There is perhaps nobody that has more experience understanding how cannabis can help PTSD than Dr. Sue Sisley, especially when it comes to helping veterans. Learn why big pharma is trying to stop Dr. Sisley’s groundbreaking research.
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[1:53] – Dr. Sisley’s background
[3:51] – Dr. Sisley talks about where the cannabis is obtained for her research
[10:12] – Understanding PTSD
[16:31] – Dr. Sisley talks about what CBD is best used for
[21:36] – Dr. Sisley discusses the conflict with the University of Arizona
[31:24] – Are there sinister forces blocking cannabis legalization
[33:56] – The effects of opiates on the liver
[35:58] – Dr. Sisley discusses how her research is progressing in Colorado
[44:13] – Dr. Sisley discusses if psychedelics are helpful with PTSD
[47:21] – Follow Dr. Sisley’s work
Matthew: Hi, I’m Matthew Kind. Every Monday and Wednesday look for a fresh episode where I’ll take you behind the scenes and interview the leaders of the rapidly evolving cannabis industry. Learn more at www.cannainsider.com. That’s www.cannainsider.com. This interview is brought to you by Dixie Elixirs, makers of premium cannabis infused products. As for a Dixie Elixir product at your favorite dispensary. Dixie Elixirs: The Future of Cannabis. Learn more at www.dixieelixirs.com. Now here’s your program.
Today’s guest is Dr. Sue Sisley. Dr. Sisley is the principle investigator for the only FDA approved randomized trial looking at the use of whole plant marijuana in combat veterans with treatment resistant post tramatic stress disorder, commonly called PTSD. In June of 2014 Dr. Sisley had all three of her university contracts taken away by the University of Arizona and she was dismissed from her job there. Since that time Dr. Sisley has been able to continue her research thanks to a seven figure research grant by the State of Colorado. Recently Dr. Sisley was honored by Americans for Safe Access as Researcher of the Year at the National Medical Cannabis Unity Conference in Washington D.C., and was also featured in CNN’s Weed III with Dr. Sanjay Gupta. Wow that’s a mouthful. Welcome to CannaInsider Dr. Sisley.
Dr. Sisley: Thank you so much. Yeah, that’s a lot, but we really appreciate all the kind words.
Matthew: Well I’m so glad to have you on, and thank you for your research. To give listeners an idea of your background, can you tell us a little bit about what you’re doing with your research and who you are?
Dr. Sisley: Sure yeah. I’m basically a primary care doc. I’m trained in internal medicine and psychiatry. So mostly I just see patients full time here over telemedicine actually. So I see patients strictly over video conferencing. I take care of a lot of military veterans and police and fire that have PTSD. So that’s slowly become an area of specialty for me. Basically about, I don’t know, it’s been about five years now that we submitted our initial study design to the FDA, and that study, as you described, a randomized control trial looking at veterans with PTSD and hoping that we could… we planned to look at four different phenotypes of smoked marijuana in these vets. And what was surprising was the FDA was really welcoming of this concept.
I think people presume that the FDA is the blockade, but they’ve been working collaboratively with their physician investigators primarily so they understand the need for whole plant marijuana to go through the entire FDA drug development process. And I think they’re eager to see that happen. So it was only a few months later, you know, we worked with the FDA to optimize the study design and finally in April 2011 is when we got our FDA approval. But as you can see since then we’ve been battling the government at all levels to try to get this underway, and we still have not been allowed to implement this study five years later. We’re still struggling to move forward.
Matthew: Now do you get the cannabis from their Mississippi grow. I know the federal government has like a grow in Mississippi where they’re… I don’t know how much cannabis they’re cultivating. Do you use that, or can you get it through your own means or how does that work?
Dr. Sisley: That’s exactly right. There’s only one legal source of marijuana in the country for any FDA approved trials and that is through the cultivation center at the University of Mississippi. So the DEA has licensed only one site in the country through NIDA. So the National Institute of Drug Abuse holds a government enforced monopoly on the only federally legal supply of marijuana, and it’s deeply frustrating because after years of fighting we finally managed to persuade the public health service to approve our protocol. They approved it with no changes required, and that happened in March of last year. And here we are now in April, you know, over a year later and we still do not have the marijuana study drug to get this process underway.
