Let's Talk Wellness Now

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Within the next seven months, up to 1.5 million Americans could lose access to a medication that they’ve relied on for decades. Not because it’s dangerous, but because a pharmaceutical giant may have lobbied the FDA to eliminate their competition. And if you’re one of them, your doctor may already have told you about this issue and stopped prescribing it.
This isn’t a conspiracy theory. This is documented in federal court filings. This is happening right now. And the company that stands to profit, well, they’re the same ones manufacturing the only product that might survive.
Today on Let’s Talk Wellness Now, we’re exposing the desiccated thyroid extract crisis, the corporate manipulation behind it, and what you need to do right now to protect your health. Stay with me because I’m about to share what could save your access to the medication keeping you alive.
Welcome back to Let’s Talk Wellness Now, the show where we uncover the root causes of chronic illness, expose regulatory capture in healthcare, and empower you with the tools to advocate for yourself. I’m Dr. Deb, naturopathic doctor, your medical detective, and today we’re diving into one of the most consequential and corrupt healthcare decisions affecting patients right now. If you or someone you love takes Armour thyroid, NP thyroid, or any desiccated thyroid extract,
for hypothyroidism or if you’ve struggled to find a thyroid medication that actually works for your body, this episode is absolutely critical. And if you have celiac disease, gluten sensitivity or corn allergies, what I’m about to reveal will make your blood boil. Now grab your cup of coffee, don’t forget your notebook and settle in because what’s happening to this medication right now is a masterclass in how pharmaceutical companies use regular

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agencies to eliminate competition, control markets, and price gouge patients. And I have all the receipts.

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Let me start with what might surprise you. Desiccated thyroid extract, or DTE as we call it, is actually one of the most oldest thyroid medications in the world. And I mean old. From the 1890s through 1970, this was the standard treatment for hypothyroidism.
Now let’s really dive into that. From the 1890s to the 1970s, this was standard hypothyroidism treatment.
In 1965 alone, and this is documented in peer-reviewed literature published in the Journal of Clinical Endocrinology and Metabolism, approximately four out of every five prescriptions for thyroid hormone in the United States were of natural desiccated thyroid preparations.
The Journal of Clinical Endocrinology and Metabolism is a very high-end journal. Now think about that. This wasn’t some fringe therapy. This was mainstream medicine. Armour Thyroid, the most recognizable brand name, has been manufactured since the early 1900s, well over a century ago.
and this is cited again in NIH bookshelf. When the FDA was officially established in 1938, Arbor thyroid was already on the market. And this is important and I want you to understand why. Under the federal Food, Drug and Cosmetic Act, any drug that was already being marketed before 1938 was automatically grandfathered into the system. That means it didn’t have to

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go through the formal FDA approval process. And this again is cited under the Federal Food, Drug and Cosmetic Act, grandfathered drugs and exemptions. And this is crucial to understanding what happens next. By the 1970s, synthetic levothyroxine, brand name Synthroid and generics became the preferred treatment. Hmm, wonder why?
It was easier to standardize, came into consistent doses, and worked well for most patients, and could be mass manufactured. By the 1980s, levothyroxine had largely replaced desiccated thyroid in clinical practice, according to the American Thyroid Association 2014 guidelines for the treatment of hypothyroidism. But here’s what matters. Some patients…
a very significant minority of them, never felt right on levothyroxine alone. Despite their lab work looking normal, they still had fatigue, brain fog, weight gain, cold intolerance, and depression.
These patients often found relief when they switched back to their desiccated thyroid, which contains both T4 and T3 hormones, the way human thyroid naturally produces them. And this is not anecdotal. This is documented in randomized double-blind crossover studies published in Endocrine Practice.
For decades, that was fine. Their doctors prescribed it, insurance sometimes covered it, patients were getting better, and the system worked really well. Until August 6th of 2025, just a short time ago, everything changed. On that date, the FDA sent letters to manufacturers, importers, and distributors of desiccated thyroid extract products stating that these medications would need an approval.

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a biologics licensed application, a BLA, to remain legally on the market. And this is cited in the FDA’s official statement, FDA’s actions to address unapproved thyroid medications. understand it says unapproved thyroid medications. However, desiccated thyroid, specifically Armour, has been approved since 1938. And this was dated August 6th through 7th, 2025.
This wasn’t a guideline. This wasn’t a suggestion. It was an endorsement of action. And the timeline they gave them? Well, just 12 months to transition patients to another medication before enforcement action could begin.
This was also cited by an FDA notice to the industry, animal derived thyroid products notice to industry, August 6th, 2025. Now do the math, that means August 2026, seven months from now, 1.5 million Americans currently taking this medication. And this number comes from the FDA official statement, citing that it’s an estimation of 1.5 million patients receiving prescriptions for these medications.
could potentially lose their thyroid access. Now, here’s where it gets interesting. The FDA didn’t wake up in August of 2025 and decide to regulate desiccated thyroid after a century. This decision has a much longer backstory. And understanding that backstory is critical to understanding what’s really happening in this industry.
The shift started in 2022. Back in September of 2022, over three years ago, an FDA branch chief sent a letter to the National Associations of Boards of Pharmacy noting that the agency had decided to designate DTE as a biological product, which would affect its eligibility for compounding.

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This also is cited in an FDA letter to the National Association of Boards of Pharmacy September 2022.
Then two months later, in November of 2022, the FDA’s Office of Compounding Quality and Compliance sent a softer letter acknowledging that many Americans take medication to treat hypothyroidism and some choose to take DTE products. The letter stated that the FDA would focus enforcement on cases that pose the greatest public health risks, such as serious adverse offense or serious product quality or adulteration.
also is cited by an FDA letter from Francis G. Bromel, the director, Office of Compounding Quality and Compliance, November of 2022. Now, let me just think about this for a second. If this drug has been on the market since the 1800s, been FDA approved since 1938, would we not have seen a health crisis long before 2022?
I honestly don’t know of any other drug that’s been around this long that’s used by this many people. Now granted, I haven’t done the research on it either, which I can do for you guys, but I’m just thinking if a drug is on the market today and it causes harm, it doesn’t make it three years, five years before you see lawsuits everywhere. Why are there no lawsuits on this drug? Why are there no major reactions that people are seen having?
Hmm, just thought. But here’s the pattern. The FDA was already laying the groundwork back in 2022, testing the waters, signaling where this was headed. The August 2025 action. Then this came down.

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August 6, 2025, the FDA announced its position publicly and sent formal letters to all DTE manufacturers, importers, and distributors. This was cited by the FDA Enforcement Action August 6, 2025, letters to manufacturers, importers, distributions of DTE products. The agency stated several concerns. First, DTE products have experienced quality and dosing issues.
The FDA cited, and I’m quoting directly from their statement, over 500 adverse events reported associated with DTE products from 1968 to 2025. From 1968 to 2025, we had 500 adverse reactions? What is that math equate to?
A couple a year? Come on guys, this is insane! With a substantial increase, you, between 2019 and 2020 that the agency suggested was related to voluntary recalls of sub-potent or super-potent products.
This was cited in the FDA statement, over 500 adverse events reported associated with ADT products from 1968 through 2025.
Second, the agency expressed concern about batch inconsistency. According to the FDA’s official statements, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Okay, this was cited in the FDA statement, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Thirdly, and I want to actually let’s back up. I want you to remember I said that

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because further down in this podcast, we’re going to talk about this. This is an important point to remember. Thirdly, the agency raised concerns about potential impurities from animal source material, including potential for viral contamination due to the animal source and supraphysiological levels of T3.
the FDA statement on impurities, viral contamination and super physiological T3 levels. Now I will tell you, I’ve been prescribing armarithograde for 20 years. I’ve rarely seen a super physiological dose given of T3 in lab results, unless the patient takes their medication like four or five hours before you do the blood test, then you’ll see a false rise because you’re actually seeing the medication. You’re not seeing people walking around
superphysiological T3 levels. Nobody would like that feeling. So anyway, I digress. Now let me pause here because this is where I need to give you some context that the FDA hasn’t quite emphasized yet. Of course, we have another connection and it is the China connection.
So the FDA’s concerns about contaminated drugs and quality issues don’t exist in a vacuum. In 2024, the U.S. over 828,000 metric tons of pharmaceuticals, seven times the level from 2000. And here’s the kicker. China and India supply the majority of active pharmaceutical ingredients. APIs for U.S. generics accounting for 70 to 80 % of the total generic
drug supply. According to Reuters industry report in 2024, they state that China supplies 82 % of the APIs for critical drugs.

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Got to question that, right? Why are we giving all of our drug formulas to China and allowing them to import them into our country? In fact, roughly 20 % of the critical drugs have APIs exclusively sourced from China. And China controls 80 to 90 % of the global production for antibiotics and other key compounds. This was also cited by Reuters industry data that
controls 80 to 90 percent of the global production for antibiotics and other key compounds. Now just think about this. They control 80 to 90 percent of our medication. They control 20 percent of our critical drugs and we just put what kind of tariff on them? Hmm.
In 2025 alone, the FDA issued multiple warning letters to foreign manufacturers for contamination issues and failure to follow good manufacturing practices. This is also cited by the FDA warning letters 2024 through 2025 and multiple citations to foreign manufacturing facilities. This is a systematic problem affecting the entire US drug supply, not just desiccated thyroid.
So when the FDA suddenly became concerned about DTE quality and contamination, part of that concern was legitimate. But this is crucial. The same inconsistencies and contamination issues exist across the entire generic drug supply. And the FDA has not taken the same enforcement action against them. Let that sink in.
They have not taken the same enforcement action against the other drug companies. So what’s behind all of this? Where is this all coming from? Hmm. Let’s address something directly, because you deserve to know it. And I’m going to cite my sources precisely so that when the medical boards have something to say about this, and they might, I have a documentation for every single word that I am about to speak.

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According to the court documents filed in October 2025, in the case of
a urine, a urine. I’m going to say that wrong. Pharmaceuticals versus Dr. George Tidmarsh from ABBV, the multinational pharmaceutical company that manufactures armor thyroid, reportedly petitioned the FDA in 2024, asking the agency to reclassify DTE as a biologic and to prohibit other manufacturers from selling unlicensed DTE products unless they have
had an investigational new drug application, we call this an IND, and a clinical development program aimed at eventual approval. This is cited in the court filing a Urena pharmaceuticals lawsuit versus Dr. George Tidmarsh, October 2025, reported by Fierce Pharma. Now let me explain why this matters and why this is one of the most brazen examples of regulatory capture I’ve ever seen in my career.
AbbeVee is one of the world’s largest pharmaceutical companies. In 2024, they reported over $54 billion in revenue. Drop the mic on that one.
They have the resources, the regulatory expertise, the legal teams, and the financial capacity to navigate a biologics license application process that costs between $500 million and $1 billion. Let that sink in.

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A drug that’s been on the market since the 1800s that was grandfathered in 1938 that’s making plenty of money right now. They’re going to spend 500 million to $1 billion to get a biologics license application. Why would they do that? Well, we’re about to find out. Most other
DTE manufacturers, smaller companies like Acela Pharmaceuticals, which makes NP-thyroid, and RLC Labs, which made WP-thyroid, do not have those same resources. And this is cited in Pharma Voice in 2025. Why a treatment older than the FDA is getting new regulatory scrutiny. So when you petition the FDA to reclassify a drug in a way that requires this type of expensive
time-consuming biological approval, you’re not just asking for safety. You’re asking to eliminate your competitors from the marketplace. Now, I want to be very precise here. These allegations are documented in federal court filings, and it hasn’t been approved in court. It’s also been reported by multiple industry sources, including Fierce Pharma. But I’m telling you,
what has been reported in legal proceedings, not stating it as an absolute fact because you deserve to know the difference and because I have to protect my license. Now, what do we know for certain?
AbbeVee is working on a biologics license application for Armour thyroid through clinical trials called Avantia. This is cited by the AbbeVee corporate statement 2025 Avantia clinical trial for Armour thyroid. A cell of pharmaceuticals has been pursuing BLA approval for NP thyroid for seven years since 2017 and it completed its phase two trials successfully in 2025. They’re now moving

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into Phase 3 trials. This is also cited by the Acela Pharmaceuticals CEO statement 2025 seven-year pursuit for BLA approval completed Phase 2 trials moving to Phase 3.
RLC Labs, which manufactured WP thyroid, has made no public announcement about pursuing BLA approval and really probably don’t have a plan to do this since they’ve been off the market for some time now. About five years, I think maybe a little longer. Here’s the market manipulation.
If only ABBV is successful and obtains a BLA approval for Armour thyroid, that company would effectively have a monopoly on the DDT market. And in pharmaceutical markets, monopolies historically lead to price increases.
We’ve seen this pattern over and over again when turning pharmaceuticals acquired Daraprim and raised their price from $13.50 to $750 per tablet overnight. When Myelin raised EpiPen increased prices by 400 % when insulin manufacturers colluded to raise prices in lockstep. This is the playbook.
use regulatory barriers to eliminate your competition and then exploit pricing power. For a drug that’s been on the market since the 1800s, guess corporate greed is everywhere. They’re not making enough money on this product already and they’re taking advantage of the rules that they can manipulate their competition by. And here’s what really makes me furious. The American Thyroid Association, the professional organization

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representing endocrinologists sent letters to the FDA commissioner on October 8th of 2025 and September 18th of 2025.
advocating for continued patient access to DTEs. This is cited in the American Thyroid Association statement and letter to the FDA commissioner dated October 8th, 2025 and September 18th, 2025. The American Association of Clinical Endocrinologists issued a statement on September 9th of 2025 supporting equitable access and personalized medicine for DTE. This was also cited in the American Association
Association of Clinical Endocrinologists, AACE, statement dated September 9th, 2025. Even the medical establishment, which has historically favored levothyroxine, is saying, wait, this is going too far. Patients need access to this medication. But the FDA is moving forward anyway. Why? Well, where does it always lead us? Follow the money trail.
Okay, so I need to explain what a biologics license application actually is because this is where the rubber meets the road for what’s going to happen to pricing and availability. What is a BLA?
A BLA is a biologics license application. It’s a formal request submitted to the FDA to market a biologic product in the United States. A biologic is defined under the Public Health Service Act section 351 as a product derived from or made using living material, in this case, animal thyroid glands. And this is cited in the FDA definition for biologic products. So they’re putting armor thyroid right

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right up with stem cells and exosomes. Think about that. Stem cells and exosomes cost thousands of dollars per application because of how they have to be harvested, stored, freezed, all of that. But we’re talking about a thyroid gland. Good Lord, people.
Unlike regular drug applications for synthetic medications which follow a simpler pathway, the BLA process is designed for complex biological products like monoclonal antibodies, vaccines, and gene therapy products. It’s a much more expensive, much more time-consuming process. The BLA process
is what manufacturers have to do. And we’re going to talk about that. So according to Reprocell and Forge Biologics analysis of the FDA’s BLA process, here’s what companies need to submit. First, they need to complete a clinical trial data, phase one, two, and three trials, proving safety and efficacy for desiccated thyroid. Haven’t we done that since it’s been on the market since the 1800s? Just saying.
This means they have to conduct large randomized controlled trials comparing it to levothyroxine, measuring safety outcomes, efficacy outcomes, and quality of life metrics. Second,
Chemistry, Manufacturing and Controls, CMC’s data. Detailed information about how the product is manufactured, quality control measures, stability testing and specifications that must be met for every batch. Third, preclinical and animal safety data. Fourth, labeling and product information. Now, I think we have labeling and product information.

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since the 1800s? But just saying. Fifth, they need Pharma Covigilance Plan, a detailed plan for monitoring safety after the product is on the market. Haven’t they had to do that since the 1800s? And they have to have a timeline. And this is the critical part. The FDA’s standard review time for a BLA is 10 months.
That’s after the application is deemed complete and accepted for filing. So this is cited by the FDA standard review timeline, BLA submission, and FDA review.
Now, before you even get to filing, you need to conduct the clinical trials and compile all the data that’s typically several years of work. How are you going to prove safety and effectiveness in a large clinical trial long term? What do they consider? What do they deem long term? Three months, six months, a year, two years. These companies had 10 months.
Well, maybe 12. They did it a year in advance. But unless you knew this was coming, how are you going to put together a trial, enroll the people, have all the trial components set up and ready to go in less than 12 months unless you knew it was coming beforehand? Even if
had started all their clinical trials in 2024, completing them, compiling the data, and getting a complete application ready for submission, this would likely take you through mid-2026, then add another 10 months for FDA review. We’re looking at 2027 at the earliest for most of these companies to receive a BLA application.

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But the FDA gave the manufacturers until August of 2026. That’s approximately 19 months from when the August 2025 letters were sent. Most companies cannot reasonably complete the BLA approval in that timeframe. And when I’m talking about the 19 months, I’m talking about the information they would have had earlier. Now the cost.
This gets me even more frustrated. Why are we spending this kind of money? The BLL process is extraordinarily expensive. The current FDA user fee for a BLA submission is approximately $483,560 just for the filing fee. And this is cited at the FDA user fees prescription drug user fee rates for 2025.
The full cost of conducting clinical trials, CMC studies, and all the supporting documentation typically ranges from $500 million to over $1 billion, depending on the scope of the trials and the complexity. And this is cited in JAMA’s network, Open2023. A cell of pharmaceuticals has been pursuing the BLA approval since 2017. That’s eight years. And it’s just now.
moving into phase three trials with a planned enrollment of approximately 300 patients. This is cited by the Acela Pharmacies CEO statement of 2025. Now that’s unusual. That’s typical for this process. This is not unusual. This is typical for this process to take seven, 10 years to get approval for this. So if Abby’s the one that requested this,
Abby V. And Acela started this in 2017. Was Abby V threatened by Acela that Acela might get this approval and it would be quietly done without anybody seeing it? And maybe Abby V would be left out of the market after a century? Who knows? It’s possible.

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But for smaller manufacturers without billions in revenue, this cost is completely prohibitive. And this is why this matters. When you push an old established medication through an extraordinary, expensive approval process with a compromised timeline, one of three things happen. First, only the largest companies can afford it, creating a monopoly. And when that happens, the company that holds the only approved product can set pricing with
minimal competitive pressures. Two, smaller manufacturers can’t afford it and their products disappear and the market shrinks and access decreases. Three, we see a combination of both and who pays the price? Literally, patients do. Now here’s where
There’s something I want you to really think about because this is where the regulatory argument falls apart when you look at it carefully. The FDA’s concern about DTE is that, and I’m quoting their official statement, tablets from the same manufacturing batches may not always provide the same thyroid hormone levels. This is from their FDA statement.
And that’s a legitimate quality concern, right? It is. Thyroid medications have a narrow therapeutic window like any other hormone, meaning the difference between an effective dose and the dose that causes problems can be quite small. But here’s what the FDA doesn’t emphasize. Generic drugs have the exact same dosing inconsistency issue, and it’s considered acceptable and has been since we allowed generics on the market.
So how does a generic drug dose work anyway? Well, for generic drugs to be approved as bioequivalent to a brand name medication, the FDA requires that the generic drugs bioavailability fall within 80 to 125 % of the brand name product. Isn’t that a dose inconsistency?

