CEimpact Podcast
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CEimpact Podcast
Psychedelics in Pharmacy Practice
Explore the emerging role of psychedelics in pharmacy practice and their potential to transform mental health treatment. This episode dives into the science, safety, and regulatory considerations pharmacists need to know as these therapies move toward mainstream use. Don’t miss this opportunity to stay ahead of the curve—tune in and expand your understanding of this groundbreaking area of care!
HOST
Joshua Davis Kinsey, PharmD
VP, Education
CEimpact
GUEST
Colby Burns, PharmD
Clinical Pharmacist, CHAS Healthcare
President, Psychedelic Pharmacist Association
Owner/Host, Neural Pharm Online Platform and Podcast
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CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Explain the current evidence and therapeutic potential of psychedelics in treating mental health conditions.
2. Identify key safety, regulatory, and clinical considerations for pharmacists as psychedelics become integrated into patient care.
0.05 CEU/0.5 Hr
UAN: 0107-0000-25-023-H01-P
Initial release date: 1/13/2025
Expiration date: 1/13/2026
Additional CPE details can be found here.
Hey CE Impact subscribers, Welcome to the Game Changers Clinical Conversations podcast. I'm your host, josh Kinsey, and as always, I'm super excited about our conversation today. Once considered controversial, psychedelics are now being recognized for their potential to revolutionize mental health care, offering hope for conditions like depression, ptsd and anxiety. As these therapies move closer to mainstream use, they bring both exciting possibilities and critical challenges for healthcare providers. In today's episode, we'll explore the science behind psychedelics, their therapeutic potential and the pivotal role that pharmacists can play in ensuring these treatments are used safely and effectively. It's so great to have Colby Burns as our guest expert for today's episode. Welcome, colby. Thanks for joining us today.
Speaker 2:Thank you, joshua, very excited to be here.
Speaker 1:Yeah, we're so glad you took time out of your schedule today to be with us. So Colby is what I would consider to be an expert in this space. He has a strong passion for this topic and I'm going to let him introduce himself, talk a little bit about his practice site and then also just kind of why he is passionate about this topic and kind of give us a little bit of background as to how long you've been in this space and what you've done in this space.
Speaker 2:Yeah, thank you. So my name is Dr Colby Burns. I'm a doctor of pharmacy. I graduated from the University of Montana Skag School of Pharmacy in 2018. I am a Navy veteran. I served in the Navy Reserves prior to pharmacy school and continued service in the Navy after pharmacy school through the Health Services Professional Scholarship Program. I was stationed at Naval Medical Center, camp Lejeune, served as the outpatient pharmacy supervisor and then supported a couple missions related to the COVID-19 efforts, led one of the mass vaccination clinics in Philadelphia. After my time in Navy I went and did a residency at Providence St Peter Hospital, worked in Genoa Healthcare Behavioral Health Setting for a while and now work in ambulatory care at a federally qualified health center in spokane, washington. Interest in psychedelics really became through my military service and time working with the military and veterans.
Speaker 2:I saw kind of the status quo for treating veterans with mental health disorders and challenges was to provide a lot of different medications.
Speaker 2:You know, the average person I would say was on benzodiazepines, mood stabilizers, antidepressants, sleep medications you know cocktail of drugs. They were taking higher doses often than the FDA would recommend. They'd come in every month, get them filled from the pharmacy. You know Lejeune and I couldn't help at some extent question the approach we were taking with them. I mean, was there any outcomes to this therapy? Were we going to just leave people on this for the rest of their lives? And what kind of side effects in poly pharmacy? We all know poly pharmacy is something we're trying to get away from.
Speaker 2:You know, when you have multiple medications and all these mixture of side effects. And it concerned me, and especially talking with some of their spouses and family members, seeing if they couldn't get their medications what would happen. You know the decompensation that would take place. But even when they are on medications they're just kind of snowed, very emotionless and reading similar accounts of veterans all over the country, similar stories. So I really started hearing since I was studying this issue of veterans' mental health about veterans going to other countries to get access to psychedelic therapies. I didn't know really anything about psychedelics myself. It wasn't something that we talk about in pharmacy school at all. It's not really a part of medical school curriculums or nursing school curriculums either. This is an entirely taboo subject.
