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At the present stage of the psychedelic renaissance, it becomes increasingly evident that it is far from a coherent movement of researchers, investors, and psychonauts all marching in the same direction. It looks more often like people converging on an ice cream parlor after long separate walks on a summer day, when each customer is eager to choose the treat most likely to facilitate the best experience to the palate; in the case of psychedelics, the most benefits for mental health. But here is the caveat: every patron should think twice before going for a mixed bowl, as some flavors do not go well with others and can ruin an otherwise pleasant day.
The vanilla type of psychedelic enterprise is based on the medicalization model, with clinical trials, FDA approvals, venture capitalists, patenting of molecules and processes, and the whole bureaucratic suite aiming at reimbursement by health insurance conglomerates. This is the flavor causing most of the fuss in business circles and media, excited, as they easily become, with any opportunity for investment in a mass market projected to reach hundreds of billions of dollars in a few years. The unimaginative choice comes sprinkled with some controversy as well, caused by companies like Compass Pathways in its all-too-broad patent filings on psychotherapy applications of synthetic psilocybin, the psychoactive agent originally obtained from magic mushrooms of the genus Psilocybe, now in clinical trials to treat depression and many other conditions.
There is also a less predictable version of the popular flavor, so to say, a macadamia brittle of psychedelics. Ventures such as the Multidisciplinary Association for Psychedelic Studies (MAPS) add unusual ingredients to the conventional recipe by putting aside profits as the primary goal and by abdicating intellectual property (IP) rights to innovation through patents. Aiming at the public benefit, MAPS goes instead for less restrictive exclusive rights to market the treatment for up to six years, conferred by the FDA’s approval of a new therapy, with the difference that such exclusivity over clinical data doesn’t preclude others from generating their own data. The Usona Institute follows a similar path by publishing all its developed steps to synthesize psilocybin, making its own form of the drug available to other researchers interested in testing it.
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And then there is what I, as a Brazilian, would rather categorize as the açaí flavor of psychedelics accessibility, the Oregon way, for its uniqueness. When voters in the Northwestern state approved Measure 109 back in November with 56% of the vote, they ignored both the vanilla and macadamia brittle options and went straight for the striking novelty included on the menu by Tom and Sheri Eckert, originators and chief petitioners of Measure 109, intended to establish a statewide psilocybin therapy program far from DC regulators and the IP beaten path.
On top of it, Oregon’s Measure 110 (Drug Addiction Treatment and Recovery Act) passed with 58% of the vote. According to an article by Ismail Ali et al., in the winter edition of the MAPS Bulletin, it is possibly the most promising drug policy reform in the United States to date, as it is the closest to repudiating the War on Drugs criminalization mentality and replacing it with one rooted in by public health, compassion, and non-coercive treatment:
Notably, Measure 110 was the first successful effort in the United States to decriminalize the personal use of a number of substances, including MDMA, LSD, ketamine, methamphetamine, and heroin while adopting the first state-level decriminalization of Schedule 1 plants, cacti, and fungi.
In other words, an even more radical move, in that Measure 110 goes far beyond 109 by encompassing all drugs and so-called recreational use, not only psilocybin by licensed facilitators.
In other words, an even more radical move, in that Measure 110 goes far beyond 109 by encompassing all drugs and so-called recreational use, not only psilocybin by licensed facilitators.
The hundreds-of-billions-dollar question at hand, going back to psilocybin-spiked flavors: Is there room for all the flavors in the same psychedelic bowl? Could açaí prove too strong for ice cream freaks? Or, vice-versa, could business folks’ preference for patent-plus-insurance vanilla swamp Oregonian efforts to render psilocybin more accessible to those in need?
“One inspiration for the campaign was simply to end the 50-year prohibition on psychedelic therapy, which was long overdue, in my opinion,”
“One inspiration for the campaign was simply to end the 50-year prohibition on psychedelic therapy, which was long overdue, in my opinion,” Tom Eckert told me in an e-mail. Sheri, Tom, and their companions were equally inspired to think about how best to regulate psychedelics into a wider model:
We saw the ballot initiative as a perfect tool to carve out a space for psilocybin therapy and put it on its own foundation. That is important because the existing frames of reference, whether pharma-driven medicalization on one side, or cannabis-style legalization on the other, did not feel quite right, or, in the case of medicalization, felt incomplete in terms of access. So, we wanted to carve out a framework that fit the offering.
