Welcome to the Dr. Gabrielle Lyon show, where cutting-edge science meets innovation and practical application for everybody. In this episode, I sit down with Sean Norian. Sean is the founder and owner of one of the largest compounding pharmacies in the country. In this episode, we talk about all things anabolic. You’ve heard about medications that can make people less obese, but what about medications that can make people, yep, have more muscle? What are the controversies around that? What about the safety profile? And what exactly is the role of a compounding pharmacy? As always, we provide this information free of cost, so please take a moment to share it, help spread the word. And now, let’s jump into the show. Sean Norian, welcome to the show. I’m really excited to have you here. And before we jump into the content, there are a number of reasons why I invite you on the podcast.

 You are owner and founder of Empower Pharmacy. This is a compounding pharmacy. You also have had your own health challenges, and because of those, you are extraordinary and have really brought to the forefront. I think you’re being very vocal about what is available to patients, providers, and a lot of the myths around compounding pharmacy.

 And before we talk about all that, I want to hear your story. Well, Gabriel, it’s an honor to be on your show and really appreciate what you do to be able to educate patients like myself on what options we have available to us. And if you want to start with my story, it kind of started before I got in the compounding pharmacy business, I was just a regular engineer. And I’d studied engineering and wanted to build cars since I was a kid. And unfortunately, when I graduated in December of 2007, the car industry wasn’t hiring, to say the least. And are you from Texas? Yep, yep, born and raised here, right here in Houston. And when I couldn’t get a job working for GM or Ford, I decided to get a job doing what most engineers do in Texas, oil and gas. So I was very lucky to get a job working for Schlumberger, doing hydraulic fracturing as a field engineer, rigging up with my crew, getting my hands dirty every single day. I loved it. And I’ve got so much respect for the guys out there that are breaking their backs every single day. And because nine months later, I broke my back. I lifted a heavy piece of metal the wrong way and I hammered several of my lower vertebrae. And I was put into physical therapy. And when I was put in physical therapy– And how old were you, 25? 25 at the time. And when I got in physical therapy, the doctor that was treating me noticed that I was very skinny from my age. I’d give you an idea of how skinny I was. I’m 5’10 and back then I weighed about 125 pounds. And I’d always been an endomorph my entire life. Couldn’t gain any muscle, no matter how much I work out, and my habits create protein, whatever I try. I just couldn’t gain muscle. So this doctor kind of found out why. He took my blood and determined that I had the testosterone level of an 80-year-old man. I was below 200 nanograms per deciliter, which is way below the normal range for anybody, regardless of their age. And when he noticed that, he sent me to a specialist at Baylor. And that specialist gave me treatment. And who was that specialist? Dr. Lipschultz. Dr. Larry Lipschultz for the listener is, would we consider him the godfather of andrology? Ah, yes. Would he be offended? He wrote the book on male fertility because not only was I hypogonadal, I was also infertile, which also explained why I couldn’t have any kids.

 So it’s a problem that I think a lot of is becoming more prevalent, especially as we’ve seen sperm counts decrease by about half over the past 100 years.

 And Dr. Lipschultz and his amazing fellows, they treated me. And once they realized what was wrong with me, it turns out I was born with a pituitary disorder. I don’t create luteinizing hormone or follicle stimulating hormone. And so which explains why I was practically azuspermic, almost no sperm. And I had a very low testosterone level. And so once they realized that I would need to be on these medications for the rest of my life, they knew that I would be better served by a compounding pharmacy instead of a traditional retail pharmacy. And why is that? Well, for one reason, compounding pharmacies can customize these drugs to be able to individualize treatment for these patients. We can also provide medications that have been backordered or on backorder, have been discontinued or orphaned for one reason or another, or whatever the doctor determines in his or her mind is the best course of therapy. So compounding pharmacies literally make exactly what the doctor ordered. But they have a really strained reputation. I know with many, well, maybe not my fellow colleagues because they are like Larry Lipscholt or Dr. Mohikara, where they all use compounding pharmacies. But the majority of providers, primary care providers, and even specialists, and even the general population, there’s a stigma with compounding pharmacies. It’s lessening. And I really, my goal for this episode is to de-stigmatize compounding pharmacies because there are options available and we need to have a transparent conversation. Absolutely. I totally agree.

 Over the past 100 years or so, we’ve seen compounding pharmacies become the prevalent source of pharmaceutical medications. For example, in 1930s, compounding pharmacies made up about 75% of all prescriptions dispensed in this country. I was going to ask you what the breakdown was. Yeah. So compounding has been around forever. Big Pharma hasn’t existed for hundreds of years. I never thought about that. Okay. Everything was manually made. If you look at pictures from the old days, you’ll see apothecary kind of using more of pestle and mixing, using graduated cylinders and alan myra flask and making a concoction that they then give to a patient one at a time. Of course, with the industrialization of pharmaceutical manufacturing, we saw that shift away from the local druggist or apothecary into these large pharmaceutical companies that we see today. So over the past 100 years, we’ve gone from 75% of the market to about 1% to 3% of all prescriptions in this country. Now, that’s 1% to 3% is still a significant amount of prescriptions.

 Patients and doctors are learning more and more that they can get better treatment outcomes if they can individualize or customize these medications for their treatment programs. That’s really the role of compounding pharmacies today.

 Doctors and patients are, as they become more educated, they use us more and they get more benefit from them. Another added benefit is that it’s typically at a much lower cost, being that we are a fully vertically integrated supply chain. The traditional pharmaceutical supply chain is a complicated mess.

 You’ve got the manufacturer at the top, let’s say Pfizer, they’re making a drug and then they sell it to a wholesaler, Mckesson, and the Mckesson then sells that drug to a pharmacy, and I’ll say Walgreens. Then Walgreens, before it can get the medication to a patient, it has to go through an insurance carrier and a PBM. What’s a PBM? Pharmacy Benefit Manager. I see.

 All these middlemen cause an increased amount of cost because every single time a drug exchanges hands, a margin has to be increased in order for that entity to be a problem. Do you think that’s one of the reasons why we see such a huge rise in prescription cost? Absolutely.

 That’s one of many reasons, but that is a primary reason.

 In order to get prescriptions to lower their cost over time, which think about it, there’s almost no industry where a product gets more expensive over time, only pretty much in the pharmaceutical industry. That’s true.

 So we ask why, even though patients are- But why did you care? You were an engineer who broke your back, got treatment.

 How did you decide to open a compounding pharmacy? Well, because I was lucky enough to be exposed to compound medicine. So when Dr. Lipschultz decided to send me to a compounding pharmacy, he knew that I would have to be on these medications for the rest of my life. And that if he sent me to a traditional pharmacy, that traditional pharmacy, on average, because all drugs do this, they increase their prices by about 11% a year on average.

 And think about it, 25 years old, average lifespan for a male in this country, about 75 years old, that’s 50 years. I’ve got to be on this medication. Imagine if that medication increased in price 11% a year. Gosh. He knew that the only way to make sure his patients would be compliant with this chronic therapy is by using a compounding pharmacy. And compounding pharmacies, we don’t increase our price. We buy that much. We increase our prices by inflation on average. So patients will never have to pay more. They can stay on these programs. And of course, at the same time, the answer to the benefit is that they’re customized for the patient too. So you’re getting better treatment outcomes at a lower cost. Did you have an aha moment where you were like, I’m going to this compounding pharmacy. Were you still working at the time as an engineer? No, no, no. I was broke, living with my mother. You know, that’s a lot different than now. But yeah, yeah, I know. But that’s the thing. I want you to know, several hundred dollars a month when you have limited income is huge. I mean, that’s like it’s like all your expendable income is being put into these medications. And that probably is like that right now for a lot of people.

