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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.