If you go to the doctor, you probably have some sort of issue you are dealing with that you hope the doctor can take care of. While you might think your situation is unique and requires special care, typically doctors don't have time to sort out your unique properties, and instead prescribe common treatment options.
If you have had medications that didn't work well for you, this is probably the situation you ran into. Unfortunately, not everyone is the exact same, therefore treatment plans should be custom tailored to your needs.
In this episode with Jim Hrncir, we discuss why compounding pharmacies are beneficial to creating customized treatment plans, and why regulatory agencies struggle with allowing compounding to happen.
What To Expect From This Episode
- How Integrative Medicine provides better outcomes for patients
- What compounding pharmacies are and what they do differently from traditional pharmacies
- Common compounded medications and their uses and benefits
- Why compounding pharmacies are having issues with regulatory agencies like the FDA
Shownotes
- [0:00] Welcome to the Summit For Wellness Podcast
- [2:45] Who is Jim Hrncir and how did he develop a compounding pharmacy
- [3:30] What is included in integrative medicine
- [5:00] What is the relationship between a pharmacy and a doctor
- [7:15] What is the difference between compounding pharmaceuticals vs medications you can grab right off the shelf
- [8:30] Compounding medicines can be a great way to make very specific treatment options
- [9:45] The whole point of a compounding pharmacy is to create plans specific to the patient's needs
- [11:15] When compounding medicines, how do you know if it'll be effective or if it could potentially cause more problems
- [12:45] Does compounding medications reduce the overabundance of unused medications that are circulating in the world
- [13:30] Does Jim Hrncir receive bulk ingredients to make up different compounds
- [15:00] What are some of the most common compounds that Jim works with
- [17:45] Is there any way to perform a random control trial on compounding pharmacies, and what are the best ways to study effectiveness of compounding medications
- [20:00] Pharmaceutical companies are known to set up their research to be in their favor, so most studies are performed with bias behind it
- [23:00] How do you create studies that don't release bad data
- [24:15] Most bad studies are not published therefore we can't learn from them to make better products and better studies
- [25:30] Why are the pharmaceutical companies lobbying so hard to fight against the bio-identical hormone industry
- [27:00] The FDA are not fans of compounding pharmacies at all
- [29:00] Some pharmaceutical companies could feel that their bottom line is impacted by compounding pharmacies therefore they would like the see them shut down
- [30:30] If I was on hormones, I would want a customized treatment designed for my body
- [31:30] What can others do to get compounding pharmacies more recognized
- [33:00] What does Jim Hrncir do daily to reach his vision of health
Resources From This Episode
Some of these resources may contain affiliate links, which provides a small commission to me (at no extra expense to you).
Transcript For Episode (Transcripts aren't even close to 100% Accurate)
[00:00:14] Bryan Carroll: If you go to the doctor and the doctor prescribes you something, do you want something that is just pulled right off of the shelf and is ready to go? Or do you want something that is catered more specifically to your own needs?
[00:00:28] That is a question we're going to be answering on this episode with Jim Hern, sir. What's up everyone. I'm Bryan Carroll and I'm here to help people move more, eat well and be adventurous. And I'm sure that you would love for your own body and needs to be very simple and have something ready to go right away.
[00:00:45] If you do go to the doctor, however, I'm pretty sure you would probably also want whatever protocol is given to you to be catered to you specifically as well. Now as you know, the things that you may need might be different than someone who's 80 years old or someone that is in a completely different state of health than you.
[00:01:06] However, in a lot of cases, these prescriptions are given the exact same. So Jim, our Hearn sir, is a pharmacist and he has a compounding pharmacy, which goes one step beyond what a traditional pharmacist with. They're taking these pharmaceuticals and they're compounding them together to create more unique and specific protocols specifically for your own needs.
[00:01:33] So, Jim Hrncir, is recognized as one of the pioneers of modern pharmaceutical compounding. He is responsible for the formulation of many bioidentical hormone, dermatological and nutritional, and anti-aging compounds and wide use throughout the. And he has worked in radio and TV, including multiple appearances on Dr.
[00:01:52] Phil as a hormone expert. We'll definitely be diving into the pros and cons of compounding pharmacies and why they should be recognized as a reliable source for treatment options for patients and why it is that there is so much pushback against it. So if you do enjoy these episodes and you do enjoy these content, Please head on over to your podcast app and leave us a quick rating and review those ratings and reviews do help us to get out in front of more people and to help the show expand.
[00:02:26] So, and it usually only takes about 30 seconds to do. All right. Let's dive into my conversation with Jim. Thank you, Jim, for coming onto the show. Hey,
[00:02:36] Jim Hrncir: thanks for having me. Bryan is great.
