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A consortium of nine universities in Florida, led by two professors at UF, is in the early stages of investigating medical marijuana. In this episode, Professor Almut Winterstein describes the consortium, its three major efforts and the opportunities and challenges in understanding how marijuana works as a medical treatment. Produced by Nicci Brown, Brooke Adams and James L. Sullivan. Original music by Daniel Townsend, a doctoral candidate in music composition in the College of the Arts.
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Nicci Brown: Welcome to From Florida where we share stories about the people, research and innovations taking place at the University of Florida. I’m your host, Nicci Brown.
Across the country a patchwork of laws and policies regulate medical and recreational marijuana. Today, we’re focused on medical marijuana and what we know about its safety and effectiveness as a prescribed treatment.
Our guest is Professor Almut Winterstein who co-leads with Robert Cook, a professor in UF’s College of Public Health and Health Professions, the state’s Consortium for Medical Marijuana Outcomes Research.
Professor Winterstein is a Distinguished Professor and chair of the Department of Pharmaceutical Outcomes and Policies at UF’s College of Pharmacy. She is also the founding director of the Center for Drug Evaluation and Safety. Professor Winterstein’s research focuses on drug safety and devising ways to improve medication use.
Welcome, Almut, we are delighted to have you on the show today.
Almut Winterstein: Thank you, Nicci, I’m glad to be here.
Nicci Brown: To support research on the clinical outcomes of medical marijuana, the Florida State Legislature created the Consortium for Medical Marijuana Clinical Outcomes Research, which you direct. Would you tell us more about the consortium? How many people are involved and, broadly, who is represented in the group?
Almut Winterstein: Yeah, so the consortium was created by the State Legislature in 2019 with the intent to have an entity within the state that conducts, supports and disseminates research on the clinical outcomes of medical marijuana. All universities in the state are open to join the consortium. So it’s a multi-university consortium currently representing nine universities throughout the state. And they’re researchers and trainees and students and all these people who are interested it in working on medical marijuana.
The lead university is the University of Florida and the executive team, if you will, with me as director, Bob Cook, as you mentioned, as associate director, is also supported by several other faculty members who lead certain cores within the consortium and they are all located within the College of Pharmacy in the College of Public Health and Health Professions.
Nicci Brown: So, this really is quite an integrated approach, if you will.
Almut Winterstein: Yes, the consortium is directed by a board. The board is represented by all these nine universities that are participating and we really are trying to have a joint enterprise going that tries to foster research and create research on this topic.
Nicci Brown: How many states have approved medical marijuana use for health conditions?
Almut Winterstein: Right now, there are 37 states in the United States that have some sort of medical marijuana program. They are quite diverse. There are also some states that, as we know, allow marijuana for recreational purposes. And there also are some states that don’t allow it at all. So it is still a fairly heterogeneous landscape.
Nicci Brown: And does that extend internationally as well?
Almut Winterstein: Yes, that does extend internationally as well. Just looking at Europe, we have countries that have legalized marijuana entirely, like, I think Holland and Netherlands are well known, and then other countries don’t allow it at all. And there’s everything in between.
Nicci Brown: The conditions for when it has been approved — is there a lot of variation there as well or are we really talking about legislatures?
Almut Winterstein: There is a lot of variation, yes. The only indication that is included in the legislation of all 37 states that have a medical marijuana program is cancer. And beyond that, there is a wide variety of psychological conditions, muscular skeletal conditions, other pain conditions, behavioral health conditions or a variety of different focus areas. And they vary very, very much across the various states.
Nicci Brown: I’ve got to imagine that’s very confusing for a lot of people, especially because we are quite a mobile society these days and move from one state to the other. So in one state, you’ve got this resource and then you may not have it in another.
Almut Winterstein: Yes. And the state legislation doesn’t cross borders, right? So you may be legally permitted to have marijuana with you here and move into another state or go and visit a friend and are actually now illegally carrying marijuana with you. And that doesn’t even include the recommendations related to clinical conditions, obviously.
Nicci Brown: And what was the motivation then behind creating the consortium? Was that part of the motivation or is it more so on the research front?
Almut Winterstein: Yeah, so I think that the Legislature really was very forward looking in creating something that supplements the research that is currently not sufficient. That is the main driver. If we put parallels to the FDA and the way that prescription drugs are regulated, they follow a very, very specific framework on how efficacy and safety must be established in clinical trials for every single indication that a drug is eventually approved for. A drug is not approved as such. A drug is approved for a specific indication and the risk/benefit for that indication needs to be weighted.
And so this framework doesn’t exist for medical marijuana right now. We don’t have a clinical trial framework that would basically approve a drug as, you know, it is safe and effective enough for patients to use it for particular condition s— so in other words, the risk/benefit is actually favorable. We don’t have that.
And we also don’t have a surveillance program on the back end like we have for drugs. We all have watched the surveillance program that is in place for COVID vaccines. That was a very nice way of illustrating what is in place in order to pick up even rare events when millions of patients are using a particular medication or vaccine in this case. We don’t have that for medical marijuana. We have experience from recreational use, but we don’t know how that translates to patients.
