Latest news with #psychedelic
Forbes
2 days ago
- Health
- Forbes
Germany Approves EU's First Psilocybin Access Program
Germany has become the first country in the European Union to allow access to a psychedelic for a limited number of patients under strict conditions. The country's drug regulator, the Federal Institute for Drugs and Medical Devices (BfArM), has given the green light for two medical facilities to offer psilocybin to adults with treatment-resistant depression. Depression is one of the most common mental illnesses in Germany, affecting around 5.3 million people. Up to a third of cases are considered to be "treatment-resistant', meaning the individual hasn't responded adequately to conventional treatments. In recent years, scientific research has pointed to psilocybin—the active ingredient found in certain types of mushrooms—as a promising treatment for this type of depression, along with other psychiatric conditions. While no drugs containing psilocybin are currently authorized for use in Germany or the EU, the Expanded Access Program enables the use of as-yet-unapproved drugs in patients suffering from serious or life-threatening illnesses. Under the direction of Professor Gerhard Gründer, head of the department of molecular neuroimaging at the Central Institute of Mental Health (CIMH), individual patients in Mannheim and Berlin will be able to receive the drug in justified exceptional cases. Prof Gründer, who successfully made the application, said in a statement: 'In selected individual cases, the therapeutic use of psilocybin as part of a Compassionate Use Program can be a medically and ethically justifiable option, provided it is carried out under strictly controlled conditions and with careful medical supervision.' Very few such programs for psilocybin have been established worldwide, with Germany's model expected to be similar to those operating in Switzerland and Canada. While Switzerland is a European neighbour of Germany, it is not a member of the EU, and regulations allowing the legal use of psilocybin, MDMA, and LSD in certain cases were introduced in 2014. Demand Expected To Exceed Supply A botanical psilocybin drug candidate known as PEX010, will be provided by Canadian company Filament Health, which also supplies the vast majority of psilocybin prescribed under Canada's Special Access Program. The drug will be administered to patients at the CIMH in Mannheim and the OVID Clinic in Berlin, on an inpatient basis only, and in combination with psychotherapy, to help patients 'release rigid thought patterns, promote new insights, perspectives, and behaviors, and improve depressive symptoms'. Announcing the news in a press release, Benjamin Lightburn, co-founder and chief executive officer at Filament Health, commented: 'The approval of PEX010 for this milestone moment in European psilocybin access reinforces Filament's position as the world's leading supplier of GMP-quality psychedelic drug candidates. 'We're incredibly proud that our drug product will be the first psilocybin to be administered under compassionate use in the EU. It's a validation of Filament's ongoing efforts to make safe, standardized psychedelic medicines available to those who need them most.' However, while an 'enormously important step', compassionate access programs are not thought to be a suitable substitute for the wider regulatory approval, and demand is expected to 'far exceed supply'. 'Experience from Switzerland shows that demand far exceeds the available supply. This is also likely to be the case in Germany,' continues Gründer 'A Compassionate Use Program cannot replace approval. We must therefore continue to work on bringing psychedelics such as psilocybin into standard care for the treatment of mental illness.' Legitimizing Psychedelic Medicine Elsewhere in Europe, the Czech Republic has also taken steps to legalize the therapeutic use of psilocybin. On 30th May, the lower house of the country's parliament passed an amendment to allow the use of psilocybin in psychiatric hospitals and clinics from 2026. If passed in the senate, this would make the Czech Republic the first EU country to legally regulate the treatment for medical use. Meanwhile, the UK has recently seen a potentially significant policy shift, with the government backing a proposal put forward by the Advisory Council on the Misuse of Drugs to remove the requirement for research licences when studying Schedule 1 drugs such as psilocybin and MDMA. Josh Hardman, founder and editor of media and consultancy firm, Psychedelic Alpha, said over email that while Germany's program may be limited in scope, it could be significant for 'legitimizing' psychedelic medicine and influencing wider regulatory change across Europe. 'While the program might only reach up to around 50 patients in its first year, the significance of the German regulator's decision should not be lost on people,' says Hardman. 'The country now joins Switzerland in allowing certain European patients to access psilocybin when they have exhausted other options. What's more, the imprimatur of Swiss engineering and German efficiency and process focus could add to psychedelic medicine's legitimacy both in Europe and beyond.' He adds: 'I have spoken with the architects of this compassionate use program and am encouraged to hear that they are keen to collect and share data from the project. Such real-world data and learnings would be very useful for the field. If those experiences are broadly positive, other EU member states might consider joining.'
