Law & Ethics: The Psychedelics Industry & Indigenous Peoples, A PBA Four-Part Series – Psychedelic Bar Association

Ever wondered what happens when you mix an Italian anthropologist, a mycologist with a Mohawk heritage, the last captive of the Comanches, an attorney specializing in psychedelic law, and a restorative justice wizard from DC? No, it’s not the start of a bar joke; it’s a powerhouse panel!

**Riccardo Vitale** is the Indiana Jones of anthropology, but instead of hunting treasures, he’s been navigating the human rights and climate change jungle in Latin America for 15 years. When he’s not advising the Union of Indigenous Yagé Medics in the Amazon, he’s probably chatting about his PhD from Cambridge.

**Keith Williams** is the mushroom whisperer you never knew you needed. With a PhD in educational studies and an M.Sc. in mycology, this Haudenosaunee (Mohawk) descendant is the Director of Research and Social Innovation at Ontario’s First Nations Technical Institute. His mission? To blend humanity’s relationship with nature, psychedelics, and traditional knowledge into a cocktail of wisdom.

**Troy Sia** might just be the coolest title holder around: the Last Captive of the Comanches. As an Eagle Priest and founder of the Sia Comanche Nation Ethno-Ornithological Initiative, he’s keeping the spirit and culture of the Comanche people soaring high while advocating for environmental action and restorative governance.

**Ariel Clark**, co-founder of Clark Howell LLP, is the legal eagle in the psychedelic and cannabis skies. She’s also a co-founder of the Psychedelic Bar Association and a UC Berkeley JD holder, battling for law reform and ethical business.

**Roman Haferd** is the justice league’s real-life hero in Washington DC, focusing on restorative justice



Reference: https://thepsychedelicbar.org/law-ethics-the-psychedelics-industry-indigenous-peoples-a-pba-four-part-series/


Published Date: None

Australië is een proeftuin voor therapeutisch mdma-gebruik: ‘Het is niet zo eenvoudig als een pilletje geven en klaar’

In a six-day extravaganza that’s part Hogwarts and part Woodstock, therapists are learning to become psychedelic guides at a workshop run by Mind Medicine Australia. Picture a woman lying on the floor, deep in a role-play exercise. Why? Because as of July 2023, Australia is the cool kid on the block, being the first country to legally prescribe MDMA and psilocybin for treating PTSD and depression. This isn’t your typical day at the office!

Emma Park, one of the attendees, swears by her own positive trips down the rabbit hole and wants to bring the magic to her practice. The globe is buzzing with research on psychedelic therapy, though not everyone’s ready to sip the Kool-Aid. Critics argue there’s more hype than hard proof, and the treatments aren’t a walk in the park.

Mind Medicine Australia, spearheaded by Peter Hunt and Tania de Jong, is front and center in making these trippy treatments legit. The therapy shows promise but isn’t cheap and there aren’t many licensed guides yet. So, in a quirky twist, a course is held in an old monastery where therapists practice with breathing exercises instead of actual psychedelics, thanks to legal red tape.

Psychiatrist Eli Kotler has a thorough approach: a prep stage, psychedelic babysitting, and aftercare. It’s like a trust fall exercise but on a much wilder ride. The bond between therapist and patient is key, and the sessions can get as intense as a finale of a reality TV show.

So, whether you’re a skeptic or a believer, Australia’s psychedelic journey is shaping up to be quite the trip!



Reference: https://www.nrc.nl/nieuws/2024/09/03/australie-is-een-proeftuin-voor-therapeutisch-mdma-gebruik-a4864455


Published Date: 2024-09-03

Biopharma deals highlight innovative approaches to treating neurological diseases

Hold onto your neurons, folks! The brain game just got a whole lot more interesting. Imagine a world where 3.4 billion brains are all crying out for help—well, that’s our world. But fear not, because big pharma is on the case!

Between December 2023 and June 2024, pharmaceutical companies decided to go all Sherlock Holmes on neurological conditions. AbbVie kicked things off by splashing $8.7 billion to buy Cerevel Therapeutics, ensuring their neuroscience pipeline got a serious upgrade. Not stopping there, they also teamed up with Gilgamesh Pharmaceuticals (no relation to the ancient king) to work on futuristic psychiatric treatments.

