00:01:41.000The latest is, you know, hot off the press as of yesterday.
00:01:46.000I know the administration is still working diligently to reclassify peptides.
00:01:51.000I know that that kind of got unveiled on the podcast.
00:01:55.000Man, 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.
00:02:03.000And 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.
00:02:11.000I 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.
00:02:25.000They just planted this little bomb in the middle of everything and classified these peptides as dangerous.
00:02:34.000And 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.
00:02:50.000I submitted 17 FOIA requests, 17 to the FDA.
00:02:56.000They have never once responded to a single FOIA request, just asking for clarity about safety and why did we make this decision.
00:03:04.000And they're supposedly by law required to respond to this request.
00:03:08.000So 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.
00:03:21.000Well, it's just very helpful that he actually uses them.
00:03:25.000That Kennedy uses them and he knows the benefits of them and he's very educated on it.
00:03:57.000You 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.
00:04:14.000And that's where I think the nuances of peptides are really difficult for a regulatory body like the FDA.
00:04:20.000And 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.
00:04:40.000Marty McCary, who's the head of the FDA, I had the privilege of knowing him before he took that role.
00:04:45.000We testified together at the Senate level.
00:04:55.000One of the things that I love is I philosophically agree with everything that Marty laid out.
00:04:59.000I 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.
00:05:24.000And 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.
00:05:34.000You 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.
00:05:43.000And 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.
00:05:52.000It 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.
00:06:06.000There shouldn't be black box warnings.
00:06:08.000The FDA has come to the consensus under this new leadership that that is the case.
00:06:13.000And they are working to remove the black box warning on hormones.
00:06:17.000They 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.
00:06:34.000And a lot of the decline that we see in our body is because of the hormonal decline that occurs in our 40s and 50s.
00:06:41.000Could you please expand on the testosterone thing?
00:06:45.000Because 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.
00:07:31.000So the chemically castrated patient, meaning they have no testosterone.
00:07:35.000So 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.
00:08:03.000But as you push past that level to optimal levels, you begin to insulate against the risk of multiple cancers.
00:08:11.000And all of the studies henceforth have shown there is not one single study that correlates testosterone therapy to prostate cancer.
00:08:19.000With an abundance of caution, some urology practices for patients who have had radical prostatectomies are reluctant to prescribe testosterone.
00:08:28.000But testosterone in no way, shape, or form is causing prostate cancer.
00:08:34.000So the best way to explain it is you can only water a plant so much, right?
00:08:38.000So once we've saturated the prostate receptor sites with hormones, they're saturated.
00:08:44.000And then when you push past that to an optimal threshold, you get the insulatory benefits of cancer reduction that testosterone appears to provide.
00:08:54.000And 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.
00:09:03.000So this initial study, like why was the one person chemically castrated?
00:09:09.000This is in the 30s, but since then, here's a really real-world example.
00:09:13.000With 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.
00:10:03.000But I don't understand about the study.
00:10:04.000So what was the conclusion of the study?
00:10:06.000The 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.
00:10:18.000And was this prevalent in this one person that was chemically castrated or was it in the other guy?
00:10:24.000The other guy who had normal testosterone levels had no increased risk.
00:10:41.000You're at increased risk of all these other chronic diseases that can kill you.
00:10:47.000But you're insulated from prostate cancer because you have zero testosterone.
00:10:51.000As 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.
00:11:01.000Well, so how was this whole opinion based on this one study from the 1930s and just repeated at nausea for decades?
00:11:09.000Well, 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.
00:11:20.000And he actually began to treat men with prostate cancer with HRT and track the results.
00:11:25.000And what he found was there was no increased prevalence of prostate cancer and it didn't exasperate or create additional issues.
00:11:32.000And so that it was debunked in the 90s.
00:11:34.000And then I would even go further to say, you launched, I think Pfizer launched testosterone cream in like 1990 something.
00:11:43.000And millions of men went on testosterone creams.
00:11:45.000If it was exasperating prostate cancer, you would have seen it then too.
00:11:49.000And 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.
00:12:04.000It's just so crazy that doctors for doctors.
00:12:07.000You have to be cautious about the potential prostate cancer.
00:12:48.000And misnomer can be adopted, and then it becomes commonplace.
00:12:52.000And 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.
00:13:01.000And then that dogma just perpetuates and it becomes almost urban legend, which is crazy to think.
00:13:12.000Another 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?
00:13:24.000When everyone, groupthink is dangerous when it is considered consensus, because groupthink isn't necessarily consensus.
00:13:32.000It's peer pressure to adopt the values and belief systems of your peers and academia.
00:13:37.000And 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.
00:13:47.000And we've seen that for the last, what, 20, 30 years.
00:13:51.000If you step out of line and even back to, you know, originally what spurred this were peptides.
00:13:56.000I think a lot of what happened with peptides are that this system is built under an entire ecosystem.
00:14:05.000It 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.
00:14:13.000Now, they're taking into account all the drugs that don't make it to the finish line.
00:14:17.000But 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.
00:14:30.000Now, 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.
00:14:44.000And so that cost-prohibitive process limits innovation and accessibility under the name of like protection and safety.
00:14:56.000But 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.
00:15:08.000The issue with peptides is there's not enough safety data.
00:15:11.000We 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.
00:15:21.000We'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.
00:15:32.000Because in clinical practice, we just weren't.
00:15:36.000And 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.
00:15:45.000We did not see a bunch of adverse events.
00:15:49.000The silence, I think, speaks for itself.
00:15:52.000I think a lot of it is dogma and confusion.
00:15:56.000And 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?
00:16:09.000It's a nuanced difference that I think even regulators are struggling to wrap their head around.
00:16:14.000We're not asking for Medicare Medicaid dollars.
00:16:19.000We're not asking for the federal government to mandate that employers and employer insurance programs cover peptides.
00:16:26.000If I'm launching a pharmaceutical drug into the market, I'm asking for everything but the kitchen sink.
00:16:31.000I'm asking for everybody else to cover the cost of my care and this medication.
00:16:36.000Peptides, proactive medicine, predictive medicine, preventative care, personalized medicine is all cash pay.
00:16:43.000It is outside of the existing ecosystem and structure.
00:16:47.000And I think that's what makes it so difficult to navigate for regulators because it's a new world to them.
00:16:54.000If 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.
00:17:18.000But 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.