And I think that’s what we’re all deeply frustrated by fact that this NIDA monopoly continues to obstruct research. There’s proof of this over and over again where they are unable to produce the variety of marijuana that scientists are requesting. They’re unable to produce it in a timely manner. They’re unable to provide competitive pricing. So any other expert grower in the country could have had study drug grown to spec for us within three months, but only the federal government, it takes them over a year and they still don’t have all the phenotypes we’ve requested. And so we’re still in limbo waiting for NIDA to produce this fourth strain of marijuana that we requested back in 2011. So it’s nothing new. It’s just that it’s clear they’re not competent.
Matthew: Yeah, yeah. That’s frustrating. And what kind of varieties do you want to execute your research in a optimal way?
Dr. Sisley: So we requested, one the study is a high THC strain which is something that they are, you know, NIDA has certainly mastered that. So that was no problem. They already had high THC, and they already had a placebo control. You know NIDA makes a zero percent THC marijuana that, you know, they basically take the plant and leech out all the cannabinoids. So you have an inner plant material that looks the same, smells the same. And then the other two arms are particularly important though. Those are part of our hypothesis is that we suspect that CBD rich strains of marijuana may perform the best in these veterans with PTSD, but that all remains to be tested. But that’s what we suspect just from interviewing vets over the last few years.
And so we requested also a high CBD formula, you know, a high CBD strain that would be basically 12 percent CBD with under 1 percent other cannabinoids. And then the fourth strain is the one that is perplexing NIDA is the 1 to 1 ratio of 12 percent CBD and 12 percent THC. And we have provided NIDA with numerous examples of other outlets that are growing this exact strain without any difficulty, and we’re not sure why, NIDA is asking us to accept a suboptimal strain that they have managed to produce. I think it’s 4 or 5 percent THC and a similar amount, a similar ratio of CBD.
I think it’s just disappointing that this is what we’re stuck with, that we have to accept the substandard product that NIDA is able to produce when in fact there’s growers all over the country who would be delighted to participate, and many of them have offered. As you can imagine, they all want to see independent research move forward. So they’ve all offered to donate study drug to us for free, but unfortunately we can accept any of that because we have to go through the NIDA monopoly which really should be dismantled. And I’m hoping that our experience, you know, being able to show the public the ridiculous hurdles we’ve had to go through dealing with NIDA, that it’s clear that they don’t deserve this monopoly anymore.
They’ve proven over and over again that they cannot meet the mandates of this monopoly which requires them to provide an adequate and uninterrupted supply marijuana at cost and at competitive pricing. And they haven’t been able to do, I mean I would hardly say that waiting… it looks like we’re going to be waiting a year and a half to get study drug. I would hardly call that an uninterrupted supply. Especially when you’re talking about a study with such a dire need. You know, the sense of urgency around this study is so clear that you would think that the government would absolutely instead of stonewalling the study, you’d think the government would make this a high priority and expedite this. But instead it’s been five years of struggles with the government at all levels.
And yet here we have a real epidemic of veteran suicide. We’ve got vets that are killing themselves each day in this country at a very high rate, much more than the 22 a day that’s being reported by the VA. And so the need… could marijuana help some of these vets? Could this marijuana have curbed this epidemic of veteran suicide? I think that’s what we’re all wondering. If there’s a chance that, you know, if the suicide rate is related to untreated or undertreated PTSD, then could marijuana have helped. These are the questions we hope to answer with this study.
Matthew: Wow that sounds like quite a bureaucracy. It’s hard to even fathom a system being that broken, but kudos to you for sticking with it. We really appreciate it. With PTSD, I mean, that’s an acronym we’ve all heard and we know it stands for Post Traumatic Stress Disorder, but what’s exactly happening? What’s going on there with PTSD with the human individual behaviors? Can you help us understand that better?
