Ninth Circuit Court of Appeals rules in favor of psilocybin rescheduling petition; Massachusetts ballot initiative advances; new psychedelic ballot initiative in California; and MindMed patents
Plus: 2024 DEA quotas for research and including shamans in psychedelic science
Happy Friday, and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
Ninth Circuit rules in favor of psilocybin rescheduling petition
Last week, the U.S. Ninth Circuit Court of Appeals ruled in favor of Seattle-based physician Sunil Aggarwal and his team of lawyers, who submitted a petition for the court to review the Drug Enforcement Administration’s rejection of a previous petition to move psilocybin from Schedule I to the slightly less restricted Schedule II. The DEA defines Schedule 1 as substances that have “no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.”
The petition is the latest in Aggarwal’s years-long legal battle to gain access to psilocybin for several cancer patients in his care through federal Right to Try laws, which allow terminally ill patients to try investigational drugs that haven’t yet been approved by the U.S. Food and Drug Administration. Aggarwal initially reached out to the DEA for guidance on how to access psilocybin, a Schedule I drug, to treat his patients, and the DEA responded that Right to Try laws do not override the restrictions placed on Schedule I drugs. The DEA therefore did not grant Aggarwal an exemption to access psilocybin.
In their decision, the Ninth Circuit Court judges wrote that in the DEA’s denial of Aggarwal’s rescheduling petition, the agency “failed to ‘clearly indicate that it has considered the potential problem identified in the petition’” and stated that the DEA did not adequately explain why it rejected Aggarwal’s request. “We thus remand for the DEA to either clarify its pathway for denying Aggarwal’s petition or reevaluate Aggarwal’s petition,” they conclude.
Kathryn Tucker, an attorney representing Aggarwal, called the ruling “a clean, clear win for the petitioners,” who are now considering their next steps. “With issuance of this decision, the stay on the Right to Try appeal will be lifted and that matter will go forward,” she says.
The State of Psychedelics: Massachusetts ballot initiative advances, new psychedelic ballot initiative in California
A Massachusetts psychedelics ballot initiative is one step closer to being on the state’s 2024 ballot. The Natural Psychedelic Substances Act, first submitted to the state in August, would allow people in the state to possess, ingest, obtain, transport, and cultivate of less than two grams of psilocybin, psilocin, DMT, ibogaine, and mescaline. A Boston Globe article published last Friday mentioned that the initiative had reached 75,000 signatures, which would mean that it has cleared its first hurdle.
New Approach, the political action committee behind the initiative, confirmed the milestone. Jared Moffat, the organization’s deputy policy director, told The Microdose that they are working with the state’s 350 town clerks to review signatures, which they’ll then submit to the Massachusetts Secretary of State before the early December signature submission deadline for ballot initiatives. After that, the Massachusetts legislature will review the initiative; they can choose to pass the measure for inclusion on the 2024 ballot, propose a substitute, or take no action. In the event that they take no action, the initiative’s organizers would then need to collect an additional 12,429 signatures.
On the heels of Governor Newsom’s veto of Senate Bill 58, psychedelics advocates in California announced a new psychedelics ballot initiative. Dave Hodges, founder of Oakland’s psychedelics Church of Ambrosia, submitted the Psychedelic Wellness & Healing Initiative of 2024 to the California Attorney General’s office for inclusion on next year’s ballot. Like SB 58, the initiative would make it state-legal for adults to possess, prepare, grow, gather, gift, and transport a variety of psychedelics found in plants and fungi. But it would also go much further by making it state-legal to sell those substances; reversing criminal charges related to entheogenic drugs; and allowing healthcare practitioners to recommend entheogenic plants and substances to treat health issues and churches and Indigenous groups to use psychedelics in ceremony.
In a press release, the initiative’s organizers say that if the California Attorney General certifies the initiative, they’ll have roughly four months to collect over 546,000 signatures from California residents to qualify for the state’s 2024 ballot.
