What Is A Compounding Pharmacy? The Science Behind Medications Customized Just for You | Shaun Noorian

Coming up on this episode of the Doctor's Pharmacy.

May utilize active pharmaceutical ingredients that have been FDA approved, but in order for a drug to be considered FDA approved, it has to go through the FDA approval process. And that process may take 10 plus years and billions of dollars. Well, that may not make sense for a small patient population that needs their medications today.

Before we jump into today's episode, I'd like to note that while I wish I could help everyone via my personal practice, there's simply not enough time for me to do this at this scale. And that's why I've been busy building several passion projects to help you better understand, well, you. If you're looking for data about your biology, check out Function Health for real-time lab insights. If you're in need of deepening your knowledge around your health journey, check out my membership community, Hymen Hive. And if you're looking for curated and trusted supplements and health products for your routine, visit my website, Supplement Store, for a summary of my favorite and tested products. Welcome to the Doctors Pharmacy. I'm Dr. Mark Hyman and this is a place for conversations that matter. And if you ever heard about a compounding pharmacy or intravenous drugs or topical hormones or different cocktails for hair loss or sex function, well this is the conversation that I think you're going to like a lot because we have on today, Sean Nurrenbern, who's the CEO and founder of Empower Pharmacy, the biggest compounding pharmacy in America. And he is on a mission to help people live healthier, happier lives. He's got a great commitment to quality innovation. And he's basically started and is now the biggest compounding pharmacy in the country that is one of the highest integrity pharmacies that serves functional medicine practices and physicians who want to create personalized healthcare. He's a whole wide variety of high quality medications, topicals, injectables, orals that are improving people's lives. And I personally use them in my practice. And I wanted to have Sean on because I met him at an event I did in Spain, a longevity retreat, and we got to be friends. And I was like, the world needs to hear more about compounding pharmacies and what they do. So Today we cover a wide ranging topics including how to get compounded semaglutide or Ozempic, the pros and cons of that and peptides, what kinds of things are available for sexual arousal disorder and sexual health, things that can help you with longevity and aging. We talk about intravenous therapies. Have you heard about IV cocktails and for immunity or for recovery? We talk about all of that. And I think you're going to find this conversation very interesting. So let's dive right in. Sean, welcome to the Doctor's Pharmacy. It's great to have you. Oh, pleasure to be on. Thanks for having me. We met in Young Forever Longevity Retreat that I did in in Ibiza. And, I was so excited to meet you because in my practice at the Ultra Wellness Center, we use a lot of compounded pharmaceuticals and drugs and compounds that your company makes called Empower Pharmacy. And, I was like, oh my gosh, I know that it's pharmacy. I use it all the time. I use their products myself. And, I was so excited to meet you and learn more about what you're doing. And, I think most people listening, I imagine, don't really know what a compounding pharmacy is. But from the perspective of optimizing your health, of getting access to innovative forms of products, delivery of products, intravenous products, injectable products, topical products that are not easily available on the marketplace or through your regular doctor, through pharmacy, you know, there's this whole parallel world of what we call compounding pharmacies, which kind of like our I think of like a mad scientist lab where you cook up all these kind of stuff that isn't made by a drug company and that you actually can use in the service of helping your patients get healthy. And I've been doing this for 30 years and I could not do medicine without a compounding pharmacy. So for those who really don't understand what a compounding pharmacy is, I want you to explain it. And today we're going to go deep into the kinds of things that are available at compounding pharmacies that people don't typically know about that can make a big difference in up leveling their health or treating chronic conditions. And you had a personal story which I think is very compelling about why you went into this. You were like an engineer, you know, may take things apart. You were not in a medicine track, but something happened to you that really affected you. So first start out with this big picture of what is a compounding pharmacy and then tell us how you yourself ended up here because your background didn't seem to lead in this direction.

I'm very lucky to have been introduced to this industry that gives us the ability to help millions of patients get access to quality, affordable medicine. And if you think about compounding, compounding has been around since the beginning of time. Before big pharma existed, everything was compounded. I'm sure you can imagine pictures of an old apothecary where they're making a concoction at the bequest of the practitioner and using mortars and pestles. Well, that is compounding. And before the industrialization of manufacturing for the pharmaceutical industry, everything was compounded. And it wasn't till the early 1900s where we saw that get transferred into factories away from the local apothecary or druggist. And by the 1930s, we saw about 75% of medications were compounded. Fast forward to the 1975 where it became only about 70, 25 prescriptions. 25% of prescriptions were compounded. And then you fast forward to today where only about 1 to 3% of compounded medications are prescribed in this country. So compounding has kind of gone the wayside over the past 150 years. But now we're seeing a resurgence because more patients and providers are becoming more knowledgeable about compounding pharmacies and the use that compounding pharmacies have when customizing dosage forms. So compounders like us, let's say you have a medication that contains a dye from a commercial product or is back ordered, discontinued, orphaned, or just not available. in a certain dosage strength, form, or combination. Well, a prescriber can work with a compounding pharmacy to give that patient exactly what the doctor ordered and optimize that patient's treatment so they can have the best outcomes. Exactly. I prescribe hormones for women, but not.

Everybody needs exactly the same standard dose, so I modify based on their symptoms and up the estrogen or lower it or raise the testosterone or lower it or raise the progesterone or lower it, and I can be like a mad scientist based on what's actually personalizing the care to that patient.

Exactly. And this is why we see functional medicine providers such as yourself utilizing compounding pharmacies because all of us patients, we have a different amount of biomarkers within our serum. And when a pharmaceutical company only makes a single product, it can't help the entire patient population that is differing. in their comorbidities as well as their health status. And so by working with a compounding pharmacy, doctors can really fine tune these therapies so that patients can receive the best outcomes.

Yeah. So you had a story which was quite unique and it's kind of a rare condition that got you into this because you were going through life feeling okay and then kind of the bottom fell out. Can you tell us your story about your own health journey and what actually led you to start Empower Pharmacy, which is now the biggest compounding pharmacy in the country.

Yeah, you know, it's a story of luck, I think. You know, so I've always been into cars and my father owned a go-kart track, so I've been racing and building go-karts and fixing them since I was five years old. And so I wanted to go get a degree in mechanical engineering with an emphasis on automotive engineering. And when I got my degree from UT Austin in December 2007, I couldn't get a job working for any car companies.

