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Psychedelics industrial complex could put psychedelic religions in jeopardy

The Oregon Psilocybin Committee is considering special protections for the religious use of psilocybin after warnings that the industry could endanger psychedelic religions.

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Psychedelics industrial complex could put psychedelic religions in jeopardy

A subcommittee of the Oregon Psilocybin Advisory Board (OPAB) is considering whether to provide special protections for religious practises involving the use of psilocybin.

The OPAB has been warned that the rise of a new psychedelics industrial complex could put psychedelic religions in jeopardy if Oregon fails to act quickly.

Attorney Jon Dennis of Sagebrush Law, warned the board that the industry has already begun engaging in aggressive tactics to prevent newcomers from entering into the industry, despite psychedelics not yet being legal at a state or federal level.

Although the US Supreme Court has already approved of granting religious liberties to churches that use psychedelic plants as sacraments, Oregon is the first state to decide the scope of freedoms for psychedelic religions through administrative regulation.

Measure 109

Oregon has one of the highest prevalences of mental illness in the nation, affecting one in every five adults. With the rise in promising results regarding the efficacy of psilocybin for mental health conditions, Oregon became the first state in the US to approve of legalised psilocybin under Oregon’s Psilocybin Services Act – “Measure 109” – in November 2020.

Measure 109 aims to develop a “long-term strategic plan for ensuring that psilocybin services will become and remain a safe, accessible and affordable therapeutic option for all persons 21 years of age…” and “establish a comprehensive regulatory framework concerning psilocybin products and psilocybin services under state law…” among other actions.

In a meeting with the OPAB, Dennis presented a set of draft regulations that would grant religious protections under Oregon’s new psilocybin law.

See also  Global coalition launches to push for psilocybin rescheduling 

Addressing the board, Dennis cited the words of medicine woman Maria Sabina, whose sacred ceremonies in Mexico were based on the use of psilocybin. When the news of her ceremonies broke in The Times, Westerners flocked to Mexico in order to experience the mushrooms. This led to restrictions from the Mexican Government on their ritual use.

“Never, as far as I remember, were the saint children [the mushrooms] eaten with such lack of respect,” Sabina had commented – saying that foreign visitors ruined the purity of the mushrooms.

Dennis commented: “When we think about what Oregon is doing right now with this new psychedelic programme, we have to consider this history – part of this history is the emergence of the psychedelics industrial complex. This is the list of companies that are publicly traded.

“Keep in mind – with about $4.8bn in market cap – non of this is really legal yet. I don’t suppose that all of these companies are engaging in aggressive tactics – but we are already starting to see the intellectual property grabs and the land grabs, to corner out other types of access to psychedelic healing modalities that exist. 

“If we as a society are to protect religious use the best way to do that is to do it now. Because as these companies get bigger and bigger and become more aggressive, and try to corner out other types of psychedelic healing and psychedelic use, it is not going to get easier as this psychedelic complex gets more entrenched.”

Concerns were also raised regarding lobbyists meddling in Oregon’s psilocybin programme.

Protections for entheogenic practitioners

Many people across the world use entheogens – psychoactive plants or substances that are used in a sacred or spiritual manner.

To reflect this use of psychoactive plants, within Dennis’ draft framework, the word “entheogenic” is used rather than “religious” to ensure that those who use these plants as part of any practice related to their sincere beliefs have their rights maintained. 

See also  Could Italy decriminalise psychotropic substance cultivation? 

Dennis proposed a partnership between the Oregon Health Authority and entheogenic practitioners that he believes would be beneficial to all parties, by bringing entheogenic practice out of the underground to “above ground”. This would provide oversight and accountability, ensuring that people are going through a screening process and safeguards are in place. It will also ensure practitioners will not have to face the risk of jail for practices related to their beliefs.

“This also helps with the tension inherent in Measure 109 around accessibility and affordability,” said Dennis. “I believe, particularly with the peer support model and homegrown mushroom model, that we can drive the price point down to something that is actually affordable.

“This cause is too important for it to be another vehicle to reinforce or deepen inequalities that exist along racial, health or financial mechanisms – it is going to be such a tragic thing as we enter into this new era where we re-establish relationships with plant medicines – it is critical we give small community-led organisations their own means of production and do something to protect that.”

Click here to read the draft framework

Community-based healing

Bob Otis Stanley, pastor and chief garden steward of Oakland-based church, the Sacred Garden Community, which uses psychedelic plants as part of their religious ritual, also highlighted the importance of community-based healing.

