Pennsylvania could become a leader in studying magic mushrooms as a treatment for mental illness under a bill that was introduced last month in the House of Representatives and is scheduled for a Health Committee vote Tuesday in Harrisburg.
The proposed legislation, the Public Health Benefits of Psilocybin Act, would establish a framework for clinical studies of psilocybin, the active ingredient in magic mushrooms. It would give researchers some cover for sidestepping cumbersome federal regulations that still categorize the substance as having no accepted medical use despite growing evidence that it does.
Experts and advocates said that even if it doesn’t become law, the Pennsylvania bill’s introduction is a sign of building momentum in the United States for research into psilocybin as a potential therapy for the most serious cases of depression, post-traumatic stress disorder, and other mental illnesses. Oregon legalized psilocybin in 2020, while Texas is sponsoring research.
“It’s very clear at this point that current treatment that we offer people is not effective. It has limited efficacy for some people and no efficacy for many people. We need to do better,” said Brett Waters, a lawyer in New York who founded a nonprofit to advocate for psychedelics-assisted psychotherapy.
“The real purpose of this effort is to prevent suicides, opioid overdose, alcohol-related deaths,” said Waters, who grew up in Wynnewood and whose mother and grandfather died by suicide after long struggles with mental illness. Waters and his nonprofit, Reason for Hope, are also pushing for research legislation in New York, North Carolina, and Florida.
Listed as the prime sponsor of the Pennsylvania bill is Tracy Pennycuick (R., Montgomery County), an Army veteran who is in her first term. She has 20 cosponsors, a rare mix of Democrats and Republicans.
Pennycuick’s bill directs the state Department of Health, which would administer the research program, to prioritize clinical trials involving military veterans, retired first responders, and their family members. The bill does not come with funding attached, which means money would have to be earmarked separately.
One expert wished the bill would generate more urgency to get people into treatment with psilocybin.
“For two decades we’ve seen rising rates of suicide, rising rates of drug overdose deaths, and so there is a certain amount of urgency on this issue, so I think increasing access is really important,” said Mason Marks, a professor at the University of New Hampshire’s Franklin Pierce School of Law and head of the Project on Psychedelics Law and Regulation at Harvard’s Petrie-Flom Center.
The Pennsylvania proposal falls between what has happened in Oregon and Texas. Oregon legalized psilocybin-assisted therapy in medical settings and is in the process of developing regulations. Texas has a law that went into effect last summer directing the state’s Health and Human Services Commission to do a clinical trial of psilocybin for veterans with PTSD in collaboration with the Baylor College of Medicine.
The Pennsylvania bill envisions research and clinical trials by universities, medical research institutes, and medical schools that are attached to a hospital and a university.
Here’s where things get complicated, because psilocybin, like cannabis, heroin, and LSD, is on the list of the most restricted substances, known as Schedule I, at the U.S. Drug Enforcement Agency.
The worry for university administrators is that if their researchers don’t go through the challenging licensing and approval process at the DEA and FDA, federal funding could be jeopardized.
“I think that’s still a concern,” said Ellen Unterwald, chair of the department of neural sciences and director of the Center for Substance Abuse Research at Temple University’s Lewis Katz School of Medicine. “Probably Temple would not want to do that if it was against a federal law.”
Even in Texas, which mandated a specific clinical trial, the Baylor researcher expecting to lead the effort, Lynnette Averill, is following the traditional route of getting a DEA license and starting an application for an investigational new drug application at the FDA.
The Pennsylvania bill caught the eyes of some observers because it would authorize the Health Department to license at least two growers of psilocybin mushrooms for use in clinical studies.
Most clinical trials of psilocybin, like those at research leader Johns Hopkins University, have been conducted using a synthetic form of the substance.
The National Institutes of Health last month awarded Johns Hopkins researcher Matthew Johnson a nearly $4 million grant to lead research into whether the combination of psilocybin and talk therapy is effective in helping people quit smoking. It is the first federal funding for psilocybin research in more than 50 years, Johns Hopkins said.
Last week, the publicly traded British firm Compass Pathways, which has a research contract with a University of the Sciences professor, released highly anticipated results from the first larger-scale study of psilocybin.
The 233-patient trial compared different-size doses of Compass’ synthetic psilocybin and found that a 25-milligram dose resulted in a significant decrease in the severity of depression after three weeks. On a scale of depression symptoms that runs from 1 to 27, with scores over 21 indicating severe depression, patients experienced an average 6.6-point reduction in depression severity. Smaller doses were not effective, the company said.
“The trial is encouraging being a larger sample of patients with a control group than earlier [treatment resistant depression] studies and having a significant effect for a clinical need,” said William R. Smith, a fourth-year psychiatry resident at Penn Medicine.
Treatment-resistant depression is a major challenge for contemporary psychiatry, Smith said. “We need more options.”