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Alliance launches to advance psychedelic healthcare in Europe

The Psychedelic Access and Research European Alliance (PAREA) is aiming to advance dialogue around the implementation of psychedelic healthcare in Europe.



Alliance launches to advance psychedelic healthcare in Europe

Psychedelic Health speaks to the founder of the Psychedelic Access and Research European Alliance (PAREA), Tadeusz Hawrot, about how the organisation aims to facilitate discussions around psychedelic healthcare in Europe.

According to the World Health Organisation (WHO) mental health disorders are one of the top public health challenges in Europe, affecting around 25 per cent of the population every year. However, only a small number of those receive treatment. 

Of those who receive treatment, many are not responsive and others can spend months or years waiting for talking therapies, for example. There have also been no advancements in the treatment of mental health conditions since the advent of SSRIs – with the area crying out for innovation following the impact of the Covid-19 pandemic.

With increasing research demonstrating the potential efficacy of psychedelic medicines for the treatment of mental health conditions, addiction and neurological disorders, advancing this area of healthcare could be revolutionary. 

See also  Advancing psychedelic therapy across Europe

Psilocybin and MDMA, for example, have both been granted US FDA granted Breakthrough Therapy designation for clinical trials investigating their use for the treatment of depression and PTSD, respectively, in combination with psychedelic-assisted therapy.

Speaking to Psychedelic Health, founder of PAREA, Tadeusz Hawrot, highlights that there is currently a long way to go in Europe to improve mental healthcare and achieve the health-related UN Sustainable Development Goals by 2030.

PAREA is aiming to help accommodate research advances in the area of psychedelic medicines and to accelerate the safe and responsible integration of psychedelic-assisted therapy into EU healthcare systems.

The coalition brings together 15 organisations in the fields of mental health, neurology and chronic pain, as well as neuropsychopharmacologists and cancer societies, psychedelic foundations and well as industry partners.

PAREA founder, Tadeusz Hawrot.

Hawrot commented: “There are massive unmet needs in the area of not just mental health conditions but in mental, neurological and substance use disorders.

See also  Advancing psychedelic healing experiences in Europe

“The issue is that, while there is a lot of research happening in Europe, and the UK is also leading away in terms of regulatory incentives, we don’t really see much happening at the level of the European institution as a regulator, as an institution.” 

The coalition’s mission advocates the rational and ethically responsible integration of psychedelic-assisted therapies into European mainstream mental health services. 

“When these treatments become available, we think that patients should have them covered within their existing healthcare framework,” said Hawrot. “So, they should become part of the standard armamentarium of different mental healthcare interventions where they live from a doctor, paid by health insurance.

“If this doesn’t happen, we might end up in a situation where people who are most in need will be left without access – people with lower incomes, from economically deprived communities, which already are disproportionately affected by poor mental health. 

“We need to think in advance about these things.”

Hawrot emphasises that one of the objectives of the coalition is to work with policymakers to develop and preserve high-quality standards and rigorous training to ensure that participants are getting safe care. He also highlights that another major barrier to advancing psychedelic healthcare in Europe is the scheduling of psychedelic substances. 

“There is an issue with research,” said Hawrot. “There is very little research at the moment, for example, in assisting people who are having difficult experiences for instance. 

“We need more research for these treatments to be rescheduled – we want to make a case to EU policymakers that they should allocate funding to research in order to make bigger sample sizes and collect more data.”

The coalition has already begun developing relationships with EU policymakers and with members of the European Parliament, having attended a number of meetings and consultations focusing on mental healthcare.

To mark its launch, PAREA will be holding an online event on 23 June, 2022 which will feature talks from PAREA Chair, Professor David Nutt, EU policy maker, Dr Sara Cerdas (Member of the European Parliament), Former Director of the US National Institute of Mental Health, Professor Thomas Insel and others. 

To register for the event please click here.

Alliance launches to advance psychedelic healthcare in Europe


US collective to push for regulated access of psychedelic microdoses

The non-profit Microdosing Collective has launched to support education around regulatory policy to permit legal microdosing.



US collective to push for regulated access psychedelic microdoses

The Microdosing Collective has stated it is committed to a world where sub-perceptible microdosing of psychedelics is legal, accessible and safe. 

With a rise in interest in the use of psychedelics microdoses – such as psilocybin – for conditions such as depression and anxiety, The Microdosing Collective will be working to promote the regulation of microdoses as over-the-counter products.

The collective suggests that one potential path forward is to regulate microdoses of psychedelics as over-the-counter wellness supplements under the purview of the Food and Drug Administration (FDA) or a state-based system.

Microdosing Collective co-founder and microdosing expert, Paul Austin, commented: “Over the past few years, there have been incredible strides made to provide psychedelic substances within a legal and regulated framework.

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“Unfortunately, none of these initiatives have created policy specific to the adult use of microdosing psychedelics. We seek to change that.”

Currently, a number of clinical studies are being carried out in the US on the benefits of psychedelics for conditions such as post traumatic stress disorder (PTSD), addiction and treatment-resistant depression.

