Oregon wrestles with offering psychedelics outside medical system – STAT
PORTLAND, Ore. — Visitors to the fabric store, kitty-corner to a Whole Foods, are greeted by a sign on the glass front door. Outlined in red, it says: “NO drugs, NO money kept in this building.” Not for much longer.
Come early next year, if all goes according to plan, the rolls of cloth and sewing machines will be replaced by magic mushrooms. The century-old wooden building will become one of hundreds of locations across Oregon where people can come to take psychedelic drugs legally.
Starting in 2023, Oregon will be the first state with widely legalized psychedelics. Technically, the state didn’t approve psychedelic therapy, though the program is often interpreted as such. Ballot Measure 109, which passed in November 2020, gave the Oregon Health Authority (OHA) the job of overseeing magic mushroom consumption at “service centers,” in the presence of “licensed facilitators.”
Everything around the bill, though, is unavoidably focused on mental health. It was widely promoted as a way to treat depression and trauma and, even among those figuring out regulations, there is confusion and debate around how medical Oregon’s psychedelics will be. “I think there’s been a disconnect in what voters were told to expect when they voted and now. People will want mental health treatment but it’s not medical,” said Kimberley Golletz, a licensed psychologist and member of the Oregon Psilocybin Advisory Board giving guidance on the rules.
The psychedelic legalization movement is progressing parallel to a gold rush to develop these same drugs as medicine. Pharmaceutical companies and several nonprofits are studying psychedelics — including psilocybin, the active ingredient in magic mushrooms — as a way to treat psychiatric conditions, with the goal of getting these treatments approved and overseen by the Food and Drug Administration. A burgeoning network of businesses, including ones to train psychedelic therapists and operate clinics, view Oregon as an opportunity to gain a foothold in the industry, turning the state into a test case, both for legalized psychedelics more broadly and the medical development of these drugs.
Last month, the Oregon Health Authority issued its first set of draft regulations around training programs for facilitators, setting standards, for example, for the content and hours of training. In the months leading up to these decisions, discussions from advisory board members kept bumping into medical issues, including if it’s possible for licensed mental health professionals to work as practitioners, and to what extent facilitators should ask about a patient’s medical history. National and international psychedelic companies have participated in these conversations.
“Oregon very much is going to allow for diagnosis and treatment. I’m not sure they’re calling it those words, but they did craft the measure in such a way where depression, PTSD, addiction are things that will be supported here,” said Myles Katz, co-founder and director of business development at Synthesis Institute, which provides psychedelic retreats and practitioner training in the Netherlands, and is setting up shop in Oregon.
Regardless of whether the state bills its legislation as therapy, the standards developed will be a foundation for how psychedelic drugs are used to treat mental health conditions.
“For better or worse, what inevitably happens is these rules will be copy and pasted to states around the country,” said Mason Marks, another member of the Oregon advisory board and lead of the Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. “It’s already happening.”
The psychedelic industry is expected to be worth $6.85 billion by 2027, and national and international companies in the space view Oregon as a major opportunity.
Psychedelic drug developers have largely stayed away; the state’s plan could potentially undercut their business model, by offering a similar product but without the need for a prescription. The website for Compass Pathways, the company funding the most advanced trials, states: “To make sure it is safe and effective in patients, psilocybin therapy needs to be approved by medical regulators, not legislators.”
Instead, most of the psychedelic companies in Oregon are focused on other aspects of the business, such as training programs and the clinics where psychedelic therapy will take place.
A company called Fluence runs several psychedelic-related training programs, including with therapists in clinical trials of psychedelic drugs, and is planning to set up a training program designed for Oregon — though it will only enroll medical health professionals. “Our focus on a program is really training therapists. That’s what we do, what we know how to do,” said co-founder Elizabeth Nielson, who works as a psychedelic therapist on several medical studies.
