Closed Minds Opening Doors
The Impact of Commodifying Psychedelic Medicine on Patients and Research
Background
Upon entering the room, a white couch is the first thing one would notice. It’s long enough to sit three, and it’s white nylon fabric glows with warmth from the dimly lit lamps on either side. The room is small, but not clustered. A Persian rug covers the ground symmetrically, and to the left, an eastern watercolor landscape painting brings opaque colors to the room. Sitting Buddha is there too, up on a shelf with a slight grin across his lips, frozen in mediation, and no larger than a kitten. Lastly, on a wooden side table nearby the couch, three glossy, glass mushrooms seem to reach towards the light of a lamp above, tilted slightly, but stiff nonetheless.
Sitting opposite the couch, Dr. Katherine MacLean, among a team of dedicated researchers at Johns Hopkins University (JHU), have facilitated over 600 psychedelic mushroom sessions — for a decade and a half — in that very room. MacLean and her team began conducting their first clinical trials back in 2001, and their findings have been promising enough that Johns Hopkins even opened an entirely new center for psychedelic research in September of this past year (2019). Before the grand opening, however, in June of 2016, Maclean stepped onto the stage at a TEDx conference and delivered an impactful speech, one that illustrated how her team of researchers are at the forefront of cutting edge psychedelic discoveries — and promised that, “… a wild and wonderful world is waiting for you.”
Introduction
Just a year before her optimist TEDx speech, MacLean came into contact with a non-profit company by the name of C.O.M.P.A.S.S. (Center Of Mental health Pathways And Support for Self-directed care). Prior to hearing from C.O.M.P.A.S.S, there only existed a handful of major medical institutions/non-profit organizations that were specializing in psychedelic research. Ever since President Nixon signed the Controlled Substance Act of 1970, labeling psychedelics as ‘Schedule I Illegal Substances,’ the only institutions that managed to begin studying compounds such as psilocybin (mushrooms), MDMA, and LSD — were ones that received respectable amounts of research funds, and bureaucratic support. Institutions like NYU, UCLA, and JHU — for example — are the only names mentioned across media platforms that have obtained regulatory approval to study these forbidden compounds in controlled environments.
For decades, this minute, specific, and specialized research community has only made progress in their field by openly sharing findings with one another. As a body, most scientific communities rely heavily on either confirming or rejecting hypotheses presented by peers; helping to advance credible ideas and prevent the spread of false knowledge. Furthermore, pharmaceutical researchers working to demystify chemicals for human consumption must be held to an even higher standard of communication — for lives could be at risk. Today, the ethical practice(s) of sharing information became known as what researchers call “open science.” When C.O.M.P.A.S.S. emerged in the psychedelic scene, their sentiment towards open science was aligned with that of the research community… so it seemed.
When the founders of C.O.M.P.A.S.S, George Goldsmith and Ekaterina Malievskaia (G&M), first contacted MacLean, they said they needed “informal advisors” that could aid the development of their non-profit. The nonprofit’s mission was to use the power of psychedelics for end-of-life-care treatment, and having just lost her sister… MacLean was happy to help. As any good researcher would do, MacLean introduced G&M to others working in the same field and even helped C.O.M.P.A.S.S. develop research protocols similar to the ones she had created at Johns Hopkins. After receiving an abundance of support from McLean, G&M ceased all communications with her — and switched C.O.M.P.A.S.S. to a for-profit organization, called Compass Pathways. Making things even scarier, Compass Pathways changed the course of their mission statement: “Founded in 2016, our first major initiative is developing psilocybin therapy through late-stage clinical trials in Europe and North America for patients with treatment-resistant depression (TRD).”
