right.

It's the people who are lying to you and people who are trying to tell you the truth. And he is trying to get to the truth. And he is asking the questions that so many Americans are asking, why are 40% of our nation's kids sick? Why do 31% now have insulin resistance? Right. But then the criticism he gets is, well, you're not a medical doctor. Well, you are, Dr. Marty. So what is your response when people say Bobby Kennedy doesn't know what he's doing?

He's not a doctor. So is he not allowed to ask questions? First of all, no Secretary of Health in recent time has been a physician. And so is he not allowed to ask questions? The questions he's asking are incredibly piercing questions. And so he will pose those questions to his large team of doctors, that includes myself. And we will talk about it and we'll take it back to the shop here and we'll run it by our subject matter experts. What I find is the best part about working for Bobby Kennedy.

is that he will say, Marty, you know, this seems concerning or it seems like there's something there. You're the medical expert. Ultimately, it'll be your decision what to do about it at the FDA. I mean, you talk about an incredible collegial relationship. Never once, as he said, I need you to do this. And so how amazing is it that we have an American at the head of HHS with an intense interest and moral compass to help children, asking big questions. And he's got doctors who like to think outside the box. We believe in scientific standards and we believe in common sense. And we can use both. Speaking of thinking outside of the box, Bobby just dropped a bombshell claiming that Tylenol use during pregnancy may be linked to autism. As a physician and now FDA

director, can you walk us through the science behind that connection? Yeah, first of all, no one was talking about autism and what's causing the epidemic of autism until President Trump and Secretary Kennedy. This was never a national priority from the government. Now, moms were talking about, parents were talking about it, teachers, counselors. They're just saying how many cases there are. You didn't see a generation ago kids that were completely nonverbal at this rate, kids with repetitive motions with these ticks. You know, still don't see people in their 60s and 70s with these repetitive ticks, completely nonverbal from birth. It was ultra rare. Something is going on. It's now like one in 12 boys in California. Right. And some of that may be increased a diagnosis,

but that doesn't account for this mass epidemic that's expanded in our generation. So something's going on. It's been off the radar of the medicalists. establishment in terms of understanding the root cause. Now, the medical field loves to play whack-mull and just treat, diagnosed, treat, the billing coding machine of the hospitals and the clinics, you know, the churnmills of, yeah, your kid has this, you know, ICD-9, you know, I'm going to add this CPT code for my bill and, you know, it's just a billing coding machine. What, stop. What are we doing? What are we doing? ADHD, similar. Or drugging our nation's kids at school. We're drugging our nation's kids at scale and no one has asked what's actually causing it. And you saw our action to remove the

non-petroleum-based food dyes. I know you were an advocate for that. So with autism, we said, we're going to take a comprehensive root cause approach. We're going to scour the literature and we're going to see everything out there that looks legit. And as we were doing that, we saw two things that we thought the public has a right to know as we are doing this expedition to study it. I think the most exciting good news story was that lucavorin, which is a prescription form of folate, can be incredibly therapeutic for a subset of kids with autism. Because autism for some kids, maybe half, a third, you know, you'll hear different estimates, maybe an autoimmune disease whereby the folate receptor in their brain is blocked.

by this autoimmune response and the brain is starving of folate because of this blocked receptor. Well, the medication that we just gave the green light for called Leukovorin bypasses the blocked receptor and delivers folate directly into the brain of a child. I just saw this video of a mother who has a severely nonverbal autistic child. She had her son take that for the first time after that press conference that Bobby and Trump did and said he was talking within, 48 hours. Oh my gosh. And that it, I mean, she was just in tears ecstatic. Wow. Well, you know, people have said, how dare you make this available without clear instructions on, you know, this, the science has not matured to the point where we know exactly who benefits. First of all, it's safe. It's been around for a century. Second of all, yes, have a physician provide guidance

and prescribe it because many physicians will first test for the antibody to the, the folate receptor to see if you have the autoimmune sort of reaction before they prescribe leukovorin. But what are we going to do? Just do nothing while all these kids have a whole different approach. Now, the medication is in generic form. So what big pharma company is going to go back and say, I'm going to do a giant study on an existing generic and try to get another indication? We are proactive. We go into the pipeline. We identified this medication.

