THE SUBCOMMITTEE ON VETERANS AFFAIRS
EVIDENCE
OTTAWA, Wednesday, November 2, 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 Veteran’s 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, a senator from New Brunswick and chair of the subcommittee. I am joined today by my fellow subcommittee members Senator Anderson from the Northwest Territories and Senator Yussuff from Ontario. Senator Duncan from the Yukon is replacing Senator Deacon, Ontario, today.
Today, we’re going to continue our study into the emerging treatments for veterans suffering from occupational stress injuries. We welcome by videoconference Colonel Rakesh Jetly, retired former Chief Psychiatrist, Canadian Armed Forces, and Mr. David Fascinato, Executive Director of the Heroic Hearts Project Canada. Thank you both, gentlemen, for joining us today by videoconference. We will begin by inviting you to provide your opening remarks, to be followed by questions from our members. I hope you can keep your opening remarks to about five minutes because we only have an hour.
I will just add that I would like to ask participants in the room to please 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 the 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. Jetly, if you can begin, please.
Colonel (Ret’d) Rakesh Jetly, Former Chief Psychiatrist, Canadian Armed Forces: Thank you, chair and committee, for this invitation. As a matter of full disclosure before I speak, my post-retirement life has found me in many spaces, including a position as chief medical officer of a small biotech firm that is developing new medicines in the psychedelic space.
I come here before you after retiring from the Canadian Armed Forces — 31 years of service — in 2021. Over my career, I had the privilege of deploying as a general duty physician to the Middle East and Rwanda in 1993-94. I trained in psychiatry and deployed twice to Kandahar in 2006 and 2007. I have seen first-hand the types of psychological injuries that can occur through all types of deployments, be they humanitarian missions, peacekeeping or war. The lasting impact not just on my patients but on my friends, colleagues, Canadians and allies and their families is evident.
I began my psychiatric career in Halifax in 2000. It was just as we were building our psychological trauma centres — the Operational Trauma and Stress Support Centres, or OTSSCs — and a few years before the Veterans Affairs-sponsored OSI Clinics were to be built. We had a tremendous amount of funding and brought in all the necessary training to provide the best evidence-based care for PTSD and operational stress injuries in general. It was pre-Afghanistan, and we were dealing with many missions from the 1990s, including Rwanda, Somalia and the former Yugoslavia. The PTSD model at that time was a fear-based paradigm, and treatment involved exposure-based therapies, which are difficult for both the patient and the therapist.
However, in 2006-07, I became the regional expert. I realized on a nearly daily basis that I was being confronted with cases that did not respond to the leading-edge evidence-based approach. It was at that time I began to realize that we needed to continue to explore these illnesses and find other safe and effective treatments. There is a scientific and moral imperative to discover and deploy newer treatments that we can offer our veterans. The responsible thing, of course, is to conduct high-quality studies to demonstrate the safety and efficacy of these approaches.
I believe that we made errors with cannabis that hopefully we can rectify moving forward. I believe the medical use of cannabis has sent a signal that there may be benefit for anxiety, pain and sleep, et cetera; yet with the legalization of recreational use, we seemed to lose interest in studying the medical use of these medicines. We need to understand who it helps and doesn’t. We also need to better understand the forms of cannabis being used — that is, the long-term effects of smoking should be understood.
Psychedelic medicine is undergoing a renaissance, but it is by no means new. Medicines with mind-altering capacity have been used throughout the world for many years, often in cultural and spiritual ceremonies. In the second part of the last century, a medical or scientific renaissance occurred. Notably in PTSD, Jan Bastiaans in the Netherlands used LSD to treat Holocaust survivors from World War II that were suffering incredibly. More recently, psychedelic-assisted psychotherapy has demonstrated efficacy and safety in various university centres treating conditions such as alcohol dependence, smoking dependence, treatment-resistant depression and end-of-life anxiety. This is the current psilocybin story that is evolving.
MDMA, although not a classic psychedelic, has a very compelling history, specifically with PTSD. In May of this year, the Multidisciplinary Association for Psychedelic Studies, or MAPS, published the results of their Phase 3 studies with MDMA-assisted psychotherapy for PTSD, showing that over 80% of subjects had a significant response and 50% no longer met criteria for PTSD. The next Phase 3 trial is under way, and we will likely see MDMA for PTSD approved by the FDA if not next year then the year after.
It is important to understand that all of these trials are to demonstrate the safety and efficacy of these medicine-associated psychotherapies. It appears that these medicines change the brain in allowing different ways of viewing oneself, the world and the past. This window allows the therapies to profoundly impact individuals, changing illness behaviour.
