LDN Video Interviews and Presentations

 

Tania Dempsey, MD - MCAS Documentary Fundraiser; August 2023 (LDN; low dose naltrexone)

 

 

Madi Wend - MCAS Documentary Fundraiser; August 2023 (LDN; low dose naltrexone)

 

 

Leonard Weinstock, MD - MCAS Documentary Fundraiser (LDN; low dose naltrexone)

 

 

Linda Elsegood: Welcome to the LDN Radio show brought to you by the LDN Research Trust. I'm your host Linda Elsegood. Today we're joined by pharmacist Mark Filosi from Family Care Compounding Pharmacy in Florida. Thank you for joining us today, Mark. We'd like to find out more about who is Mark Filosi. 

Mark Filosi: I grew up in pharmacy. My very first job was in a pharmacy when I was 14 years old. I began compounding even back then. This is before computerization, typing on a manual typewriter, filling capsules, one at a time on a torsion balance on Saturdays in support of compounding. Fast forwarding to 2023 where we've got really a state-of-the-art very high-tech pharmacy this is very very different. 

Linda Elsegood: So are you the manager? The owner? What's your role? 

Mark Filosi: I own two pharmacies. I own Family Care Compounding. I also own Live and Learn Pharmacy. I've done a brief stint as a PCAP ACHC Surveyor or accreditation and compounding both sterile and non-sterile. I also sit on the board of directors for the Alliance for Pharmacy Compounding. It's really the only advocacy group that I know of in the United States in support of what we do and allows us to be able to compound things like low dose naltrexone and bioidentical hormones. I'm a preceptor for four different universities in America. I'm a career coach for young pharmacists. I also teach educational programs for continuing education for pharmacists through the parent company that's sponsoring me on Medisca and LP3 Network. I'm a senior facilitator for them. I've worked teaching sterile and non-sterile, advanced non-sterile business for pharmacists for the last 15 years. 

I've taken on a very new role on basically off the bench now as a pharmacist, even though I still work in my stores. I'm a success partner with Medisca Pharmacy Compounding Coaching Services. That is something that's very new. When my son was younger, I was a Boy Scout leader for him and horseback riding with my daughter and all kinds of fun stuff with my wife. Now we have a a lot of hobbies and projects. 

Linda Elsegood: You are a very busy man obviously. Please tell us about your pharmacies. 

Mark Filosi: We've been in business for 27 years. I started way back when there really wasn't much support for compounding pharmacies, back when there was just a publication called the Secundum Artem. 

I would learn everything then that Mark Erickson talked about in that particular publication. I learned how to compound a progesterone suppository. Then I would go out land market that one thing to physicians and practitioners in Florida. I became so impassioned with that that I wanted to learn more. I've taken flagship programs from Medisca Sterile Compounding, non-sterile and I've really expanded the scope of what we do to the point where I would say compounding has really eclipsed all the other things that I do in pharmacy, but I've probably done just about everything you could think of as a pharmacist. My most passionate and exciting thing that I do at my pharmacy is non-sterile compounding. I just love it. 

Linda Elsegood: What forms do you compound LDN into? 

Mark Filosi: Right now we compound rapid dissolve tablets, trochees, which are just basically lozenges that you dissolve in your mouth. Capsules of course are probably our number one, but one of the exciting things that you might not know about is something called Nova film from Medisca. It can bypass down the hatch, into the stomach, then to the liver, then to the blood, then to the biological side of action. We've got a new product called Nova film which is sublingual but the unique thing about it is it's also mucoadhesive so it gives your body much more opportunity for absorption in the tiny blood vessels inside your mouth. It is similar to a Listerine strip or some of the commercial products that are like that right now. The mucosal lining is kind of a moving target. There's a turnover rate with it and this really makes it bind to that and we're really looking forward to using low dose naltrexone in that type of delivery system. It is very novel, very unique. 

Linda Elsegood: Do you make low dose naltrexone (LDN) in a nasal spray? 

Mark Filosi: It's my feeling and the feeling that the folks that support me at Medisca and LP3 that that should probably start as a sterile compounded preparation as it doesn't have direct access to the body like an injection or intramuscular, but it's still something that you wouldn't want to introduce a pathogen into somebody's body. I don't really focus on sterile compounding anymore. That's not something that I do. 

Linda Elsegood: You mentioned two pharmacies. Are they run very similar? 

Mark Filosi: Yes they are. Live and Learn Pharmacy, a pharmacy I just purchased a few months ago, was nothing but compounding, and my pharmacy was a hybrid of just about everything; DNA, retail and of course compounding.

Linda Elsegood: What kind of doctors do you deal with in Florida? I know West Coast is mainly naturopathic doctors. Do you have MDs and DOs and physician assistants, etc. 

Mark Filosi: NDs would not be the primary here because they don't have prescriptive authority in Florida. It is interesting, I could take a prescription from an ND in California because they do legally have prescriptive authority and the right to prescribe low dose naltrexone in California, so if one called to here I could fill it, but an ND in Florida, I would not be able to. It is very interesting but I would say the primary prescribers that I see here in Florida would be MDs and probably nurse practitioners. Especially because nurse practitioners here in Florida can be autonomous. They can open up their own practices and this is really kind of a niche market that's very well supported with nurse practitioners. It's something that's really within their power to do that. 

Linda Elsegood: We find that there are many nurse practitioners who seem to have more time to spend with patients than a doctor. 

Mark Filosi: Although I've got some really wonderful prescribing MDs I will say that in my experience nurse practitioners do give you more of their time and because of that it can be a very powerful experience for a lot of people 

Linda Elsegood: Now in Scotland, and we're going to start having them in England – Pharmacy Consultant Prescribers. Something so new in Scotland, I think they had it before COVID. It will mean you can go to your doctor or your pharmacist with minor things. In Scotland they could prescribe LDN as well. In England I think it's going to be minor things to begin with. Do you have that already in place? 

Mark Filosi: It depends on the state because each state is run like a small country. We have different rules within the state versus Federal law standards and guidelines. In Florida we've got two programs. We've got something called Test To Treat where a pharmacist could do a CLIA approved test and then from that we would be able to prescribe certain limited things like you're describing in Scotland. We also have something called a Collaborative Practice Model where we could create a collaborative practice agreement with a practitioner and then prescribe things within that agreement. I would think that prescribing LDN could be one of those collaborative things that we could do moving forward. 

Linda Elsegood: It is really exciting. 

Mark Filosi: I am excited for that and I think that the world has recognized that pharmacists have a great place within healthcare and that we should be recognized as practitioners and we're probably one of the best suited professions, and that we would be able to prescribe because we know the drug. 

Linda Elsegood: Doctors only do a certain amount of drug interactions because that's not their wheel house that's yours. It's the pharmacy, that's the nurse, prescribers are like doctors to a point you know. Why wouldn't you have a pharmacist prescribing like you have a nurse prescriber? I don’t see what the difference is. 

Mark Filosi: That's very true and it's funny that the lobbying groups and the association surrounding nurses and doctors are strong but historically those types of groups surrounding pharmacists have been weak. We haven't been a cohesive body. That's one of the reasons why I sit on the board of directors for APC is to give that voice 

Linda Elsegood: Because in England there's a crisis that we are short of medical professionals, doctors, nurses, etc and I'm sure it must be similar to the US. It would be so much easier for patients who have access to medical care if all those pharmacists that were ready and willing and able to become prescribers. Surely that would take a lot of pressure off your health system. 

Mark Filosi: Yeah, and I think that it's a partnership with those people. It's not like we're taking power away from a practitioner. We're sharing the process. I think we make them more effective. If a physician only has five or ten minutes to meet with a patient we can work behind the scenes and write suggested prescriptions. We can measure outcomes with prescribers and patients and it's that triad. It's the relationship between a pharmacist, a patient and a practitioner that really rounds out that whole process. 

Linda Elsegood: It is all for the good of the patient. 

Mark Filosi: Of course, it works best if you have that kind of time. That's something that APC, an independent group, they have a new product called Outcomes MD. It is a platform available to both pharmacists and providers. It interfaces with electronic healthcare records and they have a very new platform specific to naltrexone that I can text a survey to my patient. Once they receive their prescription it will establish a baseline of symptoms with that patient associated with naltrexone and then I can start to measure and monitor outcomes. The measures are to prove that it's either working or if there's some sort of gap in therapy, or is there something that I can go back and now recognize because the beauty of compounding is it something that we can modulate, fix and make better, because it's personalized medicine.

Linda Elsegood: It is always good to start with a baseline. For people sitting in that survey initially before they take the first pill, capsule, whatever it may be, you then got the baseline which makes such a big difference. 

Mark Filosi: I would say to the pharmacist in the United States that might hear this that the data that's being collected by Outcomes MD will become redacted and shared back to the Alliance for Pharmacy Compounding. This is something that we can show evidence to the FDA that compounding is valid and that the works of pharmacy are true. We've been doing this as a privilege for thousands of years. With a stroke of a pen the Federal regulatory bodies could take that away from us. I think it's important if we want to preserve really valuable and powerful things like LDN and BHRT and all those things that go with it then we have to be proactive. 

Linda Elsegood: I believe you are quite big in the hormone community. 

Mark Filosi: With the community of everything that's possible within non-sterile compounding and sterile compounding. Yes, I've got a new role. In addition to being a facilitator for educational programs I also teach. I have been teaching compounding for 15 years. I've been advocating for colleges of pharmacy and so on. When you take a program like that then people don't know what to do on Monday morning after the program, after they get home. They've taken a course, they've gone to college but they still need somebody to hold their hand through the process and Medisca, now the parent company, the global leader in compounding, really has allowed me to open this channel and I become what's called a success partner. I have two other people that are working with me. I've got another coach that's working as a coach and remote patient monitoring and clinical services. I have another coach that's specializing in pharmacy operations, CEO mindset leadership. When somebody wants to open the niche market of non-sterile compounding or maybe they already are a fantastic non-sterile compounder but they want to open the niche market of LDN I can walk them through that process and really this whole team would guide them on that effort. Something that's very new and this is what we're going to kind of splash at the LDN conference.

Linda Elsegood: Third party testing is very important and pharmacists hold that in very high regard because as a pharmacist you can say there is definitely 4.5 milligrams in my capsule.

Mark Filosi: You know I have what I affectionately call pharmacists that behave more like bartenders. They're dabblers in non-sterile compounding. Then I have pharmacists that are truly professional, personalized compounding pharmacists and they're very different. It's different than just crushing a 50 milligram tablet and dividing it in some way to make a capsule or some other preparation. If you used an FDA grade, USP grade, active pharmaceutical ingredient from somebody like Medisca and you learn how to manipulate that. 

