From Lab to Launch by Qualio
From Lab to Launch by Qualio
Innovative Approaches to Medication-Assisted Addiction Treatment with Dr. Joshua Lee
This episode we're joined by Dr. Joshua Lee, a clinician, researcher, and professor specializing in medication-assisted treatment (MAT) for alcohol and opioid use disorders. Dr. Lee discusses his extensive research on medications such as naltrexone and buprenorphine, their significance in treating substance use disorders, and the transformative potential of telemedicine platforms like Oar Health. He highlights the underutilization of effective medications in primary care, the barriers to accessibility, and the enduring stigma associated with addiction. The conversation also touches on emerging trends and the future of addiction treatment.
Dr. Lee's Bio
Joshua specializes in medication-assisted treatment of alcohol and opioid use disorders. He conducts clinical trials and treats patients struggling with addiction as a primary care physician. As a Professor at NYU Grossman School of Medicine, he leads the Addiction Medicine Fellowship and conducts research focused on justice and community outcomes.
https://www.oarhealth.com/
https://med.nyu.edu/faculty/joshua-d-lee
https://x.com/drjoshuadlee
00:00 Introduction and Podcast Overview
00:38 Introducing Dr. Joshua Lee
01:20 Clinical Trials and Medication Insights
03:46 Challenges in Alcohol and Opioid Treatment
08:50 Telemedicine and Its Impact
11:59 Addressing Misconceptions and Barriers
19:35 Success Rates and Future Trends
30:14 Fun Personal Question
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Music by keldez
Hi everyone. And thank you for tuning in to from lab to launch podcast by Qualio. I'm Meg, your host, and I'm delighted to be here with you today. Before we dive into today's episode, we'd love it if you could take a moment to rate and share the podcast with your circle of enthusiasts. And if you're interested in being a guest on the show, please check out the application in the show notes. Today, we're excited to welcome Dr. Joshua Lee. He's a distinguished clinician, researcher, and professor specializing in medication assisted treatment for alcohol and opioid use disorders. Dr. Lee's extensive experience includes conducting clinical trials on naloxone, Now, Traxalone and Binafrone in various settings from primary care to criminal justice. Dr. Lee serves as the clinical chief advisor at Or Health, a telemedicine platform that makes medication assisted treatment for alcohol use disorder convenient and private. Join us as we delve more into his work and insights. Welcome to the show, Josh. Thanks for having me. Great. So, Josh, you've conducted numerous clinical trials on naloxone and Binafrone. Thank you. Can you help me pronounce that one?
Dr. Joshua Lee:Yeah, it's naltrexone and buprenorphine. Yeah.
Meg Sinclair:And can you share some of those most significant findings you found from your research and their implications for treatments of alcohol and opiate use disorders?
Dr. Joshua Lee:Yeah, for sure. These are pretty well known medications. They're, they're decades long into their approval for alcohol use disorder in the case of naltrexone and for opiate use disorder in the case of Both naltrexone and a pill and an extended release form and then buprenorphine. Buprenorphine is best known as Suboxone that came on the U. S. market in 2002, which was kind of when I was starting as a prescriber and young faculty and treatment provider in New York City and at NYU and at Bellevue Hospital where I've worked ever since. And that really revolutionized kind of primary care treatment of opiate use disorder, which Prior to 2002, it was really restricted medically to, um, methadone clinics or opiate treatment programs where that remains the kind of exclusive setting to get methadone. So we couldn't prescribe methadone, which works great for opiate use disorder, heroin and fentanyl addictions, but you have to be working in an OTP or a methadone clinic to prescribe it. uh, We didn't have much to do in primary care for, uh, about opioid use disorder and that all changed in 2002. With buprenorphine products, uh, brand name at that time was Suboxone, uh, and that, um, that kind of brand name is lived on, but now we have a variety of buprenorphine products we can prescribe in general care settings, emergency rooms, in the hospital, in primary care, mental health clinics, and you don't have to be in a licensed addiction treatment, um, clinic to, to provide those, and that's really gotten a lot more people into treatment with effective medications for opiate use disorder. On the alcohol side, we have had naltrexone approved for any, anyone to prescribe. It's not a controlled substance. It's not restricted to any particular setting. Um, and it was originally kind of developed in the seventies and eighties and initially approved for alcohol, I think in the early nineties. And then by 2006, we had an extended release, which is like a monthly depot version of that. An injectable form of the medication approved. Um, but we found along the