What Is A Compounding Pharmacy? The Science Behind Medications Customized Just for You | Shaun Noorian - Transcript
Dr. Mark Hyman
Sean, welcome to The Doctor's Farmacy. It's great to have you.
Shaun Noorian
Oh, pleasure to be on. Thanks
Dr. Mark Hyman
a lot. We met in, Young Forever Longevity Treat that I did 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. Call them Power 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 think of like a mad scientist lab where you cook up all these kind of stuff that isn't 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 and and you had a personal story, which I think is very compelling, about why you went into this. You were you were like an engineer, you know, may taking things apart. You were you were not in a medicine track, but something happened to you that really affected you. So first, start out with the this big picture of what is a combating pharmacy, and then tell us how you yourself ended up here because your background didn't seem to lead in this direction.
Shaun Noorian
Oh, it's it's it's a pleasure, Mark. And it's it's it's a pleasure and honor to be involved in this industry where we have the ability to help patients like ourselves get access.
Dr. Mark Hyman
Is his audio good enough? Is he closer to the mic? If you
Shaun Noorian
wouldn't mind getting closer? Yeah.
Dr. Mark Hyman
Just pull the mic towards you and speak a little more louder.
Shaun Noorian
Do you want me to be more angled here?
Dr. Mark Hyman
That doesn't matter. It's more just like getting your mouth close so you see Yeah. Yeah. The volume is is good. Sure.
Sure.
Shaun Noorian
Sure. Sorry. Sorry. That's a that's a fuck moment. In the way.
Fuck.
Dr. Mark Hyman
Yeah. Sorry about that.
Shaun Noorian
Is this better?
Dr. Mark Hyman
Yeah. Like, you'll see how I've got the mic, like, I'm leaning forward on the table. Like, looking forward?
Shaun Noorian
No. This is as low as it goes, but it's okay. I can,
Dr. Mark Hyman
so So so Sean look at me like I'm I'm sort of leaning over I'm like, I'm like Gotcha.
Shaun Noorian
Gotcha. I'm
Dr. Mark Hyman
kinda like just kind of tucked in and leaning into the conversation so Sure. Sure. Yeah. And your phone's on stun?
Shaun Noorian
Yep. Yep. Exactly. Alright. Perfect.
And you can, like, you
Dr. Mark Hyman
know, just move it off to the side a little bit. You don't wanna stick it in your like, move it like this. So it's, like, kinda like
Shaun Noorian
Ah. Great point. Perfect. Thanks.
Dr. Mark Hyman
Test, 1, 2, 3.
Shaun Noorian
Testing, testing, 1, 2, 3. Okay. Perfect.
Dr. Mark Hyman
Now you can answer the question. Okay.
Shaun Noorian
So, Don't lean back. Don't lean back. That's right.
Dr. Mark Hyman
And if you go like this, then you're far away.
Shaun Noorian
Perfect. So, 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.
Dr. Mark Hyman
That's right.
Shaun Noorian
And using using mortars and pestles. Well, that is compounding. And before the industrialization of manufacturing for the pharmaceutical industry, you know, everything was compounded. And it wasn't till the early, 19 100 where we saw, that get transferred into factories away from the local apothecary or druggist.
Dr. Mark Hyman
Mhmm.
Shaun Noorian
And by the 19 thirties, we saw about 75% of medications were compounded. Fast forward to the 19, 75 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 percent
Dr. Mark Hyman
Mhmm.
Shaun Noorian
Of compounded medications are, prescribed in this country. So we've it's 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 is, 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.
Dr. Mark Hyman
Exactly. Like, I I prescribe hormones for women, but, like, not everybody needs exactly the same standard dose. So I kind of 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 kinda be like a mad scientist based on what's actually personalizing the care to that patient.
Shaun Noorian
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, you know, when when a pharmaceutical company only makes a single product, it can't help the entire patient population that is differing in their, the 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.
Dr. Mark Hyman
Yeah. So so 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 your 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?
Shaun Noorian
Yeah. You know, it's a 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 5 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, December 2007, I couldn't get a job working for any car companies.
Dr. Mark Hyman
You couldn't we couldn't get a a job at a go kart, in a manufacturer?
Shaun Noorian
Well, not the one that I wanted to work at, unfortunately. And, you know, the, the car industry wasn't doing very well. No. Not very few industries were. It was the beginning of the recession.
And
Dr. Mark Hyman
2007, you graduated. So you're 2008 here, you're talking about, which is not a good economic time in America.
Shaun Noorian
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, I was when I was out there, I saw so many injuries. And it was 9 months in when my number was up. And I was lifting a heavy piece of pipe, and I lifted it the wrong way and ended up hemorrhaging several of my lower vertebrae in the process. Mhmm. So, I couldn't work out in the field anymore, so I went to physical therapy.
And one of the chiropractors that was working with me, noticed that I was very skinny for my age. Keep in mind I'm 25 years old at the time. 5 foot 10 and I weighed about a £125.
Dr. Mark Hyman
Oh, skinny.
Shaun Noorian
Always been skinny my entire life. No matter how much I worked out, how much I ate, couldn't gain any muscle whatsoever. Mhmm. I thought that's the way it is. That 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 kinda described why I was so skinny my entire life, and why I couldn't get into 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
Dr. Mark Hyman
And and those are those are pituitary hormones that regulate your sex hormones, like estrogen, progesterone, testosterone, so forth.
Shaun Noorian
Yeah. Yeah. And for 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.
Dr. Mark Hyman
Right.
Shaun Noorian
And so I was hypogonadal, and I was infertile.
Dr. Mark Hyman
Yeah. Fun. Yeah.
Shaun Noorian
Well, you know, it's a, it became fun afterwards. Once I got my first medication from a compounding pharmacy and this is the luck 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. 1, because big pharma increases prices on average by 11% a year. And if a patient is gonna be on these medications for 50, 60 years, a large portion of the population will lose access.
Dr. Mark Hyman
Mhmm.
Shaun Noorian
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 how bad
Dr. Mark Hyman
you were feeling till you started feeling good. Right?
Shaun Noorian
Exactly. Exactly. Yeah. Anyway, the symptoms of hypogonism, depression, low libido, low stamina. I'd take a nap at 5 o'clock every single day.
You know, I was sleepy all the time even though I I get good enough sleep if you broke it up in 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.
Dr. Mark Hyman
Great. Well, that's an interesting entree into what I wanna 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 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 that
Shaun Noorian
there
Dr. Mark Hyman
are things that are not available. For example, I I get NAD from from Empower. I I have other 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?
Shaun Noorian
Well, there's, you know, every patient is unique. And so we see, you know, we manufacture 600 different drugs. And every the primary ones that we see functional medicine providers utilizing, as you said, as the base, we have the hormones. Testosterone, estradiol, progesterone, estriol, estrone, 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 better mental clarity. Maybe Ketamine for patients that have depression. Maybe we have their their patients who are obese, so they're utilizing a lipotropic injection or a b 12 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 has responded, and then adjusting therapy accordingly and sending that new compound to their company pharmacy to fill.
Dr. Mark Hyman
Are you comfortable sharing other things that you use in your stack? Things that you
Shaun Noorian
Oh so I've, I use methylene blue, testosterone of course. I make a we make a topical hair product called haristore ultra that has minoxidil, azelaic acid, finasteride, and ketoconazole.
Dr. Mark Hyman
Those are all medications. Mhmm.
Shaun Noorian
That is antifungals, hair loss drugs, things that are for, you know, androgen, blockers, like 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
Dr. Mark Hyman
Yeah.
Shaun Noorian
For the patient, what makes the patient more compliant. And also makes it a lot more cost effective making you know, providing one drug instead of having the patient apply 4 different drugs.
Dr. Mark Hyman
And by the way, these are these are generic drugs, so the costs are much, much lower. And and and, you know, 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.
Shaun Noorian
Yes. There's 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, prima becoming too systemic versus other dosage forms. And yes, drugs like finasteride can become debilitating for many men, not just causing retinal dysfunction, but a subset causing post finasteride syndrome, which they never regain their libido after. Yeah.
And that's that's That's a scary thing. That's very
Dr. Mark Hyman
scary. Yeah. So so that's part you use topical, use the methylene blue, use the testosterone. Any any other goodies?
Shaun Noorian
Yeah. My acne cream. So we have, different forms of acne cream. One of that I utilize has, tretinoin, clindamycin, and niacinamide. I use that every 3, 4 days.