Patients may not be the average recreational user. They may be patients who have very specific conditions that might affect the risk-benefit of medical marijuana quite a bit. So all of this is a very open question mark. And that also explains why there is such a difference between the various states and what they’re approving and whatnot because the evidence, unfortunately, is not straightforward.
Nicci Brown: What are some of the question, then, that the consortium is working to answer?
Almut Winterstein: Yeah, so this is a broad area. And one of the really big challenges was to narrow this down to the things that matter the most. And so our research agenda that we have established over the past three years, also considering input from clinicians who are on the front end, taking care of patients, patients themselves, as well as a very comprehensive literature review on the evidence that we have conducted. We are focusing on risk/benefit. So essentially the efficacy or the effectiveness of medical marijuana. And again, this is not as such, but rather for very specific conditions. What does it do for epilepsy? What does it do for ALS? What does it do for MS and so on.
And then the safety and the safety, there are direct side effects, but also drug-drug interactions. So again, we’re talking about patients who may take other prescription medications and there was very limited information about what marijuana does in conjunction with other medications that patients might take.
We are looking at different dosage forms, routes, as you know if anybody has visited a dispensary, this is a wide variety of things that can be purchased now that contain THC or CBD, some sort of medical marijuana. And so that is important to consider whether there are differences in those routes, again, both with respect to risk and benefit.
And then we also do some general epidemiologic research with respect to who is using it, what are their experiences, who has access to it. Lawmakers are quite interested in whether there are disparities in the patients who actually can access medical marijuana now. Obviously it’s not reimbursed by insurance. And so what is the population that is currently taking medical marijuana.
Nicci Brown: So, with all of these variables that you’ve just gone through, and I’m sure there are many more, how do you go about your analysis in a way that’s effective?
Almut Winterstein: Yeah, so we have three major arms that support and conduct research in the consortium. The first is a grants program that we have been running with a portion of the state allocation of funding that we have. So that is open to all participating universities. There are smaller grants, starter grants, that focuses on translational bench science. So oftentimes animal models as the first step towards looking at specific efficacy questions.
And so, in this grants program are researchers who conduct surveys with patients who are using medical marijuana. I should say that the classic randomized trial that we know from prescription medications for medical marijuana is very difficult because marijuana is from a federal perspective still an illegal substance. And so for a researcher to randomize patients to take marijuana or not, they need a so-called DEA Schedule I license and they’re very difficult to obtain, which hinders a lot of the research that we would typically want to see.
So a lot of the work that we’re doing is rather than randomizing patients, we are observing patients who are using medical marijuana and try to compare them to patients who have similar conditions but are not using it. So that is observational research where general randomization is missing. So we have this grants program.
The second thing that we actually are just about to launch is M3—Medical Marijuana and Me. That will be a prospective cohort of patients who are initiating medical marijuana with the idea of following these patients over a year to track their experiences. So that will give us ideas about what type of dosage, form and product do patients eventually end up on. That is a very empirical approach because we have no head-to-head comparison of what works better or worse, what kind of experiences they have, what they think works, what doesn’t, what kind of side effects they might experience and so on. And what might persuade them to continue versus discontinue treatment with medical marijuana. So that is M3, the prospective cohort.
And then the largest piece that we have been working on establishing is something called MEMORY. And MEMORY stands for the Medical Marijuana Outcomes Research Repository, which resembles very much the safety work that we are doing in particular in my department that uses prescription medication data that we have from pharmacies. And we link that to healthcare utilization data, like hospitalizations, emergency department visits, so we can basically follow patients longitudinally, very large populations, to see what kind of effects happen, positive or negative, among patients who are using certain medications.
This is the classic work that has been done for COVID to look at vaccine safety, for example, but also to answer effectiveness questions. So MEMORY will resemble the same database. The lawmakers were, again, had so much foresight to allow the consortium to have access to the dispensing data that the Department of Health maintains from medical marijuana that can be linked to the same sort of outcomes data.
So, we will be able to follow patients to see whether they have more or less hospitalizations because of their multiple sclerosis or whether their PTSD is becoming worse or less when they are starting to use medical marijuana versus, perhaps, a prescription medication.
Nicci Brown: And is this something that those patients sign up to be a part of or is this information anonymized?
Almut Winterstein: This information is anonymized, yes. It is not anonymized at this point of linkage because obviously this data need to be linked together somehow, but as soon as that linkage is completed, all these personal information, personal identifiers are stripped. And we even go that far to strip dates so that there is no way of starting to connect bits and pieces and then eventually drill down to a particular individual.
Nicci Brown: And what are you finding to date thus far as far as this research goes?
Almut Winterstein: Yeah, So MEMORY is our biggest baby and the most important baby, I must say, because we here in Florida, we have currently 700,000 registered medical marijuana patients, so it will give us access to a very large population where we can really drill down to specific health outcomes.
MEMORY is still in the works. We have worked with the Department of Health to obtain those data. The legal framework around that has taken some time. And, of course, Department of Health at some point was a little bit distracted with COVID. So, we are now in the process of hopefully signing those data agreements in the next few weeks, fingers crossed.
