An Outdated Law Has Stopped All Psychedelic Research in California

Throughout California, numerous studies looking at the efficacy of psychedelics for mental health are currently on hiatus due to the oversight of an obscure government panel. It’s called the Research Advisory Panel of California (RAPC), and it regulates research involving federally restricted drugs and addiction treatment.

Over 40 studies have been put on hold, one of which is a study looking at 5-MeO-DMT for treatment-resistant depression, the LA Times reports. Researchers at the Pacific Neuroscience Institute in Santa Monica, California, are essentially left in limbo and are facing the possibility of having to shut down their half-completed studies.

“We have to tell them we don’t have any studies enrolling right now,” said Dr. Keith Heinzerling to the LA Times. Heinzerling is the director of the Pacific Neuroscience Institute’s TRIP Center, which focuses on treatment and research on psychedelics. “We’ve been put on hold by the state.”

READ: Using Psilocybin for Mental Health Won’t Make You Feel Paranoid

The impasse, stemming from a state law mandating public government meetings, has been in effect since the fall, and it’s galvanized some scientists to advocate for the panel’s dissolution.

But what is this state law about? Over half a century ago, lawmakers in Sacramento established the Research Advisory Panel of California to vet studies involving cannabis, psychedelics, and treatments for the “abuse of controlled substances,” as outlined in the state’s health and safety code.

The panel, comprising representatives from state agencies and universities, wields the authority to reject studies that are poorly conceived, lack scientific merit, or pose excessive risk to Californian research participants. It also oversees ongoing research and can revoke approval if studies deviate from their original proposals.

Getting approval from the panel is difficult, however. But, researchers must get the green light to test and develop effective mental health treatments, including for substance use disorder, a crisis responsible for over 100,000 overdose deaths in the US annually. The panel also supervises psychedelic research.

The panel used to convene every other month, but the meetings planned for last October and December were abruptly canceled without explanation. Researchers eager to start their studies report they have not been informed about when the meetings will be rescheduled.

“I’ve been in search of a treatment that will alleviate symptoms of PTSD for a long time,” David* told the LA Times on condition of anonymity. He is looking to be a part of a clinical trial to access psychedelic therapy, which, as of now, is not widely accessible. Some traditional mental health treatments “have worked pretty well, but there are still times where there are challenges and episodes that can be pretty destabilizing,” including prolonged bouts of insomnia.

David does not want to use mushrooms at home or alone. He is in recovery from alcohol use and explained that he would only feel comfortable if it was administered by a therapist and in a therapeutic setting. The center in Santa Monica informed him that their next possible trial is delayed indefinitely.

“It feels like bureaucracy is working against meaningful solutions,” he said.

At UC San Francisco, Dr. Josh Woolley told the LA Times that two of his planned psilocybin studies are on indefinite hold. One of these studies targets young adults with anorexia, a disorder that can greatly increase the risk of death if not addressed. 

“We have no idea when it will be approved,” said Woolley, who directs the Translational Psychedelic Research Program at UCSF.

The delay has also disrupted the plans of Dr. Charles Grob, a psychiatrist conducting research with the Lundquist Institute at Harbor-UCLA Medical Center in Los Angeles. He aims to investigate whether psilocybin could offer relief to patients experiencing existential anxiety and demoralization as they near the end of life.

“Just as we’re poised for further research advancements, the field is at a standstill,” Grob told the Times.
Prior to halting its meetings altogether, the Research Advisory Panel regularly gathered in private. Scientists contended that conducting meetings in public would be unacceptable to funders who sought to safeguard their intellectual property.

“In reality, pharmaceutical companies won’t agree to have their products reviewed publicly unless there’s a meticulously devised procedure in place to safeguard their interests,” Heinzerling told the Times.

READ: Woman Dies at Mushroom Retreat in Australia

Since the panel’s last meeting in August, the backlog of studies awaiting review and approval has significantly increased. By December, there were 33 new proposals and 13 amendments to existing research projects in limbo, as reported by the attorney general’s office.

The attorney general’s office stated that it was collaborating with lawmakers and the governor’s office on a legislative remedy to address the issue but refrained from providing further details.

Originally reported by Psychedelic Alpha, this development has intensified longstanding grievances among scientists. They argue that the panel, even in its standard operations, serves as an obsolete and obstructive body that impedes crucial research progress. A recently established coalition of researchers is advocating for the removal of the panel. Their argument stems from the reality that research concerning controlled substances and addiction therapy already undergoes scrutiny from alternative regulatory bodies. They highlight that the California panel frequently revisits matters already resolved by other regulatory entities.

“I’ve never understood why this was not dismantled decades ago,” said Shoptaw, who has studied possible treatments for people who use methamphetamine.

Not all researchers are calling for the end of the panel. Grob said going through the panel is “extra work, but it’s been positive,” praising its members as astute and helpful.

“California has this extra layer of regulatory oversight, but the problem is not the committee itself,” he said. “It’s that the committee is unable to do its job.”