In the following paper, I will use the company, Compass Pathways, as an example to answer the following question: How will commodifying psilocybin in a competitive capitalist market, intended for treatment-resistant depression, affect future advancements of psychedelic-assisted psychotherapy (PAPT), and more importantly patient care? In the last half-century, the for-profit corporation Compass Pathways has notoriously attempted to gain affluence from psilocybin by increasing its accessibility to the public. In theory, the notion of creating accessible PAPT for many is a dream come true — after all, this is what researchers in the field are working towards. However, it’s the self-interested manner in which Compass Pathways conducted business that will have unfortunate implications. Using Compass Pathways as an example, I contend that commodifying psilocybin will jeopardize patients/hinder research development due to the companies lack of social responsibility in a “thin market,” utilization of common pharmaceutical tactics to secure psilocybin, restrictive manufacturing patents, and disregard for ‘open science’ ethics.
Thin Markets
To understand how commodifying psilocybin can jeopardize patient consumers, first, one needs to understand the ethical and social responsibility of ‘thin markets.’ This past May (2019), renowned psilocybin expert and author, Micheal Pollan, wrote an opinion piece for the New York Times called, “Not So Fast on Psychedelic Mushrooms.” Pollan raises concern as he states, “For the first time since psychedelics were broadly banned under the 1970 Controlled Substances Act, we’re about to have a national debate about the place of psilocybin in our society. Debate is always a good thing, but I worry that we’re not quite ready for this one.” “Not quite ready for this one,” contains a hand full of interpretations, however, I contend that Pollan was hinting that there is only a minority group of people who are qualified to debate about the place of psilocybin in society. Other than the specialized researchers who study these compounds, the people and politicians of America don’t have any foundation of knowledge to structure reasonable arguments up for debate. If politicians, among other governing bodies, don’t understand the implications of popularizing psilocybin — why would the FDA? According to Karthik Ramanna, an Oxford professor in business and public policy, this notion of limited government expertise can create “thin political markets.” Paraphrasing Ramanna, a thin market is an area of industry so specialized, that the only organization that should regulate it, is the industry itself. To contextualize this idea, third-party researchers suspect that Compass Pathways might manipulate the FDA into approving psilocybin by presenting them favorable data that the FDA can’t assess on their own behalf — for it’s out of their area of expertise. Bias by omission is effortlessly employable when one is uninformed. Due to this, industries like Compass Pathways have a social responsibility to ensure that the product they provide is consumer safe. However, like most self-interested pharmaceutical companies, Compass Pathways is very determined to obtain FDA approval because they are eager to reap profits. Hypothetically, if they receive approval, then a psychedelic drug that shouldn’t be taken lightly could jeopardize patients who consume it. This raises the question, how can Compass Pathways be held accountable in an industry that requires a great amount of ethical and social responsibility? How can Compass Pathways confirm the safety of their product if the FDA is only an unqualified bureaucratic hurdle? The solution is simple: allow the specialized psychedelic research community to have access to these drugs, and compare their findings to the clinical trials conducted by the FDA. Compass Pathways can be held accountable by academic institutions like NYU and JHU if their research aligns — but Compass Pathways refuses to let others have access to the same drug.
Seizing the Supply
In the pharmaceutical industry, companies that are successful by a large margin typically control the supply. Controlling the supply is a common pharmaceutical tactic used to prevent other sellers from having access to the same chemicals. Compass Pathways used this common tactic — which could affect research development. In order for the FDA to approve of Compass Pathways psychedelic prescription, the company had to find a way to extract the active ingredient, psilocybin, out of the magic mushrooms and synthesize it in a lab. For Compass Pathways this would be a fruitless task, so they contracted a UK based company that specializes in drug development, Onyx Scientific. According to a Quartz article called, “A Millionaire Couple is Threatening to Create a Magic Mushroom Monopoly,” written by Olivia Goldhill, Onyx Scientific is one of the, “few laboratories in the world that has the capacity and approval to create GMP (good manufacturing practices) psilocybin.” When another organization called USONA (non-profit) reached out to Onyx to obtain psilocybin, they were denied because Compass Pathways has contracted them exclusively. Similar to JHU and NYU, USONA intended to study synthesized psilocybin for PAPT but has now been forced to find another way to secure the unique and particularly expensive synthetic form of this drug. Summarized in Goldhill’s Quartz article, Compass Pathways offered to work with USONA as a counteroffer. USONA declined after finding out that Compass Pathways would license them the drug, but only for a higher price than what they typically set for academic institutions. Seizing the supply chain of psilocybin, and only agreeing to license it at steep rates, makes it obvious that Compass Pathways clearly wants to monopolize this market while it’s young. As a result, academic institutions and non-profits will be forced to find other suppliers or pay hefty fees — ultimately restricting the research they plan on doing.
