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."©2021 The Philadelphia Inquirer, LLC. Visit at inquirer.com. Distributed by Tribune Content Agency, LLC.