00:17:34.000That's where this gets so tricky with things like peptides and stem cells and all of these products.
00:17:39.000They've kind of been placed in this no man's land and they've been convicted of a crime they never committed.
00:17:46.000And 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.
00:17:54.000Okay, so we should also clarify that when we're talking about peptides and peptides being dangerous, GLP-1s are peptides.
00:18:25.000Well, 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.
00:18:39.000And a lot of times I'd say, man, you might just be uneducated on this topic and the nuances of this topic.
00:18:47.000In reality, most clinicians are prescribing drugs off-label, right?
00:18:51.000So a huge percentage of medical practices use products off-label.
00:18:55.000It's indicated for one thing or one patient population or a dosage or a chronic disease state.
00:19:01.000But clinicians have the autonomy and the authority to use that drug in a manner that it's not indicated for.
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00:20:16.000Well, this is the big challenge during COVID, right?
00:20:18.000With hydroxychloroquine and with ibermectin.
00:20:22.000And the real problem is that it interferes with the potential profits of pharmaceutical drugs that are approved.
00:20:29.000So 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.
00:20:44.000And so what created this backlash or momentum against peptides, candidly, were the GLP-1 weight loss drugs.
00:20:53.000So 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.
00:21:05.000But 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.
00:21:19.000And 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.
00:21:33.000And 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.
00:21:44.000We played within the rules of the system.
00:21:47.000And now these drugs hit the market and you're allowing compounders and small independent pharmacies to rip off our patents, right?
00:21:57.000And they plant that stake way over here.
00:22:00.000If that regulator only hears that part of the story, it's a compelling story.
00:22:05.000You look at it and go, God, man, poor big pharma, they spent all this money.
00:22:08.000But 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.
00:22:17.000So 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.
00:22:27.000The dirty secret is a large majority of the drugs that come to market come from the NIH.
00:22:32.000And phase one trials are done at the NIH.
00:22:35.000The NIH is funded by taxpayer dollars.
00:22:38.000You 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.
00:24:21.000But 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.
00:24:41.000I know that's a big number, but that was when you were asking us to make these compounds.
00:24:46.000That number is not nearly as large today.
00:24:48.000And you also shut down 503Bs, which is half of the compounding industry's ability to make these compounds.
00:24:54.000The 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.
00:25:07.000They're going to do $35 to $40 million in just GLP-1 drugs this year in revenue.
00:25:14.000So you're talking an accounting error for big pharma.
00:25:18.000And the reason I want to lay all that out is I'm not here to argue about the GLP-1s.
00:25:42.000Because 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?
00:25:49.000And in one breath, you've got big pharmaceutical companies saying, I'll use Lilly again as an example because they're the main culprit.
00:25:57.000Lilly is saying peptides are dangerous.
00:26:02.000We shouldn't allow these compounders to make peptides.
00:26:05.000Meanwhile, Eli Lilly just signed a $7 billion deal to acquire a peptide company out of China.
00:26:15.000Lilly'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.
00:26:28.000And there's just all this misnomer and dogma and it's confusing if you don't come from healthcare.
00:26:34.000Well, it seems like it would be very confusing for a regulator.
00:26:37.000Very confusing for someone who's not educated on this to get up to speed.
00:26:43.000And they have so many initiatives and so many things they're tackling.
00:26:46.000And 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.
00:27:04.000It's like trying to win a debate where I get one minute and the opposition gets nine minutes.
00:27:10.000And in the one minute, I've got to debunk all the lies that the opposition told.
00:27:14.000And I don't even want to use the word lies.
00:27:15.000You can use facts, but like we've said before, facts can be skewed when delivered inappropriately.
00:27:22.000If 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.
00:27:34.000This is dangerous and this is a liability to the American public.
00:27:37.000Politicians' ears are going to perk up, especially when you're lobbying them and funding campaigns and trying to influence those folks.
00:27:45.000But 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.
00:27:55.000You 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.
00:28:03.000And then you can talk about safety, but in reality, there were recalls from both Lilly and Novo Nordisk.
00:28:09.000There are all sorts of array of issues and label changes.
00:28:12.000And 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.
00:28:25.00060 to 80% of the drugs that make it through the drug approval process will have a major label change or recall.
00:28:33.00060 to 80 percent of the medications that come through this process end up having a major label change or recall.
00:31:24.000So 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?
00:33:48.000We are great at triaging and treating a catastrophic event, heart attack, stroke, hospitals.
00:33:55.000You're in there, something catastrophic happens.
00:33:57.000We can triage that disaster and we can get you in and out of the hospital.
00:34:01.000We are absolutely an abysmal failure at preventing chronic disease and driving health span.
00:34:10.000And the only way to do that is to get proactive and predictive and personalized.
00:34:15.000And this entire ecosystem is just not built to do that.
00:34:19.000And so my message and what I'm trying to work for is so much bigger than peptides.
00:34:24.000I 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?
00:34:33.000When 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.
00:34:49.000If 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.
00:35:07.000The cancer that you get in your 40s started in your 30s.
00:35:11.000You know, the diabetes you get in your 30s started in your 20s.
00:35:35.000And it is because we're a prescription-first society, right?
00:35:39.000And 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.
00:35:58.000Their first move is to go, okay, well, we got to get your cholesterol under control.
00:36:02.000We got to get your insulin under control.
00:36:04.000I'm going to put you on a weight loss drug.
00:36:24.000It's that you have a hormonal imbalance and your hormones are so wrecked that you're obese.
00:36:28.000Are you obese because your hormones are wrecked or are your hormones wrecked because you're obese?
00:36:33.000You 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.
00:37:37.000Okay, well, that's kind of merging into two different arenas.
00:37:40.000You've got the Peter Atias, $100-something thousand dollars to be my client that only the richest Americans can afford.
00:37:48.000And you're going to get top-tier care and I'm going to provide concierge medicine.
00:37:52.000Well, 99.99% of America can't afford that.
00:37:56.000And then you've got the hems of the world that are going the route of a pill mill.
00:38:00.000Like candidly, it isn't about quality of care.
00:38:04.000It isn't about helping patients solve a problem.
00:38:06.000It'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.
00:38:16.000To me, that's no bigger different than big pharma.
00:38:19.000And so my vision for the future is how do we combine the best of both worlds?
00:38:25.000How do we take that nuanced concierge care, make it affordable, make it scalable, and make it truly drive health span?