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from the brand name medication? 800 or sorry, 80 to 125%. According to the pharmacy times analysis of the FDA’s bioequivalent standards, the 80 to 125 % bioequivalence rule means that a generic drug can have 20 to 45 % variability compared to the original brand product.
Now, most generics are much closer than that. The FDA study data shows that the mean difference for an AUC value between generic and reference products is about three and a half percent in the two year post-Waxman hatch period, and 80 % of the generics fall within a five percent range. But the FDA’s regulations allow for that much higher variability. And this is cited in an FDA study data mean difference for AUC.
Now, let me put this in plain language. A patient could take a generic levothyroxine tablet where one batch provides, say, 75 micrograms of an active thyroid hormone. And the next batch from a different manufacturer, a different generic manufacturer, could provide up to 93.75 micrograms, 125 % of that 75. That’s an 18 microgram difference.
in the same prescribed dose. Now, this is considered acceptable and patients tolerate it and this system works.
Yet the FDA’s argument against DTE is that batch-to-batch inconsistency is unacceptable and requires this expensive biologic approval? That’s a double standard. So why is batch inconsistency acceptable for generic levothyroxine, but supposedly unacceptable for desiccated thyroid? I’ll give you the regulatory answer.

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because DDT is a biological product derived from an animal tissue and the FDA considers biological products to require more rigorous control. That’s the regulatory answer, but I’ll give you the real answer.
because there’s no billion dollar pharmaceutical company with a patent pending on generic levothyroxine who petitioned the FDA to regulate their competitors more strictly. The inconsistency argument is legitimate, but it’s selectively applied. And that matters when you’re trying to understand whether this is really about patient safety or whether it’s about market control.
Now I want to talk about something that hasn’t gotten nearly enough attention in this discussion and it’s something that makes me absolutely furious. What is Armour Thyroid? According to the official prescribing information published by AbbeV and available through rxabbev.com and the FDA’s daily med database, Armour Thyroid contains the following inactive ingredients. Calcium steroid,
dextrose derived from corn, mycocrystalline cellulose,
sodium starch glycolate and a opadri white coating. Now let’s talk about dextrose. Dextrose is a sugar derived from corn and while manufacturers claim that the corn derived dextrose in armor thyroid is gluten free, here’s the problem. Cross contamination during corn processing can introduce gluten proteins especially if the corn is processed in facilities that also handle

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wheat, barley, or rye. Corn sensitivity is extremely common in patients with celiac disease and non-celiac gluten sensitivity, and studies show that up to 50 % of the celiac patients react to corn proteins due to molecular mimicry, and the corn proteins look similar enough to gluten that the immune system attacks them. And this is cited by RestartMD.com.
And here’s what’s documented in peer-reviewed medical literature in a 2023 case report published in Case Reports in Endocrinology. These researchers documented five patients with gluten intolerance or celiac who were taking natural desiccated thyroid. Three of those patients also reported lactose intolerance. Now these patients had to switch from DTE to liquid levothyroxine formulations to avoid the inactive
So here’s my question. If AbbeV becomes the only manufacturer with an approved DTE product and their formulations contain corn-derived dextrose that triggers reactions in celiac patients, what are those patients supposed to do? They can’t take armor because of the corn. They can’t take compounded DTE because the FDA is banning compounding of these biologics. They can’t take NPKs
or WP thyroid because those companies may not survive the BLA process. So they’re left with a synthetic version of levothyroxine which may not work for them.
Now the NP thyroid and WP thyroid difference. Now here’s what’s interesting according to drugs.com comparison of inactive ingredients and P thyroid and P thyroid has calcium steroid dextrose also derived from corn, mineral oil, multi-crystalline cellulose.

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cross carmelicin sodium and a opadri to white. So NP thyroid also has corn-derived dextrose. WP thyroid on the other hand was specifically formulated to be hypoallergenic according to ROC labs, but it’s no longer available and its ingredients were inulin from chicory root and medium chain triglycerides. No corn, no gluten, no common allergies. So today
We do not have a glandular thyroid, a DTE, that is not potentially contaminated with gluten. Yet, patients with autoimmune thyroid disease are supposed to avoid gluten.
Now, some of these people can handle a DTE and many cannot, so that argument could be a mute point. But at the end of the day, the one product that we had that was designated for patients with multiple chemical sensitivities, celiac disease and coron allergies, has been off the market for a long time already.
We have a monopoly problem. So if ABBV becomes the only approved manufacturer, patients with these celiac diseases and corn allergies will either be forced to take a medicine that makes them sick and triggers their immune reaction or switch to a synthetic that doesn’t adequately treat their hypothyroidism or choose to go without treatment. This is not hypothetical. This is real patients with real medical needs who are about to lose access
to the only formulation that works for their body. And the FDA’s response is silence.

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Now I want to highlight something that hasn’t gotten nearly enough attention in this discussion. Compounding pharmacies. What is a compounding pharmacy? Compounded medications are custom made by licensed pharmacists to meet a patient’s specific needs. Maybe you need a different strength that was commercially available, but you have an allergy to a filler or a dye in the commercial product. Maybe you need a liquid formulation or instead of a tablet or you need a capsule. That’s when compounding
in. And the FDA’s, this is the FDA’s definition of compounding. And for decades, compounding pharmacies have been making desiccated thyroid extract for patients who needed customization. Some patients couldn’t take the commercial products because of the dyes and the fillers, and some needed strengths that were not available. And these compounding pharmacies filled the gap.
But reclassification changes everything. When the FDA reclassified DTE as a biologic in 2022 and reinforced that decision in August of 2025, explicitly stated, and I’m quoting directly from the FDA’s official statement, these unapproved animal-derived thyroid medications are not eligible for compounding because these products are regulated as biologic products under the Public Health Service Act.
How can that be? These products have been approved since 1938 and the Biologics Act didn’t go into effect or doesn’t go into effect until August of 2026.
So how in 2022 were they able to say that the compounding pharmacies could not make these products? Anyway, what this means is after August 2026, compounding pharmacies will no longer be permitted to compound a desiccated thyroid extract, even for patients with specific medical needs. Now, compounding pharmacies can still compound T4 and T3 separately, synthetic versions of levothyroxine and liothyronine, according to

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healing dose compounding pharmacy. These pharmacists can create custom ratios of these two synthetic hormones to approximate what a patient was receiving from a DTE. But that’s not the same thing. Some patients respond better to the whole DTE preparation than to a compounded synthetic combination. And for patients with specific allergies to standard fillers like your celiac patients that I just talked about, losing the ability to get a compounded DTE alternative is
real hardship. This is going to be a ripple effect. For a subset of patients, maybe 5 to 10 percent of those on DTE compounding was their lifeline and it was their way to get a medication formulation that worked for their unique body. When compounding goes away, these patients lose that option as well and for some it will be a significant problem. Now let’s talk about what this likely means for your wallet.
The current pricing right now, according to SingleCare and GoodRx, Armour Thyroid costs approximately $150 to $157 for a 90-day supply of 60-milligram tablets, about $1.67 per tablet. With discount cards, some patients can get it down to $101 to $152 for a 90-day supply.
Generic levon thyroxine costs about $70 for a 90 day supply, less than half that price. And p-thyroid costs approximately $133 for a 90 day supply of 60 milligrams with a discount card about $83 to $101.
What happens after we get BLA approval? Well, here’s the pharmaceuticals pricing model. When a company spends 500 million to $1 billion to bring a product to market, including conducting massive clinical trials, the cost tens of millions of dollars they recoup in that investment through pricing power. And this is cited in the pharmaceutical pricing models. If ABBIEV is the only company with an approved BLA of DTE,

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They have pricing power. They don’t have competitors. They can set their price, whatever they want. And historically, when drugs transition from grandfather status, which is basically unregulated to formal formally approved status, prices often increase significantly, not always, but often. And typically they have to get re-approval for insurance. So
Touring Pharmaceuticals acquired DARPM and raised the price again from $1,350 to $750 overnight, a 5,000 % increase. This is the playbook.
Let’s talk about insurance coverage. This is the other consideration. Insurance companies sometimes have different coverage policies for approved versions versus unapproved drugs. And right now, many insurance plans cover armor thyroid or NP thyroid, even though they’re technically unapproved because they’ve been on the market for decades and patients are on them. Once a drug becomes formally approved, insurance companies may have new contractual relationships, prior authorization requirements, or preferred drugs.
list that could affect your coverage. If 1.5 million people have to get a prior auth for their insurance to cover this new medication, this is going to drive the doctor’s offices crazy. We do not have the staff to man this. We do not have the manpower. We do not have the time. This is going to interrupt people’s ability to get their medications. This is going to create chaos within the system. And some patients might see better coverage, but many
most likely are going to see worse coverage and some might find themselves in a situation where they need to try to get the drug approved first or get an approval for something else like levothyroxine and they’re going to have to document that it didn’t work and the documentation that they had from 20 years ago is probably not going to be enough because it’s not documented anywhere. It’s lost in the system after 10 years. So for patients the practical takeaway is expect

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a price increase. I would say possible, but I don’t think that’s true. think you’re going to see a price increase if they get approved. Expect possible insurance complexities, budget accordingly, talk to your insurance company now about what your coverage is going to look like in 2027 if they even know. And if you want my honest assessment of what is likely to happen,
I’ll give you a scenario, 30 % likelihood. The FDA enforces the August 26 deadline and DTE products not approved by then are pulled from the market. Patients will have 30 to 90 days to transition to other medications. Some patients suffer significant symptom relapse. Compounding for DTE becomes illegal and this disruptiveness of the system creates a real hardship. Scenario two.
which is 50 % likely. This is actually what the FDA commissioner, Marty McCreary suggested on August 13th of 2025 when he posted on social media. The FDA is committed to pursuing the first ever approval of desiccated thyroid access pending results of the ongoing clinical trials. In the meantime, we’ll ensure access for all Americans. Hopefully that continues. What this likely means is the FDA uses enforcement discretion to allow continued
sales while approvals are being pursued and the deadline gets extended. Maybe patients get access for another two to three years while companies work on a BLA approval. This would be the least disruptive scenario, but it’s also legally uncertain because the enforcement letters have been formally rescinded. And scenario three, which is 20 % likelihood, one or two companies get BLA approval. Those products stay on the market at higher product prices and companies, products, other companies
companies, products are pulled, the market shrinks, availability is limited, prices are higher, but patients can still get something. This is likely if a seller successfully completes phase three trials for NP-thyroid. And my assessment is based on the regulatory language and the enforcement letters that have not been rescinded yet, that the pattern of FDA enforcement, I believe scenario two enforcement discretion with an extended time frame is most likely what we’re going to see.

Deb (48:49.488)
doesn’t mean patients should sit back and do nothing. It means you should be prepared for change while advocating for access. If you want to keep Arm or Thigh Right on the market, 1.5 million people need to start talking about this publicly and flooding our Congress people, Bobby Kennedy, the FDA, with what you want to see happen. We have the ability to shape this and to change this with our voice. But if we sit back on our laurels and we do absolutely
nothing. What is going to happen is what the FDA wants to have happen and ABV wants to have happen because they’re going to simply think people don’t give a shit. And if the American people are going to be lazy and not want to step forward and actually start using their voice for some good and instead of just going to social media and bitching and hoping something is going to happen, well, then we’re going to get what we deserve. But if you start taking some
action and you start advocating for the things that you want. Contacting your representatives, contacting your U.S. tell them the FDA has done this. Many of them may not know this, may not be on their radar. Tell them what you want. Start going after this. Start writing to the FDA Commissioner’s Office. They have a website. They have a Commissioner’s Office at fda.hhs.gov. Be responsible.
respectful, but be firm. Explain your scenario. How long you’ve been on DTE. Why levothyroxine doesn’t work. What symptoms you experience when not adequately treated. How this decision will affect your quality of life and your pocketbook. Let’s do something proactive. So let’s consider this. Moving forward, work with your provider who understands the regulatory landscape around DTE. You can discuss the evidence for and against combination therapy.
You can monitor for thyroid function with free T3 and free T4 testing, not just TSH. If you’re willing to try individualized approaches, you can do that. If you need help finding a functional medicine provider who understands this issue, come to serenityhealthcarecenter.com or explorethevanari.com. It’s a self-directed functional medicine support group. And right now what is happening is going to shape how history

Deb (51:19.024)
is made with not just armor thyroid, but many drugs to come. And it is important for you to take action. So I want to thank you for joining me today on Let’s Talk Wellness Now. This episode is about far more than thyroid medication. It’s about your right to personalized medical treatment. It’s about your regulatory capture and corporate influence. And it’s about what happens when billion dollar companies shape healthcare policy in ways that reduce patient choice and increase their profits.
this episode resonates with you or you know somebody who’s going to be affected by desiccated thyroid, please share it. Post it on social media, send it to your doctor, email it to your representatives, tag AbbeVee, tag FDA. Make noise because the only way we stop this is if we make it too politically costly for them to continue. Your voice truly matters. Your health truly matters and you deserve access to treatments that work best for your unique body.
If you’re ready to explore comprehensive personalized health care that puts you in control, visit us at SerenityHealthCareCenter.com. Learn more about functional medicine approaches to thyroid and beyond and explore my new platform, Venari.com, which is a self-directed functional medicine tool. Thank you for joining me today. Until next time, I’m Dr. Deb reminding you, your health is your responsibility, your choice, and your right. Be well, stay informed, fight back.
and I’ll see you in the next episode. And if you’re looking for a full citation list of this episode, you can head over to letstalkwellnessnow.com and I will post all the citations for you so you have them in your arsenal as well. Thank you again.

The post Episode 259 – The Desiccated Thyroid Crisis: FDA’s Unseen Impact & Corporate Manipulation first appeared on Let's Talk Wellness Now.

Deb (00:03.606)

Within the next seven months, up to 1.5 million Americans could lose access to a medication that they've relied on for decades. Not because it's dangerous, but because a pharmaceutical giant may have lobbied the FDA to eliminate their competition. And if you're one of them, your doctor may already have told you about this issue and stopped prescribing it.

This isn't a conspiracy theory. This is documented in federal court filings. This is happening right now. And the company that stands to profit, well, they're the same ones manufacturing the only product that might survive.

Today on Let's Talk Wellness Now, we're exposing the desiccated thyroid extract crisis, the corporate manipulation behind it, and what you need to do right now to protect your health. Stay with me because I'm about to share what could save your access to the medication keeping you alive.

Welcome back to Let's Talk Wellness Now, the show where we uncover the root causes of chronic illness, expose regulatory capture in healthcare, and empower you with the tools to advocate for yourself. I'm Dr. Deb, naturopathic doctor, your medical detective, and today we're diving into one of the most consequential and corrupt healthcare decisions affecting patients right now. If you or someone you love takes Armour thyroid, NP thyroid, or any desiccated thyroid extract,

for hypothyroidism or if you've struggled to find a thyroid medication that actually works for your body, this episode is absolutely critical. And if you have celiac disease, gluten sensitivity or corn allergies, what I'm about to reveal will make your blood boil. Now grab your cup of coffee, don't forget your notebook and settle in because what's happening to this medication right now is a masterclass in how pharmaceutical companies use regular

Deb (02:06.544)

agencies to eliminate competition, control markets, and price gouge patients. And I have all the receipts.

Deb (02:20.982)

Let me start with what might surprise you. Desiccated thyroid extract, or DTE as we call it, is actually one of the most oldest thyroid medications in the world. And I mean old. From the 1890s through 1970, this was the standard treatment for hypothyroidism.

Now let's really dive into that. From the 1890s to the 1970s, this was standard hypothyroidism treatment.

In 1965 alone, and this is documented in peer-reviewed literature published in the Journal of Clinical Endocrinology and Metabolism, approximately four out of every five prescriptions for thyroid hormone in the United States were of natural desiccated thyroid preparations.

The Journal of Clinical Endocrinology and Metabolism is a very high-end journal. Now think about that. This wasn't some fringe therapy. This was mainstream medicine. Armour Thyroid, the most recognizable brand name, has been manufactured since the early 1900s, well over a century ago.

and this is cited again in NIH bookshelf. When the FDA was officially established in 1938, Arbor thyroid was already on the market. And this is important and I want you to understand why. Under the federal Food, Drug and Cosmetic Act, any drug that was already being marketed before 1938 was automatically grandfathered into the system. That means it didn't have to

Deb (04:08.112)

go through the formal FDA approval process. And this again is cited under the Federal Food, Drug and Cosmetic Act, grandfathered drugs and exemptions. And this is crucial to understanding what happens next. By the 1970s, synthetic levothyroxine, brand name Synthroid and generics became the preferred treatment. Hmm, wonder why?

It was easier to standardize, came into consistent doses, and worked well for most patients, and could be mass manufactured. By the 1980s, levothyroxine had largely replaced desiccated thyroid in clinical practice, according to the American Thyroid Association 2014 guidelines for the treatment of hypothyroidism. But here's what matters. Some patients...

a very significant minority of them, never felt right on levothyroxine alone. Despite their lab work looking normal, they still had fatigue, brain fog, weight gain, cold intolerance, and depression.

These patients often found relief when they switched back to their desiccated thyroid, which contains both T4 and T3 hormones, the way human thyroid naturally produces them. And this is not anecdotal. This is documented in randomized double-blind crossover studies published in Endocrine Practice.

For decades, that was fine. Their doctors prescribed it, insurance sometimes covered it, patients were getting better, and the system worked really well. Until August 6th of 2025, just a short time ago, everything changed. On that date, the FDA sent letters to manufacturers, importers, and distributors of desiccated thyroid extract products stating that these medications would need an approval.

Deb (06:04.654)

a biologics licensed application, a BLA, to remain legally on the market. And this is cited in the FDA's official statement, FDA's actions to address unapproved thyroid medications. understand it says unapproved thyroid medications. However, desiccated thyroid, specifically Armour, has been approved since 1938. And this was dated August 6th through 7th, 2025.

This wasn't a guideline. This wasn't a suggestion. It was an endorsement of action. And the timeline they gave them? Well, just 12 months to transition patients to another medication before enforcement action could begin.

This was also cited by an FDA notice to the industry, animal derived thyroid products notice to industry, August 6th, 2025. Now do the math, that means August 2026, seven months from now, 1.5 million Americans currently taking this medication. And this number comes from the FDA official statement, citing that it's an estimation of 1.5 million patients receiving prescriptions for these medications.

could potentially lose their thyroid access. Now, here's where it gets interesting. The FDA didn't wake up in August of 2025 and decide to regulate desiccated thyroid after a century. This decision has a much longer backstory. And understanding that backstory is critical to understanding what's really happening in this industry.

The shift started in 2022. Back in September of 2022, over three years ago, an FDA branch chief sent a letter to the National Associations of Boards of Pharmacy noting that the agency had decided to designate DTE as a biological product, which would affect its eligibility for compounding.

Deb (08:13.972)

This also is cited in an FDA letter to the National Association of Boards of Pharmacy September 2022.

Then two months later, in November of 2022, the FDA's Office of Compounding Quality and Compliance sent a softer letter acknowledging that many Americans take medication to treat hypothyroidism and some choose to take DTE products. The letter stated that the FDA would focus enforcement on cases that pose the greatest public health risks, such as serious adverse offense or serious product quality or adulteration.

also is cited by an FDA letter from Francis G. Bromel, the director, Office of Compounding Quality and Compliance, November of 2022. Now, let me just think about this for a second. If this drug has been on the market since the 1800s, been FDA approved since 1938, would we not have seen a health crisis long before 2022?

