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Media Report: EU bodies provide perspective on regulation of psychedelics

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Psychedelic Health UK report

In what marks an important development for Europe, a number of EU bodies have published a joint commentary in the world-leading medical journal, The Lancet, acknowledging the therapeutic potential of psychedelics. 

The European Medicines Agency (EMA), experts from the EU regulatory network and representatives from the European College of Neuropsychopharmacology (ECNP) have jointly issued the commentary.

Entitled ‘The Therapeutic Potential of Psychedelics: The European Regulatory Perspective’, the commentary explores classic psychedelics specifically – mescaline, DMT, LSD and psilocybin – as potential treatments for mental health conditions. 

See also  PAREA 2023: campaigning for psychedelic therapy in Europe 

The authors highlight that, with mental health problems affecting more than one in six people, this brings considerable economic costs that exceed 4% of gross domestic product across the EU. In this regard, they emphasise the need for effective and safe new treatments for mental disorders.

Exploring a number of challenges that will need to be addressed, the authors raise issues informed by work for the EMA, the EMA’s Central Nervous System Working Party and the ECNP.

See also  Discussing Alberta’s move to regulate psychedelic therapy

The Psychedelic Access and Research European Alliance (PAREA) has welcomed the development, which it describes as an “opportunity to open up an institutional debate about moving towards safe, effective and accessible adoption of psychedelic-assisted therapies in Europe.”

Research and clinical trials

Some of the key issues addressed by the authors include challenges with research methodology to enable valid efficacy estimations in clinical trials. 

The authors cover double blinding, the roles of positive and negative expectancy, and the use of independent, blinded external raters (including psychedelic naive patients).

Additionally, the need for investigation to establish optimum doses of psychedelics and individualised dosing, along with the relation between characteristics of the acute psychedelic experience and clinical improvement, are highlighted.

Regarding psychedelic-assisted psychotherapies, the authors note the need for trials to establish the added value of psychedelics compared with psychotherapy or psychological support alone, and that preparatory psychotherapy sessions should be investigated.

Barriers to research in Europe

Classic psychedelics all sit in Schedule 1 of the UN’s Convention on Psychotropic Substances of 1971, meaning it is currently extremely difficult to carry out research into the substances due to the costs associated with licensing.

The authors highlight this as another issue that needs to be addressed, suggesting that the UN’s classification of the substances may need to change due to their potential as a therapeutic, along with the fact that they do not show potential for addiction – one of the criteria a substance must meet to be classified in Schedule 1 of the Convention.

The authors state: “Classic psychedelics do not show potential for addiction and the justification for the UN schedule 1 classification (ie, drugs with “no currently accepted medical use and a high potential for abuse”), as adopted in the 1971 Convention on Psychotropic Substances, should be questioned by evidence of the therapeutic potential of psychedelics.”

Tadeusz Hawrot, Founder and Executive Director of PAREA, told Psychedelic Health: “The most restrictive scheduling of psychedelic compounds directly contributed to and reinforced a long scientific stagnation by detracting scientists from conducting research in this area. 

“Likewise, European governments and EU bodies have been discouraged from supporting psychedelics research. This lack of public funding has been further undermining the ability to pursue psychedelics research, especially for those scientists who are less resourced and are not affiliated with the industry. 

“Consequently, companies and private donors typically fund psychedelic trials and the regulatory constraints and patent incentives create a pharmaceutical landscape that privileges high-cost synthetic variants over existing substances.

“Relying predominantly on industry-supported research to achieve the regulatory approval is not an equitable solution to rescheduling psychedelics with medicinal properties and yet, currently approval of scheduled medicines (by regulators such as EMA) and rescheduling are effectively synonymous. 

“Psychedelics should have their classifications reviewed based on the recent scientific and medical progress, independent of their possible regulatory approval as medicines. The support from The Lancet commentary authors in this regard is much welcome.”

