POPLAR affiliated reseachers

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

(Clockwise from top left: Kwasi Adusei, Ismail Lourido Ali, Jonathan Perez-Reyzin, Dustin Marlan.)

We are excited to welcome our inaugural group of affiliated researchers for the Project on Psychedelics Law and Regulation (POPLAR). Through regular contributions to Bill of Health, as well as workshops and other projects, POPLAR affiliated researchers will share their expertise and perspectives on developments in psychedelics law and policy. We look forward to learning from and sharing their insights with our audiences. Keep an eye out for their bylines!

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

What Macrodosing Can Learn from Microdosing

By Dustin Marlan

Following a recent wave of unbridled positivity culminating in a “shroom boom,” the psychedelic renaissance now finds itself under fire amidst concerns of predatory capitalism, cultural appropriation, adverse psychological effects, and sexual abuse and boundary issues by guides and therapists.

Nonetheless, the psychedelics industry is moving ahead at full speed. Oregon will begin accepting applications from businesses to run psilocybin service centers in January 2023. MDMA clinical trials are nearing completion and expected to result in FDA approval. And corporations are readying psychedelic compounds — natural and synthetic — to produce and deliver to the masses.

All of this begs the question of how psychedelics dosage should be regulated, particularly where, as journalist Shayla Love points out, “there’s reason to worry that there hasn’t been enough preparation for negative outcomes amidst the hype.”

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LSD Microdosing. Small or micro doses of LSD drug cut from a tab, presented on a finger.

A Precise Definition of Microdosing Psychedelics is Needed to Promote Equitable Regulation

By Sarah Hashkes

When we talk about microdosing psychedelics, it’s important we have a mutual understanding of its definition to be able to conduct accurate research, promote regulations, and educate the wider population. This article will look at three main questions and ambiguities regarding the term “microdosing psychedelics” and suggest a definition that would help promote coherence in the field.

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Mushrooms containing psilocybin grow in the forest.

Washington Psilocybin Bill Would Legalize Supported Adult Use

By Mason Marks

On Tuesday, Washington State legislators filed SB 5660, a bill that would legalize the supported adult use of psilocybin by people 21 years of age and older.

Sponsored by Senators Jesse Salomon and Liz Lovelett, the bill, known as the Washington Psilocybin Wellness and Opportunity Act, includes many innovative features including a Social Opportunity Program to help address harms caused by the war on drugs, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home.

I had the privilege of helping to draft the Washington Psilocybin Services Wellness and Opportunity Act with input from the Psychedelic Medicine Alliance of Washington and my colleague John Rapp of the law firm Harris Bricken. We had previously collaborated on the psychedelic decriminalization resolution adopted unanimously by the Seattle City Council.

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Traditional countryside scene in the Netherlands with windbreak lane of poplar trees in the wind under summer sky. Ens, Flevoland Province, the Netherlands.

Q&A with Mason Marks on New Psychedelics Law and Regulation Initiative

By Chloe Reichel

On June 30th, the Petrie-Flom Center announced the launch of a three-year research initiative, the Project on Psychedelics Law and Regulation (POPLAR), which is supported by a generous grant from the Saisei Foundation.

The Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will advance evidence-based psychedelics law and policy.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder, and in 2018 the agency recognized psilocybin as a breakthrough therapy for treatment-resistant depression. These designations indicate that psychedelics may represent substantial improvements over existing treatments for mental health conditions. Many other psychedelics, including ibogaine, ketamine, and dimethyltryptamine, are the focus of ongoing psychiatric research and commercialization efforts.

Despite the proliferation of clinical research centers and increasing private investment in psychedelic drug development, there is a relative lack of research on the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.

In the following interview, which has been edited and condensed, Senior Fellow and POPLAR Project Lead Mason Marks explains how POPLAR will fill this gap, and previews some of the initiative’s topics of inquiry.

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Kratom leaves and capsules.

