The Healing American Healthcare Podcast
The Healing American Healthcare Podcast

Episode 21 · 1 year ago

Pharmaceutical Compounding in the US


Ed Eichhorn speaks with Jim Hrncir, R.Ph., the founder of the Las Colinas Pharmacy, about how he got into pharmaceutical compounding and its place within a corporate-focused pharmaceutical and healthcare industry. He touches on his experiences dealing with hormone therapy, the FDA, and other highlights and challenges of his practice.


"The Discovery" 

by The Lemming Shepards 

Exzel Music Publishing ( 

Licensed under Creative Commons: By Attribution 3.0 

Our guest today is Jim Hernzer. He is recognized as one of the pioneers of modern pharmaceutical compounding. Jim Is responsible for the formulation of many bioidentical hormone, dermatological, nutritional and anti aging compounds in wide us. Throughout the United States, he has worked in radio and TV, including many appearances on Dr Phil as a hormone expert. He is a member of the board of the Alliance for pharmaceutical compounding and he's very passionate about the benefits pharmaceutical compounding can bring to patients. Hello, Jim, thank you for joining us today and I'm looking forward to a great discussion. Well, thank you for having me. It's great to be here. Well, I have some questions. Are Prepared, you know, so that our listeners can learn about you and what you've been doing in your career, and I'm like to start pretty much at the beginning. So I wanted to ask you when you were a young man planning to go to college, how did you become interested in becoming a pharmacist? I was first in high school trying to figure out what am I going to do with my life, you know, because you know at that age nobody knows and and I thought maybe I want to be a doctor. I did pretty well in school and then I had a couple of mentors that were pharmacists and they were doing very well there in my hometown and I kind of looked up to them. I thought, you know what, maybe be worth while having that in just kind of pursuing both, because there are a similar course management for those out just tried out and and it turns out I just went down the pharmacyty path. I later actually did get accepted to medical school after I was a pharmacist, but I never fully pursued that. Oh, I understand when I was working as a biomedical engineering researcher was suggested I applied to medical school. I was accepted, but at the time I was forty two years old and well into my career and I thought I would stay where I was because I enjoyed what I was doing as well. So in your career you established your compounding pharmacy with your focus on hormones and aging, and what led you down that path? You know, in the early years of my career I really hadn't even considered any other approach to medicine other than the traditional medicine approach. But when my wife experienced some significant gun incological issues and next thing I know she's had a history to move for act to me I've got a twenty eight year old minipaus a woman on my hands and in it really opened my brain because what traditional doctors were trying to do to help her was not working and unfortunately I saw this wonderful, beautiful person degrading. I mean her health was degrading, her immune system was degrading, her emotional state was degrading and this was a person that was unbelievable. Prior to that photographic memory, managed a large department store. She was in a mazy human being and so I thought I've got to try to fix her, and so I actually compounded the very first transdermal bio identical estrogen in the country. I was just trying to not be brilliant, I was just trying to simply help my life and you know, it is amazing. We've now advanced tremendously from that first compound. But it did make me open my brain and say, you know what, maybe there's more than just one solution to our health problems. Maybe traditional medicine has some answers. Integrated Medicine has some answers and let's just use the best of both worlds. Well, you've been doing pharmaceutical compounding for a long time. In fact, I think you started your company around one thousand nine hundred and eighty four, and I was just wanting to ask you you've been in this business and in this profession for more than thirty years. How is it changed over the time you've been working in this area of healthcare cash? When I graduated in nineteen seventy nine from pharmacist school, in those days we learned a lot of pharms that will calculations, which were pretty intense,...

