Medical Marijuana is More than Smoke and Mirrors

Javonte Maynor joins family doctor and medical marijuana expert Dr. Erich Schramm to discuss the changing space of marijuana research and medical marijuana in the United States. The duo discuss the frustration with politics entering the medical space when it comes to marijuana, and how changing administrations can delay research. The two get into the nuts and bolts of marijuana research, including the hoops needed to perform research, conditions being treated, and a study that may be coming soon. Dr. Schramm also explains his role prescribing marijuana for the last several years and what that entails from a legal standpoint. The two then imagine what may happen to these processes if marijuana is rescheduled from a Schedule 1 to a prescribable Schedule 3 drug; including to dispensaries, the pharmaceutical industry, and current prescribing doctors.

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Transcript

Welcome And Introductions

Announcer 0:00

Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts, hosted by cardiologist and top medical researcher, Dr. Michael Koren.

Dr. Erich Schramm 0:11

Hello and welcome back to another episode of the MedEvidence Podcast. I'm your host, Dr. Erich Schramm. I'm a board certified family physician and longtime clinical research investigator and certified principal investigator with the ENCORE Clinical Research Group. I'm very excited to be back doing another podcast with Mr. Javonte Maynor. Now, Javante is the CEO of Renew Health Clinical Research. Welcome back to the MedEvidence Podcast, Javonte.

Javonte Maynor 0:41

Thank you, Dr. Schramm. I'm excited to be back.

Dr. Erich Schramm 0:44

Yes. You know, and I'm very excited today to be talking about cannabis research. And we talked a little bit about this at our last podcast. And I'm glad we have an opportunity to come back in today and really kind of do a deep dive into that. But could you just remind our audience again, give us a little bit of information about your background and the kind of work your organization does and how cannabis research ended up in your wheelhouse?

Building A Community Research Site

Javonte Maynor 1:10

Yeah, so uh my background, I started out in the industry as a study coordinator, worked as a CRA and a clinical trial manager. Therapeutic area I worked in as a CRA at a CTM, I was in the oncology space. So as you know, in those oncology studies, you learn about different medications that the patients are taking from the actual cancer drug to the pain drugs they're taking to the medicines to keep them from being nauseated, etc. And then my organization came about during during that journey of being a CRA and a CTM, where I saw a need in my community for just regular clinical practice doctors to participate in the research. So I joined forces with a few doctors, offered them some consultative type of advice on how to get studies, how to get set up. And that was rewarding. Those offices grew and they brought trials to their patients. And I decided about two years ago to go full-time in the role. So now I'm full-time in Renew Health, running multi-therapeutic types of trials.

A Cannabis Alternative For Back Pain

Dr. Erich Schramm 2:16

Right. And you know, again, I recall that you know, you've had a real entrepreneurial spirit all along in your career path, and really been able to leverage that with relationships with, you know, sponsors and uh physician groups. Is that right?

Javonte Maynor 2:32

That's right. I mean, that's how we landed from a study with a company called Vertanical. And what they're trying to do is get a non-opiate uh opioid treatment to market to treat chronic low back pain. So I'm pretty sure most people know opiate drugs cause addictions, they have side effects, certain side effects are are unwarranted. So they're trying to take a different approach and bringing an alternative therapy to market where I think in today's society people are more acceptable or accepting of cannabis than before. So hopefully, you know, this study is study, this study brings a drug to market that can help alleviate that that issue.

Dr. Erich Schramm 3:14

Right. And as a primary care doctor and who have seen a lot of chronic back pain patients and and prescribed all the different possible pharmaceuticals, I would totally agree with that. This is you see a great uh potential for for uh breakthrough therapies here. Was this what got you into considering, you know, uh uh medical cannabis, or had you had some previous experiences with it?

Javonte Maynor 3:39

No previous experience. The study just came across. So we were working with WCG, they're a site network, and we just saw chronic low back pain trial, and we were like, Oh, yeah, we we have patients that that suffer from chronic low back pain, and I'm I'm a patient that has pain myself. But but when we saw it, we didn't see the actual drug yet, it was hidden from us. But once we got the actual protocol, we're like, this is this is a good thing. We didn't we didn't know companies were out there doing cannabis research. So with this one study, I'm now more intrigued to understand, you know, how big is the industry? You know, is cannabis research growing? Will other companies are doing cannabis research? Is this more of like an academic type of thing where only the universities and hospitals are doing the research? I'm now more curious to know like what's going on in the industry.

