Okay. We're going to get started. Good morning and welcome. I'm Dr. Mitch Priwas, Session Director and Moderator for this morning's session on Medical Cannabis, 2024 Update, Research and PM&R Practice. Before I get started, there's just a few housekeeping rules I'm told to address. This session is being recorded, so please silence or shut off all cell phones. Evaluation forms. One of the things that I'd like to encourage you to do is to fill out your evaluation form. This is actually my seventh year as Session Director being able to provide you with this type of programming and it's through your evaluations and also the support of our academy that we've been able to do so. So that's really important. They want me to remind you to visit the PM&R Pavilion, but we have a pretty tight schedule this morning. We have four speakers, so I'm going to try to get to it soon. Just a few comments. Again, I'd like to acknowledge our academy and the Assembly Education and Programming Committee for supporting us to provide this necessary education for our membership over the past decade. I don't know of any other medical subspecialty that is providing medical cannabis education. We hope someday to be perhaps a longer session than just 75 minutes because there's so much material and a lot of this is still changing from almost day-to-day. As Session Director, I've made every attempt to select practitioners and topics from a variety of practice settings who can share their expertise in this burgeoning field of cannabinoid medicine, and this year is certainly no exception. I'd also like to mention that one of our speakers, Dr. Stu Glassman, has established an online phys forum for medical cannabis that I encourage you to check out and if you're interested, join. So without further ado, I'm going to introduce our first speaker. Our first speaker is Dr. Michelle Sexton. She's a medical staff professional at the Center for Integrative Medicine here in San Diego at UCSD where she is the primary clinician at one of the first cannabis clinics in an academic setting. She earned her doctorate in naturopathic medicine from Bastyr University in Seattle, Washington. She completed a postdoctoral fellowship at the University of Washington in the Departments of Pharmacology, Psychiatry, and Behavioral Science studying the endocannabinoid system and their roles in neuroinflammation and neurodegeneration. Her NIH-funded pre-doctoral and postdoctoral research investigated cannabis use in patients with multiple sclerosis and its impact on inflammatory markers. Dr. Sexton has presented her research internationally and published in peer-reviewed journals. Her clinical practice research and teaching focus on the endocannabinoid system and potential roles for cannabis across a range of conditions and lifespan. She's a member of the International Cannabinoid Research Society and the International Association of Cannabinoid Medicine and as a trusted pioneer in medical cannabis, she also maintains a private practice here in San Diego. It is my honor to welcome, please welcome, Dr. Michelle Sexton. Thanks so much for the invitation. I'm a wanderer, so I'm going to wander around so I can also point out things on the slides that I'm showing you. I hope to give you some background in using cannabis as a palliative medicine and for potentially multiple purposes. I got involved doing this at UCSD around 2016 through the pain division at the peak of the opioid epidemic where we needed a tool to help people exit their opioids. So that was where I started this work and we eventually started a clinic within UCSD where any doctor from any department could refer a patient over just for assessing their cannabis use or educating them about using it for any specific purposes. This is my only disclosure that I have authored a book on the topic. So I'm going to talk primarily about neuropathic but also noceplastic pain today. So we know that there's a pretty high prevalence, especially in older people. 30% of people with diabetes can be affected by neuropathic pain and this coming with other quality of life eroding symptoms. And so sometimes, you know, it may look as though people are really flocking to line up for cannabis because they want off of opioids. They may not like the side effects of the other pharmacopeia that we have to try to affect neuropathic pain. So the system that we're talking about that is a complete biochemical system in the human body is the endocannabinoid signaling system which was described by a researcher, Vincenzo DiMarzo, as one to provide that we eat, sleep, relax, protect, and forget. And so since this is a pan-organ system that's acting as a homeostatic regulator in every tissue in our body, it makes sense to evaluate the whole person for their cannabis use. So with regard to pain, what is relevant is that we know that primarily the cannabinoid 1 receptor is expressed across these ascending pain pathways. So at the level of potential pain initiation peripherally on both immune cells and neurons, we have CB1 and CB2 receptor at the dorsal horn. And then in the brain, in the areas of the brain that are processing pain, the cannabinoid 1 receptor is there. So in neurons is where the negative feedback loop of how endocannabinoids are modulating neurotransmitter release was first described. So in addition, we know that these same receptors are occurring in the brainstem in the areas related to the descending pathway. So we have a lot of good rationale for targeting this endocannabinoid system in pain signaling. So what's the clinical evidence? Well, for the longest time and continuing today, as researchers, the only product available for studying cannabis has been the cannabis flower material grown at the University of Mississippi. And so a lot of the studies, especially in the past, have been looking at either literally smoked cannabis, but more commonly now, vaporization of the flower material itself. So because the compounds are on the surface of the plant material, just heating it without burning it releases this essential oil component of the cannabis without the byproducts of combustion. And so this is just a smattering of some of these trials that used inhaled cannabis. So you can see neuropathic pain in HIV. Here's one on a pain monitor with capsaicin. Chronic neuropathic pain. Painful diabetic neuropathy. And then also for spasticity and multiple sclerosis. And then subsequent to all of that, in 2017, the National Academies of Science, Engineering, and Medicine released a complete report that was put out by a panel of experts who went through all the literature. And this was their conclusion around pain, that there was substantial evidence that it could be an effective treatment for chronic pain. And then as an aside from our Center for Medical Cannabis Research at UCSD, we put out this report where there was a review of the articles and that the number treated to treat was comparable to some of the other medications being used for neuropathic pain. So with inhalation by vaporization, I think one of the reasons that it is effective is how quickly the cannabinoids are entering the bloodstream. So you can see that within minutes we've got a peak of THC. And this would also apply likely to other cannabinoids, including CBD or CBG or others you might have heard about. We don't know a lot about them therapeutically yet. And so this bypassing first pass effects by inhalation, and this comes a lot also from clinical experience, can often be a more effective type of pain relief than taking the cannabinoids orally. Taken orally, the pharmacokinetic is very different and very dependent on gastrointestinal transit time, whether they are in a fed or a fasted state, their liver enzymes and metabolism, because there is an active metabolite of THC. So this inhalation kind of bypasses that first pass effect, and this is just demonstrating that at half an hour there can be a significant blood pressure drop after inhaling cannabis. So it's less likely to occur with the oral consumption. So this is just a note for, you know, people who may already be hypotensive, or I've had people that actually had to adjust blood pressure medications as a result of adding cannabis on. So what about the potency? Oh, and this is just an example of the type of a vaporizer that we have used in research. So when cannabis is extracted, you can see here this is a representative sample of THC content in cannabis flower. You go in a dispensary today, if you walked in one here in San Diego, you would see these highly elevated numbers which are being questioned whether the plant can actually produce 35 to 40 percent of its weight in a single compound. But at the time that I did this research, you can see 20 percent THC content was sort of the average. And then when an extract was made, and this was at that time supercritical CO2 extraction, you can see the potency go up by about fourfold. And so this is the type of product that people will get in a vape pen. It's a concentrate. Sometimes it's almost a pure drug, up to 90 percent THC content. So this is why if you have a patient using, you really want to kind of drill down and ask them about what are they using, what type of product, what is the potency, how often are they using it so you can get an understanding of what they're doing. And this is important because that high potency may actually be working against the symptoms that they're actually trying to get relief from. And so this is illustrated by, this is work by