...and then we also learned some pharmacy compounding, but we were mostly going to be, you know, pill counters. In those early days we I started doing some compounding, especially when I open the store in nineteen and eighty four. I was I was doing some compounding. I don't think, not really like this, and I'm helping some people with some some broad thinking and and and of course shortly thereafter I invented the first transformal Leestra dial gel in the country. And and so I kept building on those skills and what are really embraced was technology. At first we had scales that were archaic and and then next thing I know I have these five thousand dollar electronic analytical balances, you know, that are that can measure down two point one milligram and and I have twenty thousand dollar ultrasonic powder mixers that mixes the active agredient with the inactive ingredient to make sure there's a perfect mixture before we put it into capsules. And and we have a asymmetric speed mixing centrifuge to mixed creams so that we know that the active ingredient is perfectly distributed through those creams. We even have a testing we now test potency of our compounds just to make sure that our processes or proper so that when we just spense a compound we have full confidence that it's not only safe but effective. So I love all that, that progression of Technology. But what I've also really enjoyed is the progression that light speed in our knowledge base because in this integrative arena, you know, it's not what the traditional medicine resides in. They don't it's not as out of their wheelhouses, you know, but I love having practitioners call me up and say, Jim, you know, I've got no ideas, I'm out of ideas. What? What? What could I do possible? And and then I'll become an evidence based problem solver and man that is so rewarding to be able to offer a new therapy that maybe they just haven't thought of and that the patient is going to benefit from tremendously, and so that's really fun for me. I mean that. That's really interesting. Now there's a business side of this too, of course, and I wanted to ask you are the prescriptions that you feel for pharmaceuticals that your company compounds normally paid for by private insurance and Medicare. Personally, I was a pharmacist that always put compounds on insurance. If the patient had insurance, I put it on insurance. And then in two thousand and thirteen there were a few bad actors. You know, there's always bad actors in every industry. Review bad actors that were overcharging for a specific type of compound, and so insurance companies, in a stead of just banning that type of exploited practice because they were actually making more money because, as you know, pharmacy benefit managers make more money. The more expensive it is, you know, and so they were making a lot of money off of those very expensive and, I was should say, abusive charging practices of those few compounding pharmacies. They were mostly run, by the way, by businessman and not pharmacists, so it was unethical. So insurance companies, instead of just when they got caught and they go all my Gosh, you know, all this money is gone out, instead of just saying okay, we're going to shut down that, that bad practice, they just shut down all payments for a compounds and I thought that was really inappropriate. So we've been in as a as they say in the PBM industry, time out and and now they're starting to see that, because compounds are cost saving to the medical system because most of times our compounds are much less than a manufactured drug, and so for that purpose we actually could save the system a lot of money if they would just safeguard against those maybe unethical guys who were overcharging, which is again a small, small minority. Medicare. Unfortunately, since it got set up, and I'm old enough to remember when they got set up for Medicare part D prescription payments, but unfortunately they've never paid for compounds and and it's really sad because a lot of our compounds are going for,...

