MindMed receives FDA breakthrough therapy designation for LSD; Psychedelics figure Ben Sessa’s medical license suspended for one year; Serotonin toxicity after combining psilocybin and antidepressants
Plus: City of Vancouver allows psychedelics dispensary to reopen and Oregon’s psilocybin program complaints
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
MindMed receives FDA breakthrough therapy designation for LSD
On Thursday, psychedelics company Mind Medicine, or MindMed, announced that MM120, the company’s formulation of LSD, has been given Breakthrough Therapy Designation by the U.S. Food and Drug Administration to treat generalized anxiety disorder. This is the fourth time the FDA has granted breakthrough therapy designation for a psychedelic drug. MAPS received it for MDMA to treat PTSD; Compass and Usona Institute both received it for psilocybin as treatments for treatment resistant depression and major depressive disorder.
MindMed also announced positive initial results for its recent Phase 2B clinical trial using MM120 to treat generalized anxiety disorder. Unlike most previous psychedelic clinical trials, participants did not receive psychotherapy; they either took a dose of LSD, or received a placebo. Those who received a dose of LSD showed lower scores on an anxiety scale than those who received a placebo, with 65 percent of participants who took LSD showing a significant decrease. MindMed’s results also show a small but sustained decrease in anxiety scores for people who received placebo. These anxiety scores remained steady for 12 weeks after participants’ dosing session. The results have not yet been peer reviewed, but the company said they were submitting them for publication.
Prominent psychedelics figure Ben Sessa’s medical license suspended for one year
This week, the United Kingdom’s Medical Practitioners Tribunal Service (MPTS) concluded its hearing on psychiatrist Ben Sessa’s misconduct, and issued a 12-month suspension of his medical license. According to MPTS case documents, Sessa admitted to meeting a patient at a bar and discharging that same patient from his care so that he could pursue a romantic relationship with her. (Sessa’s treatment of this patient did not involve psychedelics.) This patient later died by suicide, and in November 2022, her estranged husband brought the allegations to MPTS. The tribunal reviewing Sessa’s case concluded that the risk that he would repeat his misconduct was low. “He said he had suffered extreme distress and remorse at the loss of Patient A and that his part in the last year of her life was ‘undoubtedly the greatest personal and professional mistake of my career,’” reads an MPTS document. The tribunal also “considered that the public would be shocked if, in all the circumstances of the case, no finding of impairment were made.”
Sessa, who co-founded psychedelics company Awakn and appeared prominently in the Netflix docuseries How To Change Your Mind, has been a leading figure in the psychedelics world, and many felt the ruling didn’t go far enough. On X, Alaina Jaster, a pharmacology PhD student, said that taking advantage of patients is an abuse of power. “You should not be able to practice again. Period,” she wrote. “A 12-month suspension is nothing but a clear demonstration of a failed medical regulatory system,” wrote University of Sydney researcher Kayla Greenstien, also on X.
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Serotonin toxicity after combining psilocybin and antidepressants
In a case report published in the journal Primary Care Companion to Central Nervous System Disorders, three Penn State clinicians describe a patient who experienced serotonin toxicity after combining antidepressants and anti-anxiety medications and psilocybin. Serotonin toxicity, or serotonin syndrome, occurs when high levels of serotonin build up on the body; the condition can be fatal.
This patient had prescriptions for three different antidepressants and anti-anxiety medications— venlafaxine, bupropion, and lorazepam — and reported that she’d felt fine taking those drugs in combination with microdoses of psilocybin. But after two days of starting a fourth medication, the antidepressant trazodone, she began experiencing classic serotonin toxicity symptoms, including sweating, fever, nausea, anxiety, high blood pressure, and accelerated heart rate. She was admitted to the hospital.