Dr. Erich Schramm 4:35

Right. Because and maybe the audience isn't aware we could talk a little bit about the this difficulties and challenges of doing scheduled one research, and you know, what is what is a scheduled one substance and why that makes research you know a challenge.

Javonte Maynor 4:54

Exactly. So, you know, with Schedule One drugs, you know, the FDA, they have a lot of rules and regulations, even the DEA around using Schedule One drugs. I know with with our investigator, you have to have a special signature or whatever they call it on your license in order to participate in Schedule One research. And the regulatory aspect behind it is very, very strict. Even within our office space, our clinic, we have to have you know certain storage requirements in order to keep those types of drugs on site. So it's it's a lot that goes into conducting these trials. And then, you know, with Schedule One drugs, you know, the literature out there is saying you know they're addictive, you know, they cause so many health issues. Why do you want to use this for medicine when when they're already saying it's it's it's a bad thing for the population?

Rescheduling And The Political Mess

Dr. Erich Schramm 5:48

Right. No, no, but right, no medicinal benefit, right? That's that's yeah, - And we're talking about heroin, LSD, you know, these these kind of quote drugs of drugs of abuse. So, and you know, marijuana has been on that, you know, for more than 50 years. And I think, you know, a lot of people recognize that, you know, there is really do see and understand the, you know, the the potential you know benefits for cannabis. So now, and you've bringing this up and saying, you know, here's an opportunity in in the cannabis research space. So how would you, you know, thinking about cannabis research where we're at now, say, versus 10 years ago, what what do you see as as the difference there?

Javonte Maynor 6:30

I I think the difference is political. I believe maybe when Trump got back in office, uh, there were headlines saying he wanted to take marijuana off the Schedule One list. I'm not sure that happened yet. I haven't followed the the political landscape in that area, but I know there's talks about taking it off the Schedule One list. And I believe once that happened, it will open it up to more companies, more investors, more scientists and doctors looking into how cannabis can help treat certain diseases.

Dr. Erich Schramm 7:02

Right. And and you know, to that point, so his presidential order earlier this year was to facilitate and expedite the rescheduling to schedule three. Now, as a physician who prescribes Schedule Three, you're talking testosterone or ketamine or buprenorphine, tylenol codine. So these are prescribable drugs. Now, I my other side gig is being a cannabis certifying physician for the state of Florida. So I'm I I know this space pretty well. And when I tell patients that I'm recommending cannabis to them, I'm not prescribing it because this is this kind of nuance in this, in the the federal regulations, because you cannot prescribe scheduled one, just like you can't just give out in clinical trials, schedule, you can't just hand people Schedule One drugs to do experiments on. And as you, as you said, there's there's a lot of hoops to jump through, you know, to have to be able to be able to conduct these uh studies. So, you know, it it hopefully, you know, it looks like you know, schedule three will open up at some point. And I think that's gonna be a great benefit for researchers like us, because that's gonna really, you know, you don't have to have that, what the 750 pound safe bolted to the floor to put your products in, right? I I think I think I think we had one of those. So I mean it worked out pretty well for us, but not everybody has that. But that's that's kind of that's kind of a good example of how you know functionally, you know, what's involved in doing, you know, scheduled one research. So I think I think this is gonna be a huge opportunity.

Mental Health Questions And Patient Needs

Javonte Maynor 8:45

I agree. And I'm also just interested in learning more about the mental health aspect behind it. I knew for year, I know for years when it came to marijuana, it talked about how it caused psychosis, paranoia, and all those types of things mentally. So I am very curious to understand how even psychiatrists will view marijuana once it comes to Schedule 3.