Many of these approaches also challenge the traditional fear-based paradigm of PTSD, making room for access to other important components such as guilt, shame and anger that many feel after trauma. The term “moral injury” is often used to describe this phenomenon.
I feel that Canada should commit to joining our international allies, including the U.S. Departments of Defense and Veterans Affairs, in studying these new, promising treatments in our own populations rather than relying on others to do the work and hoping that the knowledge translation required ensures the research studies are applicable in our Canadian veterans.
While I’m excited about the research findings to date, I am also aware that there will not be a one-size-fits-all solution for the various psychological injuries that often involve trauma, loss and grief. I believe there are many other potential approaches worth exploring within the so-called interventional psychiatry space, including virtual reality, ketamine and various neuromodulation approaches.
I’m happy to take any questions. Thank you.
The Chair: Thank you, Colonel, and now Mr. Fascinato, please.
David Fascinato, Executive Director, Heroic Hearts Project Canada: Thank you, Mr. Chair and members of the committee. Today, I will be speaking on the shortcomings of both the current system of access for psychedelics, the current standard of care for treating veterans and the unmet needs this creates in the veteran population.
I’m a veteran of the Canadian Armed Forces and the Executive Director of Heroic Hearts Project Canada, a registered Canadian charity that connects veterans to psychedelic-assisted therapies. We are currently launching our organization and are developing programs that will leverage existing medically regulated pathways that support veterans seeking legal access to safe and effective psychedelic-assisted therapies. This includes facilitating access for qualified veterans to vetted clinics that provide integrated health care services as well as supporting innovative research that contributes to the growing base of evidence on the impacts of psychedelic-assisted therapies on veteran health and wellness. What we aim to accomplish in Canada builds from a successful model in the U.S. and the U.K. that, to date, has supported several hundred veterans who have accelerated their healing through psychedelics.
We exist for two reasons. First, we’re collectively living through a perpetual mental health crisis that impacts many Canadians but which disproportionately impacts veterans. I do not need to cite the statistics, but simply put, veterans suffer from elevated rates of suicide, post-traumatic stress, traumatic brain injury, addictions, treatment-resistant depression and anxiety, chronic pain, and the list goes on — not to mention overreliance and dependence on pharmacological interventions without adequate therapeutic supports. The second reason we exist is that the current standard of care is failing veterans. Traditional approaches like talk therapy, SSRIs and antidepressants are not working for many and represent Band-Aid solutions to complex mental health issues that do little to help veterans heal and live fulsome lives. The current standard of care promoted by Veterans Affairs Canada fails to adequately address the psychosocial needs of many veterans. All this compounds on us, and as a community, we often struggle with finding a sense of purpose, healing our physical, mental and emotional wounds and regaining a sense of self that lets us view life with a sense of resolve, balance and joy.
Enter Heroic Hearts Project Canada. While we are committed to working within the existing medically regulated pathways, truthfully, it will be a challenge — not impossible but a challenge, as in their current form, they are ill suited to address the urgent needs of many veterans. Today, access can be realized through three pathways: clinical trials, which are expensive, cumbersome and inaccessible to most; section 56 exemptions, which are nearly impossible to obtain; and the Special Access Program, which is currently the most viable pathway but with notable barriers that limit access to psychedelic medicines.
We are also staunchly committed to working with Veterans Affairs Canada. While we can observe that the current standard of care is failing veterans, we see the potential for collaboration with Veterans Affairs Canada on promoting and supporting access to safe and effective evidence-based psychedelic-assisted therapies. We firmly believe in the promise of this emergent treatment pathway and its impacts on individual and collective healing, and we want to help generate the data that will support discussions at Veterans Affairs Canada with regard to safe and equitable access.
Psychedelics isn’t for everyone, but considerable research to date points to a therapeutic potential that is too great to pass up given the number of veterans who suffer needlessly due to a lack of effective treatment options. Until then, many veterans, feeling let down by the system of access and the standards of care, will continue to take healing into their own hands and may turn to unregulated, illicit and potentially unsafe practices with psychedelics. If it’s easier to view psychedelic medicines as a harm-reduction issue, then let’s apply that lens and promote increased access to safe and effective psychedelic-assisted therapies for those who require it the most.
I understand the need for careful debate and data, but let us go beyond simply talking, and let us resolve to move forward. Veterans want to be empowered and enabled on their healing journeys. While the current standard of care is failing veterans, there is hope and increasing amounts of high-quality data on the safety and efficacy of psychedelic-assisted therapy. Let us once and for all seize this opportunity and match the resources with the resolve to expand access to help us generate the evidence and data necessary to advance the conversations around healing with psychedelic therapies.
Thank you.