Dr. Sisley: Yeah sure. It’s clear there’s some changes in the brain that occur when people are exposed to trauma, profound trauma. Sometimes they manifest early, you know, right after the trauma and sometimes there’s a delayed reaction months later. Symptoms can suddenly appear. It’s a constellation of varied symptoms that include everything from… I would say the hallmark of it is probably sleep disturbances that are mediated by nightmares and flashbacks that prevent sound sleep at night. So that’s the hallmark, you know, that’s the chief complaint that we hear that usually brings people in the office who said they have chronic sleep deprivation from these relentless memories, recurring memories at night, what we call flashbacks and nightmares.
So yeah that’s… and then there’s a whole other list of associated symptoms that are common with PTSD such as a downturn in mood where people feel either overtly depressed or just vague vegetative symptoms like apathy and they’re unable to get motivate. Sometimes they don’t even want to get out of bed. They feel either so fearful or so apathetic, so hopeless about the future. And then you know there’s all kinds of other symptoms like anxiety is really a paramount problem. Anxiety and panic attacks tend to be clearly associated with this when PTSD is not well-controlled. People can feel constantly fearful, on guard all the time, you know, in kind of a war… what we call a hyper vigilance. They’re constantly worried that they’re under siege. So that’s typical.
So what happens is the medicines that we have on the market are really ineffective. There’s only two medications that are available with an FDA indication for PTSD and that’s Zoloft and Paxil. And those two meds are really problematic because often they don’t work, but yet they’re riddled with all kinds of side effects like impotence, weight gain, a feeling of lethargy. So if you’re these guys, the vets come back and want to reintegrate into their family and their community. Their top priority is getting a full time job and being able to enjoy their family life again, and yet they’re plagued by all these frustrating medication side effects. Because the problem is when Zoloft and Paxil don’t work, then we physicians turn to all kinds of off-label uses of other FDA approved medicines. So we’ll use all kinds of antipsychotics and mood stabilizers and benzodiazepines and fleet meds. We’ll use them all off label to treat all these other target symptoms because we don’t know what else to do.
We feel, the physician community feels equally helpless as the patients do because this is such a complex syndrome and typically in psychiatry we take a different prescription to target each of these different symptoms. And so you can imagine how devastating this is for these vets because the first medicine doesn’t work and then we add two or three more and then the next time they come in they’re still having all these breakthrough symptoms that might be different. So they may have the added three or four prescriptions at that point. Suddenly these guys are on six to ten different prescriptions all for one diagnosis, PTSD.
So that’s why I’ve become so fascinated by marijuana because it appears that these veterans are using marijuana as monotherapy for their PTSD. So they’re able, with a single plant, able to manage the entire constellation of PTSD symptoms and actually be functional. So my impressions of marijuana before I started listening to these veterans and hearing their claims, their successful experiences with the plant, I was under the impression that this plant was really undesirable for patients. That it was really… it caused a lot of problem in people’s lives, a lot of dependency and that it was riddled with tons of side effects. And then I come to learn from patients that in fact some of my most high functioning patients are the ones who are using cannabis every day to manage their PTSD. A lot of them just use it at night for instance to help them initiate sleep. And then they wake up feeling refreshed for the first time. The first time users that’s what they report often is that they got their first good night’s sleep of their life in years, and they wake up feeling functional again. Like they can take on the day and really… and the drug is so short acting if it’s smoked or vaporized that they can actually wake up feeling alert, rested and not impaired, able to take on a full time job if needed.
Matthew: So we talked a little bit about CBD earlier, but we didn’t go in detail. Something like an indica which helps you become more restful and sleep that would make sense for a night time usage. Are you seeing or considering a CBD heavy strain of medicine to be something that would be more applicable for the day to keep the paranoia or under siege type of feeling at bay?