00:38:37.000It's the people controlling these systems and always trying to make it about money and quarterly earnings and an exit and a strategy.
00:38:44.000But 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.
00:38:56.000If 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.
00:39:03.000You get him on a weight loss drug and you hope for the best and you push him out the door.
00:39:08.000In 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.
00:39:21.000So in real time, we're able to capture how are you trending.
00:39:25.000We 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.
00:39:36.000We can tell you how much lean fat, how much visceral fat, how much subcutaneous fat.
00:39:40.000And anyone who's a member gets that scale, scans it into the app.
00:39:44.000That combined with your VO2 Max, if you come into the clinic, we can cross-reference it with a DEXA.
00:39:49.000The app will do its own algorithms to see how different it is.
00:39:52.000And 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.
00:40:02.000Like 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.
00:40:54.000Even 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.
00:41:04.000But what we should be asking is, how do I help this patient?
00:41:55.000Like, there's nothing wrong with money, but there is wrong with the motivation that comes with money, that you put money above everything else.
00:42:03.000I mean, I know Waste to Well is doing great, and I know you're making plenty of money, but most companies are only trying to do that.
00:42:11.000Whereas you are trying, legitimately trying to make people.
00:42:16.000I know, I see the look on your face when people get better.
00:43:06.000And 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?
00:43:26.000They'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.
00:43:38.000I can't compete with the scalability of that, but what I can compete with and I can destroy is the quality.
00:43:45.000Because 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.
00:43:56.000I even came on here and there's things that I've gotten wrong.
00:43:59.000I thought the fastest way to scale and to meet the needs of the American people is AI.
00:44:20.000The entire human experience doesn't exist without people.
00:44:24.000So 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.
00:44:35.000And 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.
00:44:50.000That is what a lot of these telemedicine companies are now.
00:44:53.000And it may provide accessibility, but is that optimal care?
00:44:58.000Or are we back to that same conundrum of how do we make a quick buck?
00:45:03.000How do we get this guy on a bunch of peptides or girl on a bunch of peptides and we push him out the door?
00:45:07.000And that is one of the challenges of even this emerging market is people are compromising pretty quickly.
00:45:14.000And even this market, I see the flaws.
00:45:17.000And those flaws are going to bring out the naysayers.
00:45:19.000And those naysayers are going to use the bad actors and the bad examples to crucify the industry.
00:45:25.000And I'm banging the drum a lot against HIMS right now, but I tried explaining this to Secretary Kennedy and administration.
00:45:32.000HIMS 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.
00:45:43.000And I told the administration, there is no way that a multi-billion dollar conglomerate would make this mistake.
00:45:52.000This 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.
00:46:03.000So 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.
00:46:10.000So it'd be like saying, we have Kleenex for cheaper than Kleenex, right?
00:46:32.000They spent the money, they got the patent, all of this.
00:46:35.000The reason that's important is that Trojan horse was set.
00:46:39.000It created an extreme backlash from regulators, both senators, congressmen, congresswomen, politicians from all different walks of life came out saying, this is unacceptable.
00:46:51.000All 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.
00:47:32.000And 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.
00:47:52.000And 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.
00:48:15.000All the while while they have an agreement with this pharmaceutical drug company.
00:48:22.000So 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.
00:48:34.000And I get why you, the administration, would be upset and you should be.
00:48:38.000But please do not punish an entire industry sector for one bad actor.
00:48:44.000And at the time, I was scratching my head going, this just doesn't make sense.
00:48:56.000And then a week later, they make this announcement and the stock roars.
00:49:00.000And, you know, everyone goes, oh, congrats, HIMS.
00:49:04.000And 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.
00:49:13.000I think Lee Rosebush and his firm brought it forward.
00:49:15.000He's a guy who's academically trained.
00:49:20.000I think ran the clinic at the Mayo clinic, ran the lab.
00:49:47.000Well, 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.
00:49:55.000No, the guys that were doing the bad things already inked their backroom deal and rode off into the sunset.
00:50:00.000So now what is left for the rest of the industry and where does this go?
00:50:05.000And 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.
00:50:16.000And again, Secretary Kennedy, he tweeted this, I think, before or right when he took over, save your records and pack your bags.
00:50:22.000Your war on stem cells and peptides are over.
00:50:25.000And 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.
00:51:56.000Well, 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.
00:52:04.000And so I would tell a regulator, a congressman, a congresswoman, anybody who will listen, guys, my model costs you nothing.
00:52:14.000I'm not asking for any sort of indication where I can bill insurance companies or I can build Medicare, Medicaid, or TRICARE.
00:52:20.000What 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.
00:52:31.000If 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?
00:52:47.000And 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.
00:53:05.000And the reality is that the momentum of the current healthcare system is so strong that the vast majority of Americans are going to use that anyway.
00:53:13.000It's not like it's going to completely disrupt the system.
00:53:17.000Like most people, like, I mean, how many people are listening to this?
00:53:22.000You know, I mean, it's still a small percentage of just America.
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00:55:20.000You prevented the regulatory landscape from coming in and people taking a piece of your pie.
00:55:25.000In fact, I would argue it worked too well, you know, in a way.
00:55:30.000Like, so to over-regulate based off, and that's that's the argument with the GLP1s in one bucket.
00:55:36.000My 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.
00:55:48.000What about patients who have allergies?
00:55:50.000What about the next time these things go on a backlog?
00:55:53.000What about a patient who maybe can't handle the delivery mechanism?
00:56:01.000I mean, there's dozens of different reasons why you would want to provide an alternative life raft.
00:56:07.000Can you explain the titrate up and titrate down thing?
00:56:10.000Yeah, so historically, the GLP1s came in preset dosages.
00:56:15.000And so patients did not have a way to titrate up or down.
00:56:20.000And 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.
00:56:31.000Because some of the catastrophic side effects come from a large dose.
00:58:24.000And 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.
00:58:39.000And to be clear, when it comes to peptides, Chris, Marty, Stephanie, Spear, Bobby, all of them are aligned.
00:58:49.000Like peptides, I'm being told, are done.
00:58:53.000I don't have that timeline, but it's a huge win because it goes so much bigger.
00:58:59.000I cannot stress, Joe, how close preventative longevity-based medicine was to being done.
00:59:07.000Because 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.
00:59:16.000If Kennedy wasn't the secretary and if the Maha movement hadn't started, it's over.
