Dr. Marty Makary: FDA Commissioner on Vaccines, Chronic Diseases & Drug Prices | TUH #229
What this video covers
Host Gary Brecka welcomes FDA Commissioner Marty Makary — introduced as the agency’s 27th commissioner — to The Ultimate Human Podcast, after putting him through a sauna, steam room and his first cold plunge. The wide-ranging conversation reviews Makary’s first year running the FDA: faster drug approvals, the hormone therapy labeling change, vaccine policy, food dyes and the GRAS loophole, the microbiome, and his push to cut drug prices.
Key points
- Makary states his mission plainly: his “number one priority is to deliver more cures and meaningful treatments and healthier food for children,” which he contrasts with the previous commissioner’s stated priority of fighting misinformation. He questions why a new cure should take 10 to 12 years to reach market and why animal-testing requirements persist when better toxicity-prediction technology exists.
- He says the FDA took action within weeks to remove all nine petroleum-based food dyes from the US food supply, and made its drug rejection letters public for the first time — a “radical transparency” move he says two decades of talk never produced.
- On hormone replacement therapy, Makary retells the 2002 Women’s Health Initiative story: the study’s lead investigator had written beforehand that “we have to stop the HRT bandwagon,” the published data showed no statistically significant increase in breast cancer, and the estrogen-only group had a 22% reduced risk. He puts the number of women discouraged from HRT at 50 million, and notes his FDA removed the black-box warnings.
- On nutrition, Makary says the FDA and USDA are rewriting the dietary guidelines and food pyramid — he expected them within about two months — “ending the 50-year war on natural saturated fat,” emphasizing protein and fiber, and rejecting the “calories in equals calories out” dogma he says he was taught in medical school.
- On vaccines, Makary says the FDA will return to a “gold standard science” threshold and will not “blindly rubber-stamp” annual mRNA COVID vaccines without data; he acknowledges myocarditis as a real complication seen in young men, promises no one’s vaccines will be taken away, and says an mRNA flu vaccine that failed its trial in seniors will not be approved. Brecka presses the case against the size of the childhood schedule and manufacturers’ liability shield; Makary keeps his answers to the FDA’s approval role versus the CDC’s recommendation role.
- On the microbiome, Makary cites a Mayo Clinic study of children given antibiotics in the first two years of life, reporting 20% higher obesity, 21% higher learning disabilities, 32% higher ADHD risk, 90% higher asthma, and roughly 300% higher celiac and Crohn’s disease; he argues microbiome and probiotic therapies need regulatory flexibility rather than a randomized trial for every component.
- On speed and access, Makary describes a pilot to decide applications in 4 to 8 weeks using national priority review vouchers — citing a gene therapy for congenital deafness in which, of 12 children treated, three gained normal hearing and seven improved — plus faster biosimilars (he notes Humira generics took about five years) and moving safe, non-addictive drugs like naloxone over the counter so shelf prices create competition.
- On newer therapies, Makary says peptides are “a very large bucket” that must be sorted by established safety profile versus experimental status, says the FDA must modernize so Americans stop traveling abroad for therapies with good data, and points to a PD-1 inhibitor that made rectal cancers disappear without chemotherapy, radiation or surgery as the kind of result that should not wait five years in process.