Brigham Buhler critiques Big Pharma lobbying that reclassified 19 peptides as dangerous, arguing flawed 1930s studies fueled fears about testosterone and prostate cancer while ignoring evidence that optimal levels reduce risk. He exposes how companies like Eli Lilly seek to shut down compounding pharmacies to protect monopolies, contrasting this with his cash-pay WasteWell model using AI and diagnostics to extend health span. Buhler highlights the dangers of unregulated gray markets, advocates for state-level regulatory pathways over slow FDA processes, and details a case where reducing microplastics boosted a patient's testosterone from 90 to 1200 ng/dL. Ultimately, he emphasizes the necessity of expert advocacy to navigate political opposition and ensure safe access to life-extending therapies like Muse stem cells and plasmapheresis. [Automatically generated summary]
The latest is, you know, hot off the press as of yesterday.
I know the administration is still working diligently to reclassify peptides.
I know that that kind of got unveiled on the podcast.
Man, that has been a labor of love for the last two and a half, three years, whatever it's been that we've been trying to get this done.
And I know I said this when I was on here six months ago, but I'm truly the most optimistic I've ever been and with reason.
I want to like temper expectations, but you know, the prior administration of the FDA put these things into place prior to Secretary Kennedy and this administration taking over.
It was almost like a Trojan horse.
They just planted this little bomb in the middle of everything and classified these peptides as dangerous.
And so I've, for the first time in my life over the last decade of 20 something years of being in healthcare, you know, before Secretary Kennedy and this group of folks were in a position to drive meaningful change, they made these changes with the peptides.
I submitted 17 FOIA requests, 17 to the FDA.
They have never once responded to a single FOIA request, just asking for clarity about safety and why did we make this decision.
And they're supposedly by law required to respond to this request.
So to go from that environment where you're being stonewalled and you have no accessibility and no line of sight and no answers to anything to being able to at least have a seat at the table and a voice is pretty revolutionary.
Like I, again, I was the typical American patient.
I was on the cusp of diabetes.
I was obese.
I'm a former fat kid.
You know, like everything that could be going wrong in my late 30s was going wrong because I had bought into the system and trusted the system and thought, hey, if I could get my blood work annually and I follow the doctor's rules, you know, the system's just not built that way.
And that's where I think the nuances of peptides are really difficult for a regulatory body like the FDA.
And so to like systematically try to break it down for the folks that are legacy employees at the FDA have had that opportunity thanks to this administration and Secretary Kennedy and his right-hand girl, Stephanie Speer, has been integral in setting meetings and trying to move the needle.
Marty McCary, who's the head of the FDA, I had the privilege of knowing him before he took that role.
One of the things that I love is I philosophically agree with everything that Marty laid out.
I mean, what he's saying is dogma and that medicine is so worried about defending their principles and where they stand that they're essentially ignoring at times science and they're allowing dogma to rule the day rather than letting a pragmatic, like authentic, open-minded view change your perspective and lens on topics.
And so even with this peptide topic, you know, when I had the opportunity to meet with Marty on this topic, he said, look, Brigham, I didn't really use peptides in my practice.
I was a surgeon.
You know, it's not something that I'm intimately familiar with, but I'm open to understanding and trying to research and get a better grasp.
And some of the moves that this group of folks have already made at HHS, I don't know if you're following what they did with testosterone and hormone therapy.
It is literally what you and I talked about at this point, I think five years ago, where I came on and said, all the shit you're being told on testosterone and HRT and hormones, men and women, is wrong.
It's dogma.
It's been debunked.
It's not going to cause cancer.
There shouldn't be black box warnings.
The FDA has come to the consensus under this new leadership that that is the case.
And they are working to remove the black box warning on hormones.
They are working to remove the fear-mongering around women's hormones and the women's health initiative and all these things because we now know what we've been preaching for almost a decade is that these hormones are a crucial building block that allow us to drive health span.
And a lot of the decline that we see in our body is because of the hormonal decline that occurs in our 40s and 50s.
Could you please expand on the testosterone thing?
Because one of the things that keeps coming up with people when I talk to friends that are older and I say, hey, you know, you should probably get your hormone levels checked and consider getting on TRT or at the very least, getting on something like HCG that can increase your testosterone.
So all of the fear with prostate cancer literally comes from a study from the 1930s.
And it was a urologist in the 1930s.
The patient population of this study, when we talk about random controlled trials, there were three patients in the study.
One patient dropped out.
One patient was chemically castrated.
The other patient was normal.
So the chemically castrated patient, meaning they have no testosterone.
So if you treat a patient who has no testosterone and you take them from zero testosterone to normal testosterone, so to take them from, let's say, zero to 350, during that climb from zero to 350, you can increase Theoretically, the risk of exasperating a prostate cancer that's pre existing was the fear.
But as you push past that level to optimal levels, you begin to insulate against the risk of multiple cancers.
And all of the studies henceforth have shown there is not one single study that correlates testosterone therapy to prostate cancer.
With an abundance of caution, some urology practices for patients who have had radical prostatectomies are reluctant to prescribe testosterone.
But testosterone in no way, shape, or form is causing prostate cancer.
It's a receptor site thing.
So the best way to explain it is you can only water a plant so much, right?
So once we've saturated the prostate receptor sites with hormones, they're saturated.
And then when you push past that to an optimal threshold, you get the insulatory benefits of cancer reduction that testosterone appears to provide.
And that's why the FDA is looking to change that label and get rid of the black box warnings on an array of different things that have been dogma around men and women's hormones.
This is in the 30s, but since then, here's a really real-world example.
With the boom in testosterone therapy, if there was an increased risk in prostate cancer due to hormones, you would have seen a skyrocket in the amount of prevalence of prostate cancer in all of these practices that are using hormone optimization.
You don't.
You see the same prevalence that we saw prior to hormone optimization and the boom.
And so we have now seen, I think it's one out of eight men will develop prostate cancer.
I can't remember the exact number offhand.
And that correlates exactly the same into the patient population that is on hormones.
The conclusion of the study was if we treat men with testosterone, we'll see a rise in the precursor hormone that we were worried could correlate to increasing the risk of prostate cancer.
The other guy who had normal testosterone levels had no increased risk.
And you have to push through the threshold.
So think you're at zero and then you're watering the plant.
Once that plant's watered, it can't take on any more water.
So from zero, no testosterone, which is chemically castrated, you're miserable.
You have no sexual function.
You're at increased risk of all these other chronic diseases that can kill you.
But you're insulated from prostate cancer because you have zero testosterone.
As we begin to raise your testosterone level and saturate those receptor sites, theoretically, the concern was we're increasing the potential risk of exasperating a prostate cancer.
Well, I mean, it wasn't debunked, I think, until the 90s with famous prominent urologist Dr. Morgan Tyler, where he began to do research in his practice on men with prostate cancer.
And he actually began to treat men with prostate cancer with HRT and track the results.
And what he found was there was no increased prevalence of prostate cancer and it didn't exasperate or create additional issues.
And so that it was debunked in the 90s.
And then I would even go further to say, you launched, I think Pfizer launched testosterone cream in like 1990 something.
I don't remember.
And millions of men went on testosterone creams.
If it was exasperating prostate cancer, you would have seen it then too.
And so now retrospectively, 100 years later, literally 100 years later, the FDA and our regulatory oversight bodies are now changing their lens on men and women's HRT.
And so none of these, moving forward, Dr. or Admiral Brian Christine is over the men's health initiatives over at the FDA.
And he's a prominent urologist who has years and years of practice of using testosterone.
Marty, I think, even covered hormone therapy in his book, Blind Spot.
Again, it's a prime example of the dogma of medicine.
Myth becomes reality, right?
And misnomer can be adopted, and then it becomes commonplace.
And now you go to lectures and symposiums where you hear some prominent guy on stage regurgitating what he was taught in medical school or she was taught in medical school.
And then that dogma just perpetuates and it becomes almost urban legend, which is crazy to think.
Another quote that like resonated with me from Blind Spot was Marty's book was literally it's confusing, what was it, dogma with consensus, right?
When everyone, groupthink is dangerous when it is considered consensus, because groupthink isn't necessarily consensus.
It's peer pressure to adopt the values and belief systems of your peers and academia.
And there's an immense amount of pressure to not stray from the herd, to stay within the herd, to back your peers, to toe the line.
And we've seen that for the last, what, 20, 30 years.
If you step out of line and even back to, you know, originally what spurred this were peptides.
I think a lot of what happened with peptides are that this system is built under an entire ecosystem.
It cost $1 billion to $3 billion to bring a drug to market are the numbers that are out there, anywhere from $1 to $3 billion.
Now, they're taking into account all the drugs that don't make it to the finish line.
But if you really look at the true cost of bringing a drug to market, it's still at minimal $300 million to $1 billion to bring a drug or any sort of technology into the marketplace.
Now, that whole ecosystem and structure was built around big pharma and the pharmaceutical cartels and their attempt to control what hits the market and to protect their patents and their technologies.
And so that cost-prohibitive process limits innovation and accessibility under the name of like protection and safety.
But in reality, a huge percentage, I guess one of the things that academia will say, or some of the naysayers around peptides will say is, you know, the issue with peptides is there's not human control trials.
The issue with peptides is there's not enough safety data.
We recently provided the FDA with over 800 different studies that have been done on an array of the 19 peptides that were banned under the Biden administration.
We've also made them aware that we've submitted 17 FOIA requests to the previous administration that were never responded to, just seeking clarity and answers.
Where were you seeing safety issues?
Because in clinical practice, we just weren't.
And I can tell you at WasteWell now, we're at over 90,000 patients nationwide, and peptides were an integral part of the practice of WasteWell.
We did not see a bunch of adverse events.
The silence, I think, speaks for itself.
I think a lot of it is dogma and confusion.
And the process itself of bringing a drug to market, where I was going with that is I'm not asking the FDA or a governing body to pay for this for patients, right?
It's a nuanced difference that I think even regulators are struggling to wrap their head around.
We're not asking for Medicare Medicaid dollars.
We're not asking for TRICARE dollars.
We're not asking for the federal government to mandate that employers and employer insurance programs cover peptides.