If I have five milligrams of Naltrexone, and 50 milligrams of Naltrexone it is very difficult for somebody to weigh that precisely. You have to learn how to weigh the unweighable. You need to learn how to do mixtures that if I was making a capsule, even if every one of my capsules the finished product weighed exactly 300 milligrams but the finished powders in there. If I make a hundred capsules at a time, if they all just by chance weigh 300 milligrams, my theoretical weight, how would I really know 4.5 milligrams or 1.5 milligrams on the titration was really in those capsules? That predicates itself on homogeneity and content uniformity when we make that mixture powder blend to start with. We would need devices like the Mazerustar, that's an inverse planetary mixer. We would need testing facilities to confirm and validate repeatedly that when I make a mixture in service of making a 1.5 milligram capsule or a 3 or 4.5 or what have you that I do have a homogeneous blend. When I make those capsules and they weigh the correct amount the finished preparation is correct. I believe that all pharmacists should operate by the family rule. If I was making that for my mom, I was making that for my wife, if it's not good enough to dispense to any of those people then I shouldn't be doing this. If you're just dropping a tablet into a glass of water, are you thinking about the fact that naltrexone is the salt of a strong acid and it could be either more dissociated or less dissociated in the presence of an acid or a base. It could undergo hydrolysis in water. It's not stable. What happens if a lot of the excipient ingredients have grabbed onto that drug and it's at the bottom of the glass and you're supposed to drink one tenth of this glass to give you the five milligrams which is going to be nearly impossible. At the beginning of that glass maybe you get a light dose, at the bottom of the glass maybe get a heavy dose and you're looking at a narrow therapeutic index drug where we're telling people that 1.5 milligrams in increments is what you need to do. If we're giving people instructions that are that precise. If we're doing very low low dose naltrexone, an ultra low dose naltrexone how is that possible without this committed validated process? 

Linda Elsegood: Please share your website so that people can go and find out more. 

Mark Filosi: Yes uh I would tell them to go on to Medisca.com and they can look at pharmacy success partners. They can look at our services. They can look at formulation development. We have everything. Really a need from LP3 education it's a one stop shop really to get somebody up to speed and able to do something like this. Which really is something that you really need to pay close attention to. If you don't do it right we can cause patient harm instead of patient good. I think that if you really want to do things correctly you want to work with somebody like this company Medisca. 

Linda Elsegood: Any questions or comments you may have please email me Linda@ldnrt.org. I look forward to hearing from you. 

 

 

Linda Elsegood: Today we're joined by pharmacist Dr Dawn Ipsen who's the owner of two pharmacies in Washington state. Kuslers Pharmacy and Clark Pharmacy. Could you tell us what it was that inspired you to become a pharmacist? 

Dawn Ipsen: I knew early on as a high schooler that I wanted to have a doctorate degree in something and was sort of a little bit torn between pharmacy and optometry and with long heartfelt discussions and soul-searching I became a pharmacist and very early on in my career not only was I trending towards being a pharmacist but I had an opportunity to intern at a compounding pharmacy and just absolutely completely fell in love. It was the art and the science and the way of being able to help individual patients in manner of which no other pharmacist in my area was able to do so, of providing very personalized therapies. I was able to really listen to patient needs and work with their doctors, to formulate the exact therapeutic tool that they needed to improve their quality of life. That is really what has driven me in my career. 

Linda Elsegood: When did you open your first pharmacy? 

Dawn Ipsen: I had been a pharmacy compounding lab manager for about 10 years for the Kusler family. When they were ready to go do other things in their life I was given the opportunity to purchase Kusler's Compounding Pharmacy. It had been a pharmacy I had worked at as a staff member for 10 years and took over as the owner and I've now owned that pharmacy for almost 10 years. In January it will be 10 years. That was my first pharmacy. 

I was doing all my good work up at my Snohomish Pharmacy and suddenly had a random phone call on a Friday afternoon in which the Clark family was looking for a new owner for their pharmacy. They were ready to retire and go do other things as well. I've also owned Clark's compounding pharmacy down in Bellevue Washington for six years. I've been an owner for almost 10 years total and have had multiple locations now for about six years. We service not only the entire state of Washington but we also work within nine other states as well. Our boundaries go quite deep and it's a really great way to help all types of patients all over the nation. 

Linda Elsegood: What would you say is the most popular form of LDN that you use the most? 

Dawn Ipsen: I would say primarily we use the most customized strengths of capsule formulations of low dose naltrexone (LDN). It gives patients really great consistency yet opportunity to get the doses titrated in appropriately where they need it to be. What's really great about how we approach our making of capsules is we use hypoallergenic fillers. We're also able to work specifically with patients who have sensitivities. We can customize what that filler might be and I think that's really what sets our pharmacies apart and why doctors and patients choose to work with us. 

We are experts in autoimmune and chronic inflammatory diseases and therefore we're very used to working with patients where the normal just isn't what they need and isn't what's best for them. We can customize that to be appropriate for them. Along with capsules of course, we are able to do transdermals. That's really popular in pediatrics, especially for patients with an autism spectrum disorder. We are able to make flavored liquid tinctures of it so patients are able to use various small doses to titrate up doses. We also make sublinguals. I would say capsules are pretty popular for us. 

Linda Elsegood: What kind of fillers are you asked to use? 

Dawn Ipsen: Most of the time I will steer a patient towards microcrystalline cellulose (which is a tree based cellulose). It is very hypoallergenic for a lot of patients. However, some patients know they have tree allergies and those patients primarily prefer rice flour. I do have a couple of patients, but very very rare that actually do better on lactose filler. They tend to not be my autoimmune patients. They tend to be patients in the chronic pain spectrum area. 

We have also worked with other fillers, like tapioca flour. We can be very customized into our approach of how patients need it. I've got one patient that comes to mind that loves magnesium as their filler and that's very relaxing for their muscles. I've also seen probiotics being used. There is not one right answer to how we do things. We are that pharmacy that is able to have a conversation with a patient. We talk about what their needs are and customize it based on that approach. 

Linda Elsegood: From the prescribers that you work with, do you have many consultants that you fill scripts for? 

Dawn Ipsen: We definitely do. What's also kind of a little side thing that I do. I've always been very passionate about teaching. I'm on faculty at University of Washington School of Pharmacy and also Bastyr University which is one of the top naturopathic doctor schools in the nation. I teach there during summer quarter. I teach nationally to providers continuing ed-based content that is often LDN in nature or ties into LDN. Especially with autoimmune and chronic pain and chronic inflammatory conditions. We consult a lot with doctors. I probably work with three or four hundred functional med type providers on any monthly basis even on being able to customize therapies for their patients. We are really big in the post COVID syndrome arena of helping patients that are really struggling and LDN. We're finding it pairing quite nicely in that condition as it's very inflammatory based. 

We work quite heavily within the MCAS arena for patients who have a lot of mast cell instability and need other therapies. LDN is one of the tools that is used quite frequently by those types of providers and for those specific kinds of patients. 

Linda Elsegood: Do you work with any pain specialists, dermatologists, rheumatologists, gastroenterologists? 

Dawn Ipsen: We do. Honestly, I'm quite proud of our little Seattle area of Washington because we do have MDs that are pain specialists that are now really turning towards using LDN in their toolbox of things they have available for patients. They're getting quite savvy at it. They're doing a really great job. It is super exciting. I have some dermatologists. I consult a lot with my functional med providers that are seeing dermatology conditions like psoriasis. I have an email I need to work with a doctor on after this to help them with this patient with a psoriasis case. We are seeing it in the GI world as well for Crohn's and irritable bowel disorder. Those chronic inflammatory conditions. I would say the MD pain specialists are really turning around over here. Obviously with the opiate crisis that has occurred in our nation I think most doctors of any type of credentialing or medical training or experience are quite interested in what LDN is doing for their communities and what opportunities it affords for patients who are trying to make sure they aren’t addicted to opiates but yet have something to improve quality of life and their day-to-day living. Low dose naltrexone (LDN) has been an amazing tool for that. 

Linda Elsegood: I'm always excited to meet different LDN prescribers and nurse practitioners who are providing lots of scripts. When you get an MD or a DO that is prescribing LDN and it is completely out of their comfort zone, I always think yes, you know we've got another one on board. We're making it right. We're getting it. MDs are already working outside of the box. That is normal for them to look into LDN it's not normal for MDs to look at LDN but as you know I've interviewed so many people and so many MDs when they have a patient that they can't help and fix their issues. They've tried everything and they feel as if they've failed this patient and then they try LDN. Once they have had amazing results with the first person it's then so easy for them to look into prescribing not only for other patients with that condition but for any autoimmune disease, chronic pain, mental health, etc. I mean it's really amazing and this is where people like yourself come into play. The hand-holding with doctors because a lot of them haven't got time to do the homework. They're very busy and they need somebody to tell them exactly what it is, how to prescribe it, what to look for, what to do and have somebody on hand to say, like you said, I've got a patient with psoriasis. What do I do? Can you help me? That is the way to get more doctors involved is the pharmacist doing the hand holding. 

Dawn Ipsen: There is a local psychiatrist in our area that works with younger adults with substance abuse disorders and teenagers that are having a lot of trouble with mental health. I had an opportunity to get him thinking about LDN and his patient population. I love when I get to reconnect with him every few months because he just raves He finally has a tool that actually does something. He felt the antidepressants and all these other things were not really fixing any of the issues or fixing the symptomatology. We still have the same abuse issues, we still have the same addiction issues and we still have the same levels of depression and suicide risk. But with LDN he's finding that he's actually causing positive change in his patient population and that's the only thing he really changed within his practice. 

We're really affecting the health of our community in a very positive manner with something that's really safe and low risk and not expensive. It doesn't get any better than that. It's the best compliment I could ever have. 

Linda Elsegood: It's really nice when patients take all their information to the doctor. Once you've got a doctor really hooked on prescribing LDN they can change the lives of hundreds of patients. Dr Phil Boyle uses LDN in his fertility clinic He also uses it in women's health for things like endometriosis, polycystic ovary, painful periods, heavy periods. Right across the board he uses LDN. He gets patients coming to see him with women's health problems who also have Hashimoto's or long COVID etc. 

Dawn Ipsen: I refer to his work all the time. I get questions a lot from local providers such as we have somebody who wants to become pregnant or they did become pregnant and they're on LDN and they want to know what the standard of care is and can we continue, and what's the risk and benefit are. It is so great to have providers like him out there that have been doing this work for so long that we can very confidently share those case experiences and history of using the medication long term for those patients. 

