THE SUBCOMMITTEE ON VETERANS AFFAIRS
EVIDENCE
OTTAWA, Wednesday, November 23, 2022
The Subcommittee on Veterans Affairs met with videoconference this day at 12 p.m. [ET] to examine and report on issues relating to Veterans Affairs, including services and benefits provided, commemorative activities, and the continuing implementation of the Veterans Well-being Act.
Senator David Richards (Chair) in the chair.
[English]
The Chair: Welcome to this meeting of the Subcommittee on Veterans Affairs. I am David Richards, senator from New Brunswick and chair of this subcommittee. I’m joined by fellow subcommittee members Senator Boisvenu from Quebec, Senator Anderson from the Northwest Territories, Senator Deacon from Ontario and Senator Yussuff from Ontario.
Today, we continue our study into emerging treatments for veterans suffering from operational stress injuries. We welcome by video conference Dr. Lynnette Averill, Associate Professor, Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine and Chief Science Officer at Reason for Hope; and Ms. Sabrina Ramkellawan, Co-Chair, Board of Directors, MAPS Canada — the Multidisciplinary Association for Psychedelic Studies.
Thank you both for joining us today by video conference. We will begin by inviting your opening remarks, to be followed by questions from our members. You each have five minutes for opening remarks. I would ask participants in the room to refrain from leaning in too close to the microphone or to remove your earpiece when doing so. This will avoid any sound feedback that could negatively impact committee staff in the room. I ask that you keep your questions succinct and that you identify which witness your question is directed to.
Dr. Averill, you may begin when you are ready.
Lynnette A. Averill, Associate Professor, Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, as an individual: Thank you very much to the chair and Subcommittee on Veterans Affairs for the kind invitation to join you here today. It is certainly a great privilege to be here. As a matter of disclosure, before I speak, I am presenting as an individual and all opinions are solely my own. I do not speak as a representative of Baylor College of Medicine or the U.S. Department of Veterans Affairs.
I am here today as a subject matter expert in the field of stress and trauma-related mental health concerns, with a focus on veterans’ post-traumatic mental health specifically and the investigation of novel treatments for these conditions.
I am also here as the daughter of a U.S. Marine who died by suicide after years of struggling with ineffective treatments. My father served in Vietnam, and while we have made great strides in our understanding of stress and trauma-related concerns since the early 1980s when he passed and our understanding of the effects of war and combat not only on the individuals who experience these things first-hand but also on the family, the friends, the communities at large who experience so much of these things in tandem, we have not come nearly far enough as a field. We have only two FDA-approved pharmacologic interventions for PTSD, a disorder that was introduced into the DSM in 1983. While these are critical interventions, they are simply not enough. These interventions are SSRIs — selective serotonin reuptake inhibitors — which are slow-acting anti-depressants with a latency period of weeks to months before a therapeutic benefit, a period which is dangerous and puts people at risk for self-harm and other self-destructive behaviours and has a very distressing side-effect profile.
Further, even when optimally delivered, approximately 40% of patients don’t respond. Rates of non-response are even higher among patients with chronic and complex presentations like so many of our military veterans. Even among those who do respond, many remain symptomatic and lead restricted lives.
Similar issues exist in our front-line psychotherapeutic interventions; they are also critical to our treatment toolbox and, unfortunately, also not enough. Finding trained therapists is often a rate-limiting factor and many people drop out of these interventions — as many as 50%.
The unfortunate reality of our veterans’ mental health crisis — and perhaps that of our society at large — while complex, highlights the limitations of our ineffective pharmacologic interventions and therapies in our toolbox. It is imperative that there is governmental support for exploring novel therapeutics with potential to offer relief and healing to individuals who have been failed by our current treatments, especially those interventions which have the potential to offer rapid and robust improvements. Our veterans deserve and demand a leave-no-stone-unturned approach to explore potential means of prevention and treatment.
Mounting evidence suggests that fast-acting therapeutics, like MDMA and psilocybin, currently classified as Schedule I drugs, have great potential to offer this level of healing to individuals suffering from a variety of mental health concerns. Indeed, initial clinical trials have been promising to the point that the U.S. Food and Drug Administration, or FDA, has granted breakthrough therapy designations to both MDMA- and psilocybin-assisted therapies for PTSD and depression respectively, meaning that these interventions are thought to demonstrate improvement over our currently available interventions, that these are safe and that these have limited potential for abuse.
Yet, because these drugs are classified as Schedule I, it is nearly impossible to legally access these breakthrough therapies, including for patients who have already exhausted all available interventions and are at serious risk for suicide or, at the very least, serious risk for loss of day-to-day quality of life.