Like many psychedelics, antidepressants such as venlafaxine and trazodone act on the 5-HT2A class of serotonin receptors. The risk of serotonin toxicity when combining these antidepressants with psychedelics “is thought to be low,” the authors write. “However, utilizing high doses of these psychotropics with unregulated doses of psilocybin may place the patient at an elevated risk of serotonin toxicity as seen in this case.” (For more on the potential health risks from mixing antidepressants and psychedelics, read our 5 Questions interviews with psychopharmacologist Kelan Thomas and molecular neuropharmacologist Bryan Roth.)
City of Vancouver allows psychedelics dispensary to reopen
In recent years, stores illicitly selling psychedelic products have popped up across Canada, and local police have repeatedly raided them. In December 2023, we interviewed Dana Larsen, a drug activist who owns dispensaries in Vancouver. One of those locations was raided in November 2023, and Larsen said the city would make a ruling on whether he could keep his business license for the dispensary.
This week, Vancouver councilors voted to reinstate Larsen’s business license, allowing the store to reopen. On X, Larsen said he “could not be happier” about the decision and offered customers 10% off products all week.
Vancouver’s mayor Ken Sim, however, said he was disappointed with the ruling, and issued a public statement decrying two councilors for using their position “to engage in activism on matters beyond the jurisdiction of the City of Vancouver.” In his statement, Sim wrote that the “discussion should take place at the federal level, rather than at a City Business License Hearing.”
Oregon’s psilocybin program complaints
For his newsletter Ecstatic Integration, writer and harm reduction advocate Jules Evans obtained copies of complaints submitted to the Oregon Health Authority (OHA) about psilocybin services. Evans reviews a few of the more disturbing ones, which include complaints about poorly run licensed training programs and retreats, some of which offer “underground” services in addition to state-legal ones, as well as businesses and individuals making false claims about their own licensing status or shipping customers psilocybin products (which is still illegal under both federal and Oregon state law). In some of these cases, OHA has responded that they are not able to take action if businesses are operating outside the scope of Oregon Psilocybin Services — and even those that are sanctioned or served a cease and desist “carry on regardless,” as Evans puts it.
“To me, it illustrates the challenges of introducing an expensive regulated access model within the wider context of decriminalization of psychedelic drugs,” Evans concludes. “Some companies will operate outside the rules, safe in the knowledge they are unlikely to be prosecuted, and some companies will co-opt the language of legality to mis-market services to consumers. It’s not clear who is in charge of policing the system.”
In the science fiction novel Dune and its many sequels, characters feud over the “spice” industry — a psychedelic substance found in the sand dunes on the planet Arrakis. The series’ author Frank Herbert was inspired by real-life psychedelics, according to The Telegraph. Herbert had tried peyote and had struck up a correspondence with famed mycologist Paul Stamets. The piece includes an excerpt from Stamets’ 2005 book, Mycelium Running: How Mushrooms Can Help Save the World about his experiences with the Dune author. “Frank went on to tell me that much of the premise of Dune – the magic spice (spores) that allowed the bending of space (tripping), the giant sand worms (maggots digesting mushrooms), the eyes of the Fremen (the cerulean blue of Psilocybe mushrooms), the mysticism of the female spiritual warriors, the Bene Gesserits (influenced by the tales of Maria Sabina and the sacred mushroom cults of Mexico) – came from his perception of the fungal life cycle, and his imagination was stimulated through his experiences with the use of magic mushrooms.”
The city of Denver announced last week that it is forming a natural medicine workgroup within its Department of Excise and Licenses.
Juan Pablo Cappello founded Nue Life Health, an at-home ketamine company, but now, he tells Psychedelic Alpha he no longer supports the practice of at-home ketamine.
The Denver Post’s Tiney Ricciardi reports on the companies who sell psilocybin gummies, tea, capsules, and chocolates and pay influencers to market their products online.
In an interview with The Cut, country star Kacey Musgraves talks about her new album Deeper Well, and fangirls about mycologist Paul Stamets. “I don’t get starstruck by anybody, but if I saw Paul Stamets, I would act a fool,” she said. “My dream is to go on a woodland forage with him and talk about life, psilocybin.”
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