 Did you have a moment where you said, you know what? I’m going to open one. Did you have a I did of one moment? What’s that one moment when I inject the testosterone for the first time? Really? Yeah. Yeah. I saw the benefits. My depression went away. I gained 15 pounds of muscle practically overnight without even having to work out. I got more libido, stamina, endurance. I got better sleep. I didn’t get tired in the middle of the day. I used to have to take a nap at 6 p.m. Every single day. And all that just went away and then had boundless amounts of energy and ambition. And I was like, wow, what is this stuff? You know, this is this is like this stuff literally changed my life. And is that at that moment, I realized that it became my mission in life to be able to get access to the medications to as many patients like myself that are suffering in silence. And so I decided to read about compounding with all the seminars, the conferences on the subject. As opposed to saying, you know what? I’m going to open up a local CVS or Walgreens, right? There was something because you had recognized probably that the cost was too high and it couldn’t be individualized. And also there’s a limit. It seems as if the compounding pharmacies are unlimited to what they can create, get access to versus say a large chain. Is that true? That is that that’s fairly true. Yes. You know, we can make anything that is either have been a component of an FDA approved drug at one point of time has a United States pharma, a national formula monograph. And that’s just a, it’s a compendial document that says that, you know, there are standards for this certain substance. And it’s been around the United States pharma has been around for hundreds of years. And so it’s a very trusted institution. And then three, if that substance is also in category one of the 503 bulks list, and that list is a list of substances that the FDA that either doesn’t have a USB monograph has not been a component of an FDA approved drug, but is been around for a very long time and generally recognizes safe and effective. And so these medications been grandfathered in into the compounding industry. An example of that that you could think of. Yeah, absolutely. There’s so one is methylcobalamin. It’s a methylated version of B12. As you know, there are many versions of cobalamin or B12, most popular one being sinocobalamin. And then of course, in this hydroxycobalamin and then methylcobalamin is the most popular one that we see on the compounding side. And individuals that have say, a genetic abnormality or SNP like MTHFR that they wouldn’t be able to use regular cobalamin would require a methylated cobalamin. Exactly. And these individuals would not have benefit from regular cobalamin. Absolutely. Exactly. So, you know, because methylcobalamin has never been an FDA approved drug, it does not have a USP or NF monograph, but the FDA recognizes that it’s been around forever and compounding farmers and making it safely. And it is necessary for patients that are unable to methylate sinocobalamin into methylcobalamin. I got some big news for you. I’m so excited to announce a partnership with Quicksilver Scientific. Now, Quicksilver products, I have been using these for myself and in my clinical practice for years. So when I finally had the opportunity to partner with them, I couldn’t be more excited. Let me tell you about the three top products that I have been using for over six years. And they are Thrivogen, Nanomogo, yeah, you heard it right, Nanomogo, and Lipozomal Glutathione. These products are amazing. And here is why I love Thrivogen, which is a woman based formula. It has a ton of adaptogenic herbs, meaning things that help the body’s resiliency. It has ashwagandha, rhodiola, and many other herbs that help with resiliency, stress management, and overall energy, which is one reason why I love it. And it’s in a formulation that allows for sublingual delivery, meaning you put it in your mouth, you hold it for 30 to 60 seconds, and then you ingest it. It has been so helpful for me. And then the Nanomogo is a male based formula. Nanomogo is absolutely incredible for guys that are really hard charging, and it really helps with resiliency, stress management, all of the things that I had mentioned earlier. These are two amazing products. And then of course, there’s Lipozomal Glutathione for detoxification. If you have not tried any of these three products, you should go to Quicksilver Scientific, use the code DrLion. That’s Quicksilver Scientific, and use the code DrLion for 15% off. Thank you to Thesis for sponsoring this episode of the show. I’ve been working with Thesis for a handful of years now. Why do I love Thesis? Thesis is the first and only customized nootropic company. What does that mean? Nootropics are substances, nutrients found in nature and the human body that enhance cognition, the way that you think, your memory, how sharp you are. These are critical functionings that we all need. And who doesn’t want an edge? I have used Thesis personally when I did my first TED Talk, when I was writing my first book. Thesis has been a game changer for me. Their products are evidence-based, science-oriented. And by the way, these formulations are better than any formulations I have ever seen. I went to takethesis.com. You should go there too. Don’t wait. takethesis.com. You’ll enter, you’ll take their quiz, you’ll enter in all your information, and you will get a customized nootropic box to trial different formulas. I have listed a handful of my favorite from logic, clarity, to energy. These are products that I use routinely, helped me really, really function to my full capacity. You can try yours. Go to takethesis.com, enter Dr. Lion. You’ll get 20% off your first box. That’s takethesis.com and use the code Dr. Lion. Do you want to know what I drink in the morning that is a little bit salty and gives me a huge pick me up? Well, I’m going to tell you. And that is element, chocolate element. That’s L-M-N-T in my coffee. I brew a black cup of coffee with a shot of espresso, and then I put a scoop of collagen and a little bit of MCT oil in it and one fourth a packet of element chocolate. Sometimes I use chocolate mint. I’ve also saved chocolate caramel. It’s kind of this like chocolatey caramel.

 Amazing. So I get my caffeine. I get some collagen for, of course, hair, skin, and nails. And I get electrolytes in my coffee. Sodium, potassium, magnesium, all amazing. I have now created my own supercharged drink. Maybe you get headaches with your caffeine because you dehydrate yourself, or maybe you get headaches because you sweat a lot while training, or maybe you just live in Texas where it’s hot. And so you definitely sweat a lot. You definitely get headaches, and this is why I love to add electrolytes to what I’m drinking. And it can be coffee. It can be water. Lately, it’s been coffee, and it tastes amazing. You can get yours at drinkelement. That’s drinklmnt.com. You’ll get a free sample pack when you use the code DrLion. And by the way, if you don’t like it, it’s totally risk-free. You’ll get your money back. No questions asked. I love this stuff. You will too. Back to the show. Are there other medications that people maybe think or don’t think of that you see frequently in compounding pharmacies that people are asking for or wanting? There’s so many. So we manufacture and compound almost 600 different medications, all the way from men’s health, women’s health, hormone replacement, longevity medicine, anabolic, weight management, dermatology, everything under the sun that we consider functional medicine or integrative health. And they cross each other. So a man that’s on hormone replacement therapy or testosterone, that may cause androgenic alopecia, which then puts him into the dermatology space. And if he has testosterone, he may also have a rectal dysfunction. So then we’re in sexual wellness space. And if you have problems with your sexual wellness, you may be caused by cardiovascular issues. So now, and those cardiovascular issues may be caused by obesity. So now you’re in the weight management space. And so we’re learning in order to treat the patient holistically, we need to bring all these areas of treatment together and then give the patient a program where they can be fully optimized across all areas of health. I love that. And one of the really defining moments for having you on there was there was one. And this is when everybody started talking about the GLP ones, whether it’s ozempix, amaglutide, or GIPs like trisepatide. And they are so cost prohibitive for people.

 And then I started seeing physicians saying, don’t use compounding pharmacies, compounding pharmacies, and this whole slew of misinformation, which couldn’t be further from the truth, which I’m going to have you explain. They’re going to say, oh, it’s not regulated all of these things and that you should stay away from it. And I don’t think that the physicians were misintentionally doing that, but they were uninformed. And they are making statements that are really taking health away from the general population. Because when you buy through compounding pharmacy, these medications, they are affordable.

 Right.

 Tell me some of the misconceptions that people have around compounding pharmacies, compounded medications. Please clear it up for us. I love to. You know, compounding pharmacies, we are regulated by each individual state board of pharmacy, as well as the FDA. And so we are one of the most regulated industries in the world. Think about it. You’re making drugs that are, many of them, going to be injected into humans. And there is nothing more dangerous than injecting an unsafe drug into a person. And so there are mountains of rules and regulations dictating what compounding pharmacies can and can’t do. And because we are regulated, we get inspected by all the time, by all these different agencies on a regular basis to ensure that we are meeting the standards and the standards are very high. And so, you know, if these drugs that are being made in compounding pharmacies and outsourcing facilities, they are being made in clean rooms with environmental monitoring in place, environmental sampling. I mean, we have incubators with agri-plates just filled. I’m coming to see it. I got to see this for myself. Yeah. And so we’re making these medications in the highest standards that you would see inside of a pharmacy. And if you’re getting your medications from an outsourcing facility, which is a new type of entity that the FDA created about 11 years ago with the passage of the Drug Quality Security Act, these facilities actually meet the same standards as big pharma, good manufacturing practices. Are all compounding pharmacies created equal?