And then, one that I use every night is what we call AcneDNS. It has dapsone, niacinamide, and spironolactone. And by combining all these different drugs and and and vitamin together, it's makes it much more convenient for the patient applying one medication instead of 3. And, as I mentioned, it's because of company 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 with to the patient and working with the prescriber. And so
Dr. Mark Hyman
PBMs are, pharmacy benefit managers that are basically the kind of secret and evil underbelly of the health care 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 for combating pharmacies, you can get the same things at a fraction of the cost.
Shaun Noorian
Exactly. And what we've done is we've become an FDA registered manufacturer, and 503 b 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 50 3 a 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, wholesaler as well.
So we are the manufacturer, wholesaler, and pharmacy all vertically integrated into 1. And by not accepting insurance, carriers and PBMs are out. So it's a fully vertically integrated supply chain that works directly with every single pharmaceutical end user in this country, and get the medications at a much lower cost because the lack of all these unnecessary The middlemen.
Dr. Mark Hyman
Right? Exactly. So any other goodies in your stack of of treatments?
Shaun Noorian
You know, I'm always experimenting with different forms of testosterone. There's testosterone saponate, enanthete. You know, we actually make a combination of testosterone saponate with a bit of testosterone propionate, which is a much faster acting ester. The pharmacokinetic half life of testosterone symphony is about a week long.
Dr. Mark Hyman
Yeah.
Shaun Noorian
And the half life of propionate is about 2 days. And so you can get a much different pharmacokinetic response and peak Yeah. Than you would be able to, like, by just utilizing a single ester by itself.
Dr. Mark Hyman
Yeah. So people might be listening going, well, gee, you know, like, it sounds kinda like a mad scientist. Is this regulated? How do I know the dose is right? Am I gonna take something that's got weird things in it?
There was some, you know, shady things that happened at the compounding pharmacy a few years ago with injectables that kinda got some fungal thing in some guy that not everybody kinda crazy. So so people are listening going, well, this sounds good, but, like, shouldn't I trust my pharmacy more? Why would I trust a commenting pharmacy that seems to be doing kind of experiments with all these different things? And how do you how do you answer that? Because I'm imagining people are thinking that as they're listening.
Shaun Noorian
Yeah. It's a good question. You know, compounding pharmacies, as I mentioned, like, 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 comp practice of pharmacy in 2013 with the passage of the Drug Quality Security Act because of that fungal meningitis outbreak
Dr. Mark Hyman
Yeah.
Shaun Noorian
That happened in 2012 from a company called NECC or New England Compounding Centers.
Dr. Mark Hyman
Mhmm.
Shaun Noorian
And that pharmacy made one bad batch or I should say 3 bad batches and killed 70 people and injured 700 or more.
Dr. Mark Hyman
Yeah.
Shaun Noorian
And so the FDA said congress then came in and said, how can we prevent this from happening again? And that is how the Drug Quality Security Act was passed, and this new category of 503 b 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.
Dr. Mark Hyman
So basically, in English, that means that in the drug companies, when they make a drug, have a really strict protocols in in the factory and make sure that it says what it is on the label, that the dose is the right dose, that it's clean, has no, you know, 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 that protects consumers. You know, I I I think compounding pharmacies is really important because I I I
Shaun Noorian
I Sorry. Your hands on the cable is making a noise.
Dr. Mark Hyman
Oh, sorry.
Shaun Noorian
It's okay.
Dr. Mark Hyman
So, you know, I I again, I've been practicing this for 30 years. I've been using compounding pharmacies for 30 years. One of my favorite is is in the hormone range. And a lot of women have, low libido or sexual dysfunction, especially going through menopause, hormones change. And, you know, 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 masculinization 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 drugstore through a regular pharmacist. So it's it's not exactly being a mad scientist, but it's it's actually using the compounds we have in in innovative and new ways to help patients with certain problems that that are hard to get solved with with other methods. So, you know, why when there aren't like, natural bio identical 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 why would you wanna use, compounded versions? You know, why why would that be better? You can kind of quote and quote there because I think, you know, this whole field of bio identical hormone therapy is kind of big, and hormone optimization therapy, whether it's for men or women, is sort of emerging.
And I I wrote a lot about in my book Young Forever, and I I use a lot of these compounds, but I think most people sort of, you know, wonder about, you know, 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 trochee that I put in my mouth?
Should be a pellet that I inject under my skin? Like, what? Like, there's so many choices. Right? So how do you how do you help people think about it, and how do you work with physicians to help them kind of figure this out?
Shaun Noorian
That's a great question. You know, compounding pharmacies, you know, one, people a lot of prescribers prefer to use a compounding pharmacy for a patient because, it's 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 they can 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 DHA supplement from, from a supplement store. You know, we have to test our products to meet, meet these standards, especially if they're made at our 5 zero three outsourcing facility.
Every single batch has to be tested for potency, sterility, endotoxin, and a slew of other tests Mhmm. To ensure, safety. Now when it comes to, gosh. Fuck. You asked the second question.
What was it?
Dr. Mark Hyman
You know, about how how how do you kind of know which way to to go with these different varieties of applications and formulations. Dosage forms.
Shaun Noorian
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 3 months. And so a patient that travels a lot or may forget to take a daily or weekly, a 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 trochee 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. Interesting.
Dr. Mark Hyman
Yeah. I think 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 cofounded, you know, we 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 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 prescribed at the drugstore. And it's like 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? You know?
And and I actually had an experience where I got very sick a few years ago. I had mold poisoning at my I live in a barn. It's like a 120 year old barn, and there was just mold in the basement. It used to be a horse stall. I renovate oh, shoot.
I just hit it. Oh, oh, hold on. It's gonna get better.
Shaun Noorian
You wanna massage you out? No. It's fine.
Dr. Mark Hyman
I'm sorry. I need more magnesium.
Shaun Noorian
I have some magnesium if you'd like some. It's okay.
Dr. Mark Hyman
It's just because of my back surgery,
Shaun Noorian
and sometimes, like, big weird things, symptoms happen. So, Yeah. Yeah. Those are the worst. God.
Dr. Mark Hyman
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 live in an old barn. It's a 120 5 year old barn barn. There was mold in the basement.
I renovated it down there. Used to be horse stalls and pretty freaking moldy. But the mold kinda came back. There was a leak, and I got very sick. I got a cough for a year.
I I ended up, 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, we've around the same time when I was getting the mold treated, I moved out of the house, I I got my root canal, I got my immune system was all compromised, I broke I broke my arm. I was in New Zealand riding where the 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 I just give 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. It was, like, completely unattached.
It was, like, dang, I couldn't move my arm. And and then I got really sick, and I got colitis and c diff, and I got, you know, ulcerative colitis. It's sort of started after that. I lost £30, and my I was in this catabolic state, which is a total breakdown. And and, you know, normally, well, your your fracture would heal in 6 weeks, and it was 6 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 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 6 months, or actually 8 months of, of nonunion. They call it nonunion, which is a very serious problem. I mean, like, it just my arm would be dangling, and I feel like I couldn't use it, and, you know, and I used the testosterone injections and my arm healed like that. So you know 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 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 you doctor it's not illegal. You're allowed to do it. But but there's a whole, off label sort of concept I'd love you to sort of talk about and and and how that can be helpful in getting people the compounds they need to treat the issues they need.
They might be, you you know, better served by a compounding pharmacy.
Shaun Noorian
Absolutely. 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 f no no compounding pharmacy makes a drug that is FDA approved.
Every 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 1,000,000,000 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 compounding, compounders to make these medications for that what may be considered off label use for whatever they think is best for that patient.
Dr. Mark Hyman
Yeah. And so, and this is what I do all the time. Like, there's no there's no, like, clitoral testosterone FDA approved drug, but I use it. Right? And and one of the things that I think is kind of fun is is the whole sexual health realm.
Right? You know, 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, you know, they're since they're now kind of, off patent, you know, I've seen combinations of things like oxytocin, which is the kind of feel good love hormone that you're breastfeeding or after sex, that kind of is a bonding, a 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.
Shaun Noorian
Absolutely. You know, we've seen sexual wellness come a long way over the past years, especially for men. I mean, women unfortunately don't have many FDA approved, options out there. The only there are only 2 on the market.
Dr. Mark Hyman
And I wanna talk about those because you also can get those by injections and people don't know about it. It's amazing to me how they don't know about it.
Shaun Noorian
Right. Right. Yeah. You know, ADDIE which was, the first drug approved for female sexual hyperarousal disorder. It is an oral pill.
Generic name is febanserin 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 bromelainotide under the brand name Byleesi. And that It's also a peptide.
Dr. Mark Hyman
That's right. The name is PT 141. That's right. Yeah.
Shaun Noorian
And it causes arousal, in almost anybody that injects it. Now
Dr. Mark Hyman
Men and women?
