The Ultimate Human with Gary Brecka

Episode 229: Dr. Marty Makary: Vaccines, Chronic Disease, Drug Prices & Hormone Therapy
Date: December 23, 2025
Guest: Dr. Marty Makary, 27th Commissioner, US Food and Drug Administration

Episode Overview

In this landmark episode, Gary Brecka sits down with Dr. Marty Makary, the FDA Commissioner, for an unfiltered conversation on the failures and urgent needs in the American healthcare system. The discussion traverses the systemic challenges in health, the flaws of nutritional science, the politicization of medical dogma, the critical need for transparency, revising outdated policies, and the FDA's new direction under Dr. Makary, with a focus on prevention, food reform, rapid drug approval, and empowering patient choice.

Key Discussion Points & Insights

1. The State of American Healthcare

• Both speakers agree: Despite being the world's top spender, "US healthcare has been a 50-year failure" in improving the population's health (Makary, 00:00).
• Chronic Disease: 42% of US children have at least one chronic condition (Brecka, 00:14).

2. Root Causes & Systemic Flaws

• Medicalization of Ordinary Life: Children are over-diagnosed and over-medicated without addressing underlying causes like poor nutrition or lack of natural light (Makary, 00:35; 20:56).
• Quote: “We have a whole catalog of disorders we can assign to you... we've medicalized ordinary life.” – Dr. Makary (21:00)

3. FDA's Expanded Role & Mission

• The FDA oversees 20% of the US economy, including food, drugs, devices, and more (Makary, 03:41).
• Makary’s Mission: “Deliver more cures, meaningful treatments, and healthier food for children” (Makary, 08:12).

4. Challenging Medical Dogma

• Corruption & Dogma: Nutritional guidelines and the food pyramid were shaped by industry, not science (Makary, 23:13).
• Medical education beats creative, altruistic students into "robotic" practitioners, promoting rote memorization over curiosity and prevention (Makary, 12:11).
• Quote: “We take bright, creative, altruistic young people and we beat them down…they come out as robotic and they burnout.” – Dr. Makary (12:11)

5. Big Wins & Ongoing Initiatives at the FDA

• Removing Petroleum-Based Food Dyes: Within weeks, all nine were banned after 35 years of indecision (Makary, 09:16).
• Transparency: FDA now publishes rejection and acceptance letters for full public scrutiny (Makary, 09:18).
• Hormone Replacement Therapy: Dangerous black box warnings for female hormone therapy removed (Makary, 10:03; 38:16).
• Nutrient-Based Interventions: Folinic acid now frontline for some neurodevelopmental disorders; focus on amino acids, minerals, and vitamins (Brecka, 25:14).

6. Overhauling the Food Pyramid & Dietary Guidelines

• The new guidelines will emphasize protein, natural saturated fat, fiber, and the detriment of ultra-processed foods; release expected within two months (Makary, 25:16).
• Quote: “We're going to end the 50-year war on natural saturated fat.” – Dr. Makary (23:41)

7. Prevention Before Treatment

• Shift in FDA focus to prevention through food education, sleep, light exposure, and lifestyle, instead of simply prescribing medications (Makary, 18:19).
• Confronting the disastrous results of “calories in, calories out” dogma (Makary, 23:41).

8. Transparency & Vaccine Policy

• All adverse event and internal review data (e.g., myocarditis after COVID shots) now publicly available (Makary, 39:27).
• Vaccines: Shift from mandates to informed consent; no “blind rubber-stamping” of mRNA shots; requiring gold-standard science for approval (Makary, 43:31).
• Quote: “We're not going to be blindly rubber-stamping mRNA COVID vaccines every year in perpetuity with no data… we're going to provide information so people can make their decisions.” – Dr. Makary (43:31)

9. Tackling Drug Prices and Access

• Accelerating drug approvals (“decision out in four to eight weeks”) for truly innovative therapies (Makary, 60:29).
• Lowering R&D costs, speeding biosimilars to market, and pushing more drugs to over-the-counter status (Makary, 60:50; 61:55).