We called the companies and we said we're going to expand the indication and we're going to do it in weeks. And that's how we roll. And so I'm glad to hear some kids are having therapeutic benefit. Now, the other thing that we discovered in that learning about what's involved in autism was that some studies, 27, to be exact, have found some association between prenatal, that is, acetamidifine use in pregnant, during pregnancy, and subsequent neurodegenerative disorders, that is ADHD and autism spectrum disorder. Now, it was mixed, but do we have a duty to let the public know? Yes, we do. What's your response when people say to that, well, I took Tylenol and my child doesn't have autism?

Like, how do you explain why some people wouldn't? I mean, if we're going to use anecdotal experiences like that, then snake oil cures cancer, you know, ice cream causes HIV. And, I mean, that's not the scientific process. Now, I do believe you can learn from individual cases. But the effect size, when I say the effect size, that is, if 100 women take a Cedaminifin in pregnancy, a very small subset may have an increased risk. of autism in their children. It's not a direct one-for-one if you take it. There's going to be

100% correlation. Did you and Bobby see the viral videos of people in protest on the left downing Tylenol while pregnant after this announcement? I heard about them. What was your old's reaction to that? Well, remember, so I was involved in transplant surgery and I had been involved in liver transplants for people with liver failure from Tylenol overdose. It's well-known overdosing on Tylenol can result in complete liver failure and death. And I've been involved in two cases in my life where we've tried to do an emergency liver transplant to save somebody's life after them overdosing on acetaminopin. So it is sad. You know, it's sort of the ultimate partisan contrarian mindset that is dangerous. And I hope we can have less of a sort of reactionary culture.

people can listen more, turn off the echo chambers of some of the social media that just affirms what you already think and be open-minded. How do you explain Tylenol rebuttling all of this and saying, this is ridiculous, it's perfectly safe to take this while pregnant when they themselves were tweeting for years and years and years, oh, we don't recommend you take Tylenol while pregnant. What's up with that? Well, and it came out that there were discussions years ago that they were aware and they describe the evidence of an association between a synonymifin and autism as quote unquote somewhat consistent. Those were internal communications within the company. Look, I'm not, I want American companies to do well. I want companies that do business, the United States,

to do well. I think there's a role for a synomidefin in so many settings in medicine. But look, Bobby Kennedy and President Trump and everybody else who has put this warning out there, they have a right to add to an opinion whereby they can agree with the dean of the Harvard School of Public Health, who has said that there is a causal relationship between prenatal acetaminifide. I'm quoting, there's a causal relationship between prenatal acetaminifine use and the neurodegenerative disorders of ADHD and autism spectrum disorder. When the dean of the Harvard School of Public Health says that, do we have a duty to let people know?

I believe we do. I believe we do. Is big food manipulated science the way big pharma has? Well, big food is, gosh, it's a big, it's a big tent. And so what we've been able to do is work with individual companies to say, look, we don't think you're bad people. We think what happened was in the 60s and 70s you had a charge to address starvation and food insecurity.

And so just focus on pure production. It didn't matter if the food was micronutrient poor. Didn't matter if it was loaded with refined carbohydrates. Didn't matter if all the grains were stripped of fiber and you chopped it up and it functioned like sugar in the body. It was just pure mass and maybe calories to some degree. And so the food companies did what they were told to do. Now that we see the result of that food supply, we've got to pivot. we've got to say we've done something to result in 40% of our nation's kids having

the chronic disease. It's not their fault. You know, in the medical textbooks, between the lines, it kind of suggests if a kid has diabetes, you know, type 2 diabetes or obese, it's their fault. It's lifestyle. You know, these broad terms. Could it be, food has been engineered to be highly addictive. And by the way, the vibrant colors that came with these petroleum-based food dyes mess with the developing mind of a child whereby they're full and they still want these foods. And so it's messing with their minds. And we've all been there as kids. We remember eating foods that we craved and craved. They were ultra-processed or loaded with sugar. Sometimes half-fructose corn syrup so they get pack more of the sweetness in, you know, the same animals.

And you eat, eat, eat, and then you're full, and you still want to eat it. And that is the basis by which we've had so much chronic disease in the United States. Because almost everything comes back to insulin resistance and general body inflammation. The two things we talk least about when we talk about disease. almost everything's related to general body inflammation. When we talk about health in 100 years, you might be around. I won't, I won't be, but let's say 80 years we're doing this podcast. We're going to be talking about health in terms of how's your inflammation.