Stanley commented: “We have a common faith in our church that the sacraments of our church are approached with care, respect and trust and can connect us with experience of divine presence within this lifetime. 

“But we can accept many incoming faiths – atheism, Christian, Jewish, Islam, Pagan. So, we are trying to create a strong container for the diversity that we find here in Oakland, but also who have a sincerely shared faith. 

“By trying to create this community framework that has deliberate harm reduction built-in we are recreating some of the benefits in long term culture that I have experienced in the many years visiting the Sierra Mazateca region. Each little village and valley that will have one or two, or several, curanderos [healers] will have culture integrated with that healing process – we are lacking here in the United States. 

“So to have an intentionally created community that can provide some of that support for the frameworks you may find in other traditional cultures is part of our goal.”

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Policy

EMA workshop: One small step for Europe, one giant leap for psychedelics

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EMA workshop: One small step for Europe, one giant leap for psychedelics

In a watershed moment for psychedelics in Europe, the European Medicines Agency (EMA) held a workshop from 16 to 17 April to discuss regulatory guidelines for the development and therapeutic use of psychedelic medicines.

2024 is set to be an important year for psychedelics and the EMA multi-stakeholder workshop is just one of the key events kicking it into action.

The two-day workshop – Towards an EU Regulatory Framework – brought together patients, healthcare professionals, academia, regulators and industry.

As Europe risks lagging behind countries such as Australia and America in seizing the potential of psychedelics for mental health innovation, the meeting was held in response to a letter from a group of cross-party MEPs calling for the EU to act fast on these therapies.

See also  EMA adds psychedelics to major depression guidelines

The MEPs wrote to the EMA and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) to say the organizations need to play a more active role in the advancement of psychedelic medicines in Europe.

Highlighting that the recent shift in perspective towards psychedelics has garnered interest in Europe, the EMA has stated that concerns remain over challenges developers may face in meeting the scientific and regulatory expectations for receiving marketing authorisation for the medicines – holding the workshop as a starting point in working through these issues.

While the meeting marks one small, initial step for the EMA, the organisation’s interest in this developing field of research marks a giant leap for the advancement of the therapies in Europe.

Towards an EU regulatory framework for psychedelics

The meeting heard regulatory perspectives on psychedelic drugs in psychiatry from across Europe, Australia and America, as well as insights on the legal status of psychedelics and their impact on research.

Non-profit organisation PAREA highlighted how Europe is currently facing a mental health crisis with a desperate need for innovation in care, with not a single new medicine out of the 89 approved in 2022 targeting mental health.

The organisation emphasised the obstacles posed by regulation for scientific research and proposed a number of recommendations for a more supportive regulatory framework to help move psychedelic therapies forward, including:

  • Incentives such as regulatory protection: rescheduling psychedelic drugs to enable scientific research.
  • Enhanced EMA support: Utilising Europe’s PRIME scheme which focuses on medicines under development that are not yet authorised in the EU.
  • The establishment of an EU Commission on Novel Mental Health Therapies.
  • Accelerated assessments: Utilising Conditional Marketing Authorisation (CMA) and the EMA’s Adaptive Pathways programme for early patient access.
  • A more predictable reimbursement environment.

Speaking to Psychedelic Health, Tadeusz Hawrot, Founder and Director of PAREA, stated: “An importance of collaboration among different stakeholders felt central to the discussions, highlighting a need for joint effort to address the intricate issues surrounding psychedelic therapies.”

Building on the momentum created at the workshop, Hawrot said that PAREA will be exploring opportunities for a multistakeholder collaborative project as part of the Horizon Europe funding.

“The project would involve professional societies, patient groups, EMA and national competent authorities, addressing a number of most pressing topics related to psychedelic therapies at an intersection of regulation, science, and areas needed for implementing these therapies such as standards of care,” Hawrot explained.

“An upcoming EU Partnership on Brain Health will be an important opportunity to explore in this regard.”

Research and clinical trials

Further discussions focussed on methodological issues related to research and trials.

These surrounded issues with blinding and expectations, the importance of proper dosage justification and documenting dose-response relationships, as well as the need to investigate sub-psychedelic doses and their associations with psychoactive effects and neuroplasticity.

Hawrot commented: “In terms of some key areas addressed yesterday and today, discussion revolved around designing effective trials, the importance and type of therapeutic support, difficulties with using placebos, managing expectations, and how strict drug control policies are slowing down research.

“Exploring what can be standardised in trials, the crucial role of patient input and preferences, and the need for thorough aftercare provisions were further key points.”