00:59:27.000And on that note, even here in Texas, this is where this is crazy.
00:59:32.000I've gotten to know several of the congressmen, congresswomen, Lacey Holes, a congresswoman here in Texas.
00:59:38.000Senator Colehurst, I believe she's over the healthcare committee for the Senate.
00:59:42.000Senator Colehurst was looking at forming her own FDA for Texas.
00:59:46.000That'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.
01:00:07.000So when I laid this out for Marty, one of the things I explained where here's what the naysayers will say.
01:00:39.000They got a taste of the efficacy and the benefits.
01:00:41.000And patients aren't going to stop using them.
01:00:44.000So right now, four out of five peptides being filled are being filled through gray or black market solutions.
01:00:50.000When 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.
01:01:54.000And these companies attempt to operate through a loophole.
01:01:57.000And that loophole is they claim it's for non-human use.
01:02:00.000I actually had a call with a really prominent peptide company and their CEO, who's an Ivy League guy.
01:02:07.000And 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.
01:02:18.000And I said, well, I can tell you from history, what I've seen, you are using influencers to advertise for human use.
01:02:27.000You 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.
01:02:39.000And when they do, they're going to subpoena you.
01:02:42.000And 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.
01:02:52.000So you were knowingly and willingly circumventing the safety and the laws of the land to push a illegal compound into a marketplace.
01:03:02.000I'm just telling you how this is going to play out.
01:03:47.000So 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.
01:03:56.000So 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.
01:04:04.000Right before we came on, I was telling you the FDA has been in our building five times in four years.
01:04:11.000The states have been in my building every year and I'm in 47 states.
01:04:15.000So almost every state come we're literally in an inspection all the time.
01:04:22.000We independently third-party verify every dosage.
01:04:25.000We buy API from what's called the green list.
01:04:27.000The green list is a list established by the FDA that tells us you can buy these pharmaceutical ingredients from these ingredient manufacturers.
01:05:02.000And 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.
01:05:16.000What's even scarier, though, is there's no dosing instructions.
01:05:22.000There's no explanation of how to reconstitute.
01:05:25.000Because once they're teaching you how to reconstitute and mix it, they're taking part in medical administration.
01:05:31.000And so these companies have avoided all of that.
01:05:33.000And people were using things like ChatGPT, but now ChatGPT and all the large language models have shut that down.
01:05:40.000So 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.
01:05:54.000So 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.
01:06:12.000And you put it back in the hands of trained clinicians.
01:06:15.000You 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.
01:07:02.000And 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.
01:07:16.000And 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.
01:07:26.000And the only argument against that is, well, peptides don't have enough robust human clinical trials with safety data.
01:07:35.000And 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.
01:07:42.000These are the drugs that make it through.
01:07:44.000Separate from that, every product that's in the operating room, I've covered this every time I've been on here.
01:07:49.000Every single 90% of the products in the operating room never had a human safety study.
01:07:54.000They were all brought in through the 510K approval process.
01:07:57.000Doctors are using things every day in practice that are either off label or not validation tested or have no human safety studies.
01:08:07.000It is commonplace in medicine every day.
01:08:10.000So 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.
01:08:19.000If we get this done, you've now built a regulatory pathway that provides affordability, accessibility, personalized medicine, predictive care.
01:08:29.000It is such a big win beyond a peptide because it candidly saves the industry.
01:08:34.000I 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.
01:09:48.000And that is the big challenge is the future of this regulatory pathway.
01:09:52.000And that's where I wanted to get into the state.
01:09:54.000And 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.
01:10:18.000The states picked up the torch and ran with it faster than the federal government did.
01:10:22.000And the reason that's important is we've now learned the offense.
01:10:26.000Texas passed the bills, three different bills around food and food initiatives and label changes and protecting children.
01:10:36.000I 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.
01:10:46.000So I say that because I am already working at the state level to do the same thing here in Texas.
01:10:52.000So my hope is that the federal government and the FDA get this done with peptides.
01:10:58.000And 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?
01:11:07.000The state of Texas is already raring to go.
01:11:09.000So 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.
01:11:22.000So there isn't where it's almost like marijuana law, without getting too nuanced.
01:11:26.000The 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.
01:11:35.000And 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.
01:12:51.000The risk of an adverse event is minimal.
01:12:54.000If it is an adverse event, it's flu-like symptoms and it impacts basically 10 to 15% of people.
01:13:01.000All 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.
01:13:11.000You 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.
01:13:22.000If 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?
01:13:36.000Do we build this into the insurance model?
01:13:39.000For 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.
01:13:49.000I don't want to be part of that model.
01:13:50.000I want to build a life raft that allows patients to make decisions.
01:13:54.000And the second you put this in an insurance model or a government payer model, everybody is castrated.
01:14:00.000The decisions are made at the insurance level and at the government level, and it just becomes this nuanced, challenging thing.
01:14:09.000Like an example is stem cells historically, one of the uses for purified amnion was burn victims, right, or wound management and diabetics.
01:14:19.000Orthopedic surgeons started billing wound injuries in order to get paid from the insurance companies on an ACL.
01:14:26.000Well, 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.
01:15:05.000And 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.
01:15:12.000And now you can legally use these treatments in states like Texas, Florida, Arizona, soon to be Arizona and Utah.
01:15:20.000And so there is hope because at the state level, it's moving.
01:15:23.000I do believe Secretary Kennedy and Chris Klump and Marty are very open-minded and receptive to this.
01:15:28.000They are very progressive, and they do see the challenges of this system.
01:15:33.000Marty covers it in his book, like I said.
01:15:35.000So 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.
01:15:51.000And 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.
01:16:05.000And 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.
01:16:12.000And 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.
01:16:40.000Well, 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.
01:16:52.000The 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.
01:17:04.000Because 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.
01:17:18.000I feel very confident this administration is going to get a lot of these things done.
01:17:22.000But then what happens as soon as there's a change in power down the road?
01:17:26.000And how many years can you fight this lobby, right?
01:17:32.000But I think it's crucial that we fight for sovereignty and autonomy over our health and continue to push.
01:17:40.000I can tell you at the state level, I'm very, very bullish that it will happen.
01:17:45.000And 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.
01:17:55.000And 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.
01:18:14.000We have an opportunity to turn Texas into a medical tourism destination.
01:18:19.000Can 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?
01:18:52.000And 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.
