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The Healing American Healthcare Podcast
The Healing American Healthcare Podcast

Episode 21 · 4 months ago

Pharmaceutical Compounding in the US

ABOUT THIS EPISODE

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. 

https://compounding.com/
https://healingamericanhealthcare.org/
https://www.lascolinaspharmacy.com/

Music: 

"The Discovery" 

by The Lemming Shepards 

Exzel Music Publishing (freemusicpublicdomain.com) 

Licensed under Creative Commons: By Attribution 3.0 

http://creativecommons.org/licenses/by/3.0/ 

Our guest today is jim herns er. He isrecognized as one of the pioneers of modern pharmaceutical compounding jimis responsible for the formulation of many bio, identical, hormone,dermatological, nutritional and anti aging compounds in wide youththroughout the united states. He has worked in radio and t v, including manyappearances on doctor phil as a hormone expert. He is a member of the board ofthe alliance for pharmaceutical compounding and he's very passionateabout the benefits pharmaceutical compounding can bring to patience. Hello, jim, thank you for joining ustoday and i'm looking forward to a great discussion. Thank you for havingme it's great to be here. Well, i have some questions i prepared you know sothat our listeners can learn about you and what you've been doing in yourcareer and i'm like to start pretty much at the beginning. So i wanted toask you when you were a young man planning to go to college. How did youbecome interested in becoming a pharmacist? I was first in high schooltrying to figure out what am i going to do with my life. You know, because youknow 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 pharmacistsand they were doing very well there in my hometown and i kind of looked up tothem. I thought you know what may be be worth while having that and just kindof pursuing both, because there are similar course management for those ijust trot out and it turns out. I just went down the pharmacy path i lateractually didn't get accepted to medical school after i was a pharmacist, but inever fully pursued that. I understand when i was working as a by medicalengineering researcher was suggested. I applied to medical school, i wasaccepted, but at the time i was forty two years old and and well into mycareer, and i thought i would stay where i was because i enjoyed what iwas doing as well. So in your career, you established your compoundingpharmacy with your focus on hormones and aging and what led you down thatpath? You know in the early years of my career i really hadn't even consideredany other approach to medicine other than the traditional medicine approach,but when my wife experienced some significant gonococcus ues next thing,i know she's had a historic me for ecto me: i've got a twenty eight year oldmen apus a woman on my hat and in it really opened my brain, because whattraditional doctors were trying to do to help her was not working, andunfortunately i saw this wonderful, beautiful person degrading. I mean her.Health is degrading, her immunis mister grading, her emotional state wasdegrading, and this was a person that was unbelievable. Prior to thatphotographic memory managed a large department store. She was an amazinghuman being, and so i thought i've got to try to fix her, and so i actuallycompounded the very first transdermal biodensity the country. I was justtrying to not be brilliant. I was just trying to simply help my wife, and youknow 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 morethan just one solution to our health problems. Maybe traditional medicinehas some answers. Integrated medicine has some answers and, let's just usethe best of both worlds. Well, you've been doing pharmaceutical compounding for along time. In fact, i think you started your company around one thousand ninehundred and eighty four, and i was just wanted to ask you- you've been in thisbusiness and in this profession for more than thirty years. How is itchanged over the time you've been working in this area of health caregosh when i graduated in in one thousand nine hundred and seventy ninefrom pharmacist. In those days we learned a lot of pharmaceuticalcalculations which were pretty intense,...

