THE SUBCOMMITTEE ON VETERANS AFFAIRS
EVIDENCE
OTTAWA, Wednesday, October 26, 2022
The Subcommittee on Veterans Affairs met with videoconference this day at 12 p.m. [ET] to examine and report on matters relating to national defence and security generally, including veterans’ affairs.
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, chair of this subcommittee. I am joined today by my fellow subcommittee members: Senator Boisvenu, deputy chair from Quebec; Senator Anderson from the Northwest Territories; Senator Deacon from Ontario; and Senator Yussuff from Ontario.
Today we continue our study of emerging treatments for veterans suffering from occupational stress injuries.
We welcome by video conference Dr. Muhammad Ishrat Husain, Lead of the Mood Disorders Service and Clinician Scientist, General Adult Psychiatry and Health Systems Division, Centre for Addiction and Mental Health; and Zachary Walsh, Professor, Department of Psychology at the University of British Columbia.
Thank you both for joining us today by video conference. We will begin by inviting you to provide your opening remarks, to be followed by questions from our members.
I want to remind people that before asking or answering questions, I would like participants in the room to please refrain from leaning too close into the microphone or removing 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. Husain, you may begin when you are ready. I would like between a five- and seven-minute statement, please, because we only have an hour.
Muhammad Ishrat Husain, Lead of the Mood Disorders Service and Clinician Scientist, General Adult Psychiatry and Health Systems Division, Centre for Addiction and Mental Health, as an individual: Thank you very much for the invitation to provide a statement today. I will be providing an overview of the potential role of psychedelic drugs as emerging treatments in mental disorders.
To begin with, psychedelic drugs are a loosely grouped class of drugs that are thought to exert their effects through their actions on a neural chemical in the brain called serotonin. The classic psychedelic drugs are thought to induce quite complex behavioural, psychological and physiological effects through their actions on the serotonin 2A receptor.
In the 1950s and 1960s, after these drugs were first identified, clinical research into their potential therapeutic effects in a variety of mental health conditions and substance use disorders and addictions flourished. At one point, the National Institutes of Health in the United States had funded over 100 clinical trials. However, in the late 1960s and early 1970s, once these substances became Schedule I narcotics, all clinical research came to a halt for several decades.
During the last 10 to 15 years, there has been a resurgence in the interest of using psychedelic drugs, such as psilocybin and MDMA, as novel treatments for a variety of mental health conditions, including major depressive disorder, end-of-life distress and post-traumatic stress disorder.
In the mid-2000s there was encouraging data from small, randomized clinical trials showing that psychedelic drugs like psilocybin and LSD, when combined with psychological support, could lead to large reductions in symptoms of depression and anxiety in patients with terminal cancer and end-of-life distress.
After this, there were a number of preliminary trials in patients with major depressive disorder. In 2016, a landmark study was published showing that in 19 patients with treatment-resistant depression, a dose of psilocybin, when combined with psychological support, led to large and sustained improvements in depressive symptoms in this complex group of patients.
After these studies, in the last two to three years, there has been more encouraging data from clinical trials in major depression showing that psilocybin — which is the chemical component of magic mushrooms — when combined with psychological support, can lead to quite substantial improvement in depressive symptoms when compared to a placebo condition.
A study published last year in The New England Journal of Medicine — probably the most prestigious academic journal available — demonstrated that in patients with major depression, psilocybin, combined with psychological support, was as effective as a first-line antidepressant for the treatment of major depression.
Following this, there have been a number of different trials looking at psilocybin in various clinical populations, including patients with alcohol-use disorder. A trial was published earlier this year in JAMA Psychiatry showing that patients who received psilocybin combined with psychological support had statistically significant fewer days of heavy drinking following this treatment compared to placebo.
There have also been trials of other psychedelic drugs such as ayahuasca, also known as DMT —
The Chair: Doctor, forgive me, but could you finish up? Because we have another witness and then we have questions.
Dr. Husain: I’ll conclude by saying that there has been encouraging data for psilocybin and MDMA for the treatment of various mental health conditions, including depression and PTSD. The data is from small trials. It is not data that is generalizable at this point. I do not think these drugs are yet ready for clinical translation because of the issues in the clinical trials that have been currently published, including issues with their design and the small sample sizes, which make it very hard to confirm their safety and effectiveness.
I will conclude with that. Thank you very much.
The Chair: Thank you very much.
Now we will turn to Dr. Zachary Walsh.