01:19:13.000We are the wealthiest country in the world.
01:19:15.000We are the sickest country in the world.
01:19:48.000You just said 60 to 80% of them have either major label changes or have the products removed.
01:19:54.000You think about all the different adverse side effects that are very, very well known from various pharmaceutical drugs, all these different things.
01:20:01.000How many times does this have to happen before you just want to rip that band-aid off and do something different?
01:20:09.000It's tough because, and people misunderstand.
01:20:11.000I think they misunderstand even what you and I are saying because I hear so often people going, okay, it's a conspiracy theory.
01:20:17.000They want to keep you fat and sick and monetize chronic disease and there's malicious intent.
01:20:22.000I'm like, no, what I'm telling you is this system was born in captivity.
01:21:50.000Why is there any pushback to building a cash pay model with a pathway that allows patients to access medications with their own hard-earned cash?
01:22:01.000Preventative health care instead of sick care.
01:22:12.000And I tell people the difference is with a peptide or something preventative, you're coming in and we're optimizing you, right?
01:22:20.000So, 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.
01:22:30.000It 100% improved my data recall and retention.
01:23:36.000Because they're using their money, not taxpayers' money, not an employer's money, right?
01:23:41.000The 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.
01:23:54.000You can't fire your clinician in the insurance model because the insurance model tells you where to go.
01:24:01.000Sorry, I'm ADHD, but I'm thinking about this.
01:24:03.000One 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.
01:24:11.000Guys 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.
01:24:53.000But you're not going to force people to totally get that much.
01:24:55.000And what people don't understand is in the insurance model, a patient is told, you're not allowed to go to this doctor.
01:25:01.000You got to go to this doctor because they're within your plan.
01:25:04.000And then they go to that doctor and that doctor goes, what pharmacy do you want it filled at?
01:25:08.000Well, it doesn't matter if it's CVS or Walgreens or wherever.
01:25:11.000The patient's going to have the same price because that price is controlled by the PBM, which is the insurance company.
01:25:17.000And then that PBM is monetizing that drug through rebate programs.
01:25:21.000It is a totally different system that captures a patient, controls a patient, and monetizes chronic disease.
01:25:29.000My 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.
01:25:43.000What we see is somebody starts and it's not, they start thinking they want to lose weight.
01:26:03.000He's like getting into these hobbies and these things.
01:26:06.000When he goes and spends money on a peptide, it's not because it's pseudoscience or it doesn't work.
01:26:11.000It's because he's a living example of the impact it's made on his life.
01:26:15.000And he is knowingly and willingly opting in to continue to see how far he can push this healthcare journey and how much more optimal he can get.
01:26:25.000And in real time, unlike traditional medicine, we are tracking all of this shit.
01:27:44.000I'm just a guy who's trying to solve problems.
01:27:47.000And everything that I talk about today is not me being a bro science or me trying to be an influencer or the things that people try to say.
01:27:56.000Everything I discuss comes from my mentors.
01:28:00.000And my mentor is my chief science officer, Ian White, 22 years stem cell research, Harvard and Sari Stem Cell Institute.
01:28:08.000Mari Dazawa, who discovered Muse cells from Japan and is one of the pioneers in stem cell research.
01:28:30.000And I'm doing my best to learn and distill down what I'm gathering from these folks in a manner that's digestible for Neanderthals like myself.
01:28:48.000Before I lose the real quick on the genetics, because I'm super excited about this.
01:28:52.000So one of the things we're building into the app.
01:28:54.000So 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.
01:29:05.000Because 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?
01:29:25.000And 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.
01:29:38.000And so Alan is there to help answer and fill in the gaps.
01:29:41.000And where I was going with this earlier is through large language models and AI, we're going to be able to scale concierge medicine.
01:29:49.000We'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.
01:29:59.000Like my goal is to make this as cheap as possible so everybody can afford it.
01:30:03.000And that's the goal with stem cells too.
01:30:05.000But it starts with regulatory pathways and destigmatizing these treatments and building a pathway that everyone can afford.
01:30:14.000And so one of the things we're looking to add to the app is gene sequencing.
01:30:21.000Most people don't have any clue what genes they have.
01:30:25.000And 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.
01:31:55.000Where one of the things that he's enlightened me on, because I'm not a geneticist.
01:31:59.000I don't know anything about that world.
01:32:01.000He's like, dude, if you do a gene sequencing test on a guy like Gordon Ryan, maybe there's a gene that's causing him to have these stomach issues.
01:32:09.000So we run the full gene sequencing on Gordon at Ways to Well, and it comes back.
01:32:14.000And, you know, offhand, I remember there's a couple of really interesting stuff.
01:32:18.000Gordon has a gene that is like one in 10 million that makes your tendons more dense and more resilient.
01:32:28.000So stronger, more rigid tendons that are able to are more resilient to damage.
01:33:12.000So 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.
01:33:22.000And then he also has a gene marker that makes his gut health more acidic.
01:33:28.000And so these are like rare genes and he happens to have these anomalies.
01:33:32.000So 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.
01:33:43.000But 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.
01:33:54.000And so the premise that Ryan and what we're trying to evolve and build out is 20,000 genes.
01:34:02.000Most people don't have any clue what any of their genes are.
01:34:06.000We'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.
01:34:15.000So alongside with, you know, the VO2 Max, the DEXA, go get those anywhere.
01:34:21.000I'm not trying to sell you these things.
01:34:23.000I just want the information so I can help you.
01:35:49.000He was shocked because he has that one bum knee from all those years of moaytoning and fighters just started picking off his knee.
01:35:56.000What'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.
01:36:04.000He had more muscle mass on the bum leg than on the what he thought was his strong leg.
01:36:11.000But it's fascinating because it's just data, right?
01:36:14.000And 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.
01:36:28.000We can begin to quantify that and model out your vertebral risk fracture risk, you know, your hip fracture risk.
01:36:35.000How do we preserve bone mineral density?
01:36:38.000Like 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.
01:36:48.000And 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.
01:37:17.000And then how many lives are lost in that time?
01:37:19.000That's where I'm pleading for, let's build a cash pay model that is a life raft that's an alternative.
01:37:25.000And let's build a pathway that makes sense, that maybe is a more nuanced approach to driving health span.
01:37:32.000Because 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.
01:37:47.000That has literally been the mission statement since the day we opened our fucking doors.