I honestly don't know of any other drug that's been around this long that's used by this many people. Now granted, I haven't done the research on it either, which I can do for you guys, but I'm just thinking if a drug is on the market today and it causes harm, it doesn't make it three years, five years before you see lawsuits everywhere. Why are there no lawsuits on this drug? Why are there no major reactions that people are seen having?

Hmm, just thought. But here's the pattern. The FDA was already laying the groundwork back in 2022, testing the waters, signaling where this was headed. The August 2025 action. Then this came down.

Deb (10:09.806)

August 6, 2025, the FDA announced its position publicly and sent formal letters to all DTE manufacturers, importers, and distributors. This was cited by the FDA Enforcement Action August 6, 2025, letters to manufacturers, importers, distributions of DTE products. The agency stated several concerns. First, DTE products have experienced quality and dosing issues.

The FDA cited, and I'm quoting directly from their statement, over 500 adverse events reported associated with DTE products from 1968 to 2025. From 1968 to 2025, we had 500 adverse reactions? What is that math equate to?

A couple a year? Come on guys, this is insane! With a substantial increase, you, between 2019 and 2020 that the agency suggested was related to voluntary recalls of sub-potent or super-potent products.

This was cited in the FDA statement, over 500 adverse events reported associated with ADT products from 1968 through 2025.

Second, the agency expressed concern about batch inconsistency. According to the FDA's official statements, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Okay, this was cited in the FDA statement, tablets made from the same manufacturing batches may not always provide the same thyroid hormone levels. Thirdly, and I want to actually let's back up. I want you to remember I said that

Deb (12:11.216)

because further down in this podcast, we're going to talk about this. This is an important point to remember. Thirdly, the agency raised concerns about potential impurities from animal source material,...

Dr Deb Muth 00:03
Well, welcome back to Let’s Talk Wellness Now. I am your host, Dr. Deb. And what is the most talked-about peptides in functional medicine? aren’t actually FDA approved. Not because they don’t work, but because no one’s funded the research to prove it yet. The truth is, some of the compounds that dominate wellness forums, BPC-157, TB-500, thymosin beta-4, epitalin, occupy a fascinating space between breakthrough science and unregulated experimentation. In today’s episode, we’re stepping into that grey zone, the world of investigational peptides, to separate mechanism from marketing. I’m going to walk you through the science that actually shows and where it stops, how to evaluate claims when human data don’t yet exist, and the quality, purity, and safety red flags that you need to recognise.

Dr Deb Muth 01:06
I created it in a previous episode, so go check that one out. And why honesty is the most important prescription in peptide medicine. If you’ve ever wondered whether these research-only peptides are the frontier of healing or the next functional medicine fad, this episode is for you. So grab your cup of tea or coffee, get comfortable, and let’s talk about what it really means to use peptides that are promising but still under investigation. So we’re going to break just for a second here and have a word from our sponsor. It is because of them that we stay on the air. So thank you for this. And we will be right back. Did you know sweating can literally heal your cells? Infrared saunas don’t just relax you. They detox your body, balance hormones, and boost mitochondrial energy. I’m obsessed with my Health Tech sauna. And right now, you can save $500 with my code at healthtechhealth.com slash dr-muth-req-25.

Dr. Deb Muth 02:15
All right, guys, welcome back. Let’s dive into investigational peptides, the evidence gap. So the following peptides we’re about ready to discuss are extensively in integrative, functional, and regenerative medicine circles. They may have intriguing mechanisms and promising preclinical data. However, they lack FDA approval, and the evidence quality varies dramatically. from interesting preliminary research to essentially no human data at all. And this distinction is really critical for maintaining scientific integrity. So let’s talk about immune-modulating peptides. There’s thymus and alpha-1, and this is an international story on the thymic peptides. Thymusin alpha-1, known as TA1, is marketed internationally as zidaxin.

Dr. Deb Muth 03:16
It’s a 28-amino acid polypeptide originally isolated from thymusin fraction 5, which was extracted from bovine thymus tissue. Modern production uses synthetic peptide synthesis. The thymus gland is located behind the sternum and is the primary site for T cell maturation, and thymic peptides like TA1 play roles in human system development and regulation. Now, I love thymus peptides. I love thymus glandular products. I’ve used thymus glandular products for decades. Ground-up animal thymus gland is basically what it is. There are a couple of different supplement companies that I’ve used over the years that are amazing with this. And they do a fantastic job, and they really do help to support the immune system. So when thymus peptides came out, it was really exciting because it took the whole idea of thymus support to a new level.

Dr. Deb Muth 04:17
The mechanism actually behind the thymus in alpha-1 is complex and involves multiple aspects of immune function. At the cellular level, TA1 enhances T cell maturation and differentiation, particularly the development of helper T cells and cytotoxic T cells. It modulates T cell receptor expression and can influence the balance between Th1 cell-mediated immunity and Th2 humoral immunity responses. And it also enhances the natural killer cell activity and modulates dendritic cell function, which are critical for antigen presentation. and initiation of adaptive immune responses. And on the cytokine level, TA1 influences production of interleukin-2, IL-2, interferon gamma, IFN-γ, and interleukin-10, IL-10.

Dr. Deb Muth 05:19
These create immune modulatory rather than simple immune stimulatory effects. This is a very important distinction because TA1 appears to help balance the immune system rather than simply ramping this up, which theoretically makes it safer in conditions where immune overstimulation would be a problem, such as an autoimmune disease. Hashimoto’s, autoimmune, lupus, Sjogren’s, any of those autoimmune diseases, we don’t want to overstimulate their immune system. So you want to use a product like this that’s non-stimulating. Now, the regulatory status on TA1 is geographically variable and represents one of the challenges in discussing this peptide with patients. It is not FDA-approved in the United States. However, it is approved in several other countries for specific conditions.

Dr. Deb Muth 06:19
In Italy, it’s approved for the treatment of chronic hepatitis B and hepatitis C. In China, it’s approved for chronic hepatitis B and adjunct immune compromised patients receiving vaccinations or suffering from certain infections. It has an orphan drug designation in the United States for certain cancer indications, but its designation does not constitute approval. It simply provides regulatory incentives for further development. So the evidence base for thymosin alpha-1 is substantial in some areas but comes primarily from non-US populations and research groups, which creates challenges in evaluating quality and generalizable information. So in hepatitis B and C, multiple clinical trials, many conducted in China and Italy, have examined TA1 as an adjunct to antiviral therapy.

Dr. Deb Muth 07:21
A meta-analysis by Wu and colleagues published in the Journal of Viral Hepatitis in 2013 examined 23 randomized controlled trials, including over 2,000 patients with chronic hepatitis B. The analysis found that combining TA1 with nucleoside analogs like LAMVDUDE or an and TCAVAR improved the hepatitis antigen seroconversion rates by HBV DNA clearance compared to its nucleoside analogs alone. And the effect sizes were modest but statistically significant, with the HBE-AG seroconversion rates improving from about 24% with antivirals alone to 38% in combined therapy. Now in hepatitis C, early trials before the development of direct-acting antivirals showed that TA1 combined with interferon alpha improved sustained virological responses, and compared to interferon alpha,

Dr. Deb Muth 08:30
Furon alone, particularly in difficult-to-treat populations like those with a genotype one or a high viral load. However, the advent of highly effective direct acting antivirals that achieve SRV rates, sorry, SVR rates exceeding 95%, the role of TA1 in hepatitis C has become less clear. Now in sepsis and critical illness, more recent interest has focused on TA1 in severe cases of sepsis and septic shock. Ren and colleagues published a systematic review and meta-analysis in the Frontiers of Immunology in 2022, analyzing 18 randomized controlled trials, including 1787 patients with severe sepsis or septic shock the pooled analysis showed that ta1 administration was associated with reduced 28-day mortality relative risk at 0.70 meaning a 30 reduction in mortality compared to the standard care alone and the effect appeared

Dr. Deb Muth 09:39
most pronounced in patients with sepsis-induced immunosuppression measured by HLA-DR expression in monocytes. Now, this is amazing because going forward, we’re going to talk about something that’s commonly known as cytokine storm. Now, cytokine storm really became apparent since 2020 with the viral infection that we’re dealing with in the world today. But they were already looking at this kind of cytokine storm produced by sepsis or sepsis-induced immunosuppression. And it triggered this hyperinflammatory response called the cytokine storm. And many patients who survived the initial phase of the immune suppressed stata, characterized by a T cell exhaustion, reduced antigen presentation, and increased susceptibility to secondary infections. Thymusin alpha-1, TA1, may help restore this immune competence in this phase. However, it’s important to note that patient selection and timing are critical.

Dr. Deb Muth 10:43
Giving this immune stimulant during a hyperinflammatory phase could theoretically worsen outcomes. So you don’t want to give it to them while they’re in the flare up or the sepsis or the infection, but given to them during the immunosuppression phase afterwards might be beneficial. Now there is also some cancer immunotherapy that we see with TA1 and has been studied as an adjunct in cancer treatment with the hypothesis that it could enhance immune surveillance and response to tumors. And a comprehensive review of Garci and colleagues published in Expert Opinion on Biological Therapy in 2007 examined multiple trials in melanoma, lung cancer, hepatocellular carcinoma, and other malignancies. And the results were mixed. Some trials showed improvement in the immune parameters, increased CD4 in T-cells. improved lymphocyte proliferation responses and some actually showed trends toward improved progression free survival but overall survival benefits were inconsistent and the heterogeneity of the cancer types treatment protocols and outcome measures makes a definitive conclusion difficult as a vaccine adjunct several studies particularly from china have examined ta1 as an adjunct to enhance vaccine responses

Dr. Deb Muth 12:11
in immune-compromised populations, including the elderly, dialysis patients, and transplant recipients. The rationale is sound. These populations often mount suboptimal antibody responses to vaccines, and TA1’s immune-enhancing effects might improve protection. There are small trials. They have shown improvement in seroconversion rates of hepatitis B vaccines and influenza vaccine in these populations. And though large-scale confirmatory studies are limited, there is a possibility here. Now, on their safety profile, one of the appealing aspects of thymusin alpha-A TA1 is that it’s apparently favorable safety profile in clinical trials. There are some injection site reactions with a little redness, a mild discomfort, and most commonly reported adverse effects. is that their severe adverse events attributable to TA1 have been rare in published trials. However, comprehensive long-term safety data are limited

Dr. Deb Muth 13:13
And theoretically, concern exists that immune modulation could potentially trigger or exasperate autoimmune conditions in susceptible individuals. Though this hasn’t been clearly demonstrated in clinical trials, integrative medicine considerations for integrative practitioners concerning the thymus and alpha-1, several factors require careful thought. First, sourcing and quality control are critical concerns. Since it’s not FDA approved, TA1 available in the United States typically will come from a compounding pharmacy or an international supplier with variable quality assurance. And pharmaceutical grade product with certificates of analysis showing purity, sterility, and endotoxin testing is essential, but it is readily available from many of these companies. Second, patient selection matters immensely. TA1 should be considered in complex cases where conventional approaches have been insufficient, such as chronic viral infections not responding adequately

Dr. Deb Muth 14:21
to standard antivirals, post-viral syndromes with evidence of immune dysfunction, cancer patients with immune suppression in consultation with oncology, and it should generally be avoided in active autoimmune disease unless there’s a compelling rationale and close monitoring. Now, TA1 is not a standalone therapy. In cases of chronic viral infection, Comprehensive immune support includes addressing nutritional deficiencies, optimizing vitamin D levels to be between 50 and 80, adequate zinc, selenium, and vitamin A, optimizing gut health since 80% of our immune function is in the gut, you need to optimize gut function. Managing stress from the HPA access dysfunction, chronic cortisol elevation, suppression, and immunity, ensuring adequate sleep, immune memory consolidations during sleep, addressing any metabolic dysfunction, insulin resistance, repairs in the immune function, and the bottom line on thymus and alpha-1 is

Dr. Deb Muth 15:26
is that it represents legitimate medicine in other countries with a substantial evidence base in specific contexts, but it remains experimental in the U.S., and practitioners using it should provide comprehensive, informed consent about its regulatory status, evidence quality, and source verification. while ensuring it’s part of comprehensive protocols. It is not a magic bullet. And again, what you’re gonna hear me say quite often here is that many of these peptides should be used in conjunction with something else. They should not be used alone. And can peptides be stacked? The answer is yes, they can. So if somebody has an insulin resistance, or a metabolic dysfunction, they can tier TA1 with a GLP-1 like terzepatide or semiglutide. That is not a problem to do that. You need to just work with a practitioner that understands how to do that effectively. So let’s look at BPC-157.

Dr. Deb Muth 16:26
This is a phenomenon I love BPC-157. Let’s separate it from marketing to actual mechanism of actions here. So BPC-157 stands for Body Protection Compound 157. It is a chain of 15 amino acids that are described as a partial sequence of body protection compound, a protein found in human gastric juice. It has become one of the most hyped peptides in regenerative medicine inside the athletic performance and biohacking communities with claims ranging from healing tendons and ligaments to repairing gut lining or reversing organ damage. The challenge is separating the legitimate mechanisms of science from the marketing hype. The proposed mechanism of BPC-157 are biologically plausible and intriguing. The research suggests that it may influence several growth factor pathways, including vascular endothelial growth factor, VEGF, which promotes new blood vessel formation and has improved better supply of blood flow to injured tissues, theoretically accelerating healing.

Dr. Deb Muth 17:40
It may also affect fibrous blast growth factor, FGF, and transforming growth factor beta, TGF beta pathways. both involved in tissue repair and remodeling. And some studies actually suggest that BPC-157 modulates inflammatory cascades, potentially reducing excessive inflammation while promoting the resolution phase that allows tissue rebuilding. Now I want to talk just a few moments here about these different tests that we’re talking about tgf beta veg f for those of you who are in our mold world you are very familiar with these uh lab tests we do this to see if you have a mold exposure what’s happening to your body and it’s been very challenging to try to heal this part of the mold illness and manipulate these VEGFs and TGF betas. And so with the fact that BPC helps us modulate this inflammatory cascade, BPC can be very helpful in the world of mold or mycotoxin illness in repairing those parts of the body that have been damaged by the mycotoxins.

Dr. Deb Muth 18:48
Now there is animal research on BPC-157. It is extensive and primarily from a research group led by pre-drag, oh, I can never say these names, Cyrek at the University of Zagreb in Croatia. Published studies in animal models have shown accelerated healing in a remarkable variety of injury types. A 2011 paper by Chang and colleagues in the Journal of Applied Physiology demonstrated that BPC-157 improved therapy tendon healing in rats with Achilles tendon injuries, and the treated rats showed increased tendon outgrowth, better cell survival in the injured area, enhanced cell migration to the injury site, and improved biochemical strength of the healed tendon compared to controls. Multiple other animal studies have shown similar promising effects. Ligament tears, healing faster in rabbits, muscle damage recovering more quickly in rodent models, gastric ulcers healing in rats given experimental induced ulcerations, inflammatory bowel lesions improving in mouse models of colitis, and even bone to tendon healing showing enhancement in animal studies.

Dr. Deb Muth 20:02
The breadth of injury types showing benefit in preclinical models explains the enthusiasm of this peptide. However, this is critical. These animal studies, primarily in rodents and rabbits, animal models of injury healing don’t reliably translate to human clinical outcomes. And the doses used in these animal studies when converted to human equivalent doses vary widely. And optimal human dosing is completely unknown at this point. it is all considered experimental and perhaps most importantly there are essentially no peer-reviewed controlled clinical trials in human published in humans published in major medical journals in a 2001 review of arthroscopy and the journal of arthroscopic and related surgery specifically examined in the evidence of bpc 157 and other peptides in musculoskeletal medicine The authors concluded bluntly that BPC-157 lacks evidence from randomized controlled trials and has an unknown safety profile in humans.

Dr. Deb Muth 21:09 
They emphasized that the jump from animal data to recommending peptides for humans use bypasses the fundamental requirement for Phase I safety studies, Phase II dose-finding studies, and Phase III efficacy trials that would establish whether BPC-157 actually works in humans and whether or not it’s safe. The absence of human safety data is particularly concerning given BPC-157’s proposed mechanisms. Peptides that influence growth factor signaling and angiogenesis could theoretically have off-target effects. Uncontrolled angiogenesis, for instance, is a hallmark of cancer progression. Tumors require blood vessel formation to grow beyond a certain size. And while there’s no evidence that BPC 157 promotes cancer, The complete absence of long term human safety studies means we simply don’t know. This isn’t fear mongering. It’s acknowledging uncertainty and uncertainty exists and understanding that if you’re choosing to use peptides like BPC 157, you are doing it in an experimental model.

Dr. Deb Muth 22:17
We’re experimenting with the doses that are being used. And there is potential for it to cause cancer cells in your body to grow. And you need to be aware of this and understand the risks that you’re taking when you’re using an investigational or off label use peptide. Now, quality control issues with BPC also exist. It’s not FDA approved for any indication in the US. It’s not approved in any major regulatory jurisdiction worldwide. It’s marketed as a research chemical explicitly to bypass FDA oversight. And commercial sources selling BPC-157 range from compounding pharmacies, which have some quality standards but are not FDA inspected. You can take that for what you want to believe on that one. to overseas suppliers operating with absolutely no quality assurance whatsoever. If you are choosing to use BPC-157, you have to understand who’s manufacturing it for you, where you are getting it from, how pure it is.

Dr. Deb Muth 23:26
You want to make sure that you have the certificate of analysis and that it does not contain bacterial endotoxins that can contaminate the peptide or degrade the peptide and cause other issues for you. So when you talk about peptides with patients regarding BPC-157 or if you’re listening to this and you’re already using BPC-157 or other peptides, that are quote-unquote not for human consumption, an evidence-based response acknowledges both the appeal and the limitations. And you want to talk about the animal data that’s definitely showing some progress and some potential, but we don’t know what we don’t know in humans. If people are willing to take that risk, that is up to them to do that. But using BPC right now is experimental and people need to be aware of that. Are there evidence-based alternatives for patients with tendon or ligament injuries?

Dr. Deb Muth 24:26
And there are. There’s PRP, which has been studied in multiple randomized controlled trials. for conditions like lateral epicondylitis, tennis elbow, Achilles issues, patellar issues, knee issues. However, I want to caution you on this too. So the study that was done by Cox and colleagues in muscles, ligaments, and tendons in the Journal of 2014 showed modest benefits in pain and function compared to controls. And though the effects vary by injury type, PRP preparations can be helpful. You have to understand that a lot of times when people are doing PRP injections in their office, they are not doing it exactly the same way it was done in the study. And not to mention, if you’re using your own PRP to heal a ligament or a tendon or help your arthritis and you’re 60 or 70 years old, That is not good quality protein rich plasma. It is old protein rich plasma. And you’re not going to see necessarily the same benefits that you would see if you were using placental tissue or umbilical tissue.

Dr. Deb Muth 25:33
You also want to address the nutritional deficiencies or support that’s needed for connective tissue healing. And these are collagen peptides dosed at 15 grams a day. And this has been shown in a study by Shaw and colleagues in the American Journal of Clinical Nutrition in 2017 to augment collagen synthesis when combined with intermittent loading. Vitamin C is also an essential cofactor for collagen production and stabilization of collagen structure at a dose of around 500 to 1000 milligrams a day to support this process. You also need to have good adequate intake of copper and zinc. These are cofactors in collagen. Silica is also important. This comes from horsetail extract. This provides additional support as well. So more importantly, I think remembering that rehabilitation matters as well. Doing these protocols without doing some rehab is not going to get you where you want to go.