...and then we also learned some pharmacycompounding, but we're mostly going to be. You know, pill cotters. In thoseearly days we i started doing some compounding, especially when i open theeterne thousand nine hundred and eighty four i was. I was doing somecompounding a thinking i really like this and i'm helping some people withsome some broad thinking and and of course shortly there after. I inventedthe first tranter molested le jail in the country, and so i kept building onthose skills and what i really embraced was technology. At first, we had scalesthat were archaic and, and the next thing i know i have these five thousanddollar electronic analytical balances. You know that are that, can measuredown to point one milligram and- and i have a twenty thousand dollar ultrasonic powder mixers. It mixes the active agreement with the inactiveingredient to make sure there's a perfect mixture before we put it intocapsules and- and we have a symmetric, speed, mixing center views to mixcreams so that we know that the active ingredient is perfectly distributedthrough those creams. We even have testing. We now test potency of ourcompounds just to make sure that our processes are proper so that when wedispense a compound, we have full confidence that it's not only safe buteffective. So i love all that that progression of technology, but whati've also really enjoyed, is the progression that light speed in ourknowledge base, because in this integrative arena you know it's notwhat the traditional medicine resides and they don't. They start as out oftheir wheel houses. You know, but i love having practitioners call meup and say, jim. You know, i've got no ideas, i'm out of ideas. What what?What could i do possibly and then then i become an evenus base, problem solverand man that is so rewarding to be able to offer a new therapy that maybe theyjust haven't thought of and that the patient is going to benefit fromtremendously, and so that's really fun. For me, i mean t at that's a reallyinteresting now, there's a business side of this too, of course- and iwanted to ask you- are the prescriptions that you feel forpharmaceuticals that your company compounds normally paid for by privateinsurance and medicare. Personally, i was a pharmacist. They always putcompounds on insurance. If the patient had insurance, i put it on insuranceand then in two thousand and thirteen there were a few bad actors. You know,there's always bad actors in every industry, but a few bad actors thatwere over charging for a specific type of compound and so insurance companies,instead of just banning that type of exploitive practice, because they wereactually making more money because, as you know, pharmacy benefit managersmake more money the more expensive it is, you know, and so they were making alot of money off of those very expensive and i a should say, abusivecharging practices of those few companding pharmacies. They were mostlyrun by the way by business man and not pharmacist, so he was unethical, soinsurance companies, instead of just when they got caught and they go a gosh.You know all this money has gone out instead of just saying: okay, we'regoing to shut down that that bad practice. They just shut down allpayments for a compounds, and i thought that was really inappropriate. So we'vebeen in as a quas, they say in the pb industry, time out and and now they're starting to seethat, because compounds are cost saving to the medical systembecause most of the 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 ifthey would just safeguard against those, maybe unethical guys who were overcharging, which is again a small small minority medicare. Unfortunately, sinceit got set up and i'm old enough to remember when they got set up formedicare part d, prescription payments, but unfortunately they've never paidfor compounds, and it's really sad...

...because a lot of our compounds aregoing for just say: menopause of women, interposal man just an example and theyshould be paid for and they're. Not. I wish they were. I understand you knowthe whole area of pharmaceutical payment. United states is verycomplicated, as i'm sure you know, we spend more than two and a half timeswhat the rest of the world spends for a specific antin prescription drugs, andthere is legislation that was passed by the house. I believe it's bill age orthree that deals with the pricing structure of pharmaceuticals and thelength of patents, and you know, since one thousand nine hundred and eightythree or eighty four when the orphan drug law was passed, the price oforphan drugs has increased by sixty four times, and you know those thingsneed to be addressed, and you know if what you're doing can lead to betteroutcomes at lower prices, there ought to be an effort to allow for paymentfor those kinds of products. I totally agree with you, and so i wanted to asklearn more about this. What medical specialties do you normally work with,and how does this relate to the concept of any grade of medicine because integrated medicine reaches andyou can call it functional medicine in grated medicine because it reachesacross so many different specialties? I really can't tell you that there's justa specialty that i work with, i work with all of them and if they call me upand say like it an oncologist say, jim i've got this lady. Who has we treatedsuccessfully breast cancer? We want to put her back on hormones. What are thesafest hormos we could put her on, and so i gave him the answer. I give him ananswer. This is better than what he could choose from traditional big farmaor i have a doctor a say. You know. Jim i've got a lady who is suffering froman auto mune condition, and how can we fix that? Let's just say it's eximetand i've been giving her steroids and, and all it is, is a bandaid approach,and i say what don't we get to rude calls analysis? Why don't we get to whythe immune system is malfunctioning and try to solve it? So integrated medicinelooks at rude cause and tries to solve the problem at the route so that weactually fix the problem as opposed to just putting a band aid on it minteresting. You know basil what you said about the issues of reimbursementand the bad actors that you know we're discovered in your industry some yearsago. Are there research studies, com, pounding fonceas that support yourworking relationships with medical specialties? You bet, and i love goingto a physician and saying hey. You know: we've got this therapy that you'd askabout i'm here to tell you about it and here's some science, here's somestudies that show that it really does work and we don't. We don't always havedouble bind paseo clinical trials. That's really in the arena, a big farmof trying to get a drug past- and you know, as you know, and i know as abiosense a lot of those studies, even if their double line, paseo randomizedcontrol trial, unfortunately they're biased and you and i both know thethere's all kinds of ways to insert bias into a study in order to get theresult that you want and that's not. Science science means. Okay, we have anissue we're going to pursue and let's just see where the science leads us issupposed to saying. I want this come out a certain way, so by golly, i'mgoing 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 beingis, is biased studies, but i do i do take random as control trials. I takeretrospective studies. I take observational studies and even justcase studies. You know just say: hey: we had these three patients, so we puton this therapy here was the outcome very interesting to go back to look atthe market in some of the market issues that probably exist in this area asthey do in many areas. I did some research and i learned that the ushormone replacement market was valued at approximately ten point: six billiondollars in two thousand and twenty, and...