Dr. Mark Wallace who was chair of our pain division and he had done some of these vaporized cannabis studies on neuropathic pain. And so, after a few years, he took a look back and did a data analysis of the blood levels of THC after vaporization. And so, here's the THC level in the blood, this is nanograms per mil, and just notably, you can see the scale goes up to 42 nanograms in a study of people smoking cannabis and then evaluating their driving ability. People who just smoked a joint, they were told to smoke their cannabis cigarette as they normally would, their blood levels were 150 nanograms per mil. So this low potency THC from the University of Mississippi, which is often sort of talked bad about, like, oh, it's just so weak, we've actually seen that at this level of potency, it does a great job for neuropathic pain. So the question is, do we really need a higher dose? And everybody seems to be surprised by this. But we found that there seemed to be this sweet spot in terms of the THC level in the blood where the pain benefit was the greatest, and as the THC level in the bloodstream went up, you can see up here that it's actually above the baseline pain level. So more is not better, there's a U-shaped dose response curve, and this can apply not only to pain, but also anxiety and potentially sleep. So this is called the biphasic effect. A colleague, Alexander Shusterovich, I don't know if he's here, he has a poster on a review article we did on the biphasic effects, so you might watch for that. And then this is our most recent study from UCSD, my colleague Dr. Nathaniel Shuster had a grant from the Migraine Foundation, and so we enrolled patients with migraine and also other symptoms such as phonophobia, photophobia, nausea, vomiting, and so our primary endpoint was at the two-hour time point. And so here is the cannabis flower type that we found to be the most effective here for that pain freedom. And also not shown here, but those other migraine symptoms were also reduced the best by this combination, which you could say was basically a two-to-one CBD to THC, but just look at the THC potency again, it's quite a bit lower than what a lot of people may be sold in a dispensary situation. So what's the problem with these concentrates? I mean, people think they're quick and easy and they can take it on the fly and have it in their car or in their pocket, and so why not? Well, because there's different kinds of devices, there's been reports of heavy metals getting into the vapor from these devices, not always sure about what the active ingredients are in there. There can be impurities from the processing. This should say G-R-A-S, or generally recognized as safe ingredients. So if you remember that E-Valley thing that happened, and it was vitamin E acetate that was being put in there as a thinning agent. So without regulation, we don't know what they might be putting into their lungs and into their bloodstreams. Most states do have quality control regulations around medical cannabis and also adult use cannabis. So if they're out there buying like in a hemp store, if you're in a state with hemp, that's probably where it gets a little dicier. We know that some of the incipients they were adding to thin it were being converted to acrolein and formaldehyde by the heating process. The thing that's going on in hemp states is that they're taking hemp, chemically converting CBD to Delta-8-THC, which occurs very minimally in the plant. And in that chemical process, there's a lot of impurities. So we don't even know the safety of that. There can be other contamination, I said heavy metals, but the main thing are these super physiologic doses. And so does anybody really need that dose for anything and what does it do to our endocannabinoid system? So this is a retrospective chart review. So here you see male and female patients, mostly older ages, and here are their diagnoses. And then we looked at their opioid milligram equivalent before and after initiating cannabis use. So they were sent for a cannabis consult, instructed on how to use the cannabis. They were also given a tapering schedule and that was being monitored by their pain doctor. And so this is pretty significant that we saw this great reduction in pain score, but mostly in the opioid use. Well, then I decided, well, that was so good, I'll go do a retrospective chart review. And that didn't turn out so great. So 4.58% of patients had neuropathic pain. We had 2.63 with long-term opioid use diagnosis on top of their pain diagnosis. And found that 7.1% of the total population had a dosing consultation. And this was about 57% of people who were issued a medical cannabis authorization by their pain doctor. And so these are our results, that over time with everybody, and this was I think 2,300 patients, there actually was an increase in opioid milligram equivalent over time. So this was like from 2016 to 19 at a time when we were actively trying to reduce those opioids. The medical cannabis authorization did not have a significant association. Neither did time. And the dosing consultation almost barely was a significant predictor. So maybe if we could get that up to 100%, we made sure that everybody was having a taper schedule, we could improve that. But the most notable thing was that these people with the long-term opioid use, look at this increase in opioids they have over time. So this is just kind of a red flag of if you have that person, you may wanna watch them because they may just start overusing cannabis and using it at high potency or something's going on there where they're not getting the intended benefit of adding the cannabis. So I wanted to just talk briefly about nosoplastic pain because this I think it's sort of the next area in terms of not only cannabis research, but it's what we're looking at with psychedelics as well. So you're probably familiar with nosoplastic pain, intrusive fatigue, sleep disturbance, cognitive dysfunction. But it's pain, widespread pain and nobody can really find out any reason for it. Here's the things that are most exemplified by it. So what's going on here is that what we're looking at at UCSD, we have a specialist and functional MRI where we're doing this research with cannabis and also psilocybin is looking at these brain pathways and primarily the default mode network and how these networks can just get ruts in them from living with pain over time. And so it's actually that we need to change the brain. And like my therapist used to say, change your stinking thinking. So how do we learn to think differently about pain and how can we train patients to think differently? There can be a role for cannabis because cannabis has been looked at as something that can improve interoceptive ability. So that's the ability to read the body's signals. And people with chronic or past trauma, medical trauma, including chronic pain or other things, sometimes they get dissociated from their bodies. So working with the whole person may be what we need to do. We know that there's all of these different changes going on neurochemically, immune and peripheral mechanisms. So the neurochemistry and the anti-inflammatory effects of cannabis could potentially be beneficial here along with how it's affecting those pain processing pathways. And this is a quote from the paper. Both endogenous and exogenous cannabinoid activation generally elicits biphasic effects. So I was talking about that biphasic effect with pain. They're talking about it more here related to anxiety. Lower doses have better anxiolytic properties and higher doses are gonna be anxiogenic. So even if people are using high potency and they're kind of tolerant to it, there is evidence that they may actually have increased depression and anxiety when they're using cannabis heavily. And this is from another one of our researchers, not published it yet, but Dr. Emanuel Lehrman has been working with veterans with chronic pain. And so we took veterans who had a PTSD diagnosis, veterans who did not have a PTSD diagnosis, and they had a capsaicin pain challenge. And basically what came out of that was that these people with this past trauma or ongoing stress have this hypersensitive, sympathetic hyperdrive which actually has measurable neuroinflammation and elevated pro-inflammatory cytokines that are leading to a state of hyperalgesia where they experienced more pain with the same pain challenge as those who did not have PTSD. So again, just illustrating that treating the whole person is really what it's about. We think a lot about tissue damage. We need to be thinking more about inflammation, how nutritional factors, their beliefs about pain, and all of these are gonna affect their anxiety, depression, sleep, and especially, you know, looking for that medical trauma because I'm assuming you guys may work with quite a few people that are coming from a traumatic experience. So yeah, this is just the biopsychosocial approach. And at UCSD, we now have a group medical visit for chronic pain patients where we're really addressing all of these areas, bringing in mindfulness, bringing in other meditative practices like yoga specifically, teaching them about an anti-inflammatory diet, teaching them about how they can reprogram their brains. And then I just wanted to illustrate, this is a patient, 27 years old. She had been diagnosed with colitis. And for some reason, I don't know the whole history, instead of trying to do the whole initial therapy, she went back and demanded a