Moreover, because these are Schedule I, there are some fear impediments that drive up the cost and significantly delay even basic clinical research and non-clinical research into these compounds to better understand them.
Thus, we should not be surprised, but I believe should find it highly unacceptable, that our veterans often leave the countries which they served to seek out these treatments abroad where they can do so legally.
In recent testimony to the U.S. Veterans Affairs House Committee hearing on suicide prevention, the Veteran Mental Health Leadership Coalition, which includes groups like the Heroic Hearts Project, Veterans Exploring Treatment Solutions, Warrior Angels Foundation and The Mission Within, reported that over 1,000 U.S. veterans have sought support from these organizations and found treatment outside the country.
I spoke with these organizations about their engagement with veterans of the Canadian Armed Forces and confirmed that the order of magnitude is very similar among our Canadian veterans seeking out support, desperate to find healing and finding themselves in a position of being unable to access these interventions within the borders of the country that they fought for.
There is considerable mounting scientific evidence being conducted at premier organizations across the world and significant anecdotal reports of veterans who are not only saved from suicide but from PTSD, depression, addiction, traumatic brain injury and moral injury — all of these things — and importantly also found a renewed sense of meaning, connection and purpose to themselves, their families and their communities when undergoing these interventions.
I think this point is incredibly important because I believe in psychiatry and mental health that often — unfortunately not nearly often enough — we are able to save lives. We are able to keep people at a level where they feel they can exist and they can tolerate another day. While that is a win — that is a great win and I don’t intend to minimize that in any way — it is a wildly different conversation and a wildly different experience from having people build a life that they feel they truly want to live — a life that has a sense of meaning, purpose and connection.
The Chair: Excuse me, doctor. I hate to interrupt, but could you finish up, please? You have gone a little over.
Ms. Averill: Yes, of course. When considering next steps and paths forward, I urge you to look at yourself, your family and your friends. We are at a point in our history with the mental health crisis that, again, highlights the limitations of these interventions. We find that, really, no one is truly unaffected at this point. Supporting research funding, reducing regulatory barriers to expedite research and the advancement of science, supporting expanded access programs and supporting thoughtful legislation that really looks at safe, ethical, accessible and equitable use are critical. I do thank you for your time and attention to this, and I am happy to answer questions.
The Chair: Thank you very much, doctor. Now we will have Ms. Ramkellawan, please, give her opening remarks.
Sabrina Ramkellawan, Co-Chair, Board of Directors, Multidisciplinary Association for Psychedelic Studies: Thank you, Mr. Chair and members of the committee, for having me here today to speak on this important topic. I am Co-Chair for the board of MAPS Canada. MAPS stands for the Multidisciplinary Association for Psychedelic Studies, which is committed to advancing psychedelic medicine by supporting multidisciplinary scientific research, advocating for drug policy reform, offering public education and supporting equitable access to legal and regulated psychedelic medicine in Canada.
I have worked as a registered nurse in a number of settings, including mental health, and I have worked directly with veterans and first responder populations throughout my career, and even specifically with medical cannabis. In addition, I have been conducting clinical trials for more than 20 years. My recent work focuses on supporting both psychedelic and cannabinoid clinical research.
We know that even with approved treatments for major depressive disorder, 34% to 46% of these patients do not adequately respond to treatment, and 40% to 60% of PTSD patients do not respond to SSRIs; also, other evidence-based, trauma-focused psychotherapies such as prolonged exposure and cognitive behavioural therapy result in many participants failing to respond or continuing to have significant symptoms, and dropout rates are high as well.
Psychedelic-assisted psychotherapy has been the first promising treatment in the last 30 years since SSRIs were approved and they are now first-line therapies. Psychedelic-assisted psychotherapy has demonstrated strong evidence in clinical trials, more specifically MDMA for PTSD and psilocybin for depression.
MDMA Phase 3 clinical trial results show 67% of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis, and 88% experienced a clinically meaningful reduction in symptoms. Second Phase 3 data has been completed just two weeks ago, and we are awaiting results and will be excited to share them in the near future.
Psilocybin Phase 2b clinical trial results show 30% of patients in the 25-milligram group were in remission at week three.
Our recommendations for research and access include: Conducting clinical trials with MDMA and psilocybin specifically in the Canadian veteran population that will help provide access to veterans, train practitioners and assess safety and efficacy, including health economics and cost-benefit analysis of psychedelic-assisted psychotherapy in comparison to the standard of care. Clinical trials are already happening in VA — Veterans Affairs — hospitals across the U.S.