 I would say not. You know, while we all have to meet a minimum threshold, some of us go above and beyond what is required. For example, you know, we actually incorporate several aspects of good manufacturing practices into our compounding pharmacy to be able to improve the accuracy and safety of our medications. And so sourcing your medications from a compounder that meets these higher standards is one that is of the FDA and many other regulators say are recommended. How would someone know? So there are only a handful of compounding pharmacies that also have a mature 503B outsourcing facilities as under their corporate organization.

 And the way to know is you have it’s advertised on their website. You know, you can see that they’re both considered a 503A compounding pharmacy. So they should look for a 503A compounding pharmacy only. Yeah. That’s also co-owned by a 503B outsourcing facility or sources their sterile medications from a 503B outsourcing facility. That’s not saying that compounding pharmacies in general are unsafe. You know, we all have to, all the drugs that leave our facilities do have to meet the minimum specifications of quality, sterility, endotoxin, purity, potency, to make sure that the drugs that we are putting on the market are safe and effective. Can you talk a little bit about the education around or what we need to understand as both providers and patients as say medications like testosterone for women, which right now is not FDA approved but can be used off label or Nandralone, which I think is FDA approved for, is it wasting or osteoporosis or is it an off label type drug and what does off label even mean? Great questions. You know, to start with Nandralone, you know, Which is an anabolic steroid. Yep, absolutely. And you know, it’s actually everything that compounding pharmacy does is technically off label because none of our drugs are FDA approved. You know, everything that we make while the ingredients are sourced from FDA approved manufacturers and suppliers, the indication that prescribers use could be for anything, just like they could do for any FDA approved medication as well. And for Nandralone, you know, this medication, of course, you know, it’s a perfect example of a drug that was discontinued, orphaned, taken off the market in 2007. Do we know why? The drug company says it was for reasons of safety, but as we know, you know, Nandralone if used properly is a very safe medication and can be lifesaving in many instances. And actually it was used to save the lives of patients with HIV or AIDS, you know, and when they’re going through wasting syndrome in the early 80s, when there was no FDA approved drug to help to treat AIDS or wasting syndrome, for that matter. So what we saw is buyers clubs opening up in our city and many others across the country. Explain to people what the buyers club is kind of the idea behind it. Yeah. So if anybody’s ever seen the movie Dallas Buyers Club, starring Matthew McConaughey, amazing movie, by the way, definitely have to watch it. You know, it was a way where patients with HIV, you know, would go to these groups that would provide them a membership to be able to give them access to therapies, substances that were either not FDA approved, but were known to be effective in preventing wasting syndrome. And Nandralone was one of those substances, you know, we learned that really the best way to prevent wasting syndrome is to give patients anabolic substances, things that build muscle. Right. And which by the way, that has a extremely negative connotation, but I was looking at the history and I think a large component of the negative stigma that anabolic has and you know, that it currently has came from through sports. Right. It really happened through sports. And that’s when people were saying testosterone you should be banned, Nandralone you should be banned and sports, that domain is so much different than health and longevity. And it created a misunderstanding for both patients about safety and efficacy surrounding testosterone, other anabolic and the legality of use, which these drugs are legal and it has done a huge disservice for health and wellness. I couldn’t agree more. You know, I grew up playing sports and all the sports baseball, you know, and, you know, when I saw my heroes, you know, getting asterixes next to their number of home runs, I was like, whoa, they’re cheaters. Like that’s what I was taught. And, you know, it wasn’t later until I started taking these substances myself where I was like, hold on a second, you know, it’s actually these medications are life-saving, you know, they’re life-changing at the very least. And the vast majority of patients that are taking these medications are not doing them to hit more home runs or perform better on the field. By the way, they’re not going to be able to hit more home runs, right? They might be able to be stronger, but it doesn’t mean that their aim is going to be better. Right. I could probably give my husband a ton of anabolic and I guarantee you, he still would not be able to hit the ball. Right. Exactly. You know, it’s a lot of that. But anabolic, they do exactly what they’re supposed to. They make you better. They make you heal faster from injury, recover better from workouts. So these events that these athletes are going to, you know, they’re one day after another and they’re working there, they’re exerting themselves, especially very difficult, strenuous sports, you know, basketball, football, you know, these are ones where it literally damages the body. And if they can’t recover in the meantime until their next performance, they are prone to injury. And so what they’re, the substance are actually not being used to like get all big and strong. They’re used to recover and prevent injury. And they’re not used in super physiologic doses that are going to, you know, if you Google Nandralone, what you see come up is anabolic abuse, right? There are, there are many scholarly papers, but the first papers that come up are all about abuse versus, hey, this is shown to prevent osteoporosis and or treat osteoporosis in women. Nandralone use can support and help tendon injury. All of these positive aspects, yet we can provide and prescribe medication to make someone have less body fat. Nobody blinks an eye. Nobody prescribing medication that might make your musculature bigger and stronger. If you’re like, Oh, you shouldn’t be doing that. That’s, you know, you’re, you’re cheating. You’re taking anabolic steroids, but nobody blinks an eye to make individuals less obese. Right. Exactly. Why? Why do you think that is? It’s, it’s, it’s the stigma, you know, it’s, it’s misinformation, you know, and a lot of doctors, you know, they aren’t taught this type of medicine in medical school. Do you remember? I called you and I was like, Sean, I really want to use this compound, but I’m afraid that they’re going to come after my license, but this patient really needs to put on muscle. We’ve tried testosterone. We’ve taught, we’ve tried the things that quote are within the, what we would consider the normal standard of care. And do you remember what you said to me? Yeah, I was like, it’s, it’s, we don’t see any evidence of that in our dispensing of these medications. You know, one prescribers, when they’re dispensed, these medications properly, you know, to a patient that needs more muscle mass in order to be healthier, which by the way, is almost everyone, maybe not Matt, my producer, but everybody else. Right. Right. Exactly. We can all benefit from our muscle. And most patients that are taking these are not bodybuilders, you know, and let’s say there’s anything wrong with a bodybuilder that is taking a medication, you know, years after they’ve been decades after they’ve been bodybuilding, you know, going back to an Angelone, most bodybuilders, especially, you know, when they’re in their forties and fifties, you know, they don’t take an Angelone to gain mass. They take it to help with the joints, their, their, their, the injuries that they’ve had over the years, you know, pushing thousands of pounds of weight, putting all that pressure on their joints, you know, and one of the, you know, one of the great, uh, benefits of taking an Angelone, not only does it help prevent injury, it also helps lubricate the joints. Yes. And so we’ve seen papers come out studies by Dr. Lipchalt and his fellow, right? Right. Dr. Kovac as well. He was one of those fellows that actually came up with the study, you know, he showed that, you know, it helps with osteoporosis and it helps with joint pain. And now, you know, so these are off label uses, there’s nothing wrong with a prescriber using one medication that was approved for the treatment of anemia to then be able to use it to improve another medical condition. And that would be the definition where we were to describe off label use. It would be, this is FDA approved, which you should mention what, what does FDA approval mean for a medication? I would love to be come educated on that, you know, from your perspective, let’s say, Nandralone is FDA approved, which it is for the treatment of anemia individuals with chronic kidney disease struggle to make erythropoietin struggle to make red blood cells. But an individual can use it off label, meaning it’s not FDA approved for that, or it’s FDA approved for that issue, but not necessarily for muscle mass or a number of other things which the patient could benefit. Right. There’s nothing illegal or dangerous, especially when a patient is informed of all the potential side effects and the potential benefits. You know, I was thinking about aspirin, and I was thinking about statins, and nobody blinks an eye at these medications, for example, statin, which can decrease, yes, cholesterol and have a number of downstream effects versus something like testosterone.