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MindMed patents antidepressant and psychedelic “co-treatment”
On Halloween, psychedelics company MindMed was granted a patent for “pretreating” individuals with the antidepressant escitalopram (brand name: Lexapro) before administering psilocybin as a method of “enhancing positive effects of a psychedelic.” Patent attorney Graham Pechenik tweeted that the claims were granted “despite 18 prior art references from Porta Sophia,” the non-profit organization that submits documentation to the U.S. Patent Office reviewers and challenges what they call “bad patents.” The organization defines bad patent applications as those filing for “inventions that are not actually new,” and which “block access to that which is already part of the public domain.”
In their patent application, MindMed cited excerpts from a piece by journalist Mattha Busby published in The Intercept in July, in which Busby included statistics about suicide rates among members of the U.S. armed forces and veterans. Those excerpts, MindMed wrote, demonstrate that their invention “offers ‘significant unmet need.’”
I asked Busby what he thought of the patent and his work being cited in it. “Emerging research suggests that antidepressant use can keep the doors of perception shut to people who are attempting to have psychedelic experiences. Indeed, it may be dangerous to mix serotonergic drugs with some psychedelics,” he says. “To compare the dual use of psilocybin and antidepressants to an ibogaine or 5-MeO experience, and imply that the former will be as effective for veterans suffering from PTSD, seems highly dubious. Clearly there are serious unmet needs in western mental healthcare treatment, but they won’t be met by nonsense drug combos that dilute the psychedelic experience for the sake of winning a patent.”
2024 DEA quotas for research
Psychedelic drugs like psilocybin, MDMA, and LSD are Schedule I drugs, meaning they’re illegal to possess or manufacture without special permissions. The Drug Enforcement Administration (DEA) sets annual quotas for the amount of each scheduled drug to be manufactured for research purposes. On Thursday, the DEA released its proposed quotas for 2024.
After the DEA released its quotas for 2023 last year, it revised the proposed amounts for many psychedelic drugs, more than doubling its quota for psilocybin and quintupling its quota for ibogaine. The proposed 2024 amounts are the same as those revised 2023 amounts, suggesting the government expects the current pace of psychedelic research to continue.
Including shamans in psychedelic science
“The psychedelic renaissance must not devalue Indigenous knowledge or treat it as mere anecdote,” three leaders of the psychedelic organization Chacruna Institute write in an op-ed recently published in Nature Mental Health. While many researchers are studying psychedelics for their therapeutic effects, the authors argue that the psychedelics community must not overlook the importance of therapy in conjunction with the substances, as well as the substances’ subjective effects. “Synthesizing non-psychedelic agonists to bypass such discomfort disregards this holistic approach and eludes the sacred. This oversimplification contrasts with the shamanic approach to embrace inner exploration, community, and the sacred for deeper healing,” they write. They also argue that shamans are the “world experts” on psychedelic-assisted therapy, and that they should be embraced as such. “Mainstream psychiatry would benefit greatly from direct consultation, exchange, and collaboration with shamans and Indigenous spiritual leadership, unfolding in a horizontal dialogue that is also beneficial to their communities.”
Last week, we reported on an off-duty pilot who tried to shut off a plane’s engines mid-flight and later told investigators he had taken psychedelic mushrooms for the first time a day before the incident. The psychedelics and aviation communities have been abuzz with commentary.
The Association of Flight Attendants released a fact sheet about microdosing psychedelics.
The San Jose Mercury News asks: could that pilot’s bad trip set back psychedelics legislation?
A letter to the editor of the Los Angeles Times urges readers to “not blame an innocent mushroom” for the incident.
There’s a new monthly psychedelics salon called The Chalice in Berkeley, California. “At a time of relentless hype, bitter turf wars, and crass commodification, the very identity of psychedelic plants and substances is up for grabs,” the organizers write in the description of the group’s first event. “Instead of the mainstream focus on clinical trials, legal frameworks, and psychotherapy, The Chalice will draw from the deeper humanistic wells of history, poetry, the gods, ethnobotany, humor, and mystery. We are less interested in fetishizing psychedelic substances or psychedelic experiences than in cultivating psychedelic people.”
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