If I'm launching a pharmaceutical drug into the market, I'm asking for everything but the kitchen sink.
I'm asking for everybody else to cover the cost of my care and this medication.
Peptides, proactive medicine, predictive medicine, preventative care, personalized medicine is all cash pay.
It is outside of the existing ecosystem and structure.
And I think that's what makes it so difficult to navigate for regulators because it's a new world to them.
If I'm coming from academia where I worked at a hospital where I build insurances for the last 20 years, and now I'm working at the FDA where everything we do is giant pharmaceutical companies that love the existing ecosystem because it builds a moat around their ability to monetize drugs and chronic disease, there's a benefit there to play within that ecosystem.
But if my goal is to bring innovative products to the market at a cost-effective price that the average person can afford with their own cash, you can't spend a billion dollars to do that, especially when a molecule is readily available in nature.
That's where this gets so tricky with things like peptides and stem cells and all of these products.
They've kind of been placed in this no man's land and they've been convicted of a crime they never committed.
And the truth of the matter is they were put in this no man's land because they just don't fit in the sandbox of what the system was used to.
Well, so many, so many influencers too on the academia side go online and go, I just, I would never prescribe peptides because I'm a board-certified clinician and I only prescribe things that have science and data that back them.
And a lot of times I'd say, man, you might just be uneducated on this topic and the nuances of this topic.
In reality, most clinicians are prescribing drugs off-label, right?
So a huge percentage of medical practices use products off-label.
It's indicated for one thing or one patient population or a dosage or a chronic disease state.
But clinicians have the autonomy and the authority to use that drug in a manner that it's not indicated for.
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Well, this is the big challenge during COVID, right?
And the real problem is that it interferes with the potential profits of pharmaceutical drugs that are approved.
So if you give someone the option to take something that's off-label, that's less expensive, and then it finds out, they find out it's effective, you'll get less, and then it gets public, you find out there's less people that are taking whatever pharmaceutically approved drug.
And so what created this backlash or momentum against peptides, candidly, were the GLP-1 weight loss drugs.
So I do want to put them in two different buckets because there's the 19 peptides that got moved to the dangerous list with no clear answer from the previous administration as to why or how.
But what I have seen from being able to get behind the scenes and meet with lobbyists and legislators at the state and federal level is the lobbying power of Big Pharma is real.
It's real and it's intense.
And it is not going away.
And so to put myself in the shoes of somebody, you know, like I've gotten to know Chris Klump really well at the FDA and Chris negotiated the most favored nation pricing on the pharmaceutical drugs with Lilly and Novo and all these big conglomerates.
And those companies definitively, you know, publicly and privately are banging on the table of legislators and politicians and saying, look, we spent billions of dollars to innovate these drugs.
We played within the rules of the system.
And now these drugs hit the market and you're allowing compounders and small independent pharmacies to rip off our patents, right?
And that's their stance.
And they plant that stake way over here.
If that regulator only hears that part of the story, it's a compelling story.
You look at it and go, God, man, poor big pharma, they spent all this money.
But if you zoom out and you know the lay of the land a little bit more, which is hard if you don't come from this industry, the truth is always in the middle.
So devil's advocate, of course you want to protect the patent rights of a company that spent billions of dollars to bring a drug to market.
We've covered this before, though.
The dirty secret is a large majority of the drugs that come to market come from the NIH.
And phase one trials are done at the NIH.
The NIH is funded by taxpayer dollars.
You and I are paying to innovate and create molecules that then get licensed off to big pharmaceutical companies so they can bring them through the FDA approval process.
And so I was trying to explain to the existing team at HHS, Zoom out.
The system, as much as you are being told, failed and let big pharma down and allowed people to come in and infringe upon these patents.
The truth of the matter is the FDA sent out the bat signal and said, we can't meet the need of the American people.
There is a backlog on these drugs.
It's on the backlogs list.
Can compounders make these drugs?
This has been a regulatory pathway that's been in existence for 30, 40 years.
It happens all the time.
So compounders respond to the bat signal, begin to make these medications to the benefit of the American people during the shortage list.
And then you have these big pharmaceutical companies going, look, they're making our drugs.
They're violating our patent.
If your concern is that these companies didn't get the juice worth the squeeze from the patent, Eli Lilly 7x'd the value of their company.
They're worth $800 billion.
They literally are worth more than most developed nations.
This was the biggest blockbuster molecule in the history of the world.
In the history of humanity, there has never been a drug that is this big of a blockbuster.
The money was made 50,000 times over.
Nobody was harmed.
But when I'm a legislator and I've got somebody telling me these guys hurt us to the tune of $7 billion, and I know that's what they're telling these legislators because I've met with the legislators at the state and federal level.
And then I have to go, well, hold on.
The entire compounding sector only does $7 billion.
GLP-1s were $2.5 billion.
I know that's a big number, but that was when you were asking us to make these compounds.
That number is not nearly as large today.
And you also shut down 503Bs, which is half of the compounding industry's ability to make these compounds.
The truth of the matter is, it's about $1.5 to $2 billion total that this industry was able to compound during the backlog in order to meet the needs of the American people.
They're going to do $35 to $40 million in just GLP-1 drugs this year in revenue.
So you're talking an accounting error for big pharma.
And the reason I want to lay all that out is I'm not here to argue about the GLP-1s.
It sets a dangerous precedent.
If pharma lobbies hard enough and they're able to get this done, like what they want to do, reclassifying all these as biologics.
It allows them to extend the patent for 10 to 12 years.
It's this whole shell game, but it sets precedent like we covered before.
And that precedent is dangerous.
It's a slippery slope.
Because if you do totally shut out compounders from their ability to make this for the American people, how long before they move to the next thing?
And in one breath, you've got big pharmaceutical companies saying, I'll use Lilly again as an example because they're the main culprit.
Lilly is saying peptides are dangerous.
They're getting the API from China.
We shouldn't allow these compounders to make peptides.
Meanwhile, Eli Lilly just signed a $7 billion deal to acquire a peptide company out of China.
Lilly's buying a peptide company from China while lobbying government officials and saying it's dangerous to use products from China and these compounders are dangerous and nobody's regulating it.
And there's just all this misnomer and dogma and it's confusing if you don't come from healthcare.
And they have so many initiatives and so many things they're tackling.
And then the challenge historically is when you're big pharma, and I think it was like $31 million that that industry used in lobbying power last year as an industry.
Dollars equal accessibility.
Accessibility equals impressionability.
And impressionability equals outcomes.
It's like trying to win a debate where I get one minute and the opposition gets nine minutes.
And in the one minute, I've got to debunk all the lies that the opposition told.
And I don't even want to use the word lies.
You can use facts, but like we've said before, facts can be skewed when delivered inappropriately.
If you say they cost us $7 billion and we spent $3 billion to bring this drug to market and they're importing products from China and there's no safety nets and nobody's inspecting them and this is what we're worried about.
This is dangerous and this is a liability to the American public.
Politicians' ears are going to perk up, especially when you're lobbying them and funding campaigns and trying to influence those folks.
But the truth is, yeah, if you take into account all the drugs that didn't make it and you want to cook the books, you can make it look like you spent a billion to three billion.
You can also take credit for all the drugs that were launched out of the NIH that you bought the rights to and monetized for decades.
And then you can talk about safety, but in reality, there were recalls from both Lilly and Novo Nordisk.
There are all sorts of array of issues and label changes.
And historically, even the FDA itself, this is one of the things with peptides that when I met, when I had the privilege of meeting with Marty McCary about, I said, Marty, if we're being honest, this is y'all's numbers.
60 to 80% of the drugs that make it through the drug approval process will have a major label change or recall.
60 to 80 percent of the medications that come through this process end up having a major label change or recall.
So just imagine, and I don't think this is a good idea, but imagine if only pharmaceutical drug companies were allowed to make peptides, would they just become legal?
And to think that to ask questions or to challenge that system is wrong.
And that's where I am.
So, again, I'm not sitting here.
I'm not trying to make this political because I really am not.
I don't care conservative, Democrat, Republican.
Chronic disease doesn't care about your political leanings.
It doesn't care.
Like disease and death comes for all of us.
And my goal is how do we prevent it?
How do we delay it?
How do we drive health span?
You don't do it playing whack-a-mole in treating the symptoms of a chronic disease.
You get proactive, predictive, and preventative.
And how do you do that?
Well, you've got to be able to run diagnostic tests and tools.
Well, the insurance companies shut that down and make that really hard to do.
And so in the healthcare system that exists today, in the insurance model, prescription management is the main goal of those models.
And I've said this time and time again.
You've got to view health insurance in America like car insurance.
It's there if you wreck the car.
We are great at triaging and treating a catastrophic event, heart attack, stroke, hospitals.
You're in there, something catastrophic happens.
We can triage that disaster and we can get you in and out of the hospital.
We are absolutely an abysmal failure at preventing chronic disease and driving health span.
And the only way to do that is to get proactive and predictive and personalized.
And this entire ecosystem is just not built to do that.
And so my message and what I'm trying to work for is so much bigger than peptides.
I don't want to die on the peptide hill fighting for this because it is a small sliver of what could be our healthcare establishment, right?
When we look at biologics, when we look at gene activation, all of these different modalities that are on the table, large language models, artificial intelligence, tracking data in real time, we have the ability to truly drive health span now.
If I have your genetic sequencing and your blood work and your biomarkers and your DEXA and your VO2 Max, and I put all that into the AI algorithm and we begin to track you in real time in your 30s, we are going to know years before chronic disease ever shows up on your doorstep.
The cancer that you get in your 40s started in your 30s.
You know, the diabetes you get in your 30s started in your 20s.
All of this is preventable.
All of this is preventable through diet, lifestyle, and nutrition.
We're not under-prescribed.
I think that's pretty abundantly clear.
The average American's on four or more prescription drugs.
And it is because we're a prescription-first society, right?
And we've covered this before, so I hate to beat a dead horse, but like when a primary care has six minutes on average with a patient and they're limited in what tests they can do and what diagnostic tools they can run, and a woman comes in and says, hey, I'm 40 pounds overweight, I'm depressed, I'm anxious, I'm sad, I'm all these things.