 For women or men, people are like, Oh, oh, you’re on test to Osterone. This is a huge, huge misconception. And it’s keeping our country and the rest of the world sicker. I couldn’t agree more. And, you know, I promise I’ll get back to women’s cell. I can’t wait. I talked about that. But it’s talk about the FDA approval process. So what does FDA approval mean? And does something need to be FDA approved? Do you feel like in order to utilize it, does it have to be FDA approved for muscle mass? That’s a good question. So many drugs are given one indication. So FDA approval, let’s use semaglutide, for example, because that’s all the rage. Everybody’s eating it. And you guys, that is ozumpic. Right. And, you know, for semaglutide, it was approved for the treatment of type 2 diabetes and obesity. But what we’re finding is that there are all these other disease states that it treats, you know, addiction, it treats kidney disease, cardiovascular disease, you know, it’s incredible. It and we’re learning every day, you know, it’s treats almost anything. We’re actually doing research with Dr. Keira right now. You are. He didn’t let me in on this. Give him a hard time. Yeah. It’s a show that it treats, you know, could potentially help with semen parameters, you know, help with motility for progression, you know, so there are all these ways where, you know, you can have just because a drug is indicated for one use doesn’t mean it can’t help another comorbidity and lack of evidence right now doesn’t mean it’s not there is an evidence. It’s just a lack of evidence now, which is what you guys are working on. Yeah. And as doctors get more educated, as these studies come out, that these drugs can help treat other disease states, they become more comfortable prescribing for off label use. So the FDA approval process, you know, if a drug company wants to get FDA approved, they have to go through the new drug application process. And what that consists of is course, as we know, phase one, phase two, phase three clinical trials, making sure the drug is safe and efficacious. And when drug companies are submitting these applications to the FDA, they’re typically doing it for one indication, they’re studying one area where they think that this drug could have a benefit. If they prove this to the FDA, the FDA gives clearance for them to be able to now manufacture and market this medication for that specific indication. But it doesn’t mean that a doctor can’t use it for another indication that’s off label use. And so it’s a difficult arduous process to be able to get a medication to market using the traditional FDA approval process, which takes up 10 years. And is there any benefit? So for example, is there any benefit for a drug to go back? For example, Nandralone, which in the bodybuilding world, I don’t know if you ever heard of this, Matt, it’s called DECA. DECA Drabalin. Deeball. I think that that’s Deeball, right? Okay. You know, I laugh about this, but I think that the bodybuilders had it right. You know, we’re not teasing. We’re really trying to close the gap because women and providers and guys outside of Jim Bros, they need to know about this stuff. Would it be of any benefit for something to go back to get an FDA approval for muscle mass? Or it’s not necessary. If the pharmaceutical company thinks that there is a market for it that justifies the costs of getting a drug approved through the agency, then yes, they can do that. For the example of Nandralone, you know, we mentioned it, it was discontinued in 2007. Why hasn’t a pharmaceutical company come in and brought this product back to market? Well, non-profitable for them. You know, Nandralone is so inexpensive that it just doesn’t make sense for them to invest these tens or hundreds of millions of dollars to be able to get back something that would not meet their threshold for bringing a drug to market. Now, for compounding pharmacies, we don’t need to make hundreds of millions of dollars off a product to be able to bring the market. We’re fine serving and getting that product to market at as low a cost as possible just to give us the bare minimum margins to be able to operate. And, you know, the margins for us are much lower than the margins because we don’t have all these other middlemen involved in the supply chain. So we’re not giving up margins to all these other unnecessary middlemen. When individuals use something off-label, would there be certain medications like, I don’t know, Oxycodone or certain classes of drugs that one couldn’t use off-label?

 That’s a good question. You know, compounding pharmacies, we generally don’t, well, at least ours, we don’t do pain management. And so, you know, the drugs that we primarily make are focused on integrative health. It’s extraordinary. I was looking at your catalog. I have to say for myself, my practice, we’re really grateful. And by the way, this is not, there was no financial exchange to have you come on here. I really just wanted you on here because I wanted the world. We are actually a very large podcast and we have a lot of people interested in health. I am so grateful for what you are doing. Your heart is really in the right place and you are extraordinary. Oh, well, thank you. And I just want to make sure that everybody knows that this is a purely organic podcast. We’re here to clear things up. And also, I think people should know you. You are a face behind something right now. I think there’s not a lot of information about who owns pharmacies and the reason behind it. Because if you look at what you offer, it is to make people’s lives better. I mean, I was going through, there’s six, you say 600, they look, looks like there’s more. There is so much and so much for sexual dysfunction, hair loss, rosacea, rapamycin for long, like just a tremendous selection. And if people are educated, you know, also these medications for anabolic switch, you know, I want to talk about, there’s more of them you make available. And I think that we have to stop being afraid of it. Oh, Gabriel, thank you very much for, for your compliment. You know, nothing we do is possible without the assistance of a prescriber that is educated and wants to become more educated on the use of these cutting edge therapies that, and it’s such an amazing environment that we’re creating. You know, we have the best doctors in the country working with compounding pharmacies and teaching us what they think is in the best interest of their patients. And so we’re working with prescribers and our medical affairs team, pharmacists that are then figuring out what could be the best possible dosage form, dosage strength, and dosage combination to be able to make these drugs more efficacious for, that the doctor determines what could create a clinical different, a different outcome in a patient. And so it’s just, it’s such an amazing world to be involved in, where you’re pretty much being that doctor’s R and D function. It’s so, it’s so cool, which, you know, leads me to, you were going to talk about the FDA approval. So that is a very arduous process. Something is typically indicated for one thing and then utilized for others. And the providers out there, as long as you’re educated, these off-label use medications like very particular anabolic are safe, inappropriate and they have been used for decades in other things outside of quote sports.