Rejecting ‘Open Science’
Controlling the supply of synthetic psilocybin is certainly one way to hinder research development conducted by academic institutions — however, Compass Pathways will take things even a step further — and refuse to publish any research findings from their laboratories. Abandoning what scientists’ call ‘open science’ ethics is another factor that will hinder third party research development, which will, in turn, jeopardize patient care. David Nickles, a passionate spokesman for open science policy, defines the notion as, “Placing the common good above private gain, not withholding materials or knowledge for commercial advantage, and placing discoveries into the public domain (for the benefit of all).” When Compass Pathways wanted to begin studying their personal stash of synthetic psilocybin, they hired independent research facilities to do the job. However, the independent research facilities were only contracted under strict circumstances — any findings or patentable discoveries made couldn’t be shared with anyone else but Compass Pathways. To reiterate, Compass Pathways now controls the supply of a specific synthesized version of psilocybin and refuses to share any intellectual knowledge associated with the compound. In other words, specialized researchers for PAPT, like Katherine Maclean, have never been able to obtain the same synthesized psilocybin, nor have they ever seen any publications on it. Interviewed by Goldhill for her Quartz article, John Abramson, a lecturer in health care policy at Harvard Medical School, provides the reader with his opinion on the matter. Abramson says, “These are severely restrictive contracts even by pharmaceutical industry standards… [and] the concerns are enormous, it challenges the validity of the entire body of knowledge that physicians rely on to make decisions in the best interests of their patients. It means that the body of knowledge is not trustworthy.” To clarify, all physicians and psychiatrists who attempt to educate themselves before prescribing the substance to their patients, are ultimately referring to research that reflects the findings of a single laboratory — and not the scientific body of knowledge as a whole. Furthermore, given the potential negative side-effects of psilocybin can be detrimental, patient care is completely undermined. When pharmaceutical companies restrict access to gained “intellectual property,” moving forward with manufacturing, fragile human minds are put at stake. The unsettle caused in the psychedelic community has led them to take action. Olivia Goldhill quotes in her Quartz article the “Statement on Open Science and Open Praxis with Psilocybin, MDMA, and Similar Substances,” created by a USONA board member. It reads, “From generations of practitioners and researchers before us, we have received knowledge about these substances, their risks, and ways to use them constructively. In turn, we accept the call to use that knowledge for the common good and to share freely whatever related knowledge we may discover or develop.” In a striking way, Goldhill concludes her Quartz piece stating that “Compass has not signed.”
Restrictive Manufacturing Patents
Lastly, once receiving regulatory approval by the FDA, Compass Pathways plans to patent the manufacturing method of their specific version of synthesized psilocybin — further restricting research development. As you know, when entrepreneurs create an invention and wish to gain from it, they must file a patent to begin manufacturing. According to the United States Patent and Trademark Office (USPTO), “A patent for an invention is the grant of a property right to the inventor,” which forbids others from trying to produce the same idea.” Upon further looking, one will find that you can’t patent something that already exists or is known to mankind. For example, one cannot patent an apple because the apple has no inventor. Similarly, the active ingredient in magic mushrooms, psilocybin, cannot be filed for a patent. However, in Goldhill’s Quartz article, she describes a loophole typically known to be employed by pharmaceutical companies. “ Compass could patent a new manufacturing method, which would force others who want to synthesize psilocybin to find an alternative means of doing so,” Goldhill says. As you recall, Compass Pathways contracted Onyx because creating GMP psilocybin on their own would be costly, and require a special chemical license. In other words, JHU and other academic laboratories might be forced through the same obstacles to create synthesized psilocybin for their own research — a nearly impossible task. Compass Pathways now owns the supply of psilocybin, the intellectual property generated from it, and any manufacturing patent that may come from the intellectual property. The manufacturing patent is the last key step in commodifying psilocybin for Compass Pathways — this vertical integration of their business model, this monopoly will have consequential effects on institutions looking advance research in PAPT.