Their first move is to go, okay, well, we got to get your cholesterol under control.
We got to get your insulin under control.
I'm going to put you on a weight loss drug.
Let's put you on a GLP-1.
And they push them out the door.
And they probably put them on an antidepressant because those are the tools in their tool belt.
But if you were to come into a longevity-based clinic, we're going to run you through a battery of diagnostics.
So many men come in depressed.
You're not really, it's not to trivialize your depression.
It isn't that you're depressed.
It's that you have a hormonal imbalance and your hormones are so wrecked that you're obese.
Are you obese because your hormones are wrecked or are your hormones wrecked because you're obese?
You know, sometimes that's going to take a nuanced approach and time to uncover, but we do know we can fix that, you know, and we know that through fixing those things, there's going to be a cascade of benefits that lead into other areas of your life.
Like Jellyroll is a prime example.
If he were to go to a primary care, they would have immediately put him on a GLP-1.
He's 500 pounds, you know, and they would have put him on a battery of drugs.
When Jelly Roll came to us, it was like, we're going to make this simple.
We're going to get your inflammation under control.
We're going to put wins on the board and we're going to methodically walk you through this.
Because people think that this is the other challenge, even where I was going earlier.
Even in the longevity space, the preventative care space, it's already becoming what big pharma was.
And this is one of my really big heartburns.
You've got two pathways.
See, the first, the three pathways.
The first is the traditional system.
The second is the cash pay model.
Okay, well, that's kind of merging into two different arenas.
You've got the Peter Atias, $100-something thousand dollars to be my client that only the richest Americans can afford.
And you're going to get top-tier care and I'm going to provide concierge medicine.
Well, 99.99% of America can't afford that.
And then you've got the hems of the world that are going the route of a pill mill.
Like candidly, it isn't about quality of care.
It isn't about helping patients solve a problem.
It's about monetizing a medication and putting a weight loss drug or a peptide as fast as possible in that patient's hands so you can monetize the patient.
To me, that's no bigger different than big pharma.
And so my vision for the future is how do we combine the best of both worlds?
How do we take that nuanced concierge care, make it affordable, make it scalable, and make it truly drive health span?
I don't think the issue is the arrow.
The issue is the archer.
It's the people controlling these systems and always trying to make it about money and quarterly earnings and an exit and a strategy.
But if you pivot and you make it about people and you make it about how do we help this person, the journey of a thousand miles starts with the first step.
And Jelly is a perfect example.
If you were in a traditional model, he would come in and you would sell him a weight loss drug and that's the end of your journey with him.
You get him on a weight loss drug and you hope for the best and you push him out the door.
In our model, we're there to be a passenger alongside you using large language models, wearables, and all the things we're bringing into the business to track, diagnose, and optimize where you're at in real time.
So in real time, we're able to capture how are you trending.
We even added a scale that ties into the app that'll allow you to manage your, not just your BMI, but literally almost like a DEXA with like a 1% to 2% variability rate.
We can tell you how much lean fat, how much visceral fat, how much subcutaneous fat.
And anyone who's a member gets that scale, scans it into the app.
That combined with your VO2 Max, if you come into the clinic, we can cross-reference it with a DEXA.
The app will do its own algorithms to see how different it is.
And now in real time, from your home, you can track all these modalities and you can track how you're trending on more than just blood work.
Like to me, everyone, again, when I came on here, whatever, I think it was five years ago by now, Joe, nobody was doing cash-paid blood work.
Now everybody's doing cash-paid blood work.
And I think it's great, but it isn't the holy grail.
That's just one marker in a sea of markers, one diagnostic measuring stick and a sea of diagnostic measuring sticks.
So the future for me is how do we make it affordable and how do we make this where everyone can afford it?
One of the things we're going to do is put our money where our mouth is.
You're going to be able to load your blood work from anywhere.
I don't care if you got it at your doctor, your primary care, if you got it from HIMS, if you got it from function health.
Doesn't matter.
If you want a nuanced approach and help on your healthcare journey, not the first step.
You took the first step.
You did the blood work.
Now, what do you do with that data?
What do you do with that information?
Even in the longevity space, where I was going with that, is so many companies are trying to, let me monetize this blood work, let me monetize this test, let me monetize this peptide.
But what we should be asking is, how do I help this patient?
How do I help this person?
Because if you help that person, they tell the fucking world.
Denise and I said from day one, I've known Denise, I mean, 20-something years, man.
And when we started this, she's my Jiminy cricket because even if I ever wanted to make it about money, she's never making it.
She's such a patient care advocate.
And I said, and she said, if we always make this about people, there's going to be days we lose, there's going to be days we win.
But if we always make it about people, if we make people our northern star, that is our secret sauce.
And it doesn't mean we're perfect.
Like, look, every time I come on here, we get blasted because we grow so fast.
And it's a blessing.
And I can't thank you enough.
But, you know, you can't onboard 20,000 people overnight.
And then people are like, oh, you guys suck.
Y'all are like everybody.
And it's like, no, man, we just, even as we're growing, I'm this is again back to that dogma of like, how are companies like HIMS scaling nationwide?
They're PE-backed.
BlackRock is one of their biggest investors.
HIMS is a multi-billion dollar conglomerate marketing firm.
They're not a compounding facility.
They're not a medical practice with brick and mortar clinics that are trying to truly innovate and that are into things like biologics and plasmaphoresis and all the things that we're trying to do.
I can't compete with the scalability of that, but what I can compete with and I can destroy is the quality.
Because if we provide quality care and we make sure that we scale at a level that is true and holds integrity to the patient relationship, that's one of the biggest things I saw.
I even came on here and there's things that I've gotten wrong.
I thought the fastest way to scale and to meet the needs of the American people is AI.
And I still believe that.
But where I got it wrong and where I think the nuance is important is I've had this epiphany.
AI is a tool, but like all the other tools, at the end of the day, everything always starts with people.
Everything.
The entire human experience doesn't exist without people.
So like there is never going to be anything more meaningful to a person than another human supporting them, caring for them, and being in their corner.
And that is the importance of a clinician relationship and having clinicians that are employees of an institution, not hourly people who are paid to hop on a call and on a Monday they're pulling babies and on a Tuesday they're a testosterone expert.
That is what a lot of these telemedicine companies are now.
And it may provide accessibility, but is that optimal care?
Is that preventative care?
Or are we back to that same conundrum of how do we make a quick buck?
How do we get this guy on a bunch of peptides or girl on a bunch of peptides and we push him out the door?
And that is one of the challenges of even this emerging market is people are compromising pretty quickly.
And even this market, I see the flaws.
And those flaws are going to bring out the naysayers.
And those naysayers are going to use the bad actors and the bad examples to crucify the industry.
And I'm banging the drum a lot against HIMS right now, but I tried explaining this to Secretary Kennedy and administration.
HIMS did a Super Bowl ad where they made claims and they used the literally the GLP1 brand name of Novo Nordisk's drug and violated the law.
And I told the administration, there is no way that a multi-billion dollar conglomerate would make this mistake.
This is the equivalent to somebody coming into your living room and taking a dump on your dining room table and you assuming that it was an accident.
So when you're compounding a medication, you have to use the compounded name, the generic name, not the molecule's name, not the brand name.
So it'd be like saying, we have Kleenex for cheaper than Kleenex, right?
And we have the exact same compound.
It's technically, is it the same molecule in theory?
Yes.
But in marketing, one, you're not supposed to market if you're compounding.
You're not supposed to market direct to consumers like Big Pharma does.
So there's a lot of like guidelines.
They spent the money, they got the patent, all of this.
The reason that's important is that Trojan horse was set.
It created an extreme backlash from regulators, both senators, congressmen, congresswomen, politicians from all different walks of life came out saying, this is unacceptable.
All of these people making black market peptides and GLP1s and marketing direct to our consumers and violating patent laws and infringing upon these pharmaceutical companies.
All of that shakes out.
Statements made by all these varying politicians.
And then what happens within a week?
HIMS inks a deal with Novo Nordisk to bring the pharmaceutical drug to their practice and have a sole source agreement.
So they set a landmine in the middle of all compounders.
And I'm trying to explain to the administration, you got to understand, they're not a compound.
They're a multi-billion dollar marketing firm.
There's no way this was an oversight or a mistake.
This was by design.
And then what happened is the largest run probably in the last decade of any stock price, HIMS is shot through the roof because they inked the deal with Novo and said, now we're going to provide you with the brand name of the drug after they had set this landmine off in the middle of all of these compounders.
And so the reason that's important, Joe, is there are bad actors doing things that I think are doing them by design to damage the industry and to create a battle cry and a resistance against the folks who are trying to follow the rules and navigate a very narrow pathway forward where these peptides and these treatment modalities are available to the public.
So the backlash came, a huge uproar against, and this is, the reason this is so important is I was literally doing calls with the administration to go, hey, I get why Big Pharma would be upset and they should be.
And I get why you, the administration, would be upset and you should be.
But please do not punish an entire industry sector for one bad actor.
And at the time, I was scratching my head going, this just doesn't make sense.
Why would they do this?
They're going to get hammered.
They will not win this in the court of law.
This is a terrible idea.
None of it's adding up.
And then a week later, they make this announcement and the stock roars.
And, you know, everyone goes, oh, congrats, HIMS.
And it's like, no, this was, I, I, and we'll find out because there is a, there's a huge class action lawsuit now, an antitrust lawsuit that's going on.
I think Lee Rosebush and his firm brought it forward.
He's a guy who's academically trained.
I think ran the clinic at the Mayo clinic, ran the lab.
He's a pharmacist.
He's a law degree, all these things.
And he's in this industry and in this sector.
And he's asking a lot of questions.
And I think his firm filed a lawsuit against HIMS to try and uncover what really happened there.
Well, the main reason I want to give that tidbit of information is regulators and politicians are looking and going, God, man, yeah, these guys did bad things.
No, the guys that were doing the bad things already inked their backroom deal and rode off into the sunset.
So now what is left for the rest of the industry and where does this go?
And that's a slippery slope.
And again, separate from peptides, separate from compounds, you get into the whole world of biologics and the future of biologics and stem cells and creating a regulatory pathway.