Dr. Sisley: Yeah I wish we knew. We talked at one point about actually adjusting protocol to meet the real world use. It’s clear that these veterans are often alternating strains. They’ll use a more activating strain in the daytime, and then a more sedating strain before bed time. And so I would like to be able to do that at some point, but unfortunately this study they get assigned a single phenotype for stage one. They may be rerandomized, I mean they will be rerandomized into a different strain for the crossover on. There’s a stage two where they’ll be assigned a different phenotype of marijuana, but they won’t get to adjust, you know, and utilize different strains during the same day. It will only, they’ll be assigned one strain for the entire three weeks and then rerandomized after that.
Yeah, but I think that’s a great point. I think that CBD rich marijuana certainly offers a lot of potential, but the import thing in our studies we don’t want to discount these other phenotypes that may also provide benefit or may be detrimental. I mean that’s the whole point of the study is to figure out if marijuana is helpful and then if so which strains might be best for this illness and which ones they should avoid because it’s possible, certainly we have concerns about high THC strains promoting psychosis or possibly exacerbating somebody’s existing anxiety, panic attacks. So we want to really study that aggressively in all of the strains to make sure that hopefully there will be data later that will shed light on all of these questions.
There’s a lot of vets who have not used marijuana yet. I know that everybody thinks that all the vets are active. In fact many of my patients have not tried it yet and they’re waiting for this study to get underway because they’re fearful about the side effects, and they’d like to do it in a controlled environment where they can be medically managed. So I’m excited to see them go through that process. But there are a lot of vet who won’t embark on marijuana until this data is available because these are veterans who value science. They don’t want to put things into their body that haven’t gone through the proper drug development process. So I think I admire that as much as I admire these other veterans who have the courage to try this on their own and experiment with their own observational studies.
Matthew: Now how many vets would you estimate you’ve worked with over the years?
Dr. Sisley: Oh I would say probably over a thousand that I’ve dealt with one on one, and then probably several thousand over the, you know, I first became acquainted with veterans during my residency training here at the Phoenix VA Hospital, and I was immediately enchanted by them. Their candor or just… those were my favorite rotations. They would let us rotate at the Phoenix VA. Everybody else dreaded it because the system there was so inept. But I loved it and I really welcomed it.
But anyway, so I’ve been seeing veteran patients now for about 20 years since then, and I worked at the Phoenix VA for a few years. But the system, I could handle how dysfunctional that system was. So eventually I left, but I continued to see them here in my private practice. I have a sliding scale indigene clinic where they would pay $5 and come see me here.
The veterans are the ones who’ve been teaching me. I didn’t know anything about marijuana except this sliver of information that I got in medical school that condemned marijuana as a deeply dangerous drug and something that should be avoided at all costs. And so the veterans have been teaching me about their experiences with various phenotypes of marijuana, various formulations. And I’ve been really fortunate to have so much insight from them because otherwise I wouldn’t know anything. And only recently has the medical community started to talk more openly about the potential medical benefits here.
Matthew: Now I want to get into what happened with the University of Arizona because it’s kind of like a reality TV show in terms of the drama they put you through, but I think it’s important for people to understand. Can you kind of describe your at the University of Arizona, what happened, how they let you go and how you’ve come to Colorado to continue your research?
Dr. Sisley: Yeah well what happened was I’d been working there. I think I was on faculty there about seven years in a variety… I had three different contracts there. So I was an Assistant Professor. I was Assistant Director of the Interprofessional Education at the telemedicine program. So that was how I started most of my work there in telemedicine. And then my third contract just started last year where I was the Director of a grant. We received a three year, fully funded grant from the state health department to educate physicians about the medical marijuana law.
It was a huge breakthrough because I’d been fighting for years to try to persuade… our health department in Arizona had at that time about a $9 million surplus, and it was really fascinating to me that that surplus was voter protected. So it couldn’t be swept by the legislature. It was just sitting in the health department trying to figure out what to do. The law, the ballot initiative language didn’t allow for that to be used for research. They claimed it could only be used for administration of the medical marijuana programs.