colectomy, which she got. So had a colostomy, and as a young woman, this was very traumatic for her. She had a lot of family system dynamics playing in. But what I wanted to show you, so this was 2020. She had this ongoing abdominal pain that nobody could figure out what it was or treat, and she had different procedures to try to treat it. Here was her opioid milligram equivalent at that time. These red arrows are all visits to the emergency department where she would go for acute pain, this acute. her, we have to put you on notice, you know, we're watching your opioid intake. It was suggested she go check into a drug rehab facility. Well, around this time, she went on Reddit and guess what she learned? That she had cannabis hyperemesis syndrome. And so, she went to a drug rehab place and she was like, this is just not me, this is not what's going on for me. She quit using the vape pen after seeing it on Reddit and all of her pain went away. So, just an illustration of what these vape pens can do and why it's so important to really drill down with your patients about what they're using. The vape pens, you know, it's a quick delivery, but interestingly, with inhalation, the effects are generally only about two to three hours. And just asking people, they say, with a vape pen, that the duration of effects is even shorter. So, these people may be sucking on that vape pen every hour, all day long. And so, in essence, you know, what's going on is that they're bypassing potentially the best effects that they could get by using low potency. So, we have patients self-titrating to their own effect and so they're getting to judge the benefit side effect ratio. And if they're going to use oral, uh-oh, what happened there? If they're going to use oral, you know, sometimes the starting dose might be actually really quite low. Whereas 2.5 is very similar to the drug Sativex, which is 2.7 milligrams of THC, but a lot of people can't even handle a starting dose of 2.5 milligrams of THC. So, again, going with low potency, because at low potency, we're more likely to be toning the endocannabinoid system. Our patients may actually need to hack it, so something a little more powerful, but with those vape pens, there's actual evidence of suppression of endocannabinoid system function. And so, this can affect all of the tissues and systems. And just don't forget that people who are afraid of being high, if they're really not feeling well, the mild euphoria that they feel may actually just bring them back to feeling like more of a normal person. So that can be an actual important therapeutic point around using cannabis as a medicine. Thank you all for your attention. Thank you, Dr. Sexton. Our next speaker is Dr. Michael Solino, who is Chief of Physical Medicine and Rehab at Cooper University Hospital in Camden, New Jersey. He's also Professor and Chair of Physical Medicine and Rehab at Cooper Medical School at Rowan University. He is credentialed to certify patients for medical cannabis use in both Pennsylvania and New Jersey. He has been using medical cannabis as a treatment for over five years, primarily for the management of neurological conditions and chronic pain. He will be talking to us about the use of cannabis and spasticity. My disclosures, I work with many of the neuromodulation and device companies, not super relevant to this talk. As Mitch mentioned, probably the biggest, there you go, a little bit more volume, is that I am a certifying physician in PA in New Jersey. Obviously, everything that I say will be off-label because there is no FDA approval for medical cannabis. My colleague will be talking a little bit about that in a moment. And because I have a leadership position at Cooper, anything I say does not necessarily represent the opinions of Cooper University Healthcare. As Mitch mentioned, my topic for the next bit is to talk about the interface between medical cannabis and spasticity. Certainly, spasticity is well-recognized as a content of interest and of expertise in the physiatry community. Rough kind of back-of-the-envelope calculations. A little over four million people in the United States have spasticity, more than about one and a half of the U.S. population. And at best, what is there, 8,000 of us who might be able to take care of spasticity? That's a lot of patients for each and every one of us. The whole reason why I'm here talking to you is a lot of my patients who I manage with spasticity would ask me about medical cannabis and what that is all involved. So even if you're not prescribing medical cannabis, trust me, your patients with spasticity will ask you about it. Again, my colleagues are gonna talk a little bit about the penetration of medical cannabis at a national level, how many states are involved. But just about every state that has medical cannabis available has either a direct or indirect indication. There's about 38 states and a couple of territories that have enacted medical cannabis programs. 20 of those 38 specifically delineate the spastic condition or spasticity as a qualifying condition. A couple other indirect indications, 36 states have multiple sclerosis, 20 have movement disorder, 20 have spinal cord injury. Basically, excuse me, just about every patient with spasticity can probably be shoehorned into being approved for medical cannabis. Again, your patients will ask you about it. So where does this all come from? So the original interest for utilizing cannabis products comes from an animal model that actually showed some pretty good evidence. This actually goes back to early 2000s, published in Nature, you know, a pretty high-powered journal that used an experimental model of multiple sclerosis, an autoimmune inflammatory model that when injected into mice would result in a spastic parosis and convincing evidence that interactions at CB1 and CB2 reduce spasticity. This then led to the idea that, well, if it works in an experimental animal model for spasticity and specifically multiple sclerosis, can it then convert onto humans? Probably the best study that looked at this was the CAMS study, the cannabinoids and multiple sclerosis model. This was done primarily in the United Kingdom. There were a few sites in Romania. Three-armed study. One had an oral cannabis extract. One had just Delta-9-THC, and the other had placebo. Trial duration was for 15 weeks. The primary outcome measure was the Azure scale, which is a common and required outcome measure for any spasticity indication here in the United States. The analysis was intention to treat. So the CAMS initial study showed no change in the Atheroscore between the three groups. So this was a little bit disappointing. However, from this study, an extension study was added in which folks were unblinded and there was some suggestion of a treatment effect that maybe it would have taken multiple weeks of therapy or maybe even multiple months of therapy to change the Ashworth score. After the initial CAMS study was released, this study was also undertaken again, primarily in the United Kingdom. This actually created a controversy that still exists to this day in utilizing cannabis for spasticity. Instead of using the Ashworth scale, they created a visual analog score for spasticity intensity. Most of us are familiar with that in the pain world. So if you're doing a pain trial, you look at VASPI, Visual Analog Score of Pain Intensity. They carried that over and created a VASI, Visual Analog Score of Spasticity Intensity. At the time when this project and trial was undertaken, the VASI had never been used before. So they kind of created their own scale for the clinical trial, which isn't the way you're supposed to do it, right? You wanna have a scale that's validated against other measures before embarking on an experimental approach to it. Secondary outcomes were Ashworth and spasm frequency. The results of this study, again, talk a little bit about the numerical score, again, zero being similar to pain, no spasticity at all, and 10 representing the worst spasticity trial, first time ever used in a clinical trial. Since this report, there has been pretty good validity worked on this particular scale, good consistency and inter-rater reliability, and a reasonably good correlation between Ashworth and spasm frequency to spasticity intensity, though not perfect. And this will present a problem as we move forward. This was, whoops. This was the outcome measure of this trial. So at baseline, people reported a VASI score of about six. And you could see that there was some treatment effect. The solid line represents the cannabis-treated group, and the dotted line represents placebo group, barely making statistical significance, but not a whole lot of treatment effect. You're dropping a half a point in spasticity intensity. However, this trial led to the development of a commercial product outside of the United States. That commercial product is, and this is the secondary outcome measures, no change in Ashworth, no change in spasm frequency, no, or very close to significance in the moticity index as a combined measure of strength in the upper and lower extremity. There was always concern about weakness in spasticity trial, so it was good that you saw no weakness, but really no change in the objective measures of spasticity. But this trial led to a development of a commercial product outside of the United States. That is Savitex. Savitex is a one-to-one standardized formulation of THC and CBD. There are also some excipients, ethanol, peppermint