Zachary Walsh, Professor, Department of Psychology, University of British Columbia, as an individual: Thank you so much, senators, for having me. I’m joining you today from the unceded territory of the Syilx Okanagan people in Kelowna at UBC.
I am a researcher in psychedelics and mental health and a tenured psychology professor at the University of British Columbia. I am here to speak about psychedelic-assisted psychotherapies. I have published widely on the topic and have had research funded by the Canadian Institutes of Health Research, or CIHR, the Social Sciences and Humanities Research Council, or SSHRC, and others.
In addition to being a publicly funded clinical researcher and educator, I am also in paid advisory relationships with Numinus Wellness and Entheotech BioMedical regarding the medical development of psychedelic-assisted psychotherapies. I am an unpaid member of the advisory board of the Multidisciplinary Association for Psychedelic Studies and MycoMedica Life Sciences.
I’m also a clinical psychologist —
The Chair: Doctor, might you slow down a bit to aid the translators in being able to translate? Thank you.
Mr. Walsh: Sure. I just want to make sure I get it all in.
My testimony today will draw primarily on my own research and knowledge of the empirical literature on psychedelic-assisted psychotherapies and also on my first-hand experience working with individuals who have used or hope to use psychedelics to treat PTSD and related conditions.
The category of psychedelic-assisted psychotherapy includes diverse substances and indications. In this presentation I will focus on psilocybin, MDMA and ketamine.
These three medicines are the mostly widely used and researched of the interventions typically collected under the psychedelic umbrella. They differ in important ways, but they have in common that they produce alterations in consciousness lasting two to eight hours. These altered experiences, sometimes called “the trip,” play a key role in their therapeutic effects.
It is the changes emanating from the experiences, rather than direct physiological changes associated with the medicine, that are primary. The reliance on acute subjective effects is promising in that it suggests that a few administrations may be sufficient rather than prolonged use, as is the case with most sedatives and antidepressants that are used to treat these conditions.
In this way, psychedelic therapies may be compared to surgeries. They require brief periods of intense clinical attention that produce long-lasting health changes when they work. It seems that patients take something away from their psychedelic experiences that translates into enhanced meaning in life and reductions in the hopelessness and low mood that characterize depression, PTSD and other mental health disorders.
It might seem unusual in the medicalized field of mental health to discuss things like meaning in life and hope, but it is not at all unusual in a practical sense for people to discuss single events that change their lives. We accept that singular traumas can have long-lasting consequences, and we can also recognize that profound positive experiences might have lasting effects.
Psilocybin is by far the oldest of these substances, with a long history of use prior to European colonization by the inhabitants of what is now North America. Characterizing that preclinical use is complex, but it almost certainly included applications that are similar to what Western medicine might describe as mental health and well-being. As my colleague has described, the resumption of research on psilocybin has provided some relatively high-quality evidence of effectiveness for depression and promising effects for anxiety and addiction.
Ketamine, on the other hand, is the only substance of these that enjoys widespread medical use, albeit as an anaesthetic rather than as a psychedelic, primarily. We recently completed a comprehensive review of ketamine for mental health and found good, but transient, effects for depression and suicidality.
The effects of psilocybin appear to be longer lived than those of ketamine.
Finally, MDMA combines classic psychedelic effects with stimulant-like effects that promote openness, insight and relationship with health care providers, all of which are important for addressing trauma. The literature on MDMA is focused almost exclusively on PTSD, for which it appears to demonstrate strong and lasting positive results with effect sizes that exceed those of conventional treatments.
You might notice that these are all different indications. However, things like depression, anxiety and PTSD have considerable overlap and may represent different manifestations of similar —
The Chair: Doctor, could you finish up, please, so we could go to questions?
Mr. Walsh: Sure.
One of the big concerns here is problematic use. Although these drugs are used illicitly, the risk of addiction is low and frequent use is rare, even in illegal contexts. Psilocybin is not used compulsively, even in uncontrolled settings, and work in animal models confirms this.
We have to look at the alternatives of the devastating consequences of untreated PTSD and the inadequacies of existing treatments.
With that in mind, I urge the senators to recognize that the current situation for these drugs — special access programs and admission to research studies — overburdens providers. I believe we must cut red tape and overly restrictive regulations on these treatments. The Province of Alberta has taken the important step of establishing regulations, but the wait times are already long for psychiatrists. I am concerned there will be unnecessary barriers to access for veterans who desperately need these treatments. I think they should be available to those who might benefit most, given what I feel to be a very positive risk-benefit ratio. We don’t want them to be limited to only those with a lot of resources or connections to access them. Thank you very much.
