By Vincent Joralemon
There is little consensus in defining “psychedelic.” Yet, research on and access to these substances hinges on what gets included in the “psychedelic” umbrella. It is time to talk about why we include (and exclude) particular drugs from this category.
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.
By Vincent Joralemon
Psychedelics have a public relations problem, due in part to overzealous promoters, genuine risks, and bad science. But, recent psychedelic legislation sponsored by conservative congressperson Dan Crenshaw shows minds can be changed in this space.
Public perceptions will shape efforts to reclassify, decriminalize, and make psychedelics available for therapeutic use. The most effective way to change peoples’ opinions is to highlight the success stories of those who have tried psychedelics. And, as Crenshaw’s story shows, psychedelic-assisted therapy for post-traumatic stress disorder (PTSD) is a compelling application for precisely those who harbor the most skepticism towards these drugs.
By Vincent Joralemon
A $70 million deal struck between a venture capital firm and a prominent psychedelic advocacy organization suggests that funding for psychedelic research may increasingly rely on nonprofit and commercial partnerships.
As the commercial appeal of these substances grows, this might serve as a promising model to channel the resources of for-profit entities toward this field. This funding can support clinical trials, FDA approval, and ultimately insurance coverage for these promising (but resource-intensive) therapies.
By Vincent Joralemon
Psychedelics hold immense potential to address an array of conditions that are otherwise challenging to treat, but accessing these therapies can be costly, which means that potential benefits will be stratified along the lines of socioeconomic status.
This is an acute concern, because many with conditions that psychedelics may help to treat — such as post-traumatic stress disorder, postpartum depression, treatment-resistant depression, and alcohol use disorder — lack the resources to pay for effective health treatments.
By Jonathan Perez-Reyzin
Within the psychedelic legal landscape, the U.S. Food and Drug Administration (FDA) plays a central role — it is the regulatory mechanism by which drugs like MDMA and psilocybin may soon become legal for medical use.
But for many working in drug policy, medicalization is not the exclusive goal. Indeed, there have been calls for legalization of psychedelics for non-medical use — and we are seeing an early attempt at such a model in Oregon.
These efforts are not yet reaching the federal level, but it’s only a matter of time before the legalization of psychedelics and other currently illegal drugs for adult recreational use becomes a federal question, as is already occurring with marijuana. And despite the FDA’s widely recognized role in medicine, few have considered the role the FDA would play in a federal regulatory regime for the non-medical use of drugs, even though it already does regulate at least one recreational substance legal for recreational use: tobacco.
By James R. Jolin
To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates.
The conversation was situated against the backdrop of the “psychedelics renaissance” in the United States, which has been fueled by a wave of local and state legislation reducing or eliminating the criminal penalties associated with these substances.
Though many localities have made significant strides in addressing the legal questions surrounding psychedelic substances such as psilocybin and dimethyltryptamine (DMT), federal policymakers have not pursued similar initiatives.
Suggestions and considerations for federal psychedelic policy thus formed the substance of the discussion among the panelists:
By Dave Kopilak
In November 2020, Oregon voters passed the Oregon Psilocybin Services Act (the “Act”), of which I was the primary drafter. This piece of legislation legalizes and regulates the manufacturing of psilocybin products and the provision of psilocybin services under Oregon law. The manufacture, sale, and use of psilocybin products under the Act will continue to be illegal under federal law.
The Oregon Health Authority (OHA) is the state agency that will regulate the program. The Act provides for a two-year program development period that began on January 1, 2021 and that will end on December 31, 2022. The OHA is currently engaged in the rulemaking process and will adopt final rules by no later than December 31, 2022. The OHA will begin receiving license applications on January 2, 2023, and the first licensed businesses likely will begin operating in the first half of 2023.
By Bob Wold
One understudied condition for which small doses of psychedelic substances such as psilocybin may be beneficial is cluster headache.
As founder and executive director of the advocacy group Clusterbusters, I have seen firsthand, as a patient and an activist, that, despite its modest name, cluster is far from “just” a headache. It is a chronic pain condition that lasts “on” and “off” for months or years, often with no hint as to its origin. Estimates suggest that one in 1,000 people – which equates to over 332,000 Americans – suffer from cluster headache.
By James Fadiman
Law and policy around microdosing of psychedelic substances should reflect its proportionally low risks.
“Microdosing” refers to the practice of consuming very low doses of psychedelic substances, about 1/10th to 1/20th of a typical dose, primarily of psilocybin-containing mushrooms or lysergic acid diethylamide (LSD). Doses typically are taken intermittently, over several weeks, and they do not interfere with normal daily activities, unlike the powerful consciousness-altering effects of higher doses.