Linda Elsegood: There have been so many of our members who were skeptical about using LDN during pregnancy. Doctor Boyle is always very generous with his time. I will send him details and he will answer the patient and share his experience. You know we used it once up until birth rather and breastfeeding, etc. We have those people who have done two or three pregnancies using LDN who are happy to talk to other people. This is my experience with 20 years as the charity next year, which is totally amazing, but I’ve found that word of mouth and with the education it is just spreading. 

Dawn Ipsen: Linda, you've done an amazing job with the LDN Research Trust and I thank you for that. You have made the Research Trust, its website, resources and its books into a trusted referral point that I can use with our doctors and our patients who are wanting that next level of information beyond what I'm able to say to them. They want to go see those studies themselves. They want to go read the book themselves and I know that without a doubt I can send them to your resources for them to receive complete in-depth and correct information. Thank you, Linda. You're doing amazing things and this is all because of you. 

Linda Elsegood: How can people contact you? 

Dawn Ipsen: We have two locations in Washington State. We have Kusler's Compounding Pharmacy in Snohomish Washington and the website there is www.Kuslers.com; and then we have Clarks Compounding Pharmacy in Bellevue Washington. That website is www.clarkspharmacywa.com. The WA stands for Washington. We are happy to help patients all over and talk with doctors that need guidance and assistance in learning more. I love being an educator and I love being here to support my community. 

Linda Elsegood: Any questions or comments you may have please email me Linda linda@ldnrt.org. I look forward to hearing from you. Thank you for joining us today. We really appreciated your company. Until next time stay safe and keep well.

 

 

Linda Elsegood: Welcome to the LDN Radio Show brought to you by the LDN Research Trust. I'm your host Linda Elsegood. Today I'd like to welcome our guest Pharmacist Suzanne Rosenberg from Community Compounding Pharmacy in Oregon. 

So could you tell us what made you decide to become a pharmacist? 

Suzanne Rosenberg: When I was in undergraduate school at Temple University in Philadelphia, which is my hometown, I worked at a pharmacy and I loved it. I loved working with people. I just loved everything about it and so when I graduated with my degree in psychology I applied to Northeastern University in Boston, Massachusetts and started pharmacy school two months later. I received my pharmacy degree from Northeastern. 

Linda Elsegood: Have you always stayed in the Oregon area? 

Suzanne Rosenberg: After I graduated pharmacy school I got in my car and drove to Portland, Oregon to visit some friends. I never left. That was 27 years ago. I've been practicing as a pharmacist exclusively in the Portland, Oregon area. 

Linda Elsegood: When did you buy the pharmacy? 

Suzanne Rosenberg: I moved to Portland and I worked for small independent pharmacies. I got really interested in herbal medicine. There was a company called Wild Oats that opened a large store and they had an idea where they put a pharmacy with naturopathic medicine in this grocery store with a yoga studio. They asked me to manage it. I did for six and a half years. I managed this pharmacy and turned it into a compounding pharmacy. Then another local chain recruited me and I did that for four and a half years. Then I decided that I had all these ideas of things that I wanted to do. Fifteen years ago I started Community Compounding Pharmacy in Lake Oswego, which is a suburb of Portland. It's a compounding only pharmacy. We predominantly work with integrative practitioners which I've been working with for over 23 years. I work with naturopaths, functional medicine doctors, integrative practitioners all over the West Coast. We started mainly in Portland, in the Northwest, but now we work with integrative practitioners up and down the West Coast.

Linda Elsegood: Please tell us about your pharmacy. How big is it? Do you do sterile and/or non-sterile compounding? 

Suzanne Rosenberg: We're fortunate that we only do non-sterile compounding. We're about 10,000 square feet. We have about 45 employees. We're open six days a week and we ship all over the nation, predominantly on the west coast and certain states on the east coast. Mostly on the west coast; Colorado, Arizona, Alaska, Hawaii. On the east coast: New York, Maine, Vermont, Connecticut. We are pretty much licensed mainly on the east and the west coast. We have been fortunate to have an extremely amazing staff that really supports our patients and our doctors and one of our focuses at Community Compounding is education. If you go to our website what you'll find is that we really focus a lot on education. We do that in two ways. One is we actually offer continuing education twice a year for the naturopathic community, although nurse practitioners are able to get the Continuing Education Credits as well. We actually just had one on Saturday and LDN was a big topic because it is for most ailments. One of our topics uh was PANS and PANDAS which is predominantly a childhood situation where they get inflammation. Low dose naltrexone (LDN) is a treatment for that and one of our doctors, Dr. Sarah McAllister spoke on Saturday at this conference and brought up LDN. In addition to that we also make it a priority to offer education for our patients. Patients have access to our pharmacist. We have four pharmacists on staff each day. One of the things that we really pride ourselves on is making sure that if a patient calls and has a question that their questions are answered in real time. In addition to that, every prescription, before it goes out, gets a personal phone call from one of our pharmacists to counsel them and make sure that they understand what this medication is used for, how to properly take it and just ask any questions that they may have before that prescription goes out to them. 

Linda Elsegood: Education is key. I would say pharmacists, even though they’re busy people have more time to do the research than doctors do. You are the people that educate the doctors and do the hand-holding and explaining to the doctors. They are not experts in drug interactions. That's the job of the pharmacist. We find the pharmacies that spend the time on educating their doctors help so many patients because you get a new doctor on board. How many patients does that new doctor prescribe LDN for? Then that doctor meets up with other doctor friends and they invariably end up talking about problem cases. Then LDN comes up and it's easier for the pharmacist who deals with that doctor to mention LDN because of a light bulb moment. I was talking to a colleague who talked about LDN but I don't know much about it, I don't know how to prescribe it. Without the pharmacist being so well educated themselves about LDN they wouldn't be able to convert the doctors into LDN prescribers. 

Suzanne Rosenberg: I’m trying to convert doctors in Oregon. Oregon is kind of one of the meccas of alternative medicine. In Portland and in Oregon in general we have a lot of information. We have a really tight integrative community here and it's really neat to see. They teach each other, they're supportive of each other. It's a really neat place. I feel very fortunate that I get to practice in Portland, Oregon and in the northwest. It's a really special place. Especially as an integrative pharmacist. My entire pharmacy is an integrative pharmacy. Our model is different from some of the other compounding pharmacies in the city who I have a ton of respect for. Ours is different in the sense that a lot of the other compounding pharmacies will market to doctors who are more focused on allopathic. We do work with allopathic practitioners. We are the main compounding pharmacy for OHSU. Alll of their LDN from Oregon Health and Science University or at least most of it they have a tight relationship with us. Our model is different in the sense that we really only market and seek to educate alternative practitioners at this point. 

We are licensed all over the nation and I personally will travel. I have another woman, Holly, who also helps me. And we meet with naturopaths, functional medicine doctors, integrative practitioners, doctors who are interested in learning alternate ways of treatment. What we see as our role is to go out throughout the nation and meet with these doctors. That's really our focus. We work with doctors all over the nation. We actually will travel and we do what we call a lunch and learn. On our website you can actually go onto our website and there's a doctor portal on there. In that doctor portal you can actually request lunch and learn. We go and we sit and we meet with these doctors. We go over integrative products that we have. A lot of them have never heard of these formulas. Because we work so closely with the integrative practitioner group in the northwest we're actually creating formulas, including using LDN. We've been using a lot of LDN topically at Community Compounding. We have a formula now that we're really proud of that is a topical LDN for lichen sclerosis with some herbs in it, as well as, some hormones. We also use LDN topically when it comes to psoriasis and eczema. We use that in conjunction with a product called Ketotifen which is a mast cell stabilizer. What we do is we use LDN orally but we've also been utilizing a lot in our topical preparations. And we use a lot of integrative treatments for hair loss, skin conditions, gut, gut health and will intake different products and combine them for these new products that a lot of doctors haven't heard of because they're predominantly products that we've created with doctors in the northwest. It's really neat to go out and share these products with our doctors. All of this stuff actually is available in this doctor portal on our Community Compounding Pharmacy website; you'll find it. You will need to ask for access. My assistant will send you a code within 24 business hours. You'll have access to all of our prescription pads, all of our research articles that we have in there, and recommendations for treatments. 

I have a pamphlet about a talk that I had done in January in Hawaii for some naturopaths. It is is a little pamphlet of our top 20 formulas that our pharmacists love. Not all of them are things that we do every day but they're things that patients have come back to us and said, “Wow this really works.” Or they say, “A doctor says that formula is amazing.” Then they start telling their colleagues. That's a new thing that we just came out with a couple months ago. It was serendipitous. We didn't intentionally plan to put this together but I did it for a talk and handed it out to some doctors and they loved it. So now we have a list of the top 20 formulas that we wanted to share and we'll be adding to that regularly as things come up. A place to get a lot of information is on the doctor portal. 

Linda Elsegood: You mentioned Dr. Sarah McAllister, (you can put her name in YouTube you will see that I interviewed her many years ago. Maybe even as many as 15 years ago.) It's been a long time since I have spoken with her. She is a very nice young lady. 

Suzanne Rosenberg: She's amazing. Her talk was amazing. If anyone's interested in learning more about our talks you can go online. This one we just had recently, so in about two weeks the lecture will be available. If you're interested in learning or you know can't attend any of our webinars they are in person and they are also webinar based. You're more than welcome to visit our website. You don't need to log into the doctor portal and you can get access to these conferences. We do two conferences a year. Some of our other topics that we cover are women's health, Ehlers Danlos, mold, PANS and PANDAS. We had mitochondrial health on this last one. I would say at least 60 percent of our talks have LDN in those talks because it's so prevalent now in treating so many things. We've done a lot with the gut. We've had a lot of gut talks at these conferences. Another phenomenal naturopath in Portland, but you will see that in a lot of these treatments LDN is indicated for a lot of these patients. It is a hot topic not only in terms of autoimmune which is kind of what traditionally I would think of it being used for but now we're seeing it in so many other ways to support our immune system that is pretty much in every conference whether it's at every talk maybe sometimes women health not so much. It's a hot topic at our talks. 

Linda Elsegood: What about chronic pain and opioid addictions and people off of opioids? 

Suzanne Rosenberg: We have an amazing doctor in Portland who is a naturopath. She works at the pain clinic at OHSU. She's an amazing doctor, amazing naturopath, an amazing human being. We worked very closely with her and she prescribes two things. Well, several things through us. One of the main things she prescribes through us is LDN. She does a lot of our topical pain creams as well. We also do topical pain creams for patients who are in chronic pain and the goal is to get them off of their narcotics and switch them over to LDN. I just had a patient yesterday who actually this was this was an unusual patient this was a patient who was not seeing one of these doctors, but has done her own research and is starting on a really low dose of LDN and is working with a doctor who has basically been brought in through the patient request of prescribing LDN. So here's a doctor who knew very little about LDN and here's a patient who's educating their doctor on their own. These two came together and I was counseling the patient and she was really up on her LDN. There's a lot of information out there. It was really neat to see and she was telling me, “Yeah my doctor doesn't know a lot about it so she's going to help me you know. We're gonna do this together.” That is an unusual situation but we see that too. It was a really neat conversation. 