[00:02:39] Bryan Carroll: Of course, and I'm really excited to chat with you because we'll be talking about compounding pharmacies and how to tailor medication based on the patient's needs specifically.
[00:02:49] But before we get into all that, let's learn a little bit more about you. And what is your.
[00:02:54] Jim Hrncir: Okay. Well, I got out of pharmacy school in 1979, so I'm an old guy and and not long after 1984, I actually opened this pharmacy and had been working in this pharmacy ever since we're just a corner drug store, Los Colinas pharmacy.
[00:03:08] And but we specialize in integrative medicine, you know and custom compounding therapies to satisfy that model of thinking, you know, cause some patients, most people. Enjoy some degree of natural medicine or integrative medicine in their idea of what is health, you know? So we, we fill that niche.
[00:03:30] Bryan Carroll: What all goes into integrative medicine. Is that more than just a, here's a couple of medications for.
[00:03:37] Jim Hrncir: Exactly. When, when we're an integrative medicine, we're thinking in terms of, okay. Root cause analysis. Instead, if you told me, he said, gosh, Jim, I've got high cholesterol. I wouldn't my first thought as an integrative medicine practitioner would not be, Hey, let's give you a statin drug and, and bandaid that cholesterol down.
[00:03:55] And you'd be on that medication for the rest of your life. Instead I would say, you know, what's the root cause of your hospital. And I would say, well, for most cases, that is insulin resistance. We can fix insulin resistance with a new eating style and you're going to be healthier, you know, matter of fact, I'm, by the way, Bryan, did you know that if we get your testosterone route, it'll probably reduce your blood sugar by as much as 15 to 20%, and that's going to help with this lowering cholesterol as well.
[00:04:20] So we start thinking about root. Cause I mean, if I see an auto-immune disease, I'm going to say what is going on in that person's body. That caused them to have an auto-immune disease. And then I'm going to say, what can I do to fix that?
[00:04:34] Bryan Carroll: Yep, totally makes sense. And that brings up a question that I would like to know more about what is a relationship between a physician and the pharmacy.
[00:04:43] Because it sounds like you're kind of doing both here. You're trying to work with the health needs of the person, but you're also a pharmacy. So is there a difference? Does a physician have final say in stuff, does a pharmacist have final say and what's prescribed? How does that work?
[00:04:59] Jim Hrncir: Well, physicians who choose to work with a compounding pharmacy can either go two routes, one, they can see.
[00:05:05] Gosh, Jim, you know, you know more about this than I do. What do you suggest as a treatment plan? And then also, can you suggest the best compounded medications to customize for this patient? On the other hand, there are other physicians who are highly advanced and they may say, you know what, Jim, I already know what I'm going to prescribe.
[00:05:23] I just want you to make the best possible quality compound from. And and so either way we take that charge very seriously. And and matter of fact, in, in our compounding pharmacy, you wouldn't believe how much it's changed. You know, from, from the old days when we kind of threw stuff together to now, I mean, if you're a top compounder, you have to use science, you have to use advanced knowledge and traditional integrative medicine in order to make the best decisions.
[00:05:50] You know, we, we use compounding expertise, you know, we got, you got to know like this base plus this chemical work and this chemical is a better quality chemical than that chemical, you know, we've got to use those kinds of judgments. We have to have the right. 'cause. I mean, we have, I don't know, maybe seven or eight scales.
[00:06:08] Each one of those scales is $5,000. Because we measure precise amounts of, of active ingredients. We send them off for testing, you know, to make sure that that, that, that it actually is like, if I, if I say, Hey, this is testosterone 100 milligrams per million. Transdermal cream. It really is a hundred milligrams.
[00:06:27] It's not 90 milligrams. It's not 120 milligrams. It's a hundred milligrams. And we also use, we have tons of, of standard operating procedures that we follow. All of our people are gowned in garb, just like they're in a clean room, you know? And you'd be surprised at the quality and and everything is going into each one of these compounds.
[00:06:50] Bryan Carroll: Yeah. And let's dive into what exactly a compound is. So I'm sure a lot of people are familiar with, you know, you can go to a grocery store or pharmacy and get like Advil over the right off the shelf or anything like that. So compare compounding pharmaceuticals to something that you can grab off the shelf.
[00:07:08] What's the difference?
[00:07:09] Jim Hrncir: Yeah. You know, for years I've been making something that's like Advil, it's called Ketoprofen gel. And sometimes whenever I play golf you know, I'm an old guy. My low back kind of gets a little, a little stiff on me. So I'll, I'll, I'd develop this, this transdermal cream that has a high dose of Ketoprofen that I can put right on my low back, I can play a whole round and my Mac's not any problem at all.