decades and throughout my career with alcohol, and this is what the or kind of app and intervention is meant to address is that not enough people were ever kind of told about medication options for alcohol. Um, not a lot of doctors were aware or felt comfortable prescribing these medications, even though they're fairly easy to prescribe. They're generic, they're cheap, they're, um, uh, safe and effective. Uh, and yet, um, there wasn't a lot of uptake. So there, there was a real gap in the alcohol Kind of treatment landscape between everyday patients, what they would hear from a doctor, if ever, if they ever discussed alcohol with the doctor, and then eventual kind of like net prescribing rates, you know, in this country, uh, and probably in any other. Developed economy. There's just not a lot of use of naltrexone relative to the scale of alcohol problems, which are quite vast, quite common and quite, um, you know, deadly, costly and in large part because we have good treatments. We don't use enough of, um, arguably, you know, quite preventable. So, The goal of something like or, um, and this was what I was kind of working on in my publications and our trials before or existed was just kind of proving or documenting how kind of safe, effective and easy it is to use some of these medications and primary care and then using that as an argument for more primary care docs, more general practitioners. Uh, and that includes nurse practitioners, physician assistants. It's not all doctor driven. Anyone that could prescribe it might be talking to someone with an alcohol problem could be also prescribing these medications. And then the basic rationale between behind the medications are that they really move the needle on less drinking, less opiate use. fewer overdoses in the case of opioid use disorder. Um, and you know, they work. Uh, you don't have to treat that many patients to get one patient to do a lot better. And so our, our rates of like success are comparable to most other medications we've prescribed for chronic diseases in primary care. Like I'm going to treat you for hypertension. I'm going to treat you for diabetes. That's, that's the stock and trade of primary care. We do it all day long. Nobody questions that we're all quite familiar with it and confident in doing it. But we just haven't had that for alcohol. And then it has taken a while to develop anything like those competencies across the whole workforce for opiate use disorder and the struggle continues. Like, we're still investing a lot. Um, I, my, my prime, uh, primary appointment and full time job is at NYU Grossman School of Medicine. I work with our students, our residents, our, uh, trainees and fellows in addiction medicine. And we're working on that. We're doing it one by one, trying to get the next generation of docs to be skilled, confident, and, um, quick to prescribe these medications. But I'm from a generation that didn't get that training. I graduated med school in 99, and we just didn't have a lot of teaching. We didn't have a lot of kind of models of practice to learn from, and so it was kind of brand new in the 2000s when I kind of started my career, uh, to, uh, to be doing a lot of this. Now it's more commonplace, more primary care, family medicine, FQHCs, especially, uh, kind of public sector, um, primary care sites are able to do this, but still not enough. And so one of the reasons why overdose rates remain stubbornly high, um, despite really good treatments is that we just We have trouble connecting day to day the patient in need to to the available treatment. Um, so that's what that's kind of in my whole career. Like, get get more of this stuff out to more people. I didn't invent the medications. I'm not doing a lot of medication development or kind of novel. Molecular interventions for these problems. I'm more like, okay, we have all this stuff. Why aren't we using it more? You know, we got to use it in the jails. We got to use it in the prisons. We got to use it in primary care. We got to get more of this to people with housing and security that are coming in and out of the emergency room every every week, but don't necessarily follow up. How do we get more of these medications started? You know, at the at the time we have a patient with us. So that has been. Mm hmm. Kind of the theme of my research, some of my findings in, in, uh, in my clinical trials that I've, um, developed and run, uh, and a lot of that's NIH funded. And then, uh, or has been an opportunity to really be more kind of consumer oriented, uh, be at a startup and then work on a kind of new approach. Obviously made very common and familiar since COVID of kind of telemedicine and in a kind of like prescription medication app that is directed at one condition and one medication in this case with or oral naltrexone for alcohol use disorder.
Meg Sinclair:Great. And as the chief clinical advisor at OR, and speaking about, you know, telemedicine, how do you see it transforming the landscape of addiction treatment, especially in terms of privacy and convenience for our patients?