The Chair: Thank you very much. We will now go to questions.
[Translation]
Senator Boisvenu: I apologize for arriving four or five minutes late.
I would like to thank the witnesses for coming. It is much appreciated. Indeed, this is a major issue related to our veterans, who deserve our full attention.
Could you explain the difference between substance-assisted psychotherapy and psychotherapy as currently used to treat post-traumatic stress disorder?
[English]
Col. Jetly: It’s an excellent question.
The traditional psychotherapy for PTSD is usually based on a fear-based paradigm. You have this traumatic event. Usually you’re exposed to it and relive it in the therapy room. It’s a very difficult therapy. You talk about it again and again and again until you desensitize and habituate. That’s the traditional exposure therapy. There are a few other therapies. The problem with that is the dropout rate is extremely high. Maybe if we’re lucky, it helps half the people, but about half the people drop out. It’s extremely difficult and hard. Psychologically, soldiers, men and women, are very defended and very tough, so it’s very hard to access the true feelings. They will go through the motions and they will attend the appointments, but they often don’t get better because things like shame, guilt and fear and a lot of these emotions are hard to express.
These medicines, for example MDMA, which is Ecstasy, creates something called increased empathy. If you think about it, that empathy towards others also applies to yourself, so it allows people to drop some of their defences, their guards, and really talk about what’s bothering them. That’s one thing. The therapy doesn’t necessitate having to relive the trauma. It’s more access to the deeper memories.
With psychedelics, on the other hand, like the LSD or psilocybin, it’s a much harsher experience. It’s a true experience. It causes brain changes that, again, allow new ideas or new thoughts to emerge. Sometimes the therapy is not that different, but the changes in the brain allow the new ideas, the new observations, to occur.
[Translation]
Senator Boisvenu: I understand that this is a way of facilitating a form of disinhibition in the patient that makes it easier for them to free themselves from images of their traumatic past. I understand that.
The Department of Veterans Affairs seems to be opposed to this type of treatment with psychedelic substances as compared to conventional treatments. Do you know the reason for this, Colonel Jetly?
[English]
Col. Jetly: I’m not sure I’ve had the discussion that they oppose. Veterans’ Affairs and the Canadian Armed Forces are conservative organizations, and they tend to wait. I did the same thing. They tend to wait until the evidence comes. So the definitive evidence comes, a province pays for it, and Health Canada approves it as a treatment. Right now, these medicines — make no mistake — they’re in the experimental phase, and it’s very compelling evidence. What someone like me is advocating for is we need to do it within the guise of trials. There are people who are ill who aren’t getting better. Under the auspices of Health Canada, let’s fund some trials. We’re not in a position now where legally you will have psychedelic treatment for everybody who wants it. There’s special access. I would say Veterans Affairs is conservative by design, but while you’re waiting for the approval, you could be part of the solution by having people voluntarily sign up for trials if the conventional treatments haven’t worked, and then we could contribute to the literature internationally and do the work necessary.
The Chair: Would Mr. Fascinato want to add something here?
Mr. Fascinato: I think it’s important to build on what Rakesh pointed out, which is that veterans, in the meantime, will take the initiative to heal themselves. While we don’t have a clear data picture of veteran use of psychedelics in therapeutic settings to date — that’s something we’re focusing our energy on in the year ahead to understand — and while there is some opposition, as you described, from Veterans Affairs Canada, we want to be part of that solution. We want to build the data and generate the evidence-based approaches and discussions that will be necessary, as Rakesh pointed out, to open up access. Access and evidence-based approaches can go hand in hand with access and healing.
Senator Anderson: Thank you both for your presentations.
Colonel Jetly, you spoke about the error with cannabis and the recreation versus the medical use. Moving ahead with psychedelic drugs, how do we ensure that we do not make the same mistake and utilize the lessons learned from marijuana or cannabis use?
Col. Jetly: I think commit to the research, simple as that. I think we literally had cannabis PTSD studies, protocols written, and when the legalization occurred, the money went away. It was incredible. We had a $5 billion study.
I think both of us would agree that this isn’t going to be the panacea. This isn’t going to be the solution for everybody. At the end of the day, there will be options and different types of treatments. We have to do studies to demonstrate the safety and efficacy of these approaches in our population.
The other thing with medicinal cannabis is that physicians, for the large part, aren’t part of it, because there’s no DIN and cannabis isn’t a real medicine in the eyes of most doctors and pharmacists. You’re not writing a prescription; you’re giving an approval. Somehow you marginalized most of the medical system from the medicinal use of cannabis. I think we need to go to the full board, work with FDA and Health Canada, make these real medicines that are in pharmacies that have DIN numbers, and then we’ll include the larger medical community to help people when they’re suffering.