Shaun Noorian
Men and women. Yes. It's only indicated for postmenopausal women because that's the group that was studied to get the FD 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 bromelainotide, but compounding pharmacy may be able to use it as a trochee for, for buccal or sublingual absorption. And combine other drugs like oxytocin, phenethylaminesolate. We can even combine
Dr. Mark Hyman
So what's that?
Shaun Noorian
It's a it's a vasodilator.
Dr. Mark Hyman
Oh.
Shaun Noorian
And you know, it's actually used in intracabinosal injections as well.
Dr. Mark Hyman
Oh, yeah. Yeah. So for
Shaun Noorian
men that fail on oral PD 5 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 pepaverin, phantolomimesolate, and prostaglandin that can then be injected in the side of the penis in the corporal cavernosa.
Dr. Mark Hyman
This is trimix?
Shaun Noorian
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
Dr. Mark Hyman
that's kind of last implant.
Shaun Noorian
That's right. Exactly. And so that's what that's an example of where practitioners can utilize a compounding pharmacy to create an effective drug that is not commercially available.
Dr. Mark Hyman
Yeah. So Tri Mex is something you actually can't buy from your regular pharmacist, but it's incredibly effective. And urologists recommend and use it even from academic medical centers.
Shaun Noorian
Oh, it's been used for decades.
Dr. Mark Hyman
And it's it's something that actually most, doctors don't know about. In fact, I learned about it probably 20 years ago from a patient. I'm like, 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's works every time. And it's like I felt like I'm 20 years old again. And it's it's an incredible thing that is available. For women, I think the the p t 141 or the bramblematide is is, is is available as a prescription by Lacey, 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 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 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 1,000 and 1,000 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 and, they they they 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 BP 157. It's not really an FDA approved drug, but it's incredibly effective for injury and trauma. So I've had, like, bicep injuries or, you know, tendinitis or various issues, and you inject it. It's like a miracle. Within a few injections, they go ahead.
I had someone who was, you know, was an elite athlete, he had torn his calf, and I gave him a few injections, was gone. I had tennis elbow for months months months and was treated by the traditional doctors, put a little peptide in there, it kinda got kinda got resolved. And and recently, FDA 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, that is the brand name, or the eremlutide or p t 141 for sexual arousal. There are some that have actually been FDA approved, and you can use those.
But the other ones, you can't. So we talk about like the the the state of these sort of science and also the state of the politics, of these peptides and and what your perspective is and where we should be going? So peptides are very powerful substances.
Shaun Noorian
You know, as we've seen
Dr. Mark Hyman
But insulin's a peptide, just so everybody know. Right? They know how powerful insulin is. Right?
Shaun Noorian
Absolutely. And and because they're so powerful, they are considered drugs. And, in order for a compounding So
Dr. Mark Hyman
so is your poop now. You know that? The FDA regulates your poop. You can't do a fecal transplant because it's considered a drug.
Shaun Noorian
Yeah. There exactly. There's 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.
Exactly. Right. You know, they're, they can company pharmacies can only make drugs that have met one of 3 conditions. It has been a component of an fV 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 1 of the 503 bulks 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 approved drug, but are considered safe and have been grandfathered in.
Yeah. And so these peptides, have never been approved, don't contain a USPR monograph, and aren't contained within category 1 of the five of the blood cells. So they've never been legal to be able to be made. Now a lot of practitioners and company pharmacies have promoted these drugs over the years. And now we see, finally, the states and fed and and federal regulators, FDA, are taking action against compounding pharmacies for making these peptides because they were never supposed to be made in the first place.
Dr. Mark Hyman
No more for research purposes or for
Shaun Noorian
Well, some some of these peptides, while some are very safe and efficacious, others may not be. You know, 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 conja chemical, which is the name of the company that created the, the peptide and was studying it during clinical trials. Now those trials had to be ceased.
And 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 Do
Dr. Mark Hyman
you think it's overreach or do 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 hard down on. Like, for example, N acetylcysteine, which is basically, actually something we use in the emergency room for treating Tylenol Rose. But now they 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 the 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 sort of 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 $3,000 a month.
When you look at it from a compounding pharmacy for the doses you might wanna use, it might be $20 a month. And 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 and, you know, this allows for more customization. So can you talk about what's happening around this field of compounding and these peptides and semaglutide and Ozempic and where we're at? And should we feel we'd be worried about it?
Should they be using it? You know, is it safe? Is it something that you think, you know, we should sort of sort of bypass the pharma industry and go with compounding pharmacies and stop the pros price gouging? Because, you know, if you go to Canada, it's like a $100 or something. If you go to, you know, New York, it's, you know, $2,000.
Right? So how does that make sense?
Shaun Noorian
Yeah. So so to talk about peptides and then the conspiracy theories, you know, 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 ones, 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 ones, you know, company 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 Wegovo, Wegovy, Ozempic, Zepbound and Marngiorno, 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. Now we pay a lot more for them in the United States than we pay anybody else.
Dr. Mark Hyman
Just to clarify something because I'm confused. This is maybe my ignorance. But, you know, these drugs are made by pharma. So let's say Novo Nordisk makes Ozempic and Mogolli. They're they're making it in their factories.
They've got the patent on this drug. Where do you get your semaglutide from?
Shaun Noorian
From them
Dr. Mark Hyman
or from some other company that's making it?
Shaun Noorian
It's a good question. Because a lot of patients and subscribers, it's it they think that compounding pharmacies and outsourcing facilities, we get our active pharmaceutical ingredients off the street. You know. In the back alley somewhere. Right.
Yeah. 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
Dr. Mark Hyman
But I'm confused. How can how can a drug that's is is on patent be made by another company?
Shaun Noorian
Well, the patent covers a certain dosage form, certain dosage strength, and certain indication. Yeah. 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 patent.
Dr. Mark Hyman
Interesting. So it's really about the delivery system and all that. Because because, you know, in a way, these aren't really drugs. These are these are natural compounds like testosterone or estrogen or vitamin c or vitamin d that exist in nature. They're not new to nature molecules.
And so new to nature molecules, they they are like things that we make up as in the pharmaceutical industry. But these are things that naturally exist but it's it's the the way they get these patents is through the the delivery system, the injectable form, the, like you said, the dosage and so forth. So so basically, the the these peptides have been widely available because they are natural compounds.
Shaun Noorian
Right. And you know, 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, not the the 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 ones, they are very powerful when it comes to treating, as we know, type 2 diabetes, obesity, cardiovascular disease, you know, hepatic disease, addiction, and, some case now. There's some studies showing that it helped me helped treat Alzheimer's, fertility issues, and the list just keeps going on and on.
Dr. Mark Hyman
And I wonder, by the way, I'm just gonna make a footnote here on that. I I 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 I feel strongly that and I and I've seen some data that suggest that it's actually the weight loss, not the drug.
Shaun Noorian
Right. Because these 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, you know, cardiovascular disease is the number one cause of death. Number 2 is cancer. Well, we know that obesity increases the risk of developing cardiovascular disease in cancer.
Dr. Mark Hyman
Of course.
Shaun Noorian
So by getting by by treating obesity, you really remove potential other comorbidities from happening in the first place or curing them.
Dr. Mark Hyman
And this is this is but this is not a panacea. And I and, you know, one of the things that's so I had, doctor 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. And I had a patient the other day with pancreatitis. They can cause kidney issues, thyroid issues. They're the the the the 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 what's your perspective on sort of the modulation of the dosing that's different from what the pharmaceutical companies have established as a dosing?
Shaun Noorian
So, the dosing that the pharmaceutical companies have used, they have shown, to the FDA and the panels that FDA experts that really decide whether drug is safe and efficacious before it gets approved. They've they've proven that this dosing schedule and regimen are 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.
Dr. Mark Hyman
They're stuck.
Shaun Noorian
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 do using the pen, take it out of a multidose vial using a syringe just like they would insulin or testosterone or any other medications that comes in vial.
Dr. Mark Hyman
For a 100 years in medicine.
Shaun Noorian
Yeah. And administering that a lower dose so that the patient doesn't have to experience that side effect. And then dose escalating slower than what the patient would do using a commercial product. Now Yeah. That's just an example.
That's not always the case.
Dr. Mark Hyman
And and you do the same, like, once a week injections, or can you do more frequent or less frequent? Or how do you
Shaun Noorian
Well, the FDA indicated use, recommends, once a week injections. Medi just like it's similar for testosterone. Sostarum is recommended to be dosed once a week, but we see prescribers dosing it, breaking that up into smaller injections, doing biweekly injections or injection twice a week. It's all dependent on what the prescriber thinks best for their patients.