Meanwhile, Synthesis, which offers psychedelic retreats in the Netherlands, including one program focused on depression, is also creating a training program in Oregon. Synthesis has spent $3.6 million on a 124-acre estate in Ashland, Ore. It has forests, meadows, and creeks and is just a 30-mile drive to the nearest airport, making it accessible for people who visit from out of state.
Field Trip, which owns a series of psychedelic clinics used for ketamine therapy, is also planning to set up shop here. There will be no difference between Field Trip’s clinics used for medical psychedelics and those in Oregon. “We designed our clinics to be psychedelic agnostic,” said the company’s founder, Ronan Levy. “We expect the aesthetic and design and structure of the location would be similar to what we have right now. The only difference would be you wouldn’t need a formal diagnosis of depression or anxiety or PTSD [in Oregon].”
These companies point to a potential blurring between medical psychedelics and Oregon’s legalization, suggesting people will be able to go to the same clinics and see therapists trained by the same company in either model.
Oregon is only the beginning. Several companies said they’re talking with other states about legalizing psychedelics. Red Light, which is encouraging Oregon to permit microdosing as part of its legislation, said it has hired a lobbyist in Washington state as part of its commitment to the Psychedelic Medicine Alliance of Washington, a grassroots advocacy organization, to help pass a similar bill in that state.
Red Light envisions microdoses of psychedelics becoming a new morning ritual. In place of coffee, people would go to a cafe and eat a small amount of magic mushrooms, perhaps combined with yoga or meditation.
The company has reached out to the OHA and the Advisory Board to offer support and research, said founder Todd Shapiro. “We’re trying to lend a hand to help with being a big impact on how these regulations might end up,” he said. For now, the company is focused on research and educational outreach to potential facilitators from diverse backgrounds.
“We’ll worry about the bigger business behind it later. We’re well capitalized,” said Shapiro. Once the regulations are clearly laid out, the company will be ready: “We’ll want to be aggressive in as many markets that allow us to be in.”
Currently, Washington, New York, Colorado, and California are all considering some form of psychedelic legalization, while several other states are enacting decriminalization and yet others are researching the potential medical benefits of psychedelics. As Oregon-style legalization spreads across the United States, the potential market gets ever bigger. “Oregon is just the first step. But there’s a big wave coming almost certainly,” said Field Trip’s Levy.
Several members of the Psilocybin Advisory Board have already raised questions about how much influence companies are having over the process. During the past few months, members have called for greater transparency around potential conflicts of interest at various meetings.
“There are a lot of concerns about organizations outside Oregon trying to influence the process here and to stifle real meaningful discussion by people in Oregon,” said Marks.
Toward the end of February, the psilocybin board voted that each member should disclose their personal and financial conflicts at its next meeting. This is a relatively late decision, given that speakers invited to talk to the board have long been asked to disclose their own conflicts of interest.
Chair of the board Tom Eckert, for example, has developed his own training program, and in addition to being in a romantic relationship with Rachel Aidan, the chief executive of Synthesis, is also working closely with the company.
“You want to know that people writing the rules are doing so in everybody’s best interest and not their own,” said Britt Rollins, co-founder of the National Psychedelics Association, who isn’t on the board but has been closely following meetings. “Without such transparency, it’s hard to know if people are developing rules to suit their own business interests.”
Oregon’s magic mushroom legislation and the companies developing psychedelics under FDA oversight represent two very different models of mental health therapy. But both are exploring the same drugs as ways to address the same negative emotions and experiences.
Clinical studies on psychedelics test use of the drugs in combination with therapy, usually before and after taking the psychedelic, and with a therapist available while patients are high. Oregon will also require clients to meet with their facilitator before the psychedelic experience and after — in what’s known as an “integration session,” to discuss any insights and impact from the psychedelic trip.