Speaker 2:I would say even marijuana is pretty taboo. We got one lecture on it in pharmacy school in four years and that was it. So these anecdotal stories are really powerful of people saying they tried everything to help with their mental health challenges, with post traumatic stress disorder and related symptoms, and nothing had worked until they went down to do these really intense experiences with Ibogaine and psilocybin and ayahuasca and they came back and were able to be functioning members of site again, like they felt like they're clouded and lifted over their condition. And I just started doing more research on it. Read Michael Pollan's how to change your mind. I would recommend that book.
Speaker 2:Another one, the the Promise of Psychedelics, by Peter Silverstone, another fascinating doctor who researches this field. So that got me interested in it and kind of went to the MAPS conference, which is a massive psychedelic science conference in Denver, colorado. It's actually going to be taking place this year as well, 2025 or next year. We're almost in the end of 2024. Almost there, yeah. So there's a lot of research in this field and it's just very interesting and exciting to see that there's a potential to treat chronic mental health conditions as if they can be cured rather than if we can just leave people in the status quo, because I feel a lot of our current approaches to therapy are towards, you know, continue to fill your SSRI every month, continue to go to therapy, and some people do get better, but you know the majority.
Speaker 2:We show that veterans. Their remission rates are only about 40% with first-line therapies. For veterans with PTSD. The veterans with PTSD make up 20% of suicides. In the United States there's been more veterans lost to suicide than there has been from combat deaths during the war on terror Wow. So I just am interested in these other approaches that we can try to, and it goes beyond veterans. I'm a veteran so I speak about that myself, but there's a whole population of people that have post-traumatic stress disorder first-line responders, emts, firefighters, police officers, people that are victims of horrible sexual assault. So there's all kinds of implications beyond just with the veteran population. But that's kind of where it started for me.
Speaker 1:Yeah, no, that's super fascinating, Colby, because I mean you open up. I feel like there's about six other topics we could go down the line with there on a different podcast and just veteran care in general. And you know, I know that there are a lot of hurdles in that space. Some of those stats you just shared are just sad I mean to be blunt about it. This is, I think, a very timely topic because I think it's the discussion we had a recent podcast on ketamine and how that's kind of coming back and being used in different spaces. So I feel like, as you've said, the status quo is no longer, should no longer necessarily be the accepted, you know position, and so it's really important for us to talk about these things and to really start making sure that we're making space for this.
Speaker 1:Again, pharmacists, unfortunately, I feel like sometimes we are most of the time we are trying to play catch up, we're always behind and we're always trying to react to something rather than being proactive. So that's one of the reasons why we wanted to have this conversation today is are there things that we can be doing as pharmacists to be planning for changes in this space? So that's really why we wanted to talk about it. So thanks again. Let's jump into a little bit about. You've given a little bit of the history, but just review a little bit more of the history of psychedelics. Maybe why the stigma exists and maybe when we started seeing the reemergence of these practices in healthcare.
Speaker 2:Yeah, I did mention ketamine. Actually, going back to my previous answer and what you said, the VA has certainly started to expand access now to ketamine therapy for veterans and that is a you know that's one of the agents that is legalized, whereas a lot of the other agents remain illegal.
Speaker 2:But to turn to sort of some of those illegal agents, yeah, the first psychedelic that was discovered I guess is the best word in Western medicine was LSD, which is synthetic. A lot of these other agents are plant-based, but Albert Hoffman was a Swiss chemist who was researching circulatory stimulants. For Sandoz and 1938, he discovered this 25th derivative of lysergic acid and he tried it on some animals and they didn't seem to have much of a response. He kind of determined the molecule wasn't worth anything. He put it aside and then five years later, 1943, for some reason he decided to try it again. He brought this thing out of the mothballs and resynthesized it and took it himself and that was the first modern psychedelic trip or experience.
Speaker 2:Uh, you know I won't go too much in detail on that, but it was very coincidental you know this whole experience that this happened and slowly got out of the lab into society. We know, of course, that the psychedelic movement really took off in the 1960s. Gordon Wasson was a Time magazine reporter who traveled to Mexico in the 50s and was the first Westerner to have that traditional psilocybin or magic mushroom experience and all this started to come back to the United States. There was research going on in the 60s and 70s on LSD for alcohol use disorder schizophrenia. There were actual studies happening at major research institutions.