Dr. Erich Schramm 9:11

Yeah, right. And I think again, I see the prescribing or recommending of it in a lot of diverse patient groups. But, you know, primarily the patients I deal with are going to be dealing with chronic pain. This is why the Vertanical study looks fantastic. And because it's it's so applicable. But also people dealing with anxiety, sleep issues, PTSD. You know, we have a lot of service veterans, and I treat a lot of veterans with PTSD. So there is this great, tremendous unmet need. What about the scope? You know, what do you see in terms of like the potential over the next, say, five years in this field? What's what do you see from an economic standpoint, from a research standpoint, the potential growth in that area?

Javonte Maynor 9:54

Well, I I know when it comes to say demographics, the age range of the new patients, meaning children are becoming adults. The data show that they are more they're willing to consume marijuana and cannabis than drink alcohol. So I I feel like if if cannabis became legal and doctors are using it to different ailments, I think economically it will it will grow and boom to a level that it's probably unimaginable at this time.

Closing The Evidence Gap With Trials

Dr. Erich Schramm 10:28

Uh that's right. I I would concur. I mean, I think as I see a lot of young patients in the clinic, their you know, sub their use of choice of substances is is actually right, cannabis more so than than alcohol. So and so you're right. Last time I looked, we're talking about regular cannabis users in that 40 to 50 million people range. So that's a lot. The medical medical cannabis is a much smaller portion of that, but but that gives you a really good scope of understanding, you know, just you know, with something that patients are very familiar with. So, but you know, medical cannabis has been around now for for for a dozen years in in a in a lot of these states. And so how does that look? You know, we have a lot of cannabis real world experience through through these through these and recreational cannabis in two dozen states. So we have a lot of real world experience with it, but there's kind of a gap in terms of the the research and the evidence behind that. So, how how does that work? How do we try to try to reconcile that difference?

Javonte Maynor 11:47

Yeah, so what we're what we're doing currently are clinical trials. So getting the different products into clinical trials, getting those products approved by the FDA, having conferences. Maybe you know of any conferences out there, I don't know of any cannabis research conferences, but just you know, bringing together professionals who who understand the space, who are able to design studies and protocols to help get the facts out there about how well cannabis treatments work. And then I think once that happened and once the publications start to roll and you know the news sources get involved, it will definitely close that gap to where people are like, oh, it's it's not as bad as we thought. And I I've I've heard conspiracy stories before of how like back in the day, I think it was like in the 1920s when you know they were like, oh, if someone smoked cannabis, they're gonna like go wild or something like that. Like those stories are probably like lingering out there about how cannabis turned men madmen, right? Um so hopefully, yeah, with with with research and and facts, we can dispel those myths.

Dr. Erich Schramm 13:00

Right. So yeah, cannabis and and the federal government has kind of had a sordid relationship over the last hundred years, so and not necessarily, you know, based on anything that was factual or evidential. So hopefully we may be moving into a more enlightened phase. But as you said up at the front of the podcast, is you know, cannabis, which makes cannabis, you know, interesting and frustrating for for people, it's there's a lot of political influence that occurs. So, you know, it was President Biden who initiated, you know, the change in scheduling for rescheduling for cannabis, but you know, with a change of administration, you know, there was a lot of chaos and turnover, especially with the DEA, because that's where a lot of this, not just the FDA, but in the DEA, because ultimately they have to make the final decision as to rescheduling of any of these compounds. But you know, but there's a lot of drama in that. So you it's hard to predict what's what's gonna happen in the cannabis world, but seems like we can at least assume that at some point the rescheduling is is gonna occur, but hopefully it will occur. So that's that's that's a really good, interesting point. And so from a standpoint, now you're a your background is you're you're a biochemist, correct?

Javonte Maynor 14:20

That's correct.

Dr. Erich Schramm 14:22

So I really think it's interesting when we're talking about these, you know, the cannabis research, because to understand for patients, say, well, look, it's it's it's not just like, oh, you know, it's just like a THC thing, tetrahydrocannabinol, right? THC like Delta 9, which most people seem to know what that is now these days. But you know, the cannabis plant as a as a whole really is very enriched. And so when we talk about and maybe refer to like full spectrum products or full spectrum, you know, cannabis oils versus narrow distillates. So do you do you find that uh you know, do you know very much to discuss on that or talk about that?