oil, et cetera. It is an oral mucosal spray. For those of us of a certain age, we remember back in the 70s, a device called the Bianca Blast, where it was a breath spray that you sprayed to the inside of your cheek and gums. That's what it tastes like, and that's what it looks like. So people would spray this to the inside of their mouth. At the time of development, this was owned by GW Pharmaceuticals and is now an approved product in the United Kingdom, Canada, Israel, and 29 countries around the United States. However, when this was attempted to then be brought into the United States, the VASI score was not an acceptable measure of outcome to the FDA. They had to use, the ASHRAE score had to be used to get, as a primary outcome measure, had to be used for a spasticity trial. Jazz Pharmaceuticals, which is partially based in Philadelphia, acquired GW in 2021 and attempted to go after a U.S. indication with the release trial. This was a randomized, double-blind, placebo-controlled, two-way crossover trial in about 70 individuals. So individuals were, at first, exposed to a placebo or Savitex, and then after three weeks, crossed over to the other side. The results of this study were recently published. Lead author is Francois Berthoud, physiatrist at the Cleveland Clinic, showing no difference in the lower extremity motor tone score, kind of a combining Ashworth of a couple of different muscle groups. Certainly, cheers to Francois to getting this published, being a lead author in a medical cannabis study. But this casts some doubt on what is the true efficacy of medical cannabis in the spasticity world. Most recently, Jazz has abandoned further trials in Savitex because of this, although, as mentioned, it is approved in other countries. Jazz has gone on and got a pure THC analog epidiolex approved for certain seizure disorders here in the United States. So this presents a pretty good paradox, right? We have an approved product in other parts of the world. More than half the states have spasticity, either directly or indirectly, as a certifying condition, yet the evidence basis for it is certainly somewhat limited if you look at it on an objective basis. As mentioned by my colleague, there's good experimental animal data for the interaction between medical cannabinoids and the spastic condition, but its utilization in the United States based on objective measures is pretty lacking. So you could explain that to patients as they ask you questions about it. My personal hypothesis about this is that there's probably not a direct effect on the spastic condition. It's more that people have pain relief, can tolerate more exercise and more stretching, and that relieves the spasticity rather than a direct effect. As will be mentioned by many of my colleagues, medical cannabis is a soup of molecules. There are over 200 active chemicals in the marijuana plant. To be able to isolate what particular element of that soup might be beneficial for spasticity is a long way off. So hopefully I caught us up a little bit, Mitch. And we pass the baton off to Ari. Well, let me introduce him first. Oh, go ahead. Thank you, thank you, Mike. One second. Thank you for that great review of cannabis and spasticity. Our next speaker is Dr. Ari Grice, who is a clinical assistant professor of rehab medicine at Thomas Jefferson University, who has published numerous research articles, textbook chapters, and continues to teach and lecture. Residents and medical students, his fellowship trained in sports and spine rehab. He specializes in the non-operative treatment of spinal and musculoskeletal disorders. Most uniquely, he is the director of the medical cannabis department at Rothman Orthopedic Institute. Bet you didn't believe there was such a thing. He is interested in the treatment of chronic pain with cannabis as an alternative to opiates. Ari? Thanks. Thanks for being here, everyone. We're running a little bit behind schedule, so I don't have any conflicts of interest. It's true, I'm at Rothman Orthopedics at Thomas Jefferson University. I started a cannabis department when Pennsylvania legalized it in 2018. The way I was allowed to do that was to take a little bit of a research approach and to collect outcome measures on patients. And so I've since done probably over 2,000 cannabis certifications for people with chronic pain, mostly of orthopedic origin. And today we'll talk about who's appropriate candidate for cannabis in an orthopedic practice, some of the chemical constituents in cannabis and how they work on the endocannabinoid system and can help patients with pain. And then also to try to figure out how do we go about doing this? How do you talk to patients about choosing products? It's not an ideal situation when we're giving patients sort of free access to purchase whatever they want at a dispensary. That's essentially how this works. We're not prescribing cannabis. We're just certifying that a patient has a qualifying medical condition, chronic pain or severe pain is on every medical cannabis state run list of qualifying conditions. So I personally think that healthcare involvement in these conversations is really, really important. Otherwise we're leaving patients to figure out what to purchase on Reddit or to talk to someone at a dispensary that works there without any medical knowledge. So whether you are for or against this, it's here and I don't think it's going anywhere. There's a growing trend of acceptance from the patient and as a result we have 38 states plus the District of Columbia. That means 76% of the country has access to medical cannabis and patients are using it and we need to kind of give them some advice about what are best practices. In our orthopedic practice we did a survey study, quick and easy, over 2,500 patients. We found that one in 10 were already using medical cannabis. So again, 10% of your patients are likely using cannabis too and when we surveyed patients on their attitudes, we found in line with other survey studies, over 80% of people saying that they would try cannabis if needed for a chronic pain condition. Almost 90% of people thinking that it should be legal throughout the rest of the country. But there's many barriers to accessing cannabis and the number one is cost, right? So this is not covered by insurance. Almost everyone agrees that it's expensive or not affordable, so you have a large population of patients with chronic pain, chronic symptoms of other illnesses that just simply don't have access to cannabis from a cost perspective. In addition, a lot of people believe that it's safer than opioids. So close to 80% of people would say that they believe it's safer than opioids. Many people say they would try it. Younger patients are more concerned with stigma around cannabis, which still exists, and older patients are less sure of its safety. But our conclusions from the study is that not only are people using cannabis, but they're very open to it and they feel more and more that it is a safer alternative to opioids for a chronic pain condition. So I will say that not surprisingly, the number one condition that I do certifications for is for chronic low back pain. We all know how prevalent that is. We are living in a world where the aging population is exploding, so there's more and more degenerative conditions. A lot of this is just run-of-the-mill arthritis. Hip, knee, shoulder. Some of my patients didn't have a great outcome after surgery. You may guess some of these patients had spinal fusions. And so a whole host of people with chronic symptoms that can't be fixed with more surgery, many with fibromyalgia, many with different types of neuropathies. And as Dr. Sexton mentioned, there's a lot of different physiological roles of the endocannabinoid system. We do think that this is something that we should have learned in our medical training. And I think that's probably the biggest reason that practitioners are hesitant to get involved in this space is because they don't really understand the basic human physiology around it. But there are many ways that our body responds to tissue injury and pain signaling. And this can be augmented. We see very distinct similarities between the opioid system of receptors and endogenous peptides and the endocannabinoid system. And so to date, since the early 90s, two receptors, CB1 and CB2, have been identified. We have two endogenous peptides that are produced on demand that attach to these receptors. And then we have a plant that contains over 100 chemicals known as cannabinoids. And so a lot of research has been done on these chemicals. This is a lot of preclinical research, but you can see the effects of these chemicals on the system are very pertinent to pain patients, whether it's working on just simple analgesia, symptoms of spasticity, changing our perception of the pain, there's a lot that cannabis may be doing. It comes in a lot of different forms. And this is the problem. There's lots of different routes of delivery. There's different pharmacokinetics. There's different patients that have different livers that metabolize these chemicals. And so this is not that different than other drugs, right? If you prescribe gabapentin, pregabalin, duloxetine, many patients don't tolerate these drugs. Many patients don't tolerate cannabis either, or finding the right dose is essential. And there's pros and cons to all of these routes of delivery in my mind. I mean, there's not one route of delivery. There's a problem with inhaling. You can't