A cost analysis of five MDMA trials concluded that the cost of treatment averaged just over US$11,000 per patient. Extrapolated to 1,000 patients over 30 years, it is projected to prevent 60 deaths, gain 4.9 quality-adjusted life years per patient and save just under US$133,000 per patient over the period of reduced physical and mental health care activity. Ideally, this kind of research should start as soon as possible with this new emerging medicine.
We also recommend increasing and improving access to legal, safe and medically supervised psychedelic-assisted psychotherapy for veterans. Currently, many veterans seeking these medicines outside of the legal framework — without regulated, trained and insured professionals — are being forced to break the law and, as Dr. Averill said, go outside North America to other countries to experience this. Others who are not able to gain access are missing an opportunity to relieve their suffering.
In Canada, we have two ways for legal access: through clinical trials and access to psychedelic medicines via Health Canada’s Special Access Program, or SAP. But this is case by case and subject to Health Canada approval and limited by health care practitioners willing to access SAP for their patients. MAPS Canada is starting a research study to assess the SAP from both the health care provider and patient perspective and to ascertain barriers and facilitators to accessing psychedelic medicine through that program. It’s also important for us to understand Veterans Affairs Canada’s role and process for providing emerging treatments to veterans, including how much evidence they need to add psychedelics to the list of allowable treatments. Thank you.
The Chair: Thank you very much.
Senator Yussuff: Thank you to both witnesses for being here today. Dr. Averill, if I could start with you, I want to ask specific questions with regard to the project that I understand was initiated in Texas, and maybe a bit of background as to the context of this project. Then I have more specific questions with regard to the study in general.
Ms. Averill: Thank you for the opportunity to address that. The study in Texas is in response to House Bill 1802 that was passed in June 2021. That is a bill which supports a clinical trial of psilocybin for veterans with PTSD, as well as an exhaustive literature review looking at psychedelic-assisted interventions as it relates to veterans. As you may or may not know, research specifically with veteran cohorts is relatively limited, so that will mostly be a research review of what psychedelic medicine findings have been thus far for stress- and trauma-related concerns broadly speaking.
The study is very much in early stages right now, both due to additional special legislative sessions called by the Texas governor, as well as various regulatory barriers in this sort of work. We have not formally started the study. We are in that process.
Baylor College of Medicine is currently finalizing contracting with Texas Health and Human Services and in tandem to that we are working on our drug supply contract with Usona Institute, one of the two companies that currently has the FDA breakthrough therapy indication. They will be the ones to supply psilocybin and then working on the IRB — the Institutional Review Board — regulatory piece as well.
So that is where that study is. This will be a two-dose study — two doses of psilocybin followed by an optional open label dose for all patients, regardless of whether they received a placebo or psilocybin. This will be for all veterans as well. They do not need to be veterans seeking VA treatment. It will be open to all U.S. veterans.
Senator Yussuff: Thank you. Could you provide a bit of a follow-up in regard to your thoughts about the best practices for undertaking a study for veterans that you would advocate that would be useful with regard to the work that needs to be done?
Ms. Averill: Yes. So many studies are critical at this point. Certainly, as my fellow witness suggested, studies focused on veteran cohorts, period, are critical. A lot of the research has included veteran participants, but none have been veteran focused to date. I think having studies focused on veteran cohorts is critical.
There’s not necessarily great benefit in exactly which diagnosis we’re studying because there’s so much overlap in symptoms. Having said that, of course, the way the FDA works, at least in the U.S., and the way diagnoses work looking specifically at PTSD, depression, anti-suicidal effects and anti-addictive effects — any of these things — is also critical. Perhaps looking at specific subpopulations of veteran groups — whether that is combat exposed or individuals who experienced military sexual trauma — given the way these work neuro-scientifically and neurobiologically, specifically a psychoplastogen like psilocybin, there’s a lot of interest in these drugs in terms of potential for neurobiological changes that may relate to traumatic brain injuries as well.
Certainly, something critical within the VA setting is looking at issues of scalability and how to potentially adjust or shift the mode in which these interventions are presented.
Certainly, the way these are put forth to the FDA currently is a three-part model where there are the preparation sessions, the dosing days and then the integration sessions. These are quite time intensive and are now put forward as a one-patient-at-a-time kind of intervention. There will always be a need for that model. For some patients it would not necessarily be appropriate, safe or comfortable for them to engage.
I think there’s a lot of interest and benefit, particularly within a veteran cohort, where there is so much benefit already from the community, brotherhood and camaraderie. There’s already so much happening in a group-based context; there’s a lot of interest in exploring the efficacy of these interventions when provided in a group-based context.