Meanwhile, Bristol Myers Squibb was not about to be outdone. They snapped up Karuna Therapeutics, getting their hands on KarXT, a promising treatment for schizophrenia and Alzheimer’s-related psychosis. Because who doesn’t want to corner the market on both memory loss and hallucinations?

The peak of the brainy bonanza came on May 13, 2024, when AbbVie and Gilgamesh threw $2 billion into the pot to create cutting-edge psychiatric therapies. Gilgamesh, the biotech wizard with an AI-powered platform, is crafting precision psychiatric treatments that hit mental disorders right where it hurts—the root causes. They’ve got some heavy hitters in development, including an NMDAR antagonist and a 5-HT2A receptor agonist, both in phase 2 trials for major depressive disorder.

AbbVie will lead the charge on developing next-gen neuroplastogens, giving Gilgamesh $65 million upfront, plus nearly $2 billion in potential milestones and some sweet royalties on net sales.

So, pop your popcorn and stay tuned, because the



Reference: https://www.nature.com/articles/d43747-024-00091-x


Published Date: None

Lykos Therapeutics Announces Appointments of Michael Mullette as Interim Chief Executive Officer and Dr. David Hough as Chief Medical Officer

Lykos Therapeutics is shaking up its management team like a snow globe. Amy Emerson, who’s been steering the ship for nearly a decade, is stepping down but sticking around as a senior advisor and Board Observer—think Yoda in a business suit. Enter Michael Mullette, the former COO with a resume that reads like a pharmaceutical Hall of Fame, thanks to his stints at Sanofi and Moderna, where he helped roll out the COVID-19 vaccine. He’s now the interim CEO.

Meanwhile, Dr. David Hough, a psychiatrist who probably has more degrees than a thermometer, is the new Chief Medical Officer. He’s bringing his A-game from Johnson & Johnson to oversee the clinical development of midomafetamine (MDMA), which they’re testing for PTSD treatment—no, it’s not approved yet, but fingers crossed!

Lykos, which sounds like it could be a Greek god but is actually a Public Benefit Corporation (PBC), was founded by MAPS. They’re all about revolutionizing mental healthcare with investigational psychedelics, particularly MDMA-assisted therapy. This is not just for kicks; they’re leveraging decades of solid research to help people, communities, and society at large.

So, with a new captain at the helm and a top-notch medical officer in the mix, Lykos is all set to advance its pioneering mental healthcare treatments. If you want to know more, just hit up their website or follow them on social media.

In summary: New CEO, star-studded new CMO, same mission to transform mental healthcare with some good old-fashioned psychedelic research. Stay tuned for what’s next in this trippy journey!



Reference: https://news.lykospbc.com/2024-09-05-Lykos-Therapeutics-Announces-Appointments-of-Michael-Mullette-as-Interim-Chief-Executive-Officer-and-Dr-David-Hough-as-Chief-Medical-Officer


Published Date: 2024-09-05

Psychedelic therapies under scrutiny: What’s next after Lykos’ MDMA rejection?

The FDA has firmly told Lykos Therapeutics, “Not so fast!” on their MDMA-assisted therapy for PTSD, rejecting their New Drug Application (NDA) due to issues with trial methodology (hello, “functional unblinding”) and safety risks. Essentially, they said, “Your data is about as sturdy as a house of cards in a hurricane. Try again.” This means MDMA therapy won’t be hitting the market anytime soon, leaving Lykos and the broader psychedelic community shaking their heads and staring at their calendars.

The FDA’s decision, while a bummer for some, isn’t a total buzzkill. Companies like Compass Pathways and MindMed are still in the game, tweaking their trial designs to avoid similar pitfalls. The FDA has made it clear that they want rock-solid proof of safety and effectiveness before giving the green light to any psychedelic therapies. Investors are now playing it cool, favoring the more established players who can navigate these choppy regulatory waters.

This setback is a wake-up call, emphasizing the need for rigorous research designs, better blinding in trials, and bulletproof safety and efficacy data. Companies are now scrambling to find ways to measure participant expectations, illustrate dose-response relationships, and use active placebos to address the unique challenges posed by psychedelics.