One major difference is the form of the drug: Oregon has legalized magic mushrooms, whereas researchers conduct studies using synthesized psilocybin, the key psychedelic compound in the fungi. Some of the most advanced studies include Compass Pathways research on psilocybin as treatment for treatment-resistant depression, and Usona studies on the same drug for major depressive disorder. Compass Pathways has completed a Phase 2b study and is preparing for a phase 3 this year, while Usona’s phase 2b study is currently underway.
Oregon’s measure was conceived as a way to address mental health conditions such as depression within a new system. Tom Eckert and his late wife Sheri, who sponsored the ballot initiative and led the campaign for it, had long thought the medical approach to mental health was broken. Sheri died unexpectedly a month after the referendum passed, and so Tom alone is now chair of the Psilocybin Advisory Board.
Eckert said he first felt the push to use pharmaceutical treatments and superficial therapy while getting his degree in clinical psychology. “The health insurance model was looking for quick interventions without a lot of depth,” he said. “You could feel the drift since the ’80s, and ’90s, toward antidepressants, and medications being top of the ladder in terms of how the mental health field was structured.” Eckert has considerable influence in shaping how this system develops. He speaks slowly, carefully, from a law firm in Portland that donated space in its offices to the Sheri Eckert Foundation, with expansive views of the city.
Psychedelics are, of course, also drugs. But, to Eckert, they offered a way to explore rather than tamp down anxieties and depression, and gain deep new perspectives. “We didn’t want to just hand it over to existing systems,” he said. Rather than fit within existing licensing and insurance models, he wanted to create something from scratch.
And so the measure was created as a non-medical way of treating psychiatric issues. There is precedent: Many Indigenous communities have used psychedelics for healing and spiritual practices outside the western medical model for thousands of years.
“In general, in the psychedelic world, I see a lack of awareness of the fact we’re still here and practicing our traditions,” said Keith Williams, advisory board member and director of research and social innovation at First Nations Technical Institute, an Indigenous-run higher education institution based on Tyendinaga Mohawk Territory, Ontario. “These plant medicines are very much Indigenous medicines.”
Oregon updates local tribes on its plans but, so far, there’s been limited engagement with Indigenous communities. “It’s a bunch of white folks asking native folks, hey, can we extract your knowledge, right, and put it in this paper or use it to build the system,” said Angela Carter, a member of the Advisory Board’s equity subcommittee. “What’s the reciprocity here?”
Ballot Measure 109 is trying to create a new system while referencing more clinical understandings of research and treatment. The ballot describes the severity of the mental health crisis, highlighting magic mushrooms as a way to address these problems. This is the foundation of some of the confusion around whether Oregon’s legal psychedelics will be a form of medical treatment.
Some members of Oregon’s Board also draw on research findings to determine policies: The model of having an integration session following a psychedelic experience, for example, is “safe and effective,” according to Eckert. “The science supports that.” In fact, when it comes to psilocybin, researchers are still establishing its effectiveness through a series of studies. And the best safety practices are still in development.
“We’re saying both things. This is not medical… . But this is psilocybin-assisted therapy,” said Golletz. The result is confusing. “Psilocybin facilitation. … I mean, nobody knows what that is.”
Several members of Oregon’s Psilocybin Advisory Board told STAT their discussions veer toward medical issues. “Creating any regulated system, we do have a risk of over-medicalizing it because the medical framework is all that we have for reference,” said Rebecca Martinez, who is on the board’s equality subcommittee and plans to convert the Portland fabric store into a psychedelic center in her role as executive director of Alma Institute, a non-profit training program specifically focused on working with people from marginalized and low-income communities.
Oregon’s psychedelic use should be akin to an ongoing meditation practice, she said, rather than providing magic mushrooms as a potential drug to fix ailments. “There’s a community-based path that’s orientated differently, and it feels like that needs to be protected.”
Psychedelics seem to be relatively safe drugs, according to the existing research, but, like anything, they come with risks. They can be emotionally destabilizing, potentially exacerbate psychosis for people with pre-existing conditions, and create feelings of susceptibility and emotional intimacy, which creates a risk of sexual misconduct. Oregon is the first instance of widespread legal access, and so it’s a crucial test in developing appropriate safety protocols.
