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PSYCH Symposium: advancing psychedelic healthcare in Europe
Published
1 year agoon
PSYCH Symposium returned at the British Museum on 6 July to explore how psychedelic medicines can innovate healthcare – from mental health to eating disorders and beyond.
Welcoming hundreds of delegates PSYCH Symposium saw insightful discussions, one on one interviews and workshops exploring different aspects of the psychedelic industry – from the importance of trained therapists to the challenges faced in the drug development pipeline.
Shortwave Pharma’s CEO Rivki Stern kicked off a packed day of sessions with an address to the hundreds of industry stakeholders, medical professionals and investors in the audience.
“Every time that I visit the UK or Europe, I observe the duality, the coexistence of old and new… And I believe that this unique combination of tradition and innovation that is so characteristic of the UK and Europe also defines our industry today,” she began.
Stern explained that, on the one hand, the field of psychedelics is breaking ground in the mental health sector, which has seen little innovation for decades, however, on the other hand, none of this innovation could take place without adhering to the strict and traditional regimen of scientific exploration.
With government and even the pharmaceutical industry’s interest now piqued, she said the industry was now on the way to commercialisation.
Psychedelics for eating disorders
To put the real-world potential of psychedelic treatments into perspective, the first session focused on encouraging early research into the treatment of eating disorders, which have increased 140% over the last decade.
Stern, who was part of the panel, laid out the extent of the issue, suggesting that eating disorders currently cost the US economy around USD$65 billion a year.
Clinical Psychologist at Sheba Medical Center Yoel Golbert added that ‘the reality is dire, there are lots of patients calling out for quality care, but the reality is we don’t have much to offer’.
Oxford University’s Professor Rebecca Park explained that with conditions such as anorexia nervosa, neurally patients have a very rigid system, with a “desync” between the brain and body which makes it very easy for people to starve to death.
The panel then explained how both psilocybin and MDMA showed potential in being able to “break this desync” and help encourage much-needed neuroplasticity.
Golbert said: “There are encouraging indications that brain connectivity and activity create this window of neuroplasticity which can break the inherent rigidity of anorexia. It opens up a window that we can work with through therapy and through integration.
“MDMA also can help with anxiety-reducing properties. It’s an inducement of self-compassion and self-connection.”
Challenges in drug development
Next, the focus turned to the unique challenges presented by psychedelic drug development and treatment.
Cybin’s Chief Medical Officer, Dr Amir Inamdar, explained that while psychedelics were not unique in terms of drug development, the fact that they are not taken on a daily basis, they alter consciousness and they are usually taken alongside psychotherapy means ‘they present unique challenges’.
Because of these unique characteristics, he said that the gold standard, double-blind placebo studies are ‘virtually impossible’, and that his company had had to make ‘certain decisions to that design’.
Furthermore, Inamdar stated that he was “confident” big pharma and institutional investors would eventually get behind psychedelics “because the economics make sense”.
He argued that traditional SSRI and CBT treatment represented a “constant drain on resources”, whereas psychedelic treatments needed a small number of sessions that were more intensive.
“Having been in drug development for over 20 years, I’ve never been so excited. I’m as excited as a child right now.
“Almost all of us, in some form, have been touched by mental health issues. We’ve been giving out treatments for 50/60 years now, which don’t seem to do much. Here is an opportunity to change how we see and feel about mental health.”
Ketamine-assisted psychotherapy
The following session focused on the potential of ketamine-assisted psychotherapy, which Professor Celia Morgan suggested was often seen as the ‘dodgy uncle of psilocybin’.
Despite its reputation, Professor Morgan said ketamine has a number of unique properties and presents opportunities other compounds don’t.
“It has some useful properties, and one of those is that it’s probably the most common useful analgesic in the world. It’s something that is known to physicians and I think in that way, it is quite accessible – and we know that clinicians are risk averse,” she said.