Dr. Mark Hyman
Personalization. I mean, this is what we're talking about in medicine. It's why, you know, everything is moving towards customization, personalization, not one size fits all. So this is interesting for those listening, you know, we we've had this conversation with doctor Chien Amour. 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. Like, I I did the math. It was, like, $20 versus, like, you know, 70 to $100 a month. I wanna sort of finish talking about a topic that I think is really important that has sort of hit a cultural phenomena. I've been doing it for 30 years.
It was really hard to get. It's 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 a 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 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 kinda hear your perspective on on on on the the sort of in in, intravenous nutrient therapies and and what what they can be used for, who they help, and, and and how people should think about them. It's like why not just take the vitamin. Right? Right.
Shaun Noorian
You know, a lot of these IV cocktails that these IV Nutrition Centers or mobile nurses are administering to patients, you know, they 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
Dr. Mark Hyman
gonna poop your brains out.
Shaun Noorian
You're gonna poop your brains out.
Dr. Mark Hyman
It's true. I I I you know, vitamin c can be very helpful for allergy. I had a patient with an acute acute allergic reaction to, like, environmental allergies, not like a peanut allergy, but, like, 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. On cancer therapy, they're using 75 grams.
You couldn't take that orally. Right.
Shaun Noorian
There's no way. You'd have to use you would you would poop your entire body out, I think, if you did that. And so by infusing it
Dr. Mark Hyman
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
Shaun Noorian
gonna be an enjoyable experience, but it it'll do the job. But, you know, if, for for example, for oncology treatment, you know, 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 or other infections.
Dr. Mark Hyman
Yeah. Even in the ICU, it helped, with the recovery from sepsis and other things. Yeah.
Shaun Noorian
Right. Right. And so Maybe Linus Polly was right. You know, that and, you know, we're starting to find out that natural vitamins, minerals, amino acids, they are, you know, the best form of medicine in a lot of cases. And by giving patients this medicine that they're typically lacking in their diet, that they're, you know, we're almost all lacking the right amount of vitamins and minerals from the American diet.
By infusing them, especially, you know, 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.
Dr. Mark Hyman
Just pee out the rest. Right. So so doctors say, oh, don't don't take vitamins to give you expensive urine. But I'm like, that doesn't make any sense. Like, saying don't drink water because you're just gonna pee.
You take what you need, and your body gets rid of the rest.
Shaun Noorian
Yeah. Yeah. Exactly. But but for cases where the patient needs more hydration, like after a night of drinking. And, hangover cocktail is very popular where it has a lot of the b vitamins, minerals, glutathione, maybe some Zofran for nausea, maybe, and of course, glutathione at the very end to help, bring back the antioxidants.
Dr. Mark Hyman
Fix the liver, you mean?
Shaun Noorian
Right. Exactly. Yeah. Yeah. To help repair the liver after it's just gone through, you know, quite a battle
Dr. Mark Hyman
Yeah.
Shaun Noorian
With, with a very dangerous chemical. Yeah. And, so IV nutrition, we've actually seen it grow as the the 2nd largest area of growth in our company behind GLP ones.
Dr. Mark Hyman
I bet.
Shaun Noorian
As that industry is growing about 25 percent
Dr. Mark Hyman
a year. It's quite amazing.
Shaun Noorian
It is quite amazing. 25 percent a year. I had an
Dr. Mark Hyman
idea, like, idea 20 years ago to set these IV clinics, and I was like, I don't know who's gonna do it. I was like, I should have done it.
Shaun Noorian
Well, it's never too late. Yeah. Yeah. No. It's it's, and 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
Dr. Mark Hyman
the very first
Shaun Noorian
thing you you pretty much give a patient whenever they come to a hospital. Wow. You're giving them b vitamins Yeah. 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 they could benefit.
Dr. Mark Hyman
You know, it's too 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 the only use to revive alcoholics who are massively nutritionally depleted and, you know, it's it's it's kind of miracle. I mean, there's something called Wernicke's encephalopathy, which is a condition that alcoholics have from depleted thiamine or vitamin b 1. 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.
Shaun Noorian
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 high levels of biotin.
And then you have athletic 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 it's you're getting 100% of the drug bioavailable versus some amino acids you only absorb 5% when taking orally.
Dr. Mark Hyman
So do you do you have a compound that you use called phosphatidylcholine maybe?
Shaun Noorian
We made it before, but we no longer make it. And why is that? I think it was I think it was used primarily for weight loss, spot reduction, but wasn't did not become, very popularized. And we saw that sales were decreasing over time as more and more providers were using other drugs.
Dr. Mark Hyman
So you could make it, you just don't make it? Right. It conditions it's quite big in Europe.
Shaun Noorian
And
Dr. Mark Hyman
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 I recent I I recently wrote a, newsletter, longevity newsletter, by my own experience using a series of IV compounds to kinda revitalize myself. Because I've talked about it on the podcast before, but I've had mercury poisoning. I've had severe mole 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 and and and and damage from the things that have happened to me. And I recently, you know, did this protocol, which which, initially was developed by a woman named Kane. They call it 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 high dose of biotin, methylcobalamin, which is a form b vitamin 12, and leucovirm, 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 and, and so forth. And what's remarkable about it is that it's 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, bitch out and watch a movie.
I can be functional and read and do whatever I need to do. And and I'm sort of, like, I'm very impressed by this by this approach, and I I think it's not really widely available or popular yet in America, but I think it's 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, you know, who had just generally are healthy, but wanted to up level health and feel better, sleep better, have less cognitive dysfunction or brain fog.
It's it's kind of amazing, and I think it these are the kinds of therapies that are not really available. So there there's data on it. It's not as much data as you'd like because obviously because where where the data is is from the drug companies funding the studies. Like, for example, those MPIC and these drugs, there's literally 1,000,000 and I don't know if it's probably 1,000,000,000 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 a aggressive lifestyle and dietary intervention comparing it to that, I'm guessing you're gonna say the same thing.
Because they did they did this with bariatric surgery. They basically took people who were obese who were gonna have bariatric surgery and they randomized them to 2 groups. 1 group got the surgery, 1 group didn't. They just fed them the same diet afterwards. And, you know, we say, oh, you need a bariatric surgery even if you're still obese, your diabetes goes away in 2 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. So how do you sort of grapple with this? Because you're 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 it it they look safe. But how do you kind of reconcile all that?
Shaun Noorian
You know, one I have so much respect for the academics that are doing all this research and, introducing compounded therapies to show that they may use treat indications outside of the indicated use. For example, Nangeland decanoate, also known as decadrabolin. You know, it's been it's starting to be known that it used it it helps treat osteoporosis and joint injuries.
Dr. Mark Hyman
That's an anabolic steroid.
Shaun Noorian
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 while also treating wasting syndrome for patients with AIDS, but also being now utilized for other other indications. And so there's, you know, utilizing a company pharmacy, you can you know, because a lot of the medications that we prescribed don't have indicated uses, or their 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 will work in a patient that the FDA approved drug may not have worked for that for that for a different use.
So, yeah, we we kind of are, you know, an experimental ground, if you wanna call that, for prescribers that wanna utilize a product that hasn't been on the market for one reason or another.
Dr. Mark Hyman
K. Well, I'm gonna talk to you about this PK 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,
Shaun Noorian
you know Please send send me the formulation. I'd love to dig in.
Dr. Mark Hyman
I will. I'll send you the whole protocol. And, you know, I I just wanna say that, you know, 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 it took a lot of courage for you to 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 in because of the standards we 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?
Shaun Noorian
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, if that that practitioner is really a specialist at what they do. Mhmm.
Because specialists, they will make something that is special for that individual patient. Yeah. And that's really where we see the future of medicine headed. Yeah. So, I think compounding has a very important part to play in the future of our health care system, and we're very lucky to be able to benefit tens of millions of patients and soon 100 of millions of patients across the globe as we're not just here in the United States.
No. There's a whole crisis, health care crisis, that's going on globally that these types of medications can address.
Dr. Mark Hyman
Well, Sean, thank you so much for the work you've done for joining the company and giving me a place where I feel confident to get my stuff. And for those who wanna learn more, you can read the show notes. We're gonna put links in there, the things we talked about. There's a lot of studies so far that that we kind of alluded to. And, it's been great having you on the podcast, and good luck with all this stuff.
And I'm gonna send you all that stuff about that protocol so you can have it.
Shaun Noorian
Can't wait. I love being a mad scientist in my in my spare time. But thank you for what you do to bring access, knowledge, and, different point of view to how medicine could be done in this country because there needs there needs to be a change as there is a crisis going on right now with health care costs and outcomes given a certain amount of cost given for that specific therapy. So thank you for educating all of us and bringing us into the future of health care.
Dr. Mark Hyman
Thanks. Thanks so much, Sean.