Linda Elsegood: Regarding women's health: Dr. Phil Boyle has been using LDN in his Fertility Clinic for 20 plus years now with great success. He also uses it for endometriosis, polycystic ovaries, painful periods, heavy periods, all these things that women have to endure is found to be very very helpful. 

Suzanne Rosenberg: This is also a phone call I had yesterday with a nurse practitioner. I was on the phone all day long as are my pharmacists. They are answering questions, coming up with formulas. We had a nurse practitioner call me yesterday. Again, someone I've known for 20 years and she has a patient who has severe pelvic floor pain. What we're doing for this patient is a formula. This particular patient had actually some inflammation. They had burning pain. We were doing a suppository for her. She has mast cell and we're doing cromolyn and she had already been on diphenhydramine and ketotifen which are antihistamines. I suggested that she adds some naltrexone to it. So we'll see what happens. These are the kind of formulas we're always thinking when we're having a situation where a patient is in pain and we're trying to oh wait, and put some lidocaine in there as well, um but when a patient is in pain and we're putting things together naltrexone is always something that I'm starting to incorporate into these products because I'm finding that we're getting great results. I mean the Lichen sclerosis formula has been a huge success for us and this was a formula that we had been playing around with for years. We've been working with glycyrrhiza which is licorice root, which is a common treatment for lichen sclerosis. There was a product on the market for many years that contained licorice root. This new formula that we've created is a combination of estriol, glyceriza, aloe and naltrexone and some vitamin E. It's a steroid free cream and we have been working and trying to find something that is steroid free for lichen sclerosis and this is really the first time that we're getting feedback from our doctors and our patients, our doctors primarily because you can see it. You know they try it on one patient, they try it again and they're calling me and saying what was that formula that I called in for lichen sclerosis? I need it for this patient because it works so well. That's kind of how we get our feedback. We're really excited to have that and I'm finding that when I'm creating formulas now I'm thinking a lot more of putting naltrexone in these formulas even if they're not for other areas of the body. 

Linda Elsegood: Your patients that use it for a dermatological condition, how long do you normally find it takes before they experience any improvement? 

Suzanne Rosenberg: We are at a disadvantage because we don’t have a lot of patient follow-up. Usually pharmacists hear really amazing things or we hear things when there's an issue. We don't get to see patients all the time so it's hard for me to say but I know there's a research study that PCCA did specifically on naltrexone in their zematop product for eczema. It is something that you can Google and it has some dates and some time frames. 

What we do for our eczema and psoriasis cream is we actually add ketotifen to it as well. So it's a combination of naltrexone, ketotifen in their zematop product. Typically if patients don't get results after a month they usually stop. Most of our patients are getting results within a couple weeks. I have spoken to lots of patients with skin conditions. They seem to be the people that take the longest to respond, to notice improvement. Some of them may take six months. They stick with it and it takes that long. A lot of these patients are on LDN orally so they'll be on LDN orally for a while and then we'll start the cream. They've already had the advantage of being on LDN. 

One of the things that I did want to share with you guys is that one of the things that we decided to do as a compounding pharmacy, especially post COVID, is our focus was really on becoming efficient. By that I mean having patients wait for their medications is no longer an option. We really wanted to make sure that efficiency was a priority of Community Compounding. One of the things that we did because we work very closely with the mast cell activation community in the northwest is we decided to start finding ways to have our turnaround time shortened. We really value our employees. They are making large batches of capsules and it is actually physically challenging. It's a lot of work. About six months ago, one of the things that we decided to do is we decided to invest in a tablet press and we are now pressing two drugs at Community Compounding. One of them being naltrexone. We are one of the few compounding pharmacies in the United States that is making low dose naltrexone tablets. Our low dose naltrexone tablets are a little different from some of the other compounding pharmacies because we work so closely with the mast cell activation community. We're very aware of allergens and food sensitivities and potential allergens for these patients. When you make a tablet you have to put a binder in there. A binder is something that holds it together and most binders are pretty inert unless you have mast cell activation or severe allergens. These patients can't tolerate many things including such things that you and I could tolerate easily. What we decided to do is we decided to not use any binders in our tablets. Our tablets only contain two ingredients. They contain a cellulose that we specifically use that is GMO free and allergen free. It's kosher. It's made from organic materials. The only other ingredient in our product is the drug. It is a GMO organic material, cellulose, called flow cell and naltrexone. If a patient is a vegan, if a patient is allergic to silicon dioxide (which is a very commonly used for most tablets), there's no issues with taking these tablets. The best part about these tablets is that they are scored. What happens with these tablets is they can be cut very easily. As you know most compounding pharmacies, including us, make naltrexone capsules which are great and we've been making them for 15 years. Of course capsules can't be accurately split. You can open one up and kind of guesstimate which we don't typically recommend as a pharmacist but it can be done. With these tablets you can use a pill cutter and we do recommend using a pill cutter because we use no binders. We press them really hard. So they're very hard. We do tell all of our patients that they will need a pill cutter. They can cut them right down the center so they know that they are getting 50 percent of that tablet. As an example, we only make three strands. We don't make a 1.5 because we make a one, a 3 and a 4.5. The one we make because we have so many patients who are super sensitive to medications, a lot of our patients will start on the 0.5 dose. It's not the most common but it's definitely common enough that it was something that we wanted to be able to offer this option. For the super sensitive patient you would use the one milligram tablet. You will have them cut that in half and start with a 0.5 and ramp up slowly to the desired 4.5 milligram dose or three milligram. Wherever they land. The three milligram tablet we made because that can be cut in half and they start with the 1.5 milligram tablet, half of that which is the 1.5. Half of the three and slowly ramp up to the 4.5 and then we do the 4.5 as the maintenance dose. What's really nice about it is that this saves patients a significant amount of money when they're using these tablets because as you know compounding pharmacies are very labor intensive. Any time that you can decrease labor in a compounding pharmacy what you're doing is you're significantly decreasing the labor dollars and then the goal is to be able to save the patient's money. The only way to do that as a compounding pharmacy is to decrease labor. What is important about it is that we have the same staff that we had here a year ago but people are working better not harder now. 

We now have an R&D team, which is a research and development team, that helps us when we have new products that we want to create and there's an issue with something, if we want to bring in a new base and we want to play with it, we have an entire team now who works on all these products. We have an IT team now. We just came up with a new IT team, where my staff in each department has their own IT specialist. The point that I'm trying to make is that as a result of the tablet machine and other ways that we've become more efficient we're actually a better compounding pharmacy. We are offering better customer service than ever. Our turnaround time is now one to two business days. I now have more time to go out and meet with doctors, educate, network and learn. The tablets are great for so many reasons. For the patients, for the pharmacy and for our ability to educate and really reach out to more people. We are really excited about these tablets and they've been a huge success for us. They've really been a great relationship builder, too. Doctors are able to use my local pharmacy for my estriol vaginal cream but also use Community Compounding for tablets and then we create these relationships. 

Now they have more pharmacies to network with if they have issues that come up with their patients. It could be that their compounding pharmacy doesn't carry a product that we carry and that happens often. Some things are expensive to carry and that creates new networks We work with other compounding pharmacies and share formulas and that has been a really nice way to network with doctors and our patients. 

Linda Elsegood: Can you tell people your website so that they can go and find out more about you. 

Suzanne Rosenberg: It is www.communitycmpd.com Or you can also type in Community Compounding Pharmacy in Oregon and you will find us. We are licensed in the whole west coast, most of the east coast. 

 

D

Today we're joined by pharmacist Dr Dawn Ipsen who's the owner of two pharmacies in Washington State, Kuslers Pharmacy and Clark Pharmacy. Could you tell us what it was that inspired you to become a pharmacist? 

I knew early on as a high schooler that I wanted to have a doctorate degree in something and was sort of a little bit torn between pharmacy and optometry and with long heartfelt discussions and soul-searching I became a pharmacist and very early on in my career not only was I trending towards being a pharmacist but I had an opportunity to intern at a compounding pharmacy and just absolutely completely fell in love. It was the art and the science and the way of being able to help individual patients in manner of which no other pharmacist in my area was able to do so, of providing very personalized therapies. I was able to really listen to patient needs and work with their doctors, to formulate the exact therapeutic tool that they needed to improve their quality of life. That is really what has driven me in my career. 

When did you open your first pharmacy? 

I had been a pharmacy compounding lab manager for about 10 years for the Kusler family. When they were ready to go do other things in their life I was given the opportunity to purchase Kusler's Compounding Pharmacy. It had been a pharmacy I had worked at as a staff member for 10 years and took over as the owner and I've now owned that pharmacy for almost 10 years. In January it will be 10 years. That was my first pharmacy. I was doing all my good work up at my Snohomish Pharmacy and suddenly had a random phone call on a Friday afternoon in which the Clark family was looking for a new owner for their pharmacy. They were ready to retire and go do other things as well. I've also owned Clark's Compounding Pharmacy down in Bellevue Washington for six years. I've been an owner for almost 10 years total and have had multiple locations now for about six years. We service not only the entire state of Washington but we also work within nine other states as well. Our boundaries go quite deep and it's a really great way to help all types of patients all over the nation. 

What would you say is the most popular form of LDN that you use the most? 

I would say primarily we use the most customized strengths of capsule formulations of low dose naltrexone (LDN). It gives patients really great consistency yet opportunity to get the doses titrated in appropriately where they need it to be. What's really great about how we approach our making of capsules: we use hypoallergenic fillers. We're also able to work specifically with patients who have sensitivities. We can customize what that filler might be and I think that's really what sets our pharmacies apart and why doctors and patients choose to work with us. We are experts in autoimmune and chronic inflammatory diseases and therefore we're very used to working with patients where the normal just isn't what they need and isn't what's best for them. We can customize that to be appropriate for them. Along with capsules of course, we are able to do transdermals. That's really popular in pediatrics, especially for patients with an autism spectrum disorder. We are able to make flavored liquid tinctures of it so patients are able to use various small doses to titrate up doses. We also make sublinguals. I would say capsules are pretty popular for us. 

What kind of fillers are you asked to use? 