...just say, menopausal women and a puzzle men, just an example, and they should be paid for and they're not. I wish they were. I understand the whole area of pharmaceutical payment United States is very complicated, as I'm sure you know. We spend more than two and a half times what the rest of the world spends for specific patented prescription drugs and there is a legislation that was passed by the house, I believe it's Bill Hrthree, that deals with pricing, structure of pharmaceuticals and the length of patents. And you know, since one thousand nine hundred and eighty three or eighty four, when the orphan drug law was passed, the price of orphan drugs is increased by sixty four times, and you know those things need to be addressed and you know, if what you're doing can lead to better outcomes at lower prices, there ought to be an effort to allow for payment for those kinds of products. I totally agree with you, and so I wanted to ask to learn more about this. What medical specialties do you normally work with and how does this relate to the concept of integrated medicine? Yeah, because integrated medicine reaches, and you can call it functional medicine, integrated medicine because it reaches across so many different specialties. I really can't tell you that there's just a specialty that I work with. I work with all of them and if they call me up and say, like I got a noncollogist say, Jim, I've got this lady who has we treat or successfully breast cancer. We want to put her back on hormones. What are the safest hormones we could put her on? And so I give him the answer. I give him an answer that is better than what he could choose from traditional big Pharma. or I'd have a doctor say, you know, Jim, I've got a lady who's suffering from an autoimmune condition and how can we fix that? Let's just say it's EXEMA and I've been given her steroids and and all it is is a bandaid approach. And I say, why don't we get to root cause analysis? Why don't we get to why the immune system is malfunctioning and try to solve it? So Integrated Medicine looks at root calls and tries to solve the problem at the root so that we actually fix the problem as opposed to just putting a bandaid on it. HMM, interesting, based on what you said about the issues of reimbursement and the bad actors that you know, we're discovered in your industry some years ago. Are Their Research Studies about compounding pharmaceuticals that support your working relationships with medical specialties? You Bet, and I love going to a physician and saying, Hey, we've got this therapy that you'd ask about. I'm here to tell you about it and here some science, here some studies that show that it really does work. And we don't. We don't always have double blind, Placebo clinical trials. That's really in the arena of big farm a trying to get a drug pass and you know, as you know and I know as a biostatistician, a lot of those studies, even if they're double blind, Placebo randomized control trial, unfortunately they're biased, and you and I both know that there's all kinds of ways to insert bias into a study in order to get the result that you want, and that's not science. Science means, okay, we have a an issue we're going to pursue and let's just see where the science leads us. Is supposed to saying. I want this come out a certain way, so by Godlie, I'm going to make it happen. And that's unfortunately, what a lot of studies, even in the traditional medicine and random as control trials, end up being, is is biased studies. But I do I do take random ass control trials, I take retrospective studies, I take observational studies and even just case studies, you know, to say, Hey, we had these three patients that we put on this therapy. Here was the outcome. Very interesting to go back to look at the market and some of the market issues that probably exist in this area, as they do in many areas. I did some research and I learned that the US hormone replacement market was valued at approximately ten point six billion dollars in two thousand and twenty and it's projected to grow by...

...about six percent a year through the year two thousand and twenty seven. Now, you know you're a board member of the Alliance for pharmacy compounding and I wanted to ask what your thoughts were about meeting the challenges that you have between big pharmal lobbying efforts in opposition to pharmaceutical compounding and the potential for the FDA to expand its regulatory oversight of your alliance members. That complicated issues, I'm sure, but I was wondering if you can share some thoughts about that. Man, thank you for asking about this because this is important. In the US there are currently estimate to be about eight million Americans using compounded hormones, eight million and and that represents more than half of all patients on hormones. Now, understandably, big farm is upset, you know. They want all the business. They don't want to share that business with us. They want all the business and and that's just that's just business. It's not anything other than evil. It just is what it is, you know. So after the release, I'll give you an example, after the release of the winds health initiatives, Sudy in two thousand and two it was a study on hormones with the most expensive study ever done, random ass control trial, very biased by the way, but the lead researcher went out on his own and released to the lay media that if you use hormones ladies, you'll have increased risk of invasive breast cancer. We're need to stop the study early. Well, the course of lay media ran with that. Is Bite the fact that there was only a one point two six relative risk on that, which means that it was one patient in a thousand. They could have been eaten big Max the cost of the breast cancer, you know. But anyway, what happened, unfortunately, is that eighty percent of women in America dropped their hormones and according to a Yale study, hundreds of thousands of women died early, needlessly and suffered horrible quality of life because they were too scared to use their hormones. And that is a just a crying shame. And by the way, that that study has now been one hundred percent reversed. The other researchers within that that were not biased came out as early as two thousand and seven to two thousand and twelve saying, you know what, those early releases were wrong. We're seeing increased protection of women on hormones, not increased risk. Matter of fact, breast cancer, twenty percent decrease risk. DEMENTIA, heart disease, more than fifty percent decreased risk. So yes, there are big advantages to using hormones versus not using hormones. So, anyway, what we like is is is even back in those early days in two thousand and two, when we were dropping off hormones, they said, and their doctors were saying, is they're a healthier alternative. And course they they love the idea of compounded biodentical hormones because instead of being hormones that were natural to a horse, that which is permanent pregnant Maryor's urine, which I can't believe people within their mouth. It is the urine of p pregnant mayors, okay, and and the hormones in permanent are not the hormones and human body. Okay. So we use compounded about ICAL hormones from FDA proof facilities, by the way. We buy those, those hormones, and we put them together and compounds and and so millions of women have chosen to use these and and and there. They just feel it's safer, you know, and and actually, when we look at the studies, when we look at the science, they are safer. We know that twelve percent of women are going to get breast cancer, but with our Biot entical hormones. We think we can get that risk down to as little as eight percent, which is a huge benefit for women. And we also not to mention the dramatic decrease in heart disease and stroke and the decrease in dementia. Can you imagine? I mean a study came out recently on dementia and is said that that women who are on biodentical hormones had a seventy eight percent decrease risk of developing dementia. I don't know about you, but I'm more scared Tomnia than almost anything, in spite the fact that...