And again, Secretary Kennedy, he tweeted this, I think, before or right when he took over, save your records and pack your bags.
Your war on stem cells and peptides are over.
And I can tell you from my meetings now further down the rhine with the FDA, I have just a more, I mean, I hate to concede, but I have a more nuanced lens on they're trying to navigate an absolute nightmare of regulatory landscape, of, you know, the lobbying power, the impression, the half-baked truths.
Where does the truth lie?
Well, this is how this entire system's built.
Well, this is what we know.
Well, we don't really know cash pay.
Well, we don't really, right?
The whole model is get a drug approved.
It costs billions of dollars.
Now we've got to lock in that patent.
Now we've got to let these companies make a bunch of money on it because they innovated it.
And we've got to get it on insurance formularies, Medicare, Medicaid, and TRICARE.
That's a whole fundamental difference when you're talking about even like, let's shelf peptides for a second, say stem cell therapy.
My whole mission statement on all of this is to build a life raft, right?
Henry Ford said, if we would have asked, if he would have asked clients what they wanted, they would have said a faster horse, right?
I'm not going to the FDA going, guys, how do we solve this problem?
I think the FDA has enough of their own problems just trying to manage the system the way it is.
My vision is you build a life raft.
You build a life raft parallel to the existing, much like Uber did with taxis.
And you let this go this way and you dry, drag race it against this way, and let's see who can prevent chronic disease.
Well, I think, well, and the question is, which model is going to be better for humanity and which model is going to take cost out of this system.
And so I would tell a regulator, a congressman, a congresswoman, anybody who will listen, guys, my model costs you nothing.
I'm not asking for taxpayer dollars.
I'm not asking for any sort of indication where I can bill insurance companies or I can build Medicare, Medicaid, or TRICARE.
What I'm asking the federal government to do is to trust the sacred relationship of a clinician and a patient and to allow a patient to have sovereignty and autonomy over their health.
If I'm Brett Favre and I'm diagnosed with an advanced stage of Parkinson's disease and it's a kiss of death, why would I want to wait 10 years for something to make it through the FDA approval process that could change or save my life today?
And if I have the means to pay for those things and the accessibility in a clinician who thinks that they have an answer to slow or help potentially improve the progression of a chronic disease or an ailment, I just don't think the government should stand in the way of that.
If you give those bad facts to a politician or a regulator, they go, oh my God, they cost you $7 billion.
You made $800 billion.
Your market cap is eight.
You 7xed your company.
Novo Nordisk three or four X'd their company in literally a three-year timeframe.
These are some of the most rich and powerful companies in the world.
Your patent worked.
It worked.
It upheld.
You prevented the regulatory landscape from coming in and people taking a piece of your pie.
In fact, I would argue it worked too well, you know, in a way.
Like, so to over-regulate based off, and that's that's the argument with the GLP1s in one bucket.
My argument, you know, for allowing compounders to continue to make these patient-specific are you need to allow patients to be able to titrate up and titrate down and avoid catastrophic muscle wasting.
What about patients who have allergies?
What about the next time these things go on a backlog?
What about a patient who maybe can't handle the delivery mechanism?
I mean, there's dozens of different reasons why you would want to provide an alternative life raft.
Yeah, so historically, the GLP1s came in preset dosages.
And so patients did not have a way to titrate up or down.
And so a lot of clinicians who wanted to micro-dose would use a compounding pharmacy to prescribe those medications and allow patients more flexibility on how they dose their GLP-1.
And I'm no, I love that you asked because I actually had the privilege of giving this message to Marty McCary at the FDA and also Chris Klump, who have been receptive to at least hearing the other side of the equation.
And to be clear, when it comes to peptides, Chris, Marty, Stephanie, Spear, Bobby, all of them are aligned.
Like peptides, I'm being told, are done.
It's just a matter of when.
I don't have that timeline, but it's a huge win because it goes so much bigger.
I cannot stress, Joe, how close preventative longevity-based medicine was to being done.
Because if you shut down all compounders throughout the country and they've already gone after the black and gray market, the FBI has shown up at these people's doors.
And on that note, even here in Texas, this is where this is crazy.
I've gotten to know several of the congressmen, congresswomen, Lacey Holes, a congresswoman here in Texas.
Senator Colehurst, I believe she's over the healthcare committee for the Senate.
Senator Colehurst was looking at forming her own FDA for Texas.
That's how serious that was getting because they knew that of everything that's happened, where this would continue to head, and states were looking to potentially hedge their bet to protect their state citizens from the federal guidelines that could be restrictive or preventative for care, which is crazy to think.
So when I laid this out for Marty, one of the things I explained where here's what the naysayers will say.
We don't want it to be the Wild West.
You're going to grandfather in peptides and give people accessibility to peptides, and that would be the Wild West.
And my answer to that is, we are living in the Wild West.
Today is the most dangerous time it has ever been in the history of peptides.
Peptides have grown legs.
The cat's out of the bag.
Everyone knows what they were.
They got a taste of the efficacy and the benefits.
And patients aren't going to stop using them.
So right now, four out of five peptides being filled are being filled through gray or black market solutions.
When Eli Lilly and Novo throw out a $7 billion number where they're cooking the books is they're not telling legislators that a lot of that is gray and black market, four out of five, meaning there is no clinician in the chain of custody.
And these companies attempt to operate through a loophole.
And that loophole is they claim it's for non-human use.
I actually had a call with a really prominent peptide company and their CEO, who's an Ivy League guy.
And I get on the phone with this guy and he's wanting to huff and puff and tell me how I don't know what I'm talking about and that he's safe and that he has written legal opinions and that he knows what he's allowed to do and not allowed to do.
And I said, well, I can tell you from history, what I've seen, you are using influencers to advertise for human use.
You say on your label, non-human use, but the second somebody has an adverse event and has something catastrophic happen, ODs or dies, the DOJ is going to show up on your door.
And when they do, they're going to subpoena you.
And when they do, they're going to uncover that you were paying influencers to advertise these products for human use while putting on the label they're for non-human use.
So you were knowingly and willingly circumventing the safety and the laws of the land to push a illegal compound into a marketplace.
I'm just telling you how this is going to play out.
I'm not hoping this for anybody.
And this was about eight months ago, and now it's happened.
Now the FBI has shown up at multiple gray and black market peptide facilities.
If we're being honest, it's 100% because of Redatrutide, the next blockbuster GLP1 that is in the works.
So Redatrutide is a triple agonist being developed by Eli Lilly.
And so it hits three different receptor sites.
It has less muscle wasting, much better safety profile, lower side effect profile, but people drop substantial amounts of body fat.
And that drug is not on the market.
It has not made it through phase three trials.
It's not commercially available.
So we got a letter as a compounding pharmacy under the FDA guidelines telling us it is illegal if you make this and we will come after you.
So we've never made it because we're a compounding pharmacy that has to follow the laws of the land because the state and the federal government inspect us.
Right before we came on, I was telling you the FDA has been in our building five times in four years.
The states have been in my building every year and I'm in 47 states.
So almost every state come we're literally in an inspection all the time.
There are plenty of safety nets.
We independently third-party verify every dosage.
We buy API from what's called the green list.
The green list is a list established by the FDA that tells us you can buy these pharmaceutical ingredients from these ingredient manufacturers.
And if I am a patient who wants to get on a weight loss drug and I can just buy it online and not have to go to a doctor and not have to go to a clinic and get blood work, and I can just buy it, there's no doctor, there's no pharmacist, it's drop shipped to my house.
What's even scarier, though, is there's no dosing instructions.
There's no way to reconstitute it.
There's no explanation of how to reconstitute.
Because once they're teaching you how to reconstitute and mix it, they're taking part in medical administration.
And so these companies have avoided all of that.
And people were using things like ChatGPT, but now ChatGPT and all the large language models have shut that down.
So now what you have is American people buying random product online with no guidance, no oversight, no clinician in the chain of custody, no checks and balances, no state or federal regulators.
We are living in the Wild West.
So my message to Marty and if you want to fix this, how you fix it is you bring back where we were prior to the mistake of the Biden administration, where they pulled these peptides from the market with no safety data that can support their actions.
And you put it back in the hands of trained clinicians.
You require people to go through the process where they have a clinician and a pharmacist and a compounding pharmacy under the right guidelines regulating the space because we know peptides are safe.
Like they are safe.
200 peptides are found naturally occurring in the human body.
These are raw elements that are readily available in nature.
The question is sterility, efficacy, and safety.
And through the proper checks and balances, we can minimize most of those side effect profiles and optimize positive outcomes.
But it requires restoring law and order to the land and implementing things the way they were before the mistake happened.
And that's all I've been trying to argue.
There's a way to fix this.
And if you do that overnight, as much as I hate to say this, you make these big pharmaceutical companies ecstatic because you just got rid of four out of five weight loss drugs that were being filled with no clinician.
And you do push it in a way back to the traditional system with the checks and balances that these regulatory bodies are so worried about.
And the only argument against that is, well, peptides don't have enough robust human clinical trials with safety data.
And then you go down that topic and I'm like, guys, you do realize, like we said, like 60 to 80% of drugs have a major label change.
These are the drugs that make it through.
Separate from that, every product that's in the operating room, I've covered this every time I've been on here.
Every single 90% of the products in the operating room never had a human safety study.
They were all brought in through the 510K approval process.
Doctors are using things every day in practice that are either off label or not validation tested or have no human safety studies.
It is commonplace in medicine every day.
So to make it this big to-do that all of a sudden it's dangerous, the most dangerous time we're living in is right now with no checks and balances.
If we get this done, you've now built a regulatory pathway that provides affordability, accessibility, personalized medicine, predictive care.
It is such a big win beyond a peptide because it candidly saves the industry.
I can tell you, owning clinic, owning a telemedicine company, owning all of these things, none of that machine works if we can't create products that help people.
Right?
And so quality products that are available without quality are even worse than quality products that aren't available.
You know, and those were our two options right now.
It's like they can't get a quality product and then we can't sell the quality product.
But this change will allow us to sell safe and quality products with the proper checks and balances.
