Colorado governor announces Natural Medicine Advisory Board appointees, new bills in Utah and New York, and reforming the “regulatory blackhole” of U.S. drug scheduling
Plus: The World of Psychedelics, Improving cancer patients’ well-being, and FDA approval for MDMA by 2024?
Happy Friday, and welcome back to The Microdose, an independent journalism newsletter supported by the U.C. Berkeley Center for the Science of Psychedelics.
The State of Psychedelics: Colorado governor announces Natural Medicine Advisory Board appointees; new bills in Utah and New York
Colorado has taken the next step towards implementing Proposition 122, the ballot measure passed in November 2022 that establishes psilocybin services in the state: Governor Jared Polis has announced his appointments to the Natural Medicine Advisory Board. The 15 member board will advise the state’s Department of Regulatory Agencies on creating new rules for the state’s psilocybin program.
While the group includes a few members with experience working with psychedelics or marijuana, many were appointed to represent other perspectives, such as first responders, veterans, and issues related to healthcare disparities. In his newsletter Psychedelic Week, attorney Mason Marks compiled short biographies of each board member.
Salt Lake City’s news station FOX13 reports that Utah’s senate minority leader Luz Escamilla (D) plans to file a bill creating a program for people with depression, PTSD, or anxiety to access psilocybin therapy.
This week, New York Senator Nathalia Fernandez (D) introduced Senate Bill 3520, which would provide state-level protections to facilitators administering psilocybin-assisted therapy. It would also provide grant money to help veterans, first responders, and low-income individuals access psilocybin- and MDMA-assisted therapy, and establish a state psilocybin assisted therapy program. This is the second psychedelics-related bill being considered by New York lawmakers; the other, A00114, would allow for personal possession and use of “natural plant or fungus-based hallucinogens.”
Reforming the “regulatory blackhole” of U.S. drug scheduling
Classic psychedelics like psilocybin, MDMA, and LSD are all Schedule I drugs, meaning they are considered by the federal government to have the highest potential for abuse and no accepted medical use. “Schedule I is something of a regulatory blackhole, meaning that once substances enter, they are almost never rescheduled,” legal experts Carmel Shachar and Mason Marks write in a new paper published in Nature Medicine. They review the three major avenues to rescheduling a drug — legislative, regulatory, and judicial — and argue that functionally, regulatory changes through federal agencies like the Department of Health and Human Services and the Federal Drug Administration are the only viable avenue for rescheduling drugs.
Psychedelics’ scheduling is also a major barrier to more research, write Marks and Shachar, and point to a federal appropriations rider prohibiting federal funds from supporting activities that promote the legalization of schedule I drugs. “This rider likely discouraged federal agencies, such as the National Institutes of Mental Health, from supporting psychedelics research,” Marks and Shachar write. This lack of government funding forces academics and non-industry researchers who lack the backing and capital of major companies to seek private donors instead. In this system, Indigenous communities are at a disadvantage as well as companies patent findings without acknowledging the role of long-held Indigenous traditions and knowledge.
The authors recommend changes to the drug scheduling process to better facilitate research, including increasing funding and mandating periodic review of Schedule I substances for possible reclassification. “The regulatory blackhole at the intersection of scheduling, research, and patents should be dismantled,” they write.
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Improving cancer patients’ well-being
Receiving a cancer diagnosis is life-changing, and many people report struggles with mental health as they undergo treatment and process what their illness means for them. In a study published in the most recent issue of the Journal of Affective Disorders, cancer patients diagnosed with major depressive disorder experienced positive psychological, social, and spiritual change after receiving psilocybin-assisted therapy. These thirty study participants were treated at Aquilano Cancer Center in Maryland. In advance of the dosing session, participants attended group prep sessions, and they all received their dose at the same time (in separate rooms), followed by group integration sessions.
Researchers measured changes in participants’ scores on a measure called NIH-HEALS, which is designed to capture three major factors: capacity for connection; reflection and introspection; and trust and acceptance. Participants in the study showed improvements in all three, and the researchers report that those positive effects held eight weeks after dosing. (For more about cancer patients’ experiences with psilocybin-assisted therapy, read our 5 Questions for study co-author Manish Agrawal.)
The World of Psychedelics
Last week, Mexican senator Alejandra Lagunes announced that she would be introducing a bill in the country’s Senate that would legalize psychedelics and make them available for medical treatment. According to Marijuana Moment, Lagunes spoke at a forum the Mexican Senate held the first Foro Intercultural de Medicina Enteógena (Intercultural Forum of Entheogenic Medicine) to bring together Indigenous peoples and the scientific community.
Lagunes’s comments were accompanied by a recorded statement from Oregon state representative Earl Blumenauer, and on Twitter, Lagunes thanked Blumenauer as well as Olmeca leader and traditional medicine expert Santiago Ortela and researchers such as Zara Snapp and Victor Angel-Mosti, legal expert Jesús Alonso Olamendi, as well as U.S.-based psychedelic authorities, like Oregon Psilocybin Service’s section manager Angela Allbee and MAPS policy director Ismail Ali.
Meanwhile, in Australia, researchers announced the country’s biggest psilocybin clinical trial yet. Later this year, Swinburne University in Melbourne will undertake a study investigating the drug’s potential in treating depression.
FDA approval for MDMA by 2024?
As part of their ongoing 2022 reflections, Psychedelic Alpha published a piece this week reviewing two of the biggest clinical trial results announced last year: MAPS’s second phase 3 MDMA trial for PTSD, and COMPASS’s phase 2b psilocybin therapy for treatment-resistant depression.
Based on those results and public statements from MAPS and COMPASS, they make two noteworthy predictions: first, Psychedelic Alpha lays out the potential timeline for MDMA receiving FDA approval, which would take place, “at the earliest, in 2024,” they write.
The second: it appears COMPASS might scale back the amount of therapy — or, as the company calls, it “psychological support” — provided alongside psychedelic dosing sessions to reduce costs. The shortage of therapists, especially those trained in psychedelic-assisted therapy, will only serve to drive costs up, and BrainFutures Director of Program Operations Jazz Glastra wrote about that issue and its potential solutions in another piece for Psychedelic Alpha’s 2022 Year In Review.
Here’s what Oprah thinks you should know about psychedelics.
Baylor University is launching a new program to explore the ethical, legal, and social implications of psychedelics research and therapy.
To help those having difficult trips, personal experience with psychedelics is crucial, Chris Kilham argues in an opinion piece for Lucid News. Kilham encourages people in psychedelic-assisted therapy training programs to have those experiences. “As Ken Kesey and the Merry Pranksters used to say, you’re either on the bus or you’re not,” he writes.
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Wonderful curation of information, thank you all for this important work.
This week in Australia
https://www.abc.net.au/news/2023-02-03/tga-approves-psilocybin-mdma-for-treating-depression-ptsd/101929578Call