Inside the Fight to Legalise Psilocybin Therapy in Oregon

Inside the Fight to Legalise Psilocybin Therapy in Oregon

On a sunny September afternoon in Portland, volunteers pour into a Zoom conference room. They’ve come for a weekly update from Oregon’s Yes on Measure 109 campaign — a measure which would create the world’s first market for psilocybin-assisted therapy. The pandemic prevents them from knocking on doors to reach voters. But that has not dampened their spirits. For the past month, they have gathered online to text or call and educate voters.

Campaign manager Sam Chapman briefs volunteers on news from the past week. With seemingly boundless energy, he spends much of his time hopping from one conference call to the next. On Thursdays, he leads the campaign’s healthcare committee, a group for medical professionals that support Measure 109. Other days, he holds a weekly meeting for veterans and a healthcare equity meeting focused on access and racial justice. Five days a week, his staff holds phone and texting sessions for volunteers.

During the weekly update, Chapman shows a set of promotional videos produced to reach voters. One provides an overview of psilocybin therapy. Another features retired Navy SEAL Chad Kuske, who credits psilocybin with saving his life.

A decorated veteran who served 18 years with the SEALs, Kuske experienced profound symptoms of depression and post-traumatic stress disorder after 13 deployments. Kuske enrolled in a clinical trial. Like many people who receive psilocybin therapy, he experienced a rapid, positive shift in his outlook. “The therapy provides you with a bit of a roadmap on how to change directions, to start growing and really living,” said Kuske.

Psilocybin is a substance found in over 200 wild mushroom species, and indigenous cultures of the Americas are said to have consumed it for thousands of years. In a class of drugs called the psychedelics, psilocybin alters perception and cognition, which makes it useful for changing rigid thought patterns associated with mental illness. Experts say it is surprisingly safe and nearly impossible to overdose. In the 1950s and 60s, psychiatrists studied its use as an aid to talk therapy. In the 60s, it became associated with the counterculture movement and opposition to the Vietnam War. Richard Nixon and his newly formed Drug Enforcement Administration cracked down on psilocybin and outlawed its use, bringing scientific research to a halt by the early 1970s.

Over the past 20 years, a few researchers gained permission to study psilocybin-assisted therapy, picking up where their predecessors left off. Though many obstacles remain, it has now been tested at leading universities including Yale, Johns Hopkins, NYU, and Imperial College London. In 2018, the Food and Drug Administration named psilocybin-assisted therapy a breakthrough for treating major depressive disorder. Last year, it gave the therapy this designation for treatment-resistant depression. The FDA reserves breakthrough therapy status for unapproved drugs that could be substantial improvements over existing treatments, while speeding up the agency’s process for potentially approving them. That means psilocybin may be a significant advance over antidepressants like the selective serotonin reuptake inhibitors (SSRIs) fluoxetine and paroxetine.

“The medications we have are better than placebo, but they are not great,” said Joshua Dow, MD, a Portland, Oregon psychiatrist. Up to two-thirds of patients do not respond to the first antidepressant prescribed. It can take six weeks of daily medication to experience any benefit and three months for a maximum response. People often experience unpleasant side effects such as weight gain, fatigue, and sexual dysfunction. Although they reportedly help many people each year reduce their symptoms, in some patients, SSRIs can increase the risk of neurologic dysfunction, metabolic disorders, and suicide.

Antidepressants have changed little since the first SSRI, fluoxetine, was introduced in 1988, and despite their widespread use, U.S. rates of mental illness have been rising for decades, particularly in society’s most vulnerable groups. Covid-19 is making things worse, and the Centres for Disease Control and Prevention reports increased rates of depression, anxiety, substance use, and suicidal thoughts.

Measure 109 would provide a new treatment option for Oregonians by creating a legalised system for psilocybin production, distribution, and supervised administration. Campaign manager Sam Chapman said, “according to Mental Health America, Oregon has experienced the worst mental health crisis in the country, and that was before covid-19.” Gizmodo spoke with Oregon State Senator Elizabeth Steiner Hayward, a practicing family physician, to find out why. Part of the problem is a shortage of mental health professionals. Another issue is a lack of mental health parity, the equal treatment of mental health conditions by insurance companies, which makes it difficult for mental health providers to be reimbursed for their services. As a result, many mental health professionals don’t take insurance.