Dr. Joshua Lee:I think quite transformative in that we didn't have any of it and then we had COVID and then all of a sudden we can do a lot of it. Um, and then in the case of naltrexone, it's a, it's the generic medication. It's relatively inexpensive, uh, out of pocket or, you know, in terms of insurance coverage. And it is not a controlled substance, so there's very few restrictions on its use in telemedicine. We don't have any of the light controlled substance prescribing issues, which have, in fact, complicated a lot of, like, big telehealth. Headlines and addiction. Part of that is centered around, um, and mental health. Part of that centered around controlled substance prescribing, which is kind of a landmine that or doesn't have to deal with because this medication doesn't have any of those issues. Um, so for us, it's been pretty straightforward. Um, and then, uh, the challenge is reaching enough patients, you know, reaching enough patients fast enough so that the business grows and is healthy, um, from start up to, you know, fuller maturity. Um, and I think in general, Does does, um, we don't know the full answer to this, but does addiction fit in with like care loss, erectile dysfunction, stuff that other companies have tackled 1st and are more familiar, like direct to consumer telehealth models? Um, we think, uh, uh, Alcohol smoking cessation and then other companies do do telehealth, um, opiate use disorder treatment. So they're really good examples. And I think kind of well developed algorithms for that. Um, you know, will it will it get to enough people? Will it? Um. Can it coexist and not just kind of like animal eyes like real treatment? Like, um, it doesn't have to be an opposition to like, you can get this from your doctor. You can get this from a telehealth. Like, we don't care how you get it. Just like, get it because it would be helpful to you and your health long term. So, you know, so far, so good. Uh, I don't think all the chapters have been written on where telehealth is going. Um, but it certainly seems like it's here to stay. Like it made your medical centers like NYU make it Telehealth, the routine offering now, just if I want to interact with any of my providers, I mostly do my my own health care at NYU. Um, and it's not, it's not a predominant way that I talk to my doctors. I still do a lot of physical visits, but it's an option. And then, of course, you have something like, or, which is purely telehealth. There's no brick and mortar. We're not going to get you from the app to, you know, to a face to face physical encounter. Um, and that's okay too. Uh, Because it seems to be, from our experience, still an effective way to reach people and then treat them.
Meg Sinclair:Yeah, and the two can complement each other, right? Telemedicine and those physical visits are great complements to getting that full spectrum of care. What do you think the biggest misconception about medication assisted treatment for alcohol use disorder and how can we address that to improve patient outcomes? As a, as a person with loved ones who have suffered from alcohol use disorder,
Dr. Joshua Lee:Sure.
Meg Sinclair:And thinking, like, I'm a pretty well informed person when it comes to health and what's out there. Really, the only option that I've ever felt for them was AA. So, it's great to hear that there are other options, but I think a lot of people just kind of go there first, right?
Dr. Joshua Lee:Yeah, there's a handful of medications that are approved for alcohol use disorder. Um, you could say that the narrative is largely the same with all of them, that people don't hear about them, know about them, or talk to their doctor about them enough. Yeah, it hasn't made it into the movies. You know, AA is very familiar to everyone, but starting a medication to reduce cravings, reduce your kind of liking of alcohol, and then if you do drink, you don't drink as much that occasion. That's how naltrexone works. Um, that just hasn't been familiar or popular, you know, in terms of, um, public health messaging or just how people talk about alcohol and alcohol treatment with friends and family, uh, hasn't really made it into the culture where, you know, we're trying, uh, and that's what like every paper I've ever written. Uh talks about but nobody reads my papers like in the end, you know, it's not really penetrating Media that people consume on a daily basis or how they think about You know alcohol itself and that that gets to a whole raft of like historical and current issues stigma It's it's shameful embarrassing to have um, kind of a compulsive disorder like heavy drinking Um, it doesn't have to be but it is and then people They think about themselves differently, and they think about that as as not as a health problem, but often still, it's kind of like a moral failing. We would like to convince you. Otherwise, like, we have a lot of kind of convincing foundational neurobiologic. You know, proof that it's, it's kind of like an acquired and you can have genetic predisposition, but it's eventually like an acquired, you know, kind of brain disease. That's been the motto of the National Institute on Drug Abuse, for instance, like addiction is a brain disease. Um, And in that sense, it could be like a seizure disorder, it could be like depression, it could be like ADHD. It's not your fault, it's something that's happened to you, but now it's a medical problem and we can treat it. You know, that's what we're, that's the model we're trying to promote, um, but it's not, of course, been the, the kind of popular conception of some of these problems.