The Chair: We will now go to questions. Keep your questions and answers as succinct as possible. We will start with the deputy chair.
[Translation]
Senator Boisvenu: I’d like to thank our two guests. Other than psychedelic substances like LSD or psilocybin, are there any other emerging treatments that have proven successful in helping reduce post-traumatic stress disorder in our veterans?
[English]
Mr. Walsh: My focus has been on psychedelics.
You asked if there are other emerging treatments. There are a number of behavioural interventions, and people are using cannabis to treat symptoms, but the most promising development for PTSD is likely MDMA-assisted psychotherapy. It has been fast-tracked in the U.S., and we’re already looking at special access. It seems to really accelerate the reprocessing of trauma and facilitate a strong bond between the therapist and the client in a rapid way. That’s important for veterans who are trying to go through the re-experiencing and reprocessing that’s so important in the cure for PTSD.
So MDMA is the most prominent and promising of new treatments, but there are people who are working tirelessly to find other alternatives. MDMA is the leading one.
[Translation]
Senator Boisvenu: Psilocybin was only approved this past January by the Department of Health in Canada. Do we have enough control groups to prove that this treatment has positive effects on post-traumatic stress disorder, or are we relying on the U.S. experience?
[English]
Mr. Walsh: The psilocybin research is focused primarily on depression, and a lot of that research has been conducted in Europe, mostly the U.K., and also in the U.S. at Johns Hopkins. It has focused primarily on depression rather than PTSD, although there is so much co-occurrence between the two disorders that treating depression and people who suffer from PTSD is a reasonable and hopeful approach.
As I said, for PTSD, MDMA has largely been the focus, although there is a lot of overlap with PTSD and depression.
Senator Yussuff: Thank you, witnesses, for being here, and thank you for the work that you’re doing on this.
As you know, veterans and first responders are very much struggling with PTSD. This is a challenge for us. We’ve got far too many veterans who require help, and we’ve done as good a job as we can.
How could psychedelic therapies be an improvement for veterans and first responders who are suffering from PTSD versus established treatments? We’re seeing the evidence. Obviously, the data is being peer-reviewed and what have you. What can you tell us? By the way, I will direct my question to both witnesses.
Mr. Walsh: The best existing treatments for PTSD are exposure therapies. They’re hard to access and require a very long time. To engage in those exposures can be a real obstacle for many vets.
Unfortunately, therefore, a lot of vets are prescribed selective serotonin reuptake inhibitors, or SSRIs; antidepressants; sedatives in some cases; and a combination of the two in many cases. There is not great evidence for their effectiveness. It is a kind of Band-Aid.
One of the hopes for psychedelic psychotherapies is that they provide a more acute, lasting cure. It’s based on the combination of the drug and the behavioural intervention, as my colleague stated. It really accelerates the behavioural psychological processes, rather than masking the symptoms the way that antidepressants and sedatives might. I’ll leave the rest of the response to my colleague.
Dr. Husain: Thank you.
I would agree that distinguishing psychedelic-assisted therapy from currently available treatments is that psychedelic-assisted therapy seems to have a much more potent and sustained effect on trauma symptoms than what we currently have.
As Dr. Walsh mentioned, we currently have a combination of antidepressant medications and psychological treatments based on the principles of cognitive behavioural therapy. Although they’re effective for a group of individuals, there is quite a substantial proportion who don’t respond, particularly those who have PTSD and other co-morbid mental health issues or addictions, such as depression, anxiety, alcohol use and so on. The data that is emerging from the clinical trials, which are multi-centre clinical trials — and there were some centres in Canada, as well — for MDMA-assisted psychotherapy with patients with PTSD included patients with quite complex PTSD, such as with co-morbid depression, anxiety, substance-use issues and suicidal thinking. It did show quite sustained improvement of PTSD symptoms in that group.
I will just add, though, that there have been critiques of some of the trial methodologies. As you can imagine, it’s very difficult to conduct a truly blinded, randomized clinical trial because when you are administering a psychedelic, a patient knows that they’re receiving it because the drugs are so potent in their psychoactive effects. So getting an adequate control group has been a challenge. Over 90% of people who have been allocated to receive the psychedelic know that they are receiving the psychedelic, and that’s not what we’re used to in our traditional appraisal of evidence.
So that complicates things, but, nonetheless, the data is very, very encouraging for MDMA-assisted psychotherapy in PTSD. Given how there’s such a substantial number of first responders and veterans who don’t get better with current treatments, it is definitely worth exploring MDMA-assisted psychotherapy for this group of individuals.