And it also builds a regulatory pathway that I think sets us up for long-term success with things like stem cells.
And this is something that what we saw with the food lobby, when we testified at the state level for the food program, for the SNAP program, for the school lunch program, trying to align the state with the new goal of the food pyramid and the new food guidelines and get back to eating real food, healthy food, instead of feeding kids crap all day in school.
The states picked up the torch and ran with it faster than the federal government did.
And the reason that's important is we've now learned the offense.
Texas passed the bills, three different bills around food and food initiatives and label changes and protecting children.
Arizona followed suit.
I think Florida followed, multiple states followed suit, which creates a trade win that allows the federal government to pick up what state legislators have done and mirror those bills.
So I say that because I am already working at the state level to do the same thing here in Texas.
So my hope is that the federal government and the FDA get this done with peptides.
And then the next step would be, can we do the same thing with biologics and stem cells, which are amazing tools in the tool belt to drive health span and help prevent chronic disease?
The state of Texas is already raring to go.
So the state of Texas passed the Compassionate Use Act, which says if you have a chronic disease or any sort of chronic health issue, you have the right to try.
So there isn't where it's almost like marijuana law, without getting too nuanced.
The states, if you have a clinic within the state and you manufacture the product within the state or compound within the state, in theory, you can administer within the state.
And even if the FDA has a different stance on it, the state can have its guidelines and you can fall within the rules and regulations of the state and still honor and respect the rules of the land.
And I just testified in Arizona two weeks ago on the stem cell bill in Arizona.
Senator Janae Champ called me and said, can you come out and help testify?
And can we do what you guys have done in Florida and some of these other states?
And right now it passed through the House and it's on to the Senate and the Senate will most likely pass this bill.
And so I say all that to go, the states right now are able to move faster and more nimble than the federal government.
And the states are building safety nets and checks and balances that will still allow patient accessibility at the state level.
The problem then becomes if we can get the federal government to follow these same guidelines.
And we've also submitted, we submitted a citizen's petition to the FDA around stem cells that basically mirrors the Florida law.
And the whole message is exactly what you and I have just covered.
Guys, these things are safe.
The risk of an adverse event is minimal.
If it is an adverse event, it's flu-like symptoms and it impacts basically 10 to 15% of people.
All of the major adverse events you've been told about stem cells come from improper chain of command, improper chain of custody, and improper checks and balances.
How do you fix that?
You fix that through creating a regulatory pathway with proper checks and balances, proper chain of custody, and a clinician involved in the chain of command.
If we do those things, you are going to be able to provide patients with affordable, accessible care of products that work, that are safe, while the federal government can work through, do we make this a billable product down the road?
Do we build this into the insurance model?
For me to go fight to build this into the insurance model is a monumental task that I don't have the bandwidth to take on.
And I also think it's the wrong move.
I really do.
I don't want to be part of that model.
I want to build a life raft that allows patients to make decisions.
And the second you put this in an insurance model or a government payer model, everybody is castrated.
The decisions are made at the insurance level and at the government level, and it just becomes this nuanced, challenging thing.
Like an example is stem cells historically, one of the uses for purified amnion was burn victims, right, or wound management and diabetics.
So what happened?
Orthopedic surgeons started billing wound injuries in order to get paid from the insurance companies on an ACL.
Well, that only takes a year, six months before the insurance companies ring the bell and go, wait a second, dude, this person billed us a million dollars on wound management and they're an orthopedic surgeon.
What is going on, right?
You just committed insurance fraud.
And now you've created this counterculture movement against stem cells and purified amnion and all of these products.
And that's what happened in real time.
So a lot of what we're living is the continual dogma of this broken ass system.
And it creates this trade wind that doesn't die.
I mean, this was a decade ago.
And now none of this stuff's covered from insurance.
None of it has an FDA indication.
And all of it's kind of put in this gray no man's land, even though it's used in practices every day throughout the country.
And now you can legally use these treatments in states like Texas, Florida, Arizona, soon to be Arizona and Utah.
And so there is hope because at the state level, it's moving.
I do believe Secretary Kennedy and Chris Klump and Marty are very open-minded and receptive to this.
They are very progressive, and they do see the challenges of this system.
Marty covers it in his book, like I said.
So I'm more optimistic than ever that we are going to get, if we get peptides done, the next step is to begin to work the citizens' petition to see if we can do the same thing for these biologics and make these things affordable and accessible for everybody.
And the thing that's helping the momentum, I think, is that so many people know people that have had stem cell treatment and have had amazing results, like with injuries that they just couldn't recover from.
And unfortunately, some of them had to go to Panama and had to go to Tijuana and Columbia and all these different places where it's legal.
And that's, yeah, I can't tell you how many people that I've talked to that have an injury and say, hey, I'm thinking about going to Tijuana.
What do you think?
And I say, it'll help you.
100%.
I've talked to my dad.
He went.
I talked to my uncle.
My grandma went.
This person went.
That person went.
They had results that they never achieved doing any other things.
Well, and what's amazing, though, is I'm telling you, having got to know Senator Colehurst and Lacey Hull, the representative here, we'll get it done in Texas.
Like it's coming.
The new bill that we're going to submit in January, I feel confident that we will expand upon the existing legislation around patient right to choose.
Because I think it's important to begin to hedge against the power of big pharma and to try to build out a model with peptides and other things that we include in this bill at the state level, just in case, you know, just in case, not even this administration.
I feel very confident this administration is going to get a lot of these things done.
But then what happens as soon as there's a change in power down the road?
And how many years can you fight this lobby, right?
It's still alive and well.
It's not going anywhere.
But I think it's crucial that we fight for sovereignty and autonomy over our health and continue to push.
I can tell you at the state level, I'm very, very bullish that it will happen.
And what Florida saw is a $300 million infusion of cash into the state of Florida built all around this because it's now a medical tourism destination.
And that's my message to these senators and congressmen and congresswomen in Texas is we have a legitimate opportunity to do what you did with the food bill and the Maha movement around these initiatives to drive home these same initiatives on longevity and preventative based care in the state of Texas.
We have an opportunity to turn Texas into a medical tourism destination.
Can you imagine how many people would visit Austin if we truly do build a proper regulatory pathway with all the checks and balances where people can confidently fly down here and know that they can get these treatments?
And what's really amazing to me with the Maha movement is watching people scramble to find some sort of narrative as to what they're doing is dangerous or what they're doing is bad or what they're doing is somehow or another not the way we should be going, ignoring those facts that you laid out.
And I tell people the difference is with a peptide or something preventative, you're coming in and we're optimizing you, right?
So, you know, I've taken things like Dihexa, you know, for me personally, I'm not advertising this for other people, but it's like it 100% improved my neurocognitive function.
It 100% improved my data recall and retention.
It moved the needle.
And I'm paying with my cash to use something that is doctor prescribed.
And why do I need anyone else's approval for that?
I understand the need to protect the American public with safety.
And that's where I think improving safety is important.
But the second part of the equation with the FDA is approving efficacy.
And approving efficacy, unfortunately, with the model is a multi-billion dollar process.
Those checks and balances are crucial when you do a set it and forget it healthcare system.
What do I mean by that?
You put somebody on Lipitor and the doctor doesn't see them for another year and that patient is blindly trusting that clinician.
That is the insurance model.
The cash pay model is an educated patient.
patient who's taking their health into their own hands.
And you better believe me when I say, if you don't put a win on the board, they're going to fire your ass because it's their money.
Nobody's going to take a peptide month after month after month if they don't think it's doing anything.
Because they're using their money, not taxpayers' money, not an employer's money, right?
The checks and balances are there through the consumer market because it has more integrity than the traditional model because this is the only model where if you don't produce for the patient, you're fired.
You can't fire your clinician in the insurance model because the insurance model tells you where to go.
And this is important.
Sorry, I'm ADHD, but I'm thinking about this.
One of the things that a regulator mentioned to me was, again, I hate to keep bringing up these big pharmaceutical companies, but they were lobbying saying there's a problem.
Guys like Brigham, they'll own the pharmacy, but then they also own clinics and that's vertical integration and blah, And that's not fair to a patient.
Hold on.
If you understand the law of the land, the patient has the right to take their prescription wherever they want.
Even if they come two ways too well, we may prescribe it and we send it to me, to my pharmacy, because we compete on price.
And I'm going to make this as cost effective and as beneficial to the patient as possible.
If I can't compete in an open market and make this affordable and approachable for you, take your prescription somewhere else.
But I'm going to provide quality, efficacy, and cost.
And what people don't understand is in the insurance model, a patient is told, you're not allowed to go to this doctor.
You got to go to this doctor because they're within your plan.
And then they go to that doctor and that doctor goes, what pharmacy do you want it filled at?
Well, it doesn't matter if it's CVS or Walgreens or wherever.
The patient's going to have the same price because that price is controlled by the PBM, which is the insurance company.
And then that PBM is monetizing that drug through rebate programs.
It is a totally different system that captures a patient, controls a patient, and monetizes chronic disease.
My goal is to help you drive health span and monetize your health, to help you want to be a willing participant because you feel so good in your mental, cognitive, physical function, your skin, your complexion.
What we see is somebody starts and it's not, they start thinking they want to lose weight.
Guess what?
As soon as a guy like Jelly loses that weight, now the guy, I was on the phone with him this morning.
He's running five miles talking to me on the phone.
Before I lose the real quick on the genetics, because I'm super excited about this.
So one of the things we're building into the app.
So the next iteration of the app, which will come out in a few weeks, we're just trying to improve on the simplicity of use, the ability to get refills, vertically integrating into a pharmacy.
Because so often patients will fill a prescription, go to a pharmacy they don't know, then they come back and they go, well, where am I on the refill?
And where is it out in the process?
And when does it get to my house?
And what about this?
And what about that?
And I can't remember what the doctor said on the phone.
That was the whole point of Alan, the chatbot that I showed you years ago.
Allen is a resource in your pocket.
And Alan is there to pull from your medical records, to pull from your chart in real time to answer any question about what happened on that phone consult with that clinician, because all of that's annotated and put into the system and documented.
And so Alan is there to help answer and fill in the gaps.