01:37:52.000I'm like, that's all we're trying to do.
01:37:54.000And I love it because then you get into the fun shit.
01:37:56.000Like, where do we go with all this gene activation?
01:38:00.000And where do we go with like the ability to optimize humans, right?
01:38:04.000Rather than just trying to keep you from being sick, we should strive to make you superhuman.
01:38:26.000So 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?
01:38:36.000So 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.
01:38:46.000And it begins to give you answers to the test.
01:38:49.000So you're not taking a shot in the dark.
01:38:51.000And those answers will allow us to hopefully tailor and develop nuanced treatments.
01:38:56.000Now, the future is they're able to turn off and on genes like a light switch.
01:39:02.000I 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.
01:39:10.000And they think this protein could be one of the keys to driving human health span and longevity.
01:39:15.000And 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?
01:39:28.000And would it drive our health span and reduce our risk of cancers?
01:39:32.000So the question becomes, as we evolve, what genes can we turn on and turn off?
01:39:39.000You know, what does the regulatory landscape of the future look like in America?
01:39:42.000China and Russia are already doing these things, right?
01:39:45.000And 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?
01:40:03.000At the cellular level, at the biological level, you're going to be able to fix and remediate so many of these issues.
01:40:10.000That'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.
01:40:15.000Or 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.
01:40:25.000And 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.
01:40:34.000And then at the end of that, it gets turned back off.
01:40:37.000So it's like temporary turning on a white light switch and then that light switch will eventually revert back.
01:40:43.000So this, this, Jamie, bring back up that thing with the bone mineral density.
01:40:48.000Does it prevent you from being able to swim just because you're heavier?
01:42:42.000What's what's so fascinating to all this to me is so then you've got.
01:42:45.000So 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.
01:42:56.000We share a common ancestor and i've covered this before, but Ian hypothesizes within our genetics.
01:43:03.000We share an ancestor with the eternal jellyfish.
01:43:06.000We share an ancestor with the Galapagos tortoise, with the Greenland shark.
01:43:16.000All of those black boxes are within us.
01:43:19.000If 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.
01:43:28.000The 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?
01:43:38.000So individuals with uh unexplained hbm had an excess of sinking when swimming.
01:44:59.000Sure 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.
01:45:13.000It's like, was this guy built in a lab like our wrestle?
01:45:17.000It's crazy, like he has that same tendon gene.
01:45:22.000He 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.
01:45:30.000I 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.
01:45:40.000whatever 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?
01:45:51.000The genes are inherent to you at birth.
01:45:54.000So, and then you do have epigenetics, and epigenetics are impacted by your body by activity, right?
01:46:00.000So, you may have a predisposition to developing cancer cells, right?
01:46:06.000That's unfortunate, but you may have that.
01:46:08.000But that doesn't mean definitively you're going to develop cancer.
01:46:11.000It just means you can now make lifestyle and behavioral changes to minimize.
01:46:15.000So, if you have a predisposition to that, you probably shouldn't smoke cigarettes all day, right?
01:46:20.000We should probably try to, if you have a predisposition to weak bone mineral density, right?
01:46:25.000We should probably make sure that we never let your hormones drop in your 40s where you begin that initial decline and the cascade effect.
01:46:33.000This gene mutation seems to also have a other side effect of vision loss.
01:46:39.000Yeah, because it causes some eye vascular issues.
01:46:43.000Yeah, and this is one, this is one example of genes that they were looking at, I think, at DARPA and some of these other projects.
01:46:50.000These aren't things being utilized in medicine today, but this is the direction of the future.
01:46:55.000I really do believe that they're going to solve a lot of these genetic traits and be able to figure out how to turn off and on these traits.
01:47:03.000Certain variants in LRP5 gene interfere with eye blood vessel development, causing familial exudative can lead to vision loss.
01:47:36.000So one of the other things, you said treatments that we're doing.
01:47:39.000One 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.
01:47:52.000So I don't know if you want me to talk a little bit about that.
01:47:56.000So 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.
01:48:28.000They'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.
01:48:41.000We reviewed all the research, all the data, all the literature, and it was mind-boggling.
01:48:47.000So 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.
01:48:59.000And I'm going to be clear, like we went there to debunk this shit.
01:49:03.000We thought there's no way that this is what she's presenting.
01:49:06.000It's just, it just seems too good to be true.
01:49:11.000And 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.
01:49:27.000And Ian, I think, won Regenitive Scientist of the Year last year in North America.
01:49:38.000But these muse stem cells are such a rare subset phenotype of stem cell.
01:49:44.000And 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.
01:49:58.000So what does that mean in like real world talk?
01:50:02.000Mari in her book where she writes about these cells and how she discovered them, she was in the lab.
01:50:08.000She 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.
01:50:17.000So stem cells that are already a very minute amount of the cells in our body have a subset phenotype called muse.
01:50:24.000She 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.
01:50:35.000She thought she'd go in the next day and everything would be dead when she went in because the cells don't last overnight.
01:50:41.000She goes in the next day and to her surprise, all of those subset phenotype of cells were still alive.
01:50:45.000A large majority of them were still alive.
01:50:48.000And she thought that can't be possible.
01:50:51.000And that's what began her research into what are muse.
01:50:55.000And 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.
01:51:07.000First and foremost in medicine, they say do no harm, right?
01:51:11.000And 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.
01:51:22.000And I've said this on your podcast before.
01:51:25.000Dr. Kaplan, who discovered traditional MSCs in an open letter to the scientific community, apologized and said, I should have never called them stem cells.
01:51:33.000Because the problem with these cells is they don't differentiate.
01:51:40.000But 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.
01:51:50.000So they aren't truly regenerative in that they don't become a tendon.
01:51:59.000The pros are they don't become a cancer cell.
01:52:01.000And that's the concern with pluripotency.
01:52:04.000And 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.
01:52:22.000Lo and behold, in 2010, what Mari discovered was this ultra-resilient subset of stem cell that holds those exact traits.
01:52:40.000This is the stem cell answer that has eluded scientists for decades.
01:52:46.000And it is so exciting because the multilineage, what does that mean?
01:52:51.000Multilineage just means these are pluripotent cells.
01:52:54.000Pluripotent, multilineage is a bunch of fancy science talk for they can become anything.
01:53:01.000So the way I explain that is you and I talked about this years ago.