Right now, the cannabis deal is you see the family doctor, he says, “I know nothing about it. Go see the guy down the road.” That’s not the way medicine should be practised.
Senator Anderson: Thank you.
The Chair: Did Mr. Fascinato want to add to this?
Mr. Fascinato: One brief point: I think everyone is extremely mindful of the lessons learned from cannabis. In my experiences working within this space the last couple of years, everyone is certainly internalizing those lessons learned and ensuring that risk-benefit analyses and focus on safety and efficacy and evidence is at the top of everyone’s ledger when approaching discussions around the impacts of psychedelic-assisted therapy and its role in helping to heal veterans.
Senator Yussuff: Thank you, witnesses, for joining us today and giving your experiences with challenges of dealing with PTSD and the emerging research that is showing relatively good signs with regard to using psychedelics to deal with this. Other witnesses have come before the committee to testify in that regard.
Are you hopeful this will be the new approach in trying to deal with PTSD in a more coordinated way? What are some of the barriers to overcome in Canada, especially given the significant number of veterans who are dealing with PTSD and who are not able to get themselves healed in the context of the current therapies that are available to them? I’ll start with Dr. Jetly and then Mr. Fascinato.
Col. Jetly: There are many barriers.
For somebody who is trying to do the research, CIHR just introduced a bit of funding — $3 million — last year. There’s been a lack of grants and lack of funding. Sometimes it comes from government, foundations or things like that.
The scheduling of these medicines makes it difficult. That’s a worldwide problem where there are Schedule 1 drugs like heroin and things like that. If somebody wants to do research on them in a small psychology office or something like that, they can’t; you often have to have a safe and Health Canada permission. That is despite the fact that these medicines are actually quite safe. There’s very little evidence for overdose or things like that.
Some of the barriers are our own Health Canada rules about it, which could probably be relaxed. There’s a lack of funding. Otherwise, organizations like the Canadian Armed Forces, different first-responder groups and Veterans Affairs ought to be leading the way in these therapies. There are lots of scientists at all the universities who would be happy to participate, but we can’t get these medicines to people for a few years until they are legalized and available, and then we can do large trials in people who have not responded to the treatments that they’ve received. I think we can accelerate the research, and we can get it to more people.
Mr. Fascinato: To carry that forward, at the end of the day, to speak to your first question, we still see this as part of a broader solution and an integrated approach with individual wellness and health. While it isn’t a cure-all, it is such a phenomenal tool that could be used by trained therapists and psychotherapists to support healing so individuals can regain that sense of self, happiness and joy. I’ve seen that first-hand.
The barriers here — building off what Rakesh mentioned — really come down to stigma and awareness. There’s a lot of stigma. The “war on drugs” did its job. The scheduling of psychedelic substances for the last 30 or 40 years continues to not only undermine and freeze the research that was taking off in the 1960s, but there are obviously public and individual perceptions with regard to psychedelics that are a barrier. We can do a lot by just increasing awareness and understanding of the potential opportunities with regard to healing through psychedelics.
At the end of the day, it goes back to the building of evidence and supporting broader access channels, whether, as Rakesh described, through clinical trials or broader access through existing pathways.
To underline this point, it’s the individual veterans who are suffering, and we have to acknowledge that veterans are already going out of their lanes in trying to access psychedelic supports in order to heal, which is putting them within a risk margin. That is because of the desperation they’ve encountered in working through various systems of care and standards of care that have, unfortunately, let them down. I implore the committee and everyone here to recall that this has a direct impact on individuals, their families and their communities. The discussions we are having here will hopefully lead to some concrete steps and further discussions, but especially action around how we can collaboratively work together, build that evidence necessary, expand access channels and ensure that those who need it the most and who are well suited to this approach are able to access this.
Senator Yussuff: To both of you, what would you recommend, very specifically, to our committee with regard to how we could write a report that would be of value to your efforts and those of others in helping veterans get the treatments they deserve?
Col. Jetly: In my lane as a physician, I encourage the government — Veterans Affairs and DND specifically — to conduct clinical trials in this space. The challenge is that if you have other people doing it, then you have to decide whether it applies in your own population anyway. There’s enough of a signal that’s out with these Phase 2 and Phase 3 trials that this isn’t crazy, like it was 20 years ago perhaps. There’s a solid message that this can help people. If we look at treatment-resistant people who have PTSD, then we should specifically be doing trials in this country on our people.
