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This Week in Psychedelics: Patenting psilocybin for cancer patients, crowdfunding for psychedelic brain science, and measuring psychedelic integration
Plus: The Latest in Oregon
Happy Friday, and welcome back to The Microdose. Here’s the news of the week:
Patenting psilocybin for cancer patients. Last Thursday, the U.S. Patent & Trademark Office published a patent application from NYU researcher Stephen Ross and UCSF’s Gabrielle Agin-Liebes. The application was originally filed in November 2020, but because applications are sealed for 18 months after submission, the document has just become publicly available.
In the application, Ross and Agin-Liebes lay out their claims to patent “a method of alleviating depression and/or anxiety in a cancer patient” with a single dose of psilocin or a prodrug of psilocin, like psilocybin. (A prodrug is a compound that becomes a different, pharmacologically active compound once it’s metabolized in the body. When a person takes psilocybin, the psilocybin is metabolized into psilocin.) Eight months after submitting the application, in July 2021, NYU, where Ross is a professor, entered into a deal with Reset Pharmaceuticals to license “intellectual property associated with the use of psilocybin and related psychedelics for the treatment of mental illness in patients with life-threatening diseases, including cancer.” Reset also named Ross as the chair of their scientific advisory board.
The newly-released patent application has prompted questions from legal experts familiar with psychedelics patents. “Will a patent block cancer patients from using [psilocybin]?” asked attorney Graham Pechenik in an online post. Intellectual property expert Matt Zorn called the application “hot psilocybin patent garbage” in his newsletter On Drugs. He lays out evidence that portions of the patent application were copied and pasted from a 2020 paper Ross and Agin-Liebes co-authored. He also argues that the 2020 paper — along with another paper, published in 2016 — constitute prior art, rendering their patient application claims “neither novel nor non-obvious.” Additionally, Zorn believes the patent application intentionally obscures its connections to previous studies. (For more on prior art and psilocybin patents, read The Microdose’s 5 Questions for David Casimir and 5 Questions for Graham Pechenik.)
“Here is my take: the NYU Ross crew did one study in 2016 and repeatedly published follow-up studies. Now, years later, they are trying to put the toothpaste back in the tube and seeking to monetize the research by obtaining patent protection for a study that is already thoroughly disclosed in the prior art,” Zorn writes.
An NYU media relations director told The Microdose that Ross, Agin-Liebes, NYU Langone Health, and their colleagues at Reset all declined to comment.
Crowdfunding for psychedelic brain science. While there’s some evidence that psychedelics can help people experiencing mental health issues, researchers still aren’t sure exactly how psychedelics work in the brain. A leading theory is that psychedelics can improve neuroplasticity, which allows the brain to make new connections or reorganize old connections. (For more on psychedelics and neuroplasticity in non-human animals, read The Microdose’s 5 Questions for Gül Dölen.)
Researchers at University College London are proposing a new study to record participants’ brain activity before, during, and after using DMT. The study proposes taking multiple fMRI scans of over 150 people — an expensive and labor-intensive undertaking. The result, the researchers say, would be the largest psychedelic neuroscience study yet. To fund the study, researchers are trying to raise £70,000 (or roughly $88,000) through the research crowdfunding site Crowd.Science.
Study co-investigator and psychopharmacologist Ravi Das says the team has some funding available through PhD students’ grants, but they estimate that the entire study will require well over a million British pounds. Das has previously applied for UK governmental grant funding, but was told that “the scope and ‘high risk’ nature of the study mean some initial data will be key to securing large funding.” Crowd-funding will allow the team to collect pilot data while they continue to seek grants.
The crowdfunding campaign illustrates the difficulties psychedelics researchers face in securing study funding that arrives in a timely manner and that remains free from potential conflicts of interest. “We have had several offers from venture capitalists, drug companies and private equity to fund part of the study; all of which we've turned down because the most important thing to us is maintaining scientific impartiality and independence, while avoiding conflicts of interest,” Das told The Microdose. “I feel the landscape of scientific funding, data sharing and publication culture is shifting (albeit slowly), hopefully to something more democratic and equitable. The crowd-funding is a new avenue we have not explored yet, so we wanted to see whether it's a feasible means of funding big studies.”