Are the therapeutic benefits similar or, perhaps, even enhanced when given in a group base, where you may be able to treat multiple veterans at a time, thus not only building in perhaps some added benefit because you have the other veterans engaging in the treatment with you but also from a scalability perspective, being able to have not as much burden in terms of resources-based therapist times? Those are critical as well.
One of the things that is missing in this literature, broadly speaking, is both longer-term follow-up as well as diverse populations. Certainly, our veteran community are often members of marginalized communities, whether that is based on race, religion or any number of other factors, and highlighting the safety and efficacy among those groups is another critical component.
The Chair: Thank you, doctor. Ms. Ramkellawan, do you have anything to add to that?
Ms. Ramkellawan: With clinical trials, we’re already seeing MDMA and psilocybin, and we’re looking at efficacy and safety, but we also need to understand which therapies work in conjunction with psychedelics.
We are seeing MDMA-assisted cognitive-behavioural conjoint therapy looking at dyads in which a veteran, for example, has PTSD but they’re coming in with their significant other and going through that journey together. That’s an important aspect of healing as well.
We’re seeing MDMA-assisted therapy in combination with cognitive processing therapy. We’re seeing it with prolonged exposure. I think it’s not just doing these clinical trials and getting it to market but doing it in the Canadian veteran population and understanding what works best.
You talked about group therapy as well. I want to share something. I spoke to an RCMP member just before this call, and I want to quickly talk about that conversation. He was in a situation where he was misdiagnosed, and then 17 years later he was diagnosed with PTSD and major depressive disorder. He did recently seek psychedelic-assisted therapy with ketamine and group therapy. That was not covered because it didn’t meet the criteria for Veterans Affairs Canada, or VAC, coverage. He was able to pay out of pocket, but this is not the case for all veterans who are looking at trying emergent therapies. Ketamine is now approved as a stand-alone, but it was not approved in conjunction with group therapy.
There’s not enough case study in terms of history to show ketamine and group therapy to be able to get it approved. Group therapy was beneficial for him because he was able to connect with others who were going through the same lived experience as he was. He mentioned that he would want the option of trying psychedelic-assisted psychotherapy in the future. He also noted this may be a concern with other veterans who would not be able to pay out of pocket for these types of emerging therapies.
The Chair: Thank you very much.
Senator Anderson: Thank you to the witnesses for your presentations. My question has to do with the 40% that you said are not responsive to the current treatment. With this 40% who are not responsive, what are some of the options available to them?
I also have a question with regard to the importance of psychedelic drugs and therapy. There are a number of veterans dealing with homelessness, and there’s a recognition that with homelessness there’s a higher propensity for mental health issues. When you’re looking at partnering psychedelic drugs with therapy, is the factor of homelessness also addressed as one of the factors that’s looked at for supportive housing?
Ms. Averill: To the point of the 40% and the options once someone has not responded, unfortunately, that landscape looks a little bleak. Generally, individuals who do not respond after two to three months, give or take, of regular treatment will work with a physician and be given a new prescription, generally another SSRI, and start that process over at ground zero with another two to three months of trialling that medication. The reality is the more times an individual is failed by an SSRI, the chances they will find healing from an SSRI go down, not up. So it may be a process in which you try 2, 3, 5 or 10 different flavours of SSRIs, if you will, and do not find healing.
You may be put on additional medications to help manage the side effects of the SSRIs that you’re taking. Certainly, within the U.S., it is very common for individuals to be taking 10 or more prescriptions to manage the same constellation of symptoms. That is a very common thing that happens, and it is certainly a very distressing thing for individuals not only to be packing around medications in the double digits but also not necessarily finding healing with those double digits and, for many people, actually feeling worse than they did to start with.
If you are not finding healing with SSRIs, there are options. You can try combination psychotherapy, whether that is prolonged exposure, cognitive processing, EMDR — Eye Movement Desensitization and Reprocessing — therapy, or any of these things. As I highlighted, these are also challenging interventions. They’re very difficult interventions to engage in, and finding appropriately trained therapists and working on wait lists is also very hard.
There are options within the last few years. Many people have been turning to things like ketamine. It is not FDA approved for PTSD, but does have evidence to suggest there may be some therapeutic benefit there. Esketamine specifically is FDA approved for depression now, so it is given off-label in many instances for depression, PTSD, anxiety and suicidality. The challenge with ketamine, even for those who do respond, is that the benefits are short-lived, usually lasting 7 to 10 days, at least after an IV infusion with similar sorts of results for the intra-nasal administration of esketamine.