In a presentation of her preliminary research, Morgan explained that early indications of ketamine’s ability to treat Alcohol Use Disorder (AUD) found that there was a significant increase in abstinence for those treated with ketamine.
In a separate study, she suggested that esketamine was found to significantly increase participants’ engagement and willingness to participate in mindfulness practice, while also helping to limit cravings for alcohol.
“The ketamine cat is already out of the bag, particularly in the US. It has the potential to be the groundwork for the introduction of psychedelics into mainstream medicine, but it could also be a drag on all the other psychedelics.”
Access to treatments
Following the recent significant developments in Australia, which are set to give mental health patients access to psilocybin and MDMA, the next panel focused on the recent progress and remaining barriers to accessing psychedelic treatments.
While the panel agreed that these compounds were overdue a reassessment of their current classification given their clear medical potential, they suggested that one of the biggest barriers was reimbursement.
Professor Chris Langmead, Deputy Director, of Neuromedicines Discovery Centre, told the audience: “At the moment, there is no reimbursement available through the Australian healthcare system.
“So, all of this will essentially have to be privately paid for, and that is not a sustainable situation if the global mission is trying to make these therapies as accessible as possible for the patients that really need them.
“We need to be leveraging the breakthroughs we are having now to really move the dial.”
Facilitating psychedelic investment
The following sessions of the morning turned to attracting investment into the psychedelics space, starting with a presentation of a recent survey conducted by PSYCH Symposium sponsor, FTI Consulting.
According to its survey of 104 international institutional investors, who managed a collective USD$10 trillion, there was ‘interest across the board’ in the psychedelics sector.
However, investment remained thin on the ground due to residual issues with public perception, poor company management and a lengthy return on investment.
This was echoed by Apeiron Investment Group’s founder Christian Angermayer, who said that, in a nutshell, institutional investors simply “don’t think the stock will go up”.
He continued that this was due in large part to the poor performance of the biotech sector during the past 18 months, which has been hit hard by growing inflation because of its often extended periods of loss-making before generating revenue.
Crucially, however, big pharma companies are “not sure what to make” of psychedelic treatments because they stray so far from the traditional model of selling “pills to patients every day”.
“We have to prove to ourselves that we can make this new paradigm work.”
Angermayer said he was more optimistic than many investors because he believes the rollout will be quick and organic.
“I have a very optimistic view because we have that infrastructure already there, because we have therapists. It’s practically just a bit of an add-on to traditional therapy, with a little bit more training.”
Additionally, he said that from personal experience everyone he knew who had tried psychedelics as a treatment found not only that it was effective, but also that it immediately turned them into an advocate.
“Why is this so important? Because once these medications are approved, we’re gonna see an unprecedented bottom-up drive. I think that is the number one issue which will determine the success of psychedelics – patients will demand it from their doctors.”
The future of psychedelic medicine in the EU
The final session of the morning saw some of Europe’s leading progressive politicians discuss the ‘The Future of Psychedelic Medicine in the EU’ in a session led by Psychedelic Health’s Stephanie Price.
Despite Albert Hoffman discovering LSD in Switzerland in 1938, the scheduling of psychedelic substances on the continent has seen 50 years of scientific censorship.
However, with numerous clinical trials now being carried out, policymakers in Europe are now starting to take notice.
Panelists agreed that the outlook in the EU was changing due to the growing prevalence of psychedelic clinical trials, and growing clinical evidence showing the efficacy of psychedelics as potential mental health treatments, however, they empahsised one of the key barriers to the rollout of these therpie in Europe was the ‘disparity of healthcare systems across the EU’.
Cyrus Engerer, MEP for Malta, explained: “In the EU, we have one single market when it comes to all other products. However, when it comes to pharmaceuticals and medicine, we have 27 separate markets, and that does not make sense.
“The fragmentation of the European market leads also to exclusivity. So, certain medicines are exclusive to certain patients only across the European Union, and that is unacceptable. It should be their right to access these treatments.”