Meg Sinclair:Yeah, there's some multifaceted problems there, but I love that you're spreading other options for people suffering from alcohol use disorder. Um, and you're very passionate about making evidence based treatment accessible. What are the key barriers to accessibility and what steps can be taken to overcome them?
Dr. Joshua Lee:Well, like along with like, okay, you have an alcohol problem, go to AA, that's just not appealing to a lot of people. And it's a really scary first step. Um, uh, similar to that would be, well, you have to detox, you know, you're drinking a lot every day. You have to go to some center, you have to do an inpatient episode, and then the AA starts, you know, two weeks later after you've kind of dried out. That, that's in the movies. Um, but that's not the, that's not really kind of the practical case for most people. Most people that have an alcohol use disorder, Globally and in the United States can in fact safely stop drinking. The disorder is they don't do that on their own often enough and that's like one of the definitions of uh, a alcohol use disorder, but you don't have to check yourself into a hospital or a County psych center, uh, uh, or the, the kind of, uh, one drug and alcohol treatment center that everybody kind of knows about, but doesn't like really go to or talk about, um, you, you can do it at home. You can do it in private. That's, of course, an appeal to an app like, uh, or, uh, You don't have to engage with your health care team, and a lot of people don't have a health care team. Anyway, um, people are in between positions. Never had a regular clinic to follow up with. They've moved. They're busy. They just haven't, like, kind of been doing annual doctor visits, like, um, uh, you know, in in in the movies again, but, um, that none of that is really required to access and start treatment. That's probably the revolution of telehealth, too, is that you can get to it. When you're ready at home by yourself and private, um, you can disclose that to family or not. It can be extremely, you know, kind of private and confidential, or it can be something you're sharing with the limited support network, but it doesn't necessarily involve getting in your car and driving to a doctor's office. Um, Of course, you can do that and we highly encourage that. Um, but people have also had negative experiences in regards to an addiction problem and the health care system. You know, they've been scoffed at by a provider in the emergency room when they were there for something related to alcohol use disorder. Um, they, Have seen it loom as a legal threat and therefore something that has to be hidden and not kind of openly broached and discussed and brought up. Um, so, you know, brick and mortar health care should do a better job at screening, discussing, diagnosing, treating alcohol use disorder. But it's no surprise that people are reluctant to or don't know to. You know, ever kind of like flag it themselves as a self reported health problem. And as a consequence, it just doesn't ever get kind of picked up by or treated in your medical record. And then you're living with this problem day in and day out. Um, so telehealth there, you know, if you get our, if you get our ad on your phone, um, you're more likely to, you know, through a series of clicks, be an or customer. And then at a pretty reasonable cost, you're essentially like subscribing to a confidential treatment that is going to be done by mail and purely through a computer or your phone. And you never have to do anything else. And you can make. You know, quite a bit of progress with the treatment of your alcohol use disorder. The fun thing is these medications do most of the work. Like, you can do more counseling. You can still go to AA. You can eventually talk to your doctor. But in the case of, like, opioid use disorder or alcohol with naltrexone, just getting on the medication and giving it a trial is a huge part of, like, what we're trying to do anyway in any kind of practice setting. And then staying on it long term is, like, Tasks number two, and you can do that probably as successfully, you know, from home and through a mail order pharmacy is or uses as you can, you know, following up two hours away with your doctor or however it works for you in real life. So that that's certainly some of the advantages. Telehealth some of the like opportunities. For a company like or, um, and then part of the, part of the overall kind of like problem is that people just are not going to get this ever, uh, unless we start to kind of like rethink, you know, delivery.
Meg Sinclair:Yeah. Change the conversation and let people know they have more options or reports that 65 percent of their members are meeting their goal to drink less or quit. What do you believe are the key factors contributing to that high success rate?