So the physician community started an outcry saying hey we think it’s negligent that the state would sell 60,000 card, medical marijuana cards to patients without actively conducting clinical research. So we were arguing that that money should have been allocated to research as part of administering the program. So we felt it was within the language of the law to use that money. And so that’s how I started to get in the crosshairs of some very extremist legislators here. I don’t want to just chastise the Republicans because I’m a lifelong Republican and there are plenty of good, sensible, pragmatic Republicans here, but there are a few extremists who have gone on record to say that they believe that marijuana research is kind of a sham. It’s just a strategy to promote marijuana legalization, and I think they’re very fearful that rigorous science like this type of study might actually uncover some of the benefits of marijuana. And they have to make sure that that data never sees the light of day.
So they were adamantly opposed to the point where Senator Biggs, one of our… our Senate President actually tried to initiate an amendment to a bill buried deep deep into a long, a lengthy bill where nobody would have seen it, but we managed to get a copy of it, and it said that basically no state dollars would ever go to support marijuana research at the universities. And that was really alarming to me because that would have basically decimated any future of doing marijuana research anywhere in Arizona. And so I of course notified and took that amendment and sent it out to all the media and told them look, this is what we’re up against here, and the media descended on Senator Biggs office and he immediately retracted that language. So fortunately it didn’t go through as legislation, but it could have.
Things like that obviously get buried in bills and suddenly become policy without anybody noticing. And so that was a huge, really important intervention, but it put me in the crosshairs with the legislative leadership, and I sense he’s been gumming for me ever since then. He was the one, he was quoted in the New York Times articles as saying that he contacted the University of Arizona at that point and told them that he wanted me fired. And that was sort of the smoking gun in that New York Times article where he was quoted and this was fact checked by the way. They came back to him to confirm that he really meant to say this, but he said he contacted the U of A and said that Dr. Sisley was advocating too vigorously for this study, I think was the language.
Matthew: Too vigorously.
Dr. Sisley: Yeah, and the University of Arizona came, they said well we’re looking into it, and then Tim B. who is the chief lobbyist there, he was also quoted in the New York Times saying we are taking care of her. And then literally a couple of months later I was terminated. But I had already, you know, I knew this was under way because I had already received a call from the Vice President of Health Sciences at the University of Arizona had confronted me on the phone and said that he was getting a lot of flak from the university President and the Vice President, Terry Thompson. So it was clear that the university administration had serious problems with my research because there were so many legislative leaders, not so many but there were a few legislators, who had deep concerns about the universities hosting this kind of work. And the problem is those legislative leaders are the same one who also control the university budget.
And so, you know, I knew that I was doomed at that point. I knew that my existence at the… but what was even more interesting to people is that I was just embarking on, you know, this grant from the health department would have enabled us to educate physicians statewide about how the medical marijuana law works. And we had just finished, you know, we were prepping a speaker’s bureau. We had amassed an incredible team of super talented, really conservative physicians to go around and talk to their colleagues about medical marijuana law and the notion that you can participate safely in that program without being censured by your licensing board. These are all messages that the mainstream medical community was not getting.
So here in Arizona we’ve got 60,000 card holders now, but none of them go to see their doctor and get a card because no regular MDs or DOs will write a recommendation for these patients because they’re so scared of their license being harmed or the DEA coming down on them. So what happens is all of these patients are stuck going through these certification centers which are basically naturopaths who work there full time seeing patients in bulk and authorizing cards. That’s not an optimal way, you know, ideally what we want is a patient to go have a private discussion with their doctor who’ve they’ve known for years and they would have an intimate dialogue about the pros and cons of marijuana. Is this a good choice.
That was the idea, but that’s never been able to happen here, and that’s why we started this educational campaign. So we were just getting ready to launch this speaker’s bureau when the contract was stripped, and I would say the University of Arizona even blindsided the health department. The health department was so pleased with our work. We had vetted all of the educational tools, you know, what they call the deliverables. We put together a training video. We put together all these educational drop off materials and a website, and all of it had been vetted through the health department, and suddenly they get this letter from the University of Arizona saying, thank you very much for your money, but we are returning it all back to you. We no longer want to participate in this grant, and thank you for the offer.