You couldn't get a job at a go-kart manufacturer?

Well, not the one that I wanted to work at, unfortunately. And the car industry wasn't doing very well. No, very few industries were. It was the beginning of the recession.

2007, you graduated. This is your 2008 here you're talking about, which is not a good economic time in America.

Exactly. And so I did what most engineers in Texas do. I got a job working for oil and gas. And I was very lucky to get a job working for a great company Schlumberger doing hydraulic fracturing as a field engineer. Now, working out in the fields is hard work. I have so much respect for the men and women out there that put their lives at risk to be able to give us energy that powers our society. And so, you know, When I was out there, I saw so many injuries. It was nine months in when my number was up and I was lifting a heavy piece of pipe. I lifted it the wrong way and ended up hemorrhaging several of my lower vertebrae in the process. I couldn't work out in the field anymore, so I went into physical therapy. One of the chiropractors that was working with me noticed that I was very skinny for my age. Keep in mind, 25 years old at the time, 5'10 and I weighed about 125 pounds. Just always been skinny my entire life. No matter how much I worked out, how much I ate, I couldn't gain any muscle whatsoever. I thought that's the way it is. Those are my genetics. Well, when this doctor took my blood, he noticed that I had the testosterone level of an 80 year old man, which kind of described why I was so skinny my entire life and why I couldn't gain any muscle and why I probably got injured. because I was lifting a very large piece of mass that my body could not support. And so he sent me to a specialist in Houston, which is also another very lucky part of my story. Houston being the largest medical center in the world had some of the best specialists in the world that specialized in my condition. And so the term I had, low testosterone, because I was born with a pituitary disorder, my body doesn't create luteinizing hormone or follicle stimulating hormone. And so my doctor sent me- and.

Those are pituitary hormones that regulate your sex hormones like estrogen, progesterone, testosterone, and so forth.

Yeah, yeah, and for men specifically, luteinizing hormone works on the Leydig cells to produce testosterone and follicle stimulating hormone works on the Sertoli cells within the testicle to produce sperm. And so I was hypogonadal and I was infertile. Yeah, well, you know, it became fun afterwards. Once I got my first medication from a compounding pharmacy, and this is another very lucky part, my doctor just happened to be very wise and knew that in order for his patient population to be able to be compliant with their therapies for the rest of their lives, they would have to utilize a compounding pharmacy, one, because big pharma increases prices on average by 11% a year. And if a patient is going to be on these medications for 50, 60 years, a large portion of the population will lose access. And second, he knew that in order for his patients to get the best outcomes, that he would want to customize these treatments for those patients and use products that may not be on the market commercially, but could be made by a compounding pharmacy. And so that was my introduction to compounding. I got my prescriptions filled at a compounding pharmacy in Houston, got my first injection of testosterone, and it completely changed my life for the better. I became normal. And becoming normal is an amazing thing. You probably didn't know how bad you.

Were feeling until you started feeling good, right?

Exactly, exactly.

Yeah.

The symptoms of hypogonadism, depression, low libido, low stamina, I'd take a nap at 5:00 every single day. I was sleepy all the time, even though I I'd get good enough sleep if you broke it up in enough periods. But, you know, I didn't realize that all this stuff could be fixed just by normalizing the level of testosterone in my body. And since then, I've been working and learning about this space and integrating more and more therapies into my treatment protocol to be able to optimize myself so I can be the best version of myself that I can be.

Great. Well, that's an interesting entree into what I want to talk about next, which is, you know, the, the, the other things that are available that are a little more kind of fun, like testosterone is just like core. If you don't have that, you're, you're kind of bottomed out. And, you know, not everybody has a pituitary disorder, but a lot of us are just out of whack. And, and I personally use a lot of compounded compounds. for my own health and I find them extremely effective. And I think there are things that are not available. For example, I get NAD from Empower. I have other injectables that I use in my practice all the time for IV therapy like glutathione and B vitamins and so forth. But I'm curious what other things are in your stack of compounded therapies that have helped you become more normal that you've used that you've innovated and created.

Well, there's, you know, Every patient is unique. And so we see, you know, we manufacture 600 different drugs. And the primary ones that we see functional medicine providers utilizing, as you said, as the base, we have the hormones, testosterone, estradiol, progesterone, estriol, estrodiol, whatever DHEA, whatever is out there that the patient may be deficient in. And then on top of that, then we see some providers utilizing growth hormone replacement therapy to improve immune function, hair, skin, nails, sleep, and also help repair injury. And then we see additional therapies like Nootropics, methylene blue, for example, being utilized for patients that want better mental clarity. Maybe ketamine for patients that have depression. Maybe we have their patients are obese, so they're utilizing a lipotropic injection or a B12 injection. or they're also utilizing a GLP-1. And so, you know, you see all these different areas of treatment being integrated into a patient's profile so that they can become better. And then, of course, they go back and see their doctor on a quarterly, biannual, annual basis. They take more blood, see how their body is responding. And then adjusting therapy accordingly and sending that new compound to their compounding pharmacy to fill.

Are you comfortable sharing other things that you use in your stack of things.

That you- oh, so I use methylene blue, testosterone of course. We make a topical hair product called Hair Restore Ultra that has minoxidil, azelaic acid, finasteride, and ketoconazole.

Those are all medications that is anti-fungals, hair loss drugs, things that are for, you know, androgen blockers, right?

Right, right, exactly. Combining multiple active ingredients, pretty much doing polypharmacy, but putting everything into a single dosage form. So it makes it much more convenient for the patient, what makes the patient more compliant, and also makes it a lot more cost effective, providing one drug instead of having the patient apply four different drugs.

And by the way, these are generic drugs, so the costs are much, much lower. and you get it locally, topically, rather than having to take, for example, finasteride, which is Propecia, which can cause sexual side effects and other problems when you're taking it systemically, but taking it topically, you actually can get the benefit without having to kind of load your body up with the drug.

Yes, there's less absorption when the medication is applied topically than if a similar dose was taken orally. And so the patient they get more of the local effects without it becoming systemic, becoming too systemic versus other dosage forms. And yes, drugs like finasteride can become debilitating for many men, not just causing erectile dysfunction, but a subset causing post-finasteride syndrome, which they never regain their libido after.

That's a scary thing.

That's very scary.

Yeah. So that's part used topical, use a methylene blue, use the testosterone, anything, any other goodies?