...heart disease is probably going to get me. So the alliance. I did want to talk about the alliance. It's interesting that in two thousand and seven Wyth Pharmaceuticals, the makers of permanent they had the number one drugg in the world. They had two billion dollars a year drug and it dropped eight hundred million overnight. They said we got stopped the bleeding. They blamed it on us. You know, as all all these women are using biot ICAL hormones. So they went to the FDA and they said FDA, we went as a citizens petition which is actually illegal for a company to a citizens position, but they did and said Estriol, one of the hormones that we use, which is a protective estrogen, natural and human body, said Estriol represents a significant health risk to the women of America, you should ban it. And the FDA went ahead and banned ESTRIOL. Well, the women of America, millions of women of in America, went to the FDA, they went to their congressman and they blasted them and man it was in short order that band got reversed. So so it's interesting that here we have this this drug company that has an ESTRIOL product in Europe try to get banned in the US because they didn't have an estriol continuing product in America. So they said, Oh, it's dangerous to the women of America. I'm sorry, but women in American women in Europe are the same women. Okay, so it's all about the money and it should be about what is the best for health outcomes on patients. So that's what APC is dedicated to. APC is dedicated to preserving the choice of physicians to choose compounds if they deem it best for their patients and patients if they deem it best for their own healthcare to be able to use these compounds, and so are pushes throughout the three year campaign that we have is designed to bring awareness to the fact that you could lose access to compounded medications, including competent hormones. So the alliance has gotten together with physicians, with patients and we're trying to get the word out through a very expensive campaign. And we're a little association and we are small and we are not in some mammoth Goliath, you know, and so we are simply trying to get the word out to preserve patient excess. I think that's very important. And in my first book killing American healthcare, I was writing about big Farma and I was surprised initially to learn that they have eight hundred and eighty three lobbyists that work within the industry, more lobbyists and there are members of the Senate in the House of Representatives that they are funding to take their message to legislators at every governmental level. So they're absolutely big Farma. So in dealing with big Farma and the efforts of the FDA, I found that there was a book that came out I think it was in February of this year. It was by someone named Jason Dearien and the book was called Kill Shot and it was about deaths and illnesses that were caused by the New England compounding pharmacy in two thousand and twelve. And I'm assuming you also have to deal with the challenges brought forth by this book about the difficult times of ten years ago. How does APC deal with that issue? You know, as I said earlier, this is not just about compounding pharmacists. You know, it's actually APC is about preserving access for physicians, patients and compounding pharmacists be able to provide that kind of service. And so, anyway, I'm the book kill shot was a very cleverly and sessaially written book. I mean you know if you read it, I mean it's fun to read and in a scary and it does all the right things. It pushes all the right buttons. The problem is is that it's not all that accurate. Because hetty included all the accurate statements, it wouldn't have been as fun, you know, and so what author is not going to try to make their book just a little more fun? So, for example, they didn't say that the company that started...