Most of the time I will steer a patient towards microcrystalline cellulose (which is a tree-based cellulose). It is very hypoallergenic for a lot of patients. However, some patients know they have tree allergies and those patients primarily prefer rice flour. I do have a couple of patients, but very very rare, that actually do better on lactose filler. They tend to not be my autoimmune patients. They tend to be patients in the chronic pain spectrum area. We have also worked with other fillers, like tapioca flour. We can be very customized into our approach of how patients need it. I've got one patient that comes to mind that loves magnesium as their filler and that's very relaxing for their muscles. I've also seen probiotics being used. There is not one right answer to how we do things. We are that pharmacy that is able to have a conversation with a patient. We talk about what their needs are and customize it based on that approach. 

From the prescribers that you work with, do you have many consultants that you fill scripts for? 

We definitely do. That's also kind of a little side thing that I do. I've always been very passionate about teaching. I'm on faculty at University of Washington School of Pharmacy and also Bastyr University, which is one of the top naturopathic doctor schools in the nation. I teach there during summer quarter. I teach nationally to providers continuing ed-based content that is often LDN in nature, or ties into LDN. Especially with autoimmune and chronic pain and chronic inflammatory conditions. We consult a lot with doctors. I probably work with three or four hundred functional med type providers on any monthly basis, even on being able to customize therapies for their patients. We are really big in the post-COVID syndrome arena of helping patients that are really struggling and LDN. We're finding it pairing quite nicely in that condition as it's very inflammatory based. We work quite heavily within the MCAS arena for patients who have a lot of mast cell instability and need other therapies. LDN is one of the tools that is used quite frequently by those types of providers and for those specific kinds of patients. 

Do you work with any pain specialists, dermatologists, rheumatologists, gastroenterologists? 

We do. Honestly, I’m quite proud of our little Seattle area of Washington because we do have MDs that are pain specialists that are now really turning towards using LDN in their toolbox of things they have available for patients. They're getting quite savvy at it. They're doing a really great job. It is super exciting. I have some dermatologists. I consult a lot with my functional med providers that are seeing dermatology conditions like psoriasis. I have an email I need to work with a doctor on after this to help them with this patient with a psoriasis case. We are seeing it in the GI world as well for Crohn's and irritable bowel disorder. Those chronic inflammatory conditions. I would say the MD pain specialists are really turning around over here. Obviously with the opiate crisis that has occurred in our nation I think most doctors of any type of credentialing or medical training or experience are quite interested in what LDN is doing for their communities and what opportunities it affords for patients who are trying to make sure they aren’t addicted to opiates but yet have something to improve quality of life and their day-to-day living. Low dose naltrexone has been an amazing tool for that. 

I'm always excited to meet different LDN prescribers and nurse practitioners who are providing lots of scripts. When you get an MD or a DO that is prescribing LDN and it is completely out of their comfort zone, I always think yes, you know we've got another one on board. We're making it right. We're getting it. MDs are already working outside of the box. That is normal for them to look into LDN; it's not normal for MDs to look at LDN but as you know, I've interviewed so many people and so many MDs when they have a patient that they can't help, and fix their issues. They've tried everything and they feel as if they've failed this patient, and then they try LDN. Once they have had amazing results with the first person it's then so easy for them to look into prescribing, not only for other patients with that condition but for any autoimmune disease, chronic pain, mental health, etc. 

I mean it's really amazing and this is where people like yourself come into play. The hand-holding with doctors because a lot of them haven't got time to do the homework. They're very busy and they need somebody to tell them exactly what it is, how to prescribe it, what to look for, what to do and have somebody on hand to say, like you said, I've got a patient with psoriasis. What do I do? Can you help me? That is the way to get more doctors involved is the pharmacist doing the hand holding. 

There is a local psychiatrist in our area that works with younger adults with substance abuse disorders and teenagers that are having a lot of trouble with mental health. I had an opportunity to get him thinking about LDN and his patient population. I love when I get to reconnect with him every few months because he just raves He finally has a tool that actually does something. He felt the antidepressants and all these other things were not really fixing any of the issues or fixing the symptomatology. We still have the same abuse issues, we still have the same addiction issues and we still have the same levels of depression and suicide risk. But with LDN he's finding that he's actually causing positive change in his patient population, and that's the only thing he really changed within his practice. We're really affecting the health of our community in a very positive manner with something that's really safe and low risk and not expensive. It doesn't get any better than that. It's the best compliment I could ever have. 

It's really nice when patients take all their information to the doctor. Once you've got a doctor really hooked on prescribing LDN they can change the lives of hundreds of patients. Dr Phil Boyle uses LDN in his fertility clinic. He also uses it in women's health for things like endometriosis, polycystic ovary, painful periods, heavy periods. Right across the board he uses LDN. He gets patients coming to see him with women's health problems who also have Hashimoto's or long COVID etc. I refer to his work all the time. He gets questions a lot from local providers such as we have somebody who wants to become pregnant, or they did become pregnant and they're on LDN and they want to know what the standard of care is and can we continue, and what's the risk and benefit are. It is so great to have providers like him out there that have been doing this work for so long that we can very confidently share those case experiences and history of using the medication long term for those patients. 

There have been so many of our members who were skeptical about using LDN during pregnancy. Doctor Boyle is always very generous with his time. I will send him details and he will answer the patient and share his experience. You know we used it once up until birth rather and breastfeeding, etc. We have those people who have done two or three pregnancies using LDN who are happy to talk to other people. This is my experience with 20 years as the charity next year, which is totally amazing, but I’ve found that word of mouth and with the education it is just spreading. 

Linda, you've done an amazing job with the LDN Research Trust and I thank you for that. You have made the Research Trust, its website, resources and its books into a trusted referral point that I can use with our doctors and our patients who are wanting that next level of information beyond what I'm able to say to them. They want to go see those studies themselves. They want to go read the book themselves and I know that without a doubt I can send them to your resources for them to receive complete in-depth and correct information. Thank you Linda. You're doing amazing things and this is all because of you. 

How can people contact you? 

We have two locations in Washington State. We have Kusler's Compounding Pharmacy in Snohomish Washington and the website there is www.Kuslers.com; and then we have Clarks Compounding Pharmacy in Bellevue Washington. That website is www.clarkspharmacywa.com. The WA stands for Washington. We are happy to help patients all over and talk with doctors that need guidance and assistance in learning more. I love being an educator and I love being here to support my community. 
 

 

Welcome to the LDN Radio Show brought to you by the LDN Research Trust. I'm your host Linda Elsegood. Today we're joined by Ray Solano from PD Labs. He's also a nutritionist. Could you tell us a bit of background about yourself?

 I am dedicated to getting out the word on personalized medications. We have a specialty pharmacy located in Cedar Park, Texas that's north of Austin, Texas. We focus on being able to help people in the community who have mold and Lyme conditions and autism so they can get special medications in the right dose for them. We have a full-size clinic, that lifestyle medicine clinic as well, to really be able to help people learn their nutrition balance as well. We're located in 48 states and soon to be in our brand-new facility here in Cedar Park. It is a 7,500 square foot building that will be able to grow with the community, to service them, because personalized medicine is going to be here to stay.

Wonderful. So what got you into pharmacy? 

Fortunately I've been involved in pharmacy since the early 70s. I have been able to really take medicine to a different level. l have a background in nuclear pharmacy, a very advanced technology at the time, and found my way back into compounding pharmacy over about 25 years ago, and realized that traditional medications are just not going to be able to serve people the way they're supposed to. Medications have to be personalized. Different forms, different dosage forms, different routes of administration. Previously I did a lot of sterile compounding. It is important for people to get better as opposed to just taking 15 or 16 different medications a day. Can you believe that some people still take that many medications? This is the reason why we started to be able to do this. We very recently expanded. We've merged with Hopkinton Drug, who's really been one of the leaders in low dose naltrexone for years. We merged our companies together and are able to give first class service and quality to all the patients nationwide. 

You were saying about people taking 16 drugs. I've known many people who start off with two or three and then they would take the fourth medication and of course every drug carries a list of potential side effects. You probably will never get any of them or you might get one or two of these side effects, but when you start putting a cocktail of medication together, the chances of getting a side effect becomes higher. 

I know many people who have taken four or five, and then they have to take another medication to combat the side effects. As the number grows, then they're taking like seven or eight; they take another medication because they've got more side effects. It's really not helpful for the patient to continue down this route. Not only that but they still don't get the wellness they're looking for. Sometimes they get worse. 

Unfortunately their core metabolism just becomes nutrient deficient. Their core levels of metabolic rate decreases. They gain weight and their self-image goes down. They're also finding out that their ability in energy level decreases. Unfortunately we usually have a shell of a person. It is unfortunate but you know the worst part about it is there's no end in sight. This is why many times we get to the root cause of the problem and this is many times what we're finding in low dose naltrexone is a good starting point because then they can start to corral some of the problems and get people off of some of these medications. 

This has done an amazing thing in the pain community and the chronic alcohol community. It is just amazing when we start to unravel all of these chronic conditions of how we start with this therapy and we're able to really change people's lives. It also helps people wean off of opioids. It is a really big thing. 

What doses do you go down to? 

We go down to as low as one microgram. We were a sterile pharmacy so we can do micro dosing. We do a lot of vasoactive intestinal peptide as well. We are used to micrograms as well. Low doses are something we're familiar with. One of the things that we have done that's unique is being able to take these doses and be able to make a special tablet. It is the pharmaceutical industry that uses these ingredients, but they call a cyclodextrins to be able to enhance absorption through the cell walls for these pharmaceuticals take these large molecules and give them a little bit of it an accelerator for the body to absorb them. We use these beta cyclodextrins and we make them into a special tablets so that patients could be able to change the dosage for themselves. Being able to get to the drug we get the right amount of drug and have the least amount of side effects. You know many times when people take low dose naltrexone they start in one dosage form, in a capsule form. Usually sometimes 0.25 milligrams or a 0.1 milligram, and then they have to titer their way up, and then have to get another prescription. They have to get a different strength. This is a way that people to take a half of a tablet and get started and then be able to use the full dose three four weeks from now. It ends up being less expensive for the patient. 

Special technology is making tablets, which is a specialty in itself. We feel that we’ve been doing it for the last 10 years and we were able to really make a difference in getting the best therapy tablet for patients. 

Can you do a sublingual LDN? 

Yes, we can do sublingual drops. We've been doing that for patients, especially children and some of our seniors. Being able to master all these dosage forms for patients is something that specialty pharmacies are able to offer for patients. Sublingual tablets, sublingual drops or something that is very important for many people. 

Dr Jill Smith discovered with her Crohn's patient that taking sublingual drops, that it was absorbed, bypassing the stomach. It was more effective for those patients. There are other patients now that are choosing the sublingual. We find that sublingual is more expensive in the UK. I don't know whether different dosage forms at your pharmacy are more expensive than others. 