Shaun Noorian
Pleasure's all mine. Thank you.
Sean, welcome to The Doctor's Farmacy. It's great to have you.
Shaun Noorian
Oh, pleasure to be on. Thanks
Dr. Mark Hyman
a lot. We met in, Young Forever Longevity Treat that I did 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. Call them Power 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 think of like a mad scientist lab where you cook up all these kind of stuff that isn't 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 and and you had a personal story, which I think is very compelling, about why you went into this. You were you were like an engineer, you know, may taking things apart. You were you were not in a medicine track, but something happened to you that really affected you. So first, start out with the this big picture of what is a combating pharmacy, and then tell us how you yourself ended up here because your background didn't seem to lead in this direction.
Shaun Noorian
Oh, it's it's it's a pleasure, Mark. And it's it's it's a pleasure and honor to be involved in this industry where we have the ability to help patients like ourselves get access.
Dr. Mark Hyman
Is his audio good enough? Is he closer to the mic? If you
Shaun Noorian
wouldn't mind getting closer? Yeah.
Dr. Mark Hyman
Just pull the mic towards you and speak a little more louder.
Shaun Noorian
Do you want me to be more angled here?
Dr. Mark Hyman
That doesn't matter. It's more just like getting your mouth close so you see Yeah. Yeah. The volume is is good. Sure.
Sure.
Shaun Noorian
Sure. Sorry. Sorry. That's a that's a fuck moment. In the way.
Fuck.
Dr. Mark Hyman
Yeah. Sorry about that.
Shaun Noorian
Is this better?
Dr. Mark Hyman
Yeah. Like, you'll see how I've got the mic, like, I'm leaning forward on the table. Like, looking forward?
Shaun Noorian
No. This is as low as it goes, but it's okay. I can,
Dr. Mark Hyman
so So so Sean look at me like I'm I'm sort of leaning over I'm like, I'm like Gotcha.
Shaun Noorian
Gotcha. I'm
Dr. Mark Hyman
kinda like just kind of tucked in and leaning into the conversation so Sure. Sure. Yeah. And your phone's on stun?
Shaun Noorian
Yep. Yep. Exactly. Alright. Perfect.
And you can, like, you
Dr. Mark Hyman
know, just move it off to the side a little bit. You don't wanna stick it in your like, move it like this. So it's, like, kinda like
Shaun Noorian
Ah. Great point. Perfect. Thanks.
Dr. Mark Hyman
Test, 1, 2, 3.
Shaun Noorian
Testing, testing, 1, 2, 3. Okay. Perfect.
Dr. Mark Hyman
Now you can answer the question. Okay.
Shaun Noorian
So, Don't lean back. Don't lean back. That's right.
Dr. Mark Hyman
And if you go like this, then you're far away.
Shaun Noorian
Perfect. So, 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.
Dr. Mark Hyman
That's right.
Shaun Noorian
And using using mortars and pestles. Well, that is compounding. And before the industrialization of manufacturing for the pharmaceutical industry, you know, everything was compounded. And it wasn't till the early, 19 100 where we saw, that get transferred into factories away from the local apothecary or druggist.
Dr. Mark Hyman
Mhmm.
Shaun Noorian
And by the 19 thirties, we saw about 75% of medications were compounded. Fast forward to the 19, 75 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 percent
Dr. Mark Hyman
Mhmm.
Shaun Noorian
Of compounded medications are, prescribed in this country. So we've it's 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 is, 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.
Dr. Mark Hyman
Exactly. Like, I I prescribe hormones for women, but, like, not everybody needs exactly the same standard dose. So I kind of 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 kinda be like a mad scientist based on what's actually personalizing the care to that patient.
Shaun Noorian
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, you know, when when a pharmaceutical company only makes a single product, it can't help the entire patient population that is differing in their, the 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.
Dr. Mark Hyman
Yeah. So so 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 your 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?
Shaun Noorian
Yeah. You know, it's a 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 5 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, December 2007, I couldn't get a job working for any car companies.
Dr. Mark Hyman
You couldn't we couldn't get a a job at a go kart, in a manufacturer?
Shaun Noorian
Well, not the one that I wanted to work at, unfortunately. And, you know, the, the car industry wasn't doing very well. No. Not very few industries were. It was the beginning of the recession.
And
Dr. Mark Hyman
2007, you graduated. So you're 2008 here, you're talking about, which is not a good economic time in America.
Shaun Noorian
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, I was when I was out there, I saw so many injuries. And it was 9 months in when my number was up. And I was lifting a heavy piece of pipe, and I lifted it the wrong way and ended up hemorrhaging several of my lower vertebrae in the process. Mhmm. So, I couldn't work out in the field anymore, so I went to physical therapy.
And one of the chiropractors that was working with me, noticed that I was very skinny for my age. Keep in mind I'm 25 years old at the time. 5 foot 10 and I weighed about a £125.
Dr. Mark Hyman
Oh, skinny.
Shaun Noorian
Always been skinny my entire life. No matter how much I worked out, how much I ate, couldn't gain any muscle whatsoever. Mhmm. I thought that's the way it is. That 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 kinda described why I was so skinny my entire life, and why I couldn't get into 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
Dr. Mark Hyman
And and those are those are pituitary hormones that regulate your sex hormones, like estrogen, progesterone, testosterone, so forth.
Shaun Noorian
Yeah. Yeah. And for 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.
Dr. Mark Hyman
Right.
Shaun Noorian
And so I was hypogonadal, and I was infertile.
Dr. Mark Hyman
Yeah. Fun. Yeah.
Shaun Noorian
Well, you know, it's a, it became fun afterwards. Once I got my first medication from a compounding pharmacy and this is the luck 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. 1, because big pharma increases prices on average by 11% a year. And if a patient is gonna be on these medications for 50, 60 years, a large portion of the population will lose access.
Dr. Mark Hyman
Mhmm.
Shaun Noorian
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 how bad
Dr. Mark Hyman
you were feeling till you started feeling good. Right?
Shaun Noorian
Exactly. Exactly. Yeah. Anyway, the symptoms of hypogonism, depression, low libido, low stamina. I'd take a nap at 5 o'clock every single day.
You know, I was sleepy all the time even though I I get good enough sleep if you broke it up in 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.
Dr. Mark Hyman
Great. Well, that's an interesting entree into what I wanna 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 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 that
Shaun Noorian
there
Dr. Mark Hyman
are things that are not available. For example, I I get NAD from from Empower. I I have other 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?
Shaun Noorian
Well, there's, you know, every patient is unique. And so we see, you know, we manufacture 600 different drugs. And every the primary ones that we see functional medicine providers utilizing, as you said, as the base, we have the hormones. Testosterone, estradiol, progesterone, estriol, estrone, 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 better mental clarity. Maybe Ketamine for patients that have depression. Maybe we have their their patients who are obese, so they're utilizing a lipotropic injection or a b 12 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 has responded, and then adjusting therapy accordingly and sending that new compound to their company pharmacy to fill.
Dr. Mark Hyman
Are you comfortable sharing other things that you use in your stack? Things that you
Shaun Noorian
Oh so I've, I use methylene blue, testosterone of course. I make a we make a topical hair product called haristore ultra that has minoxidil, azelaic acid, finasteride, and ketoconazole.
Dr. Mark Hyman
Those are all medications. Mhmm.
Shaun Noorian
That is antifungals, hair loss drugs, things that are for, you know, androgen, blockers, like 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
Dr. Mark Hyman
Yeah.
Shaun Noorian
For the patient, what makes the patient more compliant. And also makes it a lot more cost effective making you know, providing one drug instead of having the patient apply 4 different drugs.
Dr. Mark Hyman
And by the way, these are these are generic drugs, so the costs are much, much lower. And and and, you know, 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.
Shaun Noorian
Yes. There's 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, prima becoming too systemic versus other dosage forms. And yes, drugs like finasteride can become debilitating for many men, not just causing retinal dysfunction, but a subset causing post finasteride syndrome, which they never regain their libido after. Yeah.
And that's that's That's a scary thing. That's very
Dr. Mark Hyman
scary. Yeah. So so that's part you use topical, use the methylene blue, use the testosterone. Any any other goodies?
Shaun Noorian
Yeah. My acne cream. So we have, different forms of acne cream. One of that I utilize has, tretinoin, clindamycin, and niacinamide. I use that every 3, 4 days.
And then, one that I use every night is what we call AcneDNS. It has dapsone, niacinamide, and spironolactone. And by combining all these different drugs and and and vitamin together, it's makes it much more convenient for the patient applying one medication instead of 3. And, as I mentioned, it's because of company 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 with to the patient and working with the prescriber. And so
Dr. Mark Hyman
PBMs are, pharmacy benefit managers that are basically the kind of secret and evil underbelly of the health care 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 for combating pharmacies, you can get the same things at a fraction of the cost.