Daily Mail
6 days ago
- Health
- Daily Mail
Tragic new details of mum's 'magic mushroom death' revealed
A woman who passed away after drinking tea laced with magic mushrooms had been dabbling with the psychedelic fungi for years before she is believed to have died of 'wood-lover paralysis'. New details on the tragic death of personal trainer Rachael Dixon can now be revealed after the findings of a coronial investigation were made public. Ms Dixon, 52, collapsed hours after ingesting the toxic drink during a retreat hosted by self-proclaimed healer Deanne Mathews at Soulbarn in Clunes, near Ballarat, on April 13 last year. In delivering her findings, Coroner Audrey Jamieson stated that although she could not be certain the drink killed Ms Dixon, she believed it likely contributed to her death via a rare condition related to the mushrooms. Australian Psychedelic Society Doctor Simon Beck told the coroner he believed Ms Dixon's cause of death appeared consistent with symptoms linked to wood-lover paralysis toxidrome. Studies into the condition found those affected can start to become weak anywhere between 10 minutes to 18 hours after consuming the mushrooms. The weakness usually affects the limbs, and manifests at times in an inability to stand or walk, difficulty swallowing, or breathing difficulties. In some cases, the weakness came in 'waves', the study found. The court heard Ms Dixon had been 'very excited to go to the retreat', with her son telling the court she told him 'she thought this was going to be her big breakthrough moment'. Ms Dixon had struggled with her mental health for years, but had been reluctant to use prescribed medications to deal with it, the court heard. 'Rachael attributed her mental ill health to unresolved childhood trauma,' the coroner stated. 'There is no evidence that Rachael attended a medical practitioner, had received a diagnosis or was prescribed medication to manage the same. Indeed, (her son) recalled that Rachael was averse to pharmaceutical and recreational drugs.' Instead, Ms Dixon medicated herself with alcohol before turning to magic mushrooms. 'Even though Rachael was against drugs, (her son) believes that she saw 'magic mushrooms' as 'a natural thing'. In the years leading up to her death, Rachael experimented increasingly with magic mushrooms,' Coroner Jamieson stated. The court heard Ms Dixon met Ms Mathews to 'learn Reiki and to heal' about eight years before her death. In a booklet, Ms Dixon wrote that her primary goal was 'no binge drinking alcohol and food'. The court heard she perceived psilocybin - the active compound in magic mushrooms - as a 'means to address and resolve her childhood trauma'. 'Evidence indicates that Deanne coached and guided Rachael through microdosing, including on one occasion, instructing her to consume more psilocybin during a microdosing session,' the coroner stated. On the day of the fatal 'healing session' the court heard Mathews sourced the magic mushrooms for the group and ground them into a powder. Participants began the ritual by ingesting blue lotus, to help 'relax the body in preparation for the journey', the court heard. They consumed rice with a 'small sprinkle' of mushroom and performed a round of breath work before consuming the mushroom tea. A second cup of tea was consumed about 90 minutes later. The court heard Ms Dixon was no stranger to the sessions and had attended one with Mathews at Soulbarn every three months in the last 18 months of her life. According to Mathews, Ms Dixon had consumed the mushrooms on each occasion 'without any problem'. But Ms Dixon's son told the court he recalled differently. 'According to him, Rachael told him about her most recent experience at Soulbarn: she said she had a bad experience, went to a dark place, and didn't feel great afterwards. Rachael believed this was because "they had upped her dose of psilocybin",' the coroner stated. But Ms Dixon mostly believed that the mushrooms were helping her with her problems. 