The importance of Real World Evidence was also highlighted as a key path for advancing psychedelic therapies in Europe

Some implied next steps discussed were continuing dialogue between developers and regulators, seeking early feedback, and collaborating to address challenges in psychedelic drug development.

Patient representation and care

Ensuring the safe and effective use of psychedelic substances in clinical trials and real-world settings was also a main point of discussion, with patient representatives providing insight on their experience, as well as suggestions for patient care.

In particular, stakeholders including representatives of the Psychedelic Participant Advocacy Network (PsyPAN) highlighted the need for aftercare such as post-integrative therapy and peer support or professional guidance, however, it was also emphasised that these types of support are difficult to regulate.

The importance of patient involvement in research was also discussed, highlighting that patient involvement goes beyond study participation and includes a more active role in research design and decision-making.

Advancing innovation

Providing an environment where innovation can flourish will be vital for advancing psychedelics, and with companies already carrying out trails but hindered by strict regulations and expensive costs changes are needed sooner rather than later.

George McBride, Co-Founder of UK CMO Clerkenwell Health explained that the company is considering a significant investment into the EU to build out centres for the conduct of psychedelic research, querying the competitiveness of the EMA versus other jurisdictions such as the U.S FDA, Australia’s TGA, Health Canada and the UK’s MHRA.

EMA representatives provided assurance that the organisation is ready to be part of a collaborative and supportive effort to establish standards of care and standards for data gathering.

Speaking to Psychedelic Health, Stephen Murphy, CEO of PSYCH, commented: “This workshop is a key moment for the advancement of psychedelic medicines in Europe.

“The interest of the European Medicines Agency and the discussions in this week’s meeting highlights the organisation’s desire for innovation in mental healthcare and willingness to support psychedelic medicines through collaborative efforts.

“Taking action on psychedelic therapies now is a positive move towards preventative care in the area of mental health.

“We are pleased to see these developments at the start of 2024, which is set to be an important year for psychedelics across the globe.”

Harwot concluded: “The workshop made it clear that continuing conversations with regulators and developers and taking a measured approach to regulations are vital.

“It is very encouraging to see the degree of interest from EMA to explore the therapeutic potential of psychedelics and support developers in this field.”

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Research

Phase 2a trial to investigate 5-MeO-DMT candidate for alcohol use disorder

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Beckley Psytech and Clerkenwell Health are collaborating on a Phase 2a trial investigating Beckley’s synthetic 5-MeO-DMT candidate combined with psychological support as a treatment for alcohol use disorder (AUD).

AUD is estimated to affect around 237 million people across the globe and over 7.5 million people in the UK.

Treatment options for the harmful use of alcohol are not always effective – there are high relapse rates and there are around three million deaths each year attributed to the substance’s misuse.

Increasing research is showing that psychedelics may hold promise as innovative treatments for addiction, including substances such as ketamine and psilocybin.

See also  How psychedelics could help those living with alcohol use disorders

BPL-003 is Beckley Psytech’s short-duration and fast-acting synthetic formulation of 5-MeO-DMT – a psychedelic found in several plant species and the glands of at least one toad species – which is administered intranasally via an FDA-approved delivery device.

The compound has shown in Phase I data to be well-tolerated with a reproducible and dose-linear pharmacokinetic profile.

The Phase 2a trial

Beckley and Clerkenwell have confirmed that the collaborative Phase 2a open-label trial will evaluate the safety, tolerability and pharmacodynamic effects of a single dose of Beckley BPL-003 combined with abstinence-oriented psychological support in participants with AUD.

Currently taking place at King’s College London, Clerkenwell Health’s clinic near Harley Street, London, will provide an additional trial site.

According to Beckley, BPL-003 has been successful in eliciting psychedelic experiences of “similar intensity but shorter duration than psilocybin”.

Dr Henry Fisher, Chief Scientific Officer at Clerkenwell Health, stated: “An estimated 600,000 people are dependent on alcohol in England. This, coupled with an alarming increase in alcohol-related deaths of 89% over the past 20 years, shows the status quo isn’t working.

“Conventional treatments for alcohol dependency aren’t producing meaningful improvements and new avenues must be explored. This trial will assess whether psychedelic-assisted treatment can be an effective therapy for alcohol use disorder, with the hope of rolling out the treatment widely.

“Health professionals and policymakers should seriously consider such treatments, which could be genuinely ground-breaking for the NHS and for the hundreds of thousands of people being treated for alcohol use disorder in the UK.”

Beckley Psytech and Clerkenwell have emphasised that the results of the trial may be used to provide support for further study of psychedelic-assisted treatment for alcohol dependency.