 And they can be used for longevity. Sure. And we’re finding that more doctors are becoming educated that these substances are safe when used appropriately under a doctor’s revision and getting blood, resigned to getting biomarkers from a patient and then tracking those biomarkers throughout that patient’s therapy. So over the years and decades at that patient’s on therapy, they can see, you know, whether or not, you know, one other biomarker may be getting out of whack because of this other medication and then modify the treatment accordingly. So for example, testosterone in men, you know, what’s what doctors tech for, they should be checking for at the bare minimum is of course, hematocrit, you know, how thick your blood is getting. So that’s your hemoglobin hematocrit, which is again, the standard of care. If it’s over 52, they will say in the literature that you need to do a blood donation or decrease testosterone dose. Mo would cringe by me saying this Mo care. I would say that I think that that came from one paper and that we don’t really know where the evidence is if hematocrit goes a little higher, but I’ll just put that out there. Exactly. And then also looking at estradiol because testosterone converts to estradiol through the aromatization process. And then also looking at, you know, other parameters where testosterone may be changing or affecting the hormone cascade. And, you know, by and of course, if you’re male looking at prostate specific antigen, just to make sure that testosterone may not be causing a problem over time for some patients that may develop some prostate issues later on in life. So once a doctor has all these bits of data, you know, they can then create a baseline, determine what treatment is best for a patient, put them on that treatment and have that patient come every three, six months and see how the patient’s body is responding to that medication and modify the therapy accordingly. Which brings me to my next point. When you say modify the treatment accordingly, I had a patient and we needed to get her estrogen levels up. I didn’t want to give her oral estrogen. She’s more mature. There are risks with oral estrogen. I just, I’m not a fan. We tried a patch. We tried the non-generic. We tried the generic. Couldn’t move her levels. We also tried cream. Couldn’t move her levels. I needed to call a compounding pharmacy to get a little bit of injectable estrogen. I would never be able to call, at least to my knowledge, be able to call Walgreens and say, “Hey guys, can you make me a one milligram a week injection?” This, by being able to call you and other compounding pharmacies, it changed her life. Absolutely. You know, this is where compounding pharmacies really come in handy for a doctor’s armaments to be able to treat a patient. As you said, for estrogen, we can make any drug, any dosage form, any dose of strength to make sure the doctor can treat their patient the best possible way. Right. And different delivery systems. Right. So for example, I want to hear all about testosterone delivery because Matt has been hounding me about getting some tea. No, I’m just kidding. I’m not. I’m just kidding. We got to make fun of him. Yes. Before we talk about tea, let’s just stay on the point of estrogen. For example, there are pellets, subcutaneous implantable pellets that we manufacture that a patient can then get their estrogen replacement therapy through. And instead of having to do the creams every single day or the injections every single week, they can get this procedure once every quarter. And there is not a commercial medication out there. There is no estrogen pellet on the market. So the only way that patient could get this therapy is through a compounding pharmacy or outsourcing facility. And for testosterone, there are so many multidudative ways of getting this chemical into you. You know, you can do it through an intranasal gel. Wait, stop right there. You have to explain the efficacy. Does it work? Intranasal gel of testosterone. Does that work? So we’ve seen some studies where the real benefit of using an intranasal gel versus other delivery systems is that it peaks testosterone very quickly. And then testosterone goes back down. And if you do this gel three times a day, it doesn’t shut off the hypothalamus pituitary to circular access, which can help with fertility. Yes. And they’re still getting testosterone. Right. Right. Isn’t that amazing? Wait, did you guys hear that? Testosterone replacement therapy is largely contraindicated in times of fertility. When an individual does testosterone injections, it decreases LHFSH, it affects spermatogenesis, your ability to make sperm. What you are saying, and so guys come to me and they’re like, doc, my girl wants to have another baby. And I really don’t want to go off testosterone because I feel horrible. We could potentially say, well, guess what? Because of new innovative ways of delivery, like intranasal testosterone gel from your pharmacy, a pharmacy we trust, I trust, they can take their testosterone without having a negative impact on spermatogenesis. Right. It is possible. Yes. And this is why we see the research coming out, and of course, this is not an indicated use for this medication, but the research shows that it can be helpful for patients that want to still have a family, but not get off testosterone. That’s incredible. What I also think that you’ve done really well, and I think that this has to do with your own savvy as a human, is that you’ve partnered with extraordinary researchers. I mean, that is true, right? I say they partnered with us and we’re very happy and glad to be able to contribute to this area. But that’s unusual. I mean, you contribute to randomized control trials, studies that are being done to see alternative uses, for example, ozempic, compounded somaglutide. That is extraordinary because it moves science and evidence faster directly to patients for meaningful outcomes, which can change their life. People think in my mind, at least from my clinical experience, which is two decades, that it either has to be done naturally and all medications are bad, which is funny and silly and we have to really rein people back and say, “Okay, why do you think that to be true?”

 Yeah. There’s a stigma, I think, that we have in this country when it comes to testosterone replacement therapy. You mentioned it, the causes of it, professional sports. And I remember having the same stigma and it’s weird. I still see the stigma creeping in, even to this very day. You do. Knowing all the things that I currently know, there’s still that little part of my brain that’s been wired to say that, “Oh, I may be doing something wrong or I may be cheating.” Nothing could be further from the truth. A great movie, another movie, I think your listeners should- So we know what he’s doing on the weekends, aside from the two kids, Netflix- Documentaries, yes, exactly. I can just so much to learn and I love it all. The one movie that really changed my life, Bigger, Stronger, Faster. Oh my gosh. So Mark Bell and Chris Bell, Mark is probably one of my best friends and his brother is amazing.

 Amazing human being. Do you know them? Of course. Oh, you do know them. Yeah, Mark and Chris are great people. Chris made such an impact on my life because remember, Bigger, Stronger, Faster came in 2008, right when I was getting on testosterone replacement therapy. And when I watched that movie, that stigma that I had about testosterone being unfair and cheating, it completely made me question the way that I had been raised and the way that I thought. And that’s really when I started making these medications, I was like, “You know what? We are going to get these medications in the hands as many patients as possible.” Because Chris, he showed through his documentary, the science behind testosterone and the history behind why it became stigmatized. And so I’m forever grateful for Chris for really educating me and many millions of other patients that were lucky enough to get access to that movie. It’s amazing. And so that’s what we try to do is we try to now educate other prescribers and patients on the benefits. Yes. And for example, testosterone intranasal gel, how new is that? How often do you think prescribers are using it? Where is it in terms of getting out there? Because I do think that it’s incredible and very unusual. I’m also starting to learn about oral testosterone. I would love for you to talk about how long intranasal testosterone has been being used. What kind of doses are being used? Sure. We’ll talk about the oral in a second. Intranasal testosterone gels, they’ve only been on the market for several years. It was approved under the brand name Natesto. And this medication, once it became commercial, once prescribers understood that it’s possible to absorb testosterone and effectively do it as well through the nasal cavity, we see that prescribers are starting to use it sparingly because one, it’s more expensive and it’s arguably inconvenient for the patient because they feel like they have a running nose throughout the day. Is it a spray? Is it used as a gel that you stick an applicator into your nose and you kind of move it around and get it, cover as much surface area of your nasal cavity as possible with this gel. And the commercial product is you have to use a lot of the gel. So it may cause more of that running feeling, whereas ours is several times stronger. And so you have to use a lower amount of the gel. And doctors, they still use testosterone creams, transdermal delivery systems, and the injections more so than any other dosage form. What would a normal dose, how would the equivalent be? Is it the same? So let’s say a man is taking 200 milligrams a week of testosterone. Would the gel, the dosing, is the dosing the same or is it different? It’s dependent on the percentage where the patient’s baseline is. Some patients within the normal range, they may be in the bottom quartile, the top quartile, or somewhere in between. And so the dosage is really dependent on their baseline testosterone levels. And so we can see a doctor, typically what we see our prescribers doing is giving, I think, between five and up to 20 milligrams per use using these intranasal gels. What about for women?

 For women, we don’t really see the intranasal gels being used as much for women. They don’t have to worry about fertility issues that men do when they’re given exogenous testosterone. So for women, we see the most popular options, of course, being transdermal creams. And just to mention, to your relationship, there is no FDA approved drug on the market for females that want to undergo testosterone replacement therapy. Is he that? That’s interesting. Do you have any sense as to why that is? You know, there have been some instances where drug companies have tried to get testosterone approved, but for some reason, the expert committee of the FDA typically recommends against it. And we don’t really believe that women should not be on testosterone. It’s probably just a matter of time as more clinical trials come out, and it’s brought more to the forefront that I’m sure it’s just a matter of time. I’m sure it’s just a matter of time. Right. But in the interim, because there is no indication, you know, there is no FDA approved drug for the use of testosterone replacement therapy in women. What practitioners are doing when they want to use testosterone for women is they’re utilizing a compounding pharmacy. And then so we can create multiple dosage forms for that female patient, the most popular being transdermal creams that they can apply to their arms, their wrist. A lot of doctors are actually applying it to labia and intravaginally to be able to improve absorbance, but also help with pelvic issues that the patient may be having. There’s also injections. You know, that’s where we’re starting to see more. Except you or I am. Yep, absolutely right. We’re starting to see doctors become much more comfortable giving a patient testosterone, cipienate or enanthate for their patients. So they only have to do that injection once a week, of course, but women take about one-tenth the dose that men take. You’ve been taught well.

 Yeah. There aren’t any products on the market for an injectable for a female. And so compounding pharmacies, we can create a microdose injection for that female that the doctors determine that an injection would be the most appropriate dosage form for them. And so, you know, you have all, of course, we discussed testosterone pellets as well. Female patients can get testosterone pellets implanted along with estrogen pellets to be able to help with their menopausal symptoms.