The panel said that this framework is now on the verge of being overhauled with the introduction of a new European pharmaceutical revision – the first in 20 years – aiming to make access to medicines easier and more affordable, and to foster innovation in the medicines space.
Tadeusz Hawrot of the Psychedelic Access and Research European Alliance (PAREA) empahsised the significance of the review, noting that: “The ambition is to normalise access across the EU. And the second goal is stimulating innovation.”
MEP Mikulas Peksa – Czech biophysicist and member of the Pirate Party – emphasised that the main hurdles to the rollout of psychedelic medicines and therapies in the EU was the UN’s scheduling of substances such as psilocybin and LSD.
Whether this will change remains to be seen – but the UN this year, for the first time in its history, has included a section on psychedelics in its Word Drug Report 2023. This, coupled will the European Medicine Agency’s response to a cross-party call to be more active in psychedelics – leading to a psychedelics workshop being held in the European Parliament this year – may reinforce the changing attitudes towards these substances that have suffered decades of stigmatisation.
Reporting by Ben Stevens and Stephanie Price.
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Insight
Psychedelic-assisted therapy for treating PTSD in Ukraine brings hope
Published
4 months agoon
12th June 2024By
News EditorThe war in Ukraine brings suffering and trauma, which naturally leads to cases of post-traumatic stress disorder (PTSD) among soldiers and civilians. The Ministry of Health of Ukraine predicts that about 4 million Ukrainian civilians are suffering from PTSD.
According to the WHO, about a quarter of the Ukrainian population may be affected by disorders of mental health. In order to deal with this challenge, Ukraine must ensure access to safe, effective and adequately regulated therapy.
That is also why Ukraine is trying to support the idea that mental health will become an integral part of Ukraine’s “reconstruction.” Czech Republic can in this regard offer a helping hand in the sphere of innovative therapy. That is also one of the reasons why a Ukrainian delegation took part in the international conference Novel Mental Health Treatments and Sustainability of Healthcare Systems: Czechia as a Leader of the EU? which took place in Prague.
Psychedelic-assisted therapy is being increasingly discussed in Ukraine as a way of treating PTSD. Although the use of ketamine as part of mental illness treatment has been legal since 2017, substances such as MDMA and psilocybin are still banned. With a view to global development, which has been inching towards supporting the medical use of psychedelics, Ukrainian institutions are supporting clinical studies for psychedelic-assisted therapy as an innovative way of treating PTSD.
Medical use of psychedelics in PTSD treatment in Ukraine
The potential of psychedelic-assisted therapy in the context of the war in Ukraine was also the focus of one of the conference panels. The panel was attended by Ukrainian MPs Mykhailo Radutskyi, Dmytro Gurin, Rostyslav Tistyk and State Secretary of the Ministry of Internal Affairs Inna Yashchuk.
Over the course of the day, Mykhailo Radutskyi, Member of the Verkhovna Rada of the Parliament of Ukraine and Chairman of the Committee on National Health, Health Care and Health Insurance praised the Czech Republic and said that the country is at the forefront of psychedelic research in Europe.
“We have a large population suffering from mental health problems, but we will most likely never have enough experts. In Ukraine, we have an information campaign on how to treat soldiers who have returned from the front, and we are proposing a law which would ensure mental health,” Radutskyi stated.
“About 3.5 million people in Ukraine, and not only soldiers and veterans, currently have mental health problems because of the war, over a million war veterans will need psychotherapeutic help, and currently about half of the veterans suffer from PTSD,” said Dmytro Gurin, Ukrainian MP and member of the Committee on National Health, Health Care and Health Insurance.
“Mental health must become an issue and must play a part in the reconstruction of Ukraine. Winning the war is one thing, but we must also win the war on mental health. One way to win this war is through psychedelic-assisted therapy, and our Parliament and the Ministry of Health will support clinical trials.