And so they ship back all the money. They terminated the process so we couldn’t even embark on the educating. So that’s how scared people are here in Arizona about the mainstream medical community learning about medical marijuana law because that might actually grow the program if regular MDs and DOs started certifying their own patients, that’s very damaging to the opponents of this program who are really mad. Our legislators are angry that the voters here in Arizona passed medical marijuana law. They feel that this is a huge devastation and they are determined. Every year they try to repeal the medical marijuana law. They do everything they can to denigrate it. They’ve created a crusade now called Marijuana Harmless, Think Again. And it’s a so-called educational campaign that was developed by our county attorneys here to go take this statewide. And I would argue basically to brainwash elected officials that marijuana is a deeply toxic drug that will cause generational genocide.
Matthew: Wow. Now is there some force behind this you feel like besides… because it seems like politicians are motivated unfortunately just by campaign contributions. It’s hard for them to do anything unless there’s some sort of campaign contribution behind it. Do you see, or in your opinion is there any group behind funding this type of misinformation?
Dr. Sisley: Definitely yeah. I think there’s three groups that are clearly involved. We have law enforcement so the Prosecuting Attorneys’ Association here and other law enforcement groups are clearly behind the opposition effort. And then we also have private prisons. In Arizona private prisons dominate the landscape here, and they have a very aggressive lobbying team that will work at all costs to try to end medical marijuana in this state. They are really upset because you can imagine with 60,000 card holders, now suddenly those are 60,000 patients that are protected from being thrown in their cages. So they’re really unhappy about this law, and they’re working hard to try to make sure that elected officials know their displeasure with this.
And then of course the biggest obstacle we have is Big Pharma. The pharmaceutical companies have a deeply vested interest in thwarting any marijuana research because they know that if whole plant marijuana ever was allowed to go through the FDA drug development process, that would be a huge threat to their business model. Already we’re seeing that threat playing out in the veterans community where more and more veterans are having the courage to walk away from all of their FDA approved medicines and utilize cannabis alone to manage the whole variety of their medical ailment. So it’s been impressive. So that’s, you know, you can imagine how threatening that is to Big Pharma because they see their profits diminishing as more and more people are embracing marijuana as monotherapy or even just, you know, imagine all the companies that make pain pills. If patients are not so heavily dependent on their mega dosages of opioids and instead are utilizing marijuana as an adjunct to pain control. Then that means that rather than receiving 300 oxycontin per month, they are only picking up thirty. That’s very problematic for pharmaceutical companies.
Matthew: And what happens to someone’s liver if they take that much of a opiate in pill form? That’s got to be destructive I would imagine.
Dr. Sisley: Yeah it can be. Yeah over time if the liver’s exposed to mega dosages of opioids for years, you know on a daily basis for years, and then you combine that with other potentially liver toxic meds like a lot of the opioids have Tylenol in them. A lot of patients drink along with their pain pills. So if you’re drinking that’s a lot of stuff that’s toxic to the liver. So yeah over time that can diminish liver function and possibly even cause liver failure down the road. So we want to try to examine the possibility of marijuana as like a harm reduction technique that possibly people could utilize marijuana in lieu of being dependent on so many highly addictive prescription meds. Apparently it’s okay in the eyes of the DEA. It’s acceptable to use mega dosages of oxycontin, but as long as you’re not using marijuana. So the way the scheduling of drugs is done in this country.
Matthew: Yeah, gosh, that is so disturbing, those three interest groups you mention; private prisons and Big Pharma. Especially when you think about the revolving door between Big Pharma and a lot of the regulatory agencies combined with lobbyist pressure and money. But obviously grassroots does have an effect. I mean calling state senators and representatives in particular, they do listen and tally what people are calling in about, probably less so at the federal level. But I encourage everybody to let their state representatives know how they feel about what they see going on and what Sue’s describing here. Sue, you know, Arizona’s loss is Colorado’s gain. Can you tell us a little bit about recent developments with your research in the State of Colorado?