Dr. Deb Muth 26:33
There’s a research study by Alfredson and others for Achilles tendinopathy using the control lengthening of muscle tendon units under load to promote tendon remodeling and healing. These protocols have solid evidence and cost nothing beyond professional guidance from a physical therapist. They are important for patients seeking cutting edge regenerative approaches. Stem cell therapies, growth factors, concentrates derived from patients’ own tissues like PRP. These have a lot of good endogenous materials and they have good safety profiles. BPC-157 represents the perfect example of how promising Preclinical science gets marketed far beyond the evidence and it may eventually prove to be valuable. I think it will. But right now that determination does require some human studies and hopefully with the administration that we have right now and Bobby Kennedy, we will actually start to see some of that occur. Now the next peptide I want to talk about is TB4, thymus and beta-4.

Dr. Deb Muth 27:36
This is a wound healing peptide. It is a 43 amino acid peptide that’s naturally present in virtually all human cells except red blood cells. It’s actually one of the most abundant peptides in the human body, particularly concentrated in blood platelets, wound fluid, and many tissues. It’s naturally ubiquity makes it mechanistically interesting. The body wouldn’t produce it in such abundance if it didn’t serve a function. So the primary role of TB4 involves building G-actin. It’s a form of monomeric actin. And it’s structural protein that forms the microfilaments within the cells, providing cellular structure and enabling cell movement. TB4 prevents from F-actin filaments. I’m not going to talk too much about this. It’s really critical for wound healing as cells need to migrate into the injury sites.

Dr. Deb Muth 28:37
so the cell shape changes and the cellular response to the injury. So think of this as though you tore your meniscus and the body created all this TB4 to come to that injury to try to heal that site. That’s exactly what the TB4 is doing inside the body when there’s an injury. It’s been shown in research to help produce new blood vessel formation, promote endothelial cells, It helps modulate inflammatory cytokines, potentially reducing TNF-alpha, IL-1, and possibly protecting in programmed cell death, which we call apoptosis. And some studies suggest that it is cardioprotective in its effects in animal models of myocardial infarction, so heart attack, and neuroprotective in other models for brain injury. Now, these remain to be preliminary, but they are being seen. So the regulatory status on TB4 can create some confusion.

Dr. Deb Muth 29:40
The natural TB4 molecule itself is not FDA approved as a drug. However, TB4 based drug candidates called RGN259, formerly TB4, has been in the development by regen tree for corneal injuries of the dry eye disease. And as of recent updates, this drug is completed phase three trials for its neurotrophic keratopathy, severe corneal condition. But the FDA approval is still pending. So that means that the most advanced TB4-based pharmaceuticals hasn’t yet crossed the finish line for approval. The commercial peptide market further muddies the picture with TB500, which is often described as the synthetic fragment of TB4. However, this extract’s relationship between TB500 and TB4 varies depending on the source.

Dr. Deb Muth 30:41
So some claim that TB500 is identical to TB4, but positions 1 through 4 suggest it’s a different fragment. and the quality control across suppliers is not existent. So this confusion is part of why recommending TB500 becomes problematic for practitioners and patients, often because they aren’t certain what molecule they’re actually getting. The evidence base for TB4 in humans is limited, primarily to eye research, and the studies from Sohn’s and colleagues published in journals like Vitamins and Hormones in 2016 have examined topical TB4 for corneal injuries and neurotrophic keratopathy, dry eye, and other surface diseases. Now, these studies showed some promise in promoting this, and there is, however, a topical application to the cornea that is vastly different from a systemic injection. So for systemic use in wound healing, musculoskeletal issues,

Dr. Deb Muth 31:42
cardiac protection, neuroprotection, human clinical trials. There is scarce to non-existent evidence in humans. Most of the evidence remains in animal models or cell culture studies. And a review by Flip and colleagues in the Journal of Investigational Dermatology in 2006 detailed TB4’s effects on the matrix remodeling during wound repair in animal models, showing effects on collagen disposition, granulation, tissue reformation, and wound contraction. Another review by Ho and colleagues in expert opinion on biological therapy in 2007 discussed TB4’s potential in tissue regeneration and regenerative medicine, but noted the field remained largely blank. preclinical. So this is really important again to understand that there is just not enough human data. So there is a concern with cell division and migration. This theoretically exists

Dr. Deb Muth 32:45
for the potential effects on cancer cells, which would also rely on migration and division and other intended consequences of disrupting normal cellular architecture. These aren’t proven risks, but they are unexplored questions that we need to be aware of when we’re using peptides. This can cause cancerous tissue to grow. Very similar to what we talked about with BPC-157. These are also sold as research chemicals. There is no FDA oversight. So purity, potency, contaminations all still exist for these peptides. Now from an integrative perspective, the natural presence of TB4 in wound fluid and its biological roles in healing are legitimate science. in presence does not equal therapeutic utility. The body tightly regulates where and when and how much TB4 is present through natural production and bypassing that regulation with external dosing may or may not cause us to have beneficial or introduce risk.

Dr. Deb Muth 33:49
So we need to know that this is experimental use. Those people who are seeking wound healing and tissue repair the evidence-based approach of the body’s own capacity to heal is huge definitely want to be increasing your protein intake optimizing your zinc copper vitamin c and vitamin a and then managing glucose is really important during this time as well so let’s talk about a fun topic now and that’s growth hormone secretagogues this is the anti-aging hype machine these peptides in this category are things like semoralin ipameralin cjc 1220 1295 and others and among the most aggressively marketed in anti-aging and longevity medicine they all share a common goal stimulating the pituitary gland to release more growth hormone and the appeal is understandable. GH levels decline with age, and this decline is associated with increased fat mass, decreased lean muscle, reduced bone density, and other aspects of aging.

Dr. Deb Muth 34:55
The other times we’ll see growth hormone levels decline significantly is with chronic illness, and the logic is to restore youthful GH levels and youthful physiology. Now, semirelin from an FDA approved diagnostic to compound anti-aging product. Semirelin is a 29 amino acid peptide representing the first 29 amino acids of the full 44 amino acid human growth releasing hormone, GHRH. We talked about this on another episode of the podcast. And you can go back and listen to that one a little bit if you want. This fragment contains the complete biological activity of the full GHRH molecule and it binds to GHRH receptors in the anterior pituitary and stimulates growth releasing peptides, growth hormone releasing peptides. Semirelin was previously FDA approved as diagnostic testing of growth hormone secretion, essentially, to determine if the pituitary could still respond to GHRH stimulation in patients being evaluated for growth hormone deficiency.

Dr. Deb Muth 36:06
However, the manufacturer was discontinued and there was no longer an FDA approved semirelin product on the market in the United States. What exists now is semirelin available from compounding pharmacies used off label for anti-aging, body composition, and general growth hormone optimization purposes. This represents a significant gray area. Again, compounding medications serve a very important role, but they need to meet certain recommendations and regulations, as we’ve talked about in the past. You want to make sure that your compounding pharmacy that you’re obtaining semirelin from is qualified to do that, that they are doing best practices, and that you’re getting a good product. The theoretical advantage to semirelin over direct growth hormone administration is that it preserves more of the physiological growth hormone secretion patterns. Natural GH is released in pulses, primarily during sleep, not as a continuous elevation.

Dr. Deb Muth 37:07
So semirelin stimulates the pulses rather than providing a constant super physiological growth hormone level. And that pulsatile pattern is thought to reduce some of the side effects and metabolic concerns that we have with continuous growth hormone exposure. However, the evidence supporting semirelin for anti-aging and body composition in healthy adults is minimal. Most of the data comes from studies conducted in the 1990s when the FDA approved product existed. Not that that means it’s bad. We have drugs that have been in the market for over a hundred years that are still there, that still have the research and are still being used successfully and safely today. So we don’t want to let that really make us think that this product isn’t safe. So a 2006 review from Walker in Clinical Interventions of Aging suggested that semirelin might be a better approach than direct GH for adult onset growth hormone insufficiency, but they do acknowledge that the evidence was limited.

Dr. Deb Muth 38:12
And although we don’t have any large scale trials that we can examine for semirelin’s efficacy, it is now commonly prescribed. And the optimal dosing for anti-aging purposes is still unknown. It is considered experimental and it does vary from person to person, but it is still unstudied. The effects on cancer risk, cardiovascular disease, metabolic dysfunction over long time periods are also still unknown. I would argue that the side effects or the risk factors of not having growth hormone are equally as bad as the unknowns that we have here. We’re not looking to try to get super physiological doses. We’re trying to restore youthful GH levels. Typically, we’re not trying to restore back to a 20-year-old. We’re trying to restore back maybe 10 years. That is a better way of doing this. And I think that’s important for people to understand. Now, ipamirelin is the ghrelin mimicker.

Dr. Deb Muth 39:12
Ipamirelin is a pent-up peptide, five amino acid, that acts as a growth hormone secretagogue receptor, a GHS-R agonist. It mimics the action of ghrelin, the hunger hormone, that also stimulates growth hormone release. The proposed advantage over earlier secretagogues is that ipamirelin stimulates growth hormone release without significantly affecting cortisol, prolactin, or other glucose things, which can be increased by growth hormone secretagogues. The regulatory status is clear. Ipamirelin is not FDA approved for any indication. It’s sold as a research chemical. Human evidence is thin. It’s limited to single dose studies examining how quickly it’s absorbed and metabolized with minimal data on dosing and clinical outcomes. Now there are marketing claims for ipamirelin and they are extensive.

Dr. Deb Muth 40:13
It increases lean muscle mass, it decreases body fat, it improves sleep quality, faster recovery from workouts, enhanced injury healing, better skin quality. The evidence supporting these claims in humans is not available we don’t have it these are claims that are made by the effects that we know from growth hormone so it’s not necessarily a bad thing we know what growth hormone does we know growth hormone does all of these things if ipamorelin is a precursor to that it will obviously help improve those things making that correlation of what growth hormone does So there are safety concerns that mirror the same as any other growth hormone elevating therapy. It can cause fluid retention, joint pain, carpal tunnel syndrome, insulin resistance, glucose intolerance, and theoretically, can it increase calcium? cancer risks? It can because IGF-1 promotes cell proliferation and can inhibit apoptosis in cancer cells. Now remember, your body makes IGF-1.

Dr. Deb Muth 41:15
If it’s not making enough of it, that’s a problem. If it’s making too much of it, That’s a problem. So just understand that if you are adding these things, and especially in elevated doses, you are taking a potential risk. So there is also now CJC 1295 is a modified GHRH analog of 30 amino acid peptide based on GHRH structure, but with modifications. So it includes the addition of drug affinity complex, DACC, DAC, which involves conjugation with a small albumin binding molecule, dramatically extends the peptide’s half-life from minutes to as much as potentially a week or more. And this creates sustained growth hormone elevation rather than that pulsatile release. There are actually two versions of this. There’s CJC 1295 with DAC, longer acting version, and CJC 1295 without DAC, which is essentially a shorter duration of semirelin.

Dr. Deb Muth 42:19
And so when we’re comparing products, it is… only the difference between long acting and short acting. The human evidence for CJC 1295 is limited to a single published phase one study by Techman and colleagues in the Journal of Clinical Nutrition and Metabolism in 2006. And the study involves 18 healthy young adults showed that CJC 1295 with DAC produced a sustained elevation of GH and IGF-1 lasting several days after the injection. That’s essentially the entire published human evidence of this peptide. There are no phase two studies examining optimal dose. So that is all considered experimental. And there is no phase three studies examining clinical efficacy. So the sustained GH levels created by CJC 1295 with DAC raises specific concerns because the natural GH secretion It goes up and down, up and down, up and down.

Dr. Deb Muth 43:19
And that constant elevation may have a different metabolic and cellular effect. And we just really don’t know what that’s going to be yet. So we can understand that elevated IGF-1 levels can theoretically increase cancer concerns and metabolic risks. So rather than always injecting peptides, which are very expensive… You can do other things. And there was a study by Hartman and colleagues in the Journal of Clinical Endocrinology and Metabolism in 1992 that demonstrated the 48-hour fast increased integrated growth hormone secretion five-fold through increased GH levels. Now, the problem with this is fasting for 48 hours is a challenge. And how long is it going to increase the growth hormone secretion without causing issues? Or in general, how long is it going to go up?

Dr. Deb Muth 44:19
So we have to be cautious about that as well. Sleep optimization is non-negotiable. The majority of growth hormone secretion occurs during sleep, slow wave sleep, typically the first sleep cycle, and poor sleep quality or insufficient sleep typically. can dramatically affect your growth hormone levels. And then high intensity interval training, HIIT resistance training can stimulate growth hormone as well. This was seen in a study by Godfrey and colleagues in sports medicine in 2003 and was examined in exercise-induced growth hormone responses to athletes. So we definitely see these kinds of things. So let’s talk about some longevity peptides now. These expand the telomere. So there’s epitalin and epithalamin and when these are used in anti-aging they can produce some amazing results.

Dr. Deb Muth 45:22
So epitalin is a synthetic terapeptide, just four amino acids. It was originally synthesized as a simplified version of epithalamine. a pineal gland extract containing multiple peptides. The synthetic four amino acid version was created to isolate what researchers believed might be the active anti-aging component. The mechanism produced for epitalin centers on telomere and telomerase, Telomeres are protective caps at the end of the chromosomes consisting of repetitive DNA sequencing. And every time a cell divides, telomeres shorten slightly because DNA polymers cannot fully replicate the ends of the linear chromosomes. So this progressive shortening acts as a molecular clock. After 50 or 70 divisions, the telomeres become critically short, triggering a cellular senescence.

Dr. Deb Muth 46:22
This telomere shortening is one mechanism of cellular aging and telomeres in the enzyme that can rebuild telomeres by adding these caps back onto the end of the chromosome. It’s active in stem cells, germ cells, and unfortunately in about 85 to 90% of the cancer cells. In most adult somatic cells, telomerase is inactive or present at very low levels, allowing the telomeres to shorten with division. The research on epitalin suggests it might activate this telomeres act telomeres process primarily from a research group led by Vladimir in Russia. Vladimir Kavasan in Russia. He is a huge peptide researcher or was he passed away with publications dating back to the early 2000s and a study published in bio gerontology in 2000 by Kavasan

Dr. Deb Muth 47:25
and colleagues examined the effect of epitalin on the lifespan of fruit flies, and they treated fruit flies that showed a modest increase in mean and maximum lifespan compared to its controls by approximately 10 to 15% lifespan extension in some experimental groups. And there were other studies in 2003 that examined epitalamine in a female Swiss-derived mouse. This was done by Ann Simove and colleagues. And the researchers reported that epitalin treatment was associated with increased lifespan as well. And the most cited mechanistic work comes from cell culture studies. And that is also Cavason’s group that published this research in 2003, showing increased telomeres activity in cultured somatic cells again. More recently, between 20 and 25, the series of publications have continued to explore epithelial effects on telomere dynamics in cell cultures.

Dr. Deb Muth 48:32
So there is a lot of research that’s been done. The mass majority has been done on epithelin. And most of it has been done by a single research group in Russia. There is some restrictions on some of the cell culture data that we’re seeing. And it does show that epithelin sometimes can be described as a regulating hormone. Carcadian rhythm for melatonin production, which is derived by the penile extracts. And however the evidence for this affects minimally and mechanistically unclear, the pineal gland primarily functions as melatonin secretion in that light-dark cycles. So Epithalin or epitalin is not FDA approved. It is not approved for any major regulatory jurisdiction. It is sold as a research chemical only.

Dr. Deb Muth 49:33
So you need to follow the same safety profiles that we’ve talked about in other episodes and in today’s episodes. And when we’re talking about epithalin, and we’re excited about it being an anti-aging science, we should balance this with the honesty and the evidence of the quality of that evidence. We don’t know its safety effect. We don’t know if it’s going to increase the risk of cancer. We can’t verify that. And we need to be using it in an experimental use of unknown risks only. Of course, diet, physical activity, stress management, sleep quality, all of those things are important for us to be looking at when we’re looking at these peptides. Now, I want to get into some of the brain peptides. This is the nootrophic frontier. C-Max and C-Lank, there is Russian pharmacology that’s done. C-Max and C-Lank represent an interesting case study in how different regulatory environments and research traditions

Dr. Deb Muth 50:36
create challenges in evaluating this evidence. Both peptides were developed in Russia, are approved for their specific indications and have substantial Russian language and literature supporting their use. However, the FDA approval in the United States is still not there. C-Max is a seven amino acid. It’s a synthetic analog. It is a fragment, particularly ACTH 4 through 10. It’s sometimes called the melanocortin effects because it involves the melanocortin receptors of the central nervous system. CMAX was developed by the Institute of Molecular Genetics of Russia Academy of Sciences and is approved in Russia for several indications, including acute stroke, transient ischemic attacks, cognitive disorders. It has Russian approval and is based on clinical trials primarily in Russia.

Dr. Deb Muth 51:39
It does help to increase brain-derived neurotrophic factor, BDNF, a protein critical for neuroplasticity, the brain’s ability to form new connections and adapt to the challenges. BDNF supports neuronal survival and promotes growth of these new neurons. C-Max also influences neurotransmitter systems, particularly dopamine and serotonin, and there is some research that suggests it affects on metabolism as well, and endogenous opioid peptides that involve pain reception and mood regulation. So it has some good potentials there. There is also C-Link, which is a hepatopeptide structurally similar to Tufts’ and an immune modulatory peptide. It was also developed in Russia and was approved for anxiety disorders as a neurotropic. Its effects involve anxiolytic effects, possibly through the GABAnergic system or the GABA system of the brain, and immune modulation.

Dr. Deb Muth 52:44
The Russian research is examined by C-Link for anxiety disorders. and finding reductions in anxiety without sedation. There is a dependency potential or cognitive impairment does not exist like it does with benzodiazepines with C-Link. So that is really good. And they do report attention and memory improvement using C-Link. There is a study that was done in neuroscience and behavioral psychology in 2018 that examined C-Linx effects and proposed that it exerts cytoprotective effects through BDNF pathways similar to C-Max. So both of these are Russian research-based They’re not wrong or fraudulent. It’s just that they are from Russia and we all have our concerns with Russia. However, that does not necessarily mean their research doesn’t hold quality.

Dr. Deb Muth 53:49
Neither peptide is approved by the FDA, and so you are using this off-label. The same rules apply for all of the other peptides that we’ve talked about that are produced off label. You want to do the same things that you would do with anything else. Good protein, omegas, B vitamins, acetylcarnitine, exercise, sleep, all of that still applies when we’re using these peptides. So I want to talk briefly about clinical decision and framework when we’re looking at this. First and foremost, we always want to go to FDA-approved peptides. Secondly, we would look at international approval with peptides that are established in other countries but lack FDA approval. And then preclinical evidence only or experimental peptides. These can be used, but they are not ethically recommended in the traditional medicine world.