[00:07:32] But if I took a bunch of Advil orally, it burns my stomach. And so I, I don't do well with that. And so I'm not going to take those and affect my entire body when really I only needed to work in one area, you know? So that's just an example of a custom compound, but compounding means. Making from scratch.
[00:07:50] You know, we, we take active ingredients and inactive ingredients along with bases and all kinds of stuff and put them together and make compounds, whether it's capsules or creams or suppositories or eyedrops injectables. I mean, you can imagine we make I have something like 20 or 30,000 formulas, you know, stuff that we do.
[00:08:10] Bryan Carroll: Which is really neat because instead of being a traditional pharmacy, which is kind of like a pill distributor, you're actually getting your hands in there. You're making all sorts of different compounds and really figuring out what works well and combines well with each other. I would say that would probably make your job a lot more fun.
[00:08:28] Jim Hrncir: You met. And, you know, I had a lady she's a grandmother and she keeps her child, you know, as a two year old. And she was using topical hormones on her skin and she loved them. But when I told her, I said, now, you know, if you use those on your arms and you pick up your baby, that's going to transfer those hormones onto.
[00:08:48] And she says, well, what can I do? And I said, I'm going to give you a cream that you can use instead of topically, we're going to put it on the labia. And therefore the hormones will go through the lobby into the bloodstream. You'll get the, the good effects of your hormones without any exposure to your baby.
[00:09:04] So, so you get to continue being a grandma, you know, but it's an example of us problem solving.
[00:09:12] Bryan Carroll: Yeah. And having all these different solutions to be able to still meet the needs of the patient and be able to customize the, the protocol for that patient specifically, which I think that's kind of the main point of the compounding pharmacy.
[00:09:24] Isn't it. To customize the experience for.
[00:09:27] Jim Hrncir: That's exactly right. And, and I think that if you ask patients patients, these days are smart, you know, they, they're not just idiots. They're just say oh, you just take care of me, doctor and I will do whatever you say. They're thinking for themselves. And, and most patients I think something like almost 90% of patients trust customized treatment plan for them as opposed to a cookie cutter that this is one side of.
[00:09:52] Yeah, there's very few people who just say, you know what? I just trust what the drug companies and my doctor says, and that's, I'm not gonna even worry about it. Most people are thinking and thinking, what is is optimal for me?
[00:10:04] Bryan Carroll: Yup. Yup. And that's how it should be. You should be getting stuff specifically and optimized for your own self.
[00:10:11] Now one of the things you mentioned, you have like 20,000 plus different compounds on formula formulas that you can use. It brings up a very good point about really understanding how every single ingredient interacts with each other. And so we had talked about that physician pharmacists. Connection and relationship before, and it's very difficult to know how something is going to react with something else, unless you, you know, you spend all your time studying that information.
[00:10:40] So when you are creating these compounds, how is it that you're able to know if I change this a little bit, it's still going to be super effective or is it going to interact with the other ingredients that I might be compounding with? And that could potentially lead to, I don't know, maybe problems
[00:10:57] Jim Hrncir: or something.
[00:10:58] That's a good question. And and we do have a lot of databases that we can consult. We have experts that we can consult when you've been doing, as long as I have. You understand how to look up science science means studies and, and maybe stability studies, potency studies, you know, to, to understand.
[00:11:16] That let's just say a drug company is making a certain string of something. And the doctor says, Jim, I want you to make twice that strength. And I drop just for a bad infection because this infection that the weaker strength that's manufacturer is not going to work for this patient's eye. And and we know for a fact that we can give it a certain We have limitations on our practice, I should say that say, okay, you can only give that a certain days expiration date, because we know that potency wise, it's going to last for 14 days, but it's not going to last for two years.
[00:11:48] So, so we have to work with shorter potency dates, you know, beyond you states to what we call them. And we have to use our best judgment in order to take care of the patients.
[00:12:00] Bryan Carroll: There's a lot
[00:12:00] Jim Hrncir: of sense. It's a really good question though,
[00:12:02] Bryan Carroll: right? Yeah. And I think. It sounds like one of the neat things about that too, is, you know, a lot of people, they might have a lot of leftover medications and I don't know what it's like in your area, but we have disposals places where you can dispose of certain medications that there's extras of when you're compounding Ari.
[00:12:22] Is it less likely to have a bunch of leftover medications?
[00:12:27] Jim Hrncir: We usually give what we think they're going to use. And and for instance, that's, and that's a good thing about compounding is we can give precisely the amount that we think they're gonna need. And I give 90 day supplies and we call patients up at 80 days and say, you should be ready for a refill.