Dr. Joshua Lee:It's kind of the magic of the molecule. Now, Trexone is not going to work in everyone. So if you and I both use it to reduce our drinking, you know, chances are like we will not have the same exact experience, kind of medication effect. We don't drink for the same reasons. Now, Trexone doesn't quite interact with our brain and our receptors in the same way. Uh, and then we can have variable, kind of, You know, careers as an outrex own patient. So it's not a silver bullet. It doesn't. Those rates could be higher. Uh, those are pretty good rates. We think for for kind of what we have done initially and how we've developed the product. And I think they reflect about the. The usual expected treatment effect of Naltrexone, which is for some people it's really transformative, uh, to get into the weeds. Naltrexone is itself an opiate blocker. It goes into parts of our brain that have, it goes kind of throughout the bloodstream, of course, and then it gets in the brain. And then parts of our brain that have the most opiate receptors, in particular, the mu opiate receptor, that's also where alcohol can have some opiate-like effects that can kind of stimulate that receptor system. And drinking makes us kind of feel warm and fuzzy. It reduces anxiety. Eventually, we get kind of sedated, inebriated, um, and that is a lot like, uh, opiates that they're kind of a warm blanket, um, can reduce pain, anxiety, make us feel, uh, much better. In the short term, and then as as longer term and higher doses, they're sedating. And of course, you can get things like overdose. So for some of us, not all of us, alcohol is a is a kind of opiate like drug. And one of the reasons we like drinking are for kind of opiate like effects. It's not alcohol is not an opiate, but it does have some again, kind of activity in the opiate system. And that drives, um, A reward, so we experiencing a lot of that is like, pleasurable and then we keep repeating it and learn how to do it. And that becomes kind of a. A loop that it's hard to break, and it's successful loop and that the loop is developed to kind of. In a sense, like, tricky to keep using that substance, opiates or alcohol in this case, but that's the whole point of treatment is to kind of disrupt that network and get you back to before you were exposed or like the substance so much. So with now, Trexone and alcohol, if we plug up and kind of block. Opiate receptors and this this is also how naltrexone works for opiate use disorders Um, you get less activity less of a signal from that receptor system when you do use alcohol And so you don't find that next beer once you're on naltrexone as tasty Uh, and then a month later when you haven't been drinking you don't look forward to that after work drink as much Um, and then net net, you're just drinking a lot less over time, either increasing days where you don't drink at all, uh, so called abstinence days, um, or when you do drink, you don't drink as much. And that reduces so called heavy drinking days. Both of those are extremely beneficial. We think in terms of controlling, um, Alcohol use disorders over time, uh, getting people back to higher function and then just helping your body be more healthy and avoid a lot of the long term negative consequences from alcohol. So we just want you to get the molecule into your brain like we could have developed, um. You know, like a queue red coffee machine that spits out in our truck zone. We could have done vending machines outside of every liquor store. Like, you know, there's a variety of ways you could think of, like, distributing more now truck zone to whoever needs it or is the is the kind of direct consumer, you know, pharma app, if you will, um, of which there are many other examples now, but that that seems like a pretty straightforward and now more familiar way to do it. Um, and that's, um, that's where you get back to those success rates.
Meg Sinclair:What is the success rates for you been like in different treatment settings like primary care and criminal justice and community environments?
Dr. Joshua Lee:Yeah, about the same. We haven't done a study with alcohol, naltrexone and criminal justice populations. I'd like to do that and I've thought about it for many years. We've done a lot of opiate directed trials in the criminal justice space. In naltrexone for alcohol, my studies have been more in primary care. Um, they've been using both. The oral and the extended release form and now Trexone. Um, and they're, um, you know, that they're positive in that they confirm what other investigators and other trials have shown, uh, is that now Trexone is pretty easy for user friendly. Um, it has some side effects, but they're generally tolerable and not, uh, they don't lead to a lot of treatment disruption or, or discontinuation. Um, and, and then or has kind of mimic that. So we haven't like discovered anything new with or so much as we've kind of found a new way to bring the science and an older, familiar, well established treatment to more people. So I would say there's, there's very little disconnect between what I get when I prescribed at Bellevue hospital in a brick and mortar setting to a patient with alcohol. And then what I expect when someone signs up for or now, I, of course, I'm a. Incredible physician and my patients love me and yada, yada. Like there probably is something to, you know, the human connection for that patient that I'm connecting to, but not enough people ever kind of get to that point with the provider. And many of us just don't have that kind of long term access and kind of follow through with the primary care physician. So it may be that, like, in primary care, that's the optimal place to kind of work with no track zone, but it certainly is a pretty good. Other alternative to, to get more people, you know, more access through, um, through a website or an app like or, and there are providers at or, um, you do communicate with real people who are treatment professionals, but we do it in, you know, kind of the most stripped down way possible. So it's largely asynchronous. Um, it's not video chats. It's largely kind of text and emails back and forth. Um, but just if you're wondering, it's not like, it's not completely robot driven in terms of how we prescribe, but we do have to do it legally and with care and in a way that we think develops good success rates. So we're not like ignorant to the fact that, like, the human touch can help here, uh, you know, in primary care, it's all about the therapeutic alliance and getting people to kind of negotiate with the help of their doctor, what's best for them and what they're motivated to do. Um, and, or can do some of that, probably not exactly replicating face to face, um, and long term relationships, but, um, that may be okay for a lot of people, and it may be really good for a lot of people that wouldn't otherwise have access, you know, to that same kind of traditional doctor patient relationship.
