Person examining psilocybin mushrooms in lab.

When the Promises of a Policy Do Not Meet the Reality of Its Practice: Ethical Issues Within Oregon’s Measure 109

By Tahlia Harrison

As a practicing therapist in Oregon working with complex trauma survivors, I was optimistic at first about the passage in 2020 of Measure 109 and its promise of legalizing psilocybin-assisted therapy. Psilocybin has been shown in small samples to be an effective intervention for many challenges my clients face; I was excited about this option to further support their healing. As a bioethicist and researcher examining topics related to psychedelic-assisted therapy, and a former faculty member at one of the psilocybin facilitation programs, Measure 109 also brought feelings of trepidation and a flood of questions such as: Would my national associations be amenable to this intervention? Would my liability insurance provide coverage? What about the ethics of engaging clients in a treatment involving a federally illegal substance? What about informed consent and other ethical issues? While the current informed consent form used by facilitators does address some aspects of concern (like the use of touch, 333-333-5040 (9)), it does not address other aspects like suggestibility or power dynamics within the facilitator/client relationship. Additionally, the form states “I understand that psilocybin services do not require medical diagnosis or referral and that psilocybin services are not a medical or clinical treatment,” yet it is reported that many are still seeking this as part of treatment for a medical diagnosis. How do multiple licensures apply to understanding scope of practice? Three years later, many of these questions remain unanswered, and the option of offering psilocybin-assisted therapy remains illegal and off the table.

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Person examining psilocybin mushrooms in lab.

Microdosing Under the Oregon Psilocybin Services Act: A Definite Maybe

By Dave Kopilak

In November 2020, Oregon voters passed the Oregon Psilocybin Services Act (the “Act”), of which I was the primary drafter. This piece of legislation legalizes and regulates the manufacturing of psilocybin products and the provision of psilocybin services under Oregon law. The manufacture, sale, and use of psilocybin products under the Act will continue to be illegal under federal law.

The Oregon Health Authority (OHA) is the state agency that will regulate the program. The Act provides for a two-year program development period that began on January 1, 2021 and that will end on December 31, 2022. The OHA is currently engaged in the rulemaking process and will adopt final rules by no later than December 31, 2022. The OHA will begin receiving license applications on January 2, 2023, and the first licensed businesses likely will begin operating in the first half of 2023.

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

What Macrodosing Can Learn from Microdosing

By Dustin Marlan

Following a recent wave of unbridled positivity culminating in a “shroom boom,” the psychedelic renaissance now finds itself under fire amidst concerns of predatory capitalism, cultural appropriation, adverse psychological effects, and sexual abuse and boundary issues by guides and therapists.

Nonetheless, the psychedelics industry is moving ahead at full speed. Oregon will begin accepting applications from businesses to run psilocybin service centers in January 2023. MDMA clinical trials are nearing completion and expected to result in FDA approval. And corporations are readying psychedelic compounds — natural and synthetic — to produce and deliver to the masses.

All of this begs the question of how psychedelics dosage should be regulated, particularly where, as journalist Shayla Love points out, “there’s reason to worry that there hasn’t been enough preparation for negative outcomes amidst the hype.”

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LSD Microdosing. Small or micro doses of LSD drug cut from a tab, presented on a finger.

A Precise Definition of Microdosing Psychedelics is Needed to Promote Equitable Regulation

By Sarah Hashkes

When we talk about microdosing psychedelics, it’s important we have a mutual understanding of its definition to be able to conduct accurate research, promote regulations, and educate the wider population. This article will look at three main questions and ambiguities regarding the term “microdosing psychedelics” and suggest a definition that would help promote coherence in the field.

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Mushrooms containing psilocybin grow in the forest.

Washington Psilocybin Bill Would Legalize Supported Adult Use

By Mason Marks

On Tuesday, Washington State legislators filed SB 5660, a bill that would legalize the supported adult use of psilocybin by people 21 years of age and older.