Mr. Fascinato: To build upon that, just like what Rakesh mentioned with regard to MDMA, we need a lot of empathy and evidence. We’ll get to that point with access. We really need to take a collaborative and consultative lens, working with veterans groups, not just Heroic Hearts Project Canada but others. We need to ensure that any solutions with regard to access are done through a lens of collaboration and consultation with these patient groups and the veteran community itself so that we’re not, in an effort to broaden access, also creating any potential barriers, to ensure that we are actually driving toward that access end-state that we’re all in vociferous agreement about. We can do that through consultation and collaboration with key stakeholders and decision makers at Veterans Affairs Canada, Health Canada and elsewhere. We need to make sure our voices, through steps like this and other opportunities, are heard, understood and incorporated into any solutions so that they’re sustainable, resilient and able to support individuals in need and communities that require this support.
Senator Duncan: Thank you to the witnesses for their presentations.
I’m filling in for Senator Deacon, so this might have already been addressed, but I would like to ask the presenters this: Do you have any experience or have you examined the situation with Workers’ Compensation Boards across the country? For example, I can imagine that veterans are not the only workers who have suffered from PTSD and PTSD-like symptoms and who might have sought this treatment. Appreciating that workers’ compensation is a provincial-territorial responsibility, have you any experience or have the WCB boards throughout the country —
Col. Jetly: I’ve had considerable experience over the years. When Ontario was putting the presumptive legislation for PTSD in place, I was consulted at times regarding their assessment tools. Absolutely — PTSD, psychological trauma, our refugee population, first responders, those dealing with sexual abuse — it is not unique to veterans by any stretch of the imagination. It is interesting, though. Combat PTSD tends to respond less well to mostly evidence-based treatments. That may be more of an injury piece. I have been involved quite often. I will still consult with WSIB from time to time in Ontario. I have also spoken with the groups in Nova Scotia and Alberta. These therapies could certainly help those populations as well.
Senator Duncan: I appreciate that they could. My question specifically is whether any of them have approved these therapies.
Col. Jetly: No. They are not legal yet, just to be clear. They are in research. An insurance company or a workers’ compensation board is not in a position to approve or not approve. Ketamine is different, but in terms of MDMA and psilocybin, they are research-only at this time.
Senator Duncan: Have they been faced with the same requests? Are they undertaking the same research?
Col. Jetly: No.
Senator Duncan: I’m thinking of the Government of Canada’s mandate letters to ministers. All reference a whole-of-government approach. My specific question is how you are working and how this request is working with our provincial-territorial counterparts so that the whole of the country can be in.
Col. Jetly: Alberta is probably ahead of the other provinces. Alberta is actually talking about this. They recently passed legislation guidelines on the psychedelic therapies in anticipation of the legalization coming. That’s the first province that has had discussions, and I have been on boards advising. Ontario is considering it, and there has been some discussion, and there is also some, I believe, in Nova Scotia. There is some crosstalk, but in terms of the funding and the research being done, it’s still piecemeal.
Mr. Fascinato: It probably has to do with ketamine-assisted therapy, but this is something perhaps for the committee to look into. In B.C., I believe there is a WSIB equivalent — I think they call it WorkSafeBC — with support for ketamine-assisted therapy for first responders. I have just come across that in conversations with individuals from the West Coast. It’s ketamine-assisted therapy, not MDMA- or psilocybin-assisted, as Rakesh mentioned. There is potentially a model there to evaluate in addition to what Rakesh described happening in Alberta and other jurisdictions across the country.
[Translation]
Senator Boisvenu: Once again, I express my thanks to the witnesses who shed a lot of light on the subject. Your testimony is very important and appreciated.
Colonel Jetly, last week we had witnesses who told us about the American experiences with the use of psychedelic substances. For them, the results are very convincing and promising. As a result of these positive results on the American side, the witnesses strongly advised the federal government to start using these substances quickly.
You said earlier that what is preventing Veterans Affairs Canada from moving forward is its conservatism. However, given the evidence of the very positive effects of these substances on the treatment of trauma, can there be any other reason than the conservatism of Veterans Affairs Canada to explain why Canada is not moving forward with the use of these substances? I find this reason somewhat unacceptable.
[English]
Col. Jetly: I can’t speak for Veterans Affairs Canada. Just to be clear, the research is not complete. Even MAPS, the organization that’s been around since 1986, still has to do one more Phase 3 trial, and then the FDA will go through all the studies with a fine-tooth comb before they actually approve it. There is absolutely compelling research, and I believe this will certainly help some people, but it’s not done. Health Canada and the FDA will still have to approve these treatments. I am saying that, in the meantime, the signal is so strong that we should be doing research because that’s a way of getting people the medicines and hopefully helping some people. This will also get our clinicians trained in these therapies and get our people more comfortable. There are studies going on in Canada and all over the world, and, so far, there have been incredible results from smoking cessation and all of these, but it’s not done in the sense of an indication from the FDA in the U.S. for these therapies. It’s still illegal or experimental in the U.S. as well. They need to have DEA exemptions and so forth.