 And so there’s everything in between. We can see, you know, trochees, which are a buccal dosage form you put in between your cheek and your gums. We see capsule. Most testosterone we see is, as far as the oral is concerned, you know, patients stay away from doctors and doctors who stay away from testosterone base, pure testosterone. Because of first pass metabolism? Exactly. Okay. First pass metabolism for the listeners through the liver, so it might raise liver enzymes. The trochees do not though, right? Or do they have a slight bump in liver enzymes? A slight bump. So a certain percentage of it is absorbed buccally or sublingually. The rest does get swallowed. And so it does have some effect, but it would be much less than if you just swallowed and put that in a capsule or tablet and swallowed the entire dose. Do you find, are you hearing from providers that some will choose a trochee over a capsule versus the various types of forms? I’d love for you to mention the difference between cipienate and enanthate, or do you suggest that they’re even combined based on length of time or steady state? Yeah. Most patients that we see being treated, female patients, it’s usually the injection of the cream. We see a very small percentage of our prescribers utilizing oral dosage forms because of the hepatoxic effects that it may have on a patient. Most of the injections that patients are taking, the most common is testosterone cipienate. It’s weird because in Europe, the most common form of testosterone is testosterone enanthate. Why? It’s just how doctors were trained. The primary difference between those two injections, testosterone cipienate requires a solubizer, benzylbenzylate, in order to get that solution, the chemical into solution. Whereas testosterone enanthate does not require a solubizer. It actually goes into solution using the base oil. We use grape seed oil as our base oil because it’s less viscous than cotton seed oil and has been reported to cause less injection site pain.

 Another benefit is that it can be injected because it’s less viscous. You can use a smaller bore needle. So, it’s a sub-Q needle. Right. Which, by the way, is very small. It’s like the tip of my pen. Right. For example, I inject my testosterone enanthate using a 30-gauge insulin syringe. If you were to try to draw testosterone cipienate through a 30-gauge, the commercial product… You’d be there till next year. Yeah, you’d be there. Exactly. It allows prescribers to be able to use these alternative dosage routes that allow the patient to be more compliant with their therapies. Because putting a large bore needle into your glute, I mean, for me at least, it is scary.

 A lot of patients like myself have needle phobia. These alternatives can get a patient to become compliant with their treatment programs.

 What is the length of time, the difference of how long it lasts, how it should be dosed between the cipienate or the enanthate? It’s a good question. They’re very similar. Their half-lives are almost identical. So, we don’t really see any much… Because of blood serum values, our prescribers don’t really see that much of a difference using one or the other. It’s usually just preference to them which one they like to use. And does it matter if something is injected sub-Q versus IM for efficacy sake? Studies show that the response curve is practically identical. So, there’s almost no difference whatsoever to a patient using intramuscular versus subcutaneous.

 And women are very concerned about… So, there’s that anabolic or androgenic and anabolic ratio. Women seem to be very concerned. And when I say androgenic, meaning the side effect profile, the androgen receptors, they might see an increase in DHT or hair loss or hair growth. Typically, you have to get to very high doses to see side effects that people are concerned about, like voice changing or female anatomy changing. These are what I would to be considered unlikely side effects. Common side effects would be, again, maybe a little bit of acne, maybe a little bit of hair loss. Does the delivery method change the side effect profile?

 I’m not aware of studies showing that the delivery method changes. It’s really the amount of testosterone you have in your serum, your blood. And in general, as long as the patient is kept within physiologic ranges, they won’t experience the virilization or the gaining male characteristics like more hair or deeper voice or clitoral enlargement. We typically only see that happen in patients that are using super physiologic doses outside of a doctor’s supervision. There was another myth that I actually learned through the individuals over at Baylor, through Dr. Lipschultz reading his literature. There is this idea that one would have to cycle on and off testosterone and or cycle on and off nandrolone. But the literature doesn’t suggest that to be true. Yeah, we don’t see that happening. Most prescribers keep these patients on these medications for the rest of their lives, or at least until their disease state is no longer an issue for them. One of the things I think that the providers that are listening to this are thinking, okay, you’ve sold me on testosterone for men and women. I’m interested in anabolic. But I’m afraid that the DEA or medical malpractice will come after me. What would you say to those providers? I would say that there is little evidence of that. Have you ever seen it? You’ve had this compounding pharmacy for what, 14 years? 15. Yeah, 15. Yeah, just 15 years this month. Are you having a party? I’m inviting myself. Exactly. We’re celebrating. But if that prescriber is using it responsibly and is abiding by all the rules in the controlled substances act, then they have nothing to worry about. Now, the prescribers that are prescribing these medications and having them delivered to their office and then diverting these drugs to bodybuilders, yes, we have seen that happen before. Those physicians have been shut down and that is a major, I don’t think it’s super common, but there was- It’s very rare. But yeah, that is what the DEA is trying to do. They are trying to prevent diversion and abuse of controlled substances. Because anabolic substances, all of them are considered controlled substances, they all fall under the same category as every other controlled substance. Why do you think they are considered a controlled substance? Why? Because estrogen is not. Estrogen, so it’s odd. Estrogen is not a controlled substance. It probably has an impact on skeletal muscle health for women. It also has an impact for men, even though men don’t need to take estrogen. Estrogen is not considered a controlled substance, but any male androgen or any kind of anabolic is. Do we have any sense as to why progesterone is not considered a controlled substance? It just seems odd. That’s unfair if you think about it. Why does this one hormone get attacked when every other hormone is completely safe? And the corticosteroids, which are also hormones, are actually, could be dangerous for patients with long-term use because it’s catabolic. Right. Meteral dose packs over long periods of time, just oral corticosteroids, even injections are very damaging. Right. If you look back, and Chris Bell goes into this in his move, “Be Your Stronger Pastor,” if you go back, you can see it was actually President Biden or Senator Biden at the time that was given advice, Congress was given advice during a sports scandal to not include these medications into the controlled substance acts. So the DEA, the FDA, as well as the AMA, the American Medical Association, all advised Congress to not put this category of drugs into the controlled substance act. They were advised not to. Right. They were advised not to, but President Biden pushed it through anyways.

 At the time he was thinking he had done sports his entire life and he was very adamant about fairness in sports. And so he decided that he ignored the advice of the DEA, AMA, and FDA, and pushed it through anyways. And that is why testosterone and other anabolic substances are currently considered controlled substances to this very day. And if we were to take the percentage of professional athletes compared to the rest of the general population? 99.9% of patients that take testosterone are just normal people that are just trying to live a better life. They’re not professional athletes. And professional athletes, it’s unfair to them, they really can’t take testosterone because it’ll show up in a test and they’ll get booted from the field. Yet we have controlled these substances as if everybody is a professional athlete. Right. Yeah, it’s unfortunate how this has happened. I hope one day that the DEA, and Congress really, because it’s part of the Congress has to do this, they take these drugs out of the controlled substance act so more patients can get access to them. And the stigma can then once and for all be removed that these drugs are not dangerous, addictive, or abused as any other hormone is. Yeah. It is fascinating. I do believe that we are moving in that direction because out of need, we need it. These compounding medications, it’s interesting because when you think about, again, just go back to statins, the utilization of statins and blood pressure medications and all these other medications that the dose seems to have significant side effects. So you will lower your LDL cholesterol, but in that you will affect hormone production, you’ll affect skeletal muscle. The side effect profile is much more dangerous. And when I say dangerous, let’s say dangerous to overall health and longevity.

 Then medications that are either compounds that are produced already in the body or something similar or a derivative that is similar used in a dose that creates better all around the board clinical outcomes. Right. Yeah. And we see more prescribers shifting towards using chemicals, drugs that are endogenous produced by our bodies naturally and trying those out before they then give the synthetics a shot. There is a lot of conversation around Clomid and enclomafine. Do you see utilization of both in your compounding pharmacy? Do you find isomers of each other? So they’re close to the same compound, but different versions, again, you might be more skilled in explaining that than I am. Are you seeing both utilization? Right. You know, enclomafine, which is the N isomer of Clomifins, Clomifins has two isomers. It is a 50-50 race mix of enclomafine and zuclomafine, which is the Z isomer. And what’s thought by prescribers is that the Z isomer, zuclomafine actually causes more estrogenic effects than the N isomer does. And so compounding pharmacies, what we can currently do is make enclomafine citrate and provide it. Now, that probably won’t be around for much longer as the FDA’s Pharmacy Compounding Advisory Committee recently said that enclomafine does not have evidence of safety or efficacy compared to clomafine. And so even though it seems that Clomid can produce more estrogen like effects, right? And so we actually, our pharmacy actually was the one that was defending enclomafine against the Pharmacy Compounding Advisory Committee. And we were only given 10 minutes to speak, all substances that are nominated to be included in category one of the 503 bulk list are first put into category three, which is a category which allows you can nominate any substance that is either a not-effed-approved drug or doesn’t have a USP NF monograph to be included into the five other bulk list. But before the committee has a chance to look at the data and determine whether safe and efficacious, it’s placed in category three. So we nominated enclomafine citrate to be included into category three. So eventually it could be in category one and could be made by compounding pharmacies. And the evidence that we provided FDA and the doctors that testified, the FDA, the committee ended up determining that there was not a significant difference between the two. And so they denied it. And so while compounding pharmacies can now still currently make enclomafine citrate, it will eventually go away when the FDA updates their list. When is that going to happen? It’s not known. The FDA doesn’t say exactly when it’ll be, but we predict it’ll happen within the next year or two. Okay. And do you think that, and for the listener, Clomid was traditionally used for women. I don’t know the history of Clomid, but it was traditionally used for fertility and women.