And where I was going with this earlier is through large language models and AI, we're going to be able to scale concierge medicine.
We're going to be able to scale it in a way like never before that allows patients to get that high touch, high quality care, but for pennies on the dollar.
Like my goal is to make this as cheap as possible so everybody can afford it.
And that's the goal with stem cells too.
But it starts with regulatory pathways and destigmatizing these treatments and building a pathway that everyone can afford.
And so one of the things we're looking to add to the app is gene sequencing.
There are 20,000 genes.
Most people don't have any clue what genes they have.
And the reason that's important and what my buddy Ryan Rossner will tell you is he's a geneticist is your genes are the software that are telling the computer how to run.
He also has a gene that makes his propensity to have bone mineral density higher.
That's why his bone mineral density is higher.
That's why his bones don't break as easy.
Those are some of the positives that are in his firmware, his software that's running the biology that is Gordon Ryan.
Now, some of the downside, and this is a really cool one because we've been trying to help Gordon with this gut health issue for years.
And it's this constant battle of, you know, he's getting staph, now he's on antibiotics, now his gut health's wrecked again.
A lot of that comes down to he has a gene marker that puts him at a predisposition to get staph.
He has a weakened immune system.
So now he's in an environment where he's being exposed to a chronic issue and he has a predisposition to not be resilient to that issue.
And then he also has a gene marker that makes his gut health more acidic.
And so these are like rare genes and he happens to have these anomalies.
So it's like in one hand, he has this perfect won the statistical lottery genetic traits that put him in a position to potentially be an amazing grappler and athlete.
But then he has this Achilles heel of his predisposition to infections and his body's gut health and gut biome issues are all in that gene.
They're all in the software.
And so the premise that Ryan and what we're trying to evolve and build out is 20,000 genes.
Most people don't have any clue what any of their genes are.
We're taking all of the knowledge that Ryan and these geneticists have and we're trying to automate it using the large language models and AI and build that into the Waze to Well app.
So alongside with, you know, the VO2 Max, the DEXA, go get those anywhere.
I'm not trying to sell you these things.
I just want the information so I can help you.
I don't give a shit.
Go get your blood work from whoever.
If you can get insurance to cover it, do it.
If you can get insurance to help you with a VO2 Max or a DEXA, do it.
They're not going to, but shop it.
Find the best place for you.
And then if you have that data, when we launch the new app, we can load all that into the large language models.
We can load in your gene sequencing.
We can begin to look at you at a much broader level to try and figure out where are you headed and why?
What gene dispositions do you have?
And how do we help you navigate that?
That's predictive medicine.
That's personalized medicine.
And nobody's doing anything with genes right now.
It's crazy.
Everyone, we just got people sold on being able to do blood work.
And people are acting like that's the holy grail.
And like, I'm a believer in blood work, but it's a snapshot of you in time, right?
That's a moment of you in time.
What did you eat that day?
How did you sleep the day before?
When did you take your testosterone?
Like, there's a million variables that can throw off your blood work.
You can't lie on a DEXA.
I mean, that's a real analysis of your visceral fat, your subcutaneous fat, how much fat's packed in around your organs.
We're going to know all that.
How much atrophy is on your left bicep versus your right bicep?
All of those things.
Like Liam Harrison was just in.
I know you and Liam are buddies.
He was shocked because he has that one bum knee from all those years of moaytoning and fighters just started picking off his knee.
What's crazy is he thought he would have less muscle on that knee than that leg than the other leg because he's overcompensated and trained it so much.
He had more muscle mass on the bum leg than on the what he thought was his strong leg.
And so he was like shocked by that.
But it's fascinating because it's just data, right?
And that data gives you the ability to navigate and it gives us a blueprint because now with that data, I know things like we know how much bone mineral density you're going to lose year after year once you reach a certain age.
We can begin to quantify that and model out your vertebral risk fracture risk, you know, your hip fracture risk.
How do we preserve bone mineral density?
Like it allows us to quantify, are the hormones and these things helping preserve lean muscle mass, keep the body fat off, and optimize bone health.
All of these things.
And with what this FDA is doing with men's health and women's health and fertility and the direction it's headed, I really think we have the potential if we pull this off to enter a golden era of healthcare.
I really believe that.
But it is going to require thinking unorthodox.
It is going to require a cash pay model.
I don't think we can overhaul a system and build in all these different modalities.
I don't think we could get it done in a decade.
You know, I really don't.
And then how many lives are lost in that time?
That's where I'm pleading for, let's build a cash pay model that is a life raft that's an alternative.
And let's build a pathway that makes sense, that maybe is a more nuanced approach to driving health span.
Because I know for a fact, Secretary Kennedy has said his goal is to leave a legacy that transitioned our broken sick care system into a healthcare system, into one that prevents chronic disease rather than monetizing chronic disease.
That has literally been the mission statement since the day we opened our fucking doors.
I'm like, that's all we're trying to do.
And I love it because then you get into the fun shit.
Like, where do we go with all this gene activation?
And where do we go with like the ability to optimize humans, right?
Rather than just trying to keep you from being sick, we should strive to make you superhuman.
I mean, that's really my belief.
Like, why do you want to have normal hormones when you can have optimal hormones?
So if they find out that you have an issue, you have some sort of a genetic issue that prevents you from doing X, Y, or Z, what can they do with your genes?
So it varies by gene, but it gives us the reason to try and understand, oh, okay, this is why this has been a repetitive issue.
And it begins to give you answers to the test.
So you're not taking a shot in the dark.
And those answers will allow us to hopefully tailor and develop nuanced treatments.
Now, the future is they're able to turn off and on genes like a light switch.
I don't know if you saw, like, they just, there was a whole article about they discovered that whales have a protein unique to whales and they live over 200 years.
And they think this protein could be one of the keys to driving human health span and longevity.
And it's basically the premise is, can we synthesize and utilize this gene to turn on the gene in humans and have us secrete and produce a higher level of this protein or this amino acid?
And would it drive our health span and reduce our risk of cancers?
All of those things.
So the question becomes, as we evolve, what genes can we turn on and turn off?
You know, what does the regulatory landscape of the future look like in America?
China and Russia are already doing these things, right?
And so even if we attempt to fight the evolution of science, I think we're going to look back in a decade and go, I cannot believe we put people on petrol chemicals to solve problems because we're going to be able to go in and turn off or on a gene and fix that problem, right?
At the cellular level, at the biological level, you're going to be able to fix and remediate so many of these issues.
That's all they're doing with the bone mineral density is they're turning on a gene that tells you to increase your bone mineral density.
Or when you look at the fallostatin, you know, that they're using in cattle, that's just a gene signal that tells your gene, hey, turn on and you're going to put on muscle.
And for a six to, I think it's a six to 12 month timeframe, that statin, that fallostatin gene will be turned on and you'll put on muscle.
And then at the end of that, it gets turned back off.
So it's like temporary turning on a white light switch and then that light switch will eventually revert back.
What's what's so fascinating to all this to me is so then you've got.
So getting to meet all these different scientists right, you got Ryan, who was working for Darpa, and then I know Ian, who's been 20 years of stem cell research, and Ian, in his book, talks about that.
We share a common ancestor and i've covered this before, but Ian hypothesizes within our genetics.
We share an ancestor with the eternal jellyfish.
We share an ancestor with the Galapagos tortoise, with the Greenland shark.
Greenland sharks don't develop cancer.
They live 500 to 600 years.
The jellyfish lives eternally.
All of those black boxes are within us.
If we can find those through gene sequencing and we can identify which gene is doing that in the animal kingdom and cross-reference that to our own genetics.
The question then becomes, can you either insert that gene into humans or is that gene available and can you turn it on um and what's the side effect correct?
Sure okay so yeah, Devin came into the clinic, he's done his gene sequencing um, and it's crazy like the guy has so many genes that are just statistically impossible.
It's like, was this guy built in a lab like our wrestle?
It's crazy, like he has that same tendon gene.
He has the bone mineral density gene.
He has some very, very unique genes and so part of this is just like the, the knowledge and the excitement of what can we do in the future.
I don't know, but today I think you know, knowing your software that you're running on, it's crazy to think that everyone knows which version of the Iphone software they've got.
whatever but we don't know what code our body's running on but here's the question these Genes are inherent to you from birth, or is anything a result of training?
So one of the other things, you said treatments that we're doing.
One of the things that I think is the most exciting thing that I have come across, and I know, I think you know where I'm going with this in my entire time in healthcare is the muse stem cells.
So I don't know if you want me to talk a little bit about that.
So for the listeners, because of you, candidly, I get approached all the time from scientists, from doctors, from people going, hey, I've got this thing that's going to change the world.
And I'm like, oh, yeah, sure, you do.
And you just never know.
So I had a company reach out and they're like, hey, we would love to meet with you.
We have a sub-phenotype of stem cell that we think is going to change the world.
And so I called Dr. White, you know, who's my chief science officer, and I have him vet these folks.
And he's like, man, I don't know.
It sounds too good to be true.
They're like, we would love for you guys to fly to Japan, meet with Mari Dozwana, and hear her lectures and tour the lab and kind of see what she's been doing since 2010.
We reviewed all the research, all the data, all the literature, and it was mind-boggling.
So Ian and I hopped on a plane and went to Japan back in September and sat down with Mari and she was gracious enough to break down all of her research, answer Ian's questions.
And I'm going to be clear, like we went there to debunk this shit.
We thought there's no way that this is what she's presenting.
It's just, it just seems too good to be true.
And after sitting through those lectures and Mari enlightening us on all of her research and what she's seen, I left there with Ian and he looked at me and was like, if this is real, this is going to change everything in the regenerative space.
And Ian, I think, won Regenitive Scientist of the Year last year in North America.
He won a big award for this space.
And Ian is a stem cell scientist.
But these muse stem cells are such a rare subset phenotype of stem cell.
And so the best way to explain it is to try and break it down in like layman's terms is Muse stands for multilineage and the SE of Muse stands for stress enduring.
So what does that mean in like real world talk?
Mari in her book where she writes about these cells and how she discovered them, she was in the lab.
She kept coming across this small outlier subset of stem cells that appeared to have a lot of unique qualities, but they were less than 2% of stem cells.