Regulating psychedelic therapy

As symbolised by recent developments – such as Australia’s rescheduling of MDMA and psilocybin for depression and PTSD, Canada’s inclusion of the latter on its Special Access Programme (SAP) and Colorado and Alberta’s moves to decriminalise psychedelics – the need to address regulation around psychedelics is becoming increasingly important. 

Under Australia’s new approach, any psychiatrist looking to prescribe psychedelic therapies will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.

In their Lancet commentary, the authors stipulate that given approval, regulation around psychedelics in Europe should see conditions and restrictions related to safe and effective use defined at the time of approval, and monitoring requirements in place before, during, and after administration of the substances.

Regulatory tools that could facilitate this include product characteristics, risk management plans and pharmacovigilance studies, along with educational materials, appropriate training and controlled access programmes.

The authors conclude: “The therapeutic potential of psychedelics has triggered new hopes and high expectations, but larger clinical trials are needed to further evaluate efficacy and safety. 

“A thorough scientific assessment of the benefit–risk balance will be required, as for any other medicines. 

“Developers are encouraged to engage early with the EMA through all available scientific and regulatory platforms in their efforts to overcome the challenges associated with the development of psychedelic treatments.”

Source:  https://psychedelichealth.co.uk/2023/02/15/eu-bodies-perspective-regulation-psychedelics/



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Paper 24 October 2024: Expert recommendations for Germany’s integration of psychedelic-assisted therapy

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Psychedelic-assisted therapy (PAT) is a modality of mental health treatment that merges psychotherapeutic interventions with psychedelic states, often facilitated by substances such as lysergic acid diethylamide (LSD), psilocybin, and 3,4-Methylenedioxy-methamphetamine (MDMA). The latter two being in phase III trials. Whereas MDMA is considered an entactogen that enhances self-awareness and emotional connectivity, psilocybin is a naturally occurring psychedelic compound found in certain mushrooms. Recent research suggests that these and other psychedelics, all small molecules, most with benzene or phenyl rings, uniquely work by reopening a “critical period” in the brain, allowing for new learning within social contexts in a process involving changes in brain plasticity and oxytocin signaling [1]. Despite their classification as a Schedule I drugs under the Controlled Substances Act by the Drug Enforcement Agency (DEA) in the United States, their therapeutic potential has been increasingly recognized, with demands from the public to make them available for those with treatment resistant conditions. These among other developments resulted in MDMA being granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of treatment-resistant PTSD (TR-PTSD) in phase II, (phase III studies were for ‘moderate to severe’ PTSD). Psilocybin (COMP360) and a deuterated psilocybin analogue (CYB003) were granted FDA Breakthrough Therapy designation for treatment resistant depression (TRD) [2,3,4].

Methodologically rigorous clinical research suggests that PAT may offer substantial long-term alleviation of symptoms in patients suffering from psychopathologies such as PTSD, TRD, major depressive disorder (MDD), end of life anxiety, obsessive–compulsive disorder (OCD), substance use disorders (SUD), psychotic conditions, and more [56]. Notably, a single session of substance-assisted therapy has been reported to lead to significant symptom reduction, with some patients achieving remission that can persist for at least twelve months [7]. This enduring effect underscores the potential of psychedelic-assisted therapy in providing therapeutic outcomes that are significantly superior to antidepressant medications such as SSRIs, which often have poor efficacy rates and unwanted side-effects such as agitation, weight gain, sexual performance difficulties, gastrointestinal issues, and other symptoms [18].

In February 2024, Lykos (formerly MAPS PBC) submitted a new drug application (NDA) to the FDA for MDMA (Midomafetamine) capsules in combination with psychotherapy for the treatment of PTSD [9]. Following the submission, a citizen petition was filed, raising concerns about the integrity of the clinical trials. This prompted the FDA to convene an advisory board meeting in June 2024 to review the claims. The petition raised several issues, including alleged bias in the trial design, inadequate sample diversity, insufficient double-blinding, underreporting of adverse events such as sexual misconduct, and confusion regarding the integration of psychotherapy within the study design [10]. Despite the principal view that MDMA trials are sound, and even the FDA’s participation in the creation and oversight of the studies these concerns influenced the FDA’s review process. Subsequently, in August 2024, the FDA issued a final decision rejecting the NDA under the Prescription Drug User Fee Act (PDUFA). It is important to note however that the FDA encouraged ongoing MDMA research and asked for another Phase III trial.