01:53:04.000Orthopedic surgeons would go, you know, I use bone marrow stem cells and I don't really get good results.
01:53:10.000And I think that you can't get real stem cells because those cells have an identity.
01:53:15.000And when you take bone marrow, the cells have already become a bone marrow cell and they're not going to differentiate and become something.
01:53:26.000They 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.
01:53:37.000Where these cells are fundamentally different is think of it like a kindergartner.
01:54:00.000They already went to med school and they decided they're a doctor.
01:54:03.000You can't put those in the body and have them become something because they've already developed their identity, their phenotype.
01:54:09.000These cells will literally go into the body and take on the phenotype of any damaged cell.
01:54:18.000What is so amazing and crucial about that to understand is if they come across a torn tendon cell, they become that tendon cell.
01:54:26.000If it's a bone marrow cell, they become a bone marrow.
01:54:29.000If it's a neuron, they can become a neuron.
01:54:32.000And the process that they do it through is also pretty fascinating.
01:54:36.000It's a commonly known process, but phagocytosis, don't say it three times fast, it can get canceled.
01:54:41.000But like phagocytosis, essentially, even in that laminous term, is like, think of it like a Pac-Man.
01:54:48.000This is how Mari described it to me, because she knows I'm an idiot.
01:54:51.000And she's like trying to break it down in a way I can digest.
01:54:54.000She's like, I want you to think of a Pac-Man.
01:54:56.000Think of a damaged cell like a neuron.
01:54:58.000This 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.
01:55:14.000So, one, these cells are extremely safe in that they're non-tumorigenic.
01:55:21.000In studies, these cells had no, never became tumors in any of the studies that are ever done.
01:55:30.000Furthermore, they treated mice that had pre-existing cancer.
01:55:33.000They did not only not exasperate the tumors, in many of the studies, the tumors shrunk.
01:55:39.000And I'm not here to say like it's going to cure cancer or anything like that.
01:55:43.000The message is traditional MSCs are already extremely safe.
01:55:48.000And these MSCs appear to be even as safe, if not more safe.
01:55:54.000And 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.
01:56:12.000And that's with traditional MSCs, which is a very low safety profile.
01:56:16.000What you saw, like effective safety profile, what you saw with the muse cells in trials is 0%.
01:56:24.000Literally right now, nobody's even getting flu-like symptoms.
01:56:27.000And 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.
01:57:17.000The answer is the juices of life that allow that mother's system to immunomodulate and not turn on the baby.
01:57:26.000So 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.
01:57:40.000The risk of cancers at an all-time low while pregnant.
01:57:42.000All of this goes back to MSCs and now we believe potentially muse cells.
01:57:48.000And so they're safe, they're non-tumorigenic, they immunomodulate, meaning your body's not going to reject these cells.
01:58:05.000And the reason they use fillers instead of fat is fat lacks angiogenesis and those fat cells die.
01:58:10.000And a lot of times the success rate's not as high.
01:58:13.000So 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.
01:58:24.000So it encourages the body to accept that tissue and then helps those cells build themselves back into your system and immunoregulate.
01:58:34.000So 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.
01:58:42.000But 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.
01:58:55.000It's not going to cause any sort of inflammatory response or flu-like symptoms.
01:58:59.000So one of the safest versions of stem cells we've ever seen.
01:59:02.000And the traditional cells are extremely safe themselves.
01:59:06.000And then you get into the pluripotency.
01:59:08.000I mean, this is the first cell other than the cells that have been altered that can truly become something.
01:59:17.000And then the fourth and final thing that's really amazing about these cells is their honing abilities.
01:59:23.000So 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.
01:59:44.000And think about the results we've gotten.
01:59:48.000Mews have a 15 to 30% engraftment rate.
01:59:53.000Mews 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.
02:00:05.000They hone in at a much stronger rate than traditional MSCs.
02:00:11.000So 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.
02:00:24.000These 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.
02:00:36.000And all of this occurs within three days.
02:00:39.000So that's why you're seeing such crazy results in Dubai and overseas.
02:00:45.000And 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.
02:00:59.000The hope is that we can build a regulatory pathway at the federal level that will allow accessibility too.
02:01:05.000Because 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.
02:01:17.000I mean, there's 30, 40 years of data on these products.
02:01:24.000The question is, how efficacious are they?
02:01:27.000What disease states can they help with?
02:01:29.000And how much can they move the needle?
02:01:31.000And that's where this gets tricky because the FDA doesn't want people out there making claims.
02:01:35.000And I understand that because there's so many people who are snake oil salesmen.
02:01:38.000And my thing is, I'm not here to make a claim.
02:01:41.000I'm just here to say accessibility is important because for the people who don't have any more lifeline left, who knows what this could do for them.
02:01:51.000For the patients, you know, battling some sort of neurocognitive issue, you know, these cells are able to pierce into the midbrain.
02:01:59.000I mean, and I have all these, Jamie, a bunch of these studies I have listed on Ways to Wells website, just so I'm not throwing random stuff out there.
02:02:07.000I think I listed seven or eight of Mari Dazawa's studies that back everything that I'm saying.
02:02:16.000But the premise is, you know, the future is bright.
02:02:19.000And I think that muse will be an integral part of what we see here in the United States and the future of biologics.
02:02:26.000When we're talking about genes, these obviously are in the body, these cells.
02:02:32.000Is there a potential future where they could just turn these things on and not have to add exogenous stem cells?
02:02:41.000So here's the problem is you have a precipitous decline as you age, right?
02:02:45.000And so just like what we're seeing with peptides, you have a certain amount of these.
02:02:48.000And as you age, they appear to decline.
02:02:53.000So 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.
02:03:11.000He 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.
02:03:25.000When I look at patients that are diabetic, they don't have this subset.
02:03:30.000So what is this subset and what is it doing?
02:04:24.000But what's fascinating is it also declines as we age.
02:04:27.000So 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.
02:04:35.000And so if we can take these cells, these goodies of life, and we can administer them proactively and preventatively, they even did mitochondrial testing.
02:04:46.000I don't know if that study is released yet.
02:04:59.000And 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.
02:05:18.000We've seen miraculous results with all of these different modalities.
02:05:23.000But I look at Muse and go, this is the holy grail of what we've been trying to find.
02:07:25.000It just hasn't made it into the U.S. yet.
02:07:28.000And 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.