Sponsored by Senators Jesse Salomon and Liz Lovelett, the bill, known as the Washington Psilocybin Wellness and Opportunity Act, includes many innovative features including a Social Opportunity Program to help address harms caused by the war on drugs, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home.

I had the privilege of helping to draft the Washington Psilocybin Services Wellness and Opportunity Act with input from the Psychedelic Medicine Alliance of Washington and my colleague John Rapp of the law firm Harris Bricken. We had previously collaborated on the psychedelic decriminalization resolution adopted unanimously by the Seattle City Council.

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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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America divided concept, american flag on cracked background.

Can Psychedelics Help Save America?

By Shelby Hartman

Amid a fractured political landscape, an unprecedented pandemic, and a reckoning with the country’s racist past, psychedelics may offer some hope for healing in the United States. In recent decades, a renaissance of psychedelic drug research has grown at prominent institutions like Johns Hopkins, New York University, and Imperial College London, among others.

Psilocybin, the psychoactive component in psychedelic mushrooms, and MDMA, sometimes confused with its adulterated version, ecstasy, have both been given breakthrough therapy status by the Food and Drug Administration (FDA), because they’ve shown so much promise for treating conditions for which we currently have few effective options. Psilocybin for treatment-resistant depression and MDMA for post-traumatic disorder are projected to be legal within the next five years as drugs that will be administered under the supervision of trained therapists.

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Police cars.

The False Promise of City-Wide Psilocybin Decriminalization

By Kathryn Lucido

While city-wide decriminalization of psilocybin is a positive step toward decreasing the impact of the war on drugs, it also creates a false sense of security and progress.

Citing new research that illustrates the therapeutic promise of the drug, several U.S. cities have decriminalized psilocybin, a psychedelic compound that occurs naturally in some fungi. Though these cities have pledged not to spend resources prosecuting people for psilocybin possession, and, in some cases, limited distribution, the substance remains illegal at the federal, state, and city levels.

Psilocybin remains a Schedule I drug under the Controlled Substances Act. This classification means that — at least according to Congress and the Drug Enforcement Administration — psilocybin is a dangerous drug with no currently accepted medical uses and a high risk for abuse.

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two watercolor silhouettes.

Neurodiversity and Psychedelics Decriminalization

By Dustin Marlan

Following over fifty years of the racist and corrupt war on drugs, drug decriminalization is now a social justice issue. As I explore in Beyond Cannabis: Psychedelic Decriminalization and Social Justice, the decriminalization of psychedelic drugs, in particular, is a matter of diversity, equity, and inclusion.

Psychedelics have long been prohibited under Schedule I of the federal Controlled Substances Act. However, after successful efforts in Denver, Oakland, Santa Cruz, and Ann Arbor, there are now attempts underway to decriminalize psilocybin mushrooms and other natural psychedelics in over 100 cities across the country, including Washington, D.C., which will vote on Initiative 81 in November 2020.

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man lying on couch.

Psychedelics and America: A Digital Symposium

By Mason Marks

In 2020, the psychedelics research and policy reform renaissance is in full swing. Prohibited by federal law since the 1970s, psychedelic substances can alter how people see themselves, the world, and those around them. Clinical trials suggest they may help people overcome ingrained thought patterns associated with depression, anxiety, and addiction.

Acknowledging their spiritual and therapeutic potential, universities have established new psychedelics research programs. The Food and Drug Administration (FDA) has deemed them breakthrough therapies for depression and post-traumatic stress disorder. This designation means they could be significant improvements over traditional treatments such as selective serotonin reuptake inhibitors (SSRIs). Accordingly, the FDA has put some psychedelics on an accelerated course toward approval. Eventually, they could help millions who have not benefitted from existing therapies.

However, despite their breakthrough status, psychedelics will not become FDA approved for several years. Meanwhile, the COVID-19 pandemic is making the country’s mental health crisis worse. According to the Centers for Disease Control and Prevention, rates of depression, anxiety, substance use, and suicidal thoughts have risen in the past nine months.

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