Yeah, my acne cream. So we have different forms of acne cream. One that I utilize has tretinoin, clindamycin, and niacinamide. I use that every three, four days. And then one that I use every night is what we call acne DNS. It has Dapsone, niacinamide, and spironolactone. And by combining all these different drugs and vitamin together, it makes it much more convenient for the patient, applying one medication instead of three. And as I mentioned, because of compounding pharmacy, you know, we are kind of like a vertically integrated supply chain. We buy our drugs directly from the active pharmaceutical ingredient manufacturers that the rest of pharmaceutical manufacturers purchase them from. And because we don't have to, we probably don't work with insurance, we don't deal with carriers or PBMs, and we go directly to the patient when working with the prescriber.

PBMs are pharmacy benefit managers that are basically the kind of secret and evil underbelly of the healthcare system that controls drug pricing and is why in America it costs 10 times as much for the same drug as it costs in Europe. Just to get people on the same page and you with compounding pharmacies, you can get the same things at a fraction of the cost.

Exactly. And what we've done is we've become an FDA registered manufacturer and 503B outsourcing facility. An outsourcing facility is a hybrid compounding pharmacy slash drug manufacturer that the FDA created in 2013. to meet the needs of practitioners that want to order products for office use. And then we have our pharmacy, our 503A compounding pharmacy that makes medications at the bequest of a provider but dispenses them directly to patients to self-administer. And then we've also become a wholesaler as well. So we are the manufacturer, wholesaler, and pharmacy all vertically integrated into one. And by not accepting insurance, carriers and PBMs are out. It's a fully vertically integrated supply chain that works directly with every single pharmaceutical end user in this country and you get the medications at a much lower cost because the lack of all these unnecessary middlemen.

So the middlemen, right? Exactly.

So any other goodies in your stack of treatments? You know, I'm always experimenting with different forms of testosterone. There's testosterone cypionate and nanthate. You know, we actually make a combination of testosterone cypionate with a bit of testosterone propionate, which is a much faster acting ester. The pharmacokinetic half-life of testosterone cypionate is about a week long, and the half-life of propionate is about two days. And so, you can get a much different pharmacokinetic response and peak than you would be able to by just utilizing a single ester by itself. Yeah. People might be listening going, well, gee.

You know, it sounds kind of like a mad scientist. Is this regulated? how do I know the dose is right? I'm not going to take something that's got weird things in it. There was some shady things that happened with the compounding pharmacy a few years ago with injectables that kind of got some fungal thing in some guy that had everybody kind of crazy. So people are listening going, well, this sounds good, but shouldn't I trust my pharmacy more? Why would I trust a compounding pharmacy that seems to be doing kind of experiments with all these different things? And how do you answer that?

Because I imagine people are thinking that as they're listening. Yeah, it's a good question. Compounding pharmacies, as I mentioned, they've been around since the beginning of time. And they've been around before Big Pharma was around. And they're governed by the state boards of pharmacy as well as the FDA. And the rules around making drugs, especially drugs that are destined to be injected into people, they are some of the strictest rules of any industry. And so state boards, they inspect compounding pharmacies every single year and ensure that the rules that are primarily the United States Pharmacopeia, the standard setting organization for all drugs that are made in pharmacies, the rules that they set are being abided by. And then of course the FDA got jurisdiction of the practice of pharmacy in 2013 with the passage of the Drug Quality and Security Act because of that fungal meningitis outbreak. that happened in 2012 from a company called NECC, or New England Compounding Centers. And that pharmacy made one bad batch, or I should say three bad batches, and killed 70 people and injured 700 or more. And so the FDA, so Congress then came in and said, How can we prevent this from happening again? And that is how the Drug Quality and Security Act was passed. And this new category of 503B outsourcing facilities was created. where the drugs that come from these facilities are made under good manufacturing practices or cGMPs, the same standards that the pharmaceutical industry uses.

So basically in English that means that the drug companies when they make a drug have really strict protocols in the factory that make sure that it says what it is on the label, that the dose is the right dose, that it's clean, has no contaminants in it, and that it's stable and it's bioavailable, and there's a whole list of things that you have to go through. So this is sort of the new regulation protects consumers. You know, I, again, I've been tracking this for 30 years. I've been using compounding pharmacies for 30 years. And one of my favorite is, is in the hormone range. You know, a lot of women have low libido or sexual dysfunction, especially going through menopause, hormones change. Testosterone is incredible for libido, and women actually have naturally occurring testosterone in their bodies, but it can get lower, just like in men as you go through andropause. And one of my favorite things that I, I learned about was compounded testosterone drops that are applied directly on the clitoris that are topical, local. Don't get systemic side effects, like maybe hair loss or hair growth where you don't want it. And no, masculineization effects. But they're extremely effective because I, I know they work because I keep getting calls for refills, you know, and, and I think these are the kinds of things that you just can't get at a drug. store through a regular pharmacist. So it's not exactly being a mad scientist, but it's actually using the compounds we have in innovative and new ways to help patients with certain problems that are hard to get solved with other methods. So, you know, when there are natural bioidentical hormones now available by prescription that you can get at your regular pharmacy, like, you know, some of the patches for estrogen, or the oral micronized progesterone, that's a prescription. Why would you want to use compounded versions? Why would that be better? You kind of go through that, because I think this whole field of bioidentical hormone therapy is kind of big and hormone optimization therapy, whether it's for men or women, is sort of emerging. And I wrote a lot about my book Young Forever, and I use a lot of these compounds. I think most people sort of wonder about which form should I be using and what types and should it be liquid, should it be gel, should it be cream, should it be injectable, should it be a troche that I put in my mouth, should it be a pellet that I inject under my skin? There's so many choices, right? So how do you help people think about it and how do you work with physicians to help them kind of figure this out?

That's a great question. Compounding pharmacies, one, people, a lot of prescribers prefer to use a compounding pharmacy for a patient because they can be assured that they are getting exactly what the doctor ordered. What strength is labeled on that vial will be what that strength should be because of all the rules and regulations around the practice of compounding and manufacturing drugs in this country. So that's really why we see practitioners utilize compounding pharmacies versus sending a patient to get maybe a topical progesterone cream that's maybe over the counter or a DHEA supplement from a supplement store. We have to test our products to meet these standards, especially if they're made at our 503 outsourcing facility. Every single batch has to be tested for potency, sterility, endotoxins, and a slew of other tests. to ensure safety.