...it's projected to grow by about sixpercent a year through the year, two thousand and twenty seven now you knowyou're a board member of the alliance for pharmacy compounding, and i wantedto ask what your thoughts were about meeting the challenges that you havebetween big farmer, lobbying efforts in opposition to pharmaceuticalcompounding and the potential for the fda to expand its regulatory oversightof your alliance members that complicated issues, i'm sure, but i waswondering if you could share some thoughts about that man. Thank you forasking about this, because this is important in the us. There arecurrently estimated be about eight million americans using compounded,hormos, eight million and, and that represents more than half of allpatients on hormones. Now, understandably, big farm is upset. Youknow they want all the business. They don't want to share that business withus. They want all the business and that's just that's just business, it'snot anything other than evil. It just is what it is you know. So, after therelease, i give you an example left to the release of the winns health inistic study in two thousand and two. It was a study on hormones. W h, the mostexpensive study o were done, random as control trial, very biased by the way,but the lead researcher went out on his own and released to the lame media that,if you use hormones ladies you'll have increased risk of invasis cancer wereneed to stop this study early. Well. Of course, the lake media ran with that ispie. The fact that there was only a one point: two six rollife risk on that,which means that it was one patient in a thousand. They could have been eatenbig max the cost of the breast cancer you know, but anyway, what happened,unfortunately, is that eighty percent of women in america drop their hormonesand, according to a yale study, hundreds of thousands of women diedearly needlessly and suffered horrible quality of life, because they were tooscared to use their hormones, and that is a just a crying shame and by the way,that study has now been one hundred percent reversed. The other researcherswithin that that were not by as came out as early as as two thousand andseven to two thousand and twelve saying you know what those early releases werewrong. We're seeing increased protection of women on hormones, notincrease risk matter fact rest cancer. Twenty percent decrease risk dementiahard disease more than fifty percent decrease risk. So, yes, there are bigadvantages for using hormones versus not using horn bones so anyway, what welike is is even back in those early days in two thousand and two when wewere dropping off hormos, they said, and their doctors were saying, is therea healthier alternative and of course they love the idea of compoundedbioderm ones, because, instead of being hormones that were natural to a horsethat which is permanent pregnant merger, in which i can't believe people withintheir mouth, it is the urine of pregnant mayors. Okay and in thehormones in premerent, are not the hormones in human body. Okay, so we usecompounded about antica hormones from fda proof facilities by the way we buythose those hormones and- and we put them together in compounds and and somillions of women have chosen to use these and and ere. They just feel it'ssafer. You know, and and actually when we look at the studies, when we look atthis science, they are safer. We know that twelve percent of women are goingto get breast cancer, but with our batini hormos we think we can get thatrisk down to as little as eight percent, which is a huge benefit for women, andwe also not to mention the the dramatic decrease in heart disease and stroke inthe decrease in dimensio. Can you imagine i mean a study came outrecently on dementia and and is said that that women who are on bidenahormones, had a seventy. Eight percent decrease risk of developing dementia. Idon't know about you, but i'm more...

...scared to mention than almost anything.As far as the fact that heart disease is probably going to get me so the alliance i did want to talkabout the alliance, it's interesting that in two thousand and seven withpharmaceuticals, the makers of primin they had the number one drugging theworld, they had two billion dollars a year drug and it dropped eight hundredmillion overnight. They said we got to stop the bleeding. They blame it on us.You know, as all all these women are using bout, infor, hor moms, so theywent to the fda and they said fda. We went as a citizen petition which isactually illegal for a company to a citizens pedition, but they did andsaid estriol one of the hormones that we use, which is a protective estrogennatural. An human body, said: estriol represents a significant health rise tothe women of america. You should man, it in the fda, went ahead and bandestriol. Well, the women of america, millions of women in america went tothe fda, they went to their congressmen and they blasted them and man. It wasin short order that band got reversed. So so it's interesting that here wehave this. This drug company that has an istriel product in europe, try toget it banned in the us because they didn't have an estriol continuingproduct 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 itshould be about what is the best for health outcomes on patients. So that's what a pc is dedicated to apc is dedicated, preserving the choice of physicians to choose compounds ifthey deem it best for their patience and patience if they deem it best fortheir own health care to be able to use these compounds, and so our pushes,throughout the three year campaign that we have is designed to bring awarenessto the fact that you could lose access to compounded medications, includingcompetin hormones. So the alliance has gotten together with physicians withpatients and we're trying to get the word out through a very expensivecampaign and we're a little association, and we are small and we are not in somemay moth goliah, you know, and so we are, we are simply trying to get theword out to preserve patient access. I think that's very important, and youknow in my first book heeling american health care. I was writing about bigfarman and i was surprised initially to learn that they have eight hundred andeighty three lobbyists that work within the industry a more lobbyist than thereare members of the senate and the house of representatives that they arefunding to take their message to legislators at every governmental level.So they are absolutely big farmer. So, in dealing with big farmer and theefforts of the fda, i found that there was a book that came out. I think itwas in february of this year. It was by someone named jason deria and the bookwas called kill shot and it was about deaths and illnesses that were causedby the new england compounding pharmacy in two thousand and twelve, and i amassuming you also have to deal with the challenges brought forth by this lookabout the difficult times of ten years ago. How does a pc deal with that issue?You know, as i said earlier, this is not just about competing pharmacists,you know it's actually, a pc is about preserving access for physicians,patients and company pharmacist be able to provide that kind of service, and soanyway, the book kill shot was a very cleverly in sessai written book. I meanyou know. If you read it, i mean it's fun to read and and it's scary and itdoes all the right things it pushes all the right buttons. The problem is: isthat it's not all that accurate, because heady included all the accuratestatements it wouldn't have been as fine, you know, and so what author isnot going to try to make their bug just a little more fun. So, for example,they didn't say that the company that...