And we'll have better tests of inflammation. I can actually sense my body's inflammation. I'm very sort of aware of my physiology. Oh, 100%. You too? Yes. I think that when you. start totally changing your life, you know, what you're eating especially, you notice when

the slightest thing is off. I can, I can tell immediately something is not right. And I can attribute to like, well, I was traveling and I had that for lunch, guarantee, you know, because you become so in tune and you're such a well-oiled machine with what you're eating that if you, you know, go against that in any way, you can usually pick up on it pretty quickly. Yeah. So I think we're going to understand more about the role. of inflammation. And, you know, inflammation is entirely manageable by what we eat. There are high inflammatory foods and low inflammatory foods. Matter of fact, True Food Kitchen was based on the concept that these are low inflammatory foods. And it's not hard, right? These are whole foods

and things from good soil and natural foods. If you think about what we're doing to American kids today, we rattle them in the middle of the night when their circadian rhythm says, no, leave me alone. We put them on a school bus while it's still dark, not because it's good for their health, but because it's convenient for adults. We hit them hard with a high glycemic load with grains stripped of fiber and chopped up so it functions like sugar. We put them on a sugar high. They're tired already. They're sleepy. They sit in class at a desk. We hit them hard again with another set of ultra-processed, highly addictive, refined carbohydrates. They can't pay attention. after lunch. They're dozing off. Kids were not made to sit still at a desk for seven hours a day.

Amen. And when they can't do it, what do we do? We drug them at scale. This is an American tragedy. We have got to start talking about natural light exposure and the inflammatory reaction that kids are experiencing from all these chemicals that go down their gut. I'm so excited that you're talking about natural light and wake up start times for school. Have you ever heard Bobby talk about, hey, that's something we also need to address is just like national guidelines for, hey, we recommend school starting at this time for these age groups or anything like that. Yeah. So we talked about it and included it in the Maha report where we outlined our agenda. There's some grants at NIH to work on it. We're very excited. Casey Means is passionate about this. Yay. Yeah. So we look, we're at the beginning of just now recognizing what we're doing to our nation's kids. We've got to now talk about real ways to make. changes. You ever have one of those days where everything just implodes? A few months ago, my friend slipped on black ice, messed up his ankle, and went to urgent care. He did everything right.

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What we're concerned about are these foods that are very high in their glycemic loads. They're not even food. They're food-like substances. And they are causing an inflammatory reaction when they go down the GI tract. And so we're putting it out there to the world to say, help us craft this definition. because you'll never have a perfect definition, but we do know it when we see it. These ultra-processed foods, we've got now for the first time ever waivers in the SNAP program so that states don't have to use taxpayer dollars to fund these ultra junk food items and sugary drinks.

Now, if you want to go out and eat 50 ding-dongs, you can. This is America. When it comes to taxpayer dollars, we're starting to act responsibly. we have another meeting coming up with Pentagon. We're talking about, you know, they are a mass consumer of food in the United States. And they're feeding our, you know, military personnel. We can do better. There's a lot of questions about the standards for military, you know, what they're being fed, the water that they have on bases, things like that.

So you have heard that we're aware that there's a problem and things are being. done hopefully. Yeah, they're energetic to fix it. You know, they're obviously the largest peacekeeping, you know, force in the world and managing conflicts. And so it makes sense to me to start with our kids and our military making sure that they have the best food and the best living environment. That's the exciting thing. That's what I'm loving about this so much, is that we're not just sitting here as an angry librarian as a regulator saying, well, your application had a, you know, problem with the font. So send it back.

No, those days are over. We are a proactive, pro-health agency working in tight collaboration with all the other health agencies to try to make America healthy again. Let's talk about women's health because that's one of the most neglected and manipulated areas in public health. Women were told that hormone replacement therapy was dangerous for decades. What went wrong in the way that that data was handled and communicated and who benefited from that misinformation.