How do you kind of know which way to go with these different varieties of applications and formulations and yeah.

Yeah, so when it comes to the utilization of one dosage form versus another, whether it's better for a patient to use a capsule, a topical cream or an injection, it's really up to the prescriber to determine what is the best form of treatment to the patient for them to be compliant with their therapy, first of all, because for subcutaneous implantable hormone pellets, you only have to do those about once every three months. And so a patient that travels a lot or may forget to take a daily or weekly cream or injection, that may be more convenient for that patient. But for patients that don't want or afraid to do injections, maybe a topical cream or a troche is more appropriate. And so that's the beauty of utilizing a compounding pharmacy. We can make whatever you think is best for your patient.

Yeah, I think, you know, for hormone therapy, it's one of those things that's so individual and testing is so important. And in Function Health, the company I co-founded, you know, we do full hormone evaluation, thyroid, all the sex hormones and other leptin, many other hormones. And it's really helpful because it helps us to see where people are at and how how we can help support them in making choices about, you know, what might be helpful for them. And I think, you know, most doctors are really not familiar with looking at this carefully. They're like, okay, well, if you're under, if you're under 50, you take the pill. If you're over 50, you take, you know, a hormone replacement therapy that you prescribe at the drugstore. And it's like, it's like if you have a high LDL, you take a statin. There's not a lot of thinking that goes on, but it depends on what the symptoms the patients are having. Is it vaginal dryness? is it hot flashes? Is it low sex drive? You know, what's happening? Yeah. So. So I had my own experience of. Of using a compounding pharmacy for myself. And a number of years ago, I got very sick. I live in an old barn. It's 125 year old barn. Barn. There was mold in the basement. I renovated down there. Used to be horse stalls and pretty freaking moldy. But the mold kind of came back. There's a leak. And I got very sick. I got cough for a year. I. I ended long story getting a root canal taken out and I need clindamycin, which is an antibiotic and that gave me C. Diff and I was just so sick and, and you know, around the same time when I was getting the mold treated, I moved out of the house, I got my root canal, I got my immune system was a little compromised. I broke my arm. I was in New Zealand riding where the Lord of the Rings was shot and I'm a very good rider. And it's a long story, but the horse basically spooked and I stayed on the horse and I let the horse, I just gave the horse the rein and let it kind of go where it wanted to go and it went off the trail and there was a gopher hole or something and it stepped in the hole and the horse keeled over and I jumped off the other side and I landed on a rock with my arm and it cracked my, really cracked my humor in half. I was like completely unattached. Just like dang it, I couldn't move my arm. and then I got really sick and I got colitis and C. Diff and I got ulcerative colitis that sort of started after that. I lost 30 pounds and I was in this catabolic state, which is a total breakdown. And, you know, normally, well, your fracture would heal in six weeks and it was six months and it hadn't healed. And they were like, oh, you need surgery and you need this and you need that. I'm like, I'm not getting plates and things and surgery. And I'm like, screw this. I'm like, and as a doctor, I know that, you know, one of the things that really helps strong bones is testosterone. And, and so I checked my levels, and they were, you know, kind of mid-range pretty good. I was pretty sick at the time, so a little low. And I, and I, and I tried it, and it was like a miracle. I literally healed my fracture after six months or actually eight months of, of non-union they call it non-union which is a very serious problem. I mean, like, I just, my arm would be dangling, and I feel like I couldn't use it. And, and I use the testosterone injections and my arm healed like that. So, you know, and it's not something that my typical doctor would have prescribed. It's not something that's part of standard medicine for Orthopedics, but, but it was something that was an off-label use for a compound that we know works. Now, maybe you could talk a little about this concept of off-label use because, you know, FDA approves drugs for a certain indication based on certain studies, but doctors then can use them for whatever they want. for example, spironolactone is a high blood pressure drug, but you're using it for acne or hair loss because it has other effects. So, and then you, your doctor, it's not illegal, you're allowed to do it, but there's a whole off-label sort of concept I'd love you to sort of talk about and how that can be helpful in getting people the compounds they need to treat the issues they need. They might be, you know, better served by a compounding pharmacy.

Prescribers can utilize a drug for any indication, whether it's on label or off label, if he or she believes it will have a clinical effect for that patient. And so the practice of using medications for off label use is perfectly normal and allowable. And a lot of doctors, almost all medications in compounding are used for off label use because no compounding pharmacy makes a drug that is FDA approved. We may utilize active pharmaceutical ingredients that have been FDA approved, but in order for a drug to be considered FDA approved, it has to go through the FDA approval process. And that process may take 10 plus years and billions of dollars. Well, that may not make sense for a small patient population that needs their medications today. And so that's why doctors utilize compounders to make these medications for that what may be considered off-label use for whatever they think is best for that patient.

And that's what I do all the time. There's no clitoral testosterone FDA approved drug, but I use it. And one of the things I think is kind of fun is the whole sexual health realm. There's Viagra, Cialis and so forth. But there are a lot of other things that are available and different delivery systems and compounds. So, since they're now kind of off patent. You know, I've seen combinations of things like oxytocin, which is a kind of feel-good love hormone when breastfeeding or after sex, that kind of is a bonding hormone that's made in the brain with, for example, like cialis or viagra. And, and they can be delivered by nasal sprays or by sublingual little lozenges. So, and, and can you talk about how you're sort of innovating by taking things that are on the marketplace and then using them to kind of enhance the benefits of some of these compounds.

Absolutely. We've seen sexual wellness come a long way over the past decade, especially for men. Women, unfortunately, don't have many FDA approved options out there. There are only two on the market.

I want to talk about those because you also can get those by injection. People don't know about it. It's amazing to me. how they don't know about it.

Right, right, yeah. Addyi, which was the first drug approved for female sexual hypoarousal disorder, it is an oral pill, generic name is flibanserin, and it may help increase feelings of desire. And then the second one that's FDA approved, which recently got approved several years ago, is known as bremelanotide, another brand name Vyleesi.

It's also a peptide.

That's right.

The name is PT-141.

That's right. And it causes arousal in almost anybody that injects it.

Now, men and women.