Tom is a member of the Psilocybin Advisory Board put together by the Oregon Health Authority (OHA), as foreseen in Measure 109, with the task of developing rules and regulations to discipline applications and licensing, psilocybin manufacturing and tracking, as well as therapy facilitation. Apart from that, as explained in the Oregon.gov website, the board is also required to
develop a long-term strategic plan for ensuring that psilocybin services will become and remain a safe, accessible, and affordable therapeutic option for all persons 21 years of age and older in [the] state for whom psilocybin may be appropriate; and monitor and study federal laws, regulations, and policies regarding psilocybin
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Finally, the board has until June 2022 to make its recommendations, and the OHA is expected to begin accepting license applications by January 2023.
As described in the MAPS Bulletin,
Measure 109 maintains some of the elements of medical protocols utilized in clinical trials of psychedelic-assisted therapies (e.g., requiring a secure container, licensed facilitator, and non-drug preparation and integration time). Some elements of delivery of traditional medical care are adjusted, including barriers to access created by diagnosis requirements for patients and requirements of therapeutic licensure for guides. It is important to note that M109’s legal standing is most similar to state-legal adult-use cannabis programs, which remain illegal under federal law.
The timetable that schedules psilocybin license applications for January 2023 is apt to make psychedelic-assisted therapy available to the Oregonian public faster than any other initiative in the FDA track.
The timetable that schedules psilocybin license applications for January 2023 is apt to make psychedelic-assisted therapy available to the Oregonian public faster than any other initiative in the FDA track. Both Compass’s and Usona’s clinical trials with psilocybin for depression are still in their phase II stage, and even MAPS’ phase III trial with MDMA for PTSD is not expected to gain approval before that. This might be the reason why some vanilla enthusiasts are not happy with Oregon’s açaí.
Bronner stated not only that Compass’s patents on psilocybin synthesis could make it difficult for Usona to produce the medicine, but also that Compass’s CEO George Goldsmith was trying to drum up opposition to Measure 109 among psychedelic researchers at Oregon Health and Science University.
Among the first to cry wolf was David Bronner, self-described as Cosmic Engagement Officer (CEO) of Dr. Bronner’s, the top-selling natural soap provider. In an article published in the company blog All-One under the title “Sounding the Alarm on Compass’s Interference with Oregon’s Psilocybin Therapy Program” Bronner stated not only that Compass’s patents on psilocybin synthesis could make it difficult for Usona to produce the medicine, but also that Compass’s CEO George Goldsmith was trying to drum up opposition to Measure 109 among psychedelic researchers at Oregon Health and Science University.
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Compass denies any such interference in a message from Chief Communications Officer Tracy Cheung:
We are not attempting to mobilize opposition to implementation of 109. The people of Oregon voted in favor of the measure, reflecting the huge unmet need in mental health care. We respect and understand that, and it is not our intent to do anything to change it.
After commending Measure 109 as a radically new approach to access to psilocybin therapy with the potential to help millions of people, Cheung stated,
It also brings challenges and questions about how it will be implemented to ensure safety and equitable access to those in need. However, we believe the medical regulatory route is the best way to ensure the safety, efficacy and quality of any medicine or therapy. As such, we are developing our COMP360 psilocybin therapy through clinical trials. Clinical evidence and regulatory approval are also prerequisites for any reimbursement consideration. This means we believe the medical route is the safest and most effective way to get psilocybin therapy (if approved) into the health system, reimbursed, and made available to all who might benefit from it.
Tom Eckert explained that he has spoken with George Goldsmith during the 109 campaign, but not since. “It was informational and cordial, just sharing perspectives. He sees psilocybin through a medical lens, while I see more of an access model, or a therapy and wellness model,” he said, and denied having any information about Goldsmith’s alleged contacts with Oregon researchers.
A spectrum of products or medicines will likely be offered for use within the regulated framework, including organic ones, extracted from mushrooms.