The collective highlights that most FDA-approved research studies focus on the clinical outcomes of using consciousness-altering doses of psychedelics during guided sessions, and that state-regulated models only allow access to quantities of psychedelics that dramatically shift consciousness. 

See also  Improvements in mood and mental health after psilocybin microdosing

With a lack of regulatory pathways to accessing sub-perceptible doses of psychedelics, The Microdosing Collective is seeking to create a legal pathway for microdosing psychedelics, not as a medical treatment but as a wellness supplement.

The collective has stated that it believes Americans who microdose should not have to procure their supplements through illicit market operators.

Co-founder of the non-profit and long-time drug policy attorney, Joshua Kappel, stated: “The Collective estimates at least 600,000 people in the US actively microdose psychedelic medicines. The problem we are addressing is that none of these products are legal or guaranteed to be safe.

“Our goal is to educate the public through the Microdosing Collective about the benefits of a legal microdosing market.”

Co-founder of Microdosing Collective and CEO & co-founder of Into The Multiverse, an education-first ecosystem on mushrooms, Alli Shaper, commented: “The largest barrier to access for microdosing stems from its current classification as a Schedule I drug, which legally labels psilocybin as highly addictive with no medical benefit.

“Research shows quite the opposite. When used correctly, with the right education and support, microdosing can have a massive positive impact on people’s lives. The use of these supplementation protocols is on the rise for both mental health and human optimisation with thousands of people reaping the benefits. 

“Our goal is to provide a safe and legal channel for microdosing supplements, which is really a form of harm reduction and mitigation of the risks that come from cross contamination and incorrect dosing via underground channels.”

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Calls for psilocybin access rights for UK cluster headache sufferers

Letter to Home Office ministers calls for the rescheduling of psilocybin.



Calls for psilocybin access rights for UK cluster headaches sufferers

Backed by three top psychiatrists, 161 cluster headache sufferers in the UK have written an open letter to Home Office ministers Savid Javid and Kit Malthouse calling for politicians to reschedule psilocybin.

Cluster headache sufferers from ClusterBusters UK have said breaking the law pales in comparison to getting rid of the pain they live with. The organisation is the national branch of the global ClusterBusters organisation based in the US which works to improve the lives of cluster headache suffers.

In the open letter to Secretary of State for Health and Social Care, Savid Javid, and Minister of State for Crime and Policing, Kit Malthouse, the 161 UK citizens call for the substance to be rescheduled from its Schedule 1 status in order to fight for symptom relief.

Cluster headaches are rare and debilitating neurological condition known as suicide headaches for their excruciating pain – currently untreatable with existing treatments. The condition affects 1 in 1000 people in the UK. 

Psilocybin has shown promise in treating the condition and the citizens highlight it can also address the mental health impacts that stem from it.

The letter, which was written by ClusterBusters’ Vice President, Ainslie Course, states: “Sadly, there are very few medications which offer any relief whatsoever, and those that do are short-lasting at best but many, many people living with Cluster Headache have been successful in treating our condition with sub-hallucinogenic doses of psilocybin. 

See also  Majority in favour of changing law to boost psilocybin research in UK

“Not only is this a way to treat the physical symptoms of our condition, but this medicine can also treat the associated mental ill health, that is the depression, anxiety and post-traumatic stress related to knowing the excruciating pain will inevitably return.

“Psilocybin is helping hundreds of thousands of people to live a predominantly pain-free life with encouragingly long periods of remission. This medicine has saved my life and the lives of many others.”

Three top psychiatrists – President of the British Association for Psychopharmacology, Professor Allan Young, Wellcome Centre for Human Neuroimaging, Professor Karl Friston and Regius Professor of Psychiatry, Head of the Department of Psychological Medicine, King’s College, London, Professor Simon Weseley – have also written in support of the suggestion.

See also  Majority of UK MPs support drug policy reform

They emphasise that psilocybin research can garner insights about the human brain: “When administered as a pharmacological challenge, changes in brain activity can be brought to light that inform our understanding of functional brain architectures and processing, advancing human knowledge and translational applications.” 

Due to its classification as a Schedule 1 substance, psilocybin research is off-limits to numerous UK higher education institutions and businesses, they say, as many of these institutions “do not have the economic and temporal resources to secure the necessary licences.”

The psychiatrists also highlight that psilocybin can be used as an adjunct psychotherapeutic agent to treat conditions such as anorexia nervosa, obesity, post-traumatic stress disorder and addictions to substances such as alcohol, cocaine and tobacco.

The two letters are part of the Conservative Drug Policy Reform Group’s (CDPRG) Psilocybin Access Rights campaign. Founder of the CDPRG, MP Crispin Blunt, held a meeting with Prime Minster Boris Johnson in May 2021 in which Johnson agreed the rescheduling of psilocybin into Schedule 2. However, there have been Home Office delays relating to a misinterpretation of existing legislation.

See also  UK continues to delay on psilocybin rescheduling

Blunt raised the question of rescheduling psilocybin in Parliament later in October, to which Johnson stated he would consider the Advisory Council on the Misuse of Drugs’ (ACMD) advice on reducing barriers to research with controlled drugs, and would “get back to him as soon as possible”.