Well, first of all, this is maybe the biggest screw up in modern medicine is the demonization of hormone therapy for paramedopausal women as a carcinogen. That is, that it's going to increase her risk of dying of breast cancer. It became dogma in 2002 based on a study where a bunch of researchers were dead set on proving it. That had even gone on record before the study was done, saying we have to stop this hormone therapy bandwagon that women are taking. Well, you hadn't even done the study yet. I mean, this is the problem with science when it becomes so biased. The study they presented showed no

increased risk in breast cancer that was statistically significant. No subsequent clinical trial has ever shown that perimenopausal women that start hormone replacement therapy have an increased risk of dying of breast cancer. But yet seven or eight out of ten doctors in America, Today we'll tell women, yeah, I'd rather not prescribe it because of that breast cancer thing. They're still saying it? It's starting to change, and we had a big impact in changing that culture when we held at the FDA a couple months ago, a hormone replacement therapy roundtable that every woman should watch. You know, women go through perimenopause starting mid-40s. The symptoms may last eight to 10 years, but what it is is it's the body's natural estrogen

production sort of dropping off. And when that happens, the body doesn't benefit from that estrogen. Almost every cell in the body has an estrogen receptor. It's important in brain health and memory and cognition. It's important in cardiovascular health and preventing heart attacks and is important in bone strength. So women who take hormone therapy starting around the time of perimenopause, they have to start before age 60, otherwise it's too late and the benefits go the other way. But women who start it proper, you know, as it's recommended, have a 25 to 50 percent lower rate of fatal heart attacks later in life.

Unreal. They have a third or half the bone fractures that other women have. Their bones are so much stronger when they're. They fall, they're far less likely to need surgery or if there isn't a small car accident. They're not going to need that hip replacement sometimes because their bones are strong. The cognitive strength is remarkable. In some studies, it prevents cognitive decline by 63%. And in one study, it prevented the risk of Alzheimer's by 35%.

There's probably no medication in all of modern medicine that can improve the health of a population more than hormone therapy for women, maybe with the exception of the advent of antibiotics. It's an incredible medication whereby women who are candidates, and that's the vast majority, live longer, feel better. And those are the long-term benefits I talked about. There's also the short-term benefits of alleviating those symptoms of perimenopause, the hot flashes, night sweats, mood swings, weight gain. There's 50 plus different symptoms of perimenopause and every woman experiences them differently. Some women have minimal symptoms.

For other, many, it's severe, and it can last eight years or longer. So this is an incredible story. But tragically, 50 million women have been denied hormone therapy over the last 23 years because of a dogma that it increases your risk of dying of breast cancer. And the FDA has had black box warnings on the medication saying, you know, warning, warning, breast cancer. Are you taking this off? We're taking a hard look at that and we're going to have an announcement very soon on it.

What can we do about black box warnings on SSRIs about post-SSRI sexual dysfunction? Yes. So you may have heard of this topic. Recently, there's been some psychiatrists that have been waving a flag in the air and saying, look at the high incidence of post-SSRI sexual dysfunction. And it needs to be on the label for sure. What we have is a process by which we review the data in its entirety. It is already on the label for some SSRIs. We need to go through our normal process and make sure that people know about all these risks. Because my fear is you just come into the office saying you're feeling sad.

And within minutes, you've got a prescription for an SSRI without any discussions. What's really scary is SSRIs are not meant to be taken for decades and decades and decades. And I don't know that there is any warning about that either for long-term uses there. Well, most studies are done in a shorter period of time. So, yeah, now we have one in four to one in five women in middle age in the United States are being treated for depression. And what's the root cause of that depression? And also, are the SSRI labels only saying that you have an increased risk of suicidality for children but not even necessarily adults? I'd have to check on that, but here's something interesting.

We talked about women coming in with perimenopausal symptoms, say, in their 40s and 50s. Do you know that a woman coming in with perimenopausal symptoms in the United States today is more likely to get an SSRI for those symptoms than they are hormone therapy? We need better literacy for women's hormonal health, I think. Well, I think, you know, thanks to people like yourself and so many other podcasters who are inquisitive, and intellectually curious and bringing experts on. You see Mary Claire Haver and so many other experts out there now talking about this on social. She's an OB.

She's an expert in this field. There's about a dozen of them. We had a bunch of them here for the expert roundtable. Any woman who wants to really understand this issue, you know, that's a great resource. But that is how we're going to educate the public because the medical establishment kind of gets drunk in its own market. and develops these giant blind spots in American medicine. Opioids are not addictive. 15-year blind spot.

Dogma. Opiosers are not addicted. Natural fact causes heart disease. 50-year dogma. Not true. If you questioned it, you were sidelined. Preventing peanut allergies, you could go through the list on and on. We've had an epidemic of medical dogma, and the way we manage it is more ideas.