02:07:42.000We know, like I said, Secretary Kenney is looking to open the regulatory pathway for stem cells.
02:07:48.000And 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.
02:07:57.000And what's so exciting is that as more research develops, more of these things are going to emerge.
02:08:03.000They're going to keep the gene therapies, muse cells, it's going to continue to compound.
02:08:31.000Maybe you make sure that it's a neuron.
02:08:35.000Again, I'm way over my skis on this part because I'm a business guy.
02:08:38.000I'm just breaking down what these scientists are saying.
02:08:42.000And 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.
02:08:52.000And all muse are, are this subset phenotype of super soldier cell.
02:08:59.000And so the second part of muse is stress enduring.
02:09:02.000So 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.
02:09:16.000She would have never realized that these cells appear to be ultra resilient.
02:09:22.000They can ship these cells at room temperature and they're viable for weeks.
02:09:26.000Whereas traditional cells, we've got to keep cryopreserved and ship on dry ice.
02:09:32.000So from an administration standpoint, from a logistical standpoint, from an efficacy standpoint, from a safety standpoint, all of this could be so game changer.
02:09:42.000So 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?
02:09:53.000And 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.
02:10:10.000I'm telling you, the stuff, it's hard because, again, I'm not a clinician.
02:10:14.000I don't ever, I'm not, I don't want to make claims.
02:10:16.000I 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.
02:10:27.000The science is very early, but it is very promising on a lot of different things.
02:10:32.000And we've already had immense success on orthopedic injuries, knees, shoulders, elbows, using traditional MSCs that can't differentiate, right?
02:10:40.000They're just transferring mitochondria and temporarily putting your body in a position to heal.
02:11:04.000And 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?
02:11:12.000Because 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.
02:11:18.000And then you break in the large language model side and wearables and the ability to track in real time.
02:11:24.000But also, this is where you're going to find the resistance because there's so much money in the petrochemical drugs.
02:11:30.000When this is what's challenging with the stem cell stuff even, like if they don't work, people are not going to spend their hard-earned paycheck.
02:11:41.000Like I understand the FDA stance on safety.
02:11:44.000And again, the historic FDA stance on not even this new administration.
02:11:48.000This 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.
02:12:08.000But do we need to go through the level of rigorous, you know, multi-billion dollar process on something that can't really be patented?
02:12:19.000Or 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?
02:12:29.000If you're battling a chronic disease and you're going to die, what is the harm in seeing if this can help?
02:12:36.000If you're battling dementia or Alzheimer's, you know, that's another huge one.
02:12:41.000Like traditional MSCs are too big to pass the blood-brain barrier.
02:12:46.000Muse MSCs can be internasally administered and immediately go into the blood-brain barrier.
02:12:52.000And in trials, they were able to see the Muse cells 18 months later lit up like a Christmas tree in the midbrain.
02:13:01.000The 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.
02:13:13.000And so, yeah, there's a lot of promise.
02:13:17.000I think Muse are going to be a big opportunity here in America to drive meaningful change.
02:13:22.000It's just a matter of, you know, when and how they're available and to what capacity.
02:13:28.000You're going to see these things springing up at the state level.
02:13:31.000They're already happening all over outside the United States.
02:13:36.000It's just a little bit different market here with the regulatory landscape.
02:13:39.000Well, that's what's so frustrating is that they are being utilized effectively overseas.
02:13:44.000And you think about how many people do have people that are in the hospital, do have chronic illness, do have these problems that could be fixed here.
02:14:39.000It's used at all of these various academic institutions.
02:14:43.000It just hasn't been used for longevity, right?
02:14:46.000And in an insurance model where you're trying to get a reimbursement rate, you've got to have an indication.
02:14:52.000But 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.
02:15:18.000So for me as a 45-year-old male, I've got 45 years of all the attrition and stuff that's in my system.
02:15:25.000You get 70% of that out through one therapeutic plasma exchange utilizing the plasmapheresis machine.
02:15:32.000And so what we'll do is we'll extrapolate out systematically your plasma and replace it with young, healthy protein called albumin.
02:15:41.000And 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?
02:15:56.000So there's two different train of thoughts.
02:15:59.000And I have these listed too, Jamie, on the website.
02:16:03.000Plasmapheresis has been studied for over 50 years.
02:16:06.000It's just not been utilized for like longevity and preventative care.
02:16:11.000It's used more for systematic inflammatory issues.
02:16:16.000There's even a bunch of fascinating studies around Alzheimer's because Alzheimer's and dementia is so inflammatory related.
02:16:23.000So there's a bunch of fascinating stuff on that.
02:16:26.000But the premise of plasmapheresis is think of it like an oil change for your body.
02:16:30.000We're going to take out 70% of all the bad stuff that's floating around in your blood.
02:16:35.000We're going to replace that blood with young, healthy albumin.
02:16:39.000And 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.
02:16:53.000Can serial therapy, lower right corner, plasma exchange remove synthetic chemicals from humans?
02:18:05.000So, we ran that test, and then it was through the roof, and it scared him.
02:18:10.000And 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.
02:18:20.000And then we ran him through ways to well protocols.
02:18:23.000Not 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.
02:18:32.000Phillip's testosterone, without being on any testosterone, is at 1200.
02:18:40.000All 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.
02:18:54.000How many people out there are having shitload?
02:18:57.000That's what's like so many people come in and go, What do you have that can help me?
02:19:03.000This is another thing I want to point out about the challenge of like not making claims or understanding the nuance.
02:19:10.000We saw this with the psychedelic attempt to get psychedelics through the FDA.
02:19:14.000One of the things that they wanted to do in the psychedelic trials was provide psychiatric integration.
02:19:21.000So, 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.
02:19:31.000The 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.
02:19:40.000Well, if I'm united, I'm going to go, Well, how do I know it wasn't just the therapy?
02:19:49.000And so that's one of the challenges when people go, What do you have for microplastics?
02:19:54.000What'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.
02:20:04.000And so, so many people are doing multiple modalities.
02:20:09.000What I'm saying is it's working, but which one is the needle mover, or is it an attrition of all of them?
02:20:17.000You know, that's where this gets tough.
02:20:18.000And 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?
02:20:30.000Because so many people want to try everything, right?
02:21:04.000And 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.
02:21:10.000And 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.
02:21:27.000There's so many people on the opposite side of the aisle that it's a tough thing to navigate.
02:21:33.000And 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.