Dr. Sisley: Yeah, well we were so fortunate that you guys in Colorado passed the bill that we could not pass. Yeah we tried so hard to take some of our support’s money and allocate it to research, but the forces against us were too severe. So in the end Colorado took, out of their $13 million surplus, they took $9 million and allocated it toward ethicacy research. And I would say, you know, I really applaud Colorado because that’s probably some of the first money available to study the effectiveness of marijuana. All the other marijuana research money in the country through NIDA is only looking at safety studies, meaning the harmful side effects of marijuana or the abuse potential of marijuana, but there’s very little funding at all to look at ethicacy.
So this is it, you know, the Colorado Health Department took about $8 million of that $9 million and allocated it to 8 different projects. And our project received a $2.1 million grant.
Matthew: That’s awesome.
Dr. Sisley: Yeah, to conduct this randomized controlled trial. So the good news though about Colorado’s funding is it doesn’t preclude me working anywhere in the country. And since this is where the research was originally conceived, and this is where our opponents exist, I think the only victory for scientific freedom is to conduct this research in the state where it was barred, you know, where it was terminated. So our goal is to try to keep this right here in Arizona and keep it in the backyards of our opponents so that they’re forced to examine it and see that there is really nothing to be afraid of. And I hope that’s… we’re planning to actually sign a lease here in the next week out in North Scottsdale, and we intend to enroll… we have about a half million veterans living throughout Arizona. And I refuse to turn my back on these vets.
Many of them have been fighting side-by-side with us for the last few years trying to help us kick down the doors of the government and get this study underway finally. So I don’t want to walk away from them. Part of their hope was that the study, you know, that not just it would be implemented, but it would be implemented in a location where they could take advantage of that. And so I’m hoping that we can start screening people here. We already, the good news is we already have IRB approval. So even though all three universities in Arizona failed to embrace this study despite our best advocacy efforts, not a single state university had the backbone to find a home for this work. It was really sad.
So in the end we went through a private IRB, Copernicus, and got our letter of approval a few weeks ago. So that was a huge triumph because it proves that we don’t need a state university. We never did. We just wanted to, you know, we wanted the optics of being aligned with a prestigious public institution, and unfortunately universities, the soul of our tax payer supported universities have changed so much. The soul of these institutions used to be… used to take pride in creating a sanctuary for this type of rigorous, kind of controversial research that was cutting edge. They used to be that sandbox of innovation, but now they run from studies like this.
The word marijuana is so politically radioactive that they don’t want to come near it. They just could never wrap their head around the optics of how do they allow veterans to smoke pot on campus. They couldn’t figure out how to do that, and we gave them so many opportunities. We made it so easy for them. We said that all we needed was a simple office space that we could construct a very straightforward air scrubbing system, but they couldn’t fathom how to do it. And instead of thinking through and trying to be ingenious they shut us out. So in the end we’re going to be much… I think we’re going to be able to prove that we can do the study much more efficiently and inexpensively by being independent and outside of the university system. There’s so much bureaucracy within the universities. The process would have been slowed down tremendously by all the ridiculous signature gathering, a need for a myriad of approvals at every turn.
You know here we’re still going to continue to have very aggressive monitoring. Just because we’re independent and unaffiliated we are going to have a relentless amount of internal and external monitoring from the FDA, from the IRB, from the DEA. It’s going to be unbelievable. I feel sorry for our study coordinator who’s going to have to be managing. But it’s worth it to us because we want to have true data integrity. We want to be 100 percent transparent with the public. So when we get underway everybody’s going to be allowed to examine. Our doors are open to anyone who is interested in looking at how marijuana research is conducted in this country.
And we want… we intend to put all of the data out into the public domain, the good and the bad. And that’s really important to me. That was the only reason I was willing to work on this project is because I knew that unlike previous studies I’d been involved in with Big Pharma where you do studies where there’s so much pressure to make the numbers look a certain way. And then when the data does not make their drug look favorable, they simply suppress those studies. But we don’t do that. Here this data is all going to be put into the public domain for everyone to scrutinize, to evaluate, to understand what, if any, therapeutic value marijuana has in PTSD.