10. Forward-Looking: Functional Medicine, Biologics, & Innovative Therapies

• Microbiome: Acknowledging it as the “biggest frontier” in medicine; regulatory flexibility for probiotics (Makary, 48:14).
• Rapid Adoption: Pilot “priority voucher review” program for breakthrough therapies (congenital deafness gene therapy) (Makary, 56:42).
• Openness to New Data: The FDA is ready to consider global data on stem cells, exosomes, and novel biologics to fast-track promising treatments for degenerative disease, cancer, diabetes, etc. (Makary, 71:13).

11. Taking On Policy Headwinds

• Biggest challenges: Bureaucracy, ingrained culture, regulatory inertia, and sometimes medical establishment resistance (Makary, 74:32, 75:10).
• Quote: “Ten people will tell you fifteen reasons why you can’t do it…these are like self-imposed policies.” – Dr. Makary (75:09)

12. Science, Humility, and Legacy

• Makary emphasizes listening—to data, to patients, to critics—while avoiding paternalism in medicine and giving people access and information rather than one-size-fits-all mandates (Makary, 77:17; 73:56).

Memorable Quotes & Moments

• On Medical Paternalism:
  “We have to get away from a paternalistic mindset and we have to let people respect their own judgment and decisions.” – Dr. Makary (71:13)

• On Nutritional Dogma:
  “We’re rewriting the food dietary guidelines and food pyramid…we're going to talk about the importance of protein. It's been downplayed. It is very important to the body's physiology.” – Dr. Makary (23:41)

• On Changing the System:
  “If somebody says they’re not on board with the mission, we’re not afraid to move people if they block what we’re trying to do.” – Dr. Makary (08:12)

• On Vaccine Policy:
  "We're not going to take away anybody's vaccines, but we are going to provide information so that people can make their decisions…return to independent, objective, gold standard science.” – Dr. Makary (43:31; 46:00)

• On Drug Approval and Innovation:
  “I personally will go to scientific reviewers at the FDA and ask, 'Are you seeing anything that looks amazing, game changing, something that gives you chills up your spine?'" (Makary, 55:42)

• On His Definition of an Ultimate Human:
  “The big need right now is for us to all show some humility and to listen to one another...and I hope I can be a good dad. And to me, that would be being the ultimate human.” – Dr. Makary (77:17)

Timestamps for Key Segments

| Time | Topic | |---------------|--------------------------------------------------------------------------------| | 00:00 | US healthcare as a 50-year failure; need for a new direction | | 03:41 | FDA overview: scope, responsibility, and Makary’s leadership | | 08:12 | Makary's vision: "More cures, meaningful treatments, healthier food for kids" | | 09:16 | Immediate FDA actions: banning food dyes, transparency in drug rejections | | 12:11 | Medical education, compassion, and burnout | | 20:56 | Over-medicalization and behavioral diagnosis in children | | 23:13 | Food pyramid, nutrition guidelines, and rewriting them | | 25:16 | Timeline: New dietary guidelines out within two months | | 37:04 | Hormone replacement therapy, Women's Health Initiative controversy | | 39:27 | Transparency in vaccine data, vaccine policy | | 43:31 | Shift to consent for vaccines, data-driven approvals | | 48:14 | Microbiome—a new regulatory approach | | 56:42 | Fast-track approval for gene therapy (congenital deafness) | | 60:29/60:50 | Priority voucher review, biosimilars, OTC drug push | | 71:13 | Openness to patient-driven innovation, evidence from non-US therapies | | 75:09 | Biggest headwind: bureaucratic resistance in government | | 77:17 | Dr. Makary on legacy, humility, and being an ultimate human |

Conclusion

This episode is a must-listen for anyone grappling with America's health crises, frustrated with dogma, or curious about the sweeping, science-driven reforms underway at the FDA. Dr. Marty Makary and Gary Brecka model a new era—where curiosity, transparency, prevention, and patient empowerment redefine public health.