Speaker 2:But, studies also went outside the lab and it was really Timothy Leary who was sort of this bold, brash voice of psilocybin and LSD and kind of this tune in, turn out, drop out phrase that became very popularized by the media in the summer of love in San Francisco. There was also a high profile celebrity, diane Linkletter, who was the daughter of American media personality Art Linkletter. Yeah, apparently she jumped to her death out of a window while she was on LSD and that's very controversial the fact that. Did LSD have anything to do with it?
Speaker 2:You know she also had suicidality and mental health challenges, but that really these events like pushed LSD, pushed people against LSD in society, especially President Nixon, who really was politically kind of motivated, we feel like in retrospect, to start this war on drugs and create the drug enforcement administration. So it perhaps kind of went too far out of the lab into society when people weren't ready to deal with the implications of it. That's kind of led to the war on drugs as we know it now.
Speaker 2:And for 40 years or more. The substances were really blacklisted and we, you know, we weren't learning about it, except for the drug abuse resistant education programs and schools which just kind of categorize all legal drugs are bad. You know, we never really learned the differences in the pharmacology between any of these molecules, or addiction profile. Just Nope, they're bad. Don't do it.
Speaker 1:Right yeah.
Speaker 2:And then you know how it started emerging. I guess one thing to say is that there were people in underground settings, you know, not in traditional healthcare, but there are people that have been using these agents in therapy the whole time and they've just been assuming the personal risk to do it, and it's not something you're going to be able to get reimbursed through insurance, for you know it's happening entirely in the shadows, sure, but it has come back.
Speaker 2:You know Rick Doblin was the head of the Multidisciplinary Association of Psychedelic Studies or MAPS. Has been very charismatic and very intelligent PhD researcher, really continued MDMA research and founded the MAPS conference. Had a lot of researchers on board with trying to get MDMA approved for PTSD treatment. That effort did not succeed, as maybe it's been covered on this podcast or some people already know. The FDA declined the new drug application. But to manage to get that far, to where, after 40 years.
Speaker 2:we're finally seeing a petition from the FDA to potentially approve a therapy that had been illegal since 1985 was a pretty big step forward. So I think that, as I mentioned, the veterans who have been using these drugs and talking about their benefits, that's pretty powerful testimony that seems to be being heard in Congress to some extent. There's a congressional forum now to look to advance psychedelic therapies. There's a group of Republican and Democratic congressmen who have formed the PATH Caucus. So there is some efforts in Washington DC to try to move therapy forward and expand access, at least starting with veterans and first responders, and maybe we can move beyond there.
Speaker 1:Wow, yeah, yeah, that's all great information. I mean I told Colby in the green room before we got started that I know nothing about this space. Clearly, I mean, as you mentioned, it's not something that we're taught in school, it's not something that's widely out there to like read about. Really, you kind of really have to have the passion to go down that path and assertively seek out information. This is all just eye opening for me. So this is great information. Thanks for sharing. So you touched on briefly, colby. I want to kind of take a path here to touch on exactly what kind of conditions are we looking at, potentially these drugs coming back and treating? So I've heard you mention PTSD and depression, but what else maybe is on the horizon for utilizing these medications?
Speaker 2:Yeah, that's a good question. You know PTSD, depression, potentially anxiety. There was a therapeutic that's an LSD derivative from a small pharma company that did get breakthrough therapy designation from the FDA for treatment of generalized anxiety disorder. And then we have people who are using them for their own self-medication. I guess per se the term microdosing, which I don't want to go on that too much. But there are anti-inflammatory benefits and potentially other benefits at sub-threshold doses, meaning that these are not the doses that one would take to have a mind-altering experience, what's called a psycholytic dose essentially.
Speaker 2:So it's not a full-on psychedelic dose where it causes certain of the visual and auditory effects that occur in an altered state, but it might be more similar to say, a SSRI at a low dose where it enhances some feelings of mood and perception, maybe anti-inflammatory, but it could have implications for traumatic brain injury, pain, gut inflammation, serotonin receptors obviously are rich in the gut and these agents psilocybin is very specific for serotonin receptors, so it could potentially have impacts there. You know, we don't know enough about the research, but it doesn't seem that you would have to have a mind altering dose to be able to have benefits. That's the but. That's a question that's still trying to be worked on.