[Translation]
Senator Boisvenu: Thank you, Colonel.
[English]
The Chair: Did you want to say anything about this, Mr. Fascinato?
Mr. Fascinato: Yes. There is another wonderful lesson we can potentially replicate from the American approach. As I understand it, their VA is exploring forming a committee of representatives from across the psychedelic ecosystem — researchers, clinicians, practitioners, veterans groups and other interest organizations. I think, as Rakesh mentioned, that would still be exploratory and building the research necessary.
Having this conversation with Veterans Affairs Canada, other stakeholders in the space and other experts is extremely important to demystifying some of the decisions that might have been made in the past and to help inform a fruitful conversation that should be taking place with regard to these emerging treatments that, and I’ll say this with confidence, we know do make a difference in the lives of individuals. Yes, there is the need for more evidence building, but we know at this current point that there are positive impacts. I think the time is here to start having these conversations, pushing the ball forward and seeing what can come in the coming year or two while evidence is being built and we expand access pathways and get things going.
Senator Anderson: Mr. Fascinato, you spoke about the three venues for access: clinical trials, section 56 and special access. What, in your opinion, is the greatest barrier to access, and what is needed in conjunction with clinical trials — for example, maybe movement on legislation, education — to advance psychedelic drugs as a viable and timely option for veterans?
Mr. Fascinato: Thank you for that question.
I believe barriers come down to criteria for qualification. I’m not a clinician, so I’ll defer to Rakesh here on specifics, but as I understand it, the clinical trials are fairly narrow in their criteria and what they are looking for by way of individuals and numbers. When we are talking about how many people could stand to benefit and how many people are exploring this potentially, it’s like a waterfall into a funnel. There is no way to capture it all.
It is the same thing with section 56 exemptions. As I understand it, you have to receive sign-off from the minister of health, and then there are still issues with regard to access. You might have access to a controlled substance but not be able to carry it. Immediately, you are in contradiction to federal regulations.
With the SAP, again, it is a high bar in terms of qualifying for the special access program. Individuals, as I understand it, have been turned away because they haven’t explored every single option available to them, and that includes sometimes going to other parts of the province or out of province, and that might be beyond the financial resources of individuals who are already having a bad time.
At the end of the day, when Rakesh talks about expanding clinical trials, I think it’s just looking at the veteran population more broadly and inclusively and seeing what we can do to get more people through that access pathway — expanding the funnel, if I’m going to carry that metaphor forward. How can we ensure that more people can access this in order to build the evidence necessary to help inform the discussions at Veterans Affairs Canada and other regulators and seeing what we can do to broaden access and build evidence? It’s a concurrent path, but I think what is extremely important here is that access needs to come with evidence building. It’s a feedback loop that will generate momentum and help steer and inform conversations on these evidence-based approaches, ensuring that the very best quality, safest and most effective protocols and approaches are being designed, developed and implemented to support veterans and then, more broadly speaking, to equitable access for all Canadians who might require it — as Rakesh mentioned — various sensitive populations who also potentially stand to benefit from these therapeutic approaches.
The Chair: Colonel Jetly, very quickly, do you have something to add?
Col. Jetly: Just simply that with SAP, I’m thrilled that the Special Access Programme is available, but that doesn’t replace research. It will be a series of anecdotes. People will take it and they will say it helped, but it’s very hard to gather data to generalize the one-offs the way the SAP is set up.
Senator Yussuff: Given the challenge in getting help to veterans, not all but some that are struggling with PTSD symptoms where current therapy is not helping them, what would you offer as to why current therapies are not as successful? Secondly, what do you think Veterans Affairs Canada and Health Canada could learn from the studies that are going on around the world, especially given the promises we have seen so far with the evidence that’s available? How can that inform us as to how we try to move forward here? You are very enthusiastic in your observation about what we should be doing, but maybe you could answer some of those questions for me.
Col. Jetly: I think as to why the current therapies don’t work as well, there are a couple of things, and part of it is that when PTSD was created in 1980, it basically fell under the category of anxiety disorders, which is reasonable. It wasn’t an error. It was just that it fit at the time, and people considered it an overwhelming fear to a traumatic event. That is the so-called fear-based paradigm. As things have evolved, we have realized it’s not as simple as that. It’s not as simple as being phobic from when your buddy died. It is more that there is grief, there is horror, there is shame and there is guilt. Now within the DSM, our book, the Diagnostic And Statistical Manual Of Mental Disorders, there is now a section called “Trauma Disorders.”