Senator Yussuff: The challenges we’re facing in Canada are great, given the number of veterans we have and including first responders. What would you recommend to our subcommittee in regard to our efforts to help Veterans Affairs Canada? How can they encourage the provinces to support veterans who need psychotherapy and find treatments that will help veterans overcome their symptoms and get back to a normal life in this country?
Mr. Walsh: I’m quite comfortable in saying that I recommend increased access. As my colleague noted, we need more studies; however, if we are waiting for those, the classic placebo control is a real problem. In the control condition, the placebo condition, someone is lying down, wearing an eye mask and headphones, feeling nothing for eight hours. So it’s not only that people guess when they are in the active condition; for the people in the control condition, it can be quite unpleasant.
We need to find other ways to assess these treatments. The preliminary effects are really good, and the medicines are very safe, from what we know. Given the high rates of suicidality, overdose, the terrible consequences of PTSD and the real problems with existing treatments, I think we need to facilitate the uptake of MDMA for PTSD quite rapidly, while keeping a close eye on it in case there are things that we don’t know.
The risks of these medicines are quite well characterized because they have a long history of use outside medical contexts. Even in the illegal context, they’re not as dangerous as many drugs. They are not like opioids or cocaine or alcohol, where people become habitual users. Some will fall into that, but in general they are very safe and very promising. The conditions that we need to treat, as you know, are very dire. I don’t see a real benefit to being overly conservative.
We need to treat people as they are living right now. The hunger for these treatments is huge among people who are suffering. I’m worried that people will turn to illicit providers; they already are. We need to provide safe access to the many veterans who want to use these treatments because otherwise they will go to the grey market or remain untreated. The consequences are quite negative if we don’t allow access.
Dr. Husain: I agree that MDMA-assisted psychotherapy is a step ahead from other psychedelics in terms of the evidence base. They have a phase-three study, which is what is usually required to then translate into clinical use. That has been published. I would say that, yes, allowing easier access to MDMA-assisted psychotherapy with trained providers in the right setting and facility would be something to definitely look into.
I do have a concern about how this type of treatment would be scaled up in terms of the numbers of veterans and other people who are suffering because it is a very resource-intensive treatment. As providers, we need to think about how we could scale it up because, at the moment, it requires two trained therapists for a minimum of 12, sometimes up to 20, hours of psychological support around the treatment. Where I am in Ontario, access to OHIP-covered psychotherapy is almost impossible.
I’m just wondering how we will scale up this treatment. As you mentioned, there are a lot of veterans who are suffering, but how will we get it out to all of them or even to the more complex ones? That’s something to consider as well.
Senator Anderson: Thank you for your presentations. My question is for Dr. Husain. You spoke about the importance of psychedelics in conjunction with psychological support. What is the risk without psychological support? You did just briefly touch on these, but I was also wondering, would this treatment not face some of the same obstacles that mainstream treatment faces — the wait lists and the trained providers? If you could elaborate a bit, that would be appreciated. Thank you.
Dr. Husain: Absolutely. That’s one of my concerns about it. If and when we do show that these are safe and effective treatments, how would we have equitable access for those who need it?
In terms of your first question about the psychological support, it’s considered to be a key component of the treatment. It’s assumed that support is also contributing to the therapeutic effect. There is not enough reliable evidence to indicate that, though, because the studies — for instance, of psilocybin for depression — have still been relatively small in terms of the number of patients that they’ve recruited. Although the studies have shown antidepressant effects and they’ve shown that the relationship with the therapist has also contributed to the therapeutic effect, these are very small studies, so we can’t reliably say whether the psychotherapy is the key ingredient or whether it’s the hallucinogenic experience that these medications cause or whether it’s a combination of both of them.
There have been concerns with monitoring the person when they’re having a six-to-eight-hour hallucinogenic experience because a lot of individuals with mental health conditions, like depression and post-traumatic stress disorder, may be quite distressed by that hallucinogenic experience. It’s thought that the continuous monitoring is needed to, in a way, guide people through those distressing or difficult experiences. It’s also important, in the run-up to that treatment experience, to educate the patient on what’s involved and to set intentions for that session. Following the therapy itself, they debrief about what happened during the treatment session and how they can use the learnings moving forward and integrate them into their lives. So there is a lot of psychological support around it.
No studies, to my knowledge, have used psilocybin or MDMA or LSD in clinical populations without the use of psychological support. We can’t reliably say at this point whether we know it’s safe to deliver without that key component.