So stem cells that are already a very minute amount of the cells in our body have a subset phenotype called muse.
She had to rush out to a dinner where in Japan where she ended up eating sushi and having sake and forgot to put the cells back, take them off the Petri dish and put them back in cryopreserve.
She thought she'd go in the next day and everything would be dead when she went in because the cells don't last overnight.
She goes in the next day and to her surprise, all of those subset phenotype of cells were still alive.
A large majority of them were still alive.
And she thought that can't be possible.
And that was in 2010.
And that's what began her research into what are muse.
And so without getting too in the weeds, I'd love to like break down what it is, what makes it unique and why it's so promising if you're game.
Because it's super cool.
First and foremost in medicine, they say do no harm, right?
And so when we're lobbying and trying to educate these politicians and these regulators on the safety profile of traditional MSCs, traditional stem cells are extremely safe.
And I've said this on your podcast before.
Dr. Kaplan, who discovered traditional MSCs in an open letter to the scientific community, apologized and said, I should have never called them stem cells.
Because the problem with these cells is they don't differentiate.
They don't become anything.
That only happens in a Petri dish.
But in the body, they just signal to damage and then they transfer their mitochondria and they temporarily give your body an environment to heal faster and to recover.
So they aren't truly regenerative in that they don't become a tendon.
They don't become a neuron.
And there's pros and cons to that.
The pros are they don't become a cancer cell.
And that's the concern with pluripotency.
And so the holy grail of what people have always looked for with stem cells where could we, for lack of a better term, fuck with these cells enough in a Petri dish to create pluripotency where they can become something, but prevent tumorgenic behavior where they don't become a tumor or don't become a cancer.
Lo and behold, in 2010, what Mari discovered was this ultra-resilient subset of stem cell that holds those exact traits.
It was in us all along.
It's always been in us.
This wasn't created in a Petri dish.
This is biology.
This is the stem cell answer that has eluded scientists for decades.
And it is so exciting because the multilineage, what does that mean?
Multilineage just means these are pluripotent cells.
Pluripotent, multilineage is a bunch of fancy science talk for they can become anything.
So the way I explain that is you and I talked about this years ago.
Orthopedic surgeons would go, you know, I use bone marrow stem cells and I don't really get good results.
And I think that you can't get real stem cells because those cells have an identity.
And when you take bone marrow, the cells have already become a bone marrow cell and they're not going to differentiate and become something.
So heretofore they can't heal.
There's some truth to that.
They couldn't.
They could just help regenerate or help, I guess, optimize your body's healing through bringing down inflammation and potentially transferring mitochondria into your old tired weary cells.
Where these cells are fundamentally different is think of it like a kindergartner.
A kindergartner can be anything.
The world is that child's oyster.
If they want to grow up and be a doctor, they can be a doctor.
If they want to grow up and be an astronaut, they can be an astronaut.
The traditional cells that doctors and clinicians have been using in America, they're already grown up.
They've already chose their identity.
They already went to med school and they decided they're a doctor.
You can't put those in the body and have them become something because they've already developed their identity, their phenotype.
These cells will literally go into the body and take on the phenotype of any damaged cell.
What is so amazing and crucial about that to understand is if they come across a torn tendon cell, they become that tendon cell.
If it's a bone marrow cell, they become a bone marrow.
If it's a neuron, they can become a neuron.
And the process that they do it through is also pretty fascinating.
It's a commonly known process, but phagocytosis, don't say it three times fast, it can get canceled.
But like phagocytosis, essentially, even in that laminous term, is like, think of it like a Pac-Man.
This is how Mari described it to me, because she knows I'm an idiot.
And she's like trying to break it down in a way I can digest.
She's like, I want you to think of a Pac-Man.
Think of a damaged cell like a neuron.
This Pac-Man is going to go up, gobble up that neuron through the process of phagocytosis and take on all of the characteristics and code of that cell, meaning it will become a young, healthy version of the damaged cell.
So, one, these cells are extremely safe in that they're non-tumorigenic.
In studies, these cells had no, never became tumors in any of the studies that are ever done.
Furthermore, they treated mice that had pre-existing cancer.
They did not only not exasperate the tumors, in many of the studies, the tumors shrunk.
And I'm not here to say like it's going to cure cancer or anything like that.
The message is traditional MSCs are already extremely safe.
And these MSCs appear to be even as safe, if not more safe.
And the only knock on traditional MSCs in real-world application, when utilized appropriately, is they have an immunomodular modulatory immunoimmunity response, essentially, where 10 to 15% of people will get flu-like symptoms.
And that's with traditional MSCs, which is a very low safety profile.
What you saw, like effective safety profile, what you saw with the muse cells in trials is 0%.
Literally right now, nobody's even getting flu-like symptoms.
And it's because these muse cells go above and beyond immuno, like the ability to navigate your immune system and go into immunomodulating your immune system.
So what do I mean by that?
Mari did a study where she took mice, sutured in human livers, into the mice's liver.
The mice should reject that and die.
They implant muse cells in, and the liver will accept the human liver for a period of time.
They eventually rejected the liver, but it's able to immunomodulate.
So think about this for a simple way to explain it is the whole process I broke down before.
Like when a mother's pregnant, that baby is technically a foreign body in the mother.
So what in science stops that mother's body from rejecting and killing the baby and her immune system attacking the baby?
The answer is MSCs.
The answer is the juices of life that allow that mother's system to immunomodulate and not turn on the baby.
So not only does it build up the mom's immune system and helps the mom reduce inflammation, reduce like her risk of chronic disease and all mortality cause is at an all-time low while pregnant.
The risk of cancers at an all-time low while pregnant.
All of this goes back to MSCs and now we believe potentially muse cells.
And so they're safe, they're non-tumorigenic, they immunomodulate, meaning your body's not going to reject these cells.
You're not going to have a huge risk.
What's crazy is they're already using it in plastic surgery.
This is what I saw.
They would take historically instead of filling women were using fillers.
And the reason they use fillers instead of fat is fat lacks angiogenesis and those fat cells die.
And a lot of times the success rate's not as high.
So what they're doing in Dubai and these other nations is they're using muse when they do a reconstructive surgery to reduce the risk that you have an immune response that rejects the fat tissue.
So it encourages the body to accept that tissue and then helps those cells build themselves back into your system and immunoregulate.
So think about it for the future of like organ transplants, what this could mean if the science holds in practice of what they're seeing.
But for the sake of conversation today, the point of saying all that is extremely safe, no risk of tumors, non-tumorigenic, immunomodulating, meaning your body's not going to turn on it.
It's not going to cause any sort of inflammatory response or flu-like symptoms.
So one of the safest versions of stem cells we've ever seen.
And the traditional cells are extremely safe themselves.
And then you get into the pluripotency.
I mean, this is the first cell other than the cells that have been altered that can truly become something.
And then the fourth and final thing that's really amazing about these cells is their honing abilities.
So traditional MSCs, what we've been using at Waste Well for the last five years, even with the great success we've had, they literally have a 3 to 5% engraftment rate, meaning 3 to 5% of those cells make it to the site of damage and begin the healing process in the site of damage.
And think about the results we've gotten.
Now, look at muse.
Mews have a 15 to 30% engraftment rate.
Mews are literally half the size of traditional MSCs, and they have the ability when administered intravenously to pass the lungs and make it to the site of inflammation and damage.
They hone in at a much stronger rate than traditional MSCs.
So the way to think of it is like you're taking a heat-seeking missile that's able to find exactly where the SS1P, SP1 inflammation damage cell is, it's the signal that a cell sends out, hey, I'm damaged.
These muse cells will navigate straight to those damaged cells through phagocytosis, absorb that cell, take on its phenotype, and be a young, healthy, vibrant version of that cell.
And all of this occurs within three days.
So that's why you're seeing such crazy results in Dubai and overseas.
And these are the treatments that are coming into the U.S. that are going to be manufactured here on U.S. soil and utilized in states right now like Florida, Texas, Arizona, and the states that have built pathways that make this approachable for people.
The hope is that we can build a regulatory pathway at the federal level that will allow accessibility too.
Because what is definitively clear is these treatments, even the old MSCs and purified amnion and Wharton's jelly and all those things, there's no arguing that they're extremely safe.
So here's the problem is you have a precipitous decline as you age, right?
And so just like what we're seeing with peptides, you have a certain amount of these.
And as you age, they appear to decline.
The other thing that this is crazy.
So you've got this scientist, Dr. Dominic Deutscher out of Germany, brilliant guy, Stanford trained, went to Stanford, did research at Stanford, went to Harvard, University of Munich, crazy background, 14 years of stem cell research.
He catches wind of what Mari's doing, and he had been working on a study going, there appears to be this weird subset of stem cells that I can't figure out what they're doing, but they're not there in diabetic patients.
When I look at patients that are diabetic, they don't have this subset.
So what is this subset and what is it doing?
But he couldn't figure it out.
He was on the cusp of figuring it out.
And then he meets Mari and goes, oh my God, you literally figured out what the fuck I've been trying to solve for the last 14 years.
The reason is these patients are diabetic and their system is so chronically riddled with inflammation and all these issues.
The environment or whatever it is, their lifestyle caused the decline and basically the end of these cells.
All their ability to heal was used up.
Is that part of the reason other than just blood flow and the other challenges of diabetics?
It could be one of the under causing attributes that are causing these diabetic patients to heal poorly, to be chronically inflamed.
So it could be part of that equation.
But what's fascinating is it also declines as we age.
So you're going to see way more of these at birth, way less of these in your 30s, probably non-existent by the time you're in your 40s and 50s.
And so if we can take these cells, these goodies of life, and we can administer them proactively and preventatively, they even did mitochondrial testing.
I don't know if that study is released yet.
If it is, I'll add it to the website.
I'll find out from Mari.
But they did a mitochondrial function test.
One IV bag administration took one and a half years off the mitochondrial age.
And so I'm not saying that it reverses aging, but in these studies, it appears to have extreme mitochondrial benefits, which would logic to reason as to why we're seeing such phenomenal results with these treatments and where even, and I'm still a huge proponent of all of the traditional stuff we've been using.