measure how much is going in. That being said, cannabis users seem to learn how to self titrate. They know how many hits of a joint will get them the effect that they want. There are very potent vape pens. They're not great. But people generally only take a few hits of a more potent product. So people learn how to self titrate. The edible thing, again, it's good and bad. You can micro dose, but you can also accidentally take too much. And so we try to counsel patients about the pros and cons of each route of delivery. And I'll share with you what I tell people. But I think first and foremost, the dosage of THC is what we need to focus on in the beginning. It's not which strain. It's not, is it an edible or a tincture? It's how much THC does a person tolerate? And then can we use other cannabinoids like CBD or CBG or other full spectrum products that can maybe tamper the side effects of THC? So getting high is a real thing. People can get intoxicated from lots of pharmaceutical drugs that we prescribe, including cyclobenzaprine and tramadol. All things can alter our state of consciousness. And I do think that for a lot of patients, changing just how they feel, making them feel some form of happiness or some distraction from pain is a mechanism of how this works. But interestingly, and I agree with Dr. Sexton, that there's a window of an opportunity where the right dosage can provide symptom relief without symptoms of intoxication. And we found this out just by asking about 300 patients, do you experience the symptoms of intoxication? And a large majority of people that did not feel intoxicated felt reported symptom relief. And then of the people that did report intoxication, only a small number of them didn't like it. Most either enjoyed it or found that it didn't get in the way of their daily activities. And that's, again, because patients learn how to self titrate or they just use their products when they don't have to be doing these other activities, after work, before bed, things like that. So again, the goal is to minimize intoxication. Two to three milligrams of THC via an oral route of delivery is usually well tolerated. If patients are comfortable inhaling and vaporizing as opposed to smoking and they're picking the right product, then yeah, taking one or two small inhalations, waiting 30 minutes for it to peak in your bloodstream is another way to do this. But I do think that as practitioners, it's very difficult to recommend an inhalable product. It's not great on the lungs or the oral mucosa. And so topical, THC, oral routes of delivery I think are the best. Slowly titrating up by a couple milligrams of THC, experimenting with combinations of THC and CBD. I have had patients that don't see any difference when they add CBD to their product. But I do think that there's a problem with accessing the right product in a dispensary. You don't see all the ratios of CBD to THC that you might want. A lot of dispensaries only have THC or THC and CBD, so by accessing the hemp market, you can get CBD and create a higher ratio of CBD to THC. Again, you can distill THC out of the plant, and a lot of products in dispensaries are just distilled THC, or you can use full spectrum extraction methods that have other chemicals that may be beneficial. And I personally have had a lot of success with orthopedic pain patients using topical THC on joint pain. We don't really have much evidence for that in the literature yet. And then there's a portion of my patients that are trying to get off of opioids, and I have a clinical case to kind of share with you. But I think of five milligrams of THC being similar to five of oxyconone. That may be everyone's different. It depends on tolerance to both of these chemicals, but I think there is a way to do a slow wean off of an opioid by introducing micro dosages of THC and titrating them up higher, and then also using other pharmaceutical drugs in the mix. And so this is just one example of a patient that I had that was on opioids for a decade, axial neck and back pain, had had all the therapy and injections that you could ever imagine and came to me on hydrocodone four times a day, stating that pain was still nine out of ten, nothing was really helping, and was just looking for an alternative. And so this was someone that got certified. She tried a sublingual tincture. She titrated up on the dose. She added a little bit of vaporized cannabis in the evenings, and she started to reduce her hydrocodone very gradually. She developed a little bit of anxiety coming off of it, mostly from withdrawal. I put her on duloxetine, and then within six months, she's completely off of hydrocodone and had been on it for over a decade. And so for some people, this can work. Not for everyone. I think that cannabis is a safer and better alternative for chronic pain compared to opioids. We know that opioids are really helpful for short periods of time, but there's just less risk of dependence, less side effects, and it's not lethal. And so to me, it's a viable option for some people. And I just want to end with saying that there's real physiology here. These chemicals in the plant work on receptors in our body. We know that from the evidence, THC and CBD in combination can help patients with chronic pain who are adults, and that cannabis might be better than opioids for certain types of pain, particularly neuropathic pain. And I firmly believe that if healthcare professionals are involved in making recommendations to patients, we can minimize the incidence of intoxication, we can reduce opioid use, and for some people, improve pain and quality of life. Thank you for your attention. Thank you, Ari. Okay, so you've heard from our speakers for spasticity, neuropathic pain, and orthopedic medicine, musculoskeletal. We're now going to switch gears a little bit. Our next speaker is Dr. Stuart Glassman. He is Chief of the Physical Medicine Rehab Service at the Veterans Administration Northern California Healthcare System, based in Sacramento. He's an Associate Professor, PM&R, at the University of California Davis School of Medicine and Associate Professor, David Geffen School of Medicine, UCLA. He's also AA PM&R's delegate to the AMA, very politically active, Vice Chair for the AMA's PM&R Section Council. He served on multiple therapeutic cannabis committees for the state of New Hampshire, and he's currently involved with the AMA's Cannabis Task Force. He has decades of experience reviewing and presenting on medical, legal, and regulatory issues including medical cannabis. He was also recognized by our academy as a Distinguished Public Service Award in 2020, so Dr. Glassman will speak to us on a 2024 Review of State and Federal Cannabis Regulations. Stu? Great, thanks so much. Can you hear me now? Great. All right, thanks, Mitch. Dr. Sexton, Dr. Salino, Dr. Grice, thanks so much for your presentations. I'll probably refer back to some of those. We get to pull back now. This is the big picture, regulations, legislation, politics, and veterans, so buckle up. All right, no financial disclosures, but since I do work for the Veterans Administration, the views and opinions presented during this presentation do not necessarily represent the views of the Department of Veterans Affairs or the federal government of the United States. So we're going to try to improve your learner knowledge of the latest state and federal regulations concerning cannabis guidelines, adult and medical use, improve understanding of the just now voted on legislation for the states, and we'll go over all those that were voted on on Tuesday. Talk about CME regulations required if you're going to be a prescriber for cannabis in the medical states, of which there were 38, there may be one more next year, and improve your awareness of the Veterans Administration regulations if any of you take care of veteran patients, whether in or outside of the VA, there are some things you need to know about that as well. Okay, so this is the map as of Tuesday. This map no longer is correct based on what happened on Tuesday, but as of right now, we talked about 38 states that are for medical use, and 24 states are adult use, but there's also low THC and CBD only states, there's about nine of those. That's why this map is a little differently colored than Dr. Grice's map. And three states, anyone here from Idaho, anyone here from Nebraska, and anyone here from Kansas? Well, we're not in Kansas anymore, okay, someone's in fact there, okay, good, excellent. All right, so again, as I went through those, basically there's really four different segments you have to be aware of on that map, and we always talk about the medical use and the adult use, and it's still federally illegal at this point in time. All right, so here are some of the diagnoses on most of the states, and if you look at these diagnoses, isn't this what PMNR does on a regular basis? I just came from one of the media training sessions, and the academy has had a big focus on spasticity for years. When you go in the exhibit hall, you're gonna see a lot of stuff on spasticity. Has anyone in this room been contacted by the media about cannabis use for spasticity? No, exactly, but we should be, because like Dr. Salino said, spasticity or the derivatives of it are on 36 out of 38 states that have a medical use. This is a wheelhouse that PMNR should be very much the expert to go to for questions and descriptions from the media, from patients, so think about that. That's sort of one of my goals here, is