Men and women, yes. It's only indicated for postmenopausal women because that's the group that was studied to get the FDA indicated use. But it is reported that men and women, regardless of age, it has a similar effect. And so these are drugs that can be combined with each other by utilizing compounding pharmacy to make a different dosage form, like the injection may be only available for bromelainatide, but compounding pharmacy may be able to use it as a troche for buccal or sublingual absorption, and combine other drugs like oxytocin, phentolamine mesylate, We can even combine- what's that? It's a vasodilator. And, you know, it's actually used in intracavernosal injections as well. So, for men that fail on oral PD5 inhibitors like Viagra, Cialis, and Levitra, they can then utilize, they can work with a compounding pharmacy and a urologist to have prescribed a combination therapy of papaverine, Phentolamine Mesylate, and prostaglandin that can then be injected in the side of the penis in the corpora cavernosa.

This is Trimix.

Trimix, exactly. Yeah, and that's another option that patients have, whereas if they fail on sildenafil, tadalafil, or vardenafil, they have another option before they have to go to a penile prosthesis.

Yeah.

And that's, you know, that's kind of last.

Yeah, implant.

That's right, exactly. And so that's an example of where practitioners can utilize a compounding pharmacy to create an effective drug that is not commercially available.

Yeah, so Tri-Max is something you actually can't buy from your regular pharmacist, but it's incredibly effective and urologists recommend it and use it even from academic medical centers.

Oh, it's been used for decades.

And it's something that actually most doctors don't know about. In fact, I learned about it probably 20 years ago from a patient. he says, yeah, he's like, you know, 65, 68, whatever was having the time of his life. And I was like, what's going on? And he's like, yeah, you know, I use this thing called trimix, and it works every time. And it's like, I feel like I'm 20 years old again. And it's, it's an incredible thing that is available. And for women, I think the, the pt-141 or the gram limit tide is, is, is available as a prescription by Lucy, but it's kind of expensive. And, and the beauty of, of the, this whole field is that you can get a lot of these compounds. through your doctor that are at a much lower cost, that are just as effective and that can be actually enhanced with other components. The peptides, I want to talk about for a minute because peptides have been a big phenomenon over the last few years in the culture. Everybody's taking peptides, shooting peptides. And actually, the biggest selling drug in the world now is a peptide. guess what that's called? Ozempic, right? That's a peptide. Now, peptides are just small molecular weight proteins. They're many, many proteins, less than 20 amino acids, and that they have enormous biological effects. And there's thousands and thousands and thousands of them the body uses to regulate everything from hormones to sleep to to muscle growth to brain health. I mean, to sexual desire, to tissue repair. and they're quite amazing. And they've had their moment, and the FDA has come down pretty darn hard on these compounds, which as a practitioner I find unfortunate because, for example, one of them is called BP157. It's not really an FDA approved drug, but it's incredibly effective for injury and trauma. So I've had bicep injuries or tendonitis or various issues and you inject it. It's like a miracle within a few injections. They go, and I had someone who was, you know, was an elite athlete, and he had torn his calf, and I gave him a few injections, was gone. Another one had tennis elbow for months and months and months and was treated by all the traditional doctors, put the little peptide in there. It kind of got, kind of got resolved. And, and recently, the FDA has sort of come down pretty hard on saying these are, are not able to be used and they're not legal. And there are some peptides that are legal. So some of the ones we talked about, you do actually provide like semaglutide, which is Ozempic, as the brand name, or the liraglutide or PT-141 for sexual arousal disorder. There are some that have actually been FDA approved and you can use those. But the other ones you can't. So can we talk about the state of these sort of science and also the state of the politics? of these peptides and what your perspective is and where we should be going.

Peptides are very powerful substances, as we've seen.

Insulin is a peptide, just so everybody knows. We know how powerful insulin is.

Absolutely. And because they're so powerful, they are considered drugs. And in order for a compounding pharmacy-.

So does your poop now, you know that? The FDA regulates your poop. You can't do a fecal transplant because it's considered a drug.

Yeah, exactly. There's so many different therapies that the FDA has determined meet the classification of a drug and not a supplement, and therefore require the supervision of a prescriber to be able to ensure that the patient utilizes that medication safely and efficaciously. And when it comes to the list of peptides that have names that contain letters and numbers like BPC-157 or CJC-1295, or AOD 96-08, exactly. You know, they're, they can, compounding pharmacies can only make drugs that have met one of three conditions. It has been a component of an FDA approved drug at some point in time. It has a USP or NF monograph, and by the way, USP stands for United States Pharmacopeia, NF stands for National Formulary. These are the government bodies that oversee the practice of compounding and if they've established a compendial certificate of analysis, you can show that that drug has been studied and that it's regarded as safe. And then there's the third condition, which these drugs may have to be listed within what's known as category one of the 503 bulk list, which is a list of drugs the FDA has deemed safe and efficacious that neither have a USP or NF monograph and haven't been a component of an FDA drug but are considered safe and have been grandfathered in. And so these peptides have never been approved, don't contain a USP or NF monograph, and aren't contained within category one of the five or the bulk list, so they've never been legal to be able to be made. Now, a lot of practitioners and compounding pharmacies have promoted these drugs over the years, and now we see Finally, the states and federal regulators, the FDA, are taking action against compounding pharmacies for making these peptides because they were never supposed to be made in the first place.

They're more for research purposes or for-.

Well, some of these peptides, while some are very safe and efficacious, others may not be. Some have failed clinical trials, almost all of them have failed clinical trials, which is why they still have their their letter and numbering system. For example, CJC-1295 stands for Conjugated Chemochemical, which is the name of the company that created the peptide and was studying it during clinical trials. Now, those trials had to be ceased, I believe in phase one for that drug, because of patient death. And yeah, because these drugs, they have significant effect, especially that one on growth hormone release. And this is why, you know, Until these drugs become FDA approved, the FDA and state boards of pharmacy are not comfortable utilizing these drugs in a regulated environment.

