Hardman: So you originally were focusing on Sweden, but now you have broadened that remit to Europe generally, if I’m understanding correctly. In terms of the types of research you fund, you mentioned that you fund clinical work, but are you also funding basic science as well?
Christersson: Exactly. We fund projects within our three focus areas which are research, education and what we call implementation, which is work aimed at promoting and setting the foundation for patient access.
We have supported clinical research: I mentioned the RCT with psilocybin for depression here in Stockholm at Karolinska Institute, and we’ve supported therapist training to prepare clinicians for an MDMA study. We’re also a co-founding member of PAREA and we continue to support PAREA’s work to advocate for psychedelic science in Europe.
When it comes to our different funding remits or focus areas, we ideally like to fund research that can improve our understanding of the clinical application of psychedelic substances, and projects that can bring new insight or knowledge to these treatments. So, for example, a study looking at the young adult population or a novel indication that hasn’t been studied yet.
Currently, we do not prioritise animal studies, but there are other kind of research areas that are not only aimed at looking at strict clinical effects. That’s of interest for us as well. And that could be looking into how treatment efficacy can be predicted, or more comparative studies looking at slow-acting or fast-acting compounds or added benefits to existing treatments.
There’s also a big question around the economics of psychedelic assisted therapies as well, the cost effectiveness of these treatments to scale. And there hasn’t really been a lot of large scale trials on group therapy or research into the added value of psychotherapy compared to psychological support.
So research needs to look into what the nuances and considerations are of different therapeutic treatment models.
Hardman: Yeah. In our field of psychedelics, the trials are so expensive and resource-intensive that we have relatively small patient populations. It also means it’s harder to test different protocols, dosing regimes, and so on; or run larger, factorial trials. So there’s so much still to learn in terms of how these treatments are optimally delivered: in terms of efficacy and safety, but also scalability. I’d also think that that is an area of research where Europe is well positioned to lead, given that European member states have been quite discerning in terms of the treatments that they cover, right? In the UK, for example, (which is out of the EU now, but still geographically European!) NICE has taken a very dim view of the cost-effectiveness of Spravato.
Christersson: I think it’s the same in Sweden, actually: it’s approved but not covered within the healthcare system to a great extent. So it’s not very widely used even though it’s approved. And this is something that we would like to avoid if we have treatments that are safe, effective, approved.
So when it comes to funding research, we look to fund projects that can help us understand better how psychedelics can be used in clinical application.
Hardman: That makes sense. So you’re only ever looking at the clinical side, right? Even in your public education, it’s not harm reduction… it’s more on the side of educating stakeholders about the potential in the medical model?
Stråth: Yeah, that wouldn’t be an area that we focus on directly. It’s more the clinical application.
I think the education work is super important. It maybe goes beyond just the strict definition of ‘education’ and is more about engaging with the right stakeholders.
If we look at what’s needed to roll out these treatments it probably won’t be just like rolling out any other new pharmaceutical substance. It might even be more similar to rolling out a new psychotherapeutic model at the same time. So I think in recognising that as well as the fact that psychedelics do have unique characteristics, there are things that we could start doing right now. Things like devising safeguards for patients, different training programmes for therapists and maybe even other healthcare professionals.
We have to overcome stigma and preconceived notions and I also think we do have to recognise that there will likely be non-clinical access to a greater extent than for any other substance that has been approved in recent times.
And as Emma was alluding to, the issues relating to reimbursement, cost effectiveness and access pose challenges for a wide range of stakeholders. I think we need to start working on this sooner rather than later, and that will require collaboration not just across disciplines and sectors, but probably also across borders.
A good example of that type of project is PsyPal. Norrsken Mind is involved in the communication and dissemination workstream of that project. But we’re also in discussions and get exposed to different initiatives through our grant programme. That puts us in an interesting position to learn about what work is underway, what has perhaps worked previously, what hasn’t worked, and try to figure out which initiatives are the most impactful and, by extension, which ones we should support.
Hardman: Yeah, I think the PsyPal study is a really good example because it’s a clinical study with really diverse, and challenging, patient populations while collaborating with expertise from so many different groups.
Stråth: Yeah, and there’s the cost effectiveness avenue of PsyPal as well and that work will be carried out by Uppsala University here in Sweden.
Hardman: What would your ideal situation be in 5-10 years? How would you like to see psychedelic-based treatments integrated into healthcare in Europe? And what would you like the research field to look like?
Stråth: I will try to be a bit realistic.
In an ideal scenario we would have proven efficacy and safety for psychedelics in more than one indication from large scale studies. We would also have come further with exploring the therapeutic potential of short-acting psychedelics, which hopefully would improve the possibilities for patient access. And then I hope that we have gotten further with parsing out these key issues relating to the added value of psychotherapy versus psychological support, and other questions that were outlined in those articles about the knowledge gaps in psychedelic medicine in Europe. That’s a good framework for the issues that we need to address.
And to the points I just made, we would have prepared for an efficient and safe roll out of treatments and taken those steps well in advance. I would be hesitant to say that we have started to roll out treatments by 2030, but ideally we would have prepared for that and hopefully incorporated some of the lessons from the early adopters, the jurisdictions that have started to roll this out by then.
Christersson: I think I also, like Marcus, have a bit more of a pragmatic view on this in that we hope that things progress according to the knowledge and the readiness of society. That might be a slow process, but it’s a sustainable one. Of course, I definitely hope to see that there is an approval for psychedelic assisted therapy by 2030 in Europe.
If MDMA for PTSD is approved in the US in the coming year, my hope is that there would also be patient access to a safe and effective treatment for PTSD in Europe by 2030.
Stråth: I would add that decision makers will be faced with interesting questions come August if there is an approval in the US. If this treatment is already accessible for patients in Australia and it’s now approved by the FDA, why not here? What’s the path forward? It’s a reasonable question to ask from the populace. I think at this point we don’t have a path forward and we are interested in exploring what that could look like in Europe.