...the New England compounding center was actually a manufacturer. And they said, you know what, we don't like all the regulations around manufacturing. Let's just try to escape some of those in call ourselves a compounding pharmacy. Well, they're not. They were putting out thirtyzero compounds a week, I mean, and so that's that's manufacturing. That's not compounding, okay, and by every definition you can possibly imagine. And again they're just trying to escape scrutiny. Well, the FDA went in there and at least three times inspected them. The Massachusetts State Board of Pharmacy inspected them at least three times, and all of those visits resulted in horrible deficiencies, dangerous conditions being noted. I mean fungus grown the wall. I mean it was built right next to recycling plant. Nasty, nasty, okay. And so here is this facility with with fungus and mold on the walls and and they're allowing them to continue to practice. And the FDA is culpable, I mean, and and let's just call it exactly what it is. They're culpable for all those deaths, these this is a bad actor, one bad actor. But but they were horrible and they weren't even a compenning pharmacy, they were a manufacturer. And what did the FDA do? And the men you've in the massachusettate board of pharmacy do nothing. Nothing. And then I can tell you that that Congress of course had to act, and so they came out with something called the the Drug Quality Security Act, which was an enhancement to the FDA act and basically was aimed at helping put regulatory guidelines for compatting pharmacists. Well, we were already regulating ourselves pretty well with state boards of pharmacy, except for the Massachusetts, had overlooked these horrible conditions, and so this we actually welcomed this, because those of us that were acting ethically, which is a good, great majority of compounders, welcomed any legislation that said, hey, let's bring everybody up to the snuff that we're working at, you know. And so I think that when you read a book like that you have to understand its sensational it covers a tragedy that it should have been stopped long before it started, and so if you want to read anything into that read into the fact that when we find horrible conditions we need to stop it then, not wait until something bad happens. Absolutely well, thank you for clarifying that. I'm sure that you know, with all the efforts you're putting into reaching out to enhance compounding with patients, physicians and others, that you'll be successful and I hope that you will be, because I think you provided valuable service. You know, ad it kind of smacks in my brain of we should all be a little nervous about actions, that the FDA is an agency that needs to be there. I'm not ANTIFDA. I understand their role, but when they overreach, when they do more than what Congress charge them to do. For instance, they've stated, and and Dr Scott Got Laib, the outgoing, he's a MD, the outgoing director of the FDA, he stated in a medical conference in Houston I attended that the FDA has an internal anti compounding culture and he went on to give all the reasons why they do and most of it was emotional. It was not associated with problems, it was associated with emotions about well, I just don't like those guys. I don't like what they do. I don't understand them, I don't like them and I want them out of here. And so they're trying to use an enforcement agency, which is not a legislative agency, is enforcement agency, to to cause the death and industry. Now, can you imagine there's one bad doctor, a group of bad doctors, and then Congress knee jerks and says, Oh Gosh, we're going to present that we're going to ban all doctors and healthcare. I don't do that. And so there's no reason for them to ban compounding when we help so many millions and millions of patients because, like I say, eight million are just using hormones. That's not to mention all the millions that are using...