“We’ve done a really good job with physical health,” said Senator Steiner Hayward. “Oregon has been at the leading edge of healthcare reform and transformation for 30-plus years now, starting with the Oregon Health Plan in 1989. The challenge we face is our mental health system, which is badly broken. I don’t think anyone would dispute that.”

Many believe psilocybin-assisted therapy can help. Dr. Dow has followed the accumulating evidence on psilocybin over the past 12 years. “I think it’s very impressive, and the FDA thinks it’s impressive,” he said. “Psilocybin is relevant for Oregon’s mental health crisis, but there’s also a national and global mental health crisis where it could be helpful.”

Dow and other physicians are satisfied with Measure 109’s requirement that psilocybin facilitators and treatment centres be trained and licensed by the Oregon Health Authority. “It’s our main government agency that deals with health issues,” said Senator Steiner Hayward. “We have separate licensing boards for physicians and nurses, but OHA has a lot of experience working with health professionals and establishing rules for different types of programs.”

Dr. David Nutt, Edmond J. Safra Professor of Neuropsychopharmacology at Imperial College London, said Measure 109 “will be a step in the right direction.” He is “hopeful it will accelerate access and more clinical research by reducing the stigma and the bureaucracy related to treatment and research with psilocybin.”

Several experts said the clinical results are compelling. In one randomised double-blind trial, involving 51 participants with life-threatening cancer, psilocybin “produced large and significant decreases” in depression and anxiety while increasing optimism and quality of life. Dr. Nicholas Gideonse, a family physician and Oregon hospice director, said “we see very low rates, essentially non-rates, of dangerous or permanent side effects, and we see response rates that are really an order of magnitude greater than we see from traditional therapies.” He added, “for those experiencing depression and anxiety, particularly at the end of life, the benefit will be profound. That’s why I support it.”

Dr. Andrew Smith, an Oregon anesthesiologist, said psilocybin could be useful for treating chronic pain. Professor Nutt agreed. Like mental illness, pain syndromes are characterised by reinforcement of certain neural pathways. Potentially, “you can bypass chronic pain circuits with psychedelics, which is really promising,” said Smith. “Instead of these well-worn paths in the snow, you get a fresh shake at the snow globe, and you can create new paths. You may still have the sensation of pain, but it’s no longer associated with unpleasantness, regret, or sadness.” Nutt emphasised the ability of psilocybin to disrupt “the entrenched thinking that underpins depression” and other mental health conditions.

Many experts said psilocybin is non-toxic and non-habit forming. In a recent placebo-controlled trial with 89 participants, “there were no serious adverse events,” and psilocybin caused “no negative effects on cognitive and emotional functioning.” One literature review ranked it the least addictive and lethal drug of 20 substances studied. Fungi containing psilocybin can be purchased over-the-counter in the Netherlands, and a study commissioned by the Dutch Minister of Health concluded their availability presents few risks to individuals or public health.

Unlike drugs commonly associated with substance use disorders, including FDA-approved opioids and benzodiazepines, psilocybin has not been shown to cause dependence or problematic use. Dr. Nutt said it may even help people overcome addictions.

Still, psilocybin-based therapy might not be for everyone. Gizmodo spoke with Dr. Jordan Sloshower, a lecturer in psychiatry at Yale School of Medicine. He and Senator Steiner Hayward acknowledged that despite psilocybin’s impressive safety record, for some it could cause psychological distress. In clinical trials, participants have reported transient anxiety, transient confusion, mild and transient nausea, and transient headache. Sloshower said the treatment could exacerbate the condition of people with schizophrenia or borderline personality disorder. But he and Steiner Hayward are confident the risk could be managed with careful planning, participant screening, and ongoing support, all of which could be addressed during Measure 109’s development phase and facilitator training.

Passing Measure 109 does not mean Oregon will immediately offer psilocybin therapy. It triggers a two-year planning phase. The Governor will appoint members to an expert advisory board situated within the Oregon Health Authority. The measure requires the board to include physicians, psychologists, experts on public health, and employees from various state agencies. After the two-year development phase, the OHA will issue licenses to psilocybin facilitators and related businesses.