“I hope that we will soon approve a study researching the potential for treating PTSD through psychedelic-assisted therapy. Our task is to create fitting conditions for future clinical trials.”
State Secretary of the Ministry of Internal Affairs Inna Yashchuk said: “The Ministry of Internal Affairs is setting up mental health centers all over Ukraine, and I estimate that when we win, 80 % of the people will come to their doctors in need of psychological and psychiatric help. So mental health is not a problem today, but it will be a problem for the future.”
Czech Republic wants to help Ukraine with mental health issues
The event also featured a speech by the Governmental Envoy for the Reconstruction of Ukraine, Tomáš Kopečný, who said: “Ukraine’s reconstruction is not only about physical reconstruction, but also about the mental health of Ukrainian civilians and war veterans, it is about increasing capacities on site, so that the support reach is as effective as possible.”
Other experts also believe that one of the outcomes of the panel discussion should consist in the establishment of a structural relationship between the Czech Republic and Ukraine in the field of mental health, which would include scientific cooperation, exchange of know-how and joint research projects.
Scientific supervision of the ongoing exchange between Czechia and Ukraine in the field of mental health is primarily provided by Professor Jiří Horáček of the Faculty of Medicine at Charles University and director of the Centre for Advanced Studies of Brain and Consciousness at the National Institute of Mental Health, who has prepared an innovative clinical study of using ketamine for the treatment of PTSD in Ukrainian veterans.
In Czech Republic, the topic is also addressed by the Psychedelic Research Foundation (PSYRES). Its director, Jana Bednářová, has said that: “Research about psychedelics is crucial for the future of Ukraine and the Czech Republic. While such research will put Czech Republic on the cutting edge of the field in Europe, without breakthrough solutions for Ukraine, it can take an entire generation to regenerate mental health – in comparison, the physical recovery of the country can be a matter of mere years. Our mission is to enlist visionaries, philanthropists, organizations and the general public to support our research projects and activities and help us make treatment available to everyone who may need it.”
The issue has been resonating in Brussels, Czechia among EU leaders in mental health
The Czech Republic was the first country to put mental health back on the EU’s agenda. The Czech trial in Brussels also leads to the topic of psychedelic-assisted therapy in the treatment of PTSD in Ukraine. The topic was first addressed last year by PsychedelicsEUROPE, a platform focussing on the European regulation of psychedelics. The platform has long been working towards the approval of a new regulatory framework for the medical use of psychedelics on the European single market.
“Mental health is becoming a central issue for the EU. We are a little behind the US, the UK and Australia, but the necessary debate about the regulation of psychedelic substances is coming to Europe. In the same way that psychedelic-assisted therapy can help Ukraine, Ukraine can help the EU in this field by providing data from new research which may help with drafting good legislation. This is one of the reasons why mental health ought to be an implicit part of Ukraine’s reconstruction,” said Viktor Chvátal, founder of PsychedelicsEUROPE.
The event was organised by:
PSYRES
The mission of PSYRES, the Psychedelic Research Endowment Fund, is to provide funding to scientific projects and facilities that focus on innovative treatment procedures in the field of mental illnesses. Our task is to support research and study of the potential of psychedelics and their therapeutic use in psychiatry, neurology and addictology. Our activities help with the preparation and implementation of clinical studies and analyses and with the education of the public. We collaborate with doctors, therapists and researchers who deal in depth with altered states of human consciousness.
INSTITUTE FOR RATIONAL ADDICTION POLICIES
Institute for Rational Addiction Policies is a multidisciplinary association of independent and prominent experts who address the issue of addiction from all angles – public and individual health, legislation and other legal implications, including security challenges, and economics including market modeling, tax, economic impacts on public budgets, the field of education and prevention, and finally also the fields of social and sociological and political science.
