Federal court sides with DEA’s denial of access to psilocybin for terminally ill patients; COMPASS trigger law in Kansas; Could Arizona be first on ibogaine?
Plus: UK considerations for psychedelic-assisted therapy, and reviewing heart risks of psychedelics
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.
Federal court sides with DEA’s psilocybin access denial for terminally ill patients
Last Thursday, the Ninth Circuit Court of Appeals issued a ruling in Advanced Integrative Medical Science Institute (AIMS) v. United States Drug Enforcement Administration (DEA) that effectively denied a request from Seattle physician Sunil Aggarwal to access psilocybin on behalf of two terminally ill patients.
This is the end of the road for a years-long legal process which began in 2021, when Aggarwal, an AIMS physician, reached out to the DEA for guidance about accessing psilocybin under federal Right to Try (RTT) laws, which allow terminally ill patients to try investigational drugs that haven’t yet been approved by the U.S. Food and Drug Administration. The DEA classifies psilocybin as a drug in the most restrictive category (Schedule I), and the agency replied to Aggarwal saying that RTT laws do not override the drug’s scheduling. Ultimately, the DEA rejected his requests, and Aggarwal’s lawyers appealed that denial. In the court’s ruling, the judges upheld the DEA’s rejection, writing that the agency “provided a reasonable explanation” for its denial.
In the judges’ ruling, they write that part of the DEA’s rejection stemmed from vagueness in AIMS’s request. According to the DEA, AIMS “did not provide DEA with the proposed text, or even the scope, of the regulation [AIMS] purportedly seek[s],” which left the DEA “unable to fully assess [AIMS’s] proposal.” Kathryn Tucker, an attorney for Aggarwal and his terminally ill clients, notes that more specificity about what constitutes an exemption “could achieve a more favorable outcome.” She also noted that she and other attorneys have a related case in the works, in which they’ve petitioned the DEA to reschedule psilocybin from Schedule I to Schedule II. “AIMS [previously] won a favorable Ninth Circuit ruling on the Petition to Reschedule psilocybin from Schedule I to Schedule II and will continue to press that matter forward,” she told The Microdose.
COMPASS trigger law in Kansas
Last week, the Kansas House Health and Human Services Committee discussed HB2218, a bill proposed by the company COMPASS Pathways. The bill is a so-called “trigger bill” — if the U.S. Food and Drug Administration approves “crystalline polymorph psilocybin” — a formulation of synthetic psilocybin COMPASS has been developing as COMP360 — then HB2218 would amend the state’s Controlled Substances Act to classify it as a Schedule IV drug, allowing medical professionals to prescribe the drug. The bill would change the classification only for crystalline polymorph psilocybin, leaving all other forms of psilocybin in the Schedule I classification.
At the meeting, COMPASS senior manager of advocacy and state government policy Tess Bettler explained that if COMP360 is approved by the FDA, the DEA will be directed to consider rescheduling the drug. Most states’ laws will automatically change to reflect federal scheduling, but not all states do — and that includes Kansas, as well as Virginia, where COMPASS has filed a similar bill. “As Kansas law does not allow automatic following of the DEA’s rescheduling decision, it is imperative legislation be passed in anticipation of a potential FDA approval,” Bettler said at the hearing on behalf of the company. “Doing so will allow patients in your state with difficult-to-treat mental health conditions to have access to new treatments approved by the FDA as quickly as possible.”
Members of the committee asked questions about crystalline polymorph psilocybin, such as how long the medication has existed, how patients would take it, and how it works. In Bettler’s replies, she repeatedly emphasized that the medication would be prescribed only in doctors’ offices. Representative Allen Reavis wondered whether the bill was “putting the cart ahead of the horse,” since COMP360 is not yet FDA-approved. “What’s the hurry?” he asked. Bettler confirmed that COMPASS does not expect to finish clinical trials until 2026, but that the Kansas legislature had previously passed a similar bill to preemptively reschedule the drug Epidiolex or cannabidiol (CBD).