Is the epidemic of peanut allergies that we're seeing? in the United States caused by vaccines or bad public policy? I think the mass increase in peanut allergies since the year 2000 or so is a function of a failure of the American Academy of Pediatrics by issuing the wrong recommendation on how to prevent peanut allergies and kids. They said, avoid peanut butter until the kids about three years of age in order to prevent peanut allergies later in life. They got it backwards.

If you avoid peanut butter until age three, then a kid is more likely, much more likely to develop a peanut allergy later in life. Same with other, you know, eggs, milk, dog, cats, dusts, other, any allergen. If you have total abstinence in that period when the immune system is developing, you won't develop the tolerance. The American Academy of Pediatrics, sort of in the... their haste ignored a basic principle in medicine that has been well known. It's called immune tolerance. And that's why when our little boy is five months, six months of age,

there'll be a little bit of some of those allergens of peanut butter. But not peanut M&Ms. New. Those have food dies until those are taken out. That's right. And the truth is, if we're being honest, it's hard to find healthy peanut butter. Some of it is. I know. Oh my gosh, no, that is a real thing. Legacy media is claiming that President Trump and Bobby Kennedy want to take away access to the COVID vaccine and the flu vaccine. What is the truth? The truth is anybody who wants it can get it. But I'll tell you why I want to back up for a minute. We're the only country in the world pushing COVID shots and young healthy kids. The rest of the world is laughing at us, Alex. In the UK, you have to be 75 years of age to

qualify for the COVID booster or have a risk factor. In France, it's 80 years of age. The whole world has moved on to a risk stratified approach to say, we're only going to recommend it for people who are elderly or very elderly or have a major risk factor. So the idea that we're still saying, oh, isn't that tragic? A young, healthy kid can't just walk into a Starbucks and get their shot in 10 seconds. We're the only country talking like this. The rest of the world has moved on to a risk stratified approach. And that's what we did here at the FDA with our regulatory policy. Will you be releasing the full unredacted clinical trial data for all vaccines currently on the childhood schedule? Why haven't we seen that before? Who's keeping it locked up?

Every piece of data that we can legally release, we are legally releasing. The amount of stuff that we found that was hidden, that was essentially designed to be kept from the public, data on myocarditis and the second and the COVID shot in young healthy males. We couldn't believe what we're seeing. And so we immediately made it public and we immediately made, you know, issued a warning about it. The data on VERS, the kid dies and the doctor thinks it's from the COVID shot. It's reported into VERS. What have you heard? Nothing. Nothing. Literally, it's been like a lockdown of data. So every, piece of information belongs in the public domain. You know, vaccines are like 2% of what we do here at the FDA, but we believe in radical transparency and it will penetrate every area of that field.

Is the FDA's vaccine safety surveillance system strong enough to detect rare side effects like myocarditis or neurological issues? Well, it did detect myocarditis and then they put it under the rug. And they did it in a clever way. And the CDC was very involved in this sort of disguising of the data. What is the risk of myocarditis after the second COVID shot a young healthy male? It's actually one in 2,600. That's a lot. And on rare occasions, somebody dies from the myocarditis. That's been reported in the New England Journal medicine.

But if you say, what is the risk of myocarditis in older individuals, young, male, and female, and say, oh, it's, you know, it's some very, you know, obscure stutitis. statistic, then you're covering up the true signal in the data that was seen by scientists here in the data set. And so that's how they did it. They sort of broke it down in their own way to kind of camouflage it. So same thing with the COVID hospitalizations among those who got the COVID booster and those who didn't. In healthy people under age 50, love to see that data. It's never been made public by the CDC. Wow. And so maybe that's because they feel like you can't handle the information.

Literally there has been that mindset. And it's not new or unique to medicine back in the days when home pregnancy tests were developed. The medical field fought the ability of people to do their own pregnancy test at home. Why? Because we doctors have to tell women the information. They can't handle it on their own. It happens like every 10 years.

Same thing with HIV testing. People can't do their own HIV test. They can't even get the results on their own. They have to schedule an appointment. And we have to tell you you have this infection. And so you see this. And then about 10 or 15 years later, the system cracks. People say, this is absurd.

I demand to know. But in some states, the United States, if you go and get blood work done with your doctor, it'll say the results are complete. However, your doctor has not reviewed them yet. And therefore, you can't see them in the my chart. and that paternalism still lingers today. You saw it with home COVID testing. People can't handle this information on the other.