We are specialists in these sublingual tablets. We've been doing oxytocin sublingual for many years, and being able to use these tablet forms and to able to change up the bases that are absorbed, special ones, sublingually is very easy to do. It's not really more expensive at all, not that I have seen. Sublingual routes and nasal sprays are just a great way to bypass the stomach, because many of these patients are having a very difficult time absorbing. We use the special tablets, they get absorbed sometimes much better than capsules. 

Do you find the nasal spray helps with dry eye? 

We haven't seen very much of that. We definitely think that nasal sprays bypass the blood-brain barrier with special additives. They get absorbed so much faster. Unfortunately we haven't seen a huge increase of that here in the US yet. It is something that we're going to be promoting. because there are so many patients who would like the LDN eye drops. but because they have to be made in a sterile facility they have to be made per patient. There's not a shelf life on them. They are probably expensive, too. It makes the unit price exorbitantly expensive 

I've yet to find out myself and I've not ever tried any LDN nasal spray. and I suffer with dry eye that the nasal spray possibly could help the dry eye because it goes up the canal. 

We've made low dose naltrexone nasal spray in combination with ginsenoside R3. It's a special neural regenerative compound to stop the combination of brain inflammation. We've done a combination of those and launched that about two years ago. We have the experience to be able to do LDN nasal sprays. It's a very stable compound. It's very easy to work with. It has good dating for patients so it's something that they can be able to put in the refrigerator and be able to hold on to it for many months. That makes it economical as well which is important. Sometimes these medications can get quite expensive. 

What would the shelf life be on nasal spray be if you kept it in the refrigerator? 

Many of the regulatory law requires studies to be able to give the dating information, but we have found that at least 30 days is a minimum. We're looking at expanding that to 90 days stability. It's something that we're looking forward to. 

One of the things I didn't mention is the topical form of low dose naltrexone for many different dermatological conditions. Conditions such as eczema and psoriasis. It is a perfect additive of oral and topical as well. It's very stable. It's really important to get to the right pharmacy that understands the correct technology of being able to get penetration through that dermis skin layer. That's something we've really worked on extensively and looked to have tremendous results. I have spoken to dermatologists and pharmacists to compound LDN in topical as well as the capsules or tablets. Some doctors use both in conjunction with each other. For some conditions they prefer that people just take oral. 

The doctors that you deal with, what would you say is the most common for dermatological? 

We have a special relationship with our practitioners. It's a collaborative practice. We look at the patient to see what's best for them. We look at a case-by-case basis and they ask our opinion what's the best choice for the patients. Many times, by the time they come to us, these people, the patients, have conditions that have been ignored by many years. We'd like to be able to be aggressive at first. We recommend a combination therapy initially because it seems that they can turn it around much quicker as well. I found speaking to patients who take it for let's say psoriasis, alopecia, Behçet's syndrome, Hailey-Hailey disease to name a few, that the dermatological conditions take longer to respond than autoimmune conditions as in Crohn's disease or MS, chronic fatigue. It seems as though it needs to get into the system for quite a few months. Sometimes it takes six months. 

People have told me before that they have reverse of symptoms. Have you found that to be true? 

Yes, it is really important to be able to have the technology to get past the dermis layers. PD Labs has really started a patented process for the use of transdermal Verapamil for Peyronie's and planters fibromatosis and Dupuytren's contracture. They are all the same fibrotic tissue disorders. We've really been able to perfect the absorption across many types of different layers of subcutaneous tissue to be able to get localized absorption at the source. We've been able to take LDN and put it with transdermal Verapamil for Dupuytren's. We find it to be incredible at how fast it works. It’s important to get the right condition to have the right special base that gets absorbed and penetrates, and there's a number of different products out there that have special qualities that can get very quick absorption. It's really important because you don't want people to suffer. You want them to be able to get quick absorption. Unfortunately many of these special bases can be a little bit pricey because they're very proprietary and they're very unique. You're pushing the limits of transdermal absorption that almost rivals the fast blood levels like an injection. To be able to get people turned around quickly we find that these patients do so much better with being able to target that area very quickly because you don't want to suffer for six months at a time. 

If somebody had alopecia would they have to rub the preparation on their scalp as well as taking it orally? 

That's what we recommend. We use a combination therapy because we're able to get blood levels quicker. All these topical conditions are usually linked to gut dysbiosis and many other conditions that ultimately are able to express themselves as a skin condition. Any type of skin condition we're looking to repair the gut first. We have a number of different peptides that are used to be able to repair the gut as well. Once we are able to do that the skin heals so much faster and that's why it's so important to do both. 

Would rubbing something in your hair which makes it greasy and then that makes you want to wash your hair more be beneficial? 

No, it doesn't have to be greasy. There's cosmetically appealing lotions that we do a lot with patients' hair. They don't have to be oily. They have to be somewhat moisturizing to the skin and not drying the scalp. You can get absorption and have that smooth cosmetic feel, because nobody wants to put on something makes their hair look greasy, especially women. There's no way we're going to be able to tell them that your hair is going to look greasy. They just won't do it. Because then you'd want to wash your hair, which would be pointless of putting it on if you're then going to wash it off. There's ways to do it, and you know, it's really important when you partner with a pharmacy who has a can-do attitude and has a big tool chest. 

What are the tools that we have available? We've got a number of consultants that work for us and we've got a number of patented medications under our corporate umbrella. So we're very fortunate that we keep on digging until we can find a solution. 

Does PD Labs make their own supplements? 

Due to regulatory compliance, we don't really make them ourselves. We design them and have a special dietary supplement manufacturer strategic partner that will fulfill, make those to our custom specifications. Many times we're able legally to put a prescription drug with some of these nutritionals so they can combine them together. Many times what we do is take nutritionals and combine them with the specialty FDA approved drugs to be able to solve many of these conditions. Many times we find things like traumatic brain injuries and stroke and many of these patients that we're able to target medications using this type of therapy. 

It is really important to look at the whole body and look at the whole patient because they didn't get sick overnight and it’s going to take some time to get them well. We put a little sprinkle, a little fertilizer, at the same time. 

When you make your tablets do you do capsules as well? 

We do capsules. We do lots of capsules. 

Are you able to put nutritional supplements in those if the patient wants ginger for example. I know some people request magnesium or whatever. Are you able to do that for them or offer advice on which you think is the best? 

We do. We've got a lot of requests for items when people feel that they are having a reaction to the fillers. Many times what we find is that the body is having an over expression of histamine. Many times this over-expression of histamine is due to a metabolic imbalance that is occurring because the body's mesenchymal immune system is offline. If we can turn those systems back on, then their histamine levels or responses are normalized. It's sometimes not the small little filler that's in the capsules that is causing their problems. It's the whole body's over-amount of histamine. We're just sometimes really careful you know, because the absorption of ginger, let's say we put ginger in with LDN, do we know how much LDN is getting absorbed? Or maybe that the problem is that if the dose is too high, then they're going to get some of those same side effects. It could be the dose needs to be decreased, so that we can really modulate those side effects. I find many people feel it's almost a sign of defeat that they have to go backward in the dosing. After listening to many of your lectures it's usually that the dose is too high. 

As you said at the beginning, personalized medicine is what suits that person. Some people have it in their mind they need to be taking 4.5 milligrams. They think they have got to get to 4.5. They will think they did so well on two and a half and then went to three and didn't feel quite as good and now they feel terrible. So they think they have to stop taking it because it doesn't work for them. If on two and a half you felt wonderful then it appears that was probably the right dose for you. You should go back and see how you feel on 2.5. It's not that you're giving in. It's not a case that you've failed to reach the 4.5, you should celebrate the fact that you found the dose that works for you. 

We found that many times people are taking capsules and when they switch over to tablets they say they felt so much better on the tablets or sometimes they say I feel worse with the tablets than the capsules. We have found many people get much more positive effects at one and a half milligrams and two milligrams as opposed to 4.5 milligrams. Sometimes there's kind of a bell curve that sometimes the 4.5 milligram is something that is not really the standard. It should be maybe one and a half milligram. It should be more of a standard because we only want the body to have just as much drug as it needs. Low-dose sometimes is better than higher dose. That's what we found.

It was really interesting talking to you. Can you tell people how can they get in touch with you? 

Yes, we have a website: PD Labs that's Paul David Lives, pdlabsrx.com. You'll find a huge amount of information on LDN and all the other specialty pharmaceuticals that we do. We've got a podcast and also our TV spots. We make it very easy for people. Our phone number is 888-909-0110. We're in the continental US right now. We're looking to see how we can do this internationally, but as you well know there's a number of customs and hoops we have to go through. We're not giving up on it. 

Well thank you very much for being our guest today. 

 

 

Welcome to the LDN Radio Show brought to you by the LDN Research Trust. I'm your host Linda Elsegood. 

Dr Steve Zielinski is here today. Can you tell us who are you? What made you decide you wanted to be a pharmacist? 

I wanted to be a pharmacist because my dad was a pharmacist, and I liked it when he'd take me to work when I was a kid. I got to see him work and how he helped people. People really appreciated it. I wanted to do the same thing. 

How did you get into compounding? 

When I was in pharmacy school we were learning how to make stuff in the lab, and I was interested in making stuff. I like to cook a little bit, and compounding was just like cooking to me. That is what got me into compounding. 

Could you tell us what forms you make of LDN? 

We buy it as a bulk powder and we can make it into anything essentially. The forms of LDN we typically make are capsules, which are pretty standard. We also do a troche and we do a liquid, like an oral solution. Now we're working on transmucosal films. Those are films that you can put on the inside of your gum and it gets absorbed through the cheek. Some people complain about the troche taking a long time to dissolve and having to sit under their tongue for a long period of time. One of the things that we've started to learn to make are films that go on the inside of your gum or on the inside of your lip, almost like chew or something similar. It then gets absorbed through the skin. 

Did you learn about LDN in pharmacy school? 

I learned about naltrexone in pharmacy school. I heard it was great at 50 milligrams for treating alcohol and drug dependencies. I never learned about it at the doses that I'm using it for or the conditions that we're seeing it be beneficial for in pharmacy school. 

So how did you hear about LDN? 

Being a compounding pharmacy people would ask me, "Hey do you make low dose naltrexone?" That’s how I heard about it a lot of times. I often hear about things from other people that are wanting to learn more about it. Then it makes me learn more about it; or I get stuck in a position where I need to learn more about it because I don't know much about it, to be honest. I definitely don't claim to know everything about pharmacy, or medicine, or drugs, but when I get a question and I want to find out the answer I go and look it up. That's what I did. That's how I got started with low dose naltrexone. 

How long ago was that? 