 Men started using it between 25 to 50 milligrams. There’s various dosing schedules to increase testosterone. It increases it indirectly. It acts on the brain.

 Do you think that individuals, and by the way, it’s very safe. I think that there are some misinformation around the safety, if it affects eyesight. And we’ve consulted with physicians that have been using it for decades, many of whom you know, and they have never, nor have their colleagues seen significant negative side effects other than if an individual starts on it and feels more emotional or it impacts estrogen levels, that may be one thing where people would consider something else. Right. Yeah. We see prescribers using Clomid and Citrate for men.

 Typically, when the patient wants to have children and they don’t want to, they want to try them on Clomid before and see how they respond before they put them on testosterone and maybe HCG or another therapy that may prevent the HPTA axis from being negatively affected through negative feedback. So what we typically see is patients that try Clomid, they don’t like the feeling because one, you can’t raise what Clomid does in men is it causes an increase in LH and FSH. But it doesn’t really cause a significant increase in testosterone. And because of the estrogenic effects of zuchlomathenin, they don’t really feel the full benefits of testosterone therapy. And so for some patients, that’s not true for all patients, but for some patients, they don’t respond well to Clomid, then the prescriber has to try something else.

 But yes, Clomid has its place for patients that do want to still have a family and either can’t afford the other ancillary medications like follicle stimulating hormone or human chorionic gonadotropin HCG that would have to be ancillary treatments to testosterone if being used together. What are you seeing that is or as you talked to providers giving you clinical feedback raises testosterone levels and gives people a boost without taking testosterone. Do you see HCG used as a standalone? What are you seeing or what is some of the feedback and that you’re seeing increase in prescriptions for? The HCG, I think, is one of the most popular medications. As in what HCG is doing, it is mimicking luteinizing hormone and stimulating the late egg cells to produce testosterone. And that can be used as monotherapy for patients where testosterone used alongside HCG is inhibiting spermatogenesis. But very few patients like just monotherapy because it’s only you can only produce as much testosterone as your late egg cells can create. And if your late egg cells, if you have secondary hypogonadism or sorry, primary hypogonadism, your late egg cells don’t really respond well, then you can stimulate your testicles with HCG all day long and they just won’t produce significant amounts of testosterone, which then is why some doctors, many doctors, I think the ones that are specializing in fertility will do HCG and testosterone therapy together, where they’ll give a patient testosterone, but alongside that, they’ll give them a dose of HCG that keeps intracellular testosterone high enough so that the late egg cells still produces testosterone and the sertoli cell, believe it or not, still produces sperm. I mean, that is it’s all so fascinating. Where do you think the future of compounding pharmacies are going? So compounding has evolved rapidly over the past 12 years. You know, about 12 years ago, there was a fungal meningitis outbreak where a compounding pharmacy had made a bad batch and killed 70 patients and injured 700 more. And this was a terrible compounding pharmacy. They were not operating within the law. They weren’t investing into quality, into clean rooms, and they were making a drug that was very dangerous. If it was to be contaminated, it was an intrathecal injection. And of course, intrathecal injections, there’s very little blood flow in the area. So if an infection were to occur, it’s very difficult for the body to fight it off. And this one compounding pharmacy, when they caused this meningitis outbreak, the FDA, they then came in and recommended to Congress to create what’s now the Drug Quality Security Act, which was then passed by President Obama in 2013. And the Drug Quality Security Act, what it did is it gave the FDA, for the first time in American history, the jurisdiction of the practice of compounding pharmacy, whereas previously it was just the state boards of pharmacy that oversaw the practice of pharmacy. Now the FDA is involved in as well. And so the industry has changed rapidly over the past 12 years since that meningitis outbreak occurred. And for the better, now the FDA is involved as well. They are helping oversee the states and educating the states. And of course, inspecting compounding pharmacies that are very large and serving large patient populations as they should. But another thing that the Drug Quality Security Act created was this category called outsourcing facilities, 503Bs for short. And what an outsourcing facility does is it produces drugs in bulk, customized drugs, same drugs that a compounding pharmacy could potentially make and makes those drugs, but doesn’t just sell them to a patient, sells them to a provider or a hospital or an institution or even another pharmacy now that can then administer that medication or then dispense that medication to a patient for them to self-administer. So by us now being a 503A and a 503B, we have a direct B2C connection with every single B2C pharmaceutical user, every patient, and a direct B2B relationship with every single provider or institution that administers these medications to patients. So we’ve created a vertically integrated supply chain for every pharmaceutical end user and getting these medications directly at a much lower cost. And so now that we have these two entities, and of course, 503Bs, the quality standards are much higher than the quality standards for 503As. 503Bs have to make their drugs under good manufacturing practice. The same standards that the big pharma has to use. So drugs procured from a 503B, the FDA considers them safer than drugs procured from a 503A. One of the most important responsibilities you have as a human is to get your blood work done in a regular cadence. You cannot outwork, outthink, or outmaneuver your own health. Health is the great equalizer to all dreams. InsideTracker is the blood work company I use and recommend. No one loves getting their blood work done, but at least I can make it easy and affordable. By using my link, inside tracker.com slash Dr. Lion, you can get 10% off the Inside Tracker subscription and any plan. 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Really quickly, I’d like to take a moment to thank one of the sponsors and that’s Fatty15. You’ve heard all about essential fatty acids and Fatty15 is a new fatty acid, the first one discovered in the last 90 years. And let me tell you, essential fatty acids are critical for health and wellness. We’ve all heard this of course, but Fatty15 is unique. So it’s a carbon 15. And by the way, it is going to be helpful for cellular aging. The reality is we’re all getting older, but there are ways and things that we can do to combat the destruction and impact our lifestyle has on our body and our brain and our mood. Fatty15 is one of those supplements. Fatty15 is amazing and it’s extremely potent. And by the way, you will not be burping up Fatty15 because it is tasteless and odorless, which also makes it amazing. Fatty15 has great research behind it, which again, I think is extremely valuable. So a lot of different supplements on the market. 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And these two drugs, while they may be appropriate in certain patient populations, what we see a lot of prescribers doing is giving patients a combination therapy of testosterone with maybe a PD5 inhibitor. Which is? The sildenafil under the brand name Viagra or Tidalafil under brand name Cialis. So combining these together and also potentially combining them with oxytocin. Intranasally. Either intranasally or buccally. That’s amazing. And so patients, they can absorb these chemicals. Of course, there are no FDA-approved versions of testosterone or oxytocin or PD5 inhibitors for female patients. So by utilizing a compounding pharmacy, we can create these formulas that are not on the market and can help female patients get access to treat a hypoarousal disorder versus the other medications on the market, which may not be as efficacious.