This decision led to additional actions, including the Journal of Psychopharmacology retracting three articles related to the MDMA clinical trials conducted by the MAPS research team and the initiation of an FDA investigation. Lykos has since filed for a reevaluation of their NDA. If approved, MDMA would become the first psychedelic-assisted therapy officially recognized in the United States.

As unexpected as the August 2024 rejection of the application by Lykos for approval of MDMA was for some, the hope based on the phase II studies, remains that either MDMA or psilocybin will within the next two to three years receive a positive evaluation from the FDA although the exact timing remains unknown. Unlike the MDMA trials, where the FDA was initially satisfied with the blinding process prior to the advisory board meeting, Compass’ psilocybin trials were designed to minimize the unblinding caused by psychotropic effects, following the FDA’s advice to their satisfaction until this day.

Lykos and Compass have been the two major companies driving development, and although Lykos has yet to submit a new phase III proposal, Compass continues with their phase III clinical trial. In general enthusiasm in the field for further research continues as there remains a need for novel treatments, and despite the uncertainty, the FDA seems generally favorable toward psychedelic medicine [10].

This paper outlines the current and required infrastructure for the successful integration of PAT, including rescheduling of psychedelic drugs beyond ketamine, accessibility, reimbursement strategies, accreditation of practitioners, ethical considerations and educational requirements. The role of the German government and affiliated agencies is pivotal in shaping this framework, ensuring that the setup not only complies with regulatory standards but also supports the ethical deployment of these therapies.

Moreover, with the European Medicines Agency (EMA) currently deliberating on the integration of psychedelics within the European framework, Germany has a unique opportunity to lead by example, showcasing a meticulous approach to the adoption of psychedelic-assisted therapies and must therefore also prepare to accommodate these innovative treatments [11]. This could serve as a model for other European nations, promoting a harmonized approach to these promising treatments across the continent.

The first half of this paper covers the regulatory environment in Germany, as it is impossible to understand the steps required to make PAT a reality without some in-depth understanding of the country’s unique health care system. The second half of this paper covers the German provision of outpatient mental healthcare and how and where PAT would fit and critically, proposes a training scheme for the education of PAT facilitators.

Historical roots of psychedelics in Germany

Psychedelic research in Germany harkens back to the 1910s and 1920s when the atypical psychedelic MDMA was first synthesized, and pioneering research was being conducted on the properties of mescaline. During this early period, Beringer and colleagues [12] saw in mescaline and similar substances, an opportunity to explore the phenomenology of psychopathology, creating what they described as ‘model psychoses.’ Although problematic in many ways, this stream of research opened up a new dimension of empathy and understanding into the experience of individuals with chronic psychosis [13]. In fact, the research carried out at the University of Heidelberg, culminating in Beringer’s habilitation thesis “Der Meskalinrausch” from 1927, can be considered the first major work in the field of psychedelic psychopharmacology in the West [12]. Another noteworthy event in the history of psychedelic drugs in German-speaking Europe is Albert Hoffman’s accidental discovery of the properties of lysergic acid diethylamide (LSD) on April 19, 1943, which accelerated interest in psychedelic compounds throughout the Western world [14]. In particular, this landmark event led to the widespread experimental use of psychedelics for a diverse range of psychiatric conditions across Europe and North America.