So that will be the largest piece of research output that we will be able to generate. And I can tell you, I’m really excited about this. What we have found so far is based primarily on these smaller pilot studies that I have mentioned. So, we have had several investigators throughout the state that have looked at animal models and specific pain models.
Starting from pain after amputation to pain from certain trauma to chronic pain, a variety of different conditions. So there are some promising data with respect to effectiveness. We have looked at access as I mentioned earlier and we have summarized the evidence that is currently available. And what I can tell you is that right now there is promising and fairly solid data that supports the use of medical marijuana as an adjuvant for pain therapy.
And there’s also evidence that supports the use for certain types of epilepsy. For the majority of other conditions, we really don’t know what it’s doing. And from a safety perspective, we have even less of an idea.
Nicci Brown: Almut, how does what is happening here in Florida compare with some other states in the United States?
Almut Winterstein: Yeah, so some states have also invested some of the state revenue that is coming in from marijuana to support research. There is a center in California. I know that Colorado is supporting some research.
These are actually two states that have a huge deficit in terms of supporting research, if you will, compared to Florida, and that is that both of these states have recreational marijuana. And once it is recreational, there is no way to track anymore who is using what. So, my analogy to the prescription medications that we had earlier, we can use pharmacy records and we can actually look at what patients were taking longitudinally and follow them to look at outcomes.
The same is true with medical marijuana because for legal purposes, right now, the Department of Health needs to track who was dispensed what and how much. So, this data basically allows us to have the same framework of longitudinal follow-up with specificity of who was taking how much, when. Once this becomes recreational, this opportunity goes away and marijuana would essentially become as obscured as knowing what a patient is eating.
So, we would then have to rely on surveys to find out whether a patient is using and what he’s using and so on. So, access to the same large number of patients that we currently, hopefully, will have very soon with the 700,000 that I quoted earlier is a quite unique opportunity.
Nicci Brown: And really helps with your accuracy.
Almut Winterstein: Absolutely.
Nicci Brown: What are the next steps then for the consortium? It sounds like there are a lot of things in the works.
Almut Winterstein: Yeah, so the biggest step is indeed getting MEMORY established because of the incredible potential it has to answer a lot of questions. The most immediate step is actually our CCORC, the Medical Marijuana Clinical Outcomes conference that is actually coming up in May. This is our second conference that the consortium is holding in Orlando this year. Last year was planned in Orlando and then of course went virtual.
We had 220 something participants last year, which we were very excited about given there was constraints with COVID. So we are hoping for great attendance in Orlando. And I hope that some of the people who are hearing this podcast might consider attending. This conference is meant for anybody who’s interested in medical marijuana. So there are certainly pieces that patients might enjoy seeing, the industry and, of course, providers. But it is a research conference so it’s focusing specifically on outcomes related to medical marijuana.
Nicci Brown: And how can people sign up if they are interested?
Almut Winterstein: They can go to our website. Our website is mmjoutcomes.org and they will see a link to the medical marijuana conference there. And it’s very cheap.
Nicci Brown: That’s good to know.
Almut Winterstein: Yes, we are really trying to get people interested in this topic and in particular making sure that they have access to objective information that really allows them to make the right decision with respect to the use of medical marijuana.
Nicci Brown: We’ve seen some remarkable things in recent years. If you were to look into the future, could you give us a sense of what changes we might see? I know that’s asking you to look into the crystal ball a little bit, but when it comes to the use of medical marijuana here in the United States, do you see any big changes on the horizon?
Almut Winterstein: That’s a really good question. You know obviously there are a lot of political issues that drive the decision, you know, how to regulate access to marijuana. What we currently have here in the States is use for medical purposes. And I would like to separate that very specifically from recreational purposes. These are two completely different animals.
Recreational purposes is not different from a person’s decision to take alcohol or not. There are risks, there are benefits and they are very different from what a patient needs to know for a particular condition. And, in particular, the benefit question really needs to be answered for those patients. So where things are going, I think, is very dependent on what the political climate is going to be statewise, as well as federally, for sure. So even if we are moving towards a recreational framework at the end, and that might very well happen, the questions for patients will still not be answered because we now have very heavy marketing efforts that promises that medical marijuana is treating anything on the planet.
And those marketing efforts are not controlled as there are for prescription medication. For prescription medication, the marketing needs to follow the approval that the FDA has issued. For medical marijuana that’s not the case. So that competition is even not really fair, if you will, because a medical marijuana dispensary can make way more claims in comparison to what a prescription drug could do.
So, we really need to make sure that this information on efficacy and safety is really available to patients and providers.
Nicci Brown: All the more important to be having the kind of research that you’re doing then. So thank you.
Almut Winterstein: Exactly.
Nicci Brown: Well, Almut, thank you very much for joining us today. It’s been a true pleasure speaking with you.
Almut Winterstein: Yes. It was my pleasure, too. Thank you, Nicci.
Nicci Brown: Listeners, thank you for joining us for another episode of From Florida. Our executive producer is Brooke Adams and our technical producer is James Sullivan. I’m your host, Nicci Brown, and I hope you’ll join us next time.
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