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The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.
Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Pig Hearts for Humans and the FDA

The Petrie-Flom Center Staff Leave a comment

By Jacob Balamut

David Bennett, a man who recently underwent the world’s first successful xenotransplantation organ surgery, died last month after a sudden and as yet unexplained period of rapid deterioration.

Bennett, who was 57 years old, had been suffering from end-stage heart disease. With limited options for treatment, he underwent an experimental emergency procedure to replace his damaged heart with a genetically modified pig’s heart. The pig was genetically modified to limit the likelihood that Bennett’s immune system would reject the heart.

Many researchers and clinicians alike see the potential for genetically modified animal organs to serve as a solution to our organ transplant and supply issues. The Health Resources and Services Administration estimates that 17 people die per day on the candidate waiting list. These deaths are the result of a lack of supply of organs, which has been a longstanding issue within the United States.

However, currently, the U.S. Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use”). The lack of approved xenotransplantation products stems from a lack of safety data and concerns regarding the potential for cross-species infections to occur.

In 2016, the FDA updated previously existing guidance for xenotransplantation. The purpose of the guidance was to inform the industry of how the FDA would be handling xenotransplantation applications and to provide recommendations.  In order for xenotransplantation products to be approved, the following process must occur.

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pieces of paper with chemical structures, micro dosing concept.

Findings from the Microdose.me Study: A Large Scale Observational Study of Psychedelic Microdosing

The Petrie-Flom Center Staff Leave a comment

By Joseph Rootman

Public uptake of psychedelic microdosing has outpaced research on the practice, which has left gaps in our understanding. In order to help fill some of these gaps in the scientific literature, our clinical psychology research team at the University of British Columbia has launched the Microdose.me study along with a team of international researchers and partners. This symposium contribution provides an overview of our findings to date, and offers suggestions for future microdosing research.

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Human heart with blood vessels. 3d illustration

Safety First: Potential Heart Health Risks of Microdosing

The Petrie-Flom Center Staff Leave a comment

By Kelan Thomas

Given the current evidence for psychedelic “microdosing,” the risks may outweigh the benefits for many people.

This is because there is compelling theoretical evidence to suggest prolonged and repeated microdosing may cause valvular heart disease (VHD), and only weak survey evidence that it provides the benefits microdosers typically seek, such as enhanced cognition, or relief from depression and anxiety.

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Mushrooms, capsules, and dropper bottle.

Restricting Access to Microdosing is Morally Wrong

The Petrie-Flom Center Staff Leave a comment

By Erin Sharoni

Restricting access to microdosing, a low-risk intervention that may alleviate intractable pain, depression, and anxiety — obligatory requirements for human flourishing — is morally wrong.

Psychedelic microdosing involves the administration of a psychedelic substance in sub-perceptual doses — doses small enough not to provoke any intoxicating effects, but that potentially result in favorable physiological or psychological changes. Microdosing has emerged as a promising intervention for enhancing creativity and productivity, boosting mood, alleviating pain, and treating depression and anxiety with minimal risk of harm to the participant or society.

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Businessman's hands typing on laptop keyboard in morning light

Microdosing at Work: Business and Legal Implications

The Petrie-Flom Center Staff Leave a comment

By Vincent Sliwoski

In light of the widespread cultural and business culture adoption of microdosing, private sector employers should reconsider the implications of a blanket prohibition on workplace use of controlled substances.

Microdosing is the practice of ingesting subperceptual amounts of psychedelic drugs, such as psilocybin mushrooms or LSD. People microdose for a variety of reasons. These may include medical reasons, such as the treatment of anxiety, depression or attention disorders; or they may include “performance” reasons, like attempts to increase productivity, creativity or awareness.

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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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Bill of Health - Globe and vaccine, covid vaccine

COVID ‘Compromise’ on International IP Underscores Need for New Approach

The Petrie-Flom Center Staff Leave a comment

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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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

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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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Red corded telephone handset on blue background, top view. Hotline concept

To Promote Health Equity, States Must Restrict Police Intervention in Mobile Crisis Response

The Petrie-Flom Center Staff Leave a comment

By April Shaw and Taleed El-Sabawi

The COVID-19 pandemic and recent increases in the incidence of televised violence against Black persons by law enforcement actors and others have contributed to the worsening mental health of these subordinated and marginalized communities. While the policy solutions needed to address this disparate impact are structural and multi-faceted, the introduction of 988, a national mental health crisis hotline, offers an opportunity to positively contribute to the overall goals of decreasing police interactions with Black and Brown communities.

The Federal Communications Commission (FCC) issued a Final Rule designating 988 as a national suicide prevention and mental health crisis hotline in September 2020. Congress later passed the National Suicide Hotline Designation Act of 2020 codifying 988 as the dialing code. Per the FCC Final Rule, states are required to implement 988 into their networks by July 2022.

States have wide latitude in how they implement 988, and though many will likely stop at the bare minimum of creating a suicide prevention hotline, 988 could be coupled with the creation of police alternative (or non-police) mobile responses that assist with de-escalation, stabilization, and connection to treatment. Non-police responses promise to decrease police interaction, excessive use of force, and criminalization of mental illness. Such non-police responses have gained in national popularity due in large part to organization and protests led by Black Lives Matters activists.

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