 Tell me a little bit about the ones that you’re seeing used most commonly. I think that there are certain ones that seem to be used frequently for women. The most common one, believe it or not, is testosterone. It’s just so efficacious. And of course, a lot of female patients that are dealing with sexual dysfunction are typically postmenopausal. And most postmenopausal females, they need some form of testosterone as their levels have dropped to a significant amount at that time. And it also seems to create discourse between meridisc and meridisc. One is being treated for low testosterone. And if you only treat one party, then it is kind of a recipe for disaster. Exactly. You’re absolutely right. And this is why we saw more patients, when we treat the male and we get him fixed, we give him testosterone therapy, his libido is now improved. If that male partner, for example, has a postmenopausal female partner, then she probably has vaginal dryness. She has vaginal atrophy. And she has a lack of libido and want to have sex in the first place. And this is just like you said, a disaster. It’s keeping marriage counselors in business. Right. And so getting both patients, both partners together on testosterone therapy, I think is vital if they qualify for it. That’s a really good point. I don’t know if you know this, but women were not required in clinical research until 1993.

 Really? Wow. Yeah. They were not required to be in research as kind of 50% of the other population. I do believe that that’s one reason why we’re so far behind the science for women. And we have providers like Rachel Rubin out there, who’s a dear friend, thinking about how do we in Reena Malek, again, both we’ve done a podcast with Reena Malek and Mohikkara obviously, talking about sexual wellness for both men and women and what can be utilized and how this can really change people’s lives. Right. As Dr. Mo says, sex span. That’s right. Which is the amount of time that a patient is sexually active throughout their lifespan. It’s very interesting how tied together they are. The longer a patient can have sex, the healthier they are and actually the longer that they live. Not only does it expand lifespan, it also expands the patient’s health span. Absolutely. The amount of time in their life where they are healthy. Do you see the dosing different with Viagra and Cialis for women? We do. It is a micro dose compared to what men take. Another product that we compound is called libido cream for patients. It’s a mixture of amino phyline, pentoxifyline, isosorbidinitrate, testosterone, L-arginine, and sildenafil. And this concoction of vasodilators and s and hormones can be applied to the external genitalia, which then increases blood flow and can make the clitoral more stimulatory. And so we see patients that have never experienced it all over their body. Yeah. Hey guys, that’s not face cream. I wonder what would happen if you did that. But no, it’s really made just a vasodilate, the clitoris. And once you do that, you get more blood flow going to the area. Patients report that they can achieve orgasm faster or they can achieve orgasm at all. So many patients, many female patients haven’t even experienced what an orgasm is. And we see that these concoctions where you can put all these different blood flow enhancers together, they can really have a significant event on a woman’s pleasure. I think that that is extraordinary. And also, it’s a bit taboo, right? If you go into a Roman, you go, okay, how many of you have sexual desire disorder or hypo sexual desire disorder or are unsatisfied with their sex life? I’m sure that, I mean, I don’t know this, obviously, this is just my thought. No one is going to raise their hand. Right. It’s the same in men. Our sexual health is something that’s kept very private and it’s a source of shame if we cannot perform to the levels that our partner or even ourselves believe that we should be able to. And that’s why we see this whole industry just exploding as companies like HIMSS and Roman are going out and using telemedicine to be able to get patients direct access to a prescriber without having to go physically see one and lowering the shame threshold so that they can make that step to get access to these medications that will vastly improve their sex span and their quality of life. Do you find that or are you hearing that there are downsides or side effects to these kinds of medications? Well, every single medication has side effects. There is no such thing as a medication that has no side effects. No free lunch? There’s no such thing as free lunch. Now, it doesn’t mean the majority of patients will experience these side effects and especially when you’re dealing with medications that are applied locally instead of taken systemically. And so, for the example of libido cream, you’re applying it directly to the labia and that prevents a lot more systemic absorption if you were to take all those medications orally to get the same effect. So, we see a lot of these medication providers utilizing compounding pharmacies to create these topical dosage forms where they want to see effect in one area of the body without it affecting the entire body. Like even for hair loss, minoxidil. Right. You know, we see and for an example of that, oral finasteride, which is FDA approved for the treatment of androgenic alopecia, you know, it can cause an array of negative side effects. I never recommend that. I just want to say this, all the providers out there, finasteride, there are a lot of major, major problems. Absolutely. That we see severe depression and it really affects brain chemistry that becomes very difficult to rectify even once the drug is stopped. Yeah. You know, something that inhibits DHT, you’re pretty much killing off, you’re taking oral, you’re killing off your endogenous production of DHT. But you’ll have good hair. Terrible idea, friends. Well, for some of us that are like Samson are very, you know, very, very proud of our hair. It’s a source of our power, you know, and it is for many people. They’re very proud of their hair. When they start losing it, it’s detrimental. So, they will take the risk of destroying their libido. I don’t think they know the risk. I just don’t think that the risk is explained. Well, some people have done the risk assessment and determined that their hair is more important than the libido. Or their mood, or their mental health. Right. So, what we see prescribers doing, instead of taking oral finasteride, which kills your DHT everywhere to be able to kill it up here in the follicle, we see them dissolving finasteride into a topical solution at a microdose. So, then it can be combined with minoxidil, azelaic acid, kyukonazole, a lot of other substance that inhibit DHT, but won’t have systemic effect. I personally use that from your pharmacy. We use a lot of the topicals, topical minoxidil, topical finasteride. The doses are lower and I don’t have to take it orally. Although oral minoxidil, I feel is safe and efficacious for hair loss for both men and women, which I also use that. But for those that are concerned, there are so many topical treatments that you guys have for sexual health, for hair loss. I even saw, and I was like, “Oh, do I bring this up? I know all the women are going to want to know.” But you also even have a, and I don’t know how effective this is, but a topical cellulite cream or a body sculpting kind of cream. Mezzo cream. You guys, I don’t know if this works. I don’t know if Sean knows if it works, but I think that there’s a demand for it. Yeah, there are some studies showing the evidence of aminophylline. Which is the vasodilator, right? That is one of them, yes. It can be used to help with the reduction in body fat in certain areas. Now, it’s not as effective as diet or exercise or GLP ones, but it is an extra option that prescribers can use for patients that may be having difficulty losing fat in one area of the body or the other. So interesting. I have to say, I’ve not tried that, but people ask about cellulite, all kinds of body fat type body composition issues. So Will, if anyone uses it, let me know. Again, thank you so much for all the work that you’re doing. Is there anything new coming out? Are you working on any top secret formulation? Well, we just acquired a facility in New Jersey, the largest 503B manufacturing facility in the country. And what that facility is going to be able to do is produce 50 million vials a year for the functional medicine markets so that we can get patients that rely on these medications for the rest of our lives into a system where they don’t have to worry about losing access by one pharmacy or another, not being able to make these medications anymore. So that facility is going to change the way that health and wellness is done in this country by being able to offer these medications at scale. Gosh, extraordinary. Did you ever think you were going to be where you are right now? Oh, not at all. You know, when I first started my first compounding pharmacy in the back of a doctor’s office in 150 square foot. In the trunk of his car. No, just kidding. All compounding pharmacists are cringing right now. I didn’t really do it. Right. It was a little bigger. It was an exam room, believe it or not. I converted an exam room into a compounding pharmacy. And, you know, I just wanted to treat patients like myself in my local community. And quickly I realized that patients like myself, we’re everywhere, you know, and we all need access to not just men’s health medications, but the whole gamut of functional medicine. And so, you know, it became my mission in life to now produce these medications at scale so that patients can take advantage of them and do them affordably with better outcomes. And it’s been an amazing journey, but we’re still just beginning.

 He’s taking over the world next, friends. Well, trying to make the world a healthier, happier place. And the best way to do that is by getting patients’ chemistry right. I think what we’ll do next is for the listeners, we’ll educate very specifically, we’ll put together a schedule, we’ll choose different medications. Maybe we’ll have Dr. Lipschultz come and educate if he’s willing on testosterone, all things testosterone. Maybe we’ll do a series that I think would be incredibly beneficial for people. I love to do that. And thank you for giving me the opportunity to educate patients once again and spread the word about where medicine is going in the future and how compounding pharmacies and outsourcing facilities are playing their part to do that. Thank you. My pleasure. Thank you.