The initial treatments were simply the way you would treat somebody who has a fear of dogs or heights. You desensitize them to it, and they’ll get better. That does work if you have had a car accident or sometimes with single-episode trauma. It does actually work for lots of people, but often it doesn’t work in the more complicated trauma, including adverse childhood events as well. There might be guilt. If you’re guilty, talking about it again and again and again isn’t going to help; it actually might make it worse. There is acceptance and commitment therapy and different therapies that are coming along that don’t necessarily involve that exposure.
These medicines, again, allow one to either have empathy towards themselves or change the way they see their world. There are brain changes that occur in the brain networks of how you see yourself in time and space and history and allow therapies to work in a better way and a better way to learn.
I think that whether it’s Health Canada’s job or whether it’s academia’s job to take the lessons from the rest of the world really is — and Canada is doing research, don’t get me wrong, but I think we could be doing more. We could be doing more of our share, and I really think it’s funding and conducting trials. Almost every university in Canada is ready and excited. The scientific community is extremely excited to do this kind of work in veterans and in other people who have suffered. The University of Toronto has a good program, as does Queen’s University. Dalhousie is interested, Ottawa is interested, and Alberta is interested. I don’t think we’re asking for shortcuts without the demonstration of safety and efficacy, but we could use clinical trials to get to people that have not responded to these approaches.
[Translation]
Senator Boisvenu: My question is for Colonel Jetly. What is the key department to undertake this experimental approach with veterans? Is it Health Canada or is it Veterans Affairs Canada?
[English]
Col. Jetly: I think it’s a combination. The funding organization for research in Canada is CIHR, the Canadian Institutes of Health Research, and they have funded PTSD and they are funding psychedelics. The call for the psychedelic research right now is for specifically three indications — addictions, treatment-resistant depression and end-of-life anxiety. A lot of us were hoping there would be a call for PTSD as well, and that would have been perfect for us. I think CIHR, for sure. Veterans Affairs Canada doesn’t conduct a lot of clinical research themselves. The research they do often is epidemiological numbers and things. Veterans Affairs could fund it as well. The Department of National Defence could fund it. The government could fund it, and CIHR is the perfect organization. There is also the Canadian Institute for Military and Veteran Health Research, CIMVHR, so there are organizations that are poised to conduct the research. The funding would be key. If there was a call for psychedelic-assisted psychotherapy in veterans, ten universities will answer that call and will do the highest quality work possible.
The Chair: I’m going to ask a quick question of both of you, if I can. I suppose you don’t find that research is uniform. Every individual has a different reaction or non-similar reactions to various test cases or tests that you do or even control testing. We all know what alcohol can do to one individual or another individual. Some can be very happy; some can turn extremely violent. It probably doesn’t work for everyone the same way, and I’m wondering if you study the after-effects of ecstasy or LSD on the control studies, or do you go beyond this? How does that work over a period of time, is what I’m trying to ask.
Col. Jetly: That’s a great question. I’ll start.
Research studies do look six months to a year out. That’s usually the lens. With smoking cessation and all of this, you do look further.
Keep in mind that what we’re talking about here usually is a medicine, whether it’s MDMA or psilocybin, taken once, twice, maybe three times maximum over a few months. It’s not something that people are taking every day like they might take Prozac.
In terms of reaction, you are right. Usually the dose is 25 milligrams. For most people, that’s a full psychedelic experience, but for some people it’s not. Some people need a second dose. A second dose is sometimes higher, so there is a bit of art in the medicine.
There are so-called bad trips. People can uncover memories. That’s why when these therapies do occur, they often occur with two therapists sitting in the room with them the whole time. This isn’t something that you go home with or take it in the waiting room. You are supervised, and that’s why the safety and efficacy, and I always put those two terms together.
There haven’t been — knock on wood — any disasters in terms of people having such bad reactions that they don’t come back, and partly that is because when you control studies, you exclude people that have schizophrenia or have had psychotic illnesses in the past and things like that. Your inclusion-exclusion is fairly tight.
For treatment-resistant depression, the best so far is 24% of people respond, which means 75% don’t. So this isn’t the end. This is just another tool in the toolbox, and the traditional evidence-based approaches help some people as well. The idea is just to have more options, and when you do research, you can start looking and analyzing your data in various ways to figure out who tends to respond, who tends to respond better, what dose occurs in this type of trauma and all of this. Again, that’s the reason for the research.