Speaker 1:Sure, sure, that's great information to know is that you know, again, the stigma that still surrounds these medications, and so you know people who are like, well, why do we want to alter their, their mental status or whatever? And in that way, um, it's interesting to note that maybe it's sub-therapeutic doses or, um, there are other benefits. So, yeah, that's great. Are there currently any clinical trials in the space? So you mentioned one drug tried to get pushed through the FDA. Is there anything else that is maybe on the horizon that we should be aware of and kind of keeping track of to see if that's going to come to fruition?
Speaker 2:That's a great question the MDMA-assisted therapy for PTSD, which was sponsored by Lycos Therapeutics. They completed two phase three trials. Unfortunately, as I said, the FDA at this point is requiring them to submit data from additional trial if they hope to get full approval. We don't wanna go on that really too much, but that's something readers, listeners, if they're interested, can read more about. Several other companies have kind of phase one and two trials. We're not really seeing anything in a phase three trial yet, so it's going to take a few years to get to that point. As we know, clinical trials are a slow process. But these chemical names there's deuterated psilocybin, which is one that's just was granted breakthrough therapy for major depressive disorder, and then an LSD derivative that was, as I mentioned, I think, earlier, granted breakthrough therapy for major depressive disorder, and then an LSD derivative that was, as I mentioned, I think, earlier, granted breakthrough therapy for anxiety, generalized anxiety disorder, and these just have chemical names. So you know MM120, they haven't named it yet officially.
Speaker 1:Okay, but Colby, if I can back up really quick, would you be able to speak to what the granted breakthrough therapy means? Like what does that mean exactly?
Speaker 2:So breakthrough therapy essentially means that the FDA sees this as meeting an unmet medical need as exists currently currently. So the FDA assists manufacturers with providing more support during the clinical trial process, more communication with them, and it also, in theory, helps to accelerate the process of approval. That's just the high-level overview.
Speaker 1:Yeah, I know that's great. That's very helpful. Yeah, that's very helpful.
Speaker 2:They recognize that again, there's not a lot of truly effective therapies for post-traumatic stress disorder, as I kind of led in my beginning statistics that the remission rates are very low. So looking at alternative therapies and modalities is something that the FDA does seem very interested in.
Speaker 1:Yeah, and so I mean it bodes well that you know, if they're giving support early on like this, that potentially if the clinical trials produce data that is positive in this space, then that would be. It looks like the FDA might lean in that direction. So, yeah, that's very helpful to give that background. Yeah.
Speaker 2:And, I guess, the Spravato which some people might be familiar with S-ketamine you know that has already been FDA approved and currently almost a billion dollars in sales.
Speaker 1:So, that drug, yeah, that drug might be proving some of the commercial utility of these agents from a business standpoint, it might be that the catalyst that's needed to kind of bridge that gap from the stigma and the years of it being blacklisted, to like oh wait, we need to look at these closer. They do have therapeutic benefits, so okay.
Speaker 2:And Spravato has been approved for combination treatment for major depressive disorder, but Johnson Johnson is trying to get approval for monotherapy for major depressive disorder, so that'll be something to watch. They submitted a SND-A to the FDA.
Speaker 1:Yeah, and so yeah, I mean I would imagine cells would increase even more if that becomes, if the monotherapy is granted. Okay, obviously, our listeners are pharmacists. I think all of this has been super helpful in giving, like, the background and the review of it and, again, because this is not really something that we were all taught in school, there was not a lot of discussion about it, but one of the goals of our podcast is to prepare pharmacists for whatever it is we're talking about. So what are some opportunities? What should pharmacists be doing? Is it simply educating ourselves on what's going on? Should we be preparing in some other way? Like, what kind of advice do you have for pharmacists who find this interesting or just who want to be sure that they're ready for the changes when they occur? What should we be doing?
Speaker 2:That's a good question. I think that education is going to be a pivotal piece of it. There are quite a number of good resources out there. I might have one but I'm going to touch separately. But in terms of being prepared, I think, reading up and educating yourself on the next action of these drugs, trying to look away from the stigma and look at critically how the drugs work on the body and their receptors they're targeting and we know that there are probably already patients that might be using it and might be afraid to mention. It's always difficult because there are only recently. I feel people have been more comfortable with saying that they're using cannabis.
