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.

Read More

Money.

Conflicts of Interest in the Hospital Sector: A Q&A with Rina K. Spence

By Chloe Reichel

Brigham and Women’s Hospital recently made headlines when the Boston Globe reported that the hospital’s president, Dr. Elizabeth Nabel, held a seat on the board of Moderna, a Cambridge biotech company that is working to develop an mRNA COVID-19 vaccine. The hospital has a major role in a national study of the vaccine.

The hospital maintained that safeguards were put in place to protect against conflicts of interest during the collaboration. Nevertheless, amid public outcry, Nabel stepped down from the board.

But this story is just one high-profile case of what is commonplace in the hospital sector. A 2014 research letter published in the Journal of the American Medical Association found that 40 percent of pharmaceutical company boards of directors had at least one member who also held, at the same time, a leadership role at an academic medical center.

Read More

Conflicts of Interests and the Goals of Translational Medicine

By Matthew L Baum

There are many ways to drive medicine forward. One is to work to remove economic, political, or geographic barriers to accessing care, and thus aid those whose suffering can be assuaged but is not being so. Another is to work to develop treatments for types of suffering poorly eased (or addressed) by current care. Both are important. Serious pursuit of the second strategy, however, requires the participation of industry; to translate bench science into benefits for real people will usually require manufacture of new medicines or devices, a function that universities and public institutions do not do but industry does well.

But for those students, like myself, currently training in MD-PhD programs in hopes of pursuing this goal of translational medicine, it is not at all clear what attitude we should take towards industry. On the one hand, the vision to move science from bench to bedside would seem best served by those clinician-scientists who do not see publication as the end result but are devoted to responsibly guiding their discoveries into the industrial setting and propelling them to patients. On the other hand, connections between industry and academia are often described categorically as “conflicts of interest” that must be disclosed and ideally divested. I will not attempt to comment here on the events that have led to a prima facie (pharma facie?) negative valence of academic-industrial connections; I was struck to hear, however, one of the panelists (an academic) on a recent panel discussion on translational medicine open with a slow and measured statement affirming her belief that collaborations between academics and industry can be a “good thing.” She then paused, as if to let the shock of the statement permeate the audience.

Read More