'I think they were definitely helping her, she seemed to be getting better,' her son told the court. 'I knew she was getting better because she would stop drinking as much, she would always tell me how relaxed and how much better she felt within herself and about life.' At the commencement of the deadly session, a fellow participant noticed that 'Rachael was on a high, she was welcoming others and giving them hugs'. She repeated her intention of: 'I'm meeting myself, I'm going home', the court heard. At about 6.15pm, she consumed her first serve of mushroom tea, and at 7.45pm, consumed the second from a small bowl with a spoon. At about 11.30pm, participants noticed Ms Dixon was under the effect of the tea. The court heard Ms Dixon called out to Mathews and 'was crying'. 'Deanne comforted her and noticed she remained 'under the effect of the mushroom',' the coroner stated. 'Deanne attempted to lift Rachael to her feet however, she could not walk. Another participant tried to assist Deanne, however, Rachael fell – "it was a decent fall" from approximately 50 centimetres height.' The court heard Mathews formed the belief that Ms Dixon simply 'needed some fresh air' and so moved her to the kitchen and opened the back door to let in 'fresh cold air'. 'There is little evidence from other participants regarding the events of the evening – noting that they were under the influence of psychedelics at the time,' the coroner found. 'One participant recalls that at approximately 11.20pm, she heard Rachael say "help".' While paramedics were called at 11.53pm, the court heard Mathews made no mention of magic mushrooms being consumed. 'I was holding a ceremony and I don't think someone, she's not responding,' she told the emergency operator. When asked 'do you know what happened to her?', Mathews replied 'I don't know, she was just saying she couldn't breathe', the court heard. 'Deanne was "not too sure" if Rachael was breathing and was instructed to commence cardiopulmonary resuscitation,' the coroner stated. At about 12.45am, paramedics declared Ms Dixon deceased. A police search of Ms Dixon's home later found a small container with vegetative substance – believed to be mushrooms. A booklet supplied by Mathews, titled The Deep Self 28 Day Microdosing Experience, was found next to it. Forensic experts told the coroner there was no post-mortem evidence of any injuries which may have caused or contributed to Ms Dixon's death. On November 18 last year Victoria Police arrested Matthews in relation to trafficking in a drug of dependence. She was formally interviewed and released pending summons to appear at court. On March 13 she appeared before the Bacchus Marsh Magistrates' Court where she was found guilty. She received a fine of $3,000 but was not convicted. In concluding her findings, Coroner Jamieson noted expert observations that interest in and the use of magic mushrooms were on the rise here and internationally, driven in part by developments such as Australia legalising the prescription of psilocybin to treat certain conditions in 2023. 'This raises a concerning possibility that Victorian coroners will encounter more deaths in a setting of magic mushroom use in future. Indeed, this may already be occurring,' she stated. 'People have used magic mushrooms for a broad range of reasons for (at least) decades in Australia, despite any laws prohibiting this, and I am not so naïve as to believe I could propose any interventions that would change this reality.' While the coroner made no formal recommendations, she warned people to be aware of the possible dangers around consuming magic mushrooms. 'I have concluded that at present the most appropriate intervention to consider is user education,' the coroner stated. 'People who use magic mushrooms and/or (as in the retreat Rachael attended) facilitate others' use of magic mushrooms should be aware that, even if rare, harms including deaths have been associated with magic mushroom consumption, and if possible, they should put measures in place to recognise and respond to these harms if they occur.'