Do you think it's overreach or do you think that they're like, you know, I have this theory, maybe just conspiracy theory, but it seems like a lot of things that really work, the FDA comes hard down on, like for example, n-acetylcysteine, which is basically actually something we use in the emergency room for treating talon over those, but now, they don't want you to sell it over the counter and because for whatever reason. But it's an incredibly safe compound and it seems like there's some kind of shady business going on where pharma may be like pushing back. And it seems like when the Ozempic drugs came on, that's when the FDA started to come down hard. And I don't know if it's a coincidence or not, but there's an interesting moment happening now in the industry where the FDA says, you know what? There's a shortage of these drugs, right? And yes, compounding pharmacies can start to make them. And it's one of the things you do make, which is semaglutide, which is a generic version of Ozempic. And there's been a fair bit of warning in the press from the FDA about compounding pharmacies making these compounds and people getting in trouble because the doses aren't standardized, because the formulation may be right, because people don't know how to mix it, they don't know how to inject it. it's not standard. It's like an auto injector pen. You can't make a mistake. It's idiot proof, you know? But people, you know, have to have some degree of skill and knowledge and be able to do math and know how to dilute it and know how to draw it up and know what the units mean and the milligrams are. It's like, it's a lot. So, but you do it. What's your perspective on, on this? Because, you know, when you look at the pricing of Ozempic and similar drugs, you know, it's like 1700, 1300 bucks a month. When you look at it from a compounding pharmacy for the doses you might want to use, it might be $20 a month. And in fact, you can modulate the dose because some people are taking too much in these formulations that are prescription. There may be too much and then people get side effects and nausea and this allows for more customization. So can you talk about what's happening around this field of compounding and this peptides and semaglutide and Ozempic and where we're at and should people be worried about it? Should they be using it? Is it safe? Is it something that you think we should bypass the farm industry and go with compounding pharmacies and stop the price gouging? Because if you go to Canada, it's like $100 or something. If you go to New York, it's $2,000. How does that make sense?

To talk about peptides and the conspiracy theories, I've heard them all, and if you look at what the state and federal agencies are doing, all they're doing is the same thing they've always done, enforcing the rules and regulations that are currently in place. And so it's just a coincidence that FDA is starting to put more attention to these peptides that weren't allowed to be made in the first place at the same time as semaglutide and tirzepatide and other GLP-1s. have been on back order. It's really just about making sure that our drug supply chain utilizes drugs from regulated industries that are listed within, that the FDA and state boards allow you to make. Now, when we talk about other peptides like the GLP-1s, you know, compounding pharmacies have really stepped in and made a huge difference where there is a national and global shortage where Eli Lilly and Novo Nordisk, the makers of Humalog, Humalog, Ozempic, Zepbound and Mounjaro, the brand names for semaglutide and tirzepatide, can't keep up with demand. And during times where a drug is on shortage, the only other legal avenue for patients and prescribers to get access to these medications are through compounding pharmacies and outsourcing facilities. And that's one of the reasons why we exist, to be able to add additional supply to our country's supply chain during times of need. Now, these drugs, yes, we pay a lot more for them in the United States than we pay in other countries.

We do. Just to clarify something, because I'm confused, and this is maybe my ignorance, but these drugs are made by pharma. So let's say Novo Nordisk makes Ozempic and Wegovy. They're making it in their factories. They've got the patent on this drug. Where do you get your semiglutide from? From them or from some other company that's making it?

It's a good question. There's a lot of patients and prescribers. They think that compounding pharmacies and outsourcing facilities, we get our active pharmaceutical ingredients.

Off the street, you know, back alley somewhere.

Right. Nothing is further from the truth. We have to source, by law, we have to source our ingredients from the same exact places that pharma sources them from, FDA registered active pharmaceutical ingredient manufacturing facilities. And so we get the same, they.

Have to- But I'm confused, how can a drug that is on a patent be made by another company?

Well, the patent covers a certain dosage form, certain dosage strength, and certain indication. The active pharmaceutical ingredient, that is covered by a patent that covers a certain manufacturing process. If another API manufacturer uses a different manufacturing process, then it's not in violation of that.

Interesting. So it's really about the delivery system and all that. Because in a way, these aren't really drugs. These are natural compounds like testosterone or estrogen or vitamin C or vitamin D that exist in nature that are not new to nature molecules. and so new to nature molecules, they are like things that we make up in the pharmaceutical industry, but these are things that naturally exist, but it's the way they get these patents is through the delivery system, the injectable form, like you said, the dosage and so forth. So basically, these peptides have been widely available because they are natural compounds.

Right, and natural compounds, as you mentioned, insulin, is a natural compound, but it is a drug. You know, anything that, what differentiates a supplement from a drug is that the drug has a significant effect biologically that needs a doctor's supervision for the patient to be able to safely take that medication. Whereas a supplement, you know, it's not going to have as much of an effect, so it can be, it's considered safer. for a patient to self-administer without the use or assistance of a prescriber. And so GLP-1s, they are very powerful when it comes to treating, as we know, type 2 diabetes, obesity, cardiovascular disease, hepatic disease, addiction, and some cases, now there's some studies showing that it helped treat Alzheimer's, fertility issues, and the list just keeps going on and on.

And I wonder, by the way, I'm just gonna make a footnote here on that. I think there's some evidence that it may not be the drug itself. It may be the fact that people are losing all that weight and fixing their metabolic dysfunction, which causes all those problems. So, I think that's an open question. I feel strongly that, and I've seen some data that suggests that it's actually the weight loss, not the drug.

Right, because a lot of these other disease states are subsequent causes of obesity. And so if you, obesity is one of the leading causes of death because cardiovascular disease is the number one cause of death. Number two is cancer. Well, we know that obesity increases the risk of developing cardiovascular disease and cancer. So by treating obesity, you really remove potential other comorbidities from happening in the first place or curing them.

And this is, but this is not a panacea. And I, and, you know, one of the things that sort of, I had Dr. Tina Moore on the podcast right here, and we talked about this exact topic. And, you know, she's using compounded semaglutide in ways that are different than the traditional dosing. And so I'd love you to talk about the sort of the concept of personalization of the use of some of these drugs because they're not without side effects. They cause muscle loss. I had a patient the other day with pancreatitis. They can cause kidney issues, thyroid issues, significant muscle wasting. I think they're now trying to develop new versions of this that actually have an inhibitor of muscle loss, which would be, I guess, good and bad in some ways because it sort of like gives people a free lunch. But what's your perspective on the modulation of the dosing that's different from what the pharmaceutical companies have established as a dosing.