In February, the Oregon Health Authority published its first set of draft rules, outlining the regulations around training and the production of mushrooms. The goal is to finalize specific policies this spring, after incorporating feedback from advisory committees and the public, so that training can begin for facilitators by the summer, and they will be ready to work with clients in January 2023.
OHA laid out specific topics that training programs should cover, ranging from Indigenous reciprocity and equity to the neuroscience behind psychedelics. And it decided that programs for practitioners should include a minimum of 120 hours of learning (25% of which should be in person), plus 40 hours of practical training. Even this foundational decision, though, was subject to intense debate among the board. Some worry that mandating in-person learning will limit access for those in more rural areas. And others are concerned the program — roughly equivalent to the 150 hours needed to get a real estate license in Oregon — is too short. “I’m convinced it needs to be two to three times that,” said Harvard’s Marks.
Meanwhile, many basic questions around qualifications for becoming a facilitator and the skills and knowledge needed to pass an exam remain unresolved. “That’s been a theme,” said Marks. “Let’s kick the can down the road on the details.”
There’s still huge uncertainty over whether certain medical protections are necessary for vulnerable people. Some board members argued the training program was acceptable for people turning to psychedelics for wellness use, but not for those hoping to use the drugs to address more serious medical conditions. “The last thing as a psychologist I want to see happen is for clients to come in seeking psilocybin to improve their mental health and have it harmed and make mental health worse,” said Golletz.
The board discussed creating two types of licenses, so that some facilitators would be certified to respond to people with serious mental health conditions, but that was vetoed on the grounds that it would create a two-tier system, likely leaving less wealthy people to see those with fewer qualifications. There’s now ongoing discussion about whether some facilitators would have a broader scope of practice and the ability to work with people who have medical conditions. “You’re basically achieving the same effect of having a multi-tiered licensing system,” said Marks.
Despite some board members arguing that more vulnerable people should see mental health professionals for their psychedelic experiences, it’s still unclear whether those with medical licenses will even be able to work as facilitators. Existing medical licensing boards for psychologists and counselors haven’t indicated if they’ll allow members to do so. “Let’s say a psychologist has two licenses as a facilitator psilocybin provider, and as a psychologist, there’s a complaint. Whose jurisdiction is that?” said Golletz. “Will the liability insurance cover psilocybin services?”
The board also faces a major question that medical researchers are evaluating: What are the contraindications? Psychedelics can be destabilizing for people who’ve had psychotic disorders such as schizophrenia, and potentially for people with bipolar or borderline personality disorder. “The problem that I’ve experienced in trying to have these discussions is that there really isn’t good data,” said Golletz.
A huge safety issue around psychedelics concerns not the drugs themselves, but how to monitor therapists or facilitators. Sexual abuse has long been a problem in psychedelic therapy. All the usual power imbalances of patients and therapists are exacerbated in a setting where drugs can create feelings of sexual arousal.
“Any time you’re doing medicine, you’re in a place of power, pretty profound power,” said an underground psychedelic therapist who asked not to be identified for fear of legal repercussions. “And people are having transformative experiences that they are attributing to you. And that is irresistible. It takes a lot of training and clear community watchdogs.”
Many of those involved in Oregon’s psychedelic legalization movement were inspired by underground experiences. But she and two other underground therapists said they were worried about the lack of training involved in the current OHA guidelines, and don’t plan to become licensed facilitators.
Bringing psychedelics above ground is one way to help prevent abuse. There are potential repercussions for bad actors, and OHA has the power to take away licenses. But that is only one, fairly limited response.
Details of potential other consequences, though, are still up for debate. Marks said he’s raised the issue in training subcommittee meetings, but there wasn’t much enthusiasm to discuss it. “There was discomfort to set those penalties,” he said. “I imagine a health care provider might feel uncomfortable setting up rules by which their peers would be disciplined.”
