Preparing Europe for psychedelic-assisted therapies

Launching a Call to Action to EU policy makers, PAREA’s Tadeusz Hawrot and MEP Sara Cerdas want to see greater research into the potential of psychedelic medicines and treatments.

Navigating a mental health crisis: science tells us that novel psychedelic medicines can help says Sara Cerdas (PT,S&D) member of parliaments Environment, Public Health and Food Safety Committee

In the European Union, mental health problems affect more than 80 million people, and suicide is the second leading cause of death for young people aged between 15 and 29. The COVID 19 outbreak significantly increased these challenges. According to the International Labour Organization, in spring 2021, 64 % of young people between 18–34 years were at risk of depression, partly because of loneliness and social isolation. We are failing too many individuals, families and communities affected by mental health conditions.

Much more must be done to promote mental health, and for that I am a supporter for evidence-based treatments promoting mental health, such as the promising novel psychedelic medicines.

I cannot ignore what science has been telling us for years now. A growing, rigorous, and compelling body of research strongly suggests that psychedelic-assisted therapies may be a potent new class of treatments for mental health conditions

Psychedelic compounds - such as LSD and MDMA - remain illegal and can represent serious risks for individuals. At the same time, I cannot ignore what science has been telling us for years now. A growing, rigorous, and compelling body of research strongly suggests that psychedelic-assisted therapies may be a potent new class of treatments for mental health conditions.

It cannot be ignored that the fundamental benefit of psychedelic novel therapies comes from the combination of psychedelic medicine and therapy. They offer a therapeutic window of opportunity for people to address the root causes of their mental health problems, while being supported by trained therapists.

Being involved in shaping EU cancer policies, I also look with hope at studies showing that psychedelics can help cancer patients who often experience significant psychological distress after receiving life-threatening diagnosis.

I am reminded of the trial done at Johns Hopkins University with psilocybin-assisted therapy, in which the results were clear: most of the cancer patients experienced "significant decreases in depressed mood and anxiety", and two-thirds of them rated their psilocybin sessions among the most meaningful experiences of their lives. This really makes one have hope that we could finally find effective tools to help so many people deal with severe mental health problems. The same applies to treating addictions where psychedelic compounds have shown a lot of promise.

Research also shows that psychedelic-assisted therapy is safe when delivered in controlled and supportive settings. We need greater EU research efforts to understand these treatments better, but we cannot be blinded by stigma and prejudice toward psychedelics.


New EU partnership PAREA sets to pave the way for psychedelic-assisted therapies to help patients in areas of huge unmet needs says Tadeusz Hawrot, founder and policy lead at the Psychedelic Access and Research European Alliance (PAREA)

Kerry was diagnosed with stage 3 lung cancer in 2013. During her end-of-life treatment, she was given a large dose of psilocybin, the psychedelic agent in magic mushrooms, as part of an ongoing clinical trial. As she lay on a couch - with a blindfold to keep out distractions, headphones playing soothing music, and with trained guides watching over her - she had a profound realisation, "You are alive. Right here right now because that's all you have." Despite the progression of her cancer, after the treatment, her crippling anxiety about death was gone. You can watch a short part of her testimonial here.

Many similar stories can be found in the public domain of people receiving help by undergoing Psychedelic-Assisted Therapy (PAT) in clinical trials. These tests are investigating compounds with psychedelic properties like psilocybin, 3,4-Methyl​enedioxy​methamphetamine (MDMA) or Lysergic Acid Diethylamide (LSD). The results are extremely promising. For example, a phase 3 clinical trial published in 2021 in Nature Medicine demonstrated that a whopping 67% of participants in the MDMA-assisted therapy no longer suffered Posttraumatic Stress Disorder (PTSD). The MDMA therapy might be approved by the US Food and Drug Administration (FDA) as early as next year.

The renaissance of research into the neuroscience and therapeutic applications of psychedelics represents one of the most promising and important initiatives in brain science and neuropsychopharmacology in recent times. Europe must act now to make sure psychedelic-assisted therapies reach patients in a timely manner.

There are some thirty phase 2 clinical trials in the pipeline, investigating symptoms like treatment-resistant depression, alcohol use disorder and other addictions, various forms of anxiety or several types of pain like cluster headaches. Other early-stage trials also look at a host of neurological disorders.

Between 2017 and 2019, the US FDA granted Breakthrough Therapy designation to PATs for three trials investigating psilocybin for depression and MDMA for PTSD. Top-tier universities in the US and Europe are opening dedicated centres to study psychedelics and governments across the world start funding research into psychedelics.

The EU must follow suit by providing funding opportunities and start preparing the roll-out of these treatments. The work must now begin to ensure equitable, timely, affordable, safe, and legal access to PATs soon.

Therefore, a new collaboration - the Psychedelic Access and Research European Alliance (PAREA) - has just been officially launched. PAREA is a unique and diverse partnership bringing together 15 members spanning patient organisations, professional associations, umbrella organisations, psychedelic foundations, and the for-profit sector.

We are coming together to scale up and accelerate action on PATs by providing evidence-based policy recommendations and expertise to EU policymakers.

PAREA members launched a Call to Action to European decision makers-bringing together our key priorities and policy asks.

The renaissance of research into the neuroscience and therapeutic applications of psychedelics represents one of the most promising and important initiatives in brain science and neuropsychopharmacology in recent times. Europe must act now to make sure psychedelic-assisted therapies reach patients in a timely manner.


This content was commissioned by PAREA and produced by Dods Impact

 

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