What are they going to do with it? We have to tell them. And so medical paternalism has done tremendous damage. And now, thanks to the fact that information can get out there, medicine is more democratized. People are learning about health. Doctors are learning about health from people like yourself. It's not even in the textbooks. you learn about how pasteurization happens.

There's no part of the medical curriculum that talks about it. Petroleum-based food diets, no part of the medical curriculum that talks about its association with attention deficit disorder. But a lot of parts in the curriculum about how you treat attention deficit disorder with drugs. Be thankful this Thanksgiving that you aren't the subject of absurd conspiracy theories.

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You know, I have seen parents say, I'm going to use the Denmark vaccine schedule. It spaces things out a little bit more. Look, if people have concerns, because the reality is when you co-administer vaccines, you're going to get a bigger inflammatory response in a little baby, in a child. And so some people believe in spacing them out, and it's entirely logical and reasonable. We are creating some new regulatory standards at the FDA to say, you can't just come up with a vaccine and say, hey, we're going to give it all the same day with no studies looking at the co-administration. We want to see not just to follow up for three days or four days. We want to see some studies to give people assurances.

Can we finally fund a vaccinated versus unvaccinated study? Yeah. So the companies that make the COVID vaccine came to us and they said, we have. have an updated vaccine for the latest strain, and we'd like it approved by the FDA for everybody. And we said we will only approve it for high-risk individuals if you promise to go back and do a proper randomized control trial to give us the answer, does a healthy person have any benefit from this vaccine at this point in history? That is, population immunity is essentially ubiquitous.

Everyone's had COVID. They've got some BT cell immunity, what we call cellular background immunity. And it's very different from 2020 and 2021 when it was a different virus. It was more aggressive. And population immunity was low. And the vaccine was a good match at the time. So hopefully we're going to have those results by May. The companies have told us they're going to have the results by May. We're going to have to hold them to it. Bobby and President Trump have talked about taking mRNA vaccines off the market. What does that mean for people who have already gotten the vaccine and are concerned about spike proteins? Well, I mean, there's nothing that we can do at this point for the people who have already gotten it who have concerns. But as you did see that there was an effort to change the funding of the $500 million

that were going to MRNA technology for other uses and for vaccine, you know, vaccine technology. My feeling is, you know, people say, oh, my gosh, you know, they took away funding for MRI technology. You know what? If they want to do research on MRNA technology, go for it. They can do it on their own dime, not on taxpayer funding. These companies made $100 billion off of MRNA shots during the COVID pandemic.

They can afford to do their own research. Why are U.S. taxpayers funding research on these MRNA shots when the companies have billions? So that was my view. We're not saying this research is good, this research is bad. Look, all research is worthy if the investigator has a good hypothesis. But what are we doing? We want to see research go to study food as medicine and the microbiome and the chemicals that appear in the U.S. food supply that don't appear in Europe. And you have a kid with abdominal pain.

They go to France or Italy for a summer and they feel better. What's going to study that problem. And so we have got to start funding research. on areas that have not been getting research funding because it's not been part of the medical establishments locking arms and walking in a singular direction together without really being open-minded. We're going to do that. We're going to fund important research. We've got a project we're funding on a universal flu shot. So you don't have to come in every year where we guess what the strain is going to be. There are some promising flu shots that may provide long-term protection,

including protection against strains that have not yet mutated, that would be a win. That would be a win. A lot of people die from influenza and this sort of annual campaign to come get your flu shot. Oh, and then in the end, what percent of people got a benefit from the flu shot? Oh, 9 percent this year. It wasn't a good match. Oh, this year it was a good match.

We got 40 percent. Oh, last year it wasn't a good match. We had 32 percent. Yeah, it's like all over the place. It's all over. What are we doing? That is exciting research to have a universal flu shot. And so that's one of the projects we're funding in lieu of the MRNA $500 billion study.

Is the Trump administration planning on doing anything in regards to kids being kicked out of public school are not allowed to enroll if they don't follow the exact vaccine schedule? Well, President Trump does believe in an essential core vaccine set vaccines. That is, you look at the story of the polio virus and the tremendous disability and death that it inflicted. The iron lung machine, one of the worst images you could think of in the 1950s. When the vaccine was implemented in 1954, I think it was discovered. And a couple of years later, there was mass vaccination. That's a success story. That's a win.