The questions of how to make psychedelics safe and accessible at scale are a huge issue, but “we aren’t going to get it completely right year one,” said Elan Hagens, member of the health equity subcommittee and co-founder of Fruiting Bodies Collective, a BIPOC women-led podcast and advocacy group. “That’s naive.” Whatever mistakes are made, others in psychedelics will be watching to learn and adapt.
Oregon was not intending to kickstart another industry like the huge business cannabis has become, but it might be heading in that direction. Once states began legalizing marijuana, it quickly became a field where companies are overwhelmingly run by white men. This lack of diversity was particularly disquieting given the long history of using cannabis offenses to imprison predominantly people of color.
Oregon’s psychedelic measure was written with a focus on diversity and grassroots involvement. “Coming from a community that is largely marginalized, and because of that often impoverished, and looking at a lot of other communities that have been marginalized by the war on drugs, I really want to make it as accessible as possible to people,” said Carter, who identifies as queer and trans.
But some worry that unequal power structures and homogenous dynamics are already emerging. The original psychedelics bill didn’t have funding available to offset the costs of becoming facilitators for those from low-income communities. Recently, the state agreed to create a task force to examine potential racial and economic inequities and what would be necessary to help address them.
Oregon legislators are working to make the industry small and local, creating a residency requirement for those who want to run service centers and limits on how many service centers one organization can own. “A lot of folks would love to have a very profitable business and they see psilocybin as the avenue to do that,” said Martinez. “Out-of-state businesses that want to set up here are going to have to do a lot to prove to us that they deserve to be here.”
There will likely be ways to circumvent these rules, though.
Vince Sliwoski, managing partner at Harris Bricken law firm, acknowledges as much in a blog post on the subject: “Unfortunately, there’s a residency requirement. Fortunately, it sunsets after two years. Cue the crazy business structures,” he writes. “Potential owners and investors should pay careful attention to what the OHA rules provide, and work with an experienced business lawyer used to grappling with these strictures.”
Well-funded businesses can easily dominate, for the same reason that applies to all industries: Entering the psychedelic space takes capital to get off the ground.
Cene Salsedo Bryant, a Puerto Rican biology researcher, is one of those hoping to raise the funds to create a psychedelic service center. On a cold February morning, she showed a reporter a building she has her eye on. Currently in use as financial planning offices, it has wood paneling and a fireplace inside, with a spacious deck outside. It’s on the market for $900,000, which is typical of the sites she’s looked at.
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“I would need the money to purchase real estate or land,” she said. “That’s the biggest barrier for anyone jumping into this. If you don’t have someone who’s willing to invest in the land for you, or a million dollars or a way to leverage a million dollars, it’s gonna be really tough to carve out a spot.”
Growing the mushrooms is another new potential career path intriguing many Oregonians.
Vino Edwards developed a love of gardening with his grandmother, and originally wanted to get into growing cannabis. “As the years go by, it’s increasingly harder to get into that industry,” he said. “Especially for someone like me who has nowhere near enough financial savings.”
His interest in plants led him to study soil composition, mycelium, and mushrooms. It is legal to grow magic mushroom spores for research purposes in Oregon, and Edwards has a tent in his bedroom where he cultivates the spores. He also forages for mushrooms in local forests, expanding his understanding of what’s possible, and is planning to set up a mushroom production company, Shroom City.
“With how early on it is in the industry, there’s a lot of people looking for my knowledge. I know a lot of people willing to pay upwards of $15,000 just for me to teach them how to grow,” he said. Cannabis corporations that are trying to get into mushrooms are particularly interested, he added.
Psychedelics will inevitably become a huge new industry, and Oregon is the first step to test out the business model. “It’s an exciting time, but the dial is turned up on everything,” said the underground therapist. “The money part is going to make what happened with cannabis look like nothing.”
This content was originally published here.