Yahoo
30-07-2025
- Business
- Yahoo
Clearmind Medicine Files International Patent Application for Novel Combination Therapy Targeting Weight Loss and Fatty Liver Disease
Vancouver, Canada, July 30, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) ('Clearmind' or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced the filing of a new international patent application under the Patent Cooperation Treaty (PCT). The application covers its innovative combination therapy of MEAI (5-methoxy-2-aminoindane and N-Acylethanolamines) and Palmitoylethanolamide (PEA). This proprietary combination is designed to address two significant global health challenges: obesity and metabolic dysfunction-associated steatotic liver disease (MASLD). According to the World Health Organization, obesity affects over 890 million people worldwide and is a leading risk factor for a range of chronic conditions. Meanwhile, non-alcoholic fatty liver disease (NAFLD), which is closely linked to metabolic disorders and poor long-term outcomes, is estimated to impact more than 30% of the global adult population. Despite the scale of these problems, treatment options remain limited. The Company believes that its novel approach has the potential to offer a safe and effective therapeutic alternative, leveraging the unique pharmacological profile of MEAI alongside the anti-inflammatory and neuroprotective properties of PEA. This patent filing is part of Clearmind's ongoing collaboration with SciSparc Ltd. (Nasdaq: SPRC), a clinical-stage specialty pharmaceutical company developing therapies for central nervous system disorders. 'Our goal is to bring meaningful innovation to areas with high unmet medical need,' said Dr. Adi Zuloff-Shani, CEO of Clearmind. 'This patent filing reflects our commitment to developing novel, science-backed treatments that can potentially improve the lives of millions struggling with obesity and fatty liver disease.' About Clearmind Medicine Inc. Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The Company's intellectual portfolio currently consists of nineteen patent families including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol 'CWY0.' For further information visit: or contact: Investor Relationsinvest@ Telephone: (604) 260-1566US: CMND@ General InquiriesInfo@ Forward-Looking Statements: This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as 'expects,' 'anticipates,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates' and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its belief that its novel approach of the combination therapy of MEAI and PEA has the potential to offer a safe and effective therapeutic alternative, its goal to to bring meaningful innovation to areas with high unmet medical need and its commitment to developing novel, science-backed treatments that can potentially improve the lives of millions struggling with obesity and fatty liver disease. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ('SEC'), including, but not limited to, the risks detailed in the Company's annual report on Form 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.
Irish Times
29-07-2025
- Entertainment
- Irish Times
Pan by Michael Clune: Surreal, mind-bending tale of teenagerhood
Pan Author : Michael Clune ISBN-13 : 978-1911717614 Publisher : Fern Press Guideline Price : £16.99 'Spring is panic's season,' writes Michael Clune near the beginning of his hallucinatory novel, Pan. 'But panic, as I was to learn, isn't a disease of death. It's a disease of life.' A dense, boundary-pushing and increasingly psychedelic book that draws you into its peculiar world – much like the experience of panic itself – Clune's debut wrestles with the elusive experience of consciousness (what it 'feels like' to have thoughts) and uses malleable teenage minds to do so. It's narrated in the first-person by 15-year-old Nick, forced at the novel's start to move in with his late-shift-working father to where he lives near Chicago: Chariot Courts, the 'cheapest place in all of Libertyville'. At school Nick is mostly concerned with being cool and maintaining his 'bad-ass' reputation. But the sudden onset of panic attacks – the opposite of 'cool' – threatens to derail his standing. They crescendo just as the most popular kids in school, Tod (whose personality 'floated just out of reach') and the open-minded, beautiful Sarah, subsume Nick and his best friend Ty into their gang. READ MORE Together, they develop theories around Nick's panic attacks: that they are 'fear aroused by the presence of a god' – namely, the Greek god Pan – and that 'your consciousness gets so strong it actually leaps out of your mind entirely'. They celebrate 'Belt Day' (surely Beltaine) either to expel Pan, or surrender themselves to him. Yet the clan's drug-fuelled revelry and fanatic ideas begin to take a more sinister turn. Fusing elements of beat poetry, Greek philosophy and existentialism through the prism of American high school stories like Dazed and Confused, The Breakfast Club or SE Hinton's The Outsiders, Pan is a deliberately non-naturalistic portrayal of adolescence. The novel is rife with far-fetched theories about prophecy, age and perception, but studded with more attuned, grounded observations about class, work and family. The Ireland-born, Chicago-bred Clune is the author of two award-winning memoirs, White Out (a deep-dive into the heroin underground) and Gamelife (about gaming as a child); his two concerns, childhood and consciousness, are married here. A surreal, if slightly unwieldy, portrayal of teenagerhood, this mind-bending book is anchored by Clune's effortless, masterful humour: the result is not only an impressive debut, but a gargantuan feat in coming-of-age literature.