He doesn’t believe that Compass’s patents and movements could affect Oregon’s psychedelic path. The State will issue licenses to cultivators and product developers in accordance with its own standards. A spectrum of products or medicines will likely be offered for use within the regulated framework, including organic ones, extracted from mushrooms.
Here in Oregon, while mindful of health standards, my sense is that we do not really see psilocybin as a pharma drug, and so we are not going to regulate it in that same way. Of course, psilocybin itself cannot be patented, and, with Oregon’s legal framework and provisions for product inclusivity, patents on specific production processes do not seem so relevant. You cannot really patent growing a mushroom, and protocols for synthetic or bio-synthetic products are increasingly open source, from what I understand.
Naturally occurring psilocybin has been in use for centuries in ritual settings by traditional peoples, and for decades in alternative treatments by therapists, legally, before prohibition and then under the radar.
The main argument against Compass’s claims is based on the principle that prior art, as the IP jargon goes, cannot be patented. Naturally occurring psilocybin has been in use for centuries in ritual settings by traditional peoples, and for decades in alternative treatments by therapists, legally, before prohibition and then under the radar. Although COMPASS has already obtained three psilocybin patents issued in the US, one way to counteract its enclosure efforts is to bring together in a single accessible repository all the existent information on that particular substance and other psychedelic compounds.
At least, that’s how Usona is framing the issue. Executive Director Bill Linton made it clear in an e-mail that he is not against patents in general: “We strongly believe in the patent system, which awards the grant of claims that are deemed statutory, novel, useful, and nonobvious. Patent agents must rely on information they can easily obtain regarding information in the public domain in order to know whether to grant patent claims.”
In the next few weeks, he told me, an independent organization will be providing a reference portal designed to assist patent agents and clerks worldwide to more easily access millions of documents, published articles, scientific research results, meetings, symposia, archived libraries, web postings and similar information resources related to psychedelic therapy and related topics.
In the next few weeks, he told me, an independent organization will be providing a reference portal designed to assist patent agents and clerks worldwide to more easily access millions of documents, published articles, scientific research results, meetings, symposia, archived libraries, web postings and similar information resources related to psychedelic therapy and related topics. “This will be accessible by any individual or organization, saving time and expense involved in determining patentability,” he said.
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A similar case is Freedom to Operate, a non-profit launched by Carey Turnbull from the Usona Institute’s own Board of Directors. He founded the organization with the purpose of protecting psychedelic science and medical development for public benefit, by means of challenges to inappropriate patents: those that attempt to appropriate pre-existing knowledge from the public commons, and then sell it back as a novel invention. The rationale is that mistakenly issued patents prevent research and innovation by other organizations and create excess burden or loss of economic efficiency.
One wonders if all that wouldn’t be too little too late, in face of the tremendous momentum already gathered by investors jumping on the psychedelic bandwagon.
Tom Eckert, from his side, is no pessimist when it comes to varied models for bringing psychedelic benefits to those in need:
FDA approval of psilocybin and MDMA would be enormously positive, and I appreciate organizations like Usona and MAPS as they attempt to envision better approaches, based on open science, than what we have perhaps come to expect from the pharmaceutical industry.
In his view, if a prescription and insurance model for psychedelics were to be approved, Oregon’s evolving infrastructure would support and facilitate that, while continuing to offer safe access for presumably larger numbers of people who are without prescriptions or diagnoses.
Both models should naturally coexist within an integrated framework. For those in search of psychedelic healing, it should be a matter of comfort and choice; all options of responsible use should be allowed. Success in one area or approach should in no way block success in another area or approach. Cohesion between medicine, therapy, and wellness best serves the movement and best serves the public.
Mixing up the peculiar açaí with other flavors in the same bowl doesn’t look like the smartest choice
In sum: mixing up the peculiar açaí with other flavors in the same bowl doesn’t look like the smartest choice for some conventional palates, but one should be free to go for it. The precondition for that is to keep açaí on the psychedelic ice cream menu.
Disclaimer
Opinions and interpretations presented in this article are the author’s own, and do not necessarily coincide with Chacruna’s positions.
Art by Mariom Luna.
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