When we think of the law one has to also equate the word independence. For it was independence that created the system of laws in this country that formed the basis of our legislative system and consequently our legal system as a profession.
This past week Harvard, the first law school in the country, is taking a step to legitimizing psychedelics as an emerging law profession which further puts a stamp on this emerging curative discipline. Law informs policy and policy tells us what we can do. For lawyers interested in psychedelic access there may be much at stake picking up the reins in the dawn of this era. https://en.wikipedia.org/wiki/Harvard_Law_School
The Project on Psychedelics Law and Regulation (POPLAR) was launched by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School as a three-year “initiative to examine the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics”.
“This three-year project will promote safety, innovation, and equity in psychedelics research, commerce, and therapeutics. It is supported by a generous grant from the Saisei Foundation.”
Harvard sees a future need for research into how the current clinical research and decriminalization advances will impact the commercial, legal, ethical, and medical ‘camps’ in the greater psychedelic industry and how that will affect policy. There is a gap to fill and the law is the discipline to fill it.
Due to their therapeutic and commercial potential, the U.S. market for psychedelics is projected to reach $6.85 billion by 2027, attracting a significant number of for-profit companies and investors. However, despite the proliferation of clinical research centers, increasing private investment in psychedelic drug development, and widespread state and local decriminalization, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.
POPLAR is the first academic initiative focused on psychedelics law and policy, positioned to be a global leader for research and education in this space.
“Right now, there are a handful of psychedelic research centers at universities around the country. However, they are focused on clinical research,” said Mason Marks, MD, JD, Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. “There is no systematic research being done on psychedelics law, and POPLAR will fill this gap.”
The Project will focus on “five key areas”:
- “Ethics in Psychedelics Research and Therapeutics
- Challenges at the Intersection of Psychedelics and Intellectual Property Law
- Opportunities for Federal Support of Psychedelics Research
- Access to Psychedelic Therapies and Equity in Emerging Psychedelics Industries
- The Role of Psychedelics in Healing Trauma”
“The Petrie-Flom Center is excited to add POPLAR to its research portfolio,” faculty director I. Glenn Cohen said. “In addition to developing the field of psychedelics law and policy, this innovative work will have broad implications for drug policy, pharmaceutical development and intellectual property law more generally.”
Mason Marks, the POPLAR project lead, has had two interviews which are well worth the indepth read.
First, with Chloe Reichel, a communications associate at Harvard, Marks explained so eloquently how POPLAR will fill in that gap with an inclusion for social equity, cognitive liberty and a respect to indigenous values. Read the interview here:
https://blog.petrieflom.law.harvard.edu/2021/07/01/poplar-petrie-flom-center/
This particular question and answer from the Reichel/Marks interview particularly caught my attention. It speaks to the various “camps’ that are or could be stakeholders in the use of these extraordinary substances and without a legal framework we stay in the grey area of privilege, disadvantage and exploitation.
“CR: Who might benefit from the legalization and commercialization of psychedelics? Who might be left behind?
MM: Who stands to gain? The pharmaceutical companies, venture capitalists, and the patent holders certainly stand to benefit from commercialization. In contrast, it is unclear to what extent people most in need of psychedelic therapies will benefit. If these treatments are too expensive, few people will be able to afford them. Widespread insurance coverage for psychedelics seems a long way off, further restricting access, and requiring patients to pay cash. Unless something changes, corporations may experience the greatest benefits of psychedelics commercialization.
These problems are not unique to psychedelics. In recent years, we’ve seen drug prices rise, even for essential medicines like insulin, which have been around for decades. Some life-saving medicines, such as biologic drugs for muscular dystrophy, can cost hundreds of thousands or millions per year, or even per dose. These trends reflect deep, systemic problems with the health care system that the emerging psychedelics industries highlight. But there are also certain features of psychedelics that warrant special attention.
For instance, the long history of prohibition and punitive drug enforcement has caused irreversible trauma that disproportionately impacts vulnerable groups including communities of color and people with disabilities. By preventing research for decades, prohibition also likely deprived people with mental health conditions of more effective therapies, costing countless lives and billions of dollars over the years.
There are other groups that could be left behind. Communities who have used psychedelics for hundreds of years may view patents and psychedelics commercialization as forms of exploitation and theft of their sacred knowledge and technologies. All these groups will potentially be marginalized in the push to commercialize psychedelics.”
It is within the law to legislate how any one of these topics are treated, where the bar falls on what is just and fair and to whom and about what [particular issue]. Vague issues that become tangible and real when in fact the very substances we are talking about seek out experiences of the mind that are vague and non-ordinary. Harvard is tying the knot on recognizing what the emerging business of psychedelics mean to the ever changing landscape of how people view mental wellness and what that means for law, laws, lawyers, and policy.
Another interview that is worth the time and read is with Marijuana Moment and there was one quote with Marks that brought a smile to my face as I was reading it. It leaves room for cognitive liberty and the idea that the “cottage community” of psychonauts is not forgotten as it speaks to “set and setting”.
