Overview

In this wide-ranging conversation, Brigham Buhler, founder of Ways2Well and ReviveRx Pharmacy, returns to Joe Rogan's podcast to deliver an urgent and optimistic update on the regulatory battle over peptides, hormones, and regenerative medicine under the new HHS leadership. The central thesis is that the American healthcare system is a broken "sick care" model that monetizes chronic disease rather than preventing it, but that a historic window has opened under Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to reclassify peptides, remove black-box warnings on hormone therapy, and build a parallel "life raft" of cash-pay, preventative medicine. The conversation moves from the absurd origins of medical dogma (a 1930s study on three patients, one of whom dropped out) to the cutting edge of MUSE stem cells, gene sequencing, and plasmapheresis, all while Buhler argues for patient sovereignty and a state-level regulatory pathway that could make Texas a medical tourism destination.

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1:44The Peptide Reclassification Fight

Buhler reveals that the Biden administration's FDA, in what he calls a "Trojan horse" move, classified 19 peptides as dangerous shortly before leaving office, with no clear safety rationale. He submitted 17 FOIA requests to the FDA seeking clarity on the decision and never received a single response—despite the legal requirement to do so. Under the new administration, Buhler has gone from being stonewalled to having "a seat at the table," meeting directly with Kennedy, FDA Commissioner Marty Makary, and key staff like Stephanie Speier. He emphasizes that Kennedy personally uses peptides and understands their benefits, which has been transformative for the regulatory conversation.

The core of Buhler's argument is that the existing drug approval ecosystem—costing $1–3 billion to bring a single drug to market—was built around big pharma's need to protect patents and monetize chronic disease. Peptides, being short-chain amino acids found naturally in the body, don't fit that model. They can't be easily patented, and they're typically prescribed in cash-pay, personalized settings rather than through insurance. Buhler argues that the FDA's previous hostility wasn't based on safety data but on a system that simply doesn't know how to handle products that fall outside the traditional pharmaceutical sandbox.

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6:50The Testosterone Myth and Prostate Cancer

Rogan asks Buhler to expand on testosterone replacement therapy (TRT), noting that many older men fear it will cause prostate cancer. Buhler traces this fear to a single 1930s study with three patients: one dropped out, one was chemically castrated (zero testosterone), and one was normal. The study's flawed logic suggested that raising testosterone from zero to normal could theoretically exacerbate pre-existing prostate cancer—but no study since has ever correlated testosterone therapy with causing prostate cancer.

Buhler explains the mechanism using a "watering a plant" analogy: once prostate receptor sites are saturated with hormones, pushing past that threshold to optimal levels actually provides "insulatory benefits" against cancer. He cites Dr. Morgan Tyler, a prominent urologist who debunked the myth in the 1990s by treating men with prostate cancer using HRT and finding no increased risk. The FDA under Makary is now working to remove the black-box warning on testosterone and women's hormones, a move Buhler has been advocating for nearly a decade. He points out that if TRT caused prostate cancer, the massive boom in testosterone use over the last 30 years would have produced a skyrocketing prevalence—but it hasn't. The rate remains one in eight men, identical to the general population.

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19:19GLP-1s, Big Pharma Lobbying, and the Hims Controversy

Buhler makes a critical distinction: GLP-1 weight loss drugs like Ozempic are themselves peptides, yet the pharmaceutical industry that profits from them is simultaneously lobbying to shut down compounding pharmacies that make affordable versions. He reveals that Eli Lilly, worth $800 billion and having 7x'd its value, is the "main culprit." Lilly signed a $7 billion deal to acquire a peptide company in China while simultaneously telling U.S. regulators that peptides from China are dangerous and that compounders should be shut down.

The most explosive segment involves Hims, the telemedicine company. Buhler alleges that Hims ran a Super Bowl ad using Novo Nordisk's brand name for a compounded GLP-1, which is illegal—compounders must use generic names. This triggered massive backlash from regulators and politicians against all compounders. Then, within two weeks, Hims inked a deal with Novo Nordisk to distribute the brand-name drug, and its stock "shot through the roof." Buhler calls this a "landmine" set deliberately to damage the compounding industry while Hims rode off into the sunset with a backroom deal. A class-action antitrust lawsuit has been filed by Lee Rosebush's firm to investigate. Buhler's message to regulators: "Please do not punish an entire industry sector for one bad actor."