[00:12:41] And it helps us to know if they're compliant with their therapy. If they say, oh my gosh, I've still got a bunch left. Yeah. But on the other hand, though, we would not give a 90 day supply if they're only supposed to use it for two weeks. Yeah. And, and so again, we're customized therapy. One size does not fit all for us, you know?
[00:13:00] So another good question. Yeah.
[00:13:02] Bryan Carroll: And when it comes to the different ingredients, are you receiving that in like a bulk powder form? How does that work?
[00:13:09] Jim Hrncir: Yeah, absolutely. And, and I'll tell you when you look at the very tip top compounders versus some of the guys who are maybe getting started and just don't know as much.
[00:13:20] It makes a difference where you buy your chemicals and, and what quality you're buying them in. Because most of them have a designation that's called USP or NF. And, and basically it's a standardization. I can give you an example. Had my, my wife she's one of my hormone patients and we had her on a hormone, estrogen cream for her estrogen replacement and the, my supplier of the tip top quality chemical ran out.
[00:13:49] And so I bought it for another supplier. And her serum level of, of estrogen dropped from, from 50 down to not measurable. In spite of the fact I use the right chemical I made the compound the right way, but the quality of the chemical made that make a difference. And she, cause she told me, she said, Jim, I'm having a hot flash.
[00:14:09] Couldn't be, I made it correctly. I checked the formula and I found out that we'd had to change suppliers because the chemical was not available. It was backordered and unfortunately it made a big difference in her therapy success.
[00:14:22] Bryan Carroll: Interesting. Yeah. Controls
[00:14:24] Jim Hrncir: important. I could buy the cheap chemicals and save a lot of money, but to me, the most important thing is how is it working in my patient?
[00:14:32] Not how much money.
[00:14:35] Bryan Carroll: Yep. And that's how it should be. That's the crew healthcare right there. What are some of the common medical conditions that you're discovering is very effective to use a compounding pharmaceuticals with?
[00:14:46] Jim Hrncir: Yeah, we do a lot of bioidentical hormone therapy and bioidentical means biologically identical to what your body makes and, and patients like that idea.
[00:14:55] They're like saying, okay, these are. Chemically changed. They're exactly the same hormones that your body, my body's made my whole life. We say yes. And they said I'm comfortable with that. And so we do a lot of customized hormone therapy for both women and men. We do a lot of thyroid therapy for thyroid optimism.
[00:15:13] We make a veterinary products for, for pets and for large animals like horses. We we make all kinds of things for mood disorders pain therapy beauty products. Matter of fact, I developed a whole beauty line for a very famous person, you know, she wanted to, and she came to me and said, Jim, would you help me develop my beauty line?
[00:15:33] We did. Yeah, because I know ingredients and I knew how to make that right work. And you know, one of the most starring things I do Bryan, is we all love veterans, you know? And they've given a lot for this country and, and so I'll work with a foundation called defenders of freedom. And and I treat patients veterans who have had traumatic brain injury, which leads to neuroinflammation in the brain PTSD severe anxiety disorder, depression and suicidality.
[00:16:00] These guys can not function in society. A lot of them, you know, when, when they've had this traumatic brain injury, you know, blasts, you know, blown up in all kinds of stuff. So, but what we can do is is we can have a lot of compounded protocols that I came up with that make these guys. And you know, it's amazing the success stories we're having.
[00:16:18] Matter of fact, the DOD department of defense I've met with them in no, in November. I met with them again in March because they're so interested in this work and the results we're getting with competitive medications to help these guys get better, that they want to help. They want, they want to, to facilitate a way for us to help even more better.
[00:16:38] Bryan Carroll: I love that. Yeah, that is awesome. That's amazing work that you're doing down there. So one of the questions that came to mind is everyone always seems to want, is it random control trials that people are saying is a gold standard for Stunning anything which is very difficult to do because it's very easy to screw them up.
[00:17:00] But if you're making all these different compounds on the site, it's very hard to do an RCT. On these specific formulas because you are tailoring it to specific individuals. So what are your thoughts on that?
[00:17:13] Jim Hrncir: Matter of fact you know, I, I didn't even go, I quickly just give you a couple of other conditions.
[00:17:18] We do a lot of auto-immune conditions and, and fibromyalgia, chronic fatigue, limes multiple chemical sensitivities, inflammatory bowel diseases, severe asthma. I just want to give you a few more things. I get to treat every day. You know, there's so much fun, but anyway, back to your randomized controlled trials matter of fact, I wrote a paper on that and and randomized controlled trials are also called double blind placebo trials.