...started the new england competingcenter was actually a manufacturer, and they said you know what we don't likeall the regulations around manufacturing. Let's just try to escapesome of those and call ourselves a company pharmacy. Well, they're, notthey were putting up thirty sand compounds a week i mean, and so that'sthat's manufacturing, that's not compounding okay and by everydefinition you can possibly imagine and again they're just trying to escapescrutiny. Well, the fda went in there and at least three times inspected them.The massachusetts state board of pharmacy inspected them at least threetimes, and all of those visits resulted in horrible deficiencies, dangerousconditions being noted. I mean fungus growing the wall, i mean it was builtright next to recycling, plant, nasty, nasty, okay, and so here is thisfacility, with with fungus and mold on the walls and and they're, allowingthem to continue to practice and the fda is culpable, i mean, and let's justcall 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'teven a competing pharmacy. They were a manufacturer and what did the fda doand the menu and massachusetts more to pharmacy do nothing nothing, and then i can tellyou that that congress of course had to act, and so they came out withsomething called the the drug quality security act, which was an enhancementto the fda act and basically was aimed at helping put regulatory guidelinesfor competing pharmacist. Well, we were already regulating ourselves prettywell with state boards of pharmacy, except for the massachusetts hadoverlooked these horrible conditions, and so this we actually welcomed this,because those of us that were acting ethically, which is a good greatmajority of compounders, welcome to any legislation that said: hey, let's bringeverybody up to the snuff that we're working at you know, and so i thinkthat when you read a book like that, you have to understand it's sensational.It covers a tragedy that should have been stopped long before it started,and so, if you want to read anything into that, read into the fact that whenwe find horrible conditions, we need to stop it, then not wait until somethingbad happens. Absolutely well. Thank you for clarifying that am i'm sure thatyou know with all the efforts you're putting into reaching out to enhancecompounding with patients, physicians and others that you'll be successful,and i hope that you will be because i think you provide a valuable service.You know, and it kind of smacks a my brain of. We should all be a littlenervous about actions that the fda is an agency that needs to be there. I'mnot anti fda, i understand their role, but when they overreach, when they domore than what congress charged them to do, for instance, they've stated a dand r scott got lab the outgoing he's, a md by the outgoing director of thefda. He stated in a medical conference in houston. I attended that the fda hasan internal anti companding culture and he went on to give all the reasons whythey do, and most of it was emotional. It was not associated with problems. Itwas associated with emotions about. Well, i just don't like those guys. Idon't like what they do. I don't understand him. I don't like them- andi want them out of here and so they're trying to use an enforcement agency,which is not a legislative agency, is an enforcement agency to to cause thedeath of an industry. Now can you imagine, there's one bad doctor, agroup of bad doctors and then congress need jerks and says oh gosh, we'regoing to prevent that we're going to ban all doctors in health care. Theydon't do that and so there's no reason for them to ban compounding when wehelp so many millions and millions of patients because, like i say, eightmillion are just using hormos, that's...

