Marcelo Leite, Ph.D

Despite political and bureaucratic obstacles, controlled use of psychedelics should begin in 2023

Over four intense days, from September 15th to 18th, at the Portland Museum of Art, Oregon, nearly 900 people attended the first Horizons psychedelic conference outside of New York, Horizons Northwest. They were interested in pioneering the controlled use of psilocybin from so-called “magic” mushrooms in the northwestern US state. This controlled use should start in the middle of 2023.

Oregon’s model for decriminalizing psychedelics differs from the path taken by medical cannabis, with its dispensaries and prescriptions, and from the path favored by researchers, companies, and other activists taking part in the revival of psychedelics, who aim to get mind-altering substances approved by the Food and Drug Administration (FDA) as aids to health insurance-funded psychotherapy.

Researchers have studied psilocybin to treat mental disorders, especially depression, with phase 3 clinical trials in preparation. Another promising area is addiction, as in the case of alcohol. Next to MDMA (the basis of ecstasy) for post-traumatic stress disorder (PTSD), it is the psychedelic which is most advanced on the official drug approval path, which can take several years and tens of millions of dollars.

A MAJORITY OF OREGON VOTERS (56%), WITH 1.3 MILLION VOTES CAST IN NOVEMBER 2020, APPROVED BALLOT MEASURE 109, TO ESTABLISH “PSILOCYBIN SERVICES” WITHIN TWO YEARS.

A majority of Oregon voters (56%), with 1.3 million votes cast in November 2020, approved Ballot Measure 109, to establish “psilocybin services” within two years. An advisory committee was created to propose to the Oregon Health Authority (OHA) a regulation, which is in the final stage of public consultation for adoption in December.

Many details remain to be defined, but the general plan is already clear. Persons over 21 would receive doses of the order of 20 to 30 mg from a licensed “facilitator” who would have completed 120 hours of training in accredited courses (candidates requiring only two-year Oregon residence and completion of high school).

Only one psilocybin-containing mushroom species, Psilocybe cubensis, can be used though there are over 200 that produce the psychedelic. Fungi production facilities must also be licensed, and all samples will be genetically tested by authorized laboratories.

“This therapy is impressive,” praised Representative Earl Blumenauer, 74, representative of Oregon in the US Congress, in the museum’s auditorium. “A new era is opening up in the state, with great potential for impact. It is a foundation on which to build.”

“I feel [we have] very much of a community here,” said Tom Eckert, one of the creators of 109 — alongside his wife Sheri, who died in 2020, weeks after the measure was passed. “Shoulder to shoulder, looking toward the horizon. Our vision was not of statutes or regulations, but of people.”

“An impressive revolution” said Bia Labate, present at the event. Bia is a Brazilian anthropologist who founded and directs the Chacruna Institute, responsible for portals on power plants in English and in Portuguese and Spanish. She added: “What? Psilocybin products?” rubbing her eyes to signal surprise at the pace of regulation of substances which have been used for centuries or millennia by traditional peoples.

To ease access to mushrooms for those who are suffering, today, 109 proposes to remove them from strict control by the clinical status. Shamans, healers, naturopaths, or anyone else will be able to administer psilocybin without a doctor’s prescription, as long as they do so in a licensed facility with the same traceable product. However, the sessions will not be allowed to be called “(psycho)therapy.”

SHAMANS, HEALERS, NATUROPATHS OR ANYONE ELSE WILL BE ABLE TO ADMINISTER PSILOCYBIN WITHOUT A DOCTOR’S PRESCRIPTION, AS LONG AS THEY DO SO IN A LICENSED FACILITY WITH THE SAME TRACEABLE PRODUCT.

Hence the preference of the new regulation for generic terms such as “facilitators” (instead of therapists) and “services” (instead of treatments). However, before and after dosing, “preparation” and “integration” sessions will be required, the precise terms derived from the psychotherapy protocols supporting the psychedelics under investigation by academic institutions. This may give rise to misunderstanding by the public.