Despite its therapeutic promise and apparent safety, the future of psilocybin therapy is uncertain. FDA approval is years away, and disruptions of clinical research due to covid-19 may cause further delays. Experts said pharmaceutical companies could patent formulations of psilocybin and monopolise the market, which could raise prices and reduce access to this emerging breakthrough therapy.

Unwilling to wait for Congress or the FDA to act, and frustrated by the expanding mental health crisis, four U.S. cities have already decriminalised psilocybin. That means people can grow their own psilocybin mushrooms, and the cities will not spend money or other resources arresting or prosecuting them for personal use. However, decriminalisation provides no infrastructure for people to purchase psilocybin or use it with guidance. Oregon’s Measure 109 takes a different approach by creating a reliable means of access. If it passes, adults 21 and over could visit trained and licensed facilitators who provide the therapy in supportive and controlled settings. After an evaluation and screening process, facilitators will discuss participant expectations during a preparation session. On the day of treatment, the facilitator guides the participant through the experience. Days later, the client returns to discuss the treatment during an integration session.

Unlike many state cannabis laws, which allow retail sales and home cultivation, Measure 109 will not establish psilocybin dispensaries or allow residents to grow psilocybin-producing mushrooms at home. Instead, it creates a regulated system for supervised administration.

Several doctors praised this approach. “The advisory board established by Measure 109 will include a wide variety of professionals who will bring a lot to the table, and there will be opportunities to bring in other experts on an ad hoc basis,” said Senator Steiner Hayward. It will use the latest scientific evidence to design systems for psilocybin manufacturing, distribution, and administration.

Dr. Sloshower agreed the advisory board will play an important role. He urged members to develop rigorous standards for screening people prior to therapy, preparing them for treatment, and providing appropriate after care.

There are existing models for training psilocybin therapists that the advisory board could draw upon. Dr. Dow suspected OHA’s facilitator training might follow a model established by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organisation that pioneered clinical research on psilocybin-assisted therapy. Existing treatment protocols, such as the Yale Manual for Psilocybin Assisted Therapy of Depression, co-authored by Sloshower, could potentially be adapted for use in Oregon’s therapy sessions. However, the system will not materialise unless the measure passes. Hundreds of Oregonians are working hard to ensure that it does.

Back at the campaign meeting, Chapman shows a video featuring community activist Cameron Whitten, the CEO of the Portland non-profit Brown Hope. He told Gizmodo, “Our entire country is in need of healing. We are dealing with a true epidemic of mental health crises, trauma, and PTSD because we are living in a time where there is no greater level of inequality, where social unrest is a daily experience.” He said, “Black, Brown, and Indigenous communities have endured the shockwaves of historic injustice for generations,” and “one of the ways we’ve seen that is with these blanket generalisations around things like psilocybin, which have shown to provide healing and support people’s sustained mental health, and yet they are criminalised, and folks who turn to that are stigmatised.”

The campaign’s promotional videos reflect the diversity of support for Measure 109, which includes dozens of doctors of psychiatry, internal medicine, family medicine, anesthesiology, and palliative care, as well as nurses, social workers, veterans, state senators, and a U.S. Congressman.

Many supporters contributed testimonials to the Oregon voter’s pamphlet, a thick booklet distributed to voters in mid October. It describes each ballot measure and includes arguments in favour and against Measure 109. There are 11 pages of statements of support drafted by dozens of supporters. But not everyone approves of the measure.

A single argument opposing Measure 109 was submitted by the Oregon Psychiatric Physicians Association. Gizmodo spoke with the organisation’s president, Dr. Nicole Cirino, a Portland psychiatrist and certified sex therapist. She said the clinical evidence for psilocybin therapy “is promising, but it’s far from complete.”

Cirino is concerned that under Measure 109, facilitators need not have advanced degrees such as the M.D. required to become a psychiatrist. In contrast, Dr. Sloshower said he doubts that a doctoral degree is necessary to safely conduct most psilocybin therapy sessions, and he is sceptical of overmedicalising the practice by, for example, requiring that it be provided only in medical contexts by people with a narrow range of credentials. He emphasised the importance of providing access to psilocybin in ways that respect the diverse cultures and indigenous communities that developed it first. He clarified that an important exception may be when working with people with moderate to severe diagnosed mental health conditions, such as major depressive disorder or PTSD. However, he added, “I’m sure there will be some licensed [medical] providers within the Oregon system. There may be a way to funnel people with certain histories or diagnoses to particular providers, and others will go to other providers.”