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37:36The Broken System: Sick Care vs. Health Care

Buhler paints a stark picture of the current system: 1.7 to 1.9 million Americans die annually from chronic disease—more than all U.S. wars combined. The U.S. is the most obese, disease-ridden society in history, spending more on healthcare than any other nation while getting worse outcomes. The average American is on four or more prescription drugs. He argues that health insurance should be viewed like car insurance—it's there for catastrophic events, not for preventing chronic disease.

The primary care model is broken: a doctor gets six minutes per patient, is limited in diagnostic tools, and defaults to prescription management. A woman who is 40 pounds overweight, depressed, and anxious gets a GLP-1 and an antidepressant because those are the only tools in the toolbelt. In contrast, a longevity-based clinic would run comprehensive diagnostics, fix insulin and hormones, and address root causes. Buhler cites Jelly Roll as an example: instead of immediately putting the 500-pound singer on a weight-loss drug, Ways2Well focused on fixing his insulin, hormones, estrogen, and inflammation first, then walked him through a methodical process. Jelly Roll is now running five miles and bow hunting.

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1:00:59The Wild West: Black Market Peptides and the Path Forward

Buhler reveals a staggering statistic: four out of five peptide prescriptions are currently filled through gray or black market channels, with no clinician in the chain of custody. This $7 billion black market is the real danger, not regulated compounding pharmacies. Products are often dosed incorrectly—sometimes 2x what they should be—leading to muscle wasting and other catastrophic side effects. Companies operate through a "non-human use" loophole, labeling products for research while paying influencers to advertise them for human consumption. The FBI has now shown up at multiple gray-market facilities.

Buhler's proposed solution is straightforward: restore the regulatory framework that existed before the Biden administration's ban, requiring patients to go through a clinician and a licensed compounding pharmacy with proper checks and balances. He argues that this would make big pharma "ecstatic" because it would eliminate 80% of the black market overnight. The only remaining objection—that peptides lack robust human clinical trials—is hypocritical, he says, given that 60–80% of FDA-approved drugs receive major label changes or recalls, and 90% of products used in operating rooms never had human safety studies (they entered via the 510(k) approval process).

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1:16:20State-Level Action: Texas, Florida, and the Stem Cell Pathway

Buhler describes a parallel strategy at the state level, where legislatures are moving faster than the federal government. Texas has already passed the Compassionate Use Act, allowing patients with chronic diseases the "right to try" treatments manufactured and administered within the state. Florida saw a $300 million infusion of cash from medical tourism after creating a similar pathway. Buhler recently testified in Arizona on a stem cell bill that passed the House and is headed to the Senate.

His vision is to turn Texas into a medical tourism destination where patients can fly to Austin instead of Tijuana, Panama, or Colombia for stem cell treatments. He's working with Texas Congresswoman Lacey Hull and Senator cohost (who chairs the healthcare committee) on a new bill to expand patient choice. The strategy mirrors what happened with food policy: states passed bills around school lunches and labeling, creating a "trade wind" that allowed the federal government to follow. Buhler has also submitted a citizens petition to the FDA around stem cells that mirrors Florida's law, arguing that adverse events are minimal (flu-like symptoms in 10–15% of patients) and almost always result from improper chain of custody, not the cells themselves.

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1:55:09MUSE Stem Cells: The Holy Grail

Buhler's most futuristic segment covers MUSE (Multilineage Stress-Enduring) stem cells, discovered in 2010 by Japanese scientist Mari Dezawa. These cells represent less than 2% of all stem cells but possess extraordinary properties: they are pluripotent (can become any cell type), non-tumorigenic (never formed tumors in studies), immunomodulating (no flu-like symptoms, unlike traditional MSCs), and have a 15–30% engraftment rate (compared to 3–5% for traditional MSCs). They are also half the size of traditional stem cells, allowing them to pass through the lungs and hone in on damaged tissue.

Buhler explains the mechanism through phagocytosis: a MUSE cell acts like "Pac-Man," gobbling up a damaged cell, absorbing its code, and becoming a young, healthy version of that cell—all within three days. In Japan, children born with encephalitis who received MUSE cells within eight days of birth all developed normal brain function. In Dubai, a comatose car accident victim who was scheduled for organ harvest showed brain function return after intravenous MUSE treatment. Mitochondrial testing showed that a single IV administration took 1.5 years off mitochondrial age. Buhler's chief science officer, Ian White (22 years of stem cell research, Harvard-trained), initially went to Japan to debunk the claims but left convinced that MUSE cells "will change everything in the regenerative space."