This period of research during the 1950s and 1960s, though short-lived, would later become known as the first wave of psychedelic research [1415]. During this brief moment in history, Betty Eisner, a German-educated American, first described the implementation of low-dose LSD in combination with psychotherapy, making a major contribution in the field which still today remains underrecognized [16]. Margot Cutner, a German psychoanalyst who was leading psychedelic research in England after fleeing from the Nazis, provided some of the first insights on the relevance of the role of the facilitator in psychedelic-assisted therapy (PAT) and the now well-known notion of ‘set and setting’ [16]. Following this, Hanscarl Leuner coined the term “psycholytic therapy” at the University of Göttingen underscoring the drug’s therapeutic potential in a sub-threshold dose range [17]. Despite Leuner and colleagues’ extensive research on LSD being among the most comprehensive bodies of work on the topic to date, it has been largely neglected until recently due to never being published in English [18].

A surprising turn of events occurred when in 1961, the United States passed the seemingly politically motivated US Controlled Substances Act, which resulted in an immediate and indefinite suspension of psychedelic research throughout the U.S. Europe was quick to follow suit, and psychedelics became labeled as potentially dangerous and addictive with no accepted medical use [19]. Subsequently, despite early breakthroughs and extensive research, these restrictions ushered in a prohibition era that would last decades, hampering progress and limiting the exploration of psychedelic compounds throughout the Western world. Germany was no exception, and psychedelic treatments now being championed for their therapeutic potential were outlawed.

Economic burden of treating PTSD and depression in Germany

The economic and human costs of PTSD and depression in Germany highlight an urgent need for more effective interventions [20]. Trauma-related healthcare costs range from 524.5 million to 3.3 billion euros annually [21], while depression adds another 1 to 5.2 billion euros [2223]. Current pharmaceutical treatments, such as serotonin-reuptake inhibitors (SSRI), offer limited efficacy and fail to fully address the needs of individuals with PTSD, depression, or their comorbidities [24].

A recent study of German insurance claims highlighted both the direct and indirect costs of PTSD (ICD-10-GM F43.1) [2021]. PTSD patients typically suffer for about 6 years, with a 50–100% likelihood of comorbid conditions such as major depressive disorder (MDD), panic disorder, and substance use disorder (SUD). Per-patient costs were 43,000 EUR, three times higher than for those without PTSD, driven by increased healthcare utilization, impaired work capacity and reduced quality of life. PTSD also accounts for approximately 200,000 Disability-Adjusted Life Years (DALYs) annually in Germany, a metric that reflects both premature mortality and years lived with disability, quantifying the overall burden of disease [25].

Similarly, depression carries significant economic burdens with indirect costs from labor absenteeism, social benefits, and prevention measures estimated at 10 to 16 billion euros annually, surpassing direct healthcare costs [2627]. Depression accounts for approximately 470,000 DALYs in Germany [28], while globally, PTSD contributes an additional 3 million DALYs, underscoring its substantial public health impact.

In short, PTSD and depression remain conditions with a high unmet need. SSRIs, first introduced in 1988 (fluoxetine), are still the primary pharmaceutical treatment for many psychological disorders, despite their limited efficacy and adverse side effects, including symptom exacerbation and suicidal thoughts [29].

Regulatory landscape

The European Medicines Agency (EMA) grants marketing authorization for new medicines across the EU. The sponsor of the medication submits an application for approval to the EMA following phase III trials, and after EMA approval, marketing authorization is granted, which allows the medication to be sold in all European Union member states. Sponsors then must decide which member states they wish to enter, as, even if the Sponsor has marketing authorization, each EU state has its own rules about how health insurers will be reimbursed for new medications. European member states furthermore have country specific processes and infrastructure around the provision of therapeutic services which are an essential part of PAT.

In Germany, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) oversees both clinical trial approval (pre- and post-EMA approval) and the documentation as well as considerations related to safety, efficacy, and quality, and specific labeling requirements tailored to the German context (Fig. 1).