Three main strategies are emerging: simplifying therapy protocols, finding ways to minimize the “trip” effects (looking at you, Delix Therapeutics, AbbVie, and Intra-Cellular Therapies), or fully embracing and clearly defining assisted therapy, sometimes with a splash of AI magic.

In summary, the FDA’s thumbs-down on Lykos’ MDMA therapy has thrown the psychedelic drug market into a spin, but it’s also laying



Reference: https://www.labiotech.eu/trends-news/psychedelic-therapy-fda-rejection-impact/


Published Date: 2024-09-06

Drug Science and University College London Collaboration: Advancing MDMA-Assisted Therapy

Drug Science and University College London (UCL) are teaming up to crack the code on MDMA-assisted psychotherapy, focusing on the often overlooked but oh-so-crucial psychotherapeutic aspect. This dynamic duo aims to polish the therapeutic model, appease the FDA’s worries about combo therapy, therapist training, and long-term perks. Despite previous trials hinting at MDMA magic, the FDA recently said, “Not so fast!” requiring more proof. Enter this collaboration, ready to innovate for better safety and effectiveness, with participant recruitment set to start in 2025.

Drug Science, a UK-based independent charity untainted by political or commercial agendas, is diving into the psychological workings of MDMA. They’re even testing it on psychotherapists who know their way around a mental maze. The mission? To elevate MDMA-assisted therapy to mainstream respectability.

UCL, the multidisciplinary heavyweight founded in 1826, brings its brainpower to the table, boasting a vibrant community of over 16,000 staff and 50,000 students. For the scoop, hit up James Bunn.



Reference: https://www.drugscience.org.uk/uclmdma


Published Date: 2024-09-02

Push to legalize psychedelics moving into the spotlight

**Happening Today**:
– **8:30 AM**: The Massachusetts Health and Hospital Association’s conference on how to handle substance use and harm reduction without becoming a mess.
– **9:00 AM**: Gov. Healey says hi at the 45th annual meeting of New England governors and Eastern Canadian premiers in Boston.
– **10:00 AM**: The Cannabis Control Commission searches for a new boss, like finding a needle in a very hazy haystack.
– **11:00 AM**: Mayor Wu gets grilled by the public at the Boston Public Library, probably wishing she was somewhere else.

**Ballot Questions and Campaigns**:
– Money is flowing like a waterfall for November’s ballot questions, including the hot topics of booting MCAS and giving drivers a union.
– Legalizing psychedelics (Question 4) has raised over $4.7 million—turns out mushrooms can grow money too. Supporters and veterans will chat about this in Springfield.
– The Legislature is sitting on its hands after getting mixed reviews on the psychedelic question.

**Shannon O’Brien Fired**:
– Treasurer Deborah Goldberg axed Cannabis Control Commission Chair Shannon O’Brien over “gross misconduct.” O’Brien says she was just trying to clean up the place and got slandered. Expect more legal drama than a daytime soap.
– People involved in a ritzy brothel scandal are fighting to stay anonymous—like that’s going to work.
– The Massachusetts 2024 Competitiveness Index shows the state is an expensive place to live and work.
– MBTA’s Phil Eng is pondering late-night services again, probably dreaming of night owls with transit passes.
– Worcester City Council debates speed limits, MC



Reference: https://massterlist.com/2024/09/10/push-to-legalize-psychedelics-moving-into-the-spotlight/


Published Date: 2024-09-10

Psychedelics ballot question campaigns heat up ahead of November

In a Massachusetts showdown that could be straight out of a psychedelic soap opera, supporters of a November ballot to legalize certain psychedelic substances are groovin’ and movin’ in Springfield! Leading the charge is Massachusetts for Mental Health Options, boasting endorsements from state Reps. Lindsay Sabadosa and Carlos González. They argue that psychedelics could be the magic potion for veterans with PTSD and others grappling with mental health issues.

However, not everyone is ready to trip the light fantastic. Opponents predict a future filled with DUIs, rogue toddlers, and pets having out-of-body experiences, not to mention the rise of a psychedelic black market. For the record, this measure isn’t about turning Massachusetts into a 24/7 rave—it’s more about setting up a regulatory commission, not legalizing recreational use.