Speaker 2:For a long time Patients didn't want to say anything about it. There could be we know some of the risks of these agents, but there could be other risks that we're not even aware of. They'll come into the forefront. To be honest, we didn't know anything about cannabis hyperemesis syndrome until we started seeing the er. You know, I had a patient the other day who was mentioning that to me that he had sickly bombing syndrome in his record and he said actually they determined it was hyper cannabis hyperemesis because when he stopped smoking after eight years of smoking, all of a sudden. Now he doesn't have that condition anymore, so we we didn't know what it was and there could be things like that happening, where there might be something we don't know yet and haven't seen yet Granted.
Speaker 2:Again, as I pointed out, these plant medicines have been used for a long time, but I think, that making sure to keep up to date on case reports of toxicities, too, and communicating with your peers, sharing resources, is a real positive thing we can do. And then, yeah, just keeping up to date with clinical trial developments and hopefully more podcasts that are pharmacy focused. We'll talk about them like this one, instead of kind of ignoring it.
Speaker 1:Yeah, keeping it in the background because you don't want to cross that barrier of discussing, yeah for sure. So, colby, prior to discussing, before we started into the space here, you had mentioned that you do have some colleagues that have some, I guess, their hand in the pot here with the different things. Are there some things you can mention there? Again, those are movers and shakers in the space that other pharmacists can follow and can try to get involved in that way as well. Is there anything you want to share on that?
Speaker 2:Yeah, you know, in terms of opportunities, I guess, for pharmacists in this space, since we're always wondering that's always the question you know, how, how does pharmacists, how, what can they do in this space? I know entrepreneurial opportunities are out there there's I have a colleague who's in clinical trial consulting particularly for companies that are performing clinical trials around psychoactive agents. Policy and advocacy there are right now. It feels like we're really approaching this on a state by state level. We know that Oregon has a law that regulates psilocybin service centers. You know they are allowing access in Oregon. Colorado is set to become the second state to do that in 2025.
Speaker 2:So, being involved in policy and advocacy and helping to get more pharmacists, maybe that are writing the rules if we do establish a medical model for these agents. And then, of course, providing education. You know, as myself and Dr Ben Malcolm I'll just mention he's one that probably a lot of people that are familiar with his work already, if they're in the space at all, yeah, and as well as another interesting business of connecting employer health plans to psychedelic assisted therapy. That's an interesting business opportunity that I've heard about from one of my colleagues. So ketamine, of course, which is already available, but a lot of plans don't cover it.
Speaker 1:Sure.
Speaker 2:So trying to bridge the gap there, to get more people that could qualify for care and maybe benefit from care to be able to get in there and afford it.
Speaker 1:Yeah, and have access to it, yeah, so again.
Speaker 1:So what I you know in previous episodes I would consider these to be non traditional opportunities for pharmacists. You know, like, typically we're saying like, okay, here's the questions you ask your patients and here's what you look for and whatever. But this is great information because, again, I feel like the profession as a whole sometimes is reacting to things and we're not always super proactive, and I think these are some ways that we can be proactive in this space and really kind of make sure, like you said, that we're shaping the policies that are being written about these therapies and about the clinics that are going to be popping up. What we see in two states, you know, I would say in a decade we'll see that in many more states, and that's exactly what happened with the cannabis movement.
Speaker 1:So, yeah, this is great information for our listeners if they're interested in the space to kind of get out there, do a little bit more research, educate yourself, get up to date on what's being talked about and, you know, maybe there is some opportunities there to explore. So just touch on briefly. We mentioned, obviously, that these medications are currently illegal and so there are some things that we have to consider from legal and ethical standpoint. Can you just touch on that briefly for our pharmacists so that they are making sure that they're staying within that space that they should?
Speaker 2:Yeah, there certainly are obviously legal concerns, being that everything other than ketamine that we've discussed is a Schedule I drug. You know, marijuana is still a Schedule I drug. Federally it is illegal. You know, psilocybin possession arrests, from what I've read, are up. Even if your community has determined that it's decriminalized within that region, that does not stop the federal government from being involved.