Cirino also expressed concern that Measure 109 does not require a prescription to receive therapy. “If you look at the fine print of the measure, you don’t even need a mental health diagnosis to receive the psilocybin treatment,” she said. Dr. Dow said that is by design. It was important to the measure’s chief petitioners, psychotherapists Sheri and Tom Eckert, to avoid over medicalising psilocybin therapy. In 2019, Tom Eckert told the Oregonian, “psilocybin services might also be accessed for personal development . . . to enhance a general sense of well-being, openness and creativity, and spiritual connectedness.”

Dustin Marlan, law professor at the University of Massachusetts School of Law, believes that allowing fair access to psilocybin is a matter of social justice. He said, “Beyond the medical paradigm, psilocybin reform implicates cognitive liberty, meaning that people should have the right to alter their own consciousness. Measure 109 can also be thought of as furthering neurodiversity — the belief that atypical cognitive preferences, such as the desire to access altered states of consciousness via psilocybin, should be respected as a source of creativity and spirituality, not stigmatised and criminalised.”

Dr. Nutt shares Cirino’s concern that therapy might be delivered by non-medically trained people without sufficient safeguards. However, he said Oregon should not wait for psilocybin-therapy to be FDA approved before moving ahead with Measure 109. “There is plenty of safety and efficacy data already, and it may be many years before these trials read out, in which time many patients will have suffered and some committed suicide.” He hopes Measure 109 will establish “a high-quality system of therapist training and supervision” and that “psychiatrists will become a part of this.”

Other doctors do not share Cirino and the OPPA’s concerns. “I don’t see how their safety concern is legitimate,” said Dr. Dow. “The measure addresses the safety concerns just as much as the licensing of psychiatrists does. Psychiatrists have to go through a licensing process,” as do other kinds of mental health providers “such as psychiatric physician assistants and psychiatric nurse practitioners.” He added, Like in any other profession, “there is potential for people to do harm by being kind of reckless in how they do things.” However, “the two-year development period and advisory panel are a very thoughtful approach.” Senator Steiner Hayward agreed, stating, “I’m a little hard pressed to understand the opposition really well.”

Some doctors felt the OPPA’s opposition to Measure 109 might be motivated by factors other than patient safety. “I think the Oregon Psychiatric Physicians Association understands that this [Measure 109] is hazardous to their profession and their incomes,” said Dr. Dow. Others mentioned a history of turf wars that could be influencing the OPPA. “They get threatened,” said Dr. Heather L. Stein, a Portland clinical psychologist. “When there was a move to have psychologists get prescription privileges here in Oregon, they really wanted to shoot in down because they are threatened by the competition. They are concerned that it will dilute the practice,” she said. The push for prescribing privileges for psychologists “didn’t go anywhere, in part because they [the OPPA] had good lobbyists.”

Cirino says psilocybin must be tested in thousands of people before it can be considered safe. But while some approved drugs undergo that much clinical testing, not all do. In 2019, the drug Zulresso was approved for treating postpartum depression, largely based on two phase 3 trials that included a total of 246 participants. Zulresso, costing up to $US35,000 ($49,158) per dose, can have side effects including “excessive sedation and sudden loss of consciousness,” according to an FDA warning. Cirino is among those who champion Zulresso’s use despite its phase 3 testing in fewer than 250 people.

By comparison, “we have 40 years of experience researching psilocybin,” said Senator Steiner Hayward, referring to the decades of research before the DEA’s ban and growing but limited research commenced decades after prohibition. Moreover, “people have been using it for thousands of years without serious adverse effects.” Several experts argued that indigenous experience using psilocybin and other psychedelics safely should be trusted and respected.

Dr. Sloshower, who leads a psilocybin trial at Yale, stated “it’s almost impossible to overdose.” Moreover, across all the trials conducted at Yale, NYU, and Johns Hopkins, he wasn’t aware of any adverse reactions requiring medical intervention. Dr.Nutt added, “it’s been used in many hundreds of patients with few if any significant adverse effects.”