Dr. Deb Muth 54:50

If patients use them, we need to have appropriate counseling about the evidence surrounding them, the safety, and where to find them. how to find them and how to ask for these certificates of analysis. So I think it’s really good that we were exploring all these peptides and understanding what they are. There’s a lot of controversy out there. There’s a lot of concern out there. And what we can say with confidence is that peptides are powerful biological signaling molecules. Some peptide based medications, semi-glutide, triseptide, PT 141, Lupron that are all FDA approved. can dramatically improve outcomes in patients that are obviously selected for the correct ones. There are many other peptides that we address that are integrative and longevity space in the regenerative medicine. These peptides are all experimental. That does not automatically make them wrong.

Dr. Deb Muth 55:50
It just means that we need to be honest about what we’re doing with them and we need to be cautious with the patients so that they can make a decision to be part of an experimental study. in looking at how to use these peptides. So peptides are tools like any other tools. They work best in the hands of skilled people, and they are applied to appropriate situations, integrating into comprehensive approaches that address root causes. The most powerful peptide administered to a patient with untreated inflammation, hormonal chaos, nutritional deficiencies, and disorders of sleep will disappoint. The simplest evidence-based interventions apply. to a patient whose foundational physiology has been optimized. And this is the art of the science of peptide, right? If done right, respecting both the power of these molecules and the complexity of human beings that we are privileged to serve can make a difference in their lives. So thank you for listening to this episode.

Dr. Deb Muth 56:52
I hope this was helpful. If you can know of somebody that might benefit from this, please like, share, and subscribe. It means a lot to us. And I hope you join us for our next episode of Let’s Talk Wellness Now. Welcome to Let’s Talk Wellness Now, where we bring expert insights directly to you. Please note that the views and information shared by our guests are their own and do not necessarily reflect those of Let’s Talk Wellness Now, its management, or our partners. Each affiliate, sponsor, and partner is an independent entity with its own perspectives. Today’s content is provided for informational and educational purposes only and should not be considered specific advice, whether financial, medical, or legal. While we strive to present accurate and useful information, we cannot guarantee its completeness or relevance to your unique circumstances. We encourage you to consult with a qualified professional to address your individual needs.

Dr. Deb Muth 57:54
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The post Episode 258 – Investigational Peptides: What’s Promising, What’s Hype & What You Must Know first appeared on Let's Talk Wellness Now.

Dr. Deb Muth 00:03

Well, welcome back to Let's Talk Wellness Now. I am your host, Dr. Deb. And what is the most talked about peptides in functional medicine? aren't actually FDA approved. Not because they don't work, but because no one's funded the research to prove it yet. The truth is some of the compounds that dominate wellness forums, BPC-157, TB-500, thymosin beta-4, epitalin occupy a fascinating space between breakthrough science and unregulated experimentation. In today's episode, we're stepping into that gray zone, the world of investigational peptides to separate mechanism from marketing. I'm going to walk you through the science that actually actually shows and where it stops, how to evaluate claims when human data don't yet exist and the quality, purity and safety red flags that you need to recognize. I created in a previous episode,

Dr. Deb Muth 01:06

so go check that one out. And why honesty is the most important prescription in peptide medicine. If you've ever wondered whether these research-only peptides are the frontier of healing or the next functional medicine fad, this episode is for you. So grab your cup of tea or coffee, get comfortable, and let's talk about what it really means to use peptides that are promising, but still under investigation. So we're going to break just for a second here and have a word from our sponsor. It is because of them that we stay on the air. So thank you for this. And we will be right back. Did you know sweating can literally heal your cells? Infrared saunas don't just relax you. They detox your body, balance hormones and boost mitochondrial energy. I'm obsessed with my Health Tech sauna. And right now, you can save $500 with my code at healthtechhealth.com slash dr-muth-req-25.

Dr. Deb Muth 02:15

All right, guys, welcome back. Let's dive into investigational peptides, the evidence gap. So the following peptides we're about ready to discuss are extensively in integrative, functional and regenerative medicine circles. They may have intriguing mechanisms and promising preclinical data. However, they lack FDA approval and the evidence quality varies dramatically. from interesting preliminary research to essentially no human data at all. And this distinction is really critical for maintaining scientific integrity. So let's talk about immune-modulating peptides. There's thymus and alpha-1, and this is an international story on the thymic peptides. Thymusin alpha-1, known as TA1, is marketed internationally as zidaxin.

Dr. Deb Muth 03:16

It's a 28 amino acid polypeptide originally isolated from thymusin fraction 5, which was extracted from bovine thymusin tissue. Modern production uses synthetic peptide synthesis. The thymus gland is located behind the sternum and is the primary site for T cell maturation and thymic peptides like TA1 play roles in the human system development and regulation. Now, I love thymus peptides. I love thymus glandular products. I've used thymus glandular products for decades. Ground up animal thymus gland is basically what it is. There's a couple of different supplement companies that I've used over the years that are amazing with this. and they do a fantastic job and they really do help to support the immune system. So when thymus peptides came out, it was really exciting because it took the whole idea of thymus support to a new level.

Dr. Deb Muth 04:17

The mechanism actually behind the thymus in alpha-1 is complex and involves multiple aspects of immune function. At the cellular level, TA1 enhances T cell maturation and differentiation, particularly the development of helper T cells and cytotoxic T cells. It modulates T cell receptor expression and can influence the balance between Th1 cell-mediated immunity and Th2 humoral immunity responses. And it also enhances the natural killer cell activity and modulates dendritic cell function, which are critical for antigen presentation. and initiation of adaptive immune responses. And on the cytokine level, TA1 influences production of interleukin-2, IL-2, interferon gamma, IFN-Y, and interleukin-10, IL-10.

Dr. Deb Muth 05:19

These create immune modulatory rather than simple immune stimulatory effects. This is a very important distinction because TA1 appears to help balance the immune system rather than simply ramping this up which theoretically makes it safer in conditions where immune overstimulation would be a problem, such as an autoimmune disease. Hashimoto's, autoimmune, lupus, Sjogren's, any of those autoimmune diseases, we don't want to overstimulate their immune system. So you want to use a product like this that's non-stimulating. Now, the regulatory status on TA1 is geographically variable and represents one of the challenges in discussing this peptide with patients. It is not FDA approved in the United States. However, it is approved in several other countries for specific conditions.

Dr. Deb Muth 06:19

In Italy, it's approved for treatment of chronic hepatitis B and hepatitis C. In China, it's approved for chronic hepatitis B and adjunct immune compromised patients receiving vaccinations or suffering from certain infections. It has orphan drug designation in the United States for certain cancer indications, but its designation does not constitute approval. It simply provides regulatory incentives for further development. So the evidence base for thymosin alpha-1 is substantial in some areas but comes primarily from non-US populations and research groups, which creates challenges in evaluating quality and generalizable information. So in hepatitis B and C, multiple clinical trials, many conducted in China and Italy, have examined TA1 as an adjunct to antiviral therapy.

Dr. Deb Muth 07:21

A meta-analysis by Wu and colleagues published in the Journal of Viral Hepatitis in 2013 examined 23 randomized controlled trials, including over 2,000 patients with chronic hepatitis B. The analysis found that combining TA1 with nucleoside analogs like LAMVDUDE or an and TCAVAR improved the hepatitis antigen seroconversion rates by HBV DNA clearance compared to its nucleoside analogs alone. And the effect sizes were modest but statistically significant with the HBE-AG seroconversion rates improving from about 24% with antivirals alone to 38% in combined therapy. Now in hepatitis C, early trials before the development of direct acting antivirals showed that TA1 combined with interferon alpha improved sustained virology responses and compared to interferon alpha,

Dr. Deb Muth 08:30

furon alone, particularly in difficult to treat populations like those with a genotype one or a high viral load. However, the advent of highly effective direct acting antivirals that achieve SRV rates, sorry, SVR rates exceeding 95%, the role of TA1 in hepatitis C has become less clear. Now in sepsis and critical illness, More recent interest has focused on TA1 in severe cases of sepsis and septic shock. Ren and colleagues published a systemic review and meta-analysis in the Frontiers of Immunology in 2022, analyzing 18 randomized controlled trials, including 1787 patients with severe sepsis or septic shock the pooled analysis showed that ta1 administration was associated with reduced 28-day mortality relative risk at 0.70 meaning a 30 reduction in mortality compared to the standard care alone and the effect appeared

Dr. Deb Muth 09:39

most pronounced in patients with sepsis-induced immunosuppression measured by HLA-DR expression in monocytes. Now, this is amazing because going forward, we're going to talk about something that's commonly known as cytokine storm. Now, cytokine storm really became apparent since 2020 with the viral infection that we're dealing with in the world today. But they were already looking at this kind of cytokine storm produced by sepsis or sepsis-induced immunosuppression. And it triggered this hyperinflammatory response called the cytokine storm. And many patients who survived the initial phase of the immune suppressed stata, characterized by a T cell exhaustion, reduced antigen presentation, and increased susceptibility to secondary infections. Thymusin alpha-1, TA1, may help restore this immune competence in this phase. However, it's important to note that patient selection and timing are critical.

Dr. Deb Muth 10:43

Giving this immune stimulant during a hyperinflammatory phase could theoretically worsen outcomes. So you don't want to give it to them while they're in the flare up or the sepsis or the infection, but given to them during the immunosuppression phase afterwards might be beneficial. Now there is also some cancer immunotherapy that we see with TA1 and has been studied as an adjunct in cancer treatment with the hypothesis that it could enhance immune surveillance and response to tumors. And a comprehensive review of Garci and colleagues published in Expert Opinion on Biological Therapy in 2007 examined multiple trials in melanoma, lung cancer, hepatocellular carcinoma, and other malignancies. And the results were mixed. Some trials showed improvement in the immune parameters, increased CD4 in T-cells. improved lymphocyte proliferation responses and some actually showed trends toward improved progression free survival but overall survival benefits were inconsistent and the heterogeneity of the cancer types treatment protocols and outcome measures makes a definitive conclusion difficult as a vaccine adjunct several studies particularly from china have examined ta1 as an adjunct to enhance vaccine responses

Dr. Deb Muth 12:11

in immune-compromised populations, including the elderly, dialysis patients, and transplant recipients. The rationale is sound. These populations often mount suboptimal antibody responses to vaccines, and TA1's immune-enhanci...

Dr. Deb Muth

0:00

Welcome back to Let's Talk Wellness Now. I'm your host, Dr. Zab, and we are continuing our discussion this week on

0:08

peptides. And so, if you haven't heard our first conversation about peptides,

0:13

please go back and look at that episode. We talk all about the manufacturing, the safety, the quality of peptides, and we

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dove into GLP1s. And today we're going to dive into peptides for sexual

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wellness, immune function, growth hormone, and all the amazing fun things

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we can do with peptides. So, as usual, grab your cup of coffee or tea, settle

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in, and let's talk wellness now. And we're going to take a short pause from our sponsor. I know we've got to do

0:44

that, you guys. They're who keep us on the air. So, I'm going to pause for just a minute and be right back after this

0:50

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1:15

right, everybody. We are back. And are you ready? We are talking all things peptide and I am opening the show today

1:23

with sexual wellness. Yes, I'm going there, you guys. I am going there. You

1:29

know, this has really become a big issue for people um of all ages. It's not just

1:34

us older people. It's younger people, too. And there's a whole variety of reasons why we have sexual dysfunction.

1:42

And when we're talking about sexual dysfunction, we're not just talking about it doesn't work, right? Or I can't

1:48

reach orgasm. A lot of it is around desire and um the thought of it and

1:54

wanting to connect, wanting to be kinder to one another, wanting to be touching

2:00

one another. A lot of it resolves or revolves around that. And so there are some peptides that can help us and I'm

2:08

really excited to be able to talk about those today. So the first one is called PT-141.

2:14

This targets the brain not the periphery. Right? So for many women I

2:20

will always tell you sex starts between here. It is a brain thing for us. It is

2:26

not necessarily a physical thing. For guys that's a little different. It's very physical. For women it's all in our

2:32

brain. So tip for you men that are listening. You have to prime your woman's brain first if you want her to

2:38

have sex with you that night. You have to be nice to her. You have to bring her flowers. Do the dishes for her. Do

2:45

something kind. Bring her a cup of coffee or tea or a glass of wine. Take her to dinner. You have to woo her. And

2:51

I don't care how long you've been married. That has to happen. And tip number two, don't say anything stupid

2:57

that day. I'm just being honest. When you guys say things that make us upset,

3:03

that lingers with us for the rest of the day. And it's it's a turnoff for us. And

3:08

for a lot of women, we can't get past that when it comes time to snuggle at night. And sex doesn't always have to be

3:14

at night either. So, you can tell I really love talking about this conversation, but we're going to get into the peptide part of it because this

3:21

is going to help people. So, um, PT-141 is marketed as I'm going to slaughter

3:28

this name, Vali, and it represents a fundamentally different approach to

3:34

sexual dysfunction than the PDE5s inhibitors like Slenden, Viagra,

3:40

Tedataphil, which is Seialis. And while the PDE5 inhibitors work specifically by

3:47

enhancing blood flow to the genital tissues, PT-141 works centrally in the brain by

3:54

modulating neural s neural circuits involved in the sexual desire and

4:00

arousal. Now PT-41 is a cyclic hpatipeptide. It's seven amino acid

4:07

peptide arranged in a cyclic structure that acts as a melanoortin receptor

4:13

agonist and with particularly the infinity for MC3R and MC4R subtypes.

4:20

It's actually a metabolite of the melanotan 2, a peptide originally

4:26

developed for tanning that was also found to enhance sexual desire in early

4:31

studies. Now the melanoortin system in the brain is involved in multiple functions including energy homeostasis

4:39

but it also is involved in sexual motivation and arousal behaviors. The FDA approved PT-141 in 2019 specifically

4:48

for the treatment of acquired generalized hypoactive sexual desire

4:54

HSDD in permenopausal women. So for the first time we have a medication that was

5:01

approved by the FDA to use for women for sexual dysfunction. We have had all of

5:07

these seialis tedataphil viagros for men but we had nothing for women. And so

5:12

this is amazing that this is available for women and approved by the FDA. It's a big deal. This represents the first

5:19

and only FDA approved medication specifically targeting these circuits of sexual desire rather than the peripheral

5:27

arousal mechanisms. And this indication is quite specific, meaning it was developed at some point, not lifelong.

5:35

So I if you've had sexual dysfunction your entire life, this medication was

5:40

not approved for you. But if it's something that you developed over time, like when you went through pmenopause or

5:46

menopause or some women have this experience happen after childirth, that's what we're talking about here.

5:53

Now, it's also not just um supposed to be used if you dislike your partner,

5:59

right? If your relationship is bad and you dislike your partner, this probably isn't going to fix a ton. It might help

6:05

a little bit, but that's not what it's meant for. So, you really have to know what you're using it for and why. And

6:11

the other thing that I would say is this is something that we don't go to if your hormones are not balanced properly. You

6:17

have to balance your hormones properly before using something like this because it still may not work. Now, the only

6:24

caveat to that is if you're a woman that has a risk of breast cancer and can't use hormones, then that's a different

6:31

story and we would have that conversation about whether or not this medication would be appropriate for you. Now, the FDA label specifies PTA1 uh

6:39

PT-141 as it not being indicated for HSDD in causes where low sexual desire

6:46

is due to coexisting medical or psychiatric conditions, problems with relationships, like we had talked about,

6:53

side effects to medications or other substance use. This specifically reflects the importance of differential

6:59

diagnosis. Low sexual desire can have many root causes and PT-41 is only

7:05

appropriate when those causes have been ruled out. Now, I have I used PT41 in

7:10

people who have sexual dysfunction issues as a result of using

7:16

anti-depressants. Yes, I have. I've used Flynn in that effect as well. And it

7:21

does work sometimes, but it doesn't work completely. But you need to know that that is not what the approval is for the

7:27

FDA. So that is done in something that we call off label use. So very important

7:33

to know. Now in these clinical trials leading to FDA approval, this was published by Kinsburg and colleagues in

7:40

obstetrics and gyne gynecology in 2019. PT-141 demonstrated statistically

7:46

significant improvements in sexual desire and decreases in distress related

7:51

to low desire compared to placebo. The effects manifest over 45 minutes to

7:56

several hours after the injection and the mechanisms involved modulation of dopamine and melanoorton pathways in the

8:04

hypothalamus and the brain regions that involved sexual motivation. Now cardiovascular effects of PT 141 require

8:12

careful attention. This drug causes transient increases in blood pressure about 3 to four points and transient

8:20

decreases in heart rate. And because of this, it is contraindicated in patients

8:25

with uncontrolled hypertension or known cardiovascular disease. And it has been studied in patients who've had recent

8:32

cardiovascular events or sorry hasn't been studied hasn't been studied in patients who've had recent

8:39

cardiovascular events. So patients need to have their blood pressures checked before starting therapy. Nausea is

8:45

extremely common. It is one of the biggest things I often will tell people to take an anti-nausea medicine if

8:52

they're going to do this because the last thing you want to do is inject this medication and think it's going to give

8:57

you this great time with your partner and you're so nauseated that you can't even perform, don't want to kiss, don't

9:05

want to do anything. It it can be pretty profound for some people. um it does affect about 40% of the patients in

9:12

clinical trials which is why many clinicians require or recommend an

9:17

anti-nausea medication like I had just said other common adverse effects include flushing injection site

9:24

reactions headache in about 13% of the population whic

Dr. Deb Muth

What if the reason you’re not healing isn’t that you need another diagnosis?

0:08 It’s that your cells aren’t receiving the right signals. Because the body doesn’t run on diagnosis, it runs on

0:16 communication. And peptides are one of the most powerful, most misunderstood

0:21 tools we have for cellular signaling, immune balance, tissue repair, gut

0:27 lining support, metabolic control, brain signaling, sleep cycles, and even sexual

0:35 wellness. Today, I’m going to do what most people won’t. Define peptides in

0:41 plain English for you. break them into categories by what they’re best at and

0:47 tell you which ones are FDA approved on the list and which ones are commonly

0:53 used off label or investigational with the evidence that actually says these

1:00 work. This is going to be a powerful episode and if you’ve ever felt like you’re hearing hype without clarity,

1:07 this one’s for you. So, as usual, grab your cup of coffee or tea and settle in

1:13 as we talk about peptides that can fit into your healing journey. We’re going

1:19 to have a short word from our sponsor. You know, we got to do that. That’s how we stay on the air here. So, we will be

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1:54 All right, here we go, guys. I am excited to dive into peptides with you.

2:00 So understanding peptides is foundational, right? And I’ve been

2:06 studying peptides now for about nine years. Um, and I find that they are

2:13 incredible. Um, so I want to break down for you what peptides actually are, what

2:19 they do, and some of the top peptides that are available today, and how they

2:25 can be utilized. Because I think it’s really important. And I think it’s it’s there’s a lot of confusion out there about what these things actually are and

2:32 are they safe? Are they not? When do we use them? What’s the science behind them? So, we’re going to dive in and

2:38 we’re going to talk about all things peptides. So, let’s get ready here. Here we go. So, peptides are short chains of

2:45 amino acids and they typically range anywhere from 2 to 50 amino acids and

2:51 they’re linked by peptide bonds. So think of them as the superglue that holds the amino acids together. They sit

2:58 between the amino acids and they are full proteins in terms of their size and

3:04 their complex structure. And what makes peptides particularly interesting in

3:10 medicine is their role as signaling molecules. They’re essentially the

3:15 body’s text messages carrying specific instructions to cells and tissues. And

3:21 unlike our proteins which often serve as structural roles or act as enzymes,

3:28 peptides typically function as hormones, neurotransmitters and growth factors and

3:33 they bind to specific receptors on the cell’s surfaces or within the cells and

3:39 they trigger this effect. It’s like a cascade effect of a biochemical reaction

3:45 that ultimately changes the cellular behavior. So basically, it’s changing

3:50 the way the body’s cell structure acts. And this is why peptides can be so

3:56 incredibly powerful and therapeutic when you introduce the right peptide signal.