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2:22:59Plasmapheresis and Microplastics

Buhler describes plasmapheresis (therapeutic plasma exchange) as "an oil change for your body." The machine runs blood through a dialysis-like process, removing 70% of inflammatory markers, endocrine disruptors, and accumulated toxins from the plasma, then replaces it with young, healthy albumin. The treatment has been used for 50 years at institutions like the Mayo Clinic but never for longevity.

He shares the case of mutual friend Philip Franklin Lee, who came in with chronically low testosterone (around 80–90 ng/dL) and extreme fatigue. A microplastics test showed the highest levels Ways2Well had ever seen—likely from Lee's sushi-heavy diet and plastic bottle use. After plasmapheresis and lifestyle changes, Lee's testosterone rose to 1,200 without any exogenous testosterone. Buhler emphasizes that microplastics and phthalates are endocrine disruptors that cause cascading health effects, and that many people's low testosterone, chronic inflammation, and fatigue may stem from environmental toxins rather than primary hormonal failure.

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1:33:04Gene Sequencing and the Future of Personalized Medicine

Buhler introduces Ryan Rosner, a geneticist who worked for DARPA and whom he describes as being able to "build real-life X-Men." Rosner's work involves gene sequencing to understand the "software" running each person's biology. Buhler gives the example of Gordon Ryan, the elite grappler: sequencing revealed a 1-in-10-million gene for denser, more resilient tendons (explaining his injury resistance), a gene for higher bone mineral density, but also genes predisposing him to staph infections and an acidic gut—explaining his chronic health struggles.

The future, Buhler says, involves turning genes on and off like light switches. He references a protein discovered in whales that allows them to live over 200 years, and the possibility of synthesizing it for humans. He also notes that China and Russia are already pushing the envelope on gene editing, including an injection that can make bone mineral density eight times stronger (though with a trade-off of difficulty swimming). Ways2Well is building gene sequencing into its app, aiming to combine it with blood work, DEXA scans, VO2 max, and wearables to create a comprehensive, real-time predictive health model.

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Conclusion

This episode matters because it captures a rare moment of regulatory optimism in American healthcare. Buhler, who has spent years fighting FDA stonewalling, now finds himself inside the room with Kennedy and Makary, arguing for a parallel system that respects patient autonomy while maintaining safety. The conversation is dense with specific, verifiable claims—from the 1930s three-patient study that created the testosterone-prostate cancer myth, to the Hims "landmine" strategy, to the MUSE stem cell trials in Japan. What stays with the listener is the sheer absurdity of a system where 80% of peptide users rely on the black market, where the FDA's own data shows 60–80% of approved drugs get major label changes, and where the wealthiest nation on earth is also the sickest. Buhler's vision—a cash-pay, preventative, personalized "life raft" running parallel to the insurance-based sick care system—is both pragmatic and radical, and it's closer to reality than it has ever been.

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Key takeaways

• The FDA under Secretary Kennedy and Commissioner Makary is actively working to reclassify peptides and remove black-box warnings on hormone therapy, reversing decades of dogma.
• The fear that testosterone causes prostate cancer originates from a single 1930s study with three patients (one dropped out, one was chemically castrated); no subsequent study has confirmed the link.
• Four out of five peptide prescriptions are filled through gray or black market channels with no clinician oversight, creating far greater safety risks than regulated compounding.
• Hims allegedly set a "landmine" for the compounding industry by illegally using a brand name in a Super Bowl ad, then inked a deal with Novo Nordisk two weeks later—a class-action antitrust lawsuit is now underway.
• MUSE stem cells, discovered in Japan in 2010, are a naturally occurring pluripotent stem cell that can become any damaged cell type, have zero tumor risk, and show a 15–30% engraftment rate (vs. 3–5% for traditional MSCs).
• State-level action in Texas, Florida, and Arizona is creating regulatory pathways for stem cells and peptides faster than the federal government, potentially turning these states into medical tourism destinations.
• Plasmapheresis can remove 70% of inflammatory markers and microplastics from the blood; one patient's testosterone rose from ~80 to 1,200 after treatment without exogenous hormones.
• Gene sequencing is the next frontier: knowing your genetic "software" allows for truly personalized, predictive medicine, and gene editing technologies (already used in China and Russia) could eventually turn genes on and off like light switches.