There is a view that there are core vaccines. If you look at, say, the Denmark vaccine schedule, they're given a third of the shots that we give in the United States. They don't have mass outbreaks of all these other conditions. So what's going on there? Do you think President Trump's position is that there should be at least a small amount of recommended vaccines to attend public school? There should be a core set. Okay. What do you think after looking at all the data becoming FDA director has been the most overhyped or falsely marketed? drug in the last 20 years. Gosh, the story of my life is people come up to me and say, oh, you're at the FDA now,

you know, we have this drug that cures cancer and it also cures Alzheimer's and athletes' foot and on the side it cures Lyme disease and it's a natural, botanical. And the FDA is just being so difficult and not approving it. So then we'll go back and look at the file and it turns out there's no efficacy in any of the studies doesn't work. And there's 10 sterility safety violations at the manufacturer. And so that's kind of the story of my life. So I would tell people, beware a little bit when they hear like, oh, there's an amazing thing. And the FDA is just being difficult. We've got now regulatory flexibility. We've got open-minded approaches. We've got new pathways. We're getting stuff done.

I think we're going to be on track to approving more cures and meaningful treatments this year than ever in FDA history. We're working hard. We've got this pathway to get decisions out in weeks. It's an exciting time. So I would say there's not one that comes to mind, but certainly there are a lot of gimmicks in medicine. What does success look like for you as FDA director? What is a headline that you hope to read in 2028 when this administration is no more? You know, I want people to talk about diseases like they were things of the past like Rubela or polio. I want to be able to be in a position where people say, you know, back in the day, I used to have type 1 diabetes. And a younger kid will ask, what is that? I don't know what that, you know, I've never heard of

that. I don't know of anybody with it. I think if we can deliver on more cured, and meaningful treatments, then I think that'll be the mark of success. If we can make the food supply incrementally better, you know, we got a big commitment from Tyson. You may have seen one of the largest food makers getting rid of high fructose corn syrup, all nine petroleum-based food dyes, titanium dioxide, which is sort of that second tier of chemicals beyond the nine petroleum-based food dies. We've asked companies to remove Mars company, the biggest candy maker, removed it. And BHT is going to be removed from all Tyson foods. Good.

You know, Sam's Club made a big statement. Walmart said all their branded foods. They're also going to remove a whole series of chemicals, not just non-petroleum-based food dyes. Oh, really? Yeah. So we're seeing significant progress. And we're going to keep going. We're going to keep going.

We have tremendous clout. We have convening power. The companies need us. And so we want to do good things for the food. them and at the same time ask them to behave responsibly by committing to a healthier food supply for children. Would you ever support mandatory FDA approval live streams of meetings so that Americans can see what goes on with a decision making? I love it. It might be the most boring meetings somebody who watches. You made it sound exciting. Well, people like watch C-SPAN,

right? People nerd out over that. I'm like, it must be, it would probably be the same. Yeah, It might be the same. When are pharma ads coming off TV? Oh, yeah. So we took the biggest action in a generation to crack down on pharma ads. They're creating a misleading impression. It's distorting the relationship between a doctor and a patient. People are coming in demanding these medications.

They don't even understand them because the ads create a misleading impression. And just so, you know, pharma ads used to be rare, but the FDA over time got lax in its enforcement of pharma ads. They used to send out over 100 letters a year. In the last administration, it trickled down, whereby in 2023, they only sent one enforcement letter to pharma companies. And last year, they sent zero. I sent 108 enforcement letters a few weeks ago, and another 1,500 letters to the industry

warning them that we're going to take swift action. If we see an ad that's misleading in any impression, the endless singing and dancing, not disclosing the side effects, online pharmacies promoting drugs without any side effects, and social media influencers paid by pharma companies to promote drugs without mentioning any side effects, we're going to consider that an action by a pharma company. And so we are going to take that very seriously. We've got regulations. It's just nobody's enforced it. So much has been accomplished year one. year two, what are the big, exciting initiatives that Bobby Kennedy is saying, I want us to focus on these next in 2026. Gosh, there's so many. And we have had a major announcement every week.