I want to say close to five years ago. People were coming in looking for it for different conditions, and specifically pain, and I suggested this because it is low dose, not habit forming. I thought I'd give it a shot for somebody. We did and it worked. 

How many patients do you think you have on low dose naltrexone right now? 

Probably about 30 or so patients on it. 

How many doctors are sending scripts to you? 

About 10 or 11 right now. 

If you have 10 or 11 then they haven't got many patients each on LDN. What would you say is the stumbling block for them not to prescribe it more widely? 

I don't think they're aware of all the different things it can be used for. I think that's the biggest issue. I think the biggest stumbling blocks are having a good understanding of it for what they could be using it for, and then I think another stumbling block is the dosing of the medication. There's not a package insert that comes with this like there is for every other medication. You can't look this little drug up in the Physician Desk Reference and see how you prescribe low dose naltrexone. 

That's not there, but you know if you look up naltrexone, you're going to see a 50 milligrams dose and how to use it, but you're not going to see the different doses that could be used for in a different dosage forms. That's available from a compounding pharmacy. I think that's one of the hindrances that we see with this medication being prescribed. 

Did you know the LDN Research Trusts have three guides on our website. 

Those are great references that I'd love to make available to the prescribers that I work with. 

It's on the LDN Research Trust.org website under resources called LDN Guides that might be a benefit to you and your doctors. Many pharmacists that have been doing LDN for many years will have a seminar in their pharmacy and have an evening where they invite doctors to come. You give them a presentation and explain it to them.
Can you explain what conditions LDN could be used for treatment? Pick a couple and give some case studies. Tell them that you are available to answer their questions. I'm sure there are thousands of people in your area who have either chronic pain, mental health issues, autoimmune disease or cancer. The number of people you know that could be using LDN is endless. Anybody who's in your area who would like to help you expand the client database to get more doctors prescribing LDN in your area would be amazing. It would be great to see yourself grow. 

I think we end up using it as an option a lot of times when other things fail. I think that's how we get people started on it for the most part. The most interesting one has been with hair loss post COVID. I think it has been really interesting to see when people have been having their hair falling out. Whether it's from having COVID or exposed to COVID or don’t know what it is, I don't know the diagnosis but we try treating hair loss and nothing's working and then we try low dose naltrexone and it works. It has been a new one for me. 

Having COVID happen and the pandemic and everything has been a springboard for low dose naltrexone because LDN works so really well for long COVID. There are two chapters in the LDN Book Three that address long COVID, and you can hear Professor Angus Dalgleish saying that he's a cancer oncologist. He also is a virologist. He treats people with long COVID and he says that it should be a first line of treatment because patients do so well on LDN. He said some people have said it's placebo and that there's nothing to this treatment. He says that once they stop LDN all their symptoms come back. When they restart the symptoms go away. You then know it can't be placebo. It should be a first line of treatment. When people have COVID, you know they are worried about getting long COVID. They should take LDN. It really a game changer for them. There are people who have had chronic fatigue for years. Years ago they were dismissed as being imaginary or told it's depression. There is nothing wrong with you. Deal with it. Now COVID has come along and some have similar symptoms and all these people are saying who've got long COVID. Fatigue is terrible. It's absolutely awful and that's been around for a long time. People who had it were not believed. I think it is going to raise awareness that will help people with chronic fatigue syndrome. People recognize it as a condition and not just an imaginary condition. 

You said with chronic pain, are people using it to wean off of opioids? Are they using it once they're off the opioids? What I'm trying to say is, are you using micro-dosing LDN alongside of opioids to get patients off the opioids? 

Yes and it's really interesting to see because there's a lot of hesitation and nervousness by the prescribers to do that, because but it's such a low dose that you can wean somebody off of opioids and morphine with it. We've been successful with it and it's been pretty neat, because when you're dealing with long-term chronic pain, to use something that doesn't cause you the side effects, constipation and things like that, on top of the opioid addiction. It's pretty nice to have that in your in your toolbox as not every doctor has that, because they have that tool in their toolbox they could use, but they hesitate because of not understanding how low dose naltrexone is going to work in combination with a stronger pain medication like an opioid. It always amazes me that there are people who have had chronic pain for 20 years and they have taken the highest dose of Oxycodone, they then have another fentanyl patch put on and they end up with this cocktail of pain medication. They have to take other medications to combat the side effects that these medications have caused and their pain is still a nine to a ten every day. This time they can't come off those pain medications. They're addicted to them, although they're not working and my understanding being non-medical that these high doses of pain medications are very bad for your organs. They are damaging themselves at the same time as it's not working. 

To actually take a micro dose alongside of those medications where you don't have to reduce the dose initially everything stays the same. You're not going to go through withdrawal. You're not going to feel your security blanket has been taken away from you, but it does make the opioids you're on more effective. That means you can titrate the opioids down while titrating up the naltrexone and people come off it and I'm happy when people say for 20 years they've suffered. They've come off the opioids. They didn't go through withdrawal. People say that they feel no pain anymore but some will say I still have pain but it's a three or a four and I know it's there but it doesn't stop me from carrying on to live a normal life. I can still achieve what I want to achieve. The pain isn't stopping me and I think from the LDN point of view that is just totally mind-blowing because you think of these opioids as being like a sledgehammer. The LDN being a feather, you think how can it properly be effective but you've seen it too. I have seen it and I think it's really very interesting because people don't just come off of their opiates when they go on LDN. 

That's where they start. They start coming off of their pain medications with the hardest ones first but then the longer and longer they stay on the low dose naltrexone more things can start falling off after that as well. It's really interesting to see the same doctors that are hesitant to start the low dose naltrexone for people on chronic pain medications to be the ones that would be the one recommending that and not the next pain medication. I had a patient that was on a morphine equivalent and maybe an oxycodone or Oxycontin or something like that at the same time for chronic pain and it wasn't going away and he was on there for about two years and then something about nerve pain was mentioned and neuropathy. I had recommended using low dose naltrexone and he used it and then the doctor started titrating the doses of these medications away and it wasn't just those two it was also other things. There was Topamax for pain that wasn't needed anymore. You're not just relieving a couple of medications, it's a lot of medications. It starts with a couple and we titrated it up slowly at the same time of weaning them off of one of the pain medications. Then once he was comfortable without one of the pain medications then he learned that he could also stop a second pain medication. This was a period of maybe six to eight months and over six to eight months that he was opioid free. No morphine, no opiates. Strictly just using low dose naltrexone with other muscle relaxants as well. Then a year later or two years after that he was even able to stop some of those. It's not just stopping opiates it's stopping other medications as well. 

I know some people who had fibromyalgia or who have fibromyalgia who were taking like 14 different medications a day and some of them have got down to just taking two or three including LDN. That has to be better for your system. The less medication you're putting in your body the better. Obviously medications are important when your body isn't working correctly and you are in a lot of pain. Sometimes if the necessary evil is but I think it's a good starting point to see what alternative dosage forms and treatments can do. I think that's what I really like about it is because I kind of play and not play, but I kind of work in a pharmacy where I'm doing both nutrient depletion compounding and traditional medicine. It's not one side or the other, but how do you use them both together, and I think when you can use something that can get an effect that the doctor wasn't aware about, or wasn't completely knowledgeable about, and it works, it starts getting people interested in their own health and seeing what else is out there. I think that's the best thing about low dose naltrexone. It's one of those things that does just that because it's okay what is possible because my pain was forever and now it's gone. I had to use these opiates forever and now I don't. Once you do this and they get that X they get exposed to that then they start taking their health in their own hands. 

The favorite part of this drug is people start taking control of their own health. They can bring questions and stuff, but ultimately they take control of their health back in their own hands. Doctors if they were listening to you and work out, I think that's something we do well is we only have about 30 to 35 people. I think low dose naltrexone, but I think that's one thing we do is we run into all those stumbling blocks, those challenges. We can make the recommendation that they should do it but it's something that their doctor ultimately has to make the decision on, and so we try to equip them, to empower them to have the right information in their hands. This is where it's worked before. How can I start trying this or how can I take this step? I think that's what we do pretty well. Not with just low dose naltrexone, but all medications. If a patient has a high blood pressure and they're not sure which medication is causing it, maybe they have two or three different blood pressure medications, pharmacists are in a great position to be the advocate of saying talk to your doctor about this blood pressure medication and see all the time these medications have a risk and reward. If a medication has more risk or more downside than the actual benefit but low dose naltrexone there is a lot of good literature out there. Whether it's a case study or a larger study on multiple people or case reports or controlled trials they're out there. The data's out there. There's plenty of evidence to support using it to where it's still evidence-based medicine that we're practicing. 
 

 

 

Welcome to the LDN Radio Show brought to you by the LDN Research Trust. I'm your host Linda Elsegood. I have an exciting lineup of guest speakers who are LDN experts in their field. We will be discussing low dose naltrexone and its many uses in autoimmune diseases, cancers, etc. Thank you for joining us. 

Today we're joined by clinical pharmacist Sebastian Dennison from PCCA. Thank you for joining us today Sebastian. 

Thank you so much for having me. Can you tell us about your role in the PCCA and how that involves LDN? 

PCCA is a company that helps compounding pharmacists realize the needs of individual patients by providing education training, as well as, components for compounding everything from equipment to specialized bases to specific bulk active pharmaceutical ingredients AKA drugs so to speak. 

As a clinical pharmacist my role is to consult with both technicians and pharmacists when they're faced with problems that they haven't seen before. PCCA has evolved over the last 40 years of their existence as well as our role as clinical pharmacists. We're now doing a lot more external education events, working with providers and external education providers. The LDN Research Trust is a brilliant organization and because we are the ones who are pharmacists compounding LDN we're getting more and more questions on it. 

In about 2014, 2015 I was given the role of educating a lot of our members on the evolving and emerging uses of naltrexone. It grew from there obviously because as I learned more I got more and more excited about it. I realized that there was a lot more to this fancy little molecule than what we had previously known and we're still learning every day.

What would you say are the main topics that you give when you're educating pharmacists as in conditions? 

I guess I always have to go back to my own understanding of most diseases. I have to understand the underpinnings of the pathophysiology and the drivers of disease before I can understand how any drug or any sort of therapy will have a positive intervention. This goes back to something called structure activity relationships. This is the bread and butter of pharmacy. If we understand how a drug works in a set receptor or receptor families we understand how that drug will impact the disease long term. 