4:02 Now, you could theoretically redirect cellular processes toward healing,

4:07 towards metabolism, immune balance, tissue repair. Any of those things can

4:14 be manipulated to do a certain thing once we add the peptide. The challenge

4:19 in peptide medicine though lies in distinguishing between those peptides that have been rigorously studied,

4:26 proven safe and effective and approved by regulatory bodies like the FDA versus

4:31 those that exist in what we call the gray zone of a promising clinical data.

4:36 But they really lack human validation so far. And this distinction is critical because the presence of a plausible

4:43 mechanism does not guarantee safety or efficacy in living humans. So, this is

4:50 really important and we’re going to dive in and look at some of the research on all of these different peptides that are

4:56 available and I’m excited to say there’s some amazing peptides being studied right now that unfortunately are not

5:01 available. But I can’t wait to see them hit the market for us because it is going to be a gamecher as far as health

5:09 and longevity. So there is a quality control issue and there is a hidden

5:14 variable in peptide medicine with this and it’s one of the most underappreciated aspects of peptide

5:21 therapy particularly for non-FDA approved peptides. It’s quality control.

5:26 When we discuss pharmaceutical medicines, we take for granted that the pill contains what the label says. Not

5:32 always true depending on where it comes from. You guys, if you’ve heard my episodes before talk about how many of our medications are made in China and

5:41 have been contaminated with other things, you will realize that that is not always true. So, just because it has

5:48 the FDA stamp of approval on the medication, it still does not necessarily mean it’s safe and we still

5:54 need to do our homework on it. So, sorry for digressing on you guys, but you know, when we get a medication, we we

6:00 think that what the amount says is what is there, doesn’t have contaminants, it’s manufactured with good

6:06 manufacturing practices. You’ll see that listed as GMP on the bottle, and it’s been stored properly, it’s been

6:12 maintained stable, and with research peptides and compounded formulations,

6:17 none of this can be assumed. So, I will share a story with you. There was a gentleman that was purchasing these

6:24 peptides online from a research facility and um did not know that they were

6:30 coming from China and he was ordering a particular growth hormone peptide and

6:35 after a little while he had he had done fine for the few first few bottles. After a little while he started having

6:42 some complications. He started getting really irritable and angry and ragy and

6:47 he didn’t quite know what was going on. And so he decided to go get some testing done. He had some blood testing done and

6:53 his testosterone level was over 5,000. So for those of you who know what testosterone level should be for a guy,

7:00 they really shouldn’t be any higher than about 1,00200 would be absolute max that we’d want to see. Now he was taking

7:06 testosterone but not to that degree. And prior to adding this peptide, his

7:12 testosterone was very stable. What they ended up finding out was the peptide that he was getting, whoever was

7:18 manufacturing it added testosterone to the peptide. They felt like if if it had growth hormone, that was great, but if

7:25 it had growth hormone and tes testosterone, all the better. And he didn’t know that. And this is the

7:31 problem that we can have with peptides if you don’t source them properly. if you’re not working with somebody that

7:37 knows how to source them and can prove that they are what they say they are. Um, I’m sure there’s a whole bunch of

7:42 studies out there too of people getting these peptides and paying hundreds of thousands of dollars for them over their

7:48 lifetime and finding out they were nothing more than just sterile water. So, you really do need to be careful

7:53 with your quality control. Now, this kind of leads us right into the next topic that we’re going to talk about and that’s the manufacturing question,

8:00 right? The FDA approved peptides are manufactured in facilities subject to

8:05 the FDA inspection rules following our GMP regulations and these facilities

8:11 must validate their manufacturing process, demonstrate consistency batch to batch, test for purity and potency.

8:18 They need to test for bacterial endotoxins and sterility and they need to maintain detailed records. So, when a

8:25 pharmaceutical company submits a drug application, the FDA inspects the manufacturing facility as part of the

8:32 approval process. If you’re getting peptides from a different country, none of that is happening. And there are some

8:38 ways for us to determine if that is what you’re getting. Typically, the rule of thumb is if your peptides are coming

8:44 with a different colored top, every one of them has a different colored top. Those are typically being sourced out of

8:49 China. I wouldn’t say that’s 100% but that’s kind of the rule of thumb that people follow. So compoundingies these

8:56 are thearmacies that make our bio identical hormones. They can make medications in any dose or strength or

9:02 route. There are thousands of them in every not that not in every state but

9:08 there are thousands of them around the country right now. So these compoundingies are registered as 503A

9:15 facilities. They do traditional compounding for individual prescriptions, right? Like they can make

9:20 thyroid, they can make LDN, they can make estrogen. You can also have a 503b

9:27 facility, which is an outsourcing facility. And these companies produce larger batches of products. They’re they

9:34 have some oversight, but they’re less stringent than for FDA approved

9:40 manufacturers. And state boards of pharmacy regulate a 503A pharmacy. And

9:45 the FDA can inspect the 503b facility, but doesn’t preapprove any of their

9:52 compounding products. So, they can inspect it, but they don’t approve them. So, research chemicals and these

9:58 suppliers operate essentially with no oversight. They explicitly market products for research use only, not for

10:06 human consumption to avoid FDA regulation. If they put that on their

10:12 product, they don’t have to comply to what the FDA is saying. And there is no required manufacturing strategies or

10:19 standards, no required testing, no required sterility assurance, and no enforcement mechanisms if products are

10:26 mislabeled or contaminated. So basically, they don’t have the liability, but that doesn’t mean that

10:31 all of them are badies or bad suppliers. It just means they don’t have to comply

10:37 to the FDA rules. Now, there are many of these companies that I’ve seen and I’ve talked to that do do a lot of this. They

10:44 do test their product for sterility. They do test their product to make sure it is what it says it is. They don’t

10:51 have to, but they do. So, if you’re going to decide to use a company that

10:56 has research only, not for human consumption, at least ask for their

11:02 proof of testing so that you know that the product you’re getting is what it says it is and that it’s clean. Because

11:08 this is where we run into the problem is in purity. So in purity peptide

11:13 synthesis can produce not just the targeted peptide but also related

11:19 peptides with deletions, substitutions, truncations or truncations of amino

11:25 acids. Sorry. And this high performance liquid we call it uh chromatography can

11:30 separate these related impurities and quality and quantify the actual target

11:35 of the peptide content. So a certificate of analysis is what you want to ask these companies for. This shows the HPLC

11:44 the testing mechanism with greater than 95% or ideally 98% purity which

11:51 indicates a higher quality product. So this certificate of analysis can be fabricated may not represent the

11:57 specific batch being sold. It happens. We need to know not everybody is honest. Not everybody, you know, does what they

12:03 say and it does what’s right. But at least you at least they’re giving you something and you have some security.

12:10 and then choose a company that was referred to by someone else that has done some homework as well. In in

12:16 commercial research, there’s independent testing and they research peptides and this has been really shocking

12:23 variability that they’ve seen. Some products contain 50% or less of the

12:29 claimed peptide and some contained primarily degradation of the product or manufacturing impurities and some

12:36 contained bacterial endotoxins at levels that could cause fever and systemic

12:42 inflammation if it was truly injected. And I would also worry with some of those problems, you know, depending on

12:48 what impurity or bacterial endotoxin was there. If you’re using a product to boost your immune system and your immune

12:54 system is already compromised, these bacterial endotoxins can actually make you sicker instead of what you want it

13:02 to do, which is making you better. So, sterility is always an issue with anything that is manufactured,

13:08 especially things that we’re doing as an injection. Peptides are intended for injection. They must be sterile. They

13:16 must be kept safe. And pharmaceutical manufacturers conduct this sterility testing on every batch.

13:22 Compoundingarmacies should conduct sterility testing particularly for high-risisk compounded

13:28 sterile preparations and research chemical suppliers may or may not conduct any testing. So injecting

13:35 non-sterile material can cause local infections, abscesses at the injection

13:41 site and or if the bacteria enters the bloodstream could potentially be

13:46 life-threatening and you could have sepsis. Now, excuse me. We saw this

13:52 happen in a compounding pharmacy uh gosh, it’s probably been 10 years ago

13:57 now, I think. um they unfortunately had a strep uh contamination in their

14:03 product and they weren’t testing it. It was a large compounding pharmacy out of Florida and they were making products

14:08 that were being injected into the joints and um these people got very very sick

14:14 and some of them died and um some of them got very very injured by this uh

14:21 complication that happened. So it’s not like this doesn’t happen. It does, but it doesn’t happen often. And that’s what

14:28 we have to know about. And so, when we’re talking with you guys about storage and stability, it’s really

14:34 important to make sure you maintain your peptides well. So, many peptides are unstable at room temperature. They

14:41 require refrigeration or freezing. We tell everyone to make sure you’re refrigerating your peptides. That way,

14:48 there’s no question about it. when it stays cold um it prevents or slows down

14:54 the process of uh bacteria growing in it. So some of these peptides actually

14:59 degrade very rapidly in the solution and they must be reconstituted immediately before use and reconstitution of the

15:07 peptides really has limited stability often just days to weeks not months. So

15:13 improper storage, temperature, um changes during shipping or prolonged

15:19 storage of a reconstituted product can lead to degradation into inactivity or

15:25 potentially even a harmful breakdown of the product itself. So if you have a product that’s been sitting in your

15:30 refrigerator for a month or two months or 3 months or 6 months, just throw it away. It’s not going to be any good.

15:37 you’re not going to actually get the peptide and the uh potency that you’re looking for anyway out of it and the

15:44 potential of you introducing an endotoxin, a bacterial endotoxin is quite high at that point. So you just

15:50 really don’t want to take the risk, excuse me. So what practitioners, what

15:56 should we do and what should patients do? Well, for any peptide therapy, we

16:03 want to source our verification. know where the peptide product comes from. Is

16:08 it an FDA approved product? Is it a 503b compounding? A research chemical

16:14 supplier? Is there a certificate of analysis? Request and review this COA.

16:20 And you want it to show purity greater than 95% but ideally greater than 98%.

16:27 You want that identity be identity to be confirmed by mass spectromedy. Uh

16:33 sterility testing should be done. Bacterial endotoxin testing should be done. Batch number matching of the

16:39 product that you received should be done. Proper storage. You want to know that this has been refrigerated or

16:46 frozen as directed once it’s been mixed. Look at the expiration dates for reconstituting your peptides. Track that

16:53 reconstitution date and discarded accordingly like we just talked about. Monitor for your adverse effects. Even

17:01 with the perfect quality control, monitoring for adverse effects is essential with questionable quality and

17:08 vigilance is really critical here. I know it’s frustrating for a lot of patients when they have to get several

17:15 bottles and they only last a week or two. right here, you guys. This is why

17:21 they only last a short period of time because once they’re mixed, they start

17:26 to degrade and they won’t be good and you won’t get the benefit from it. So,

17:31 it’s really important with these research peptides specifically, practitioners should recognize that all

17:38 recommending products without quality assurance violates the fundamental medical principle of first do no harm.

17:45 If a patient is determined to use research peptides despite counseling, providing guidance on quality

17:52 verification, requesting those COAs, using pharmaceutical grade sources when available, proper testing, this all

17:59 reduces harm, but doesn’t constitute necessarily that recommendation. Now,

18:06 that being said, today it’s very difficult to find peptides by the compoundingies because of what the FDA

18:13 has done. So most of the peptides that are available to us have been labeled

18:18 not for human consumption, not because they’re not good products, but because

18:25 of what the FDA did. And this is how these companies have been able to

18:31 continue to provide peptides to the medical community. And if you know you

18:36 have a good company, then you’re, you know, you’re still taking the risk, right? But at the end of the day, the

18:42 reason they’re doing that is to protect themselves from the FDA, from liability. Um, so just kind of know that there is

18:50 some talk in the community with um Bobby Kennedy that this is going to change and

18:55 they are going to bring peptides back to the compounding pharmacies. Now, we don’t know which ones they’re going to

19:01 bring back. Uh, will it be all of them? Will it just be some of them? What’s going to happen here? Um, is it going to

19:07 go to the pharmaceutical companies like our GLP1s did? We don’t know what that’s going to look like quite yet. Um, but it

19:14 is coming and that is positive news. So, let’s talk now about FDA approved

19:21 peptide medications. So, this is the metabolic revolution, right? GLP1

19:28 and our dual increeting agonists. This is an exciting time. GLP-1s are amazing.

19:35 Um, a lot of people are skeptical, a lot of people love them, a lot of people hate them. Whichever side of the fence

19:42 that you’re on, I understand. But I want to talk about the science of it today

19:48 and what it actually means for people. So, the story of GLP1 glucagon like

19:54 peptide one represents one of the most significant advances in metabolic

19:59 medicine in the past several decades. GLP-1 is an accretin hormone. It’s

20:05 gutder derived peptide that potentiates insulin secretion in response to food

20:11 intake. And the body naturally produces GLP-1 in the intestinal L cells, but it

20:17 rapidly degraded by the enzyme DPP4 giving it a halflife of only about 2

20:24 minutes. So this rapid breakdown made in therapeutically impractical until

20:31 research was developed and modified the analoges that resist the enzyme degradation. So for those people who

20:39 never feel full when they’re eating, never feel satisfied when they’re done, this is because their body is either not

20:46 producing enough GLP1 or it’s not getting the signal right. And this is a

20:51 leptin issue. This is an insulin issue. It’s a GLP-1 issue. It’s a complicated

20:56 issue. This is not anything that the person is doing wrong. It’s what is happening to their body. And so GLP1s

21:03 have really revolutionized this. So one particular GLP-1 that we have is

21:09 semiglutide. And this GLP-1 agonist is what changed everything in the world of

21:16 metabolic medicine. Semiglutide is marketed as ompic for type 2 diabetes

21:23 and it’s marketed as WGOI for chronic weight management. It is a modified

21:29 GLP-1 analog with 95 or sorry 94% amino acid sequence uh homology to human

21:37 GLP-1. So it means that it’s it’s just like our own GLP-1 that we make. This

21:42 modification includes specific amino acid substitutions and the addition of C18

21:50 a fatty acid chain which allows the peptide to bind to albumin. Now this

21:56 albumin binding dramatically extends the half-life to approximately one week

22:01 enabling one weekly dosing which is a major advantage over the earlier GLP-1

22:07 agonists that require daily or twice daily injections. The mechanism by which

22:13 semiglutide works is multiaceted. At the pancreatin level, it binds to GLP-1

22:20 receptors on the pancreatic beta cells enhancing glucose depending sorry

22:27 enhancing glucose dependent insulin secretion. This glucose dependency is

22:33 crucial. It means the peptide only stimulates insulin release when blood glucose is elevated. This dramatically

22:41 reduces the hypoglycemic risk compared to insulin or even uh sulfuras.

22:47 Simultaneously semiglutide suppresses glucagon secretion from pancreatic alpha

22:53 cells further improving glycemic control. This is really amazing because

23:00 over the years when we’ve used insulin, which is also a peptide by the way, you

23:05 had to dose it just right because if you didn’t, you would produce so much insulin that it would crash the blood

23:12 sugar and then somebody would have too low of a blood sugar. They’d be hypoglycemic and they’d have to eat more

23:18 sugar and then they’d have to modify the insulin again and the person would be going up and down, up and down, up and

23:24 down all day long. And that created a lot of problems for people and so this

23:30 helps to stabilize that so it is not such an intense change. Now in the GI

23:36 tract semiglutide delays the gastric emptying particularly pronounced during

23:41 the initial weeks of therapy. This slowing of the gastric emptying contributes to the sensation of being

23:48 full and early satiety that patients often describe. However, this effect

23:54 tends to attend to weight over time as the body adapts through the appetite

24:00 suppressing effects generally persist through central mechanisms. So, when we

24:05 talk about what is actually happening, we’re slowing that digestive process down. That’s why people aren’t so

24:11 hungry. It’s why they’re not eating so much. This is why people can develop constipation with these products because

24:17 it’s slowing the body’s digestive tract down. Now some people will call this

24:22 gastroparesis. Um gastroparesis is actually different.

24:28 It is when we lose control over what’s happening in the in the colon like the

24:34 nerves and things like that just stop working. I have never seen that with the GLP1s that we prescribe in micro doing.

24:42 um it’s been documented. It can happen, but again it a lot of it is dosing and a

24:48 lot of it is staying on top of your client and what’s happening and what’s going on and what you’re doing and making sure that they do have good

24:54 motility still. So a lot of these things can be mitigated if you have problems

24:59 with them. Now one of the most profound effects of semiglutide occur in the

25:05 central nervous system. GLP-1 receptors are widely distributed in the brain

25:10 particularly in the hypothalamus and the brain stem area where we are involved in

25:15 appetite regulation. So when when wilding and colleagues published their

25:20 landmark step one trial in the New England Journal of Medicine in 2021,

25:25 they demonstrated that participants receiving 2.4 4 milligrams of semiglutide weekly achieved an average

25:32 weight loss of 14.9% of their body weight over 68 weeks. Now, I want you

25:39 guys to really understand this. We’re talking roughly 15% body weight loss

25:45 over a year, longer than a year. 52 weeks is a year, right? This is 68

25:50 weeks. So, it took longer for them to lose. We’re not talking about giving

25:55 somebody a dose to lose 15% of their body mass in a month or two. That that

26:01 is not healthy for any of us. That is not what we’re talking about doing here. Now, they compared this to placebo and

26:08 the placebo was only 2.4%. So, that is a significant difference.

26:14 And even beyond the numbers, patients reported something very qualitatively different, a reduction in what’s now

26:21 called food noise. Everybody knows what food noise is. We’ve talked about this long before GLP1. It’s that craving.

26:28 It’s that part of your brain that just keeps thinking about I want to eat something. You know, that was actually

26:34 reduced and they didn’t expect to see that happen. Now, this refers to the constant mental preoccupation with food,

26:42 the intrusive thoughts about eating, the difficulty in feeling satisfied. Semi-glutide appears to appears to

26:49 modulate reward pathways in the misolyic system reducing hedonic eating and food

26:57 cravings. Now there are also great cardiovascular effects of semiglutide

27:02 that extend beyond weight loss. Uh the sustained six and select trials

27:07 demonstrated significant reductions in major adverse cardiovascular events uh

27:14 mace in high-risisk populations. The select trial published in 2023 showed

27:20 that semiglutide reduced cardiovascular death, non-fatal myioardial inffection

27:25 and non-fatal stroke by 20% in adults with overweight or obesity and

27:31 established cardiovascular disease but without diabetes. So this suggests that

27:37 mechanisms beyond glucose control and weight loss possibly including

27:42 anti-inflammatory effects, improvements in endothelial function and favorable

27:47 changes to lipid profiles. Now I will tell you the clients that I work with that are on GLP1,

27:53 they will tell you that their inflammation has been significantly reduced. We are also seeing really

28:00 amazing results in lipid profiles. um part of its weight loss, but there is a

28:06 component to this that is lowering the triglyceride levels because it’s related to sugar and how the body’s processing

28:11 it. And we’re seeing better profiles, less need for statins as a result of

28:17 that. If if you want to listen to my episode on statins, I have one on that. Uh they are not my favorite medication.