to make you understand, if you're in this room, maybe you're a believer to some degree, you're trying to find out, but you have to be able to get out there and get the message out if you believe that it's a tool in your toolbox for your patients as well. Okay, so a big thing that started last year, August 2023, was that Health and Human Services sent a request letter to the DEA asking that marijuana be reclassified from Schedule 1 to Schedule 3 within the Controlled Substance Act. Fast forward about nine months, April of this year, 2024, the DEA agreed with that letter request to reschedule it, and the next month, they posted a 60-day online comment period that ended in July. Did anyone post anything on that open public comment website? No. Okay, be involved, it's important. Forty-three thousand other people commented, but nobody in this room, and we might know some of this stuff better than others. Being involved in the creation of regulations and legislation, it's proactive. You really have to be involved up front, not after the fact. So in August, the DEA announced, after getting those 43,000 comments, that they're going to have a hearing held between an administrative law judge. I'm sure any of you in inpatient rehab have heard of the ALJ, when you get denials from Medicare on your inpatient rehab cases. So an ALJ is going to have a hearing on December 12, 2024. However, you have to register by September 25, a month and a half ago, in order to speak. Did anybody register for that hearing? No. Just what I thought. But you could probably watch the hearing or follow it, maybe they'll stream it. So after the hearing, the administrative law judge is going to write up a report, then the DEA is going to get that report, look at all the comments, and then come out with their final rule-making decision about whether they should reschedule marijuana from one to three. That'll probably happen in the spring. I think if they get the report from the ALJ in 30 days, they might have 30 or 60 days to come out with their report, as well. So we should know something by hopefully February or March of next year, as well. So does anyone certify patients in your state right now for medical cannabis? Raise of hands. Okay. So 38 states, right, we've said that a couple times. Of those 38 states, where do you need C&E to actually certify patients? In 29 of them, you don't need any, okay? Kind of a scary thought, if you think about it. We didn't learn it in medical school, and you don't need to have any education in order to sign that form saying they have access to the program. Two hours of C&E in four states, Florida, Massachusetts, New York, and Ohio. Three hours in Oregon and Rhode Island, and four hours in Pennsylvania, Washington, and West Virginia. And the reason why this is, and I served on the Cannabis Legislation Task Force for six years, is the legislature really doesn't want to make it so tough to get patients certified. This was driven by patient desire to have access to cannabis. And they don't want to put all these regulations in place that say only doctors that have ten hours of C&E can certify someone. Because if they did that, a lot of patients wouldn't get certified because those doctors don't get the education and training. So they have wanted to make it sort of open access to some degree. So you've got the will of the people, you've got science, and you've got legislation and politics in this space, for sure, as well. There are a couple of national proposals for federal law that were submitted last year, dealing with the one-to-three federal DEA rescheduling, banking issues, transport across state lines. These are all stuck in subcommittees, nothing's been passed yet at all. But there were some state proposals that were voted on on Tuesday. So who's in, he was here from Florida. Anybody from Florida? Okay, Amendment 3 did not pass. That was to get marijuana adult use legal. Why did it not pass? You had to have 60%, and only 56% voted for it. So a majority voted, but not 60%. So there's medical use there, but it is not for adult use at this point. North Dakota, anybody here from North Dakota? Okay, so North Dakota had a legalization for Measure 5, because they have medical already, and this is for adult recreational use, it did not pass. You had to have 50% plus one, they got to 47%. So, still a lot of people wanted it, but not enough. South Dakota, anybody from South Dakota? Okay, so South Dakota, Measure 29, also for recreational use. Failed, same reason, only 44% approval. Okay, Nebraska, anybody here from Nebraska? Any Cornhuskers out here? No? Okay, so Nebraska was one of those three states that had no access to cannabis. That changed on Tuesday, because they passed two initiative ballot measures. 437 was to allow for medical cannabis use. And 438 was for, so actually 437 was for, I think the legal issue of actually adult use, and then the regulation of it. So now we have one more state that has medical use, once it goes into effect next year, because if this gets passed, now you have to create the infrastructure of a cannabis commission, and people to serve on it, and figure out how you're gonna actually grow it and distribute it. So, it doesn't happen overnight, but the map next year will be somewhat different as well. And anyone here from Arkansas? Okay, so Arkansas is unique because they wanted to expand the medical cannabis law, allowing home cultivation. It was printed on the ballots, but the state Supreme Court said, you know what? We think this is actually a bad ballot measure, and we're not gonna count any of the votes at all. So you wanna talk about voter fraud and ballot issues? It actually happened there, because it was on the ballot, people voted for it, but the votes did not count. So maybe there is some truth to the fact that in this country, votes don't count, who knows what. Anyway, so some media information there. Next year, you'll see the map will have 25 adult use states, so 50%, and then 39 medical use states for that. And I told you politics, right? What's the one thing that Vice President Harris and President-Elect Trump agreed upon? That cannabis should be rescheduled from schedule one to schedule three. So there was something they actually both thought was good, all right. And President-Elect Trump came out with it first in September, and Vice President Harris in October as well. All right, so the American Medical Association, of which I'm one of your delegates, Susan Hubbell from Ohio is the chair of the delegation, Carla Malani's on that as well, Rosalie Connick, and Prakash Jalabulon is for the AAP. And we're all meeting in Orlando tomorrow, so I'm flying tonight to Florida, and I'll miss the midway. The AMA came out with a cannabis task force, and it came out with that because myself, Carla Malani, and some others pushed to have this be a focus of the AMA. And Dr. Kimisha DeLeeser is the representative for the AAPMNR on the task force, we're one of the specialty societies that are part of that as well. There have been a number of meetings about safety and highway crashes and impact on health and resolutions at the AMA level, which is sort of like legislation but in the House of Medicine. For things like marketing and safety issues for pregnant women and things like that as well. And even now, there's been some CME articles on the AMA website, Education Hub, some podcasts involving the board of trustee members for cannabis. So it is picking up some steam for sure as well. Okay, quickly for the Veterans Administration, and Dr. Sexton, you talked about the issue of veterans and capsaicin response and PTSD. 65% of veterans suffer from chronic pain and are twice as likely to die from an accidental prescription opioid overdose compared to non-veterans. Medical cannabis could be an alternative for chronic pain. Over 20% of the Iraq and Afghanistan veterans will have PTSD or depression. And because the VA follows federal law, VA physicians cannot certify patients to get access to cannabis. However, they're supposed to actually ask them about it. There's a policy director that's been out since 2017 saying that VA physicians actually need to know what their patients are doing, documented in the record, even if we're not gonna fill out the forms for them to be able to get cannabis or even recommend it. But we at least wanna know about it as well. And we're looking potentially at starting a research study looking at the understanding and attitudes of the VA physicians themselves if they know about the directives and are documenting what their patients are doing as well. So again, if it gets rescheduled, this will change. And if the rescheduling happens, well, guess what? Now cannabis is a schedule three drug. Well, now you're gonna see lots of companies and lots of physicians wanna get in that space. And I'm telling you, we should be in that space in a major way right now at a meeting like this with cannabis companies talking to us, wanting to get thought leaders and experts about where this is gonna fit in the future. Cuz it's already a multi-billion dollar industry, and if it gets rescheduled, it's gonna be even bigger than that as well. And again, VA scientists can conduct research on cannabis with veterans. But if you're a VA employee, you have to be subject to drug testing as well. Okay, so understand the status of therapeutic cannabis laws and medical use, adult use laws in your states. And again, it changed in Nebraska as well. Be aware of some of the federal legislation, which