New Mexico becomes third state to establish a state psilocybin program; Federal bill to improve veteran access to psychedelics; DOGE eliminates 10,000 HHS positions
Plus: Reducing bias in psychedelics studies and Illicit European MDMA production
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.
New Mexico becomes third U.S. state to establish a psilocybin program
It’s official: New Mexico is the third state to create a state-regulated psilocybin access program, and it’s the first in the country passed via legislation. Both Oregon’s and Colorado’s programs were approved via ballot initiative. Senate Bill 219, the Medical Psilocybin Act, passed the legislature in mid-March with large majorities; the Senate voted 33-4 to advance it, while the House passed it 56-8. It was signed by governor Michelle Lujan Grisham on Monday.
The new legislation makes it state-legal for clinicians, manufacturers, and patients to grow, prescribe, and use psilocybin for medical purposes, and it would establish a state department and advisory board to create the state medical psilocybin program. Unlike Colorado’s or Oregon’s programs, New Mexico’s requires patients to receive approval from a licensed health care provider before being eligible to receive psilocybin. The details of how such referrals will work and how providers will be given authority to issue them are still to be determined; the advisory board will issue recommendations.
Per the final version of the bill posted on Tuesday, the bill defines the term “psilocybin” as meaning both the naturally occurring psychedelic compound 4-PO-DMT found in mushrooms and its metabolite psilocin, “but does not include synthetic or synthetic analogs of psilocybin,” such as those being developed by psychedelics companies such as Compass and the nonprofit Usona Institute. (If the U.S. Food and Drug Administration were to eventually approve lab-made, synthetic psilocybin or a psilocybin analog, that approval would be for the use of synthetic psilocybin for a specific indication, rather than the wide array of qualifying conditions specified by this bill.)
New Mexico’s state-legal psilocybin program is required to begin by the end of 2027.
Federal bill to improve veteran access to psychedelics
Last Thursday, U.S. Representatives Lou Correa (D) and Jack Bergman (R) introduced House Bill 2623, the Innovative Therapies of Excellence Act. The bill is meant to increase funding for research on using psychedelic-assisted therapies to treat veterans. It is the first psychedelics legislation introduced by the Psychedelics Advancing Therapies (PATH) Caucus, a bipartisan group organized by Correa and Bergman in 2023 to address mental health issues through psychedelic research.
While the full text of the bill has not been posted, the bill summary proposes amending U.S. code to require the Secretary of Veterans Affairs to designate VA medical facilities as “innovative therapies centers of excellence.” A press release from Rep. Correa states that if passed the bill would create at least five such centers to study “MDMA, ibogaine, ketamine, psilocybin to treat anxiety, bipolar disorder, chronic pain, depression, Parkinson’s disease, PTSD, substance use disorder in Veterans.”
Last week, VA Secretary Doug Collins appeared on veteran Shawn Ryan’s podcast to discuss methods to improve veteran access to psychedelic therapies. Between this new bill and Collins’s apparent buy-in on psychedelics treatment for veterans, the VA seems poised to ramp up its psychedelics-related offerings.
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DOGE eliminates 10,000 HHS positions
Last week, as the incoming U.S. Food and Drug Administration commissioner Martin Makary took office, the Department of Government Efficiency eliminated 10,000 jobs at the Department of Health and Human Services. The terminations will hamstring basic science research in the U.S., as well as drug approvals and safety evaluations. Some 1,200 of the terminated HHS positions were at the National Institutes of Health and 3,500 at the U.S. Food and Drug Administration, eliminating around 19% of the agency, according to STAT. Included in those firings were 800 positions at the Center for Drug Evaluation and Research, reports NPR, including the Center’s entire media and communications team.
Typically, the agency issues at least one weekly round-up summarizing drug approvals or safety bulletins. (When The Microdose reported on the FDA’s decision not to approve Lykos Therapeutics’ New Drug Application for MDMA in the treatment of PTSD last August, the FDA’s public facing communications not mentioning the drug was an initial clue that it had not been approved.) However, since April 1, the day Makary took office and the layoffs were announced, the FDA has not issued any public communications.