Some physicians questioned whether Dr. Cirino’s opinion reflects the views of the psychiatrists she represents as OPPA President. When Chapman approached the organisation to provide an information session to its membership, the OPPA directors refused his offer. Dr. Cirino declined to comment on who made the decision to oppose Measure 109.

Senator Steiner Hayward said, “I appreciate Dr. Cirino’s concerns. You know, to a carpenter, every problem looks like a nail. I’m not saying that Dr. Cirino and her colleagues are short sighted, but I think they are trained to think about these problems in one specific way and trained to understand how to deliver these services in one specific way.”

Cirino also expressed concerns that psilocybin therapy should not be provided by ballot measure, stating: “We can’t vote on the newest treatment for hypertension, or the newest treatment for migraines, why then should we vote through majority opinion on access to a medication?” But ballot initiatives have a fascinating history that puts this issue in perspective. Their roots date back to the 1600s, when New England colonists voted on town ordinances.

In the early 20th century, ballot initiatives gained popularity as a means for ordinary people to oppose corporations and other wealthy groups with deep pockets to influence legislators. In recent years, the healthcare and pharmaceutical sectors have spent more money on lobbying than any other industries, an average of $US233 ($327) million per year between 1999 and 2018.

The OPPA’s parent organisation, the American Psychiatric Association, also opposes Measure 109. It straddles a fine line between being a healthcare-related nonprofit and a labour organisation that protects the interests of psychiatrists. In 2008, Congress investigated the association out of concerns it was susceptible to pharmaceutical company influence. According to the New York Times, in 2006 “the drug industry accounted for about 30 per cent of the association’s $US62.5 ($88) million in financing.” Its president, Dr. Saul Levin, declined a request for interview or comment.

Commercialising psilocybin is big business. Analysts project the market for commercialised psychedelic therapies to reach $US6.8 ($10) billion by 2027. Experts said that if Measure 109 passes, it could threaten companies developing and patenting psilocybin therapies such as Compass Pathways, a UK-based company backed by Silicon Valley venture capital. Measure 109 could be a way for Oregonians to maintain some measure of influence over psilocybin therapy, ensuring access to a treatment that might otherwise be swallowed up and controlled by large corporations.

“I’m inclined to support it,” said Dr. Sloshower. “Especially as you’re seeing Compass Pathways and other entities that are trying to set up their brand of clinics. It’s important for there to be a diversity of different service provision models out there, especially ones that are more community based. To that extent I think it’s going to be interesting because this [Oregon measure] will be a different model than just one big for-profit company trying to be the main psilocybin provider across the country.”

Oregon is known for passing innovative healthcare ballot measures. In 1994, voters approved Measure 16, Oregon’s death with dignity initiative, which legalised physician-assisted suicide. It passed by over half a million votes. Other states, including Washington and California, followed its example. Many Oregonians take pride in their state’s record as a healthcare innovator. “I’m thrilled to be living in a state that thinks outside the box,” said Dr. Stein.

With Measure 109, many Oregonians hope to bring the state’s ailing mental healthcare system in line with its more robust physical healthcare programs. “I want every Oregonian who is suffering to have this option available to them, to do it in a safe, secure setting with people that care and have their best interest in mind and can help them through the process,” said retired Navy SEAL Kuske.

Dr. Stein asks Oregon voters: “Are you willing to give people who are committed to helping and healing others an opportunity to create a program that could positively impact others and trust that we’ll be doing it ethically, humanely, carefully, and slowly?” Senator Steiner Hayward added, “we don’t have enough options for people with persistent mental illness. Almost everybody knows somebody who is struggling with a mental health challenge, and almost everyone knows somebody who has not gotten the relief they deserve from traditional therapies. I’m not saying psilocybin is going to fix every one of those problems. I am saying, I think people should be open and allow people the opportunity to pursue something like this legally, as effectively as possible, through trained facilitation. I’m hard pressed to see a downside, and I see a lot of potential upside.”

Mason Marks, MD, JD is a law professor at Gonzaga University and the Edmond J. Safra/Petrie-Flom Centre joint fellow-in-residence at Harvard University.

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