Meg Sinclair:Great. What emerging trends in the industry do you find most promising for the future of addiction treatment and recovery?
Dr. Joshua Lee:Uh, great question. Uh, there's still a lot, you know, there's a billion molecules that are candidates for the next brain drug that could help with smoking, shrinking, methamphetamine, alcohol. Um, it's, it's a long, laborious, expensive process to like test them in humans and then get one of them to market. Um, so we're, we're not like waiting for a new blockbuster every year in this space. Um, you know, we had buprenorphine in 2002. We had extended lesion altraxone in 2006. We had, by 2017, a extended release buprenorphine formulation, so just a new package to an old drug. Uh, we haven't had, um, we had acamprosate, another alcohol drug, in the 2000s. Um, so, you know, every decade, there's like one new label emerging for addiction. Uh, you know, across all drugs and alcohol. So that's not, like, a really Uh, you know, uh, pace that we can't keep up with. If anything, we'd like to see that speed up. And, you know, the federal government to their credit invests in this and is looking for that. Um, I would call all too big and small pharma and entrepreneurs out there to keep looking. And, um, you know, I think there is eventually a market for this stuff, although these conditions have traditionally been so stigmatized and kind of, um, other that, um, That it hasn't attracted some of the same type of investment that, you know, cancer, cardiovascular disease, uh, have, and yet smoking, alcohol, opiates, when you consider overdose, like they contribute to about as much cardiovascular and cancer death as, as any other risk factor, um, that you could think of beyond age. Um, so. I think there's something there in terms of opportunity and room for improvement in all the medications we have. One thing you'll hear about at any addiction conference or psychiatry meeting now is psychedelics. Or doesn't do this. I don't do this. I know about it through friends and colleagues. And my spouse is a psychiatrist kind of working in this space. So, Um, do, uh, does psilocybin, does, uh, LSD, does MDMA, uh, other forms of kind of traditional and atypical, uh, psychedelics, are they going to help with smoking, with drinking, with opiates? Um, there's some real possibility there, uh, but then it's also hard to imagine scaling psychedelics To help a lot of people as soon as possible because the protocols have been pretty intensive on the therapy side and not just the drug and people do seem reluctant as we saw the FDA just kind of pause or or thumbs down to MDMA for PTSD, um, just recently, and many people in the field expected that to kind of fly through and get approval. But the caution was like, These studies are still limited. We haven't done it in that many patients. Um, there's some limitations to the resource that gave the FDA pause. And then there's some real safety diversion and and addiction kind of liability. You know, people can develop, um, Misuse of some of the same compounds that we're seeing as therapeutic agents. So watch the psychedelic space. It's not my kind of item. Um, I'm not working on it directly, but I think that one is getting a lot of press a lot of attention in terms of addiction.
Meg Sinclair:Yeah, we've had a few of those founders and CEOs on on there for conversation on here for conversations before.
Dr. Joshua Lee:Yeah,
Meg Sinclair:well, Josh, our last question is more of a fun one to ask each of our guests. Okay. If we ran into you at a bookstore or at your local library at NYU, in which section would we find you?
Dr. Joshua Lee:I would say I'm a broad reader, but I consistently go back to kind of history and nonfiction. Um, I love just kind of learning trivia about past events, biographies, etc. So probably non fiction, you know, world's history.
Meg Sinclair:Well, maybe I will bump into you there. It was a pleasure speaking with you today, Josh. Thank you so much.
Dr. Joshua Lee:Thanks so much, Meg.