Javonte Maynor 15:08

I'd say the surface level, I know about that information. When I was in that California, so I went to school in California and in college, you know, I experimented a little bit with with the cannabis plant. So I know I know a little bit about it from a surface level. Yes.

Dr. Erich Schramm 15:26

Yeah, because one other thing I really like about the Vertanical study was they I thought they were really spot on with the product. They did a you know, they were doing and utilizing a full spectrum cannabis oil. So it had all the terpenes and flavonoids. So it's a very, it's a very good medically therapeutic product, not just distilling out THC or just CBD, because a lot of times for patients, they'll say, okay, well, you know, is this a THC effect or is this a CBD effect or what's what's happening? But it's a it's a full spectrum, full plant. So I feel like that's these, you know, medicinal botanicals, I think, are fantastic. We've got, you know, right now as a physician, you can prescribe Epidiolex, which is a uh prescription grade pharmaceutical CBD product. And there are three other synthetic cannabis related or cannabis-derived products out there that are prescribable, but there's really nothing else. So when we talk about prescribing cannabis, I think this is why a vertical product will probably really be a game changer in the space because you know, as a physician, they want to have confidence that what they're prescribing is going to be safe, it's gonna be effective, it's gonna be tested, and you would have a good idea and understanding what the side effects could be. So you can give good, you know, good information to patients. And so for me, I would say that this is a good opportunity for that particular product to be able to check off all those boxes.

Javonte Maynor 17:02

Yeah. And that's I'm glad you brought that up because the reason why we have the FDA and all these coming bodies is because before those agencies came into effect, there was no way for doctors, even medical professionals to know if the drugs that are coming to market were safe or not. Within cannabis plant, you have to grow in a certain way to produce those chemical properties that you just listed off. So that that's going to be a big thing as well. If cannabis comes to market, how's it being grown? What what products and things are used to grow these plants to produce chemical properties that will exhibit a good therapeutic product.

Dr. Erich Schramm 17:47

Oh, absolutely.

Javonte Maynor 17:50

You could grow it anywhere you want, but you can grow a plant with a lot of a lot of THC, not enough THC, a lot of you know, CB D, the terpenes, it just depends on the the growth of that plant.

Florida Access How Certification Works

Dr. Erich Schramm 18:04

Right. And I'd say in the state of Florida, I feel, you know, we do this very well here. We've got now over 900,000 patients uh in the state, and the state does its due diligence in terms of ensuring the quality of the products, they everything is tested, everything is labeled, so you know exactly what your THC percentages are, you know which the terpenes, you know, you have this quality assurance. So when patients come into the clinic and ask about the relative safety of products, I can to assure them and say yes. And they maintain consistency, which I know is a big, is a big important thing for doctors because you don't want to have, you know, oh, well, you know, you got a good batch one time, but then you didn't get a good batch of it and got a whole different kind of effect. So I think the state has moved in a lot of ways in the direction in which the pharmaceutical industry will want to look to try to pursue in the way that they the manufacturing and the testing and the way that these products are being done. Now, one of the things that's uh interesting is because you know in Florida, we are a medical, we're a medical marijuana state, not a recreational state. And so uh the question becomes, well, if you're and we've got 40 states doing medicinal marijuana, what what about those patients? You know, so we've got one system for access through the states, but if there's rescheduling and now physicians can prescribe, then you know what is what does that landscape look like between you know the uh prescribing as a federal schedule three versus those patients are already getting and receiving medical marijuana through the level of the state? And I didn't know if you had any thoughts on that.

Javonte Maynor 19:52

I don't, so I am curious to know how does a physician open a medicinal marijuana practice? Like, is that is that something that anyone can do live in a certain region of Florida, different certain city? Like, how does how does uh a physician get involved in marijuana?

