Lykos board shake-up; Colorado’s Natural Medicine program weighs new at-home facilitation rules; LSD for mind control
Plus: Psilocybin bans expire in 14 Oregon municipalities, and the State of Psychedelics
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.
Lykos board shake-up
On Tuesday, Lykos Therapeutics announced changes to its board. That board is comprised of “independent directors” appointed by Lykos, as well as members appointed by the non-profit MAPS, which originally spun out Lykos (formerly known as MAPS Public Benefit Corporation or MPBC) as an entity to bring MDMA to market.
This week, three of the board’s independent directors — Scott Giacobello, Jason Pyle, and Jeff George — resigned. The Microdose reached out to each but none provided comment. Filling those vacated spots are Joseph McCowan, a psychedelic therapist who worked on MAPS’ phase 3 MDMA trials; executive coach Ron Beller; and Joe Green, co-founder of the Psychedelic Science Funders Collaborative.
The announcement comes days after the Financial Times reported last Friday that the board is considering a proposal from billionaire Antonio Gracias to take a controlling stake in the company with a $100 million deal. A source close to the matter told The Microdose that the funding, if accepted, would actually come from the Antonio J. Gracias Family Foundation, a nonprofit which has previously given a $16 million gift to Harvard for psychedelic studies.
It’s no secret that Lykos needs new investments; last summer, the company submitted a New Drug Application to the U.S. Food and Drug Administration for the use of MDMA in the treatment of PTSD, but the application was not successful. Shortly after, the company laid off 75% of its employees, and they’ve since announced that they are working with the FDA to develop another phase 3 trial.
According to another source with knowledge of the situation, the Gracias bid was spearheaded by MAPS-affiliated people. Helena, a private equity firm that is currently Lykos’s lead investor, has put forth a different proposal. But after the board’s meeting last Friday, it was clear the board reached an impasse over which proposal to move forward with, and that spurred Giacobello, Pyle, and George’s resignations.
Colorado’s Natural Medicine program weighs new at-home facilitation rules
Colorado’s newly-launched Natural Medicine program is still weighing changes to its rules, and made a new round of updates last Friday. The current version widens who is eligible for at-home psilocybin sessions, and sets minimum session lengths for microdoses at 1 hour. These changes appear to be driven directly by feedback the state’s Department of Regulatory Agencies (DORA) received via public comment from over 30 individuals, and a listening session it held last week. (DORA also held a listening session this Tuesday.)
As we reported last week, the version of the state’s rules proposed this fall allowed psilocybin sessions outside of licensed healing centers, but DORA quietly changed those rules to clarify that only people in palliative care would be eligible to receive at-home psilocybin. Many individuals who submitted public comment urged DORA to expand that scope. Commenters encouraged DORA to consider allowing a wider range of people to be eligible for at-home sessions, pointing out that clients with physical disabilities, chronic pain, severe anxiety, or PTSD may also have a hard time traveling to a center. One end-of-life doula wrote that she visits clients in their homes, as they are too ill to travel, and points out that “not everyone with a life-limiting diagnosis pursues palliative or hospice care for a variety of reasons.”
Additionally, several facilitators pointed out that requiring that sessions take place in healing centers can drive up costs and decrease accessibility. “It is quite likely that there may only be one [healing center] that opens within a 60 mile radius of me,” wrote one aspiring facilitator. “This would require both myself and my clients having to drive a long distance to do a session at a healing center.”
The newest update to the rules would allow anyone receiving palliative care services or hospice care to be eligible for at-home sessions, as well as anyone who has a disability, as defined by the Americans with Disabilities Act. Those who meet criteria for being “homebound,” or who can receive a recommendation letter from a healthcare provider about their advanced chronic or terminal illness are also eligible.
Tasia Poinsatte, Colorado director of the non-profit psychedelic access group Healing Advocacy Fund, applauded DORA’s revised rules to expand access to psilocybin services. “We think this is a significant positive step which will broaden access to a range of people who might otherwise face significant barriers to accessing care,” she told The Microdose.
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LSD for mind control
On December 23, the National Security Archive released a new collection of documents about the U.S. government’s MKULTRA program, in which the Central Intelligence Agency tried to develop drugs and methods for “mind control” in the 1950s. The archive includes documentation of the government’s use of LSD and LSD-like drugs on incarcerated people and in “safe houses,” where CIA agents lured targets and drugged them without their knowledge. People have since described the project as a continuation of work from Nazi and Japanese concentration camps. Over the 10 years of the program, the government also tried radiation, electro-shock, hypnosis, sensory deprivation, and verbal and sexual abuse as interrogation methods.