For people who have tried everything, ECT — electroconvulsive therapy — continues to be a last-ditch effort. Many places are engaging in some of the interventions that are more neuromodulation things, such as TMS and rTMS — transcranial magnetic stimulation or repetitive transcranial magnetic stimulation — which are more neurobiologically based interventions. Again, the challenge here is that these are difficult to access; often, insurance does not cover them and limited providers offer these kinds of things. It is a significant challenge to that piece.
The Chair: Doctor, once again, I will give Ms. Ramkellawan a chance, and then we will go on to another question. Thank you.
Ms. Averill: Of course. Thank you.
Ms. Ramkellawan: A number of years ago, when medical cannabis was just approved, I was working with a lot of veterans and first responders in terms of accessing and assessing. We were looking at pain for cannabis and other things, and all of a sudden we were getting a huge number of veterans who wanted access for PTSD, and there was no literature or support.
I did a prospective observational study many years ago when medical cannabis was just approved and saw improvement, but medical cannabis is symptom management. I saw improvements with PTSD, and I saw improvements with sleep. That is one area that I saw where veterans were seeking alternative treatments, and these were situations where other medications and therapies were not working. I have experience in that area.
You spoke about access if a veteran was homeless, and Dr. Averill touched on diversity. When I spoke about the options that are available, we have clinical trials, and if a veteran were to go into a trial — and there are some clinical trials happening in Canada with psilocybin and MDMA — and if they happen to fit the inclusion/exclusion criteria, that is one way somebody could have access without paying out of pocket.
The Special Access Program, or SAP, is another area, but that would be hard for someone to have access to if they do not have the means to pay for it, because it is not covered under Veterans Affairs Canada.
There is an access issue, even though we have the Special Access Program. We also, more recently, heard about Alberta, and they are going to be looking at psychiatrists only. They would go through the Special Access Program, but if you are looking at getting access in Alberta, you would have to go through a psychiatrist only. There are bottlenecks with that, because there is already a waiting list to see a psychiatrist. If it is only limited to psychiatrists, there is another access issue and barrier there.
There are talks that there has to be specific training, but we do not know exactly where that training is coming from, which has to be done by those psychiatrists, and who would be allowed to access the SAP for patients in Alberta. There are some access issues, for sure, that need to be looked at in terms of the regulations and access for veterans.
The Chair: Thank you very much.
I would like to mention that Senator Boisvenu from Quebec has joined us.
Senator M. Deacon: Thank you to our witnesses for being here. This is some tough testimony for a population that urgently deserves and needs our support.
In preparing for this meeting, in our briefing I noticed or reminded myself that two medications, paroxetine and sertraline, were the only two medications approved for treatment of PTSD at this moment. I am wondering if you are able to share with me some of the possible side effects of those medications and if our veterans have to take these medications indefinitely in order to note improvement, and the cost. I’m trying to get a sense and a baseline for what a standard prescription would be for either one of these approved medications. Let’s start there.
Ms. Averill: That is an excellent question.
The primary side effects are the usual gamut of things that I think get slapped on everything: headache, nausea, diarrhea, all of those things. The things that people find most distressing are that there is often cognitive impairment. People report problems with memory and attention, which also relates to issues with compliance. If I cannot remember whether I took my medication or not, that is obviously problematic.
The issues of weight gain or loss can happen very quickly for people. Sometimes losing or gaining 20 to 30 pounds in a couple of months, where you may get to the end of it and not really have had any clinical benefit but certainly had a significant shift in weight, either up or down, is very distressing for people. And there are sexual side effects; sexual dysfunction is, of course, also very distressing.
As a reality check for any of us, if we are struggling with any concern, and our doctor says, “I have something for you that may or may not work at all, and you will lose or gain 20 pounds, not be able to remember if you took it and not be able to perform sexually,” probably none of us are going to jump at the chance to sign up for that.
In terms of cost, that is a little bit of a complicated question. Depending on whether you get a generic or non-generic, the costs are, of course, different there. I am not familiar enough with the Canadian health care system to be able to speak to insurance coverage or these sorts of things.
Sometimes, cost-wise, it is not too detrimental if you have a robust insurance plan that will cover these. You can get it for a very limited amount each month. The challenge, of course, is that you may be paying a limited amount, which is great — $10 or $20 a month — but not actually feeling any better, so you are potentially paying for nothing or potentially paying to feel worse, in some cases.
I am not sure if my colleague, Sabrina Ramkellawan, may want to add to that.
Ms. Ramkellawan: I would say that I do not know the cost, but with Canadian veterans, because it is an approved therapy, my understanding is that that would be approved. It is the emerging treatments that are not approved. It would not be an issue in terms of them getting coverage.