[00:17:40] Right. And for those of us who, people who don't know studies or science, but, but bottom line is, is the people who do the trial. Are are biased. They want a certain outcome to happen. So even though it's randomized controlled trials, you know, they're biased and they manipulate the data and they manipulate the study to get the result they want.
[00:18:04] Whereas there's another, and that's called clinical utility. If you, you prove, or with a randomized controlled trial that a drug is going to work for something that's clinical utility. Well, there's also another definition of clinical utility and that is if it's being used. In a, in a broad section of patients in, with successful clinical outcomes.
[00:18:24] And there are small little studies, you know, maybe not randomized controlled trials, but observational studies trials, and all these little trials all say the same thing that it works. Well, whenever you have both of those combined, that is actually the new definition for clinical utility. And so I don't know how you knew that Bryan, but, but, but that's pretty impressive that you were on that path.
[00:18:47] And and so I was, matter of fact, I, I testified in front of the national academy of science, engineering, and medicine on that topic in conjunction with bio-identical hormone usage.
[00:19:01] Bryan Carroll: Yeah, it's a, it's interesting. Cause I believe it's about one third of all pharmaceuticals that are approved by the FDA are then pulled off of the shelves within four years of their approval. And a lot of it that goes back to the trials and the bias in the trials of certain companies want certain data to be in their favor.
[00:19:23] Jim Hrncir: Right. You know? Th the, the, the biggest example of this ever Bryan was, uh, you remember it? Well, you're, you're too young, but in 2002, you weren't even born then. But in 2002, there was a study released called the women's health initiative studies, the largest study ever done on hormones for female. Largest study ever done.
[00:19:46] And anyway there was a bias researcher and he released a bunch of bad data, very early on in the study that said women, if you're using hormones, cause he hated hormones, he wanted women off hormones and that was his personal bias. And he said, you will get invasive breast cancer and you'll also get heart attack and stroke and you know, He didn't have the data to support that, but he just hated him so bad.
[00:20:09] He released that to lay media instead of to like professional journal. Okay. And anyway, since then women immediately dropped all of their hormones. I mean, you can imagine Premarin, which was the drug that was studying that pre pregnant mare's urine. It's a ton of estrogen. It's, it's actually pregnant measure and they collect it and dry it and put it into a tablet, you know, number one drug in the world at the time.
[00:20:32] The number one drug in the world was dried horses, PIs. Okay. Excuse my microwave. And, and and their sales dropped from 2 billion a year to 800 million in one year, a 60% drop overnight. Well, you can imagine pharma was just pulling their hair out big pharma because they had the golden goose with this, this pregnant marriage.
[00:20:53] Premarin drug and women are not taking their hormones. And if they do choose hormones, what are they choosing? They're choosing biologically identical hormones. Cause it seems to them to maybe to be safer. Well, since that study Bryan, um, the researchers that were not the lead researcher, but the other researchers in that study have come out and said, you know what?
[00:21:13] That was wrong. Women are more protected on hormone. They're more protected from dementia and, and heart attack and stroke and breast cancer than if they were not taking hormones. So in other words, everything was released early on that caused this hysteria about hormones was false. And so, and I don't know how many women, I know that still today, even though it's been proven false, that women are more protected with hormones they're more protected from, again, breast cancer, a 20% decrease risk fit diversity, decreased risk of heart attack and stroke.
[00:21:49] And also what about dementia and everything else? 78% decreased risk of dementia if they use botanical hormones. So, so all of this has come up. But women are still scared of hormones because of that bad guy who released some bad data.
[00:22:06] Bryan Carroll: How do you prevent that? How do you create studies that don't release bad day?
[00:22:12] Jim Hrncir: You know, I wish I could tell you that.
[00:22:18] Because as long as there's money involved and, and egos involved there's always going to be that, that kind of those people out there. We always hope that they're getting. That they'll do the right thing because those researchers have had egg on their face. And they said, wait a second. That does not represent our opinion about hormones.
[00:22:36] And, and they had the courage to stand up and say, you know, what, what was released was wrong. And we're sorry for that. Here's the right data that took courage.
[00:22:50] Bryan Carroll: Yup. Yeah. And isn't it. Most studies if If a company or whatever, doesn't get the result that they want and their studies, they typically don't want to publish that study, even though that could help to benefit future studies in being able to, okay, we know this information, this happened in this trial, even though that wasn't the result that that company was looking for we can then take that, create a better study, learn from that study and then create even better studies from that.