The state’s pharmacy board submitted neutral testimony in response to HB2218, saying it had no concerns upon reading the bill. James Davis, founder of advocacy group Bay Staters for Natural Medicine and a divisive figure in Massachusetts psychedelic circles, submitted opposition as a “fourth generation Kansan,” which included the argument that “state
governments should not enact policies or loopholes that benefit specific businesses. In so doing, HB 2218 would steer private and perhaps public research dollars toward the ‘pharmaceutical composition of crystalline polymorph psilocybin’ rather than similarly beneficial and interesting forms.”
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Could Arizona be first on ibogaine?
Last Thursday, Arizona state representative Justin Wilmeth (R) introduced House Bill 2871, which would designate $10 million from the state’s general fund to study ibogaine in the treatment of neurological diseases, including traumatic brain injury and PTSD. In a video posted to X, Wilmeth said Arizona had the “opportunity to be a pilot, to be the first state in the union to authorize this treatment.” (To be clear, the bill would authorize the study of ibogaine, not the treatment as a whole.) In a press release, Wilmeth pointed to other Republican politicians, including Congressman Morgan Luttrell and former Texas governor Rick Perry, as ibogaine advocates.
UK considerations for psychedelic-assisted therapy
Last week, the UK’s Parliamentary Office of Science and Technology published a briefing on policy considerations for using psychedelic-assisted therapies to treat mental health conditions. Psychedelics in the UK are classified as class A drugs, or drugs with no recognized medical use, but the report notes that researchers, patients, and even members of parliament have called for the drug to be rescheduled to class B, which would remove some barriers to conducting clinical trials with the drugs. The report notes that drug diversion — theft or misuse of drugs designated for research — is not seen as a major risk and that statistics from Germany suggest that psychedelics research has not been linked to an increase in diversion or misuse. The report also includes suggestions from researchers that drug administration sessions be filmed and include at least two trained monitors “to minimize risks to participants.”
Reviewing heart risks of psychedelics
In a new paper published in Nature Cardiovascular Research, Harvard Medical School researchers review the existing literature on how psychedelics affect the heart. While heart problems are uncommon in people taking low to moderate doses of psychedelics, high doses have, in rare cases, been associated with cardiac arrest and other serious heart issues. These risks are higher in people with a history of heart problems, or when psychedelics are taken with monoamine oxidase inhibitors, which can amplify the effects of classic psychedelics like psilocybin and DMT. Repeated exposure to large psilocybin doses as well as fairly standard doses of ibogaine have been linked to irregular heartbeats, and some long-term MDMA users develop heart valve issues.
More research is necessary to understand how these drugs can affect people with a history of cardiac issues and those who use psychedelics regularly, and the specific risk profiles of commonly used psychedelic substances. Given the variety of psychedelic drugs, “it is inevitable therefore that the potential side effects, toxicities and risks of these agents will vary widely, making broad generalizations about the safety and efficacy of psychedelics unwise and potentially hazardous,” the authors write.
WIRED interviews the co-founders of a company offering a 3-day, $3000 retreat offering “ketamine-assisted leadership coaching” in the Bay Area, who describe their clientele as “CEOs of Fortune 100 companies, CFOs, C-level founders of startups”: “the loneliest people” who are “all in a pressure cooker.”
In part one of a two-part series, Paonia, Colorado public radio station KVNF show Local Motion reports on the state’s new Natural Medicine Health Act and recent research on psilocybin-assisted therapy. (Bonus: You’ll hear from yours truly.)
Psychedelic Alpha interviews Chief of Inpatient Psychiatry at the U.S. Army Aaron Wolfgang about the study design of the Department of Defense’s new MDMA-assisted therapy clinical trial, which will treat PTSD with MDMA-assisted therapy in active-duty service members using Acceptance and Commitment Therapy (ACT).
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