Senator M. Deacon: If you take that to the other end, and that is the approved medication, I am trying to think about the possibility or the window of something that may be more proactive in the process. Leave the drugs for a minute.
I am wondering if there is any work done to potentially get ahead of this in our Canadian Armed Forces and in our police services. During service, are there routine check-ins or the possibility of therapy sessions during a soldier’s service that may help diminish the odds of them suffering from PTSD when their duty is done or if they encounter a singular event that could result in an occupational stress injury?
Is there any work being done on that?
Ms. Averill: I will certainly admit I am not nearly so familiar with what is happening in the Canadian Armed Forces as in the U.S. armed forces and the Department of Veterans Affairs.
I think, though, there certainly is some of that work happening. In militaries across the world, I think there has been a lot of work on prevention efforts, on building resilience, on doing debriefing and on any of these kinds of things. Those are not without their limitations for a myriad of reasons, including because there is such a stigma within the military to address mental health concerns or acknowledge having mental health concerns.
Certainly, not only from the stigma perspective but also from a fear of, perhaps, being deemed unfit for service, how much are people willing to acknowledge that they may be struggling?
I think that it is a significant challenge to have people still in the midst of a chronic, ongoing stress and trauma while also trying to treat said stress and trauma. For many people, they are just in that mindset, and for a lot of folks, they are not aware of how significantly they may be impacted until they have transitioned home and transitioned into more of that civilian life and find there are all of these things coming up that are problematic, that are distressing and disruptive.
The Chair: Thank you, Doctor Averill.
Ms. Ramkellawan: In terms of talking to veterans, it seems like the support is a lot better now than it has been in the past, but there are still timeline issues. It is still weeks and weeks for diagnosis, weeks and weeks to look at starting new treatments. There is still a bit of those issues in terms of the promptness of the services.
Even the story I gave you with the RCMP veteran, he just did not want to go through all of the hassle of trying to figure out how to get coverage. He just wanted to take care of his PTSD and improve his symptoms and those interactions with his family and those impacts; as you said, it is the impact when they get home when they have to transition to this other life. They are not in the military anymore or with the RCMP. They are trying to figure out what that looks like, and now they are dealing with PTSD and the impacts on their families.
Support is also a factor. If those things don’t work, what do they do next? In a lot of cases, they are figuring it out on their own.
It is great that we are talking about emerging treatments now, because that is part of the issue of how you access other things. There are limited treatments, and if those do not work, then what? What are they to do at that point in time? That is a big issue for many veterans.
The Chair: Thank you very much to both witnesses.
Senator Boisvenu, you came late but did you have a question for either witness?
Senator Boisvenu: Yes, please.
[Translation]
I’m sorry for being late for the meeting. I had a little health issue this afternoon.
Thank you very much to our witnesses for educating us on this. We know that Americans have a long history of treating trauma among soldiers and veterans. Just think about the Vietnam War, which left a legacy for U.S. veterans; there’s a long history of that.
I recently read a report by Dr. Rothbaum from the Emory University School of Medicine in the United States, in which it was mentioned that one of the programs was producing very good results in the area of psychotherapy. These were intensive inpatient psychotherapy using the prolonged imaginal exposure approach. Are either of you aware of this program? Is it being used in Canada?
[English]
Ms. Averill: I am not certain exactly which treatment you are referring to. I know that Dr. Barbara Rothbaum has been engaged in a lot of prolonged exposure research and clinical work at Emory. Right now, it is in relatively early stages, and perhaps Ms. Ramkellawan has a better sense of this and is engaged more closely with MAPS. I know they are doing a study of prolonged exposure and MDMA. I cannot speak to where that study is in terms of completion, but I know that is something they are looking at.
Prolonged exposure is one of the front-line gold standard trauma-focused treatments. I know that is something she has done a lot of. She has also done some work with virtual reality, not in conjunction with psychedelics at this time, as far as I know, but she has also done some of that work.
For both prolonged exposure and virtual reality, there is evidence to suggest that both of those have therapeutic benefits. Those are both very good treatments. As I commented upon in my opening remarks, the challenge there is that they do work for some people, but what about all of the people they do not work for?
So as my fellow witness suggested, there is a lot of interest in doing studies that would combine those things — that will take some of these gold standard psychotherapeutic treatments — and see what outcomes we might get if we combine those with MDMA, psilocybin and other things.
I hope that answered the question at least a bit. I am sorry I cannot speak more to that.