The dosing that the pharmaceutical companies have used, they have shown to the FDA and the panels that of FDA experts that really decide whether a drug is safe and efficacious before it gets approved, they've proven that this dosing schedule and regimen will produce a certain effect. Now, that doesn't mean that prescribers have to use that exact dosing schedule and dose escalation. They can use whatever dose that they think is most appropriate for that patient. So, for example, if a beginning dose that only comes in one strength with the commercial product causes nausea and some of these other side effects that you mentioned, They're stuck. They're stuck. Exactly. There's no other option. What are they to do? Well, that prescriber can utilize a compounding pharmacy where a patient can get that medication instead of using the pen, take it out of a multi-dose vial using a syringe just like they would insulin or testosterone or any other medications.

I've done that for 100 years in medicine.

And administering that a lower dose so that the patient doesn't have to experience that side effect. dose escalating slower than what the patient would do using a commercial product. Now, that's just an example. That's not always the case. And do you do the same once.

A week injections or can you do more frequent or less frequent or how do you?

Well, the FDA indicated use recommends once a week injections. Just like it's similar for testosterone. Testosterone is recommended to be dosed once a week, but we see prescribers dosing it breaking that up into smaller injections, doing bi-weekly injections or injection twice a week. It's all dependent on what the prescriber thinks is best for their patients.

Personalization. I mean, this is what we're talking about in medicine is why everything is moving towards customization, personalization, not one size fits all. So this is interesting for those listening. We've had this conversation with Dr. Tina Moore. I encourage you to listen to that a little more depth, but this is a place where you can actually get this compound and do it in ways that may be safer, may be more effective, and may actually be a lot cheaper. I did the math. It was like 20 bucks versus 1700 bucks a month. I want to finish talking about a topic that I think is really important that has hit a cultural phenomena. I've been doing it for 30 years. It was really hard to get. It wasn't respected and recognized. but it's IV nutrient therapy and IV therapy of different compounds to help optimize and enhance health. And unfortunately, there's very little data, good large randomized trials around using these things, but a lot of doctors do it and a lot of doctors see benefits from it, whether it's B vitamins, whether it's vitamin C, whether it's mineral cocktails, amino acid cocktails, whether it's glutathione, whether it's phospholipids, there's a whole range of things that can be used intravenously to help optimize health. And now there's like, you know, clinics almost on every block, there's mobile nurses that come. I was at a wedding this weekend and they had a nurse come and give everybody IVs, you know, after a party weekend. You know, I'd love to kind of hear your perspective on the sort of intravenous nutrient therapies. and what they can be used for, who they help, and how people should think about them. It's like, why not just take the vitamin, right?

You know, a lot of these IV cocktails that these IV nutrition centers or mobile nurses are administering to patients, you.

Know.

They are 100% bioavailable when infused. And some of these, you know, you'd have to take tens of grams or hundreds of grams orally to be able to get an equivalent effect. And some of these you can't take in those amounts. For example, vitamin C. If you take more than a gram. You're gonna poop your brain out.

You're gonna poop your brains out. It's true. Vitamin C can be very helpful for allergy. I had a patient with an acute allergic reaction to environmental allergies. Not like a peanut allergy, but he was just miserable. And I hooked him up and I gave him 50 grams of IV vitamin C, which is a very large dose. And cancer therapy, they're using 75 grams. you couldn't take that orally.

Right, there's no way. You'd have to use, you would poop your entire body out, I think, if you did that. And so by infusing it, and by.

The way, people, if you're constipated, taking a lot of vitamin C is gonna help you, and it's not gonna hurt you.

It's not gonna be an enjoyable experience, but it'll do the job. For example, for oncology treatment, vitamin C has been known to be used off-label to potentially help the patient's immune system, you know, fight whatever disease. It's also been used to help fight viral or other infections.

Yeah, even in the ICU to help with the recovery from sepsis and other things.

Right, right.

And so- maybe Linus Pauling was right.

You know, and you know, we're starting to find out that natural vitamins, minerals, amino acids, they are the best form of medicine in a lot of cases. And by giving patients this medicine that they are typically lacking in their diet, we're almost all lacking the right amount of vitamins and minerals from the American diet, by infusing them, especially drugs that may be water soluble, they are much safer than oil soluble medications because the risk of overdose is lessened. and the body gets what it needs and typically passes out the rest. Pee out the rest.

So doctors say, oh, don't take vitamins, they give you expensive urine, but I'm like, that doesn't make any sense. Like saying, don't drink water because you're just going to pee.

You take what you need and your body gets rid of the rest. Yeah, yeah, exactly. But for cases where the patient needs more hydration, like after a night of drinking and a hangover cocktail is very popular, where it has a lot of the B vitamins, minerals, glutathione, maybe some zofran for nausea, and of course glutathione at the very end to help bring back the antioxidants.

Fix the liver, you mean?

Right, exactly. Yeah, to help repair the liver after it's just gone through quite a battle with a very dangerous chemical. And so IV nutrition, we've actually seen it grow as the second largest area of growth in our company behind GLP-1s, as that industry is growing about 25% a year.

It's quite amazing.

It is quite amazing. 25% growth.

I had an idea 20 years ago to set up these IV clinics, and I was like, I don't know what's gonna do it. I was like, I should have done it.

Well, it's never too late. I think one of the reasons why we see so many clinics doing this is because it's banana bags have been around in medicine forever. It's like the very first thing you pretty much give a patient whenever they come to a hospital. You're giving them B vitamins, riboflavin, which is what makes it yellow, and other minerals to help because almost all patients that introduce to the emergency center, they all, they could benefit.

It was, you know, it's typical we use it for alcoholics. You know, it's like we call it a banana bag because it looks yellow like a banana, but it's literally what we use to revive alcoholics who are massively nutritionally depleted. And, you know, it's incredible. It's kind of a miracle. I mean, there's something called wernicke's encephalopathy, which is a condition that alcoholics have from depleted thiamine or vitamin B1. And they're literally. It makes them like crazy.

And you literally just give them B vitamins intravenously, and then it's a miracle cure. Like, literally, it's amazing. Right, right. So you have immune cocktails with high doses of vitamin C, you have hangover cocktails with high doses of glutathione, you have. beauty cocktails that have high levels of biotin. And then you have AthletiComp cocktails that help with recovery by introducing amino acids like citrulline to help patients improve the performance of their body. And of course, getting it directly infused means that you're getting 100% of the drug bioavailable versus some amino acids you only absorb 5% when taking orally.

So do you have a compound that you use called fosetyl-choline IV?

We made it before, but we no longer make it. I think it was used primarily for weight loss, spot reduction, but did not become very popularized. And we saw that sales were decreasing over time as more and more providers were using other compounds.