...other things for autoimmune disease, inflammatory disease and and just quality of life. I think you're right. I think people want to have the option to do what they think is best for their healthcare, dealing with ethical providers in every theater. You know you're comment about physicians when when physicians have been investigated for inappropriate funding by various agencies, you know they're not allowed to practice medicine, but it doesn't mean that other people in their specialty aren't allowed to continue to do what they do for their patients, and thank you. You know that's the way at all to be so exactly. I appreciate that. You know, you've given us just a lot of information to think about and I wanted to ask you one more question, if I could. That's a little bit outside of compounding itself. In healthcare today and the big issue we hear about every day is coronavirus and a covid infection, and my concern is that today between seven and ten million Americans are covid long haulers and they suffer from a variety of symptoms for extended periods of time. In some cases it's thought that these will go on for the rest of their lives, and these symptoms can include things like extreme fatigue, mental fogginess, neurological, cardiac and kidney complications. And you know, what can compounding pharmacies like yours do to help this large group of patients? And with the current Delta virus so variant, I think that's actually going to grow, unfortunately. So what role can you all take in helping these patients? One of the things I mean, just an example, prevention and treatment of early cases of Covid it was Iver metted. Iver met in is proven in twenty six double blind placebo studies, been pro clinical trials, to do amazing things that preventing covid. I mean there was a study done in a hospital system in Brazil and they gave half of the employees in this system, it was one tho patients. I gave five hundred ever matching. They gave the other half nothing, and of the group that did not have over macton, fifty percent of them came down with covid on. The group that that had over macton, very few cases were reported. Now that just goes to show you that a drug that has almost no side effects, that can be taken once a week, is dramatically effective in preventing covid. And, matter of fact, in the early stages of Covid it causes the disease to become much less burile and so it causes much less inflammation, because inflammation is what covid causes. I mean, whether it's an Endocarditis, myocarditis, whether it's the lung inflammation and five browsing in the lungs causing the long hollowers, we can prevent that. Once you have it, we've got to get a hold of inflammation. An example that we can do is, once we see we have a long hollowers integrated medicine, doctors going to go hmm, let's just see what can we do? We could give Antioxidant Ivy's. Matter of fact, in New York, when when the governor their manned hydroxy chloroquin in the early days positions, were left with no drugs to use and so they said, why don't we use bottom and C, which is anyocidant IV, and they found out it was working and so they gave steroids and and about it. Been C Bouda, been c being an antioxidant, calming down free radicals, Calming Down Oxide of inflammation, and the patients were getting better. That's an idea that you know. That was come from integrated medicine, can come from traditional medice. And then what about Lodos Nott, trecks zone? Let us not trecks zone has an effect on opioid growth factor, which causes the immune system to be bolstered to be able to fight viruses and also to calm down inflammatory sidic kinds, inflammatory sidic kinds being the cause of you heard of the sodic kind storm in the lungs. It actually calms that down allows the lungs to heal as much as possible. It's going to cause neurological healing. It's going to cause amazing effects in the body all...

...over the inflammatory and autoimmune processes in the body, and it's a drug that has no side effects. We use in Lotoste tracks and we use one to four milligrams, a tiny, tiny dose, which causes these giant effects. So and I've even seen doctors using inhaled glutef Ion to calm down inflammation in the lungs and help healing in the lungs of these long haulers. So so I'm Indo is giving used a few examples of the things we do that think outside the box. When I and I should say think out of the box, I should say thinking of broader box, an evidence based but broader box. Hmm Wow, that's fascinating not I really want to thank you for joining us today. You've provided a lot of information that we need to think about and as we end our podcast, I wanted to know if there's anything else you like to share with our listeners. I do think that I'm hoping that that some of the listeners who have been help by compounds or who are motivated by this kind of talk and this kind of healthcare that might want to go to our website, wwwcompoundcom and give a testimonial. We're going to Congress. We have a large PR campaign that we are undertaking and it's going to be a multimillion dollar campaign and for our little association that is a big deal. And we're a targeting lawmakers, were targeting positions and we're targeting other healthcare providers and we're targeting patients to bring awareness to the fact that the FDA may be trying to overreach and take away your choice. And so please go on there and help us out and we would really appreciate that support and because it does support individualized, custom ask care, which I think is important in this country. Well, I want to thank you once again for being with us today, Jim, and if there's anything we can do to help you from the healing American Healthcare Coalition, I'm happy to offer our support. Thanks again for being with us today. Well, thank you so much for having me at it's been a pleasure and and thank you for the work you're doing. Appreciate it very much. If this is the first time that you've listened to the healing American healthcare podcast, I'd invite you to learn more about our coalition by visiting healing American Healthcare Dot Org. Joining our coalition is not expensive, and if you do that, you get a copy of our book, healing American healthcare, how to provide care for all and save a trillion dollars a year. Thanks for listening and have a great day.

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