The Oregon Psilocybin Advisory Board (OPAB)— a review panel appointed to oversee the implementation of Measure 109 — submitted its first report, saying “psilocybin is efficacious in reducing depression and anxiety, including in life-threatening conditions.”
Oregon entered a two-year programme to develop a regulatory framework on January 1, 2021, after Oregonians voted in favour of ballot Measure 109 last November, legalizing psilocybin for medical use. Following that, Gov. Kate Brown appointed the board in March to carve out the administrative regulations for the state’s psilocybin therapy model, also allotting $5.6 million for the measure’s implementation in the 2021-23 budget.
The advisory board met its initial deadline, submitting recommendations to the Oregon Health Authority (OHA), which was due on June 30, studying the available medical, psychological, and scientific studies related to the safety and efficacy of psilocybin for treating mental health issues. The report was made available to the public on July 29.
“I want to thank the Oregon Psilocybin Advisory Board for their tremendous work in delivering these findings and recommendations to OHA. As we continue in the development period for psilocybin services, this report will serve as an incredible resource,” Angie Allbee, Manager of the Psilocybin Services Section at the Oregon Health Authority Public Health Division tells Truffle Report.
The advisory board — composed of 17 members — noted, “The FDA has designated psilocybin a breakthrough therapy for treatment of depression, indicating that preliminary clinical evidence suggests it may represent a significant improvement over existing therapies.”
“Initial research also suggests that psilocybin may be efficacious in reducing problematic alcohol and tobacco use,” the review and recommendations report says. “Across studies, psilocybin increases spiritual well-being which may mediate other observed benefits. Study participants also commonly rate their psilocybin experiences as highly meaningful,” it adds.
“This is a significant step forward, as the finding and recommendations from the advisory board will help us develop a comprehensive regulatory framework for psilocybin services,” Allbee says.
“This report represents the first time a state government has done a thorough review of the available research demonstrating the efficacy of psilocybin in treating depression and anxiety, as well as substance use disorder. It’s another proof point in the growing evidence that psilocybin can be an effective treatment for treatment, healing and growth,” says Sam Chapman, Executive Director of The Healing Advocacy Fund. Chapman led the Measure 109 ballot campaign.
The first report was focused on studying “high quality published works”, answering questions formed around the potential benefits, risks of psilocybin in controlled and uncontrolled settings for treating mental health issues like depression, anxiety, trauma and palliative care. The psilocybin advisory board also delved into studying risk assessment tools and risks/benefits associated with different sources of psilocybin.
“As was designed in Measure 109, this research will now be the foundation for creating the regulatory framework Oregon voters approved last November for the introduction of a psilocybin services program in 2023,” Chapman says. “We believe this research will guide a thoughtful and comprehensive psilocybin services program that makes a powerful therapy legal and accessible to people across a spectrum of mental health needs, from well-being to prevention of symptoms to those with a mental health diagnosis,” he tells Truffle Report.
This report will also be made available for public comment in August.
Oregon Psilocybin Advisory Board Recommendations:
1. To end evidence inequity, Oregon Health Authority (OHA) should gather additional information from individuals, communities, and institutions not represented in Western scientific literature (e.g., those administering psilocybin in cultures with longstanding practices and others with experience administering psilocybin in the community) to aid in developing best practices for a psilocybin services framework that maximizes equity and potential benefits and minimizes risks.
2. The OHA should consider strength of evidence and risk of bias in developing a psilocybin treatment framework, particularly given the early stage of most psilocybin treatment trials.
3. OHA should consider commissioning an ongoing review (a.k.a. “living review”) mechanism to periodically summarize updates in the field of psilocybin research as they arise, given the rapidly evolving evidence base for psilocybin potential benefits and risks.
4. OHA should consider how consumers and providers of psilocybin services are informed of the potential negative effects that can occur during and after psilocybin administration (e.g., citizen education initiatives and informed consent process for consumers; incorporation of common acute and rare long-term adverse events into training, licensing, and ongoing continuing education processes for providers).
5. Because there is evidence of dose dependence of the potential benefits and risks of psilocybin, OHA should support the development of guidance regarding optimal dosing parameters to minimize these negative effects and consider how this knowledge should be disseminated to psilocybin providers and consumers (e.g., during provider training and licensing and/or via product monitoring and control).
6. OHA should consider the role of screening processes to identify individuals at higher than usual risk of negative physical and psychological effects of psilocybin and how to use this information to promote safety while preserving equitable access.
7. Given the limited generalizability of currently available clinical trials, OHA should explore the feasibility of developing a voluntary process and outcome measures for ongoing monitoring of psilocybin services implementation in Oregon, including consensual assessment of implementation in key population subgroups (e.g., by race/ethnicity, gender, and comorbid medical conditions), indications for psilocybin services, psilocybin exposure (e.g., amount and source type of psilocybin), and condition-specific outcome measures to help inform safety and equitable access to psilocybin services. Declining to share information should not affect access to psilocybin services, and the optional nature of the data sharing should be prominently emphasized during the informed consent process.
8. OHA should consider the range of research on cultivating and characterizing psilocybin-containing mushrooms (e.g., genotyping to confirm identity, methods for measuring psilocybin concentration) in developing a regulatory framework.
9. Because of toxicity concerns, OHA should initially consider prioritizing cultivation of Psilocybe cubensis and use of grain-based substrates for cultivation rather than dung or wood, and revisit cultivation of other species as more information becomes available.
10. OHA should explore feasibility and capacity of employing modern DNA sequencing-based techniques to identify fungi and fungal tissues for use in production licensing and quality control.
11. OHA should facilitate the development of screening requirements for possible mushroom contaminants. These may include the following:
- Residual solvents and/or disinfectants used in the extraction or sterilization processes
- Toxic metals, pesticides, antibiotics, herbicides, livestock medications, and other potential bioaccumulation contaminants from growth substrates or direct application
- Pathogenic microbes (bacteria, viruses, parasites, other fungi) and microbially produced toxins.