So I’m really excited. And I think that’s really what I wanted to emphasize for your audience is just that we are going to collect the most objective data. It’s going to have supreme data integrity and we’re all blinded, independent investigators. None of us have any agenda here other than to collect data that is truly unassailable and be able to publish that in peer reviewed medical journals so that we can share some enlightenment with our mainstream medical community. So I’m really excited about that. That’s my only… I’m not part of… I’ve never used marijuana personally in any formulation. I’m not part of the industry and I don’t own dispensaries. I have no vested interest in the outcome of this data. I only want us to try to help answer questions for the public. Obviously the public is, you know, with the growing number of states that are adopting medical marijuana laws, I think we have a duty to all of these patients to collect objective data and get it published, and see if we can create some enlightenment here and see if we can push the need for science over politics.
Matthew: Now some people are saying that there’s certain psychedelics that may be helpful for PTSD or other neurological disorder. I believe you’re involved with MAPS, the Multidisciplinary Association for Psychedelic Studies. Do you believe that at all? Is there MDMA, maybe psychedelic mushrooms mushrooms or anything else that might be able to help people with certain disorders?
Dr. Sisley: Yeah I think the data is already available from MAPS that’s showing remarkable results with MDMA and PTSD. And MDMA, also known as Ecstasy. What MAPS is studying is a very purified form of research grade MDMA in minute dosages that are delivered to patients within the context of a very structured psychotherapy program. So nobody’s arguing that MDMA is a treatment for PTSD, but MDMA assisted psychotherapy seems to be extremely valuable. So much so that the FDA has now allowed MAPS to move into Phase III, and that is incredible.
So MAPS has been doing Phase II trials on MDMA and PTSD now for a few years, and they’ve finally gotten approval to move into Phase III. And you know after Phase III, if the data looks feasible, then the FDA could approve MDMA assisted psychotherapy to be on the market as a legitimate treatment option where patients could actually get MDMA through an insurance company formulary. So that would be an incredible breakthrough, and I think that’s the goal is to put MDMA through the entire FDA drug development process just in the same way MAPS is trying to do that with marijuana.
And so I think that this is exciting, and what’s even more thrilling about that intervention is that the Phase II trials look like… I think their data showed that they were getting 80 percent of the patients were actually going into remission. I might be wrong on that number, but I know it was definitely a majority of the patients were finding that their PTSD was going into remission. I mean that is extraordinary because that’s completely different than marijuana. The profile of marijuana is that it seems to be very effective in symptom control, but nobody, not any veterans are arguing it’s a cure for PTSD. They’re just saying it seems to be useful in managing daily symptoms. But the notion that MDMA could actually put PTSD into remission eventually is a tremendous gift to these folks that are suffering. And so we’ll see what Phase III show, but I’m really excited. Phase III is usually, you know, 1,000 patients over many many different sites around the country. So we’ll see how quickly they can enroll people and start really elucidating that further.
Matthew: Well thanks so much for educating us about PTSD and all the work and research you’re doing, Dr. Sue. This is amazing what you’re doing here, and we really appreciate it, the cannabis community. As we close, what’s the best way for listeners to follow and support your work?
Dr. Sisley: Yeah actually I would go to MAPS. So www.maps.org is the best. They update their website regularly, and you can even sign up for a newsletter there and get an update in your email learning about, you know, and this is particularly important right now because hopefully NIDA will eventually have the final arm of our study drug and we can… we hope to get underway this summer. So if the NIDA monopoly gets dismantled or if NIDA finally figures out how to grow the marijuana we need, then we may be screening patients as early as June and enrolling people in July and getting this study rolling finally. So if your audience has veterans that have combat related PTSD and want to be screened, that’s the way to do it is go through the MAPS website and they’ll start advertising probably an 800 number they can call.
Matthew: Okay. Well Dr. Sisley, thank you so much for being on CannaInsider today, we really appreciate it.
Dr. Sisley: You bet. Thank you for the invite, and I look forward, hopefully you’ll let me update you down the road once we get started.
Matthew: Oh for sure.
Dr. Sisley: That would be great. All right thank you again.
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