Mr. Fascinato: I would direct you toward Drug Science U.K., a research body in the U.K. that speaks about harms. They have a wonderful chart that speaks directly to the harm of alcohol, for example, on both the individual and their community. At a rating out of 100, it’s at 90 or 82, I believe. You go along the chart and you see the harm to self and others with regards to pharmaceutical-grade MDMA and psilocybin and other traditional psychedelics. The harm to the individual and to others is negligible in comparison to those things that are currently free to use in society. That’s an interesting point because there is all the stigma and skepticism around psychedelics, for example, and talk about bad trips and all this other stuff. I apologize for citing a source that I don’t have readily accessible in front of me, but when you look at the actual evidence, the harm to the individual and to others is extremely low. It can happen, of course. I’m not saying it’s always perfect, but in comparison to something that’s legally accessible — for example, you can go buy alcohol or cigarettes as an adult — it’s like comparing apples to oranges.
Rakesh also talked about this. Psychedelics open up all the windows and doors in the room of your mind. It takes a lot of work. It’s not a one and done. It’s not something that, as I said before, is a cure-all. It’s not a panacea for mental health issues. However, it allows the individual to work with their support network, with mental health professionals, and with their families in many cases, to work through their issues and work on themselves. For those studies, as Rakesh mentioned, checking either six months or a year out underline the point that there is a lot of work to do. It’s not just going to a clinic, having one session and potentially another one two or three weeks later, whatever the protocol might be. It’s a continuous journey of self-improvement. Psychedelics open up all the windows and doors and allow fresh air into the mind of the individual. It allows them to regain that sense of balance, joy and love that will allow them, hopefully, to take the steps to heal from whatever traumas, incidents or issues might be unresolved from their past.
Yes, of course, we’re dedicated and committed to helping support an evidence-based discussion on the impacts of psychedelic-assisted therapy. It’s worth going back to the point that we know as well that there are clearly recognizable impacts and high-quality data coming out of other jurisdictions. I hope we can take those steps and help leverage that knowledge, build our own and move forward.
The Chair: Thank you. We’re coming to the end. I wonder if any other senator would like to ask a final question.
Senator Yussuff: Obviously, the development in Alberta is a good initiative in the context that at least one province has recognized the use of psychedelics and is now working through the process of how that might be accessible for people needing therapy. Given the research that is much farther along in the U.S., is it absolutely necessary for us to have to repeat the same degree of research that’s going on in the U.S.? We’re hearing there is the possibility of a third trial with this therapy. Wouldn’t that equally inform us as to how we can then make some direct recommendation that we should proceed because we now have evidence-based research to support it? In Alberta, we will have an opportunity to gather incredible additional data if psychedelics become available for treating PTSD and other issues that people might be struggling with.
Col. Jetly: To be clear, the research isn’t just in the U.S. Research has been done in Canada as well. The two main companies that are furthest ahead of in terms of indication with the FDA — and there has been communication with Health Canada as well — are COMPASS Pathways for its psilocybin for treatment-resistant depression and MAPS for MDMA. There have been RPIs in Canada that have done it. There have been trials in Canada and all over the world. So, yes, the data from the two Phase 3 trials can be presented to the U.K., the EU and the FDA. You don’t have to do the trials.
For me, the trials are for three reasons. First, it gets access to people. It might take two years for these indications to come. It gives access to Canadians to this medicine that many of us believe will help. I think the trials are for that purpose. Second, it’s a training ground to help people understand the medicine and the therapy. If, all of a sudden, Health Canada says that it’s approved, the universities aren’t training people in this. It allows us to train people; otherwise, we create this need-care gap that is going to be insurmountable when everyone wants to have these medicines. The training and the expertise are there. Third, Canadian veterans may be a bit different than U.S. veterans, so I would have more confidence if we had done more studies on our own people to recommend it. I think it’s threefold. From a wait-and-see perspective, we can absolutely wait on that and see the data. Some of the data is gathered in Canada.
Senator Yussuff: Thank you for the work you are doing and equally thank you for being here today as witness.
The Chair: Mr. Fascinato, did you want to say something quickly before we wrap up?
Mr. Fascinato: Underlying the points, expanded access through clinical trials and expanded clinical trials will help drive the evidence, the information and the data collection that’s necessary to help inform better decisions about the care of Canadian veterans. Whatever can help Canadian veterans gain access to these emerging therapies sooner rather than later in concurrence with what’s being done and accomplished in other jurisdictions is going to help individuals and communities heal. That’s going to help build stronger communities and stronger individuals. We owe that to Canadian veterans, first responders and others. If we can take a leadership role and help drive that discussion through evidence-based approaches, I think that’s the clear way forward.
The Chair: Thank you to the witnesses for being here.
(The committee adjourned.)