Dr. Erich Schramm 20:14

That's a that's a great question. In this state, you have to go, there's a required two-hour for physician state mandated course, and then you've got to take an exam, and you gotta, of course, pay a fee for that because you know nobody's gonna give it away for free. And so that that allows yourself to be eligible to be able to do a certifying physician. But the the interesting or ironic thing about it is the state, it's it's really more of talking about the legal precedence and the potential reliability as a physician to be recommending cannabis. It has nothing to do with teaching doctors about cannabis, zero. It has nothing to do with learning about any elements of medical marijuana. So, so it's very interesting. So we could consider that if if there's rescheduling, one of the big things that would happen that if a physician is required or is going to be prescribing, then they have to be held accountable, and that has to show up, you know, in the medical boards. It has to be part of the medical education system and getting back to understanding if you can and why it could open up access better for patients is by educating the physician. So once that takes place, the rescheduling, then you'd see the physicians becoming having to be more involved with that. But right now, that's really not the case.

Javonte Maynor 21:35

I mean, if if it becomes a schedule three, then yes, I believe it will hurt or it would it would challenge the the practices that are currently open to prescribe the schedule one. Well, where I think the the the doctors who already are prescribing the medicine will benefit is they will have the knowledge of how to treat the patient before the doctor. Who was in clinic, maybe just prescribing regular prescription drugs at this time. In Florida, I've never worked with a medicinal marijuana practice before. So I don't I don't know the setup or anything like that. When you walk into one, is it like a dispensary, or how is the makeup of the marijuana practice?

Dr. Erich Schramm 22:22

Great. That's a great question. So the state separates the certification from the dispensation, dispensing a product. So I, you know, I have a freestanding physician office and there's no products on site. So you gain access through the physician doing certifications, and those patients have certain qualifying conditions, and then it allows them to be eligible for them to get a medical card through the state program. And then once they have paid the state medical card fee, then they can go in and secure products. We here we have probably at least 26, 28 different business licensed dispensaries. And a lot of these are chained. So this is the quote big, big cannabis companies here. And it's a big business. I mean, it's multi-billion dollar business. And so that's how patients in the state here will access those products.

Javonte Maynor 23:17

Okay. All that makes sense. Yeah. So the the freezer's still there serving as like kind of like the pharmacy for the products. Yep, makes sense.

Dr. Erich Schramm 23:28

Right. And you know, it's it's it's very interesting because unlike traditional pharmaceuticals where you can walk into any, you know, particular drugstore or grocery chain or just about anywhere to secure a specific prescription for a product, and it's it's all the same, whether you get your blood pressure pill from CVS, Walgreens, Publix, wherever, it's different. That these cannabis, these dispensaries are are cultivating and retailing their own different products and unique products. So it's not all the same. So patients who may need one set of products may be looking at a certain dispensary for one condition, or they may be going to a different dispensary to look for a different kind of product for a different for a different issue. So and there's a lot of competition, so that there's a good from a cost benefit standpoint for patients, it's very cost effective for the patients right now because a lot of the competition. So it's it'll be interesting. And I what's another thing to see how the pharmaceutical industry, when they get to really fully embracing a cannabis product, how they'll have to address issues, cost issues if they're going to be having to compete with retail. Well, I'm saying retail just cannabis dispensaries, but but it could be a it'll be something they'll need to really sit and look at because the the cost of the products in the dispensaries are relatively cheap.

Javonte Maynor 24:56

Do you is it possible to create a patent in cannabis research, or you think it's it's it's like a free market? If you grow it, you just sell it and treat someone and produce those results? Like, can I grow a plant and get a patent for like that particular like that particular you know?

Dr. Erich Schramm 25:18

I don't know. I'd I'd have to do a little more research on to what extent there's a ton of varieties, and you know, the plant gen uh geneticists out there are designing every kind of hybrid imaginable, combining, you know, if you grew up or spent time in California, you would have known that there were all kinds of plant varieties that were being cultivated. I'm not sure whether those are necessarily trademarked. So that's a great question. I'll have to do a little bit of research on that, but but the products are very interesting because you can, you know, they market, and I mentioned was talking about the terpene profiles because you can within the products that are available, you have a lot of different selections about what terpene effects you're looking for, not just THC and and CBD, but but those terpene effects as well. So so I'm not sure if if those I would assume there must be some patent on those, but there's literally tens of thousands of products out there in the on on in the market right now. So good good question.

Javonte Maynor 26:24

I'm also curious, I wonder if they're going to start making like like artificial like cannabis types of medicinal products, meaning you know, going in a lad and trying to create them without actually growing the plant. What are your thoughts on that?