We've seen miraculous results with all of these different modalities.
But I look at Muse and go, this is the holy grail of what we've been trying to find.
And Mari did it.
Like she found it.
She discovered it in 2010.
They started using it in human patients in 2019.
These products are being used every day in Dubai and overseas.
People are flying over there and paying buku dollars to these clinics to get treatments with muse cells.
In fact, one of the sheiks of United Arab Emirates or one of those, his son got in a car wreck.
He literally was in the hospital.
This is a true story.
They said, he's done.
Pull the plug, harvest his organs.
Dominic was able to get a hold of the hospital, the German scientist, and say, hold on, can you guys do a call with Mari?
I may have a solution.
They treated a kid who had been comatose, non-responsive.
Take his organs.
Like, he's done.
The neurologists are like, he's done.
There is no brain here anymore.
They treat this kid with intravenous muse cells and his brain function has come back.
He's not talking, but he's responding to his mother.
He's moving his hands.
They're no longer looking to harvest his organs.
And this is a catastrophic example.
But in a more real world, relevant example is in Japan.
They used it with children who were born with encephalitis.
And what they saw is these children who are left untreated will definitively have neurocognitive issues and defects, mental retardation.
The children treated with muse within eight days of birth, all of those children had normal brain function.
And so the studies beyond that, and then you get into what they saw in hearts, what they saw in myocardial infarctions.
Like you just go down the list and there's so much promising data.
And there's a decade worth of it.
It just hasn't made it into the U.S. yet.
And these are technologies and science and modalities that are going to be adopted in the near future at minimal at the state level and then hopefully at the federal level because they're already looking.
We know, like I said, Secretary Kenney is looking to open the regulatory pathway for stem cells.
And Muse are just a subset of that same class, but an even safer, more efficacious version from what we're seeing in all of the trials.
Well, and then you've got guys like Ryan who go, if you could take a muse cell and a cell that could be anything, right?
And it already has, it's ready to learn.
What if you can take a muse cell and you can teach it to be exactly what you want it to be?
And then you administer that cell into the body, but you've already given it its commands.
You've already taught it that it wants to be a doctor, right?
It wants to be whatever it is.
Maybe you make sure that it's a neuron.
Again, I'm way over my skis on this part because I'm a business guy.
I'm just breaking down what these scientists are saying.
And all of it is exciting and promising to me because, again, we've had such phenomenal results with traditional MSCs, you know, with traditional MSC.
And all muse are, are this subset phenotype of super soldier cell.
They're more resilient.
And so the second part of muse is stress enduring.
So the whole point is Mari has a chapter in her book called Sake in Science because through drinking sake, she realized that there was an element of the science behind this that she would have never uncovered had she not gone to that dinner.
She would have never realized that these cells appear to be ultra resilient.
They can ship these cells at room temperature and they're viable for weeks.
Whereas traditional cells, we've got to keep cryopreserved and ship on dry ice.
So from an administration standpoint, from a logistical standpoint, from an efficacy standpoint, from a safety standpoint, all of this could be so game changer.
So then the next question just becomes, how do we build a regulatory pathway in this country that allows accessibility so that Americans aren't having to go to other nations?
And the states, some of the states are doing it, but ideally, it would be optimal to work with the federal government to build those same pathways at the federal level now that the states have already jumped on board.
I'm telling you, the stuff, it's hard because, again, I'm not a clinician.
I don't ever, I'm not, I don't want to make claims.
I don't want it to be, I am very excited about this, but I want to temper my excitement because I have to be cautious to say, I don't want to give people false hope.
You know, we don't know.
The science is very early, but it is very promising on a lot of different things.
And we've already had immense success on orthopedic injuries, knees, shoulders, elbows, using traditional MSCs that can't differentiate, right?
They're just transferring mitochondria and temporarily putting your body in a position to heal.
These muse cells differentiate.
So they literally are regenerative cells that become the broken cell that allow your body to heal.
I mean, and what we do with that and what the future holds with that, the sky's the limit.
And that's where I just think eventually we're going to get to a point where it's like, do we really prescribe everyone petrochemical drugs to fix problems?
Because the genetic side of the world and the stem cell side of the world and the biologic side of the world and all of these things.
And then you break in the large language model side and wearables and the ability to track in real time.
And again, the historic FDA stance on not even this new administration.
This new administration has made it clear their plan is to open up the regulatory pathways on peptides and stem cells and cash pay products and to figure out a pathway that makes sense for the American people while still honoring the safety and integrity of what they're trying to implement on a grander scale.
But do we need to go through the level of rigorous, you know, multi-billion dollar process on something that can't really be patented?
Or if it's safe and the safety profile is proven and it's readily available in nature, does it make sense to grandfather these treatments in and to allow patients compassionate use?
If you're battling a chronic disease and you're going to die, what is the harm in seeing if this can help?
If you're battling dementia or Alzheimer's, you know, that's another huge one.
Like traditional MSCs are too big to pass the blood-brain barrier.
Muse MSCs can be internasally administered and immediately go into the blood-brain barrier.
And in trials, they were able to see the Muse cells 18 months later lit up like a Christmas tree in the midbrain.
The reason that's important is midbrain is where Parkinson's and so many of these neurocognitive disease states reside and where most of the dysfunction is occurring.
And so, yeah, there's a lot of promise.
I'm excited about it.
I think Muse are going to be a big opportunity here in America to drive meaningful change.
It's just a matter of, you know, when and how they're available and to what capacity.
You're going to see these things springing up at the state level.
They're already happening all over outside the United States.
It's just a little bit different market here with the regulatory landscape.
No, the other is just, you said some of the treatments.
You know, one of the ones that I heard Dana White talk about, and he had said, well, you got to go to Mexico is plasmaphoresis.
Like we have plasmapheresis here in Austin, Texas.
We use it.
We added it to the clinic, I guess, three months ago.
Plasmapheresis is also known as therapeutic plasma exchange.
Essentially, we run your blood through a dialysis machine.
It's been used for over 50 years.
It's used at the Mayo Clinic.
It's used at all of these various academic institutions.
It just hasn't been used for longevity, right?
And in an insurance model where you're trying to get a reimbursement rate, you've got to have an indication.
But in a cash pay model, and this is where the world is your oyster, in a cash pay model, a clinician and you, the patient, can make a decision that you want to get proactive and predictive and you want to run your body, your blood through a plasma phoresis machine and basically isolate out within the plasma itself, the liquid, are all the inflammatory markers, all the leftover bad stuff that you don't want in your blood.
So for me as a 45-year-old male, I've got 45 years of all the attrition and stuff that's in my system.
You get 70% of that out through one therapeutic plasma exchange utilizing the plasmapheresis machine.
And so what we'll do is we'll extrapolate out systematically your plasma and replace it with young, healthy protein called albumin.
And then where we go an additional step at Waste Well is we're developing a protocol where we also add in the MSCs and peptides and all of the things that are missing from albumin, right?
So there's two different train of thoughts.
And I have these listed too, Jamie, on the website.
There's a bunch of different studies.
Plasmapheresis has been studied for over 50 years.
It's just not been utilized for like longevity and preventative care.
It's used more for systematic inflammatory issues.
There's even a bunch of fascinating studies around Alzheimer's because Alzheimer's and dementia is so inflammatory related.
So there's a bunch of fascinating stuff on that.
But the premise of plasmapheresis is think of it like an oil change for your body.
We're going to take out 70% of all the bad stuff that's floating around in your blood.
We're going to replace that blood with young, healthy albumin.
And then, you know, what we're attempting to do is stack it with our own protocol where we add in MSCs, extracellular vesicles, all of these cellular goodies that are readily available at birth that have a precipitous decline as we age.
So, we ran that test, and then it was through the roof, and it scared him.
And Philip stopped drinking out of plastic bottles, took a very like measured approach to trying to be aware of how much plastic he could inadvertently be consuming.
And then we ran him through ways to well protocols.
Not only can we quantify it through his testing, which I think he posted on his Instagram, we quantified how much we reduced the level of microplastics.
Phillip's testosterone, without being on any testosterone, is at 1200.
All of that inflammation and shit that was in his system was causing chronic inflammation, chronic fatigue, running down his immune system, and causing all of these cascade effects that led to him essentially having a low testosterone.
That's what's like so many people come in and go, What do you have that can help me?
And this is what's challenging too.
This is another thing I want to point out about the challenge of like not making claims or understanding the nuance.
We saw this with the psychedelic attempt to get psychedelics through the FDA.
One of the things that they wanted to do in the psychedelic trials was provide psychiatric integration.
So, you come out the other end of a mushroom journey and you talk to a therapist and you walk through what you experience to process your thoughts and emotions.
The system's not built to do that because now you're taking two different things and attempting to build a bill master code and get an indication.
Well, if I'm united, I'm going to go, Well, how do I know it wasn't just the therapy?
And so that's one of the challenges when people go, What do you have for microplastics?
What's tough is a lot of people come in and they go, Hey, man, I'm going to do the Hawket and I'm going to do the plasmapheresis and I want to do MSCs and I want you to bring down my inflammation.
And so, so many people are doing multiple modalities.
What I'm saying is it's working, but which one is the needle mover, or is it an attrition of all of them?
You know, that's where this gets tough.
And that's where I want to track and do a better job of like tracking and quantifying individuals who just do one test or one treatment or one aspect of what we're doing at Ways to Well, which one's moving the needle the most?
Because so many people want to try everything, right?
They're already here.
They already flew in.
So they're like, Yeah, let me do this today, this tomorrow, this.
And then they all report back.
I go, I'm feeling phenomenal.
I feel the best I've felt, but they did five things.
And if you wouldn't have had me on here to talk about this, I wouldn't have got to meet Secretary Kennedy and we wouldn't be in a position.
And I will tell you, not being hyperbolic, if you weren't here and fighting for peptides and accessibility and you hadn't given me a platform, I don't know if anybody would be helping this administration navigate all this.
I really don't.
There's so many people on the opposite side of the aisle that it's a tough thing to navigate.
And it takes somebody who knows and has been in the industry enough to explain it, hopefully in a way that resonates, where we can get things done.