[00:23:17] But it's almost like the bad. The bad studies are being kind of shuffled under the desk, even though we should be looking at all the studies good and bad to be able to create better studies in the future. Yeah,
[00:23:29] Jim Hrncir: that's true. And every now and then you'll see a researcher who, who will go in and find a bad study that got.
[00:23:35] And and then, you know, he's the big hero because he brought this up and of course the drug then gets pulled off the market and, you know, it's happened over and over, you know? But I, I just I liked the idea of, of using it in my little world. You know, we, we have successful patient outcomes, otherwise we wouldn't be doing them.
[00:23:53] And the doctors are recognizing that every patient they put on this, these types of therapies, these, these tighter custom tailored therapies are doing. And I mean, like I have, I have therapies that, that have an 80, 90% success rate and most drugs. I mean like antidepressants have a 20% success rate.
[00:24:12] Yeah. We have an 80, 90% success rate and with most of our therapies. And so we don't, we were held to a very high standard, you can imagine, but when you're in this world, you bet you better show the results. You know,
[00:24:26] Bryan Carroll: why is big pharma lobbying so hard against bio identical horns? Well,
[00:24:31] Jim Hrncir: that study I told you about they, they lost 60% of their sales overnight.
[00:24:36] That was why pharmaceuticals now have been bought out by other companies. But, but then they were so angry about that, about losing all those sales, you know, their golden goose and that, that they started putting out misinformation about us. And doctors would call me up and say, Hey, you know, the wife sells one was in and they were telling me stuff about you and Jim.
[00:24:54] I know it's not. Can I say, you know what they're trying to to maintain their own sales. And they think the best way to do that is to get rid of us. So they've lobbied matter of fact, why pharmaceuticals went to the FDA and they said, we think that a certain form of estrogen called estriol represents a health risk to the women of.
[00:25:15] Now why the pharmaceuticals was being hurt by the fact that we could compound with STL, but they didn't have a manufactured product in the United States that had estriol in it. So therefore they went to the FDA and tried to get us to stop compounding with estriol. You know what the interesting was thing was over.
[00:25:35] That in Europe, they had two products that had estriol in it and they were selling them like crazy. And I guess European women were not being hurt by real, but American women were going to be hurt. It had to do with dollars. It had nothing to do with the health of women, but they were trying to get the FDA to do their dirty work for them.
[00:25:55] Now that is sad. Isn't it? That's that's. And we had, we intercepted emails from them that said that that was their strategy
[00:26:02] Bryan Carroll: interrupt. So the FDA, they're not very big fans of a compounding pharmacies, I'm assuming.
[00:26:09] Jim Hrncir: Yeah. You know, matter of fact, the, the, the, the, the last head of the FDA, Dr. Scott Gatlin was speaking at a compounding conference last year.
[00:26:18] And he said, you know what? He said, when I was ahead of the FDA, we had an anti compounding culture, you know, we hated compounders and. We didn't even think about it. You know, all we knew is we, we wanted we didn't want them around, you know, and he said this anti compounding culture was just something I stepped into when I took over FDA.
[00:26:41] And when I walked out, it was still in effect. He said, now that I'm out I'm looking, I'm touring, compounding pharmacies, I'm touring facilities that supply you guys with chemicals. And he said, I am impressed with the quality that I'm seeing. And he said, I didn't know this stuff when I was. And, and he said, he said, I didn't want to know this stuff.
[00:26:58] He said, all I wanted to know is what is, what, what already. And he said he said, I'm, I'm kind of apologize until you a little bit, although a couple of you have misbehaved, you know, in which there's bad actors in every, in every profession. Right? Bryan, I mean, there's bad doctors. There's bad lawyers.
[00:27:14] There's bad CPAs. There's bad preachers. You know, I mean, we know that there's bad guys in every profession and there have been some bad compounders, but that doesn't mean that, that the 99% of us that are the good guys should be punished. And da actually thinks that, and, and they, they, I'm not anti FDA.
[00:27:34] They do a great job on, on manufactured drugs. It's just that when it comes to compounds, they've got a blind eye to us and we've tried to reach out to them. We've tried to work with them. We tried to say, let us show you what we do. And then maybe you realize that we have value in quality.
[00:27:53] Bryan Carroll: Do you think that also goes back to a dollar.
[00:27:57] 'cause you're kind of mixing a matching different pharmaceutical ceuticals so certain bigger pharmaceutical companies might not be making as much money because their products are being compounded with other stuff.
[00:28:09] Jim Hrncir: I think that there's, yeah. I hate to think that a regulatory agency like the FDA is capable of, of of doing things from money, you know?