Shaun Noorian
Exactly. And what we've done is we've become an FDA registered manufacturer, and 503 b 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 50 3 a 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, wholesaler as well.
So we are the manufacturer, wholesaler, and pharmacy all vertically integrated into 1. And by not accepting insurance, carriers and PBMs are out. So it's a fully vertically integrated supply chain that works directly with every single pharmaceutical end user in this country, and get the medications at a much lower cost because the lack of all these unnecessary The middlemen.
Dr. Mark Hyman
Right? Exactly. So any other goodies in your stack of of treatments?
Shaun Noorian
You know, I'm always experimenting with different forms of testosterone. There's testosterone saponate, enanthete. You know, we actually make a combination of testosterone saponate with a bit of testosterone propionate, which is a much faster acting ester. The pharmacokinetic half life of testosterone symphony is about a week long.
Dr. Mark Hyman
Yeah.
Shaun Noorian
And the half life of propionate is about 2 days. And so you can get a much different pharmacokinetic response and peak Yeah. Than you would be able to, like, by just utilizing a single ester by itself.
Dr. Mark Hyman
Yeah. So people might be listening going, well, gee, you know, like, it sounds kinda like a mad scientist. Is this regulated? How do I know the dose is right? Am I gonna take something that's got weird things in it?
There was some, you know, shady things that happened at the compounding pharmacy a few years ago with injectables that kinda got some fungal thing in some guy that not everybody kinda crazy. So so people are listening going, well, this sounds good, but, like, shouldn't I trust my pharmacy more? Why would I trust a commenting pharmacy that seems to be doing kind of experiments with all these different things? And how do you how do you answer that? Because I'm imagining people are thinking that as they're listening.
Shaun Noorian
Yeah. It's a good question. You know, compounding pharmacies, as I mentioned, like, 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 comp practice of pharmacy in 2013 with the passage of the Drug Quality Security Act because of that fungal meningitis outbreak
Dr. Mark Hyman
Yeah.
Shaun Noorian
That happened in 2012 from a company called NECC or New England Compounding Centers.
Dr. Mark Hyman
Mhmm.
Shaun Noorian
And that pharmacy made one bad batch or I should say 3 bad batches and killed 70 people and injured 700 or more.
Dr. Mark Hyman
Yeah.
Shaun Noorian
And so the FDA said congress then came in and said, how can we prevent this from happening again? And that is how the Drug Quality Security Act was passed, and this new category of 503 b 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.
Dr. Mark Hyman
So basically, in English, that means that in the drug companies, when they make a drug, have a really strict protocols in in the factory and make sure that it says what it is on the label, that the dose is the right dose, that it's clean, has no, you know, 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 that protects consumers. You know, I I I think compounding pharmacies is really important because I I I
Shaun Noorian
I Sorry. Your hands on the cable is making a noise.
Dr. Mark Hyman
Oh, sorry.
Shaun Noorian
It's okay.
Dr. Mark Hyman
So, you know, I I again, I've been practicing this for 30 years. I've been using compounding pharmacies for 30 years. One of my favorite is is in the hormone range. And a lot of women have, low libido or sexual dysfunction, especially going through menopause, hormones change. And, you know, 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 masculinization 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 drugstore through a regular pharmacist. So it's it's not exactly being a mad scientist, but it's it's actually using the compounds we have in in innovative and new ways to help patients with certain problems that that are hard to get solved with with other methods. So, you know, why when there aren't like, natural bio identical 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 why would you wanna use, compounded versions? You know, why why would that be better? You can kind of quote and quote there because I think, you know, this whole field of bio identical hormone therapy is kind of big, and hormone optimization therapy, whether it's for men or women, is sort of emerging.
And I I wrote a lot about in my book Young Forever, and I I use a lot of these compounds, but I think most people sort of, you know, wonder about, you know, 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 trochee that I put in my mouth?
Should be a pellet that I inject under my skin? Like, what? Like, there's so many choices. Right? So how do you how do you help people think about it, and how do you work with physicians to help them kind of figure this out?
Shaun Noorian
That's a great question. You know, compounding pharmacies, you know, one, people a lot of prescribers prefer to use a compounding pharmacy for a patient because, it's 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 they can 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 DHA supplement from, from a supplement store. You know, we have to test our products to meet, meet these standards, especially if they're made at our 5 zero three outsourcing facility.
Every single batch has to be tested for potency, sterility, endotoxin, and a slew of other tests Mhmm. To ensure, safety. Now when it comes to, gosh. Fuck. You asked the second question.
What was it?
Dr. Mark Hyman
You know, about how how how do you kind of know which way to to go with these different varieties of applications and formulations. Dosage forms.
Shaun Noorian
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 3 months. And so a patient that travels a lot or may forget to take a daily or weekly, a 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 trochee 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. Interesting.
Dr. Mark Hyman
Yeah. I think 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 cofounded, you know, we 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 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 prescribed at the drugstore. And it's like 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? You know?
And and I actually had an experience where I got very sick a few years ago. I had mold poisoning at my I live in a barn. It's like a 120 year old barn, and there was just mold in the basement. It used to be a horse stall. I renovate oh, shoot.
I just hit it. Oh, oh, hold on. It's gonna get better.
Shaun Noorian
You wanna massage you out? No. It's fine.
Dr. Mark Hyman
I'm sorry. I need more magnesium.
Shaun Noorian
I have some magnesium if you'd like some. It's okay.
Dr. Mark Hyman
It's just because of my back surgery,
Shaun Noorian
and sometimes, like, big weird things, symptoms happen. So, Yeah. Yeah. Those are the worst. God.
Dr. Mark Hyman
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 live in an old barn. It's a 120 5 year old barn barn. There was mold in the basement.
I renovated it down there. Used to be horse stalls and pretty freaking moldy. But the mold kinda came back. There was a leak, and I got very sick. I got a cough for a year.
I I ended up, 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, we've around the same time when I was getting the mold treated, I moved out of the house, I I got my root canal, I got my immune system was all compromised, I broke I broke my arm. I was in New Zealand riding where the 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 I just give 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. It was, like, completely unattached.
It was, like, dang, I couldn't move my arm. And and then I got really sick, and I got colitis and c diff, and I got, you know, ulcerative colitis. It's sort of started after that. I lost £30, and my I was in this catabolic state, which is a total breakdown. And and, you know, normally, well, your your fracture would heal in 6 weeks, and it was 6 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 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 6 months, or actually 8 months of, of nonunion. They call it nonunion, which is a very serious problem. I mean, like, it just my arm would be dangling, and I feel like I couldn't use it, and, you know, and I used the testosterone injections and my arm healed like that. So you know 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 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 you doctor it's not illegal. You're allowed to do it. But but there's a whole, off label sort of concept I'd love you to sort of talk about and and and how that can be helpful in getting people the compounds they need to treat the issues they need.
They might be, you you know, better served by a compounding pharmacy.
Shaun Noorian
Absolutely. 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 f no no compounding pharmacy makes a drug that is FDA approved.
Every 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 1,000,000,000 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 compounding, compounders to make these medications for that what may be considered off label use for whatever they think is best for that patient.
Dr. Mark Hyman
Yeah. And so, and this is what I do all the time. Like, there's no there's no, like, clitoral testosterone FDA approved drug, but I use it. Right? And and one of the things that I think is kind of fun is is the whole sexual health realm.
Right? You know, 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, you know, they're since they're now kind of, off patent, you know, I've seen combinations of things like oxytocin, which is the kind of feel good love hormone that you're breastfeeding or after sex, that kind of is a bonding, a 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.
Shaun Noorian
Absolutely. You know, we've seen sexual wellness come a long way over the past years, especially for men. I mean, women unfortunately don't have many FDA approved, options out there. The only there are only 2 on the market.
Dr. Mark Hyman
And I wanna talk about those because you also can get those by injections and people don't know about it. It's amazing to me how they don't know about it.
Shaun Noorian
Right. Right. Yeah. You know, ADDIE which was, the first drug approved for female sexual hyperarousal disorder. It is an oral pill.
Generic name is febanserin 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 bromelainotide under the brand name Byleesi. And that It's also a peptide.
Dr. Mark Hyman
That's right. The name is PT 141. That's right. Yeah.
Shaun Noorian
And it causes arousal, in almost anybody that injects it. Now
Dr. Mark Hyman
Men and women?