On the green side of things (and we’re talking cash, not plants), the “yes” campaign is rolling in dough, with Dr. Bronner’s Magic Soaps cleaning up with a hefty donation. Even some wealthy Boston tech execs have chipped in, making campaign finance records read like a who’s-who of the Silicon Valley of the East.

Meanwhile, the Coalition for Safe Communities, the buzzkill squad, has been slower on the uptake but is now shaking the money tree and appealing to first responders, district attorneys, psychiatrists, and even veterinarians to join their cause.

This psychedelic proposition is just one of five hot-button statewide initiatives on the horizon, with some local spots already saying “yes” to decriminalizing psilocybin possession. Get your popcorn ready, Massachusetts, because this trip is just getting started!



Reference: https://www.nepm.org/regional-news/2024-09-11/psychedelics-ballot-question-campaigns-heat-up-ahead-of-november


Published Date: 2024-09-11

Psychedelic plant and shroom fest returning to University of Michigan campus

Get ready for a mind-expanding trip—no, not that kind! The fourth annual Entheofest is landing at the University of Michigan on Sept. 22, celebrating all things psychedelic (plants and fungi, that is). This shroom-tastic event marks the decriminalization of magical plants in Ann Arbor, featuring big-name speakers like Washtenaw County Prosecutor Eli Savit and state Sen. Jeff Irwin.

But hold your horses—no one’s selling psychedelics here. Organizers are all about education, not transactions. Thanks to UM’s Student Association for Psychedelic Studies, you can expect a blend of activism, art, music, and drug policy reform shenanigans.

The speaker lineup is enough to make you trip over your excitement, featuring author William Leonard Pickard and UM researcher Kevin Boehnke. The festival runs from 1:11-4:20 p.m.—yes, you read that right—with early bird activities like yoga at 10 a.m. and a “sound bath” at 11 a.m. (rubber duckies not required). Speeches kick off at the very precise time of 1:11 p.m. and culminate in a performance by the Tamerrian Institute.

And if that’s not enough to tickle your psychedelic fancy, there’s a free afterparty at the Rabbit Hole bar with live music. Dive into the full details at Entheofest.org and prepare for a groovy day.



Reference: https://www.mlive.com/news/ann-arbor/2024/09/psychedelic-plant-and-shroom-fest-returning-to-university-of-michigan-campus.html


Published Date: 2024-09-10

A Psychedelic Debacle: 4-AcO, Microdosing, Media Panics and the Risks of Prohibition

Diamond Shruumz, the Willy Wonka of the psychedelic snack world, just got their golden ticket revoked after their chocolate and gummies allegedly sent 113 people on an unplanned trip to the ER across 28 states, with 42 VIP hospital stays. The mystery illness menu featured seizures, vomiting, and respiratory failure, leaving experts scratching their heads and conspiracy theorists pointing fingers at psychedelics.

This recall has crackled up debates around 4-AcO-DMT, the sketchy cousin of psilocybin often moonlighting in “magic blend” products at smoke shops. Notorious for being cheaper and easier to whip up than traditional shrooms, it’s sparked a turf war with old-school mushroom growers. Cue the déjà vu from the 2019 vaping scare, a not-so-gentle reminder of the perils of unregulated goodies and the media’s love for a juicy panic story.

Recent sensational headlines about microdosing mushroom chocolate bars causing illnesses have muddied the waters further, suggesting poisoning when the real culprits might be foodborne nasties or dodgy solvents from back-alley production lines. The media, hungry for clicks, skips over the lack of solid evidence linking the symptoms to substances like psilocin, 4-AcO, or even kava.

Industry whispers hint at serotonin syndrome following a formula tweak, but with a massive batch and relatively few cases, the plot thickens. The bottom line? We need less alarmist spin and more solid consumer education and regulation to prevent snack-time from turning into a medical mystery tour.



Reference: https://www.rollingstone.com/culture-council/articles/psychedelic-debacle-4-aco-microdosing-panics-risks-of-prohibition-1235098751/


Published Date: 2024-09-11