[00:28:21] So I, I hate to condemn them like that. You know, I do know that the FDA wants to get bigger. You know, even though it's a regulatory agency, it's like a business, it wants to get bigger and have more. Power to regulate, you know, and that's just, that's just natural tendency of humankind, you know? And so yes, they want to get bigger and have more of their belt.
[00:28:42] And, and, and they, they actually said in an email that we took, we intercepted from them that, that a new restrictive regulation that came out said, this is another nail in the coffin of compounder. So yes, they are biased against us. And I'm sad about that because I really think that, that we do a lot of good for a lot of patients.
[00:29:04] Matter of fact, on hormones, Bryan, um, 55% of Americans who are on hormones, Ron compounded custom made hormones. 55%. That's over 8 million Americans are choosing custom combat and medication. Their doctors are choosing custom compound medications and you know, and they have a choice and they're choosing that well, that, that upsets the manufacturers.
[00:29:31] Bryan Carroll: Yeah. Yeah. It's if I was on hormones, I would want it to be custom tailored to my own. That's
[00:29:38] Jim Hrncir: absolutely needs, you know, when you get to be, you know, 20, then I'll, I'll talk to you about it. Okay. I mean, I'm 66 and I'm on hormones. And and I honestly think that it. It's one of the things that I do that keeps me younger.
[00:29:53] I mean, you know, that, that I'm not afraid of getting old and dying, but I don't want to hurry it along. This is a gift I was given and I want to take care of it as well as I can, you know? And so I do a lot of healthy things, but, but, you know, hormones are something that I readily admit I'm doing because at 66, my hormones were not what they were when I was 20, you know?
[00:30:12] So
[00:30:14] Bryan Carroll: they change as you age, unfortunately. Well what are some things that we can do to kind of get the FDA to open their eyes a little bit more to compounding
[00:30:26] Jim Hrncir: pharmacies? One of the things is I'm a member of a group called the Alaska pharmacy compounding APC, and APC is our professional group, you know, and, and advocates for compounders and also for patients rights and also for the physicians rights to be able to choose compounds.
[00:30:43] So, anyway, Patients and doctors who might be listening if they'll go to the APC website, or if they just go to a compounding.com ww.company.com and just tell their story, just say, you know what? I was helped by this. We're using those stories right now to convince congressmen to, to pay attention to us, to convince FDA, to pay attention to us and, and not to ban this, these needed critical therapies that were able to produce.
[00:31:15] And you know, when you, when you see every day, the miracles that I see in my patients you'd understand that, but they don't want to understand that. And so we, so we're appealing both to the public, to Congress and to FDA, and we're using patient stories and doctor stories in order to get that message out.
[00:31:33] So if you go to company.com and tell your story, we will use that. And so please do it. You compounding has helped you or a family member. Go to company.com. Tell your story.
[00:31:45] Bryan Carroll: Perfect. It's a simple ask. And if you have benefited from compounded pharmaceuticals, then definitely be an advocate for it and go to compounding.com to be able to share your story.
[00:31:57] So that can be used to keep this compounding pharmaceuticals going. Well, Jim one final question for you, and that is what is your vision of what healthy looks like and what are three things you do daily to reach that.
[00:32:11] Jim Hrncir: I thought about this a lot and you know, I like to see patients striving for optimal health and, and also quality of life, you know, because it's not good to just strive for one or the other you want to do.
[00:32:22] Healthy and quality of life, you know? And, and so the thing I see most Americans shooting themselves in the foot with is their eating style. You know, people just eat horribly. It's called the sad American diet. The standard American diet is sad for a reason. And you know, we've got so many things pounding us about, about what we need to eat and mostly.
[00:32:43] Her. So I'll tell you, I use a, kind of a clean protein, you know, I usually use free range, you know, organic proteins you know, I use low glycemic index vegetables. I eat almost grain-free. Grains are inflammatory to everybody in spite of the fact that I don't have stupid my forehead. I love grains, but they're just not good for, you know Cleveland clinic had a study on grains.
[00:33:06] They were inflammatory to 100% of people who eat them. So it doesn't make any sense to eat grains whenever they're bad for you, except for the fact that they just taste good. You know, so, yeah, so I eat differently than a lot of people ate low inflammatory, but, but also and you know, exercise is not.
[00:33:24] Yeah. One of my doctors told me that late years ago said gym exercise is not optional. And and I also maintain balanced hormones and thyroid in myself. And and I challenged my brain. And you know, Does not understand that brain plasticity is something you earn and you know, you doing new things.
[00:33:46] If it's uncomfortable to your brain, do it, that you know, that that makes your brain do new, new neural pathways and as much work as I do on brain for my soldiers with traumatic brain injury it's so important to work on brain plasticity by doing new things, learn a new language, you know, learn an instrument.