In their letter, the psychiatrists state: “The Government has confirmed that there has been no recent review of the evidence for psilocybin’s current scheduling,” calling for Chief Medical Officer Chris Whitty to review the evidence that support rescheduling the substance.

“Having assessed the evidence and history of this legislation ourselves, we understand that there is not and has never been an evidential basis for psilocybin’s current scheduling, based as it is on the UN Single Convention on Psychotropic Substances 1971. This is strange given the emerging evidence of psilocybin’s therapeutic potential and clear neuroscience research utility.”

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Why Italy blocked the campaign on psychotropic substance cultivation

Legalizziamo! campaign coordinator Marco Perduca shares his thoughts on why Italy’s court has blocked the referendum.



Why Italy blocked the campaign on psychotropic substance cultivation

Last week Italy’s Constitutional Court blocked the country’s campaign calling for the decriminalisation of psychotropic substance cultivation.

The motivation for not allowing the referendum to proceed is not yet clear and the campaign has been accused of being misleading, says campaign coordinator Marco Perduca. 

Despite handing in 630,000 verified signatures calling for a referendum, Italy’s Constitutional Court stated that the campaign will not trigger a referendum. The Legalizziamo! campaign group has said the decision is a win for the mafia and “the failure of a court that cannot guarantee Italians a constitutional right”.

The campaign aimed to modify the wording of “cultivation” in the Consolidated Law on the Discipline of Narcotic Drugs and Psychotropic Substances in Presidential Decree 309/1990. The court, however, stated that the campaign would force the country to violate its obligations to the UN regarding the prevention of drug trafficking.

Find out about the global coalition pushing for psilocybin rescheduling

Marco Perduca is co-founder and international co-ordinator Associazione Luca Coscioni and founder of Science for Democracy, the international platform promoted by the Luca Coscioni Association. He has been the coordinator for the Legalizziamo! campaign since 2015.

In a comment to Psychedelic Health, Marco Perduca, said: “The motivation of the decision of the Constitutional Court against the admissibility of our referendum has not been published yet so we can only respond to the words of Giuliano Amato the President of the Court uttered in his press conference on 16 February.

“We were accused of having submitted a referendum that was poorly drafted, with a misleading title and that the whole proposal was not in line with Italy’s obligation stemming from the ratification of the three UN Conventions.

“Mr Amato made reference to the website address on which we collected the signatures knowing quite well that that was the name of the political campaign to collect signatures but not the actual title of the question, which was decided in conjunction with the Cassation Court.

“Italy’s drugs law is very complicated to interpret but once you know your way through that legislative maze you know where it is heading: to punish conducts from cultivation to production, from transportation to export and import of illicit plants and substances. 

“Our referendum was deleting penalties only for one of those actions, cultivation, keeping all the other conducts in place – hence only growing for personal use would have been decriminalised, as massive cultivation would have remained illicit. Furthermore, one doesn’t need to be a botanist to know that one grows plants and not substance, one thing is cultivating coca bush, another producing cocaine, one thing is growing poppy seeds, another refining heroin. We do not cultivate wine but grapes.

“Mr Amato made that confusion and “forgot” to mention that prohibition to grow cannabis indeed appears in a paragraph of one of the articles we deleted as well as in the previous one – the 1990 law was toughened in 2006 but changed again in 2014 and sometimes it is difficult to keep track of all the changes, also for jurists – so, the accusation of having poorly drafted the referendum is a judgement that is up in the air as the law says otherwise. 

“Until we won’t have the motivations of the decision we can only speculate on the rationale behind it and respond to a brief, if not superficial, summary of the President of the Constitutional Court shared in a very unconventional manner on behalf of the 15 judges that took that decision.”

Speaking to Psychedelic Health, Perduca previously highlighted that the campaign also aimed to allow people to use cultivation for scientific research targeting specific physical conditions or pathologies. Perduca said that Italy is lagging behind other countries in psychotropic substance research. 

“We only have one centre at the University of Rome that is starting to study psilocybin for therapeutic purposes. We also grow cannabis for medical reasons, but nobody’s studying it,” said Perduca.

Find out more on what the campaign means for the Right to Science

Perduca is also now involved in a campaign for the Right to Science – an enshrined right in the International Covenant on Economic, Social and Cultural Rights. This entered into force in 1976 and covers freedom of research, freedom of knowledge, including open access, as well as free and open data.

Whilst more studies are demonstrating the efficacy of psychotropic substances, such as psilocybin, for treating mental health conditions, prohibition of cultivating such substances hinders scientific research in Italy that could contribute to this new fountain of knowledge. 

To address what the country lacks in the field of psychedelic research, Associazione Luca Coscioni recently published a collection of presentations and international symposia – The Dose Makes the Poison. The collection features psychedelic pioneers such as Amanda Feilding, Rick Doblin, Ben Sessa, Carl Hart and Raphael Mechoulam.

The campaigners have stated they will not stop the fight to push through the referendum.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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