PSYCHEDELICS EUROPE
PsychedelicsEUROPE (PE) is an innovative public affairs mental health platform based in Brussels that brings together leading research centres, NGOs, investors, philanthropists and private companies. Based on the latest scientific evidence, PE advocate in the EU for a regulatory environment that promotes modern therapies, cutting-edge research, and innovative industry.
Insight
Psychedelic therapist training programmes are not fit for purpose
We must learn from our mistakes when conducting Psychedelic Assisted Therapy.
Published
4 months agoon
12th June 2024Psychologists, therapists and counsellors play a fundamental role in treating common mental health disorders such as anxiety and depression. With little advancement in treatments for common mental health issues for over half a century, reliance on therapy to support people with such conditions is extremely high in the UK.
However, most training programmes for these professionals do not focus enough on skills acquisition and we are simply not training enough therapists to meet the growing demand. This will not fix the nation’s mental health crisis.
Don’t believe me? Look at the variance in outcomes between therapists. Look at the sheer number of people in England who are prescribed antidepressants by their GP. The figure now stands at more than 8 million people, with over 2 million having been taking them for five years. Look at the number of people on waiting lists to start therapy. It all points to a fundamental problem where many people, with a common mental health problem, are unable to access therapy that works.
One of the reasons lies in the way we train therapists. On most training programmes, students are assessed as competent to practice through their academic writing and the submission of one or two, self-selected, recordings of therapy sessions. They typically have a placement to apply their new skills. However, unlike other healthcare professionals, these sessions occur behind closed doors, without direct observation. Imagine training a nurse, a surgeon or a dentist like this.
This lack of direction observation makes it difficult to know what the trainee is doing with their patients, whether they can consistently deliver therapy with fidelity to the therapy model, and how they interact with patients/clients. It makes it difficult to give the trainee meaningful feedback that will enable them to become better at what they do.
The system encourages higher and higher academic qualifications. However, in my own experience of teaching and supervising mental health professionals, there is no association between competence and the level of academic qualification. Dare I say it, but it is not necessary to have a degree in order to be a highly effective therapist.
This is why Clerkenwell Health has recently launched their Foundations Programme – a practitioner programme for healthcare professionals interested in Psychedelic Assisted Therapy (PAT). Programme participants will be provided with the knowledge required to prepare to safely, ethically and effectively deliver psychedelic treatments.
As we move towards a future where Psychedelic Assisted Therapy (PAT) becomes more mainstream in treating metal health disorders, we must ensure all training programmes robustly assess whether a trainee can consistently deliver high quality therapy that makes measurable difference to patients’ lives. This is what really matters.
Clerkenwell Health’s Foundations Programme leaves no stone unturned. The course explores both the ethical and practical aspects surrounding psychedelic treatments within a regulated healthcare setting, with the teaching delivered by practitioners at the forefront of psychedelic research in the UK, including Dr Sara Tai, Professor of Clinical Psychology at the University of Manchester; Dr David Luke, Associate Professor of Psychology; and Dr Jules Evans, the writer, philosopher and award-winning author of Philosophy for Life.
I asked one organisation, that provides training in PAT, how they selected their trainees, and I was told that it was done “with the gut”. The current approach runs the risk of training a new workforce who are not fit for purpose.
What’s more, all of the existing programmes use ‘psychedelic-psychobabble’. Trainees are taught to ‘trust the medicine’, ‘trust your instinct’ or ‘trust that the participant has the power to heal themselves’. These terms are not widely understood within mainstream healthcare and have, in some cases, led to acts of gross misconduct.
We need a more sober, science-led and evidence-based approach to training. Clerkenwell Health’s Foundations Programme tries to achieve this by providing learners with a thorough background in the history, current state of evidence, treatment modalities, putative mechanisms of actions, and future of psychedelics.