Shaun Noorian
Men and women. Yes. It's only indicated for postmenopausal women because that's the group that was studied to get the FD 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 bromelainotide, but compounding pharmacy may be able to use it as a trochee for, for buccal or sublingual absorption. And combine other drugs like oxytocin, phenethylaminesolate. We can even combine
Dr. Mark Hyman
So what's that?
Shaun Noorian
It's a it's a vasodilator.
Dr. Mark Hyman
Oh.
Shaun Noorian
And you know, it's actually used in intracabinosal injections as well.
Dr. Mark Hyman
Oh, yeah. Yeah. So for
Shaun Noorian
men that fail on oral PD 5 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 pepaverin, phantolomimesolate, and prostaglandin that can then be injected in the side of the penis in the corporal cavernosa.
Dr. Mark Hyman
This is trimix?
Shaun Noorian
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
Dr. Mark Hyman
that's kind of last implant.
Shaun Noorian
That's right. Exactly. And so that's what that's an example of where practitioners can utilize a compounding pharmacy to create an effective drug that is not commercially available.
Dr. Mark Hyman
Yeah. So Tri Mex is something you actually can't buy from your regular pharmacist, but it's incredibly effective. And urologists recommend and use it even from academic medical centers.
Shaun Noorian
Oh, it's been used for decades.
Dr. Mark Hyman
And it's it's something that actually most, doctors don't know about. In fact, I learned about it probably 20 years ago from a patient. I'm like, 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's works every time. And it's like I felt like I'm 20 years old again. And it's it's an incredible thing that is available. For women, I think the the p t 141 or the bramblematide is is, is is available as a prescription by Lacey, 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 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 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 1,000 and 1,000 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 and, they they they 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 BP 157. It's not really an FDA approved drug, but it's incredibly effective for injury and trauma. So I've had, like, bicep injuries or, you know, tendinitis or various issues, and you inject it. It's like a miracle. Within a few injections, they go ahead.
I had someone who was, you know, was an elite athlete, he had torn his calf, and I gave him a few injections, was gone. I had tennis elbow for months months months and was treated by the traditional doctors, put a little peptide in there, it kinda got kinda got resolved. And and recently, FDA 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, that is the brand name, or the eremlutide or p t 141 for sexual arousal. There are some that have actually been FDA approved, and you can use those.
But the other ones, you can't. So we talk about like the the the state of these sort of science and also the state of the politics, of these peptides and and what your perspective is and where we should be going? So peptides are very powerful substances.
Shaun Noorian
You know, as we've seen
Dr. Mark Hyman
But insulin's a peptide, just so everybody know. Right? They know how powerful insulin is. Right?
Shaun Noorian
Absolutely. And and because they're so powerful, they are considered drugs. And, in order for a compounding So
Dr. Mark Hyman
so is your poop now. You know that? The FDA regulates your poop. You can't do a fecal transplant because it's considered a drug.
Shaun Noorian
Yeah. There exactly. There's 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.
Exactly. Right. You know, they're, they can company pharmacies can only make drugs that have met one of 3 conditions. It has been a component of an fV 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 1 of the 503 bulks 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 approved drug, but are considered safe and have been grandfathered in.
Yeah. And so these peptides, have never been approved, don't contain a USPR monograph, and aren't contained within category 1 of the five of the blood cells. So they've never been legal to be able to be made. Now a lot of practitioners and company pharmacies have promoted these drugs over the years. And now we see, finally, the states and fed and and federal regulators, FDA, are taking action against compounding pharmacies for making these peptides because they were never supposed to be made in the first place.
Dr. Mark Hyman
No more for research purposes or for
Shaun Noorian
Well, some some of these peptides, while some are very safe and efficacious, others may not be. You know, 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 conja chemical, which is the name of the company that created the, the peptide and was studying it during clinical trials. Now those trials had to be ceased.
And 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 Do
Dr. Mark Hyman
you think it's overreach or do 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 hard down on. Like, for example, N acetylcysteine, which is basically, actually something we use in the emergency room for treating Tylenol Rose. But now they 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 the 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 sort of 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 $3,000 a month.
When you look at it from a compounding pharmacy for the doses you might wanna use, it might be $20 a month. And 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 and, you know, this allows for more customization. So can you talk about what's happening around this field of compounding and these peptides and semaglutide and Ozempic and where we're at? And should we feel we'd be worried about it?
Should they be using it? You know, is it safe? Is it something that you think, you know, we should sort of sort of bypass the pharma industry and go with compounding pharmacies and stop the pros price gouging? Because, you know, if you go to Canada, it's like a $100 or something. If you go to, you know, New York, it's, you know, $2,000.
Right? So how does that make sense?
Shaun Noorian
Yeah. So so to talk about peptides and then the conspiracy theories, you know, 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 ones, 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 ones, you know, company 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 Wegovo, Wegovy, Ozempic, Zepbound and Marngiorno, 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. Now we pay a lot more for them in the United States than we pay anybody else.
Dr. Mark Hyman
Just to clarify something because I'm confused. This is maybe my ignorance. But, you know, these drugs are made by pharma. So let's say Novo Nordisk makes Ozempic and Mogolli. They're they're making it in their factories.
They've got the patent on this drug. Where do you get your semaglutide from?
Shaun Noorian
From them
Dr. Mark Hyman
or from some other company that's making it?
Shaun Noorian
It's a good question. Because a lot of patients and subscribers, it's it they think that compounding pharmacies and outsourcing facilities, we get our active pharmaceutical ingredients off the street. You know. In the back alley somewhere. Right.
Yeah. 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
Dr. Mark Hyman
But I'm confused. How can how can a drug that's is is on patent be made by another company?
Shaun Noorian
Well, the patent covers a certain dosage form, certain dosage strength, and certain indication. Yeah. 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 patent.
Dr. Mark Hyman
Interesting. So it's really about the delivery system and all that. Because because, you know, in a way, these aren't really drugs. These are these are natural compounds like testosterone or estrogen or vitamin c or vitamin d that exist in nature. They're not new to nature molecules.
And so new to nature molecules, they they are like things that we make up as in the pharmaceutical industry. But these are things that naturally exist but it's it's the the way they get these patents is through the the delivery system, the injectable form, the, like you said, the dosage and so forth. So so basically, the the these peptides have been widely available because they are natural compounds.
Shaun Noorian
Right. And you know, 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, not the the 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 ones, they are very powerful when it comes to treating, as we know, type 2 diabetes, obesity, cardiovascular disease, you know, hepatic disease, addiction, and, some case now. There's some studies showing that it helped me helped treat Alzheimer's, fertility issues, and the list just keeps going on and on.
Dr. Mark Hyman
And I wonder, by the way, I'm just gonna make a footnote here on that. I I 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 I feel strongly that and I and I've seen some data that suggest that it's actually the weight loss, not the drug.
Shaun Noorian
Right. Because these 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, you know, cardiovascular disease is the number one cause of death. Number 2 is cancer. Well, we know that obesity increases the risk of developing cardiovascular disease in cancer.
Dr. Mark Hyman
Of course.
Shaun Noorian
So by getting by by treating obesity, you really remove potential other comorbidities from happening in the first place or curing them.
Dr. Mark Hyman
And this is this is but this is not a panacea. And I and, you know, one of the things that's so I had, doctor 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. And I had a patient the other day with pancreatitis. They can cause kidney issues, thyroid issues. They're the the the the 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 what's your perspective on sort of the modulation of the dosing that's different from what the pharmaceutical companies have established as a dosing?
Shaun Noorian
So, the dosing that the pharmaceutical companies have used, they have shown, to the FDA and the panels that FDA experts that really decide whether drug is safe and efficacious before it gets approved. They've they've proven that this dosing schedule and regimen are 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.
Dr. Mark Hyman
They're stuck.
Shaun Noorian
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 do using the pen, take it out of a multidose vial using a syringe just like they would insulin or testosterone or any other medications that comes in vial.
Dr. Mark Hyman
For a 100 years in medicine.
Shaun Noorian
Yeah. And administering that a lower dose so that the patient doesn't have to experience that side effect. And then dose escalating slower than what the patient would do using a commercial product. Now Yeah. That's just an example.
That's not always the case.
Dr. Mark Hyman
And and you do the same, like, once a week injections, or can you do more frequent or less frequent? Or how do you
Shaun Noorian
Well, the FDA indicated use, recommends, once a week injections. Medi just like it's similar for testosterone. Sostarum is recommended to be dosed once a week, but we see prescribers dosing it, breaking that up into smaller injections, doing biweekly injections or injection twice a week. It's all dependent on what the prescriber thinks best for their patients.