Dr. Erich Schramm 26:40

Well, we've got as I said earlier, they've got for an example, marinol is a synthetic cannabinoid. And you know, the here's here's the pros and cons. The the pros is is that it's it is FDA approved, prescription can any you know, prescribing physicians and patients can get access to it, but it's not a it's not a uh full spectrum, it's not a natural product. So when we look at something like in the in the Vertanical study, and I said, you know what, they their platform for this drug is a full spectrum, it's a sativa strain, has a wonderful terpene profile. It's really what I would say much more medically enriched rather than just a synthetic. Because, you know, when you look at and going back, thinking about your in your biochemistry days, you know, you're affecting a lot of different receptors. You're getting CB1, CB2 receptors, but it's it's hitting a lot of other downstream receptors that are having anti-inflammatory effects. They're having, you know, the terpenes are doing certain things that analgesic effects and things. So there's this kind of entourage effect to the plant that we talk about that is more so than just isolated components of it. And that's why I think the synthetics are becoming are are less, as I see it, less potentially desirable, you know, kind of moving forward. So I think Vertanical is on the right, on the right path with this, on the right track.

Javonte Maynor 28:10

Yep. This is your first cannabis study done others in your past?

Dr. Erich Schramm 28:17

This this will be our this will be our first. So we are eager to put that on. I'm eager to have that on my resume, quite honestly, because I feel just like you, we're we're a community-based research organization, and I know you're a big advocate for community-based research, and I appreciate the talks we've had before about that. And so as a community-based researcher, and you can get access, allow access, you know, to patients, and for these kinds of studies, where patients look at you know, those investigators and the research staff as you know, as really credible resources for you know health care information. And so this is, I think, really exciting. And to that, you with your experiences and and like I said, as being in a community site, have you found it you know challenging or what what kind of problems have you come up with or come across looking at trying to find those patients and recruit those patients?

Javonte Maynor 29:22

Yeah, so we're we're starting early. I know the study is uh planned to start by September. So what we're doing is we're just going around to different doctors' offices and you know, making them aware of this trial. We can't put anything out there yet because it's not IRB approved. So we're going to we're going to health fairs, you know, we're doing community events, we're at barbershops. And when patients walk up, we just talk, we talk to them about you know what we do, and and we say, hey, we have this exciting trial that's coming up. You know, we we're looking to recruit patients with chronic low back pain. Do you have low back pain? You know, yeah. We're like, okay, go to our website and it's your information, and we'll follow up with you once the study is ready to start recruiting. So right now we can't say much because it's not FDA it's not due to the regulatory process, but we are putting fillers out there and trying to get everyone involved.

Dr. Erich Schramm 30:17

No, well, that's great. And I think we're probably similarly aligned and trying to get those patients identified. And you know, we're we enjoy having spirited discussions and very glad we could sit down again today and really kind of hammer out some more of the whole this whole cannabis, uh, medical cannabis and cannabis research. Thank you so much. You've been very generous with your time, Javonte. Anything else that any question I should have asked that I didn't?

Javonte Maynor 30:48

No, it was it was great to to understand, you know, the the clinical side of marijuana and where marijuana is going as far as research is taking us. So definitely interested in learning more about how physicians and clinicians and research can come together and do further further cannabis research.

Dr. Erich Schramm 31:10

That's right. We're at the beginning of a of a hopefully a long and healthy and happy uh, you know, relationship with cannabis research, and and we'll look forward to at some point we'll have to do another podcast and do an update. How about that?

Javonte Maynor 31:26

Yeah, so yeah, once the Vertanical studies start and you know we're getting to the end, we can talk about you know how how well and when or lessons learned.

Dr. Erich Schramm 31:36

Yeah, that's right.

Javonte Maynor 31:37

That's looked out there for more opportunities. Hopefully, this study will open the floodgates for more types of trials like this.

Where To Learn More

Dr. Erich Schramm 31:45

Open some doors. Alrighty. Yeah, Javonte Maynor, thank you so much. Thank you so much for your time, and we'll look forward to talking to you next time.

Announcer 31:53

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