28:24 I think it’s overprescribed and overused um and not really affecting or

28:29 addressing the problem. So these things can really be helpful. There’s also some

28:34 uh ramblings going on with GLP-1s saying that they may be able to help with

28:40 addiction in the future because of where they’re finding it affecting the brain and how it affects the food noise and

28:47 the cravings that we have for food and the addiction for food. Could it potentially help with other addictions

28:53 down the road? We’ll have to wait and see on that one. So semiglutide’s FDA prescribing information also includes a

29:00 box uh boxed warning about thyroid sea cell tumors. So in rodent studies

29:06 semiglutide caused dose dependent and treatment duration dependent sea cell

29:12 tumors at clinically relevant exposures. So while it’s unknown whether or not

29:17 semiglutide causes uh thyroid cancer tumors in humans and the rodent thyroid biology

29:26 differs significantly from humans, the drug is contraindicated in patients with a personal or family history of

29:33 medillary thyroid carcinoma or in patients with multiple endocrine neopl neoplasia syndrome type two. it is

29:42 uh contraindicated for safety effects with that. Um I have seen endocrinologists okay GLP1s to be used

29:50 in patients who’ve had other forms of thyroid cancer just not the meillary

29:55 thyroid cancer. So there is possibility there. Now the most common side effects

30:00 are gastrointestinal. It’s nausea affects about 20 to 44% of patients

30:06 depending on the formulation with diarrhea, vomiting, constipation, abdominal pain, and also frequently

30:13 reported in clinical trials. I see this in my clinic, too, especially dose dependent. Um, and it happens early on

30:20 when you’re first starting the medication, but seems to settle out over time. The one that I would add to this

30:26 that I don’t think they have on here is an increase in acid reflux. We also see that quite often uh especially in people

30:33 who suffer with acid reflux to begin with. Now these effects are typically most

30:40 pronounced during the escalation and they like I said often improve over time

30:45 but more serious but less common adverse effects include acute pancreatitis.

30:51 The medication needs to be discontinued immediately if this is confirmed. You can see some diabetic retinopathy

30:57 complications in patients with pre-existing retinopathy and acute kidney injury. Um, this usually happens

31:05 secondarily to dehydration from the GI effects. There are some gallbladder disease um that can occur and people who

31:13 have a sensitive gallbladder will describe uh discomfort with that. I’ve

31:18 even seen some people who’ve had their gallbladder out on GLP1s at the higher doses complain of similar pain that they

31:25 used to have when their gallbladder was in. So, really important to just kind of monitor these symptoms and work closely

31:32 with somebody that understands them and can be on top of them quite quickly if this happens. Excuse me. From an

31:39 integrative medicine perspective, semiglutide really represents a powerful tool, but it’s not a standalone

31:46 solution. Remember, the medication addresses one aspect of the metabolic dysfunction, the signaling systems

31:53 controlling appetite and glucose homeostasis, but it doesn’t address the root cause that led to the metabolic

32:00 disease in the first place. Patients who rely solely on the medication without addressing the ultrarocessed food

32:07 consumption, the ccadian disruptions, the chronic stress, the sleep apnea, or

32:12 underlying hormonal imbalances often experience weight regain when the medication is discontinued.

32:20 The drug is also not a substitute for addressing the emotional and psychological drivers of eating

32:26 behavior, including the unresolved trauma that may manifest as emotional eating. I think this is really important

32:33 because we don’t address the trauma issue enough with clients and we need to

32:38 be looking at that. There is a huge trauma effect out there these days that is I don’t want to say leading to or

32:45 causing but it is definitely contributing to chronic illness and it’s not being talked about enough. So we

32:52 really need to be talking about this and addressing this trauma aspect. Now the next GLP that one that I want to talk

32:59 about is trespathide. This is a dual agonist. It takes center stage. It is my

33:05 favorite GLP one. Trisepatide is marketed as Mangjaro for type 2 diabetes

33:11 and Zepbound for chronic weight management and it represents the next

33:16 evolution in increantbased therapy. This is a dual agonist a 39 amino acid

33:23 synthetic peptide structurally based on the human glucose dependent insulin tropic peptide so GIP sequence but

33:31 modified to activate both the GIP receptors and the GLP1 receptors. So the

33:37 addition of the GI GIP agonism to the GLP1 agonism appears to create this

33:46 synergistic effect that goes beyond simply adding the two mechanisms together. So the GIP like GLP-1 is an

33:55 increant hormone secreted by what is called the K cells in response to nutrient intake. It enhances glucose

34:02 dependent insulin secretion but it also effects on atapost tissue metabolism

34:09 potentially improving the insulin sensitivity in fat cells and influencing

34:14 how the body stores and metabolizes fat. So some research suggests that GIP may

34:20 also have effects on energy expenditure though this remains an area of

34:26 investigation. So basically what we’re saying is this drug may actually help

34:32 people who are insulin resistant or insulin sensitive, not just somebody who

34:38 has problems with glucose control. So, this is super exciting because it opens

34:43 up the door for all of these people for decades that we’ve been trying to manage with insulin resistance and trying to

34:50 prevent diabetes and honestly most of the time have been unsuccessful

34:56 unless you can keep your diet at 50 grams of carbs or less a day, which is extremely difficult. Um, and take some

35:04 supplements that may or may not work and or take some metformin that may or may not help. this drug actually really

35:11opens that up and helps in that capacity. So there was a clinical trial

35:17 called the surmount clinical trial which demonstrated that trespathide produces

35:22 even more substantial weight loss than semiglutide. In the surerount one trial published by uh J tree I might have said

35:31 that wrong. I apologize if I slaughtered your name and colleagues in the New York England Journal of Medicine in 2022.

35:38 Participants receiving the highest dose of trespide, which is 15 milligrams, achieved an average weight loss of 20.9%

35:47 of their body weight over 72 weeks, compared to 3.1% with placebo. This

35:54 level of weight loss approaches what’s typically only seen in beriatric surgery. So, this is amazing because if

36:02 this medication works and we don’t have to do beriatric surgery, stomach stapling basically, um, oh my gosh, it’s

36:11 amazing. There are so many complications and risks that go with stomach stapling and the different procedures that they

36:17 do these days. People don’t absorb their nutrients properly. They have to do liquid nutrients. It’s very complicated.

36:24 It’s very challenging. Many of these people gain their weight back. Um, and

36:30 this procedure is not fun to go through. So, if we could change that and change

36:35 the lives of people who’ve really been struggling, it is amazing. And I will tell you that I have seen this work. I

36:42 have seen people lose 100 150 pounds on these medications over a year or two

36:50 period of time. It is definitely slower than beriatric surgery on some standpoints, but that is okay. You don’t

36:56 want that rapid weight loss. It’s not good for you. It’s not healthy for you. It doesn’t look well. You know, we want

37:03 to do this safely and effectively in the best way that we can possibly do that for you. Now, the adverse effect profile

37:10 is similar to semiglutide. It’s dominated by gastrointestinal effects.

37:15 Nausea, diarrhea, decreased appetite, vomiting, constipation. These were all commonly reported in the surmount

37:22 trials. And like semiglutide, tricepide carries a blackbox warning regarding the

37:27 thyroid sea cell tumors based on the rodent data and it shares the same contra indications in patients with a

37:34 family history of thyroid cancer and men too. So the mechanism behind why

37:40 tepatide often produces more substantial weight loss than GLP-1. The agonism

37:45 alone remains under investigation, but it may relate to the complimentary effects on the different aspects of

37:51 energy homeostasis or to GIP’s effects on atapost tissue and potentially on

37:58 central central nervous system pathways that GLP1 alone doesn’t fully address.

38:03 Now patients often report even more profound reductions in food noise with tricepide compared to GLP1 and uh sorry

38:12 GLP1 the agonists through this is anecdotal and hasn’t been regularly

38:17 quantified in quality studies. So I’ve done both uh personally and in my

38:22 practice. I really like trespide better than semiglutide. For me I had too many side effects with semiglutide. uh I had

38:30 less side effects with trespathide. I also plateaued on semiglutide which I

38:35 didn’t really care for. And with Tresepide, I haven’t plateaued and I’ve been able

38:42 to lose about 25 pounds in um a year and a half and I’ve been able to maintain

38:49 that. Um and I continued to use it because I do have a strong family history of cardiovascular disease. And

38:56 if this could help me so that I don’t follow my family lineage with cardiovascular disease, I am all for

39:03 trying to do that. I’ve watched too many of my family members suffer from this. I’ve lost my dad at a very young age. I

39:09 lost my grandfather at a young age to it. All of their brothers to this. And I don’t want to be that same person. So

39:16 that is why I chose to do that. And I think it’s really important for us to take a look at that and understand that.

39:24 Now, I know this has been a really long podcast and I don’t typically do podcasts this long. I have a whole host

39:31 of information on additional peptides. So, I’m going to break this up for you

39:36 guys and I’m going to do another episode and we’re going to pick up where we left off here with these peptides so that we

39:43 can actually start to dive into different peptides as well. So, check

39:48 out my next podcast show when we’re going to dive into the peptides that

39:54 talk about sexual wellness, immune function, and all the other cool things

39:59 that we can do with peptides. So until then, remember to like, share, and

40:04 subscribe. It really helps us get out to other people and share our information,

40:10 and join us for our next episode as we continue the talk about peptides.

40:15 Welcome to Let’s Talk Wellness Now, where we bring expert insights directly to you. Please note that the views and

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The post Episode 256 – How Peptides Work, Benefits, and FDA-Approved vs Off-Label Use Explained first appeared on Let's Talk Wellness Now.

What if the reason you're not healing isn't that you need another diagnosis?

0:08

It's that your cells aren't receiving the right signals. Because the body doesn't run on diagnosis, it runs on

0:16

communication. And peptides are one of the most powerful, most misunderstood

0:21

tools we have for cellular signaling, immune balance, tissue repair, gut

0:27

lining support, metabolic control, brain signaling, sleep cycles, and even sexual

0:35

wellness. Today, I'm going to do what most people won't. Define peptides in

0:41

plain English for you. break them into categories by what they're best at and

0:47

tell you which ones are FDA approved on the list and which ones are commonly

0:53

used off label or investigational with the evidence that actually says these

1:00

work. This is going to be a powerful episode and if you've ever felt like you're hearing hype without clarity,

1:07

this one's for you. So, as usual, grab your cup of coffee or tea and settle in

1:13

as we talk about peptides that can fit into your healing journey. We're going

1:19

to have a short word from our sponsor. You know, we got to do that. That's how we stay on the air here. So, we will be

1:26

right back after this. Did you know sweating can literally heal your cells?

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right now, you can save $500 with my code at healthtechalth.com/drmuthqen25.

1:54

All right, here we go, guys. I am excited to dive into peptides with you.

2:00

So understanding peptides is foundational, right? And I've been

2:06

studying peptides now for about nine years. Um, and I find that they are

2:13

incredible. Um, so I want to break down for you what peptides actually are, what

2:19

they do, and some of the top peptides that are available today, and how they

2:25

can be utilized. Because I think it's really important. And I think it's it's there's a lot of confusion out there about what these things actually are and

2:32

are they safe? Are they not? When do we use them? What's the science behind them? So, we're going to dive in and

2:38

we're going to talk about all things peptides. So, let's get ready here. Here we go. So, peptides are short chains of

2:45

amino acids and they typically range anywhere from 2 to 50 amino acids and

2:51

they're linked by peptide bonds. So think of them as the superglue that holds the amino acids together. They sit

2:58

between the amino acids and they are full proteins in terms of their size and

3:04

their complex structure. And what makes peptides particularly interesting in

3:10

medicine is their role as signaling molecules. They're essentially the

3:15

body's text messages carrying specific instructions to cells and tissues. And

3:21

unlike our proteins which often serve as structural roles or act as enzymes,

3:28

peptides typically function as hormones, neurotransmitters and growth factors and

3:33

they bind to specific receptors on the cell's surfaces or within the cells and

3:39

they trigger this effect. It's like a cascade effect of a biochemical reaction

3:45

that ultimately changes the cellular behavior. So basically, it's changing

3:50

the way the body's cell structure acts. And this is why peptides can be so

3:56

incredibly powerful and therapeutic when you introduce the right peptide signal.

4:02

Now, you could theoretically redirect cellular processes toward healing,

4:07

towards metabolism, immune balance, tissue repair. Any of those things can

4:14

be manipulated to do a certain thing once we add the peptide. The challenge

4:19

in peptide medicine though lies in distinguishing between those peptides that have been rigorously studied,

4:26

proven safe and effective and approved by regulatory bodies like the FDA versus

4:31

those that exist in what we call the gray zone of a promising clinical data.

4:36

But they really lack human validation so far. And this distinction is critical because the presence of a plausible

4:43

mechanism does not guarantee safety or efficacy in living humans. So, this is

4:50

really important and we're going to dive in and look at some of the research on all of these different peptides that are

4:56

available and I'm excited to say there's some amazing peptides being studied right now that unfortunately are not

5:01

available. But I can't wait to see them hit the market for us because it is going to be a gamecher as far as health

5:09

and longevity. So there is a quality control issue and there is a hidden

5:14

variable in peptide medicine with this and it's one of the most underappreciated aspects of peptide

5:21

therapy particularly for non-FDA approved peptides. It's quality control.

5:26

When we discuss pharmaceutical medicines, we take for granted that the pill contains what the label says. Not

5:32

always true depending on where it comes from. You guys, if you've heard my episodes before talk about how many of our medications are made in China and

5:41

have been contaminated with other things, you will realize that that is not always true. So, just because it has

5:48

the FDA stamp of approval on the medication, it still does not necessarily mean it's safe and we still

5:54

need to do our homework on it. So, sorry for digressing on you guys, but you know, when we get a medication, we we

6:00

think that what the amount says is what is there, doesn't have contaminants, it's manufactured with good

6:06

manufacturing practices. You'll see that listed as GMP on the bottle, and it's been stored properly, it's been

6:12

maintained stable, and with research peptides and compounded formulations,

6:17

none of this can be assumed. So, I will share a story with you. There was a gentleman that was purchasing these

6:24

peptides online from a research facility and um did not know that they were

6:30

coming from China and he was ordering a particular growth hormone peptide and

6:35

after a little while he had he had done fine for the few first few bottles. After a little while he started having

6:42

some complications. He started getting really irritable and angry and ragy and

6:47

he didn't quite know what was going on. And so he decided to go get some testing done. He had some blood testing done and

6:53

his testosterone level was over 5,000. So for those of you who know what testosterone level should be for a guy,

7:00

they really shouldn't be any higher than about 1,00200 would be absolute max that we'd want to see. Now he was taking

7:06

testosterone but not to that degree. And prior to adding this peptide, his

7:12

testosterone was very stable. What they ended up finding out was the peptide that he was getting, whoever was

7:18

manufacturing it added testosterone to the peptide. They felt like if if it had growth hormone, that was great, but if

7:25

it had growth hormone and tes testosterone, all the better. And he didn't know that. And this is the

7:31

problem that we can have with peptides if you don't source them properly. if you're not working with somebody that

7:37

knows how to source them and can prove that they are what they say they are. Um, I'm sure there's a whole bunch of

7:42

studies out there too of people getting these peptides and paying hundreds of thousands of dollars for them over their

7:48

lifetime and finding out they were nothing more than just sterile water. So, you really do need to be careful

7:53

with your quality control. Now, this kind of leads us right into the next topic that we're going to talk about and that's the manufacturing question,

8:00

right? The FDA approved peptides are manufactured in facilities subject to

8:05

the FDA inspection rules following our GMP regulations and these facilities

8:11

must validate their manufacturing process, demonstrate consistency batch to batch, test for purity and potency.

8:18

They need to test for bacterial endotoxins and sterility and they need to maintain detailed records. So, when a

8:25

pharmaceutical company submits a drug application, the FDA inspects the manufacturing facility as part of the

8:32

approval process. If you're getting peptides from a different country, none of that is happening. And there are some

8:38

ways for us to determine if that is what you're getting. Typically, the rule of thumb is if your peptides are coming

8:44

with a different colored top, every one of them has a different colored top. Those are typically being sourced out of

8:49

China. I wouldn't say that's 100% but that's kind of the rule of thumb that people follow. So compoundingies these

8:56

are thearmacies that make our bio identical hormones. They can make medications in any dose or strength or

9:02

route. There are thousands of them in every not that not in every state but

9:08

there are thousands of them around the country right now. So these compoundingies are registered as 503A

9:15

facilities....

Dr. Deb Muth 0:03

Welcome back to let's Talk Wellness. Now, I'm your host, Dr. Deb. If you're a woman who's doing everything right, eating clean, exercising, taking supplements, yet you still feel exhausted, inflamed, or like your body suddenly stopped cooperating, this episode is for you. Today's conversation challenges one of the biggest myths in women's health. That midlife struggles are just about hormones or worse, just part of aging. My guest today is Dr. Deb Heald, a naturopathic physician with one of the most fascinating backgrounds I've ever encountered. Yeah, she's got a really diverse background, which is kind of exciting. She's been an ER nurse, a stockbroker, a Silicon Valley data analysis, teaching machines to learn from microbiome research. And yes, she holds an mba, too. But it was her own menopause crash that changed everything. When the protocols she had been teaching stopped working for her, her, she didn't double down on templates or trends. She did what she was trained to do. She followed the data and what she discovered reframed menopause, metabolism and women's longevity in a completely different way. This isn't about willpower. It's not about another diet, and it's definitely not about copying what worked for someone else. It's about learning to listen to your body and finally understanding what it's been trying to tell you and all along. So grab your cup of coffee or tea, settle in, and let's dive into this amazing conversation about women's health and menopause. And right after our guest is arriving with us, we're going to get a word from our sponsor quick here. And then we are going to come right back to having this conversation with Dr. Deb Heald. Ladies, it's time to reignite your vitality. Primal Queen supplements are clean, powerful formulas made for women like you who want balance, strength, and energy that lasts. Get 25% off@primal queen.com Serenity Health. Because every queen deserves to feel in her prime. But okay. All right. Welcome back, everybody. I am here with my new friend, Dr. Deb Heald. And she has such an amazing background, like I shared with you a few minutes ago. But I would love for her to give us her insight in how she got where she did, because it's rare that you find somebody with a data background and a medical background. So, Dr. Dove, welcome.

Dr Deb Heald 2:30

Thank you. I am so glad to be here, and it's a real privilege to meet you.

Dr. Deb Muth 2:34

I feel the same way.

Dr Deb Heald 2:35

Yeah, it's. I think that the more of us that start to think and practice this way, the easier it's going to be for women going forward. Because it's not easy.

Dr. Deb Muth 2:44

It is not easy. I mean, I've been in this industry a long time, over 25 years. And every time I think it's getting easy, it's getting harder for a variety of reasons. It's the medical system, it's the. The clients we work with are sicker. It's taking longer to get them to a place where they feel good. There's just so many variables these days. So tell me a little bit about what got you here.