The need for that is unknown, but as I mentioned earlier, 12 to 20 hours of psychotherapy around each session is a hell of a lot of psychotherapy, and I do worry about how we will increase access to prevent it from becoming something that’s only available to a select few.
Mr. Walsh: That is one of the things that we’re working on. As someone who’s involved and who’s done some of this therapy, it’s hard to imagine doing it without meeting the person first. You need at least one session beforehand to discuss it, and then the session itself takes about eight hours, and then you have to talk about it afterwards as well. We’re trying to refine it down to address some of those barriers, but it’s hard to imagine that you could do it with less than a substantial session before. Then, you need someone there the whole time, someone who’s trained, in case it gets complex, which it might, and then, you need someone to sort of unpack it. That’s for only one administration; often it’s two.
It’s hard to imagine getting it down to less than 20 hours, but the comparison to surgery is appropriate because when these things go untreated, we end up spending much more than 20 hours in treating long-term, treatment-resistant PTSD.
Senator M. Deacon: Thank you both for being here today. I’ve tried to do a little bit of homework on the MDMA-assisted psychotherapy before we met today, particularly from a domestic and a global perspective, but I keep coming back to the intent of trying to help the veteran user. I don’t know if I’m making a false assumption or not when I go at this. I’m trying to think what the 10-hour process that you talked about looks like. There is the issue of the willingness of veterans to accept treatment for operational stress injuries. You would know better than I would, but I suspect for some vets — and perhaps those who need it the most — there’s a hesitation to seek these kinds of therapies, et cetera, and a resistance to taking prescriptions or seeing a psychotherapist because of some misplaced or habitual sense of weakness associated with these things.
To continue this line of thinking, is that the case? Do you think there would be more of a willingness to utilize substances like MDMA or cannabis because they don’t have the pharmaceutical stigma attached to them and maybe are seen more as a recreational drug along the spectrum? Am I accurate or am I way off the mark on this one?
Mr. Walsh: One thing that is appealing for these is there is a bit of a battle mentality that goes into it. They are going to go in and tackle this problem in an active and a more aggressive way than an endless cycle of talk therapy and prescription medications. It is appealing to some. However, some will not want to take it because it is intimidating to go in and re-experience the trauma, which is the mechanism that is curative. The MDMA provides a safe space to go in and wrestle with the demons that haunt so many of these folks. There is a piece of it that appeals to a kind of action-oriented mentality that may overcome some of the stigma and the real concern about how continually talking about this will help. I am a proponent of behaviour therapies, but I also understand the resistance of some who think, “How am I supposed to talk to this person? I already talked to the last person.” This is something different that, I think, offers real hope of an acute and active resolution of the trauma.
Dr. Husain: I agree. I think it is appealing to a certain group of individuals. It’s particularly appealing to those that are not getting better with what’s currently available.
With regard to those who see a stigma towards traditional approaches to treatment of mental health conditions, I think it offers something new and novel and a different way of doing things. There is less stigma to this approach in some ways, particularly now with such a highlight on this area and all the media focus on it. The potential benefits of this treatment are very much in the public realm. It comes with less stigma than a lot of other mental health treatment approaches.
Senator M. Deacon: Thank you. It would be wonderful if we were at that moment in time where we could have that conversation with someone who has been through this therapy, this process. I’m thinking about that as I am speaking.
Finally, Professor Walsh, you appeared in 2019 before the Veterans Committee in the House on the topic of the legalization of cannabis and how this might help treat veterans with operational stress injuries because it removes the stigma around the substance. Have you encountered a similar stigma around what we are talking about today? This question is not that different from my first question, but I wonder if you can make a connection with the work that you did in the past.
Mr. Walsh: I think they’re complementary therapies in some ways. Cannabis is more for treating the symptoms. I don’t think it’s as curative. Hopefully, by treating the symptoms, people can get more engaged in their life and do some of the things that can help them reconnect with family and work because they are getting a good night’s sleep and maybe they are not so anxious and overactive. That’s the hope and effect of cannabis. This is more curative. It’s more like a surgery, where people go in and re-experience the trauma.
Our understanding of PTSD is that it is about that unresolved, repetitive reiteration of the traumatic experience that never gets fully digested. By going in deep with an MDMA session, people can start to digest these traumas and have some resolution and understanding of how it fits with their life rather than having it constantly nagging at the back of their consciouses. Cannabis is more like a Band-Aid. Band-Aids are not necessarily bad things, but this is something that is more deeply curative, whereas cannabis is more like symptom management.
Senator M. Deacon: Thank you for being here.
The Chair: Dr. Husain, are you going to add anything?