So you could make it, you just don't make it. Right. It's interesting because it's quite big in Europe. and it's used for all sorts of neurological conditions, whether it's ALS or Parkinson's, Alzheimer's, cellular detoxification. And I would say, you know, I recently, I recently wrote a newsletter, longevity newsletter, by my own experience using a series of IV compounds to kind of Revitalize myself, because I've talked about on the podcast before, but I've had mercury poisoning, I've had severe mold toxicity. I've had, you know, severe Lyme disease, Babesia, obviously I'm 64 years old, I've been exposed to tons of toxins just by living in the modern world, even though I try to live a clean life. I have had specific mitochondrial injury and damage from the things that have happened to me. And I recently, you know, did this protocol, which an issue was developed by a woman named Patricia Kane, they call the PK protocol, but it's modified quite a bit. And, it uses high doses of IV phosphatidylcholine, which is basically the building blocks of your cell membranes. And, it uses hydrosolubile biotin, methylcobalamin, which is a form B vitamin 12, and leucovorin, which is a form of folic acid or folate, and then glutathione for detoxification, and then a whole series of amino acids and minerals to help with also detoxification and so forth. And what's remarkable about it is that it's literally changed how I feel from, you know, feeling generally okay to feeling like Superman in terms of cognitive function, energy levels, no, I don't bonk at the end of the day and just need to like veg out and watch a movie. I can be functional and read and do whatever I need to do. And I'm sort of like very impressed by this by this approach. And I think it's not really widely available or popular yet in America, but I think it's something that has such potential for all kinds of things. I actually am treating a patient with dementia now that's recovering from dementia with it. A patient with Parkinson's who couldn't play music, she was a guitarist, now can play music. I've had patients who have just generally are healthy but wanted to up-level their health and feel better, sleep better, have less cognitive dysfunction or brain fog. It's kind of amazing and I think these are the kinds of therapies that are not really available. There's data on it. It's not as much data as you'd like because obviously, because where the data is is from the drug companies funding the studies. Like for example, those NPECC and these drugs, there's literally millions and I don't know if it's probably billions of dollars now in funding for these drugs for every possible indication. But if you actually did a sort of a head-to-head comparison of an aggressive lifestyle and dietary intervention comparing it to that, I'm guessing you're going to say the same thing. Because they did this with bariatric surgery. They basically took people who were obese who were going to have bariatric surgery and they randomized them to two groups. One group got the surgery, one group didn't. They just fed them the same diet afterwards. And, you know, we say, oh, you need bariatric surgery even if you're still obese, you diabetes goes away in two weeks. Same thing happened to the control group. because it wasn't the surgery, it was the diet. And so I think, you know, the idea here is that there are a lot of therapies out there that, that can really be effective if, if we start to sort of look at them. But the problem is, there's lack of research. How do you sort of grapple with this? Because you're, you're providing a lot of compounds that, that have a tremendous amount of research behind them, right? Like semaglutide. But then there's all these IV therapies where well, what do we know about them? And there's some evidence, but it's not that much and they look safe, but how do you kind of reconcile that?

One, have so much respect for the academics that are doing all this research and introducing compounded therapies to show that they may treat indications outside of the indicated use. For example, nandrolone decanoate. also known as Decadron, you know, it's starting to be known that it helps treat osteoporosis and joint injuries.

That's an anabolic steroid.

Right, right. And so we see a lot more prescribers getting comfortable with this medication that was primarily used to treat anemia, you know, several decades ago, also treating wasting syndrome for patients with AIDS, but also being now utilized for other indications. And so, utilizing a compounding pharmacy, because a lot of the medications that we prescribe don't have indicated uses or the prescribers utilizing it for a use that may not, the FDA approved drug may not have been studied under, they can use it for whatever treatment that they deem would have a clinically significant benefit to that patient. And so, you know, we've actually sponsored several studies utilizing compounded medications to see whether a patient, it'll work in a patient that the FDA approved drug may not have worked for a different use. So, yeah, we're kind of are an experimental ground, if you want to call that, for prescribers that want to utilize a product that hasn't been on the market for one reason or another.

Well, I'm going to talk to you about this PKE protocol because I think this is in my view as a practitioner, it's one of the most exciting things I've seen clinically in a long time.

So, please send me the formulation.

I'd love to take a look at it. I'll send you the whole protocol. And I just want to say that it took a lot of courage for you to as a sort of a non-medical person. I mean, obviously you've got pharmacists on staff and you're not the guy mixing all the stuff in the back, you're the business guy. But, you know, it took a lot of courage for you to start something from scratch like this and to create what is now the biggest compounding pharmacy in the country. It's one that I personally use in my practice and that I feel confident because of the standards you use, because the quality I get, and because of the results that I get with my patients. So there's a lot more to this. We could go on for hours and hours. Where can people learn more about Empower Pharmacy?

You can visit our website at empowerpharmacy.com, where we have a knowledge base and a drug catalog that lists everything you would need to know about the medications that we manufacture and produce. And also to educate prescribers on how to utilize some of these compounded medications in their practice. Also, if patients want to learn more about compounding, they can go to compounding.com, they can also ask their practitioner how they utilize compounded medications in their practice. and that's typically an indication if that practitioner is really a specialist at what they do. Because specialists, they will make something that is special for that individual patient. And that's really where we see the future of medicine headed. So I think compounding has a very important part to play in the future of our healthcare system and we're very lucky to be able to benefit tens of millions of patients and soon hundreds of millions of patients across the the globe, as we're not just sick here in the United States. There's a whole crisis, healthcare crisis, that's going on globally that these types of medications can address.

Sean, thank you so much for the work you've done for starting the company and giving me a place where I feel confident to get my stuff. For those who want to learn more, you can read the show notes. We're going to put links in there, the things we talked about. There's a lot of studies so forth that we kind of alluded to. It's been great having you on the podcast. Good luck with all the stuff. I'm going to send you all that.

Stuff about that protocol so you can have it. I can't wait. I love being a mad scientist in my spare time. But thank you for what you do to bring access, knowledge, and a different point of view to how medicine could be done in this country. Because there needs to be a change as there is a crisis going on right now with healthcare costs and outcomes given a certain amount of cost for that specific therapy. So thank you for educating all of us and bringing us into the future of healthcare. Thanks so much, Sean.

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