The new documents reveal a wide-ranging program with little oversight. In a memo included in the newly released collection, a CIA chief attempted to provide answers about the program after one of their LSD experiments was tied to the death of a U.S. Army scientist, but he seemed unable to provide even some of its most basic details. “Dr. Gibbons was not clear as to the mechanics of CIA acquisition of LSD but said he would get answers,” the 1953 memo reads. “Most LSD obtained by the CIA comes from the Eli Lilly Company with head offices in Indianapolis, Indiana. Dr. Gibbons thought some might have been obtained from other parties but he was not certain.”
Psilocybin bans expire in 14 Oregon municipalities
Oregon’s Psilocybin Services division released their 2024 year in review, which includes information about the program’s updated rules and regulations, as well as administrative data on licensed facilitators and businesses, and administrative violations and license denials. According to OPS, 18,424 psilocybin products were sold to clients. “While this may contain
secondary doses sold to clients, it provides a glimpse at how many clients may have accessed services,” the report says.
The report also included information about municipalities that have opted out of psilocybin services. Shortly before the program launched in early 2023, many municipalities enacted psilocybin bans in the November 2022 election. Some of those bans were permanent, but others placed a two-year moratorium on psilocybin. In the November 2024 election, some of those municipalities with temporary bans asked voters to weigh in again. In early December, we reported that 15 towns and the unincorporated areas of Clackamas County enacted permanent bans, and the city of Redmond passed a measure to extend its existing two-year ban. The only city to reject a permanent ban in the November 2024 election was Nehalem.
But other municipalities with temporary bans did not vote again in 2024 on extending their bans or permanently banning psilocybin. According to OPS records, bans in 13 cities and the unincorporated areas of Clatsop County expired on December 31, 2024.
The State of Psychedelics: Colorado and Virginia thinking ahead to psilocybin FDA approval; Washington state proposes psilocybin services
Three members of the Colorado assembly introduced HB 1063 last week, which would make it state-legal to prescribe, dispense, distribute, possess, use, and market prescription “crystalline polymorph psilocybin” in Colorado if the drug is approved by the U.S. Food and Drug Administration. The best-known commercial product that takes this form is COMP360, a formulation developed by the company COMPASS Pathways, whose attempts to patent COMP360 were challenged by a non-profit watchdog group called Freedom to Operate in 2022. Colorado’s House Health and Human Services Committee voted 12-1 Tuesday to advance the bill, which will now go to the full assembly.
Meanwhile, senators in Virginia, too, filed a similar bill ahead of the start of its legislative session — but while CO alludes to COMP360, SB 1135 specifically names it. The bill proposes that “upon approval by the U.S. Food and Drug Administration of the pharmaceutical composition of crystalline polymorph psilocybin, known as COMP360,” it would be state-legal to prescribe, dispense, possess, distribute, transport, and use the drug.
Senators in Washington state have introduced SB 5201, which proposes a state-regulated psychedelic services program similar to those in Oregon and Colorado. The bill is being spearheaded by Senator Jesse Salomon (D), who proposed a similar bill in 2023. The version of the bill that passed only created a program to study psychedelic treatment.
As peyote shortage continue, members of the Native American Church are asking non-Natives to stop poaching the cactus, reports The Guardian.
Veterans Affairs Under Secretary Shereef Elnahal tells Politico’s Erin Schumaker that he wants to join forces with Robert F. Kennedy Jr. on continuing psychedelic research at the VA. “I haven't been asked to stay, but if I am asked, I would stay," Elnahal told Schumaker. "I'd be honored to continue on and advance the agenda for veterans."
Once known as a club drug, ketamine is becoming the drug U.K. youths take at home to “chill out” after a long day, according to The Guardian.
Correction: In our last issue, we incorrectly stated that some Colorado facilitator licenses were free to apply for, and that fees only apply after an application is accepted. There are actually two fee schedules at play: all applicants must receive licensure from the state’s Department of Regulatory Agencies (DORA), and some of those licensees must pay additional fees to the state’s Department of Revenue (DOR). The DOR waives some of those application fees for DORA-licensed facilitators but all facilitators pay some state fees upon application. We regret the error.
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