Understanding both the disease pathophysiology and understanding how the drugs work give us insight and so what's changed is as we understand that naltrexone has more and more receptors that it works in and more specifically at this sort of very subtle dosing in the LDN and very low dose world. We understand how it can have differential benefits in these patients and so it used to be in the the late 90s it was MS, fibromyalgia and migraine. It has since turned into so much more. The big ones that I see right now are pain, inflammation, arthritis, fibromyalgia, MS, autoimmune disorders and now we're starting to touch upon things like anti-aging uses, mental health issues, adjunct care to other disease states and you know the big ones. Cancer is becoming huge. Dermatology it's enormous. More recently some new evolving uses that I've been discussing for a couple of years and a couple that I'm really excited to be presenting in the upcoming conference.

We had a fantastic presentation last week. I believe it was from a colleague of yours, Nat Jones, on Dermatology. It was a very good presentation, and we've also had a presentation from you as well. What would you say if a patient or a pharmacist says that they've got a patient who is really skeptical about trying LDN and he's worried what effects it would have on them? People who haven't really done the homework and don't really know the ins and outs of the LDN how would you get the pharmacists to address that?

The part of my role, because it's a clinical role, and ensuring patient safety is a priority, that always goes hand in hand with pharmacy ,but in the compounding world there seems to be this lack of information because we may be new to using many molecules in new and interesting ways. That's part and parcel of what we always do, is we look at safety. We look at information that's available and we also look at side effect profiles. 

There is a saying that you get in pharmacy school, no side effect, no effect. Dosing appropriately for the patient to avoid any side effects and to avoid harm. Those are the two crucial pieces that you have to start with when counseling any patient or any person who's thinking about low dose naltrexone. The scope of health has to be made aware of the safety profile. 

There was a brilliant paper that was published in 2019. The author was Bolton He discusses the side effect profile of this all-inclusive retrospective analysis and they had almost 11,000 plus patients and they were looking at it and saying that the side effect profile is very similar to that of placebo. Which is really an interesting piece because placebo effect is very common. Headache, tinnitus, nausea, vomiting, diarrhea. We actually use that as an indication that the patient is getting too much of something. This is actually part and parcel of a dosing discussion that I'll be having in a couple of weeks with the LDN Research Trust is understanding how dosing has to be much more nuanced and much more specific. 

We do have to look at starting low, going slow, titrating to a patient response. The difficulty with low dose naltrexone is giving a patient a stable dose. It may take up to eight weeks to see a benefit fully to realize just how much the patient has changed. We know by the side effect profile very quickly whether or not we're giving them too much or things are going the wrong direction. An exacerbation of their symptoms or a worsening of their symptoms or I'm getting headaches that I didn't get or my sleep disturbances are so bad I just can't sleep at night. 

Those are all signs like I'm giving too much; as a clinician and I can decrease the dose. One of the biggest problems that we see is with providers they’re thinking some is good more must be better. They do this very regressive increasing of dose and I think that's the part where we really have to focus on in the low dose naltrexone world is lower doses starting lower titrating more individually because what we're starting to see with this proliferation of use is much wider dosing parameters and we're seeing doses go all the way up to 12 to 15 milligrams in some patients and as low as 0.1 milligram and others. We don't know until we start with the patient. The last thing any of us ever want to do is see a patient come to harm or or have any negative consequence because they're already sick and they're already having problems. This is why part of my job is convincing people to start at a lower dose and titrate a little bit slower. Just to make sure that we don't go past their need point and help have the patient give us that feedback. 

That's one of the nice things about naltrexone is there is an incredibly wide safety margin. I think there's information out there where we have patients at 150 milligrams as a chronic ongoing dose for other purposes and high-dose naltrexone so to speak. Alcohol use disorders where they're taking 150 to 300 milligrams in a day. Low dose world isn't a concern of toxicity or harm. It's more not getting the right immunological modulatory response. That's the discussion and there is actually a case study where a patient ended up taking almost a whole bottle in one sitting. They were fine. They felt pretty chummy for about 24 hours but we're talking about 50 milligram tablets that I consumed, quite a few of those tablets. Our worry about harm is mitigated on the fact that we have much higher doses that are used for regular dosing naltrexone and most patients respond very favorably once we start initiating and when we see a, “Oh I don't feel right or it's getting worse,” that's usually a sign of too much. It's not going to harm you but we don't want to miss the nice response of LDN. That's the beauty of this drug. We can say to patients very comfortably, “Well the harm in trying is very minimal.” It's actually no physical harm or there's no consequence to the patient other than it may not work, as opposed to some drugs. If it doesn't work you may have some serious side effects and that we are very aware of. The discussion is very useful with other clinicians because in pharmacy, as well as, in medicine and any sort of healthcare provider is the risk has to be balanced against the benefit for the patient. When you're talking about a drug that has very minimal side effect profile especially the doses we're talking about with very small steps forward, it's a very favorable risk-benefit ratio, so to speak. Lots of benefit participation, very little risk. 

There you go in a nutshell. I mean some people, not myself, I must admit when you get medication from the doctors, not compounded, you know off the shelf, there is a leaflet inside telling you how to take it, when to take it, possible side effects, all that kind of thing. You don't get that with LDN and some people would like more information.

There is this great website you can go to, the LDN Research Trust. They have some resources there like a recent dosing guide. There is a list that we're suggesting, and I've been an advocate for this for a long time. I love the fact that the LDN Research Trust has this as an open source. There's no membership, no fees, no cost to find information. You can go and you can find patient dosing information. You go to the resources tab, highlight it and then you get a drop-down menu. You can find LDN guides - click on that and then you can find it right there. It's a PDF, you can download and print. It's actually something that we in the compounding world have been suggesting, because it's such a useful tool. It's referenced, it's got scientific references behind it, it's got information and it's got available dosing recommendations that are very different than what we saw even five years ago. 

We start at much lower doses. We titrate to patient response, that's all included in there. Unfortunately it's a 2022 reference dosing guide and I think that your team may have work too, because in 2023 we're going to see some positive changes where it's going to be reinforced by the dosing parameters that we're working with, but new references. That's going to be the tough part, is updating it. But it's brilliant. That's where I would go. And then the other one is to talk to your clinical pharmacist. If they don't have the information, find a compounding pharmacy that is already working with low dose naltrexone. 

I can walk into five pharmacies from the office that I'm sitting in currently, and I can ask them what they know about low dose naltrexone. I don't know; they'll say not a lot, because not every pharmacy has the same focus of practice, or the same education behind them. 

Our role here at PCCA is education, clinical consulting support for those people who are invested in compounding. We've seen some pharmacies here and they're like oh you just take a tablet, mix it up and throw it in some water and they’ve failed to mention that water doesn't have a preservative and if you mix it up you may not be getting a consistent dose. How much to take and you go to a clinical compounding pharmacy with that niche practice and they're worldwide by the way, we've got some members all over the world, so big shout out to all of them doing brilliant work. They're focused on this and they are advocates for the patient. They're advocates for the patient's health and so they'll give you the best up-to-date information. If not, the LDN Research Trust website, talk to a clinical compounding pharmacy that's focused on LDN.

We still have people unfortunately that think they can buy 50 milligram tablets off the internet or buy in fact LDN off the internet or make their own and it's very scary not to be recommended.

I'm going to be as diplomatic as I can. There are a lot of good people out there who are trying to do good work. There are pharmacies that are available online and you can order items from them as long as you have a valid prescription in the country to which you are sending that prescription. The difficulty with internet commerce is there's a lot of people who are great. There's someone out there who wants to buy something and I want to make some money and so they will ship you stuff that doesn't contain naltrexone. It's just got some bad tasting chemical in there that they think will change how you think. Unfortunately we see this not only in the internet commerce, but we see this in a discussion of drug supply. We don't want to see any patient take something that they think like this is going to be great and it's cheaper, and you know it's just as good quality. I can make claims on the internet all day long, and if I do that for a year, and I can sell you dirt out of the parking lot; it'll take a long time for me to be shut down. There's a lot of patients that can come to harm from that practice. 

We always suggest working with a regulated compounding pharmacy, and every pharmacy that would be available to you is regulated by your local government. It is a brick-and-mortar place that you can tangibly speak to a person, and you can ensure that you're getting a quality product, from the reason we talk about compounding, and getting it dosed individually for you. I went to school for a number of years just to learn to be a pharmacist and then I spent a number of years being trained to become a compounding pharmacist. When you're talking about 0.1 of a milligram, we're talking about smaller than a speck of sand that you can see and we're trying to dose that consistently and accurately every single time. It's a big difference than someone making at home without training and thinking like yeah I'll mix it together. We are not making cakes, we're not making omelets. We're making drugs that impact your health. We need accuracy and precision to create a clinical outcome for the health of the patient. Getting tablets off the internet from someone who's selling it to you cheap 's a little bit like buying tires that you bought that you're getting from someone that doesn't make tires. They're just trying to sell you something cheap. It's always a consequence to the patient and you hear about this over and over and over again. You hear the story of people who are unscrupulous and they're preying upon people who are in need. I would rather see a patient get a quality product because that will improve their health so significantly that all of a sudden all those other concerns evaporate. I can't speak to pricing but I can speak to when I see a quality product is used we get quality outcomes. That's the connector. That's why we work with you, because we see the quality education and the conferences and resource sharing. 

The LDN Research Trust is focused on the same outcomes you want. The best for the patient and being advocates. We want the best presentation by advocating for the best product. They go hand in hand. 

It does scare me when companies out there, or individuals that I don't know who they are, but you can actually buy LDN without a prescription, but it's a prescription-only drug ,and that should set off alarm bells that you know it's bypassing all regulations. It can be anything, and I wouldn't want to play with my health or my life. 

I would challenge anyone to really really think about this. If we say that it's a prescription item and it's only available from a registered regulated pharmacy under the guidance of a healthcare provider. Would you go and buy a heart medication off of some guy in the corner? No, you'd be thinking I'm getting this cheap and he's pretty shady and I don't know what he's up to, but you know it should work. He wouldn't take that chance with your heart. Why would you take that chance with your immune system? Why would you take that chance with anything? It's terrifying to me. I will be brutally sharp on this one. We see what's happened in the illicit drug supply with people who are changing drugs with everything from carfentanyl to dalzine to fentanyl and these are people who are a high high risk for what drugs they’re taking. What's to stop these extremely unscrupulous people who are selling things on the internet from starting to use tainted drug supply for those purposes. This is not a good group of people. They're breaking the law. 

There there's so many issues here and the intention is to become healthy. Why would we take a legal practice and start our journey there. It just it doesn't make sense to me. Yeah it's cheap, great, it's illegal. You don't know what you're getting and you're setting yourself up for a high risk, high harm potential. That's not what any of us want to see. So please there's one thing I can suggest is don't do that. 

Thank you so much for having spoken with us today Sebastian. We look forward to your conference presentation in a few weeks.

I am so excited about it. I get to come in early. I'm going to be there for the entire conference. The collection that you have put together is just amazing.