Dr. Husain: I have nothing further to add.
[Translation]
Senator Boisvenu: Thank you once again to our witnesses. I agree with my colleague Senator Yussuff that the work you’re doing is very important, because you’re helping our veterans, who are suffering from often chronic medical conditions.
We know that the suicide rate among veterans is well above average compared to the general population. Can a causal link be made between the efficacy of post-traumatic stress disorder treatments and the reduced suicide rate, Dr. Husain?
[English]
Dr. Husain: Yes, evidence does show that as symptoms of PTSD resolve and then remit, which means they totally go away, there is a much lower risk of any form of suicidality, whether that includes suicidal ideation, attempts at suicide or completed suicide. Any treatment that improves symptoms of post-traumatic stress disorder will, I believe, undoubtedly, also reduce an individual’s risk of suicide.
Mr. Walsh: I agree 100%. In addition to suicide, we have to think about the overdoses and accidental deaths that may be almost a slower form of suicide. I think we can see reductions in those as well.
It might be outside the scope of this review, but ketamine therapies have also demonstrated remarkable anti-suicide effects. The extent to which they are psychedelic is debatable. It’s another emerging therapy that might be helpful for the acute suicidal period that we should be looking at. It’s already in use, just not enough.
The Chair: Thank you very much.
Senator Yussuff: Thank you again to the witnesses. I have a couple of points coming back to an earlier response. Development in Alberta is very positive in regard to the use of psychedelics. However, that’s just one jurisdiction. We have a lot of other jurisdictions that have yet to recognize the use of psychedelics for treating PTSD, and importantly, our veterans are in every region of this country.
Dr. Husain, coming back to a point you made earlier, what would be your recommendation for how we can provide some direction to Veterans Affairs regarding how we scale up access to this therapy while recognizing that every province has their own approach to how they’re dealing with certain evolution of the therapy to begin with. How can we do this? Veterans in Alberta will at least get recognition by their provinces, but we don’t have the same approach in this country. That’s only one jurisdiction. Veterans need help right across this country.
Dr. Husain: I will focus my answer on PTSD, as it is probably the prevalent mental health condition in veterans. Associated with that, MDMA-assisted psychotherapy is the one leading candidate to make it to clinical use.
In terms of advocating for our veterans to be able to access this, first, we should identify which veterans would be the ones who would most benefit. From the data that we have, I think it would be the ones that have complex PTSD, the ones that have not gotten better with what the current evidence-based established treatment guidelines recommend.
In terms of taking a federal approach to this, we have to be advising provinces that, generally, the data is very encouraging, not only from the effectiveness side but also from the safety profile side. In fact, we aren’t going to be able to generate more data on safety and effectiveness until we have easier access to this treatment for our Canadian veterans who are suffering from intractable PTSD symptoms.
I don’t think I have the knowledge or expertise to comment on how that advocacy should go from a federal to a provincial level, but I would say that the way that we would make it available would be for a select group of people who are not responding to what’s currently available. We should make sure that we, as a country, have a form of registration or database for trained providers, because I don’t think this is something that can be delivered by any psychotherapist or any person. There needs to be standardized training and approaches to be able to deliver this treatment.
There is a fair bit of work to do to iron some of that out, but we need to focus, first of all, on those veterans who need it most.
Senator Yussuff: Dr. Walsh, do you want to add anything?
Mr. Walsh: One of the concerns is if it’s entirely overseen by psychiatrists, that will be the bottleneck. It will be very difficult to get access to that. We need to find a program where we have oversight by psychiatrists but we give licensed social workers and clinical psychologists a big role in it.
There is a lot of enthusiasm from providers because they see the hope in these therapies. With some medical oversight for any acute problems, which we don’t expect to see, I don’t think it is too dangerous to allow people with some supplementary training to deliver these therapies. Those eight-hour sessions are very long. They require someone to supervise them, and it’s hard to find psychiatrists or MDs who have that kind of availability.
Having said that, untreated PTSD is a tremendous burden on the health care system over a longer period. We have to acknowledge that if we put in the hard work at the front end, it will ultimately be not only more effective for the patients, but there will be savings in the long run if we look at the suicides, the overdoses and the other things that come from untreated PTSD. It can be very cost-effective, and we need to provide opportunities for not just for MDs to oversee some of the hands-on pieces of it. Otherwise, there will be a huge bottleneck.
Senator Anderson: What is the average time from a control group study to implementation? Could you identify what psychedelics are actually legally able to be used in Canada?