“Marijuana Moment: As a member of Oregon’s advisory group, what lessons have you already learned/issues you’ve identified that you think should be prioritized for this new institute?
Mason Marks: Despite recent progress on destigmatizing psychedelics, a lot of misinformation and stigma remains. That’s something POPLAR will address by promoting evidence-based psychedelics law and policy.
There is also a tendency for people to overmedicalize psilocybin services and psychedelics in general. Really, psychedelics represent a new paradigm of mental healthcare. For many psychedelic experiences, safety and efficacy may be less about the substances themselves, and more about one’s mindset and the environment in which psychedelics are administered (the “set and setting”). In other words, creating circumstances that are conducive to beneficial experiences is just as important, if not more important, to safety and efficacy as a substance’s physiologic effects. Psychiatry, in recent years, has moved away from talk therapy to focus on drug therapy and biochemical hypotheses regarding mental illness. Psychedelics highlight the importance of taking a broader, biopsychosocial approach to mental health.”
Initiatives to decriminalize psychedelics and allow for access in perhaps a more informal setting support those who are advocates for cognitive liberty. “Set and setting” are supreme to the psychedelic journey and without both “in place” a wise psychonaut might be best to put off the trip. A setting could be one’s own couch with a support person nearby or a more modish setting similar to the ketamine clinics in vogue now. Access and affordability are the issues and will depend on what the law eventually mandates. Mason Marks speaks to this topic as it pertains patenting to with Choloe Reichel:
“CR: Most psychedelics are not FDA approved. But ketamine is, so it may provide a window into the issues we might see in the future, in terms of drug development and access. What are we seeing so far with ketamine?
MM: Ketamine is an interesting example because it is an extremely safe drug that’s been around since the 1960s. It’s on the World Health Organization’s list of essential medicines because it’s so important; it’s routinely given to pediatric patients, and it’s used on battlefields to treat injured soldiers.
More recently, ketamine has been used off-label for its antidepressant effects. Capitalizing on this development, Johnson and Johnson, and its subsidiary Janssen Pharmaceuticals, essentially took a generic drug that’s common, inexpensive, safe, and widely available, and isolated half the molecules in it. Ketamine is really a mixture of two compounds that are mirror images of one another: S-ketamine (also called esketamine) and R-ketamine. Jannsen isolated esketamine, packaged it in a proprietary single use nasal spray, and marketed it as Spravato.
The issue is, esketamine isn’t a novel invention, and there’s no compelling evidence that Spravato is any more effective than generic ketamine. But it’s more expensive. One of the most useful features of generic ketamine is that it has multiple potential routes of administration including oral, intramuscular, and intravenous, which provides clinicians with flexibility. But Spravato is the version that can be reimbursed by insurance because it’s FDA approved for treating depression. Janssen’s patent on Spravato gave the company exclusive rights to this form of therapy, but did it improve the quality, cost, and availability of ketamine therapy for patients? So far, that’s questionable.
We are already seeing similar developments with other psychedelics. Psilocybin is a naturally occurring substance that is widely available and has been used by some communities for centuries. Compass Pathways has patented a formulation of psilocybin and is attempting to patent methods of synthesizing and administering it.
This process of patenting subtle variations on naturally occurring substances, or widely available generic compounds, is controversial. It may limit access to therapies that are not actually new and could otherwise be inexpensive and widely available. POPLAR will research these issues and how they affect the psychedelics industry.”
The Internet was the greatest invention of the 20th century because it changed the course of humanity.
“The Internet is “a global communication network that allows almost all computers worldwide to connect and exchange information” (dictionary.com)”
The psychedelic industry is in this writer’s humble opinion to the 21st century what the internet was to the 20th century and Harvard just blessed that with the launching of POPLAR as the link that will allow for rightful independence, access, and policy advancements.
To quote Michael Hoyos who co founded the Conscious Fund in his article in Chicago Business:
“Over the next decade, the mental health and addiction treatment industries will be fundamentally transformed by psychedelic drugs. Yes, you read that correctly— psychedelic drugs. While this may sound insane to the uninitiated, the reality is that we are currently witnessing the birth of a multi-billion-dollar industry with the potential to drastically improve patient safety and treatment outcomes for indications including depression, anxiety, PTSD, OCD, cluster headaches, nicotine dependence, ADHD, alcoholism, and even suicidal ideation, to name a few.”
“While we are still in the very early days of this nascent industry, it is becoming increasingly clear that psychedelics are gearing up to disrupt a combined $250B+ mental health and addiction treatment market.” http://www.chibus.com/people/2020/10/14/psychedelics-the-next-big-thing
Kudos to Harvard for taking the reins on walking through the doors to legitimize psychedelics in the world of law and policy and advance a field that has been in Harvard’s DNA beginning with two young Harvard professors who have now become icons of psychedelic drug use.
Author: Sherri Margolin (Dark Matters)