The zeal to prevent psilocybin services from being confused with therapy is such that the draft rules prevent psychologists and doctors from presenting themselves as such in case they act as facilitators. They will need to take the regular course, like anyone with a high school diploma, and will only be able to give psilocybin to “clients” (not patients) in approved facilities.

In the discussions at the Horizons Northwest conference, it became clear that many consider regulation to be overly bureaucratic and artificial. Angie Albee, who leads the Oregon Health Authority’s Task Force on Psilocybin Services, believes this is the price to pay for prioritizing the safety of those treated with mushrooms.

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In addition to safety and easing the access to the mental benefits of mushrooms, 109 also places an apparent emphasis on equity. In other words, it intends to make both the substance and the authorization to administer it to interested parties accessible to many, in a legal way (there were always those who applied it clandestinely; psilocybin is subject to a federal ban), and not only the well-paid medical professionals.

This is where another problem discussed at the event comes from, the costs. The fee to obtain a facilitator license will be $2,000. To license a production, test or application site, each developer will have to shell out $10,000. The values ​​were established based on the Oregon Health Authority budget, which has to be covered by its own resources.

As a result, it is estimated that each treatment of three sessions to use psilocybin in one of them will cost between $1,500 and $2,000. Considering that the expense will not be covered by health insurance until the federal ban falls, the “service” will not be within the reach of most citizens—who may have difficulty understanding why this is not a therapy and cannot be paid for by insurers.

Concerned about the high costs, Tom Eckert created a foundation in the name of his deceased wife to offer grants to facilitators who cannot afford training courses (such as the Inner Trek company he started). Ways are also being sought to assist entrepreneurs to pay fees to license mushroom application, production, and testing facilities.

Despite the difficulties, a tone of optimism prevailed at the Horizons Northwest conference. Graham Boyd of New Approach, an initiative supporting popular proposals to decriminalize cannabis and psychedelics, predicted that within five years up to 50% of the US population might have access to MDMA for treatment, and perhaps psilocybin.

GRAHAM BOYD OF NEW APPROACH, AN INITIATIVE SUPPORTING POPULAR PROPOSALS TO DECRIMINALIZE CANNABIS AND PSYCHEDELICS, PREDICTED THAT WITHIN FIVE YEARS UP TO 50% OF THE US POPULATION MIGHT HAVE ACCESS TO MDMA FOR TREATMENT, AND PERHAPS PSILOCYBIN.

Boyd recommended keeping a detailed record of both successes and adverse events in psilocybin services. The idea is to be able to later show, with facts and figures, that the problems are rare and the benefits many, as was the case with medical marijuana. Researchers such as Robin Carhart-Harris and Brian Anderson also recommended paying attention and giving transparency to the issue of risk, however uncommon as it may be.

In fact, learning from the Oregon experience has already begun, even before it goes into full effect (license applications will begin to be reviewed in January, and the first services are expected to be authorized in mid-2023). On November 8 the state of Colorado will vote on the National Minority Health Association (NMHA) project, which extends the M109 proposal to include other features.

Among other innovations, the legislative proposal includes immediately decriminalizing the possession and cultivation of small amounts of natural psychedelics such as DMT, psilocybin, ibogaine, and mescaline (except the peyote cactus), for personal use or donation. Regulated services would start with psilocybin, as in Oregon, but it is planned to expand to these other entheogens and create funds to pay for licenses and the consumption of these substances for those on low-income.

Even the US federal government is beginning to show signs of interest in psychedelic therapies. The US—like so many others in these times of COVID-19, a reheated Cold War, and the precariousness of work and income—is facing a mental health crisis with no solution in sight along the dominant clinical and pharmacological paths.

A new era, indeed, seems to be beginning in Oregon. It may not be that of Aquarius, which the hippies of the 1960s/70s tried to initiate in their own way by dropping out of the system, but who knows, we may be in the Cubensis Mushroom Era, an armistice in the failed War on Drugs achieved along the well-behaved route of citizens’ initiatives and popular referenda.

This article was originally published in Portuguese by Folha de S.Paulo in the blog Virada Psicodélica, HERE.

Translation by John Milton.

Art by Mariom Luna.


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