pretty much stuck in Congress, not going anywhere. We'll see what gets reintroduced with the next Congress in January. If you take care of veterans, understand that they are in a unique situation, because they can't get it through their VA pharmacy or dispensary. There are no federal dispensaries in the VA. They can't have their VA doctors actually certify them. So you see them on the outside, you may be able to actually help them get certified as well. And for our academy, we established the Therapeutic Cannabis FIS Form. I'm the chair for that right now. And we just had a delegate meeting yesterday. And again, there's about 66 people signed up for the FIS Form site right now, but there's more than that in this room. So anyone who wants to sign up for it, log in, post a discussion. It's a great place to actually exchange ideas. And it's important because the academy staff monitors FIS Form on a regular basis. And if there's a lot of traction for certain issues, that will lead to other things happening. Such as a white paper from our academy about cannabis, or the potential for even more education, like a half day course potentially. If FIS Form is showing it, the staff looks at it, and it starts to get some traction as well. Okay, that's it. Surf's up, and we'll talk now. Thanks. Thank you, Stu. We are out of time, but we're gonna stick around for ten more minutes for some Q&A. I'm gonna invite all of our speakers up, and we'll have some Q&A and a panel discussion, cuz I'm sure that there's lots of questions on your mind. All right, so it's still being recorded. I'm going to ask a question. Yeah, and come to the microphone if you can as well, and don't forget to fill out your forms. Because it is being recorded. Actually, Stu, I wanted to ask you a question. You're going to this AMA delegates meeting tomorrow, and the question I have is, if we do go to a Schedule III, is that going to, in any way, influence the AMA's position on medical cannabis, do you think? Oh, completely. Because if it goes to Schedule III, I can guarantee there's going to be resolutions submitted probably by our academy members, the delegates, about more research on the effects of cannabis. Because the AMA has been very skeptical, as have a lot of other medical organizations for a long time, because again, the science wasn't great because you couldn't really do the great research. You've got stuff out of Mississippi, sure, you can get it from there. So if it goes to Schedule III, guaranteed, I think the AMA will embrace it even more, but ask for even more studies as well. Okay, just tell us your name and where you're from and your question. Good morning. Good morning. I'm Brenda Waller. I'm from Lynchburg, Virginia, private practice. Full disclosure, I am an industrial hemp grower, have been for the last five years. Great. I'm also a provider that certifies patients for their cannabis license. So my question is, has there been value in consulting with the dispensary pharmacists on dosing of the patients? And second question, we do have adult use in Virginia as well, and how are we to regulate the adult use, because they are able to grow their own, and also help them with opioid use? Let me start with that. That's an excellent question. There's just not enough of us around to go. I practice in the state of Connecticut and we have a pharmaceutical model, which is, I think, kind of unique. Some of the states have adopted that. What that means is that all of the dispensaries are treated like pharmacies and the producers are treated like pharmaceutical companies. So they're very tightly regulated and every patient who is registered has an opportunity to meet with the pharmacist who goes over their medications and can make recommendations regarding certain products, but that does not exist. I know there are some states that have nurses working in dispensaries, but Stu can talk to this. There is no standardized format from state to state in terms of medical use, which is why it's critical for us and other physicians to get involved with this. I will say that the National Nursing Association has really taken the bull by the horns on this and they have a subsection of cannabis nursing, but there are no physicians really... There is a Society of Cannabis Clinicians, which I encourage you to join if you're interested in this, and they have a lot of great information and education where you can get some training too. But apart from that, every state operates differently. Hi. My name is Sri. I'm a medical student from the University of Kansas, actually. My question really... And I apologize if it's really broad for this session, but Kansas has no measures at all currently right now to even consider medical cannabis, like much less recreational right now. I'm hoping things like getting the drugs rescheduled to Schedule 3 is a good way to start the process, but let's say it does get rescheduled. How can physiatrists in the state of Kansas or any other state that currently has no apparatus at all to go about prescribing medical marijuana to patients? What are some of the first steps that physiatrists who are interested in advocating in a state with no infrastructure at all can take? Right. So talk to your state medical association because a broad coalition gets things done in a better way than a single interest. So you want to be able to talk to your state medical associations because not only do they have the broad access to different clinicians and patients across the state, but the staff will know the legislators in the state house in Kansas to figure out who you really got to talk to. You know, who really on the health subcommittee for the state of Kansas is important. Where does KU fit into what they think of? Not only do you want to know who is with you, you want to know who's against you because you may have to spend more time talking to the people that are going to resist you to convert them over to your side. So definitely go through the state medical association. To educate them. And educate them too. Exactly. Yep. Thank you. Sure. Hi. Hello. Okay. There we go. Hi. My name is Isabel Moctadary and I'm a medical student from Albany Med. Was curious about the range from THC to the combination with CBD to just CBD products themselves because at a sleep talk I went to about a year and a half ago, there was a difference in terms of being efficacious for sleep quality on the THC side of the spectrum versus just like CBD only products. So I was curious for pain, like let's say you have a patient who says, I want as minimal THC as possible. Does the literature even show that the higher ratio of CBD to THC or only CBD products is that even efficacious at that point for pain? Such a great question and we didn't discuss that. The evidence for CBD as an analgesic is very, very weak. You know, if an individual patient tells me it's working, I believe them, but I've had too many come and try CBD first, you know, because they want to avoid THC or they're stigmatized or whatever, who come and say, oh yeah, I tried CBD. Well, who knows what they tried, what the dose was. Often a hemp product, you know, maybe a 10 milligram gummy. But the evidence for pain for CBD is very weak, whereas for THC it's much stronger. When we get over into the area of sleep, again, you know, we just don't have a lot of research. A one dose CBD of, I think it was three or four hundred milligrams, because it's not an equipotent molecule, you know. THC is very potent at low dose. CBD does not appear to be. Didn't change any sleep architecture. Another company has come out with a 300 milligram dose of CBD that they did a study on people with insomnia and claimed that it improved insomnia. It's a white paper. So you know, if people don't want to use THC, if they're going to try CBD it would probably be at those much higher doses that would be beneficial. But for THC, you know, there's the same biphasic potential effect where in the early days very high doses of THC were used in sleep studies, 75, 125 milligrams and they showed this suppression of REM sleep and everybody kind of banks on that today. Like cannabis is bad for sleep. Don't do it. But there's two studies where they looked at Marinol at 2.55 and 10 milligrams for actually for sleep apnea and they claimed it reduced the apnea index and also had a positive effect on sleep architecture. So all of these ratios have not been studied whatsoever. The one-to-one is the only one that we have strong evidence on and I personally stick with the evidence base. I haven't found a one-to-one to inhibit sleep at all, but I have not found like a 25-to-one CBD to THC to help sleep either. Yeah. One point about CBD that I wanted to make that I don't think was covered is that if you're going to recommend CBD to your patients, you know, they're not... They shouldn't be going to the smoke shop to get their CBD. Any product that has CBD that is kind of commercially available needs to have a certificate of analysis. It's very important and this is what we typically find in a dispensary. But the problem is if you're going to a recreational dispensary, they're not going to have very good CBD products. It's usually in the medical dispensary end where they have high CBD to THC ratios. So if you're looking for a product and you're advising them to try CBD with a low THC and legally any product that is dispensed outside of a dispensary has to have less than 0.3% THC, otherwise it qualifies as marijuana. But you want to look at a product that's full