Dr Rob Conley, Chief Medical and Scientific Officer at Beckley Psytech, added: “We’re committed to developing a transformative and effective treatment option for individuals struggling with alcohol use disorder.

“Based on our preclinical and Phase I data, we are optimistic about the potential therapeutic benefits of BPL-003 for substance use disorders and we are excited to evaluate the compound further in this clinical trial.

“I want to extend my thanks to the team at Clerkenwell Health and King’s, as well as to the patients who have joined, and will join, this study. Their participation, support and collaboration are absolutely critical to furthering research into this area of huge unmet need.”

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Research

The Entourage Effect in Mushrooms: Natural psilocybin may outperform synthetic

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The Entourage Effect in Mushrooms: Natural psilocybin may outperform synthetic

A new study from the Hebrew University-Hadassah Medical Center has indicated that natural psilocybin extracts may demonstrate superior efficacy to synthetic psilocybin extracts.

Recent years have seen a boom in research into psilocybin for the treatment of mental health conditions such as anxiety and depression.

Many of the clinical trials investigating psilocybin use synthetic extracts rather than natural ones. This is because synthetic extracts will contain psilocybin alone, whereas natural psilocybe mushroom extracts will contain several different compounds such as psilocybin, psilocin, baeocystin and norbaeocystin.

Having multiple compounds can pose a challenge when running clinical trials as identifying which compounds are active and what their impact is becomes difficult to measure, and the concentrations of these compounds can vary depending on factors such as growth conditions and processing techniques.

This makes the standardisation of multi-compound medicines a huge challenge, as medicine consistency, reproducibility and dosing become difficult. However, these are essential factors when it comes to conducting clinical trials and receiving approval for medicines from regulators.

The Entourage Effect

In 2011 Dr Ethan Russo put forward the theory of the Entourage Effect in cannabis. 

The cannabis plant contains over 400 different cannabinoids that have so far been identified, such as THC, CBD, CBN and CBG.

Russo hypothesised that these different cannabinoid compounds work synergistically to create a therapeutic effect, as opposed to compounds such as THC or CBD working in isolation.

This hypothesis has been touched on only a few times in the scientific literature in relation to psychedelic mushrooms.

For example, in Dr Jochen Gartz’s 1989 paper ‘Biotransformation of tryptamine derivatives in mycelial cultures of Psilocybe’ which proposed a synergistic relationship between compounds in the mushrooms, and a 2015 paper by Zhuck et al, ‘Research on Acute Toxicity and the Behavioral Effects of Methanolic Extract from Psilocybin Mushrooms and Psilocin in Mice’, which observed that the effect of psychedelic mushroom extracts on mice was much stronger than pure psilocybin.

There has been very limited research on this hypothesis in mushrooms since. 

A new study: Natural may outperform synthetic

Now, a research team from Hebrew University-Hadassah Medical Center BrainLabs Center for the Psychedelic Research have compared a natural psilocybin extract to a chemically synthesised version.

Published in Molecular Psychiatry, results from the study indicate that the natural extract increased the levels of synaptic proteins associated with neuroplasticity in key brain regions, including the frontal cortex, hippocampus, amygdala, and striatum.

The ability of psilocybin to induce neuralplasticity has been indicated as one of the key features that contribute to its therapeutic effects.

The researchers suggest that these new study results indicate that nautral psilocybin extracts may offer unique therapeutic effects that may not be not achievable with synthesised, single-compound psilocybin alone. 

Metabolomic analyses also revealed that the natural extract exhibited a distinct metabolic profile associated with oxidative stress and energy production pathways.

The researchers write: “In Western medicine, there has historically been a preference for isolating active compounds rather than utilising extracts, primarily for the sake of gaining better control over dosages and anticipating known effects during treatment. The challenge with working with extracts lay in the inability, in the past, to consistently produce the exact product with a consistent compound profile. 

“Contrastingly, ancient medicinal practices, particularly those attributing therapeutic benefits to psychedelic medicine, embraced the use of extracts or entire products, such as consuming the entire mushroom. Although Western medicine has long recognised the “entourage” effect associated with whole extracts, the significance of this approach has gained recent prominence.”

However, compared to cannabis, the researchers suggest that mushroom extracts present a unique case, as they are highly influenced by their growing environment such as substrate, light exposure temperature and more.

“Despite these influences, controlled cultivation allows for the taming of mushrooms, enabling the production of a replicable extract,” the team writes.

The researchers emphasise that this research underscores the superiority of extracts with diverse compounds, and also highlights the feasibility of incorporating them into Western medicine due to the controlled nature of mushroom cultivation.

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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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