There has never been a more exciting – or bewildering – time in the world of psychedelics. Don’t miss a beat.
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The Latest in Oregon
New rules announced. Last Friday, Oregon Psilocybin Services released a portion of their final rules for the state’s training curriculum for psilocybin services and for the sale and testing of psilocybin products. Along with those rules, OPS included a letter outlining their responses to public feedback they’ve received. Community members still disagree on key issues: for instance, some expressed concern that requiring 120 hours of training for facilitators was too burdensome, while others thought the number of required training hours should be much higher. OPS also detailed the limitations of their regulatory ability: “OPS is unable to regulate the scope of practice of licensed clinicians and other professionals,” they write. The rules they set out apply to all facilitators of psilocybin services, but they do not dictate how therapists or other professional groups operate. There are still more rules in the works, which OPS will discuss and adopt by December 31, 2022.
Oregon DOJ weighs in on entheogenic practitioners. In a meeting on Wednesday, the Oregon Psilocybin Advisory Board met to discuss some of the remaining rules. The meeting included discussion of thorny issues, like what to do if a client wants to leave a psilocybin service center before the end of a session, but perhaps the most contentious was the question of adopting a framework for entheogenic practitioners proposed by activist and lawyer Jon Dennis. The framework lays out privileges and duties for “entheogenic practitioners,” and would operate separately from Measure 109’s rules on licensure. The proposal is meant to protect the rights of people using psilocybin for religious and spiritual practices, since Measure 109 does not address religious use of psilocybin. (Read more about the framework from David Bronner and the Green Light Law Group.) OPS’s licensing and equity subcommittees voted in favor of the proposal in March and recommended it to the larger advisory board.
Dennis’s proposal did not pass on Wednesday, and minutes after the meeting, OPS announced that they’d received a public memorandum from Oregon’s Attorney General on the matter. The proposal “raises a number of legal questions,” the Oregon DOJ writes. The Oregon Health Authority doesn’t have authority to exempt anyone from licensure, and that “applying fewer restrictions on entheogenic practitioners would likely be viewed as granting a privilege to religion that is not available on a secular basis.”
Measuring psychedelic integration. For people undergoing psychedelic-assisted therapy, the psychedelic “trip” is just the beginning of their treatment. Facilitators work with clients for weeks or months after a psychedelic experience in a process called integration, where people discuss their trip and how it might inform their daily life. (Many practitioners work with clients seeking only integration, since giving clients psychedelics is still illegal in settings outside clinical trials.)
What integration looks like can differ greatly between practitioners, and few researchers have studied how integration sessions affect people’s behavior and psychological states in the long-term. A new paper published in Frontiers in Psychology introduces two new psychological scales that attempt to measure the effects of psychedelic integration. The Integration Engagement Scale is designed to elicit participants’ behavioral responses to integration work; it asks people how strongly they agree or disagree with statements like, “I’ve applied learnings from my experience to my life,” and “I’ve made healthy life choices for myself because of my experience.” The Experienced Integration Scale focuses on the psychological effects of integration; participants mark how much they agree or disagree with statements like “I feel at peace with my experience” and “I feel greater self-awareness since my experience.”
To develop and test the scales, researchers at Columbia University, Pacifica Graduate University, and Johns Hopkins conducted a series of five studies, which relied on surveys and interviews with people who have had psychedelic experiences and with psychedelic clinicians and facilitators. Their results indicated a high correlation between participants’ responses to the two scales, suggesting the scales may not be measuring markedly different aspects of their experience — nonetheless, the study represents a move within the field towards finding empirical measures of integration outcomes.
The New York Times reports on female veterans seeking psychedelic-assisted therapy.
Canadian senator Larry Campbell told the audience at last week’s Catalyst Psychedelics Summit in Ontario that his mood had mysteriously improved over a couple of weeks during the pandemic — and his wife admitted she’d been spiking his coffee with microdoses of psilocybin, writes Psychedelic Spotlight.
You’re all caught up! Have a great long weekend. For any veterans reading, thank you for your service. We’ll be back in your inbox next Friday for another issue of This Week in Psychedelics.
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