Dr Deb Heald 3:06

Well, I made the decision when I was graduating from high school to be a nurse instead of a teacher, because those were really still the two options that were common for women. I thought about medicine at that point, but my sister convinced me that if I would spend all that time learning and practicing medicine, I might not be as good of a mom. So I took the path of nurse, because nurse works around kids schedules and that sort of thing. I'd only been practicing about six months before I thought, oh my gosh, there has to be more to it than this, and toyed with the idea of starting med school at that point, but then married and started having children, and I just sort of fell into that pattern. But I typically work emergency room. There was a short stent in the post anesthesia recovery room as well. And emergency room was a place where western medicine actually shone. Right. People come in, they are no longer capable of functioning, they're having a heart attack, they lost limb. Whatever else, they do need the, the bells and the whistles of western medicine. But when you think about it, western medicine was derived out of the Civil War where you didn't have to say what's the cause of the problem. It was a bullet or a bayonet, and it was, it was about patching up the soldiers and getting them back on the front line so they could continue to fight. And naturopathic medicine, which had been a lot around for an awful lot longer than that, just didn't work in the battlefield then. The assessment was done in the early 1900s as to which style of medicine got people back to work faster. The Flexner report was all about how corporations could maximize the value of employees. And naturopathic medicine didn't win because nutritional fixes take a long time. Taking away somebody's stress so that they can just function more capably is. It's a, It's a big ask, right? So the funding of naturopathic medicine went away and western medicine became all that we knew. So in context to the emergency room, it worked. But when I saw the same person coming in, having their third heart attack, I just thought, how is this happening? Has no one told this person what, what's going on in their lifestyle that's creating this environment for them to continue to have heart attacks? And so that's when I made the switch. And that was after 17 years in practice as a nurse to head on over to the naturopathic side. There was a little bit of a, a segue there, but we'd need a much longer interview to get into the details of that. I was a stock broker for six years. Anyway, when I jumped into the idea of med school, it didn't make sense to be practicing the same thing that was already being practiced because I saw where it worked and I saw where it was failing. So hopped into the naturopathic tract. I also had one child that had a lot of physical and emotional ailments that western medicine couldn't solve. Their answer to everything was putting her on amoxicillin. And I, I just absolutely could not convince the medical system that she didn't have a deficiency of antibiotics, but that was their only solution. And so while she was on the antibiotics, her sinuses were clear, her sleep apnea was not an issue, and she appeared better, but her microbiome got decimated. She was on antibiotics for seven years. So, yeah, so my pursuit down the naturopathic pathway was in large part to try and figure out what else could be done for my daughter. And I did take her to a naturopath or I embarked on the field myself. And her GP threatened to call social services. Oh my gosh, yes.

Dr. Deb Muth 6:22

You hear these stories, I've heard these stories from clients before over really dumb things that they're going to call CPS for. And it always blows my mind that we think it's appropriate to call CPS on somebody who's truly not injuring their child.

Dr Deb Heald 6:38

So anyway, that started my 17 year path in the naturopathic realm. And after, after I've been in practice about 10 years, an opportunity came up to move to Silicon Valley and research the microbiome and then take what we were learning from the microbiome and program it into AI. So I did that for a few years and it was amazing. There was a huge disconnect between the funding model and what its expectations were and what the research was able to do. There was a time gap, there was a funding gap. And so I thought, medicine doesn't understand what's important to business. And Business isn't understanding what's critical to research. So I went and did my MBA and wanted to be able to be the translator between those two worlds. And then the pandemic hit and then.

Dr. Deb Muth 7:24

Everyone'S life got turned upside down, right?

Dr Deb Heald 7:26

Yeah. Yeah. So I'm back in private practice. My, my practice always tended to be more autoimmune focused, which is predominantly women and predominantly middle aged women. But through my own experience of menopause and looking at how I assisted people that were in menopause before I was, you know, that the success rate wasn't as high as it needed to be. And I started to really drill down into the biochemistry behind what was going on and then also realized that my menopause was very different than even my sister's menopause. There we were, the same genetic template, the same lived environment, though very different lived experiences in that environment. And realized that we have to find ways to make it relevant to the person in front of us. And it's not so much which herbs will or won't work historically, it's how is this person's body responding in the immediate term to the diet we've put them on, to the nutritional plan we've suggested to the supplements, and because we've come so far in the data world, our whoop straps or aura rings or whatever else, there's so many devices that are actually able to let us know whether somebody's burning carbs or fat in this moment or ketones. We can see how an individual's body is responding and course correct right now. And it isn't that a ketogenic diet may not be helpful down the road. It's right now it's actually putting more stress on your body than it's already under, which puts you into fight flight, which stops you from burning fat. So, and it's not just the burning fat, it's the inflammation. Right. So our food is completely void of nutrients. And we used to have 24 inches of topsoil, now we've got, so who's eating four times the number of vegetables that we, we used to eat to get the same number of nutrients? We're just not. And our environment is so full of plastic and chlorine molecules and just toxins that our liver says, I have no idea what that is, I have no idea how to detoxify it. And we can't,...

Dr. Deb Muth 0:03

There's a quiet shift happening in healthcare right now, and most doctors aren't talking about it yet. People aren't chasing diagnoses anymore. They're exhausted by them. I see it every single day in my clinic. People who come in with stacks of paperwork, portals full of results, and a list of diagnoses longer than their grocery receipt, yet they're still not living their lives. And they'll say to me, Dr. Deb, I don't want another label.

Dr. Deb Muth 0:32

 I just want my life back. If you've ever been told this is just how your body is, if you've been diagnosed, rediagnosed, and then dismissed, if you've been handed labels but never handed a roadmap, today's episode is for you. Because we are officially entering what I call the post diagnosis era and it's changing everything about how healing actually happens. So grab your cup of coffee or tea and let's settle in to let's talk wellness. Now, before we dive in, we need to take a quick pause to thank today's sponsor. And when we come back, we're going to talk about why diagnoses are no longer the most important thing about you.

Dr. Deb Muth 1:17

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Dr. Deb Muth 0:47

It was three years ago Christmas that I received my Ms. Diagnosis. And I remember it very clearly. It was the day before, two days before Christmas Eve, that I got the call and I heard the words, you have white matter brain disease. That's consistent with Ms. And I immediately stopped in my tracks and thought, okay, well, this is just the way it is. We're gonna fight this. We're gonna figure this out. And it led me down a deeper path of healing and spirituality and emotional growth. And there were some really difficult days ahead for me because I remember thinking, what am I gonna do? How am I gonna practice what's going to happen in my life? And every year at this time, I reflect back to that day that I got the call that really changed my life. And not for the worse, but for the better. It changed the way I was thinking about life.

Dr. Deb Muth 3:01

It changed the way I was complaining about things being ungrateful for all the amazing things that I have in my life. Not intentionally, but just living the American life. Right.

Dr. Deb Muth 3:14

And striving for more and wanting more and chasing more and doing more, and never really having the opportunity to just be present and just really think about life and enjoy what the Lord has given us and enjoy what's around me, the people in my life, the family that I have, the amazing practice that I have, and the amazing people I get to work with and change lives with. And it really changed me for the better. And I've watched diagnoses like this change people for the worse and for them to sink deep into a depression and give up and. And live to their label instead of living to their potential. And that's why I think this episode is so important for us, because we all have a choice in life. When we get dealt something kind of difficult, we can let it consume us and let it take every ounce of life from us, or we can allow it to become the fuel that makes us better, makes us contribute to life maybe differently, but in a better way. So, you know, I know that this idea of letting diagnoses lose their power can be really uncomfortable for some people, because there's people that are waiting for that diagnosis. I'm in some. Some social media groups, and I'm listening and reading to people who are saying, I'm so angry I didn't get the Ms. Diagnosis today. I'm so angry I didn't get the Lyme diagnosis today. I'm so upset that they can't find anything wrong with me. And I understand.

Dr. Deb Muth 5:20

I know the feeling of wanting to put a name to what you're feeling so that you have validation and you have power around this diagnosis, and you can prove to people that what you're feeling is not in your head. I get all of that. But for many people, the original diagnosis is meant to help guide treatment in the conventional sense. It's a created, shared language that we have, and it brings clarity. But for many people, you give that label and that name so much power and so much control over your life and who you are and what you're being. And that's not what the label is meant for. Somewhere along the line, medicine started confusing naming with healing. And today, we have more diagnoses than ever. We have more testing than ever. We have so many thousands of specialists, and yet people are sicker. They're more inflamed, they're more exhausted, they're more confused than ever. And that's not just a coincidence. That is how the system is meant to work. It's meant to confuse you.

Dr. Deb Muth 6:44

It's meant to keep you dependent on it. It's meant to. Meant to keep you on medical management for the rest of your life. And by doing that, we enrich the pharmaceutical companies to the point where their whole role is to continue to create drugs that you need to be on for the rest of your life. And the hard truth about all of this that I've seen in my practice is for many patients, the diagnosis really becomes their identity. They own it, they gravitate to it. It's who they are. It also becomes their prison because they only live confined inside the diagnosis. I can't do this because I can't do that, because if I do this, this will happen, because I have. They've capped their ceiling of life based on a couple of words that somebody gave them at a point in their life when they were so low and potentially so desperate that they needed that name to identify themselves and what was going on. And instead of asking, why is this happening?

Dr. Deb Muth 8:05

Why are these symptoms happening? What's causing these symptoms? They're told, this is what you have, and this is what you're going to have to live with. And instead of restoring function, these people become managed. Like I said, they're managed with drugs. They're managed inside the system. And instead of healing, they're monitored with this blood test and that blood test and this MRI and that mri. Instead of providing hope, they're handed a lifelong prescription with expectations that do nothing but decline. So you walk out of that room with this expectation that your life is never going to be the same, that your function is going to decline, your neurological disease is going to take over eventually, you're going to be put in a home, you're going to lose everything you have because you're not going to be able to afford the care that you need. And that's the expectations of our healthcare system today. When you're labeled with a chronic illness diagnosis, and for a woman, especially women, this is magnified because their symptoms are told to them as. It's stress, it's hormones, it's anxiety, it's aging, it's motherhood, and then, of course, it's perimenopause. Like that is some major traumatic thing that should disrupt your entire life. Yet it shouldn't, and it does, and it doesn't have to. And of course, my favorite is always, but your labs are normal. We don't know what's wrong with you. It must just be in your head.

Dr. Deb Muth 9:53

And this is why women are done being dismissed, why this shift is happening now that we are empowering women to take back Their lives, take back who they are and take back how they're being treated in the healthcare system. And it is one of the most important things that we can do right now is to give women their power back so that they can stand strong in who they are and in their intuition and fight and say, no, this is not happening to me right now. I am not accepting this label. I'm not accepting this diagnosis. I will fight, I will find answers, and I will do what I need to do to be the woman that I want to be. So why is this conversation exploding right now? Well, there's actually three big reasons, and first and foremost, it's over. Diagnosis, burnout. People are collecting diagnoses without solutions. Autoimmune labels, syndromes, vague neurological names, but no one's connecting the dots.

Dr. Deb Muth 11:02

You see, when you start to stack these labels on top of each other, one after the next after the next, you know, it's celiac disease, it's Hashimoto's, it's fibromyalgia, it's autoimmune. You know, rheumatoid arthritis. It's. Whatever it is, it's long haul Covid. These days, no one is putting these connections together to say, why are you developing so many diseases that are so similar in nature, ones that just kind of domino after each other? Nobody's looking at your immune system. Nobody's measuring it, Nobody's telling you how well it's working. No one's supporting it. They're just throwing these biological drugs at you. And if there's an autoimmune disease and sending you on your way and saying, this is what you have to look forward to for the rest of your life. But don't worry, these side effects are rare, including cancer. It does not make sense to me that we are not looking at the root cause for all of these crazy diagnoses that we are labeling people with today. And I am guilty of it myself, because within the system that we work, we have to label something in order for you to receive the care that you need, for your insurance, to pay for the treatment, for the tests, for the visits. There has to be a label. And that's what we call an ICD10 code. And if we don't have the appropriate label, none of what we're recommending gets covered for you. And that's the label game began. The second thing is long haul Covid. And post viral illnesses.<...

Dr. Deb Muth 0:03

Today's guest is someone I'm honored to call both a friend and a mentor, and one of the most trusted voices in medicine for patients with complex chronic illness. Dr. Neal Nathan is a board certified family physician who has spent decades caring for patients who don't fit neatly into diagnostic boxes. Patients with mold related illnesses, Lyme disease, mast cell activation, and profound nervous system dysregulation. These are the patients who are often told their labs are normal and their symptoms are anxiety or that nothing more can be done. Instead of dismissing them, Dr. Nathan listened and he asked better questions. His work, including his landmark book, Toxic, has helped thousands of people finally feel seen, believed, and understood, and more importantly, has given them a path forward when medicine failed them. This conversation is for anyone who reacts to supplements or medications, for anyone who has gotten worse instead of better with treatment, and for anyone who knows their body that something deeper is going on, even if they've been told otherwise. Dr. Nathan, I'm deeply grateful for your mentorship, your integrity, and the way you continue to advocate for the most vulnerable patients. I'm so glad to have you here today. And before we begin, grab a cup of coffee, tea, or whatever grounds you, because this is the conversation you'll want to settle into. Now, before we go onto this conversation, we need to hear from our sponsors. So give us just a quick moment and then Dr. Nathan and I are going to dive in to his story and how this all started for him and leave you with some nuggets of wisdom that you can help yourself with. Ladies, it's time to reignite your vitality. Primal Queen supplements are clean, powerful formulas made for women like you who want balance, strength, and energy that lasts. Get 25% [email protected] Serenity Health that's PrimalQueen.com Serenity Health because every queen deserves to feel in her prime the right places and then we can get started. All right? So, Dr. Nathan, like I said, I'm so excited to have you here today. Tell us a little bit about how did you start your career? Because you didn't intend to work with the most complex and sensitive patients, I'm sure when you started out. But what did you notice early on that made you realize medicine was missing something?

Neil Nathan MD 3:03

You know, Deb, actually, I did start out wanting to work with the most complicated cases. My delusional fantasy when I started was I wanted to help every single person who walked into my office. And so when I left medical school, I realized pretty quickly that the tools that I learned there were not adequate to do That I needed to learn more. So I started on a passionate journey of discovery, if you will, in which I started studying with anyone who had anything interesting about healing to talk about. And I want to emphasize that I was interested in healing, not in what I'll call medical technology. So medical school taught me to be a good medical technologist, but it didn't teach me about healing. I graduated a long time ago. I graduated from Medical School in 1971. And the word holistic wasn't even a word back in those days, but that's what I was looking for over many, many years. I studied osteopathic manipulation, homeopathy, therapeutic touch, emotional release techniques, hypnosis. If it's weird, I probably have studied it at some point. I wasted some weekends studying things that I don't think were particularly valuable. And I've had some remarkable experiences with true healers that taught me how to expand my understanding of what healing really meant. So early on, when I first started practice, I would invite my colleagues to send me their most complicated patients because that was my learning. That makes me weird. I know that. I love some problem solving. You know, I'm the kind of person who I get up in the morning and I do all of the New York Times kinds of puzzles. That's. That's my brain wake up call. So actually I did invite my colleagues to send me their complicated patients, and they did. So, I mean, they were thrilled to have me in the community because these were people they didn't know what to do with. And I was happy as a clam with all these complicated things that I had no idea what to do with. But it pushed me to keep learning more, to keep searching for this person's answer. And this person's answer, that constant question is, what am I missing? What is it that I don't know or understand? What questions am I not asking this person that would help me to figure it out? So sorry for the long winded digression.

Dr. Deb Muth 6:14

No, I'm glad you shared that. I'm very similar to you. I didn't seek out working with the most complex, but as I started that, I was always very curious as well. So I was the same as you. Every weekend I would learn something and hypnosis and naturopathic medicine, homeopathy, and all these quote unquote weird things, right? And there's always a pearl that you learn from something. You never not learn anything, but some of it, you kind of take or leave or integrate or not. And, and I think it, it makes you a better Practitioner, because you have all these tools in your toolbox for helping people that nobody else has been able to help. And. And it's just kind of fun learning. I mean, I'm kind of a geek that way too. I like to learn all those things.

Neil Nathan MD 7:00

Learning is my passion. One of my greatest joys in life is going to a medical meeting and getting a pearl. Literally. I'm not one of these people at medical meetings that have a computer in front of me listening. And I have a pad of paper and I'm writing down ideas next to people that I'm working with. So that, oh, let's bring this up for these people. Let's bring this up for these people. So it's like, oh, great. Can't get right back to the office on Monday so I can start, have some new ideas about what I'm missing.

Dr. Deb Muth 7:38

Yeah, I do the same thing. I have my pad of paper and I do the same thing. And as I hear something, I'm thinking about a person that's in my office that I haven't been able to help, or we've been stuck on something, and I'm like, oh, there's a new thing we can try. And it's so exciting. I love that. Let me ask you this. Was there a time when you finally thought, like, if I don't listen to these patients differently, they might not ever get better?

Neil Nathan MD 8:04

That's a very complicated question. The people that I was treating that weren't getting better were the ones that got my greatest attention. And one of the questions that constantly troubled me still does is, is this person not getting better because of some feature of themselves, or is it because of something that I don't know? So I've wrestled with that for a very long time. My answer to it now is, For a long time, I've been able to see what I will call the light in a person. Call it a healing spark and energy. It isn't truly light. There's just something about that person when I work with them where I know this person will get well if I stick with them long enough. And then when I don't get that, I don't think I've helped any of those people over the years. Yeah, so it was a very long process of really not helping people for five years daily. And I would. I would ask those patients, I would say, you know, I haven't helped you. We've been doing this for a very long time. Why are you still here? And they would say, because you care. And I would. Back when I was Younger, that was enough for me to go. That's true. Okay, I'll keep working at it. But as I've gotten older, caring isn't enough. It's. I'm not sure I'm the right person for you. And so as I've gotten older, when I don't see that spark, when I don't get that sense of someone, I'm more inclined early on in the relationship to tell them I'm not the right person for you. Yeah, you know, see if you can find someone else who can understand what you're going through and help you. Because I, I'm not it.

Dr. Deb Muth 10:16

Yeah, you, you kind of know that you can help them or not. Yeah.

Neil Nathan MD 10:21

I don't know how to define that sense, but it's very clear to me. I call it like seeing the inner light of another being. If it's not there, and maybe it's not there for me to see as opposed to someone else can see it.

Dr. Deb Muth 10:41

That's interesting. So you're known for working with patients who are highly reactive. They don't tolerate supplements, a lot of times medications, or even some of your most gentlest protocols. Why are these patients so often misunderstood?

Neil Nathan MD 10:59

Because they appear to their family and to many other physicians to be so sensitive that the thought process of families and other physicians is often. Nobody's that sensitive. This has got to be in your head. And that is what is conveyed to those patients. And they're told it's gotta be in your head. Go see a psychiatrist or a therapist. But I can't help you. And unfortunately, we have learned in the last 20 years a great deal about, is making our patients so sensitive. It is a true reaction of their nervous system and immune system, and it is in response to various medical conditions they have. So again, as we've been talking about, those were the people that got sent to me for many years. And I, I have never believed that the majority of any. Anything that someone has experienced is in their head. Yeah, Almost everything I look at is real. I may not understand what is causing it, but for me, doubting a patient's experience is not something I've ever done. And that's what's helped fuel what I've learned and what you learned over the year. That, okay, if this is real, and it is, I'm sure it is,...