Yeah. For the secretary, he's laser focused on the health of kids. And one thing we talk about a lot are THC vaping devices used by children that are targeting. children. It's very common in the United States. It's been off the radar. And it's something we have to pay attention to. It falls under our jurisdiction as we have a tobacco center. Let me ask you something kind of spicy. Yeah. Do you think that there is a correlation between vapes and the rise in colon cancer in people under 30? I don't know. I mean, look, a lot of the vapes that are illegal, we don't know what's in them. Right. So there is a concern there. I think the rise, and colon cancer and GI cancers in general in people under 50 is from all of the exposures

that are creating a bit of an inflammatory response in the gut. And we know that chronic inflammation has always been a precursor for pre-cancerous cell development. So I think it's all, everything we put down. And if you look at the one thing that's changed over the last half century, it's what we put down. We don't value the microbiome enough. And when we had our baby, gosh, I was a pop a bear with no antibiotics for the baby unless

I approved. And the baby was sick. Yes, we don't want the infection to rage. But just routine antibiotics. Here, throw some antibiotics in their eyeball. You know, here's an antibiotic before a C-section just to give the antibiotic, antibiotic after the C-section is just as effective. You don't need to have it in the baby's blood system as the first pharmaceutical the baby experiences. So we have to value the microbiome.

Breastfeeding when possible and feasible has health benefits. It's not politically correct to say so, but we're learning more and more about those health benefits. We're going to tell people the truth. and that's part of microbiome health. And fixing baby formula. Thank you for mentioning that. So we've had a big expert panel on fixing baby formula. It's a whole string of things that are broken. Suntan lotion, the same thing, the FDA.

Oh, my gosh, yes. Yes. Are you guys going to focus also? We talk so much about food and pharma, but beauty products for women? Yeah. So we also regulate cosmetics and, you know, overall the FDA regulates 20% of the the U.S. economy. So it's... Our standards are awful compared to everywhere else. We are going to make a couple major changes. One of them that we just announced is any adverse

event to a cosmetic product will be available to people in real time. So you can go in there and see this product has had this litany of adverse event reports and we're making that available to the public. And hopefully some third party can collate that information to make it very user friendly for individuals, maybe on an app. something like that. Look, it's a big project and it's something that needs to be fixed. It's, you know, one of many things. Yep, I know. You've got your hands full. If you could offer one remedy to heal a sick culture, physically, emotionally, or spiritually, what would it be? Well, I think the spiritually part is important. It's the biggest part we don't talk about. It's behind all the mass

depression and drugging our nation's kids at scale. Obesity and insulin resistance is an addiction. It's a glycemic, essentially sugar addiction. So we've not treated it like an addiction. We've treated it like, oh, you're just a bad kid, or you're being naughty, or you have a willpower problem. And so I would often tell my patients when they would come in and they had to get healthier before surgery in six months or three months, I'd say drink water, healthy water, filtered water, and eat foods from good soil or meat from good farms or fish that are raised in a healthy way. Sustainably raised does not always mean healthy. And so wild caught, healthy, fish, healthy meats, and foods out of the ground with good soil. You can't go wrong. You can't

overeat if you tried. If you want to overeat on turmeric, it's like impossible. Or steak, it's impossible. Your body will naturally respond with that satiety reflex. Well, Dr. Marty, I am so excited that basically almost exactly a year later, I get to sit down with you because the first time we met was on Senator Ron Johnson's Chronic Disease Panel at the Senate. You were amazing. You were amazing there. Thank you. Thanks for saying that. Well, I was so excited to meet you and get your book.

And I was like, oh my gosh, this is so neat. And then just to see you in this role has been incredible. We're all so proud of you and support you. And I mean, what a legacy. This is just such a great opportunity. And I'm so thankful that Bobby, you know, saw on you what so many other people have seen in you for forever. So thank you for coming on Culture Apothe. Thank you so much, Alex. Great to be with you. And just keep up the great work. I've seen your

podcast get so much popularity. And that's because you're educating people and you're bringing on people with different perspectives. And that's, I think, how we're going to improve the health of the population. One of my favorite episodes to do this season, please leave a five-star review for us, for Dr. Marty and all the work that he's doing. Tell others why they must be listening to Culture Apothecary. You really can't miss an episode or you're going to be so behind. We're on a mission to to heal a sick culture twice a week on Mondays and Thursdays, 6 p.m. Pacific, 9 p.m. Eastern. We are trying to do that. Healing a sick culture, physically, emotionally, and spiritually. I'm Alex Clark, and this is Culture Apothecary.