Dr. Mark Hyman
Personalization. I mean, this is what we're talking about in medicine. It's why, you know, everything is moving towards customization, personalization, not one size fits all. So this is interesting for those listening, you know, we we've had this conversation with doctor Chien Amour. 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. Like, I I did the math. It was, like, $20 versus, like, you know, 70 to $100 a month. I wanna sort of finish talking about a topic that I think is really important that has sort of hit a cultural phenomena. I've been doing it for 30 years.
It was really hard to get. It's 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 a 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 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 kinda hear your perspective on on on on the the sort of in in, intravenous nutrient therapies and and what what they can be used for, who they help, and, and and how people should think about them. It's like why not just take the vitamin. Right? Right.
Shaun Noorian
You know, a lot of these IV cocktails that these IV Nutrition Centers or mobile nurses are administering to patients, you know, they 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
Dr. Mark Hyman
gonna poop your brains out.
Shaun Noorian
You're gonna poop your brains out.
Dr. Mark Hyman
It's true. I I I you know, vitamin c can be very helpful for allergy. I had a patient with an acute acute allergic reaction to, like, environmental allergies, not like a peanut allergy, but, like, 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. On cancer therapy, they're using 75 grams.
You couldn't take that orally. Right.
Shaun Noorian
There's no way. You'd have to use you would you would poop your entire body out, I think, if you did that. And so by infusing it
Dr. Mark Hyman
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
Shaun Noorian
gonna be an enjoyable experience, but it it'll do the job. But, you know, if, for for example, for oncology treatment, you know, 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 or other infections.
Dr. Mark Hyman
Yeah. Even in the ICU, it helped, with the recovery from sepsis and other things. Yeah.
Shaun Noorian
Right. Right. And so Maybe Linus Polly was right. You know, that and, you know, we're starting to find out that natural vitamins, minerals, amino acids, they are, you know, the best form of medicine in a lot of cases. And by giving patients this medicine that they're typically lacking in their diet, that they're, you know, we're almost all lacking the right amount of vitamins and minerals from the American diet.
By infusing them, especially, you know, 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.
Dr. Mark Hyman
Just pee out the rest. Right. So so doctors say, oh, don't don't take vitamins to give you expensive urine. But I'm like, that doesn't make any sense. Like, saying don't drink water because you're just gonna pee.
You take what you need, and your body gets rid of the rest.
Shaun Noorian
Yeah. Yeah. Exactly. But but for cases where the patient needs more hydration, like after a night of drinking. And, hangover cocktail is very popular where it has a lot of the b vitamins, minerals, glutathione, maybe some Zofran for nausea, maybe, and of course, glutathione at the very end to help, bring back the antioxidants.
Dr. Mark Hyman
Fix the liver, you mean?
Shaun Noorian
Right. Exactly. Yeah. Yeah. To help repair the liver after it's just gone through, you know, quite a battle
Dr. Mark Hyman
Yeah.
Shaun Noorian
With, with a very dangerous chemical. Yeah. And, so IV nutrition, we've actually seen it grow as the the 2nd largest area of growth in our company behind GLP ones.
Dr. Mark Hyman
I bet.
Shaun Noorian
As that industry is growing about 25 percent
Dr. Mark Hyman
a year. It's quite amazing.
Shaun Noorian
It is quite amazing. 25 percent a year. I had an
Dr. Mark Hyman
idea, like, idea 20 years ago to set these IV clinics, and I was like, I don't know who's gonna do it. I was like, I should have done it.
Shaun Noorian
Well, it's never too late. Yeah. Yeah. No. It's it's, and 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
Dr. Mark Hyman
the very first
Shaun Noorian
thing you you pretty much give a patient whenever they come to a hospital. Wow. You're giving them b vitamins Yeah. 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 they could benefit.
Dr. Mark Hyman
You know, it's too 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 the only use to revive alcoholics who are massively nutritionally depleted and, you know, it's it's it's kind of miracle. I mean, there's something called Wernicke's encephalopathy, which is a condition that alcoholics have from depleted thiamine or vitamin b 1. 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.
Shaun Noorian
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 high levels of biotin.
And then you have athletic 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 it's you're getting 100% of the drug bioavailable versus some amino acids you only absorb 5% when taking orally.
Dr. Mark Hyman
So do you do you have a compound that you use called phosphatidylcholine maybe?
Shaun Noorian
We made it before, but we no longer make it. And why is that? I think it was I think it was used primarily for weight loss, spot reduction, but wasn't did not become, very popularized. And we saw that sales were decreasing over time as more and more providers were using other drugs.
Dr. Mark Hyman
So you could make it, you just don't make it? Right. It conditions it's quite big in Europe.
Shaun Noorian
And
Dr. Mark Hyman
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 I recent I I recently wrote a, newsletter, longevity newsletter, by my own experience using a series of IV compounds to kinda revitalize myself. Because I've talked about it on the podcast before, but I've had mercury poisoning. I've had severe mole 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 and and and and damage from the things that have happened to me. And I recently, you know, did this protocol, which which, initially was developed by a woman named Kane. They call it 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 high dose of biotin, methylcobalamin, which is a form b vitamin 12, and leucovirm, 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 and, and so forth. And what's remarkable about it is that it's 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, bitch out and watch a movie.
I can be functional and read and do whatever I need to do. And and I'm sort of, like, I'm very impressed by this by this approach, and I I think it's not really widely available or popular yet in America, but I think it's 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, you know, who had just generally are healthy, but wanted to up level health and feel better, sleep better, have less cognitive dysfunction or brain fog.
It's it's kind of amazing, and I think it these are the kinds of therapies that are not really available. So there there's data on it. It's not as much data as you'd like because obviously because where where the data is is from the drug companies funding the studies. Like, for example, those MPIC and these drugs, there's literally 1,000,000 and I don't know if it's probably 1,000,000,000 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 a aggressive lifestyle and dietary intervention comparing it to that, I'm guessing you're gonna say the same thing.
Because they did they did this with bariatric surgery. They basically took people who were obese who were gonna have bariatric surgery and they randomized them to 2 groups. 1 group got the surgery, 1 group didn't. They just fed them the same diet afterwards. And, you know, we say, oh, you need a bariatric surgery even if you're still obese, your diabetes goes away in 2 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. So how do you sort of grapple with this? Because you're 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 it it they look safe. But how do you kind of reconcile all that?
Shaun Noorian
You know, one I have so much respect for the academics that are doing all this research and, introducing compounded therapies to show that they may use treat indications outside of the indicated use. For example, Nangeland decanoate, also known as decadrabolin. You know, it's been it's starting to be known that it used it it helps treat osteoporosis and joint injuries.
Dr. Mark Hyman
That's an anabolic steroid.
Shaun Noorian
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 while also treating wasting syndrome for patients with AIDS, but also being now utilized for other other indications. And so there's, you know, utilizing a company pharmacy, you can you know, because a lot of the medications that we prescribed don't have indicated uses, or their 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 will work in a patient that the FDA approved drug may not have worked for that for that for a different use.
So, yeah, we we kind of are, you know, an experimental ground, if you wanna call that, for prescribers that wanna utilize a product that hasn't been on the market for one reason or another.
Dr. Mark Hyman
K. Well, I'm gonna talk to you about this PK 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,
Shaun Noorian
you know Please send send me the formulation. I'd love to dig in.
Dr. Mark Hyman
I will. I'll send you the whole protocol. And, you know, I I just wanna say that, you know, 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 it took a lot of courage for you to 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 in because of the standards we 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?
Shaun Noorian
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, if that that practitioner is really a specialist at what they do. Mhmm.
Because specialists, they will make something that is special for that individual patient. Yeah. And that's really where we see the future of medicine headed. Yeah. So, I think compounding has a very important part to play in the future of our health care system, and we're very lucky to be able to benefit tens of millions of patients and soon 100 of millions of patients across the globe as we're not just here in the United States.
No. There's a whole crisis, health care crisis, that's going on globally that these types of medications can address.
Dr. Mark Hyman
Well, Sean, thank you so much for the work you've done for joining the company and giving me a place where I feel confident to get my stuff. And for those who wanna learn more, you can read the show notes. We're gonna put links in there, the things we talked about. There's a lot of studies so far that that we kind of alluded to. And, it's been great having you on the podcast, and good luck with all this stuff.
And I'm gonna send you all that stuff about that protocol so you can have it.
Shaun Noorian
Can't wait. I love being a mad scientist in my in my spare time. But thank you for what you do to bring access, knowledge, and, different point of view to how medicine could be done in this country because there needs there needs to be a change as there is a crisis going on right now with health care costs and outcomes given a certain amount of cost given for that specific therapy. So thank you for educating all of us and bringing us into the future of health care.
Dr. Mark Hyman
Thanks. Thanks so much, Sean.
Shaun Noorian
Pleasure's all mine. Thank you.