Patient safety, robust standards and clinical effectiveness are of utmost importance in our work at Clerkenwell Health. It’s for these reasons that we’ve launched the Foundations Programme, a course which carefully selects its trainees, assesses their competence and efficacy and is scientifically and theoretically robust. This is not the place where you can try out some psychedelics and suddenly feel qualified to be a psychedelic assisted therapist. This is the place where healthcare professionals come to train in evidence-based practices that are proven and safe. PAT must grasp the golden opportunity to set the standard for a new paradigm in mental healthcare.
If you’re interested in learning more about Clerkenwell Health’s Foundations Programme, you can find out more here: https://training.clerkenwellhealth.com/foundations
This article was written by Dr Sarah Bateup, Scientific Advisor at Clerkenwell Health. Sarah has delivered over 30,000 hours of therapy and taught at Kings College London and Exeter University before joining ieso digital health where she helped scale the company from 10 therapists to 1000.
Insight
Psilocybin therapy for end-of-life care supported by 79% of Canadians
Published
8 months agoon
7th February 2024A new survey has revealed that over 79% of Canadians support psychedelic-assisted therapy for existential distress at the end of life.
People facing a terminal diagnosis often experience significant distress. Depression, anxiety, existential distress and loss of meaning or purpose can make this type of diagnosis difficult to deal with.
Current treatments consist of counselling of cognitive behaviour therapy (CBT), but these are not always effective for everyone, creating a need for innovative new approaches to end-of-life care.
Increasing research is now showing that psychedelic therapy may be beneficial for treating existential distress in patients diagnosed with incurable diseases.
For example, a review published in 2018 in Neuropsychopharmacol Biol Psychiatry found that patients with life-threatening diseases associated with symptoms of depression and anxiety benefitted from the anti-anxiety and anti-depressant properties of psychedelics.
The studies reviewed anecdotally reported that patients experienced quality of life improvements along with a reduced fear of death.
A randomized double-blind trial carried out by John Hopkins University also revealed that high-dose psilocybin produced significant decreases in depression, anxiety and death anxiety, and improvements in quality of life, life meaning, and optimism.
A further clinical trial from New York University found that 60% to 80% of participants experienced anti-anxiety and anti-depressive effects from the treatment, along with benefits for existential distress, quality of life, and attitudes towards death, noting that “the psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression.”
Supporting psychedelics for end-of-life care
In light of psychedelic therapy’s inclusion in Canada’s Special Access Programme in 2022, which enables authorised patients to receive access to these therapies if other treatments have been unsuccessful, a team of researchers set out to understand the public’s opinion on the potential easing of rules surrounding the medical use of psilocybin.
The survey, published in Palliative Medicine and carried out by Michel Dorval and Louis Plourde at Université Laval’s Faculty of Pharmacy and researchers from McGill University, Université de Montréal and UQAR, revealed that nearly four out of five Canadians support the use of psilocybin as a treatment for end of life existential distress.
In a statement, Dorval commented: “Studies have already shown that psilocybin, combined with psychotherapy, produces rapid, robust and lasting anxiolytic and antidepressant effects in patients suffering from advanced cancer.
“This substance can bring about a profound awareness that leads the patient to view existence from a different perspective. Treatment with psilocybin, combined with psychotherapy, can produce relief for up to six months.
“Our results seem to indicate that the social acceptability of this intervention is high in the Canadian population. If we consider only Québec respondents, the acceptability rate is similar to the national average.”
The findings also revealed that public support for psilocybin is higher among respondents who have already been exposed to palliative care, as well as higher in respondents who have already used psilocybin.
“Having been close to loved ones at the end of life, or having witnessed their distress, could explain this openness to new approaches designed to help people at this stage of their life,” added Dorval.
“There are still many prejudices against psychedelic substances. Familiarity with these substances probably helps to better understand their true effects as well as their therapeutic potential.”
The authors write: “The social acceptability of psilocybin-assisted therapy for existential distress at the end of life is rather high in Canada. These findings may contribute to efforts to mobilise resources and improve access to this emerging therapy in palliative and end-of-life care settings.”
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