[00:34:03] I mean, learn a new sport. I mean, Do stuff that your brain is not comfortable doing.
[00:34:11] Bryan Carroll: Excellent. Well, Jim people can find you at Las Colinas, pharmacy.com. You're also on Facebook, Twitter as well. And people can learn more about that in the show notes for this episode. Is there any final things you want to.
[00:34:26] Yeah,
[00:34:26] Jim Hrncir: I just want to thank you for having me on and allow me to, to spout some of my opinions and, and also you know, some advocacy things, because I just want everybody to maintain choice. I want, I want you to be able to choose what therapy you want. If it's traditional medicine or natural medicine, I want you to be able to choose that, and I want your doctor to be able to choose that.
[00:34:45] And so, you know, help us out, you know? And so thank you for allowing me a little platform to talk about that.
[00:34:50] Bryan Carroll: Of course, Jim, and it was fantastic having you on the show. I hope you were able to learn a little bit more about the pharmaceutical process and how pharmacies operate and especially how compounding pharmacies are changing the game.
[00:35:04] And I hope you also recognize that there are certain regulatory issues that are involved when it comes to compounding pharmacies and hopefully the FDA and other organizations are able to take a look at these and see that it is a complimentary option for helping patients. And to not just shove it to the side.
[00:35:25] So if you want to learn more about Jim and then head on over to Los Colinas, pharmacy.com if you wanna learn more about compounding pharmacies, head on over to compounding.com and you can find more about Jim on Facebook, Twitter as well. All right, next week I have Dave Sherwin on the show. Let's go learn who he is and what we'll be talking about.
[00:35:45] I am here with Dave Sherwin. Hey Dave, what is one unique thing about you that most people don't. I
[00:35:50] Dave Sherwin: almost never get asked about my family on podcasts because the nature of health people want to hear about health, but I have six kids and six grandkids. And so that's something that most people probably wouldn't know because I'm rarely, I rarely talk about it and I'm trying to be healthier than all of them.
[00:36:08] Bryan Carroll: Okay. You can't let any of them pass you in anything
[00:36:11] Dave Sherwin: and anything. I want my grandpa to be better than their 20 year old.
[00:36:15] Bryan Carroll: Exactly. I love it. Well, what will we be learning about in our interview together? Will it be
[00:36:21] Dave Sherwin: learning about coming up with effective supplementation and nutrition and fitness strategies and ways to make it more fun and enjoyable and, and several tips.
[00:36:33] I think there's going to be quite a few nuggets of, of general health that I think would help people to, to raise their, their fitness or nutritional level.
[00:36:43] Bryan Carroll: In what are your favorite nutrients or foods that you think everyone should get more of in their diet?
[00:36:48] Dave Sherwin: Number one is we've got to increase the quality of our nutrition and by getting five to nine servings of fruits and veggies every day, that's the number one way to do it.
[00:36:58] Unfortunately, we also know from the healthy biohackers of the last 10 years or so that even when you eat really healthy, there's some nutrients you're still going to be deficient in. And so come up with an effective supplementation strategy. And so I'd say, start with food, make food. The base of course, but then also figure out the supplements that will fill in the deficiencies that aren't coming from our modern food
[00:37:20] Jim Hrncir: anymore.
[00:37:22] Bryan Carroll: And what are your top three health tips for anyone who wants to improve their overall wellness?
[00:37:27] Dave Sherwin: Actually, my number one is a non-physical thing and it is meditation. I think that a lot of people are struggling to reach goals because of, of stress and difficulties in their lives and having a stress management program like a daily practice of just simple meditation.
[00:37:43] I'm not talking about becoming a, a monk or anything like that. Just getting like an app, you know, Headspace or waking up or insight timer, any of them and just say, For 10 to 20 minutes a day, I think was a wonderful habit. And then starting a reasonable health program, too many people are bouncing from named diet to named diet and never arriving at a real world thing that they can do for the rest of their lives.
[00:38:08] So. Finding a reasonable plan you can follow. And another, and the last one is we're learning from these blue zones, the five areas of the world where people live exceptionally long, happy, healthy lives that there's other non-physical things. That are important for our health, like humor like being positive.
[00:38:27] And we live in a world of negativity, negative news, negative people, negative celebrities, negative politicians, you name it. And we have to combat that by turning them down and by turning up positive people and positive influences and humor in our lives. So those are, those are things I think that would make for a much better and more enriching life.
[00:38:50] Bryan Carroll: I just love Dave's approach that you can be fit at any age and how to cater your workouts based upon your fitness level in your age group. So until next time, keep climbing to the peak of your health.
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