Washington Post
26-07-2025
- Entertainment
- Washington Post
‘Pan' is funny, insightful and a little unhinged
On the face of it, Michael Clune's 'Pan' appears to traverse rather straightforward territory. At the dawn of the 1990s, a teenage boy in a Midwestern suburb is sent to live with his father after his parents' divorce. He begins to suffer panic attacks. He meets new friends, starts experimenting with drugs in a secluded hayloft he and those friends refer to as 'the barn,' and … well, to describe it any further in those terms would be a complete violation of what 'Pan' is actually about. Clune's vision here is essentially religious, and I don't mean religious in the way that Flannery O'Connor was a Catholic writer or Isaac Bashevis Singer was a Jewish one. I mean, rather, that 'Pan' is saturated with a grand, psychedelic spirit, the sort of holy mania one finds in writers like William Blake or Christopher Smart. The effect, to the extent one can refer to it as merely an 'effect,' is dazzling. Clune, a celebrated memoirist, delivers with 'Pan' a debut novel that is at once startlingly funny and radiantly — if here and there a little perplexingly — strange. The prose is colloquial and direct — Clune's narrator, Nick, is 15 and speaks the argot of an ordinary teenager — and yet somehow everywhere Nick's eye alights the world feels like it's being flayed bare. In a classroom, he notes: 'Winter in Illinois, the flesh comes off the bones, what did we need geometry for? We could look at the naked angles of the trees, the circles in the sky at night. At noon we could look at our own faces. All the basic shapes were there, in bone.' It's a mood, and a style, that could easily become exhausting if it were not so perfectly matched not just to Nick's panic attacks but to the mock-heroic register of adolescence in general. Because it is, Nick's encounters with teenage effluvia take on a revelatory intensity: Boston's 'More Than a Feeling' is 'just a quiet glitter of melody, a whisper of rhythm. Like a glass man, striding alongside the car, bones tinkling'; at his after-school job at Ace Hardware, he looks to avoid 'the three stigmata of idleness … the hanging hands, the half-open mouth, the unfocused eyes.' It's tempting to say that nothing much happens in this novel, but for the fact that everything that does happen is charged with so much fearsome grandeur that even the book's micro-movements feel operatic. Whatever 'Pan' might lack in terms of old-fashioned narrative mechanics, it more than makes up for in humor, particularity and what I am forced to refer to simply as meaning. Nick comes to believe that his panic attacks are not merely medical events but rather instances when he is being possessed by the spirit of the Greek god Pan. This rather baroque conceit is not so much a matter of plot — whether he is or isn't ultimately seems beside the point — but it thoroughly destabilizes any attempt to read 'Pan' through a modish lens of mental health or disability. 'Because a panic attack doesn't feel like a panic attack,' Nick observes at one point. 'It feels like insight.' Insight, indeed, is what 'Pan' offers in spades, and part of what makes it so delicious is the way it mulches up both the familiar materials of millennial adolescence ('Gilligan's Island' reruns, crappy after-school jobs, the video game 'Ghosts 'n Goblins') and more esoteric ones ('Ivanhoe,' Giovanni Bellini's painting 'Drunkenness of Noah,' a fantasy novel called 'Nifft the Lean') into something that feels at once semi-typically earthy and decidedly cosmic, at times very nearly unhinged. This quality of insight is what art is for, but it is so rare at this point that 'Pan' feels almost like a work of outsider art. Ultimately, it's not, but the novel's brilliant intensity is such that it grows difficult to describe or boil down to its constituent parts. When Nick's friend Ian unpacks a theory of what he calls 'Solid Mind' ('when your thoughts flow in grooves, built deep into your brain. You don't even notice them') it feels both like the hilarious, weed-addled invention of almost any suburban teenager and like an intense theory of cognitive behavior that might belong to this book alone. It's a doubleness that makes Clune's novel approachable and inviting but also wild enough to seem practically avant-garde. Perhaps that's a quality not all readers will be inclined to prize — 'Pan' might be expressionist enough to disorient a traditional reader yet formalist enough to frustrate an avant-gardist. But for those who wonder if the American novel has anything new to offer (and perhaps for those who, rather tediously, have chosen lately to litigate the question of whether novels have abandoned male experience and male readers), 'Pan' is exhilarating, a pure joy — and a sheer, nerve-curdling terror — from end to end. Matthew Specktor is the author, most recently, of 'The Golden Hour.'