While there has not been any indication yet that the layoffs have affected FDA drug reviewers, many people who support new drug applications and approvals have been fired. Roles in the center’s office of management, regulatory policy, and training programs were eliminated.
When The Microdose contacted members of the FDA communications team we had been in contact with previously, we received auto-replies that those email addresses could not be found. While journalists can usually contact communications officers directly, HHS now requires journalists to submit requests via a web form. Via that form, we reached out to HHS communications office, who declined to provide on-the-record comment.
Reducing bias in psychedelics studies
Bias is a concern with any type of research — and it’s been a hot topic for psychedelic clinical trial design in recent years. A new paper in Research Ethics from Johns Hopkins researchers delves into the types of bias psychedelic research may be especially susceptible to, and suggests solutions to reduce such bias. The authors discuss financial conflicts of interest, something they say might be more common in psychedelics work, given the relative lack of funding from government grants. The paper also discusses intellectual conflicts. “Various stakeholders in psychedelic research, such as trial therapists, may also hold intellectual COIs, for example, by believing in the benefits of psychedelics to the extent of ignoring all contradictory evidence,” the authors write.
Many journals and research organizations already require scientists to disclose conflicts of interest, but those “may not be the most effective method of avoiding biases, and instead provide a false sense of comfort as they may not actually achieve their goals of preventing actual or apparent bias, nor of helping the reader to assess the influence of the COI present,” the authors write. Instead, they suggest that adversarial collaborations — partnerships between researchers who disagree on key theoretical issues or have different hypotheses for a study — or using independent raters unaware of the study design to assess participants and analyze data could reduce bias as well.
Illicit European MDMA production
As researchers around the world study MDMA’s potential in treating mental health disorders, MDMA remains a controlled, illegal drug in much of the world. A recent report released by the European Union Drugs Agency reviews the European MDMA market, which the EUDA estimates generates around 72 million tablets annually. Most of that supply is made in the Netherlands and Belgium, and the bulk of PMK, a key chemical compound used in the production of MDMA, is shipped from China in packaging mislabeled to appear to contain some other chemical, or electronics. After being manufactured in Europe, that supply of MDMA is shipped to Oceania, Asia, and increasingly, Latin America. “In some instances, there have been reports of barter deals, where MDMA has been traded for cocaine, between European and Latin American criminal networks,” the EUDA report says.
Phoenix NPR station KJZZ reports that former U.S. Senator Kyrsten Sinema has been hired by Hogan Lovells, a law firm that represents the psychedelics company MindMed. Sinema recently publicly supported Arizona HB 2871, which proposes allocating $5 million for ibogaine research.
Atmos talks with Māori people creating and participating in the Tū Wairua project, a Māori-led psychedelic therapy trial. The project is designed to address substance abuse, mental health issues, and intergenerational trauma, and to reconnect Māori people with native mushrooms and traditional practices.
On his blog, Imperial College London researcher David Nutt recounts his experience speaking to the Pontifical Academy of Sciences about psychedelics. The conference, held at the Vatican, discussed neurostimulation technologies for wellbeing. Nutt writes that he initially thought the invitation was a hoax, so he reached out to another neuroscientist for his thoughts. Nutt writes: “He reassured me it was for real, and I would be speaking in the footsteps of other scientists such as Galileo – which wasn’t totally reassuring given he was given the choice of recanting his theories or death!”
In a 3-part mini series on NPR’s podcast Short Wave, UC Berkeley - Ferriss Fellow Rachel Carlson delves into why it's hard to study the neuroscience of psychedelics; would ketamine treatment help if you didn't know you got it?; and why researchers are making new psychedelic-like drugs — without the trip.
The Portland Tribune reports on former NHL player Daniel Carcillo’s new psilocybin service center.
John Lennon accidentally took LSD before recording The Beatles’ song “Getting Better,” and the drug helped him bond with Paul McCartney, reports People.
From The Needling, Seattle’s version of The Onion: “Microsoft Admits its AI is just Clippy on Shrooms.”
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