Speaker 2:Federal laws supersede local and state laws, so that's obviously something to keep in mind at the forefront, and being very cautious when talking to patients about it. I think, as I said, if somebody were to tell you that I'm doing this and I want to know how to use it safely, there's an element of harm reduction where we can be involved with to try to help them. Maybe we could mention that. Hey, be aware of the legal implications too, but it's certainly unfortunately. It really prevents healthcare professionals with a license from recommending them, right, or from start initiating a conversation about them.
Speaker 1:Yeah, we kind of have to wait to be approached.
Speaker 2:Yeah, yeah, and then the other risks or side effect profiles. You're talking about something that does carry some ethical considerations, because you're putting people if they're going to take a dose that's above that threshold dose which I kind of alluded to. If you want to have an experience that does put you in an altered mental state, then really important that there's someone else around when you're doing it you're not doing it on your own.
Speaker 2:You know we've already seen that with ketamine of people taking home ketamine dosing, and things have happened that are not good outcomes. You know, either emergency room visits or up to including death. So having someone there who can help you if you run into an experience is difficult If you have supply that might not be reliable or reputable. Until we get more regulated access, that's going to be a concern.
Speaker 1:Yeah, yeah no that's all that's all great information.
Speaker 2:Oh, and there are physical effects as well. You know, these agents are somewhat stimulating, so they do increase heart rates and blood pressure. So you know, it's not just the psychological effects, there's also, you know, are they safe for people that have a history of heart disease?
Speaker 1:you know myocardial infarction?
Speaker 2:Probably not If they're certainly uncontrolled hypertension you're talking about. Raising their blood pressure can put them at risk of a secondary cardiac event. So these are screening questions that you go back to policy standpoint and we're evaluating. You know, oregon has really extensive screening criteria for the use of these drugs. And another thing maybe pharmacists could help with the screening behind it.
Speaker 1:Yeah, yeah for sure, and I think it's you know. I think it's also important to point out those things. So thank you for bringing those up, because, as pharmacists, you know if you are approached by a patient, you don't want to seem like you don't know anything about it. So it's important to know that you know there are considerations for some of the other potential effects of these drugs, and we want to make sure that they're aware of that and then also just ensuring that you know we're protecting ourselves as a professional to ensure that we're not overstepping legal and ethical consideration. All right, so, colby, I think we're running out of time.
Speaker 1:This topic is so interesting and you have brought so much information that I was not aware of, and I know our learners are gaining a lot of information as well, so thank you for that. One thing I'd like to do before I wrap up each session is to talk about the Game Changer, since our podcast is the Game Changers podcast. So what is the Game Changer in this space, colby? What's the one thing you want our learners to walk away from today, from this episode?
Speaker 2:I think the one thing to walk away from is to just pay attention to what's going on in this field, in this space, and to really look at the pharmacology and risk profile of agents that are even listed as Schedule 1. To understand that the scheduling and this has taken me a while to understand the scheduling and wrap my head around it.
Speaker 2:I don't want to make it sound like I'm anti-DEA or anti-FDA, but the scheduling isn't necessarily based on the actual science of the addiction profile of these agents. I mean, we've grouped a lot of different agents with different pharmacology together and say schedule one, schedule two, schedule three, schedule four, schedule five. There's a little bit of political element behind that. That might sound a little charged, but no, no, it makes sense.
Speaker 1:Yeah, no, it makes sense, and I think it's important for for our learners to know that. You know, it's important for us to dig deeper and to be aware of things and to be ready for changes and, again, be proactive in the space. So, no, I think that's great information.
Speaker 2:Yeah, to be proactive, I think that's true. And yeah, you can keep it up online and be proactive and to think outside the box, you know.
Speaker 1:Yeah, for sure. Yeah, that's great. Well, we know that this topic is a little it's a little hot issue for some and people don't want to tread down the path.
Speaker 1:So I appreciate you, colby, taking time out of your schedule to talk about these things with us. I think these are questions that we have received from our listeners about this psychedelic space and like we need to know more. We need to know more, we need to be up to date, and so that's why we wanted to kind of tackle the topic. So thank you for for joining us. We really appreciate all the insight you brought today. So thank you. Okay, all right, thank you. If you're a CE plan subscriber, be sure to claim your seed credit for this episode of game changers by logging in at CE impact comm and, as always, have a great Week and keep learning. I can't wait to dig into another game changing topic with you all next week.