In totality (and chronological order), this paper discussed the following topics: how ‘thin markets’ can create conditions for unaccountable regulatory approval, how Compass Pathways has secured the limited supply of research-grade synthetic psilocybin, how the same company has intentionally abandon ‘open science’ policy for profitable gain, and lastly, how they have strategically patented the manufacturing process for psilocybin to prevent others from creating the same synthetic form. All of the discussion points listed above are clear examples of how a for-profit pharmaceutical company might commodify psilocybin — and inevitably — have a severe negative impact on the development of third-party academic-based research; along with more consequential effects on patients who potentially ingest the compound to treat depression. The compound psilocybin, and its mystical effect on our minds, is an area of study that researchers have spent the last two decades trying to comprehend. To fully understand the psychedelic drug, scientists would have to have a complete understanding of consciousness itself. But as Micheal Pollan has said in his early lectures years ago, “Consciousness? That’s something we leave to the poets.” The possibility that this magical compound, psilocybin, can take something as precious as our consciousness on a spectacular ride, light or dark, possibly affecting our life outlook years to come… is not something the public should take lightly — and neither the companies that grant us access.
Citations
Carey, Benedict. “Johns Hopkins Opens New Center for Psychedelic Research.” The New YorkTimes, The New York Times, 4 Sept. 2019, https://www.nytimes.com/2019/09/04/science/psychedelic-drugs-hopkins-depression.htm
Center for Drug Evaluation and Research. “Facts About the Current Good Manufacturing Practices (CGMPs).” U.S. Food and Drug Administration, FDA, https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps.
“Center for Psychedelic & Consciousness Research.” Center for Psychedelic & Consciousness Research, https://hopkinspsychedelic.org/.
Gershonok, Gili. “Statement on Open Science and Open Praxis with Psilocybin, MDMA, and Similar Substances.” Beyond Psychedelics 2018, 28 May 2018, https://beyondpsychedelics.cz/statement-on-open-science-and-open-praxis-with-psilocybin-mdma-and-similar-substances/.
“General Information Concerning Patents.” United States Patent and Trademark Office — An Agency of the Department of Commerce, USPTO, 1 Oct. 2015, https://www.uspto.gov/patents-getting-started/general-information-concerning-patents#heading-2.
Goldhill, Olivia. “A Millionaire Couple Is Threatening to Create a Magic Mushroom Monopoly.” Quartz, Quartz, 16 Nov. 2018, https://qz.com/1454785/a-millionaire-couple-is-threatening-to-create-a-magic-mushroom-monopoly/.
Maclean, Katherine. “Open Wide and Say Awe.” YouTube, TEDxOrcasIsland, 20 June 2016, https://www.youtube.com/watch?v=ZljALxpt3iU.
Nickles, David. “Commodifying The Sacred: Considerations on COMPASS, Capitalism, &the Mainstreaming of Psychedelics.” YouTube, YouTube, 29 Jan. 2019, https://www.youtube.com/watch?v=rB0_anPmQak.
Pollan, Michael. “Michael Pollan: Not So Fast on Psychedelic Mushrooms.” The New York Times, The New York Times, 10 May 2019, https://www.nytimes.com/2019/05/10/opinion/denver-mushrooms-psilocybin.html.
Ramanna, Karthik. “Thin Political Markets: The Soft Underbelly of Capitalism.” California Management Review 57, no. 2 (Winter 2015): 5–19.
