Tag: psychedelic therapies

Washington, D.C. skyline with highways and monuments.

Psychedelic Lobbying and Regulatory Capture

Vincent Joralemon Leave a comment

By Vincent Joralemon

Psychedelic companies and advocacy groups are spending substantial resources to influence regulatory policy, shaping what the blossoming field will ultimately cohere into.

Although regulations are designed to protect the public interest, the rulemaking process is often dominated by lobbying from those with special interests in the fields meant to be regulated. When that leads to undue influence, the result is known as “regulatory capture.”

Yet, not all lobbying campaigns are necessarily problematic — the goal instead should be for regulators to leverage industry insights while maintaining independence in their ultimate decision-making.

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Hundred dollar bills rolled up in a pill bottle

Ketamine Is the New Viagra

Vincent Joralemon Leave a comment

By Vincent Joralemon

Spravato, the first FDA-approved psychedelic therapy, just outsold Viagra. Johnson & Johnson’s ketamine-based formulation generated $183 million in Q3, surpassing Pfizer’s erectile dysfunction (ED) drug, which earned $110 million over the same period. Remarkably, a therapeutic made from ketamine, once dismissed as a “club drug” or “horse tranquilizer,” now sells more than one of the most notable 21st-century pharmaceuticals. 

Yet, these two drugs have more in common than meets the eye, and the path Spravato has taken looks strangely similar to that of Viagra. By looking at the journey traversed by Viagra over the past twenty years, we can predict where Spravato (and other psychedelic therapies) are headed.

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POPLAR affiliated reseachers

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

The Petrie-Flom Center Staff Leave a comment
(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

Dustin Marlan Leave a comment

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

The Petrie-Flom Center Staff Leave a comment

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

Chloe Reichel Leave a comment

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

The Myth of Psychedelic Exceptionalism

Dustin Marlan Leave a comment

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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The Cost of Exclusion in Psychedelic Research

The Petrie-Flom Center Staff Leave a comment

By Xinyuan Chen, Mackenzie Bullard, Christy Duan, Jamilah R. George, Terence Ching, Stephanie Kilpatrick, Jordan Sloshower, and Monnica Williams

In the last two decades, researchers have started to reexamine psychedelics for their therapeutic potential. Though initial results seem promising, the research has a significant shortcoming: the lack of racial and ethnic diversity among research teams and study participants.

In the 1960s, psychedelic substances such as LSD, psilocybin, and mescaline were a major part of American counterculture. Less well-known is that, concurrently, researchers were studying potential therapeutic uses of these mind-altering substances. Unfortunately, psychedelics were classified as Schedule I drugs in 1970, halting research into their therapeutic benefits.

The recent renaissance of psychedelic research shows these substances have significant capabilities for treating anxiety, depression, posttraumatic stress disorder (PTSD), and substance use disorders. But these promising results are limited in their applicability: an analysis from 2018 showed that 82.3% of all study participants in psychedelic trials internationally were non-Hispanic Whites, and only 2.5% were African-American.

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