[Translation]
Senator Boisvenu: Do we know if it’s used in Canada with our veterans?
[English]
Ms. Averill: I am not 100% certain of that, but I have a high degree of confidence that it is. It really is a gold-standard treatment. Prolonged exposure and another treatment called cognitive processing therapy are really the two gold-standard psychotherapeutic interventions for post-traumatic stress disorder.
I know there are a number of therapists, with Dr. Candice Monson, based in Canada, being one of those who has done a lot of work on CPT, or cognitive processing therapy.
But because prolonged exposure is so well respected and does have a very large evidence body, I am very confident that it is used with Canadian veterans and perhaps within the Canadian Armed Forces as well, but unfortunately, I do not have a lot of details about that.
[Translation]
Senator Boisvenu: Thank you very much.
[English]
Ms. Ramkellawan: There is a cognitive processing therapy study with MDMA happening in Toronto. It is already under way. It is not specific for Canadian veterans; it is open to the population that meets the inclusion/exclusion requirements. Again, that is happening in Canada with Dr. Anne Wagner. I wanted to put out there that it is happening.
As Dr. Averill said, CPT is a gold standard. It is great to look at psychedelic with gold-standard psychotherapy. That is happening in Canada.
The next study that will happen after that is the one I mentioned, which is MDMA-assisted cognitive behaviour conjoint therapy. That is looking at couples. Again, that is not specific to Canadian veterans, but there is the potential that there will likely be some Canadian veterans in those studies.
The Chair: Thank you.
It has been skirted around, but what is the long-term prognosis after clinical trials? Is there any reason to think that these ongoing therapies will be useful beyond the clinical trials? Will they be used, or are we just in such early days that we do not know?
Ms. Averill: There is incredible potential for them to very much become gold-standard interventions. The clinical trials have been very promising to date. The MAPS studies, as well as the studies from COMPASS and the Usona Institute, the two psilocybin companies, have been incredibly promising. I think we will see those roll out and gain FDA approval within the U.S. and similar approvals across the world.
Of course, the challenge is the issue of scalability and those sorts of things. As they are presented right now, they are very resource-heavy. The benefit, though, is that, while they are resource-heavy, they are not like SSRIs or other interventions where you may be taking it for months or years — decades — into the future. One area of research that we do not have a lot of answers for yet is the durability of effect, which is how often people may need to re-engage in those interventions. Anecdotally, there are some patients who will engage in these interventions, either in a clinical trial or outside of the country in a therapeutic setting and never go back — never need anything again. That is an outcome we have repeatedly seen.
There are other patients who will engage in those interventions and perhaps continuing taking an SSRI but have it be much more effective. They will continue seeing a therapist but have it be more effective.
There are many people who are going through an initial course of MDMA, psilocybin or other interventions. Many people are leaving the country and engaging in other psychedelics — ibogaine or 5-MeO-DMT — that might have a significant benefit for six months or a year, and then they do sort of a “booster session,” if you will, by engaging in some other intervention.
There is incredible potential. We do not necessarily know yet exactly what that trajectory of care will look like, but there is incredible potential there. They are more resource-heavy up front, if you will, but offer a much more significant durability of effect.
As I commented upon very briefly, I think they also offer a much more robust and transformative effect for many people — not for all people, of course, but for many people, there is a more robust effect as well.
The Chair: Thank you, doctor. Do you have a comment, Ms. Ramkellawan?
Ms. Ramkellawan: Yes. You were speaking of when those would be approved or come to market as medicines, MAPS in the U.S., the sponsor of the MDMA trials, has just completed their second Phase 3 study. They are putting that data together. They are going to be submitting to the FDA in early summer 2023. It is probably the closest that we will get to something potentially being approved. The studies they’ve done are not just in the U.S.; we have had people participate in Canada as well, which is significant. We are probably looking at the next year or two to have these approved.
As Dr. Averill said, it is not that it is approved and — boom — everyone is using it. There is scalability. We already know that there is likely going to be a shortage of people who are trained to do psychedelic psychotherapy. It is almost as if we have to start thinking of that now. In addition to MAPS Canada, there are a number of universities that are already looking at training in this space and are preparing. There is likely going to be a lot of training that needs to happen. Psychotherapy is resource intensive in the short term. You are typically looking at two people with a patient for 8 to 12 hours during the experience with the psychedelic, preparation and then post-integration. It is intense, but it is shorter term than someone being on treatments for the long term. I definitely see that this could potentially be, once approved, the gold standard in the future.
The Chair: Thank you.
Senator Yussuff: My sincere thanks to both witnesses in regard to sharing this information with us.