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https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-06141-3?utm_medium=email&_hsmi=97789529&utm_content=97789529&utm_source=hs_email



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Jacobin Article: “Nationalize Psychedelics” | Cannabis Law Report

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Here’s the introduction

here were high hopes that MDMA-assisted therapy would be approved by US regulators in 2024. The data showed that the drug-therapy combo significantly reduces post-traumatic stress disorder (PTSD) symptoms, or even eases them completely — despite a strong placebo effect in the trials, which involved well under a thousand participants. When the study data was published in September 2023, the New York Times reported that MDMA-assisted therapy was “inching closer to approval.” But in an August ruling that came as a wake-up call to figures in the nascent psychedelic industry as well as an underlying psychedelic movement made up of a hodgepodge of campaigners, the Food and Drug Administration (FDA) declined to give the green light, citing a lack of convincing clinical evidence and issues with the studies. The FDA requested further data from a new study, which would take several years, marking a significant setback for the prospect of medical psychedelics.

As early as 2026, however, the FDA will likely have another opportunity to approve another psychedelic drug for Americans with depression — psilocybin, which is derived from magic mushrooms — depending on the results of late-stage research. Even if it does pass, the therapy will likely not be immediately covered by insurance and so will remain beyond the reach of most Americans. This reality, plus the fact that psychedelics are meant to make you feel more interconnected (and thus perhaps less likely to want to squeeze profits from your peers), raises an intriguing possibility: that the psychedelics industry could be nationalized for the public good.

“Psychedelics, like pharmaceutical products, are just going to be inaccessible to many, many people,” says Professor Susi Geiger, a patent expert from University College Dublin. Step one to ensuring equitable access, and giving hospitals some respite from the straightjacket that often forces them to pay well over the odds for drugs, is reforming a patent system that enables Big Pharma to hike prices on existing drugs cartel-style thanks to the monopolies they enjoy over their products. To prevent the far-out possibility of Google founder Sergey Brin controlling the price of certain psychedelic therapy protocols, Geiger suggests a complete moratorium on private patents over psychedelics. “That’s the equivalent of nationalizing it at the source and keeping it as a public good.”

The idea may sound utopian and raise more questions than it immediately solves, even if the US patent office got on board and Congress created a European-style semi-socialized health care system, free at the point of use. “How can we trust exclusive access through a national health service when the state has only previously handled access [to psychedelics] through prohibition and religious censorship?” asks Chris Byrnes, a patent attorney at CalyxLaw. Matt Brockmeier, counsel at Antithesis Law, says less charitably: “I don’t trust the federal government — this or any other administration — to oversee something as monumental as our collective consciousness. Their track record is abysmal; they ruin everything they so much as look at because of the influence of special interests, fraud, waste, abuse, outright corruption, and general incompetence.”

Read the full article

https://jacobin.com/2024/10/psychedelics-nationalization-psilocybin-mdma-therapy



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Canada -Chocolate bricks filled with magic mushrooms seized at Peace Bridge warehouse

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Members of U.S. Customs and Border Protection said they are continuing to investigate after several shipments of chocolate bricks filled with magic mushrooms were found at the Peace Bridge warehouse at the Port of Buffalo, New York.

In a news release, U.S. CBP said officers discovered “multiple commercial shipments” containing psilocybin, the chemical compound found in magic mushrooms, at the warehouse over the past 30 days.

The shipments were coming from Canada to the U.S.

“CBP officers working in the Peace Bridge cargo facility discovered multiple shipments manifested as ‘chocolate and other food preparations,’” the news release read.

“Upon further inspection of these shipments, it was discovered that the chocolate bricks contained psilocybin, a schedule 1 controlled substance.”

The chocolate bricks were “field tested” by officers and the substances tested positive for the “properties of psilocybin.”

According to the release, there were a total of 15 seizures with a weight of about 10 kilograms in the last 30 days.

The estimated street value of the drugs, officers said, is believed to be US$165,000.

https://www.cp24.com/news/canada/2024/10/11/chocolate-bricks-filled-with-magic-mushrooms-seized-at-peace-bridge-warehouse/



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