A Sensible, Evidence-Based Proposal for Kratom Reform

By Dustin Marlan

In May 2021, the U.S. Food and Drug Administration (FDA) announced the seizure of 37,500 tons of adulterated kratom in Florida, worth an estimated $1.3 million.

But rather than focusing on the fact that the seized substance was adulterated, FDA Commissioner Janet Woodcock emphasized the alleged toxicity of kratom. This telling choice falls in line with recent efforts by the FDA to end U.S. kratom sales, distribution, and use, including a failed 2016 attempt to have kratom placed into Schedule I of the Controlled Substances Act, along with other federally prohibited drugs such as cannabis, psilocybin, and heroin.

This reactionary prohibitionism is likely to do more harm than good. Moreover, it does not reflect the state of the science, which remains unsettled as to kratom’s risks and benefits.

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Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

The Myth of Psychedelic Exceptionalism

By Dustin Marlan

The “latest frontier” in drug law reform is the loosening of legal restrictions on psychedelics, such as psilocybin, ayahuasca, and ibogaine. But not all drug reform advocates are thrilled about this development.

Some are concerned that singling out psychedelics for legalization or decriminalization perpetuates the stigma surrounding other illegal drugs. Most prominently, Dr. Carl L. Hart, professor of neuroscience and psychology at Columbia University argues that all drugs “interact on receptors in the brain to produce their effects… we shouldn’t be treating some drugs as if they’re special while others are somehow evil.”

“Psychedelic exceptionalism” describes an ideology that claims psychedelics should be privileged for reform, but other purportedly more harmful drugs, like heroin and cocaine, should remain prohibited. As journalist Madison Margolin frames the question, “Should psychedelics be treated so differently from other drugs, given that any substance may have the power to soothe or scorch the human psyche, and body too?”

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Person typing on computer.

Lessons Learned from Deep Phenotyping Patients with Rare Psychiatric Disorders

By Catherine A Brownstein and Joseph Gonzalez-Heydrich

Given the potential sensitivities associated with describing (i.e., phenotyping) patients with potentially stigmatizing psychiatric diagnoses, it is important to acknowledge and respect the wishes of the various parties involved.

The phenotypic description and depiction of a patient in the literature, although deidentified, may still be of great impact to a family.

By way of example, a novel genetic variant was identified as a likely explanation for the clinical presentation of a patient in a large cohort of individuals with neurodevelopmental and/or psychiatric phenotypes, a finding of great medical interest. The research team elected to further study this candidate and collected samples for functional evaluation of the gene variant and preparation of a case report.

Because the patient had a complicated phenotype, several physicians from various specialties were involved in the patient’s care. The paper draft was circulated amongst the collaborating clinicians and researchers and ultimately shared with the patient’s family by one of their involved caregivers. This is typically not a requirement of such studies, as the informed consent process includes the subjects’ understanding and consent for dissemination of deidentified results in the scientific literature. But as a general practice, families are informed about manuscripts in process, and in this case the family had requested to be kept abreast of ongoing developments.

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Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

Data Talking to Machines: The Intersection of Deep Phenotyping and Artificial Intelligence

By Carmel Shachar

As digital phenotyping technology is developed and deployed, clinical teams will need to carefully consider when it is appropriate to leverage artificial intelligence or machine learning, versus when a more human touch is needed.

Digital phenotyping seeks to utilize the rivers of data we generate to better diagnose and treat medical conditions, especially mental health ones, such as bipolar disorder and schizophrenia. The amount of data potentially available, however, is at once both digital phenotyping’s greatest strength and a significant challenge.

For example, the average smartphone user spends 2.25 hours a day using the 60-90 apps that he or she has installed on their phone. Setting aside all other data streams, such as medical scans, how should clinicians sort through the data generated by smartphone use to arrive at something meaningful? When dealing with this quantity of data generated by each patient or research subject, how does the care team ensure that they do not miss important predictors of health?

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