Dr. Husain: I can answer the question on the timeline. Clinical trials, which is the gold standard way of establishing the effectiveness and safety of any intervention, usually go through phases. There is phase I and II, and then you need data from phase III clinical trials to then get approval for clinical use.
So far, the only psychedelic drug that has reached the phase III mark has been MDMA for PTSD. There is a plan for phase III studies, which are multi-centre, international studies of the psilocybin-assisted therapy for treatment-resistant depression, which are also under way.
I would say the timeline from when the phase III study is completed to actual use in the clinic could still be two to three years at minimum, with regard to the approvals required from any given jurisdiction to be able to then access the controlled substance for use. I would stay that it is still a way off in terms of regulated clinical usage.
In terms of what legal psychedelics are available, I’m not fully aware. I don’t think any of the ones that have been tested in clinical populations thus far, such as LSD, psilocybin and MDMA, are legally available in Canada at this point.
Mr. Walsh: You’re dead-on with the timeline, but I would say that it’s a bit of a mismatch to expect psychedelics to go through the same process, because unlike novel drugs, we have a lot of understanding of some of the risks, because these drugs have been used outside of medical contexts for quite a while, and there is a whole literature from the 1940s and 1950s that also adds to that. Hopefully, there can be savings if we refer to some of that literature.
In terms of legal psychedelics, ketamine is somewhat psychedelic. There is debate about whether it fits in, but it has a number of similarities. It’s widely used as an anaesthetic and is increasingly being applied as an antidepressant. So that one is legal, and a number of people who are interested in developing psychedelic psychotherapies as they wait for the approval of things like psilocybin and MDMA, are working with ketamine because it is available. But I believe if psilocybin and MDMA were available, they would be more likely to use those.
Another benefit of ketamine is that it is not as long-lived. The effects are more like two hours rather than six to eight hours. So it’s less resource intensive, but the effects seem to be shorter-lived as well. We need more research to understand how ketamine fits into this paradigm, but it is approved as an antidepressant in Canada and the U.S. under the name Spravato.
Dr. Husain: I would like to respectfully counter one point with regard to relying on previous data for safety. For psilocybin, in particular, the clinical trials that have been conducted thus far have been quite highly selected patient groups. For instance, all of the trials have excluded patients with suicidality, and we know that in patients with depression, suicidality is very common. I think it would be a bit premature to extrapolate some of the previous safety data from recreational users into clinical populations. For instance, there have been no studies in patients with bipolar disorder or patients with a family history of psychosis or schizophrenia spectrum disorders. So we have to be a bit mindful and careful with extrapolating that previous data.
Mr. Walsh: I agree, but it’s not totally unknown. There have been millions of people who have taken these drugs, which is not the case with novel pharmaceuticals.
[Translation]
Senator Boisvenu: As I listen to my colleagues and our guests, one question comes to mind. The CAF ombudsman spoke out yesterday, criticizing the government for not effectively treating our Rangers and Reserve Force members suffering from illnesses or disorders because they have been in combat situations.
I understand our veterans may be in the same situation. Do we have reliable data on the number of veterans who are being or have been treated with these substances?
[English]
Dr. Husain: I’m not aware of the data specific to veterans through the clinical trials.
I don’t know, Dr. Walsh, if you have knowledge of that.
Mr. Walsh: I’ve worked on the MDMA trials in Canada, and it was primarily not with veterans. It was people who had PTSD from other causes. So the short answer is: No, we do not have reliable data from Canadian veterans on the effects of these medicines.
[Translation]
Senator Boisvenu: I understand that we’re starting with a blank slate and that, as the months or years go by, we can draw conclusions about the efficacy of these drugs, or we can rely on what’s been done in other countries. I’m also trying to understand the medical context in which these substances may be used to possibly draw conclusions about their efficacy.
[English]
Dr. Husain: I think that, for instance, the data on MDMA-assisted therapy for post-traumatic stress disorder in non-veteran populations could still be extended to veterans. I think that gives you an idea that MDMA-assisted psychotherapy is safe and is effective for PTSD. In terms of how you would make a decision on how it would benefit veterans, I would suggest, again, that we focus on those who need it most, which would be those that have not gotten better with the currently available treatments.