spectrum that has all of those cannabinoids we mentioned and not an isolate, which is just looking at CBD. You're not going to have that kind of what we call concierge effect of an herb. But you want to make sure they have that certificate of analysis and if you're working with a company that cannot provide it, go somewhere else. Thank you. Hello there. My name is Scott Erickson. I'm a third year medical student out of Washington State University. This might be a naive question, but say this schedule change proceeds as indicated, when then would you be able to start putting out new grants that treat it as that schedule change? Like months, years, it might be political undermining. I imagine that if it were to be rescheduled, which would be sometime next year, there would probably need to be a few more months of trying to figure out if there's going to be grant funding, NIH, NIDRR, to put all that together. You know, not to mention the fact that those states where there's no access now, well, guess what? Now it's not federal legal anymore and then they have to figure out how to have access so that they can be part of the research studies, because they can't as it is right now. So I would imagine if it gets rescheduled that probably within six months after that, you might see access to at least some studies, you know, for requests for proposals maybe. I don't know if anyone else has any idea about that. It's a good question. I mean, I think for starters, the one benefit would be just getting some of these studies approved by your local IRB. I mean, it's been unbelievably difficult to do anything in the cannabis space, even look at a hemp CBD product where I work at Thomas Jefferson University. So rescheduling, I think, would, you know, again, prevent researchers from having to get a DEA license, it should relax, you know, the IRB's approval of these studies. I think funding is going to be a different issue. The problem that I ran into with looking even at CBD is because Epidiolex was approved by the FDA, all these studies, if you really want to do a good study, it's basically like doing a new drug trial. You're creating a new use for a suddenly legal drug, and those are multi-million dollar studies, you know, and so there's many hurdles. This is just one of them, and in the end, I think we're going to need lots of funding to do the research that we need to be doing. And of course, the other issue is where do you get the product to do the research? Mississippi? Well, if it becomes legal, you can't grow, you know, 50 million pounds of marijuana overnight. So that's the other question is now where is the actual, you know, cannabis going to come from in order to be part of the study? So that's the other one. Well, we also have seven new DEA licensees and so I'm suspecting they're quite excited about this move, because I know, for instance, the new provider licensed grower here in California already has another minor cannabinoid product that they're getting ready to put into clinical trials. So I suspect several of them already have products in the pipeline, you know, that they've formulated maybe for a specific purpose, but still, you know, it's going to take a while, right? Because they have to have FDA approval. So these companies have to raise money and then do the clinical trials. Absolutely. So it's not a fast path for medicine for our patients. Yeah, absolutely. I don't think there's going to be a pharmaceutical grade, you know, cannabis that you're going to get in a pharmacy, much like they have in Israel by the way. But I think even if it goes to schedule three, physicians are not going to easily adopt this until they have some education. So I think there's still going to be medical dispensaries. I don't think that's going to change overnight and again, if they're going to see a physician for a schedule three drug that they need to go to the dispensary, they want to have some level of comfort, both the physician and the patient, which is why, you know, we're providing this type of education and encourage you to do the same in your particular state. Right. And the other area is where marijuana is being grown in California and I forget which bill opened up those other six locations. Now you've got to transport it to another state. That brings in the legislation of transport of a now illegal substance, now that's going to be legal, that takes congressional action. So it may be more than six months. I probably misspoke earlier on that, but there's a lot of steps along the way, for sure. Okay. Got it. Thank you. Thank you very much. Yeah. We're going to wrap up. Yeah. Alright, this is the last question. Go ahead. You got it. So first of all, thank you all for doing this. The question I have for you is one point that wasn't brought up, but I thought it was what we were talking about. I do a lot of work and I do a lot of publishing in addiction and what we have seen in the addiction substance use world is people who do use cannabis have a decreased relapse rate and quite frankly a much less death rate. And this is within one year of sobriety. So I just thought that's worth pointing. We don't know why. We've actually looked at that data ourselves. I'm sorry, where do you practice? I'm at Rowan University in Southern New Jersey. Rowan Virtue. Yeah. Yeah. As a colleague of yours. Yes. Okay. So we have done that. We published some of that data and it's really encouraging. And I think it's important we know that, because in addiction programs a lot of times they use marijuana as something as a, quote, violation and it shouldn't be. So I just throw that out there. Second is, and this is the question I have for you, is I've looked at some of the data on vaping, because this came up a little bit, but you guys didn't talk about it. Vaping versus smoking versus oral. In the addiction world there's a little scary data that vaping actually may cross the blood-brain barrier much quicker than smoking and definitely much quicker than other formulations. Which could then lead to a higher level of, quote, addiction. So I'm wondering if you know about that. The other is inflammation. There does seem to be quite a bit of data that vaping may actually increase inflammation as opposed to other forms. So I was just wondering if this is crossed over in some of what you guys are looking at, because it really does come down... You get a lot of questions as to how should I do this, right? So I was just wondering if you've looked at some of that data or have an opinion on it or we just don't know enough yet. When you say vaping, are you talking about dry vape of flour? Are you talking about vape pens that are highly concentrated? Vape pens and yeah. We have a couple of studies and this was part of my postdoctoral fellowship looking at the effects of cannabis on inflammation. And so in patients with multiple sclerosis and healthy subjects who were using cannabis, they had a... We saw a global reduction in all pro-inflammatory cytokines. We have a smoked cannabis study of people with HIV at UCSD where they analyzed cerebrospinal fluid and also blood. Again, showing reduction in pro-inflammatory cytokines. So you know there's probably some tipping point in terms of endocannabinoid system regulation of inflammation and neuroinflammation and dose. We don't know exactly where that is. It appears that just smoking cannabis flour was not at that dose, but it would not surprise me to know that vaping highly concentrated products might swing the other direction in terms of that biphasic effect. And of course it does cross the blood-brain barrier very quickly and we think it may be beneficial in the lower doses because that CB2 receptor and agonism of that receptor by THC is turning down the volume on inflammation. Not immunosuppressant, but immunomodulatory. And I'll just add to your point. Like one of the things that's very true is it's hard to find what we might consider medically appropriate products in dispensaries. There's oftentimes not much difference between a medical menu and a rec menu. There's a plethora of overly potent products out there and there's a ton of marketing and in the dispensary, as much as we like to think that we're educating patients and Pennsylvania has pharmacists that work in every dispensary, there's still a bunch of misinformation being spewed about terpenes and this strain and that strain and it's all made up. None of it's based in research and that's largely what the public is shopping. Yeah. Those are the shopping choices. That is absolutely true because, you know, as a business, the states are making money on the recreational end. They're not making it on the medical end. That's why in most states they only tax the recreational up to 20%. So it's a lot of revenue for a state and a governor who's approving this. And as a result of that, I would echo what Ari is saying is that some of my patients were looking for products that have, say, a 20 to 1 CBD to THC ratio on the medical end. Some of those popular products they run out of, but they have plenty of the high THC and the vapens with Dr. Sexton's talking about that can be abused. So it is a problem in terms of control. At least in our state, if you have a registration at one particular popular dispensary, you can go to any of the other dispensaries and find out if they have the product that you want. Alright. Thank you all very much. I appreciate it. Don't forget to fill out your evaluation forms. Good job.

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