Looking at where we are in Canada, it is a challenge to get Veterans Affairs Canada and the Canadian government to recognize the importance of psychedelics for the health of veterans and others who are dealing with post-traumatic stress disorder.
From both perspectives, what you would recommend that the Canadian government could benefit from in regard to our veterans who have been demanding more treatment, but equally looking at new therapies that are now available? I recognize it is very limited in regard to the evidence that we are seeing, but we are hoping that that will be confirmed with ongoing and future studies going forward. Are there any recommendations that you would have?
And as a follow-up question, is there any documentation that you can share that will help us in regard to our subcommittee work on the recommendations that we will ultimately make at the conclusion of our study?
Ms. Averill: Veterans Affairs is very nicely aligned, I will say, to really take the lead on this kind of work. Certainly, within the U.S., and I would imagine it is very much the case in Canada, the Department of Veterans Affairs is one of the largest health care providers in the country, and certainly the largest health care provider for veterans. It’s probably the largest mental health care provider for any group who is struggling with stress- or trauma-related concerns.
In my opinion, I see that there is enough scientific evidence at this time that suggests these are safe interventions. They are effective interventions. They have incredible potential. I see no reason — no excuse, honestly — that the Department of Veterans Affairs should not be at the forefront, leading the charge of this research saying that if there is potential here for therapeutic benefit for PTSD, depression, suicidality, addiction, a traumatic brain injury — TBI or any of these things that priority operational areas for the Department of Veterans Affairs, they should be funding this.
They should be supporting and encouraging this work because, as I said, our veterans deserve and demand that any of us in a position of power who are doing this research, who can be supporting this research and who can be engaging in this need to be doing it. The Department of Veterans Affairs could be funding research projects and could be supporting this body of work, whether that is supporting investigators in-house doing this or people in the community doing this sort of research. Of course, veterans often are engaged in therapy outside of Veterans Affairs as well. Certainly, things such as what Ms. Ramkellawan commented on — the couples’ work and things that are family or community based — any of these things are critical.
I am not familiar with how your committee relates to Veterans Affairs Canada, but I would say anything that could be done to support them in supporting this work, any funding that could be shifted toward veteran-focused studies and veteran-focused research and anything that could be done to encourage or nudge them is important. In terms of adding extra funding to the budget, I would imagine that Veterans Affairs Canada is similar to the U.S. department in that there are so many fires that need to be put out with limited funds, so asking for funds for this out of the pot that already exists may be a challenge. Thinking about whether there are ways to establish a specific pot of money that could support this line of research is critical.
The Chair: Thank you.
Ms. Ramkellawan: I completely agree. We have advocacy groups like ourselves trying to raise funds for research happening in Canada. But if VAC is looking for evidence specifically in Canadian veteran populations, I do think that that funding needs to come from VAC. We have seen that the Canadian Institutes of Health Research — CIHR — did fund $3 million for psilocybin, which is great, but not enough. It takes a lot of money to get clinical trials done — even a small, basic study is $5 million — so there has to be that funding there, especially since we are seeing such strong evidence. I think it is critical at this time to fund veteran research with psilocybin and MDMA so that we can also understand what works best for our veterans in terms of what therapies match best with MDMA, psilocybin, et cetera, and looking at measuring those outcomes. That is really critical at this stage in time.
[Translation]
Senator Boisvenu: My question is for Ms. Ramkellawan. Very simply, right now, in terms of the use of psychedelic substances that are in clinical trials, which ones are the most promising in terms of therapy? Based on our knowledge of the scope of use, can we establish a hierarchy from the most effective to the least effective?
[English]
Ms. Ramkellawan: It is hard to say, because there are still more clinical trials that need to happen with other psychedelics, but I would say that MDMA is very promising because it is already in Phase 3. Ketamine is already approved, but I think there could be work done looking into how therapies could help with ketamine, specifically with PTSD. We do not have data with respect to that indication specifically. There are opportunities there. Obviously, psilocybin is going into Phase 3, which is promising in terms of the stage that it is at. Those three would be the ones that would be a priority if we had to rank them.
I think I missed one thing from the last question in terms of how we can help VAC. There are already studies and data for studies. There could be collaboration and sharing of information to help VAC if they were looking to do clinical trials with Canadian veterans. There is definitely a body of knowledge and a body of therapists and investigators who have already been active in this area who could potentially give that advice and input to help support that.
The Chair: Thank you to our witnesses, and to the senators. This has been extremely informative. Thank you very much, Dr. Averill, and thank you, Ms. Ramkellawan. We hope to see you again sometime.
(The committee adjourned.)