The legalization of psilocybin mushrooms is a cause that is gaining support from the public, scientists and political leaders every day. Scientific study has repeatedly shown this drug to have the potential to be used therapeutically, and now researchers say there is strong evidence that it can even curb major depression symptoms. But psilocybin reform may still be years away. Despite laws that allow terminally ill patients to use mushrooms as a treatment when every other path has been closed, federal law enforcement refuses to allow access to the drug.
Last week federal police officers arrested 17 protesters who were staging a “die-in” on the steps of the Drug Enforcement Administration (DEA) headquarters in Virginia. The protesters lay in front of the building’s entrance and refused to move until DEA leaders heard their complaint. Demonstrators set off colorful smoke bombs, defaced the DEA building, removed the agency’s flag and chanted pro-mushroom slogans.
“We’re not asking DEA to be compassionate,” said Dr. Bronner’s Magic Soaps CEO David Bronner at the start of the protest. “We’re asking them to follow established law.”
The Right To Try Act was signed by former President Donald Trump in 2018. The law gave terminally ill patients the right to try investigational treatments when all other avenues of treatment have proven fruitless and entry into clinical studies have been blocked. Experimental drugs can be accessed through the Right To Try Act if they have completed a Food and Drug Administration (FDA)-approved Phase 1 clinical trial, are currently in an active clinical trial as part of an application for approval with the FDA or are being actively produced and not discontinued by the manufacturer or put on clinical hold.
In late 2020 the co-director of the Advanced Integrative Medical Science Institute (AIMS) in Seattle, Wash., Dr. Sunil Aggarwal, applied to state and federal regulators for approval to cultivate psilocybin mushrooms for use in treating his terminal patients. “We know that [psilocybin] is a naturally occurring substance that we can cultivate safely, we know how to dose it and there’s really good reason to believe it can help,” Aggarwal told reporters.
In January 2021 Aggarwal wrote to the DEA for approval to grow mushrooms but was flat-out denied. The DEA’s February response claimed that the drug’s status as a Schedule I substance according to federal law overrides any allowances given by Right To Try. “The [Right To Try] does not waive the requirements of any provision of the [Controlled Substances Act] or its implementing regulations,” wrote the DEA. Since psilocybin has already completed an FDA-approved Phase 1 clinical trial, it should meet the criteria of the law and be available to terminally ill patients, but the agency told Aggarwal that the only way to legally dispense magic mushrooms was through the approval of a federal research permit. The agency noted that the doctor was not eligible for such a permit.
In March 2021, AIMS filed a lawsuit against the DEA. “I just felt like this is the same old pattern that the DEA has been in since they were founded in the ’70s by Richard Nixon, which was really this politically politicized institution that tried to shut down research and medical progress with cannabis and psychedelics,” said Aggarwal.
In February 2022, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit dismissed the case. AIMS had been advised that it could petition the decision if Aggarwal applied to obtain researcher registration with the DEA, and since the agency hadn’t reached a “final” answer on the matter, the appellate court said it was not within its jurisdiction to hear the case.
Right To Try Denied
“We’re here today to demand that the DEA open a pathway to access,” said AIMS lead litigator Kathryn Tucker last week at the DEA headquarters. “We approached the DEA in January of 2021. That is now 15 months ago, and the DEA refused access. So we took the DEA to federal court in a lawsuit known as AIMS v. DEA that pended in the 9th circuit for 10 months in which we had a deep drill-down into what the law requires. The DEA understands now that it has a duty and an obligation to open and create a pathway to access. And yet, the court sent the matter back to the DEA.”
The protest was livestreamed on Facebook—including the moment when Bronner, the demonstration’s organizer, and 16 others were arrested for trespassing. They were immediately released with a court summons for May 19. At one point in the protest, police entered DEA headquarters and reportedly tried to find a member of the agency who would be willing to come speak with the protesters. No member of the agency made an appearance at the demonstration.
The protesters regarded the event as a victory of sorts. In a group photo posted to Twitter by the Right To Try Psilocybin account, participants can be seen in a group photo, holding up their court summons and zip-tie cuffs. Most of the cuffs remained intact despite having been worn by protesters.
“Note some of the zip ties,” tweeted commenter Adam Eidinger. “Proof federal protective services didn’t make the cuffs tight due to their sympathy to the issue and attempts to negotiate with DEA for a meeting about #RightToTry.”
Studies over recent years have shown psilocybin to be a potentially therapeutic drug for treating PTSD, anxiety and a number of other psychological ailments—especially for terminal patients. Earlier this year, Johns