With regard to other psychedelics, veterans suffer from other mental health conditions as well. They suffer from depression, anxiety, alcohol-use disorder and other types of addictions. I think that there is still a lot we have to learn about psilocybin-assisted therapy and its potential effectiveness and safety. I think that we will learn a lot in the coming years. I know that next week there is a large study being published on the effectiveness of psilocybin-assisted therapy for treatment-resistant depression, which will add more safety and efficacy data. The Canadian Institutes of Health Research put out a funding call specific to psilocybin-assisted therapy that is looking at three different clinical populations — depression, alcohol use disorder and end-of-life distress — to look at the effectiveness and safety in Canadian populations. Again, that will be giving us more safety and efficacy data. It’s a two-year study period, and they are expecting quick results from those funding opportunities. I think all of these things will provide us with more information to be able to conclusively say whether these treatment approaches are safe and effective.
The Chair: Thank you.
Mr. Walsh: I don’t have much to add to that other than I agree. As we wait, I think we can extrapolate from non-veteran populations, particularly from studies in the U.S.
Senator M. Deacon: Thank you. Perhaps I will move forward with what my colleague Senator Boisvenu started. Clearly, in this country, mental health issues in and outside the veteran population are absolutely rampant. It’s a great concern in all communities. We can learn, absolutely, across and within the sectors that we’re looking at.
As a senator, I can’t help but think, so now what? Not so what, but now what? I’m asking you today from the perspective of the work we’re trying to do in this study to support our veterans who are in crisis. You explained some of the things a moment ago that are hopeful with research, grants and some upcoming further data and opportunities. What are you looking for from us?
Dr. Husain: I would welcome any funding opportunities to conduct research and clinical trials of these very promising and emerging treatments, specifically in the veteran population. That addresses two things. First, it allows easier access for veterans in a safe setting, and it also allows us to develop a growing evidence base for their safety and effectiveness. I think it addresses two things at once. By funding more clinical trials, we are able to improve access and get more safety and efficacy data.
Mr. Walsh: I agree that we need more trials. I don’t know if that is going to meaningfully impact access in the short term. I think I might take a slightly different approach, which is to make sure we increase access and then monitor it carefully. I’m kind of saying the same thing, but instead of saying let’s have trials and people can get access through the trials, I think we should be providing access.
The risk-benefit is very good for these interventions, even given the limits of our current knowledge. We need to carefully monitor the clinical rollout and let that inform us, but clinical trials are expensive and slow and the classic randomized controlled trial may not be the best way to understand these medicines that have such an acute psychoactive effect. It is a bit of theatre to do a placebo control when the person who is in the placebo condition knows they are lying there experiencing no effect, and the person who is in the active condition is having one of the most pronounced psychoactive experiences of their life. I feel we’re trying to shoehorn these into the clinical trials with placebo control, and that may not be the most effective way to do it.
I think real-world evidence will inform us perhaps better and more meaningfully and in a more valid way. I think we should be foregrounding the patients, foregrounding the veterans and providing access, but also making sure that we’re doing a good job of monitoring people who are getting this treatment at this early stage so that we can refine these treatments moving forward. But I don’t think we should be waiting for randomized control trials. Those tend to benefit the researchers, the research agencies and all of us who want to produce knowledge, but there is enough hurt on the ground right now that we need to try to get these medicines to people who need them.
The Chair: I would like to thank both witnesses. MDMA, the street name is ecstasy, isn’t it? Is that ecstasy?
Mr. Walsh: In general, yes, there is overlap, but what people get on the streets as ecstasy is often not MDMA. A lot of the concerns that come from street ecstasy is that it’s a dog’s breakfast of a variety of white powders. I don’t think we can say there is total equivalence there.
The Chair: I was wondering about certain negative effects of substances after the controlled experiment. Do you have any feedback on that? Certainly, with ecstasy or MDMA, there is a downside of depression and feeling alone or feeling not completely yourself for some days after. I’m wondering if that has ever happened with the treatments of MDMA that your studies have done or any of your other tests.
Dr. Husain: If you look at the data and the participants who received MDMA or psilocybin and then compare it to the control groups, there is no statistically significant difference in any adverse events. Generally, there were no serious adverse events in any of the trials.
That is encouraging. It shows that some of the preconceived notions that you have, this sort of decline in mood after taking MDMA may not be, in fact, correct. I think that comes with street ecstasy use, and often people are using that in combination with other substances like alcohol and so on, which may be contributing.
Mr. Walsh: That’s why it’s psychedelic-assisted psychotherapy. Having the preparation and then having someone who can check in after can go a long way, and I agree that it is not a major concern. Even so, having someone check in with you after can make a big difference. Typically, someone gets a call the day after their session and will come in within a week for follow-up. I think that goes a long way to alleviating that concern.
The Chair: Thank you very much, and thank you to the witnesses and to the senators participating. Thank you.
(The committee adjourned.)