...not to mention all the millions thatare using other things for auto immune disease, inflammatory disease and andjust quality of life. I think you're right. I think peoplewant to have the option to do what they think is best for their health caredealing with ethical providers in every theater. You know you're coming aboutphysicians, when physicians have been investigatedfor inappropriate funding by various agencies, that you know that they'renot allowed to practice medicine, but it doesn't mean that other people intheir specialty aren't allowed to continue to do what they do for theirpatients. And you you know that's the way it ought to be so exactly. Iappreciate that now you've, given us just a lot ofinformation to think about, and i want to ask you one more question: if icould that's a little bit outside of compounding itself in healthcare today,the big issue we hear about every day is the corona virus and of covedinfection, and my concern is that today, between seven and ten million americansare coved long hollers and they suffered from a variety of symptoms forextending periods of time. In some cases, it's thought that these will goon for the rest of their lives, and these symptoms can include things likeextreme fatigue, mental fogginess, neurological, cardiac and kidneycomplications, and you know what can compounding pharmacies like yourstudent of this large group of patients and with the current delta virusovarian? I think that's actually going to grow. Unfortunately, so what role?Can you all tank in helping these patients? One of the things that meanjust an example: prevention and treatment of early casesof ovid was ibama. Aver macdon is proven in twenty six double bind.Placebo studies have control clingan trials. To do amazing things atpreventing covas i mean there is a study done in a hospital system inbrazil and they gave half of the employees in this system. It was onethousand patients. I gave five hundred a remato. They gave the other halfnothing and of the group that that did not have oberman. Fifty percent of themcame down with coved on the group that that, had, i emack in very few caseswere reported now that just goes to show you that a drug that has almost noside effects that can be taken once a week is dramatically effective inpreventing coved and matter of fact, in the early stages of coid. It causes thedisease to become much less murie, and so it causes much less inflammation,because inflammation is what cogit causes. I mean whether it's anendocarditis mio car ditis, whether it's the lung inflammation in bibrociin the lungs and causing long hollers. We can prevent that once where you haveit. We've got to get a hold of inflammation, an example that we can dois once we see we have a long, hollers and grated medicine doctors going to go.Hmm, let's just see what can we do? We could give antioxidant iv s matter offact in new york, when the governor there band hydrate chloroquine in theearly days, positions were left with no drugs to use, and so they said whydon't we use vitamin c, which is danny occident iv and they found out it wasworking, and so they gave steroids and biton c vitamin c being an anti oxidentcalming down. Free radicals call me down oated inflammation and thepatients were getting better. That's an idea. You know that was came fromintegrated medicine that in come from traditional medicine, and then whatabout load us to trek son lotus at track? Stone has a effect on opiogrowth factor, which causes the immune system to be bolstered, to be able tofight viruses and also to calm down inflammatory sided kinds, inflamatorysided kinds being the cause you heard of the sided kind storm in the lungs itactually calms. That down allows the lungs to heal as much as possible. It'sgoing to cause neurological healing is...

...going to cause amazing effects in thebody all over the inflammatory and auto immune processes in the body, and it'sa drug that has no side effects we use in loosened. We use one to formmilligrams, a tiny, tiny dose which causes these giant effects so, and i'veeven seen doctors using inhaled blue to by on to calm down implanting in theloans and help healing in the lungs of these long haulers. So so in demes,giving you us to a few examples of the things we do that think outside the box.He in a way, i should say think out of the box, i should say thinking abroader box in evidence based, but broader box. Mmwoo, that's fascinating!Not! I really want to thank you for joying us today. You've provided a lotof information that we need to think about and, as we end our podcast, iwanted to know if there's anything else, you'd like to share with our listeners. I do think that i'm hoping that thatsome of the listeners who have been helped by compounds or who aremotivated by this kind of talk and this kind of health care that might want togo to our website www pennycoed and give a testimonial we're going tocongress. We have a large pr campaign that we are undertaking and it's goingto be a multi million dollar campaign and for our little association that isa big deal and we're targeting lawmakers were targeting positions andwe're targeting other health care providers and we're targeting patientsto bring awareness to the fact that the fa may be trying to overreach and takeaway your choice, and so please go on there and help us out, and we wouldreally appreciate that support and because it does support individual ascustomers care, which i think is important in this country. Well, why? Iwant to thank you once again for being minus today, jim and if there'sanything, we can do to help you from the healing american health carecoalition. I'm happy to offer our support thanks again for being with ustoday. Well, thank you. So much for having me ad, it's been a pleasure and,and thank you for the work you're doing appreciate it very much if this is thefirst time that you've listened to the healing american health care. Podcasti'd invite you to learn more about our coalition by visiting healing americanhealthcare got org joining our coalition is not expensive, and if youdo that, you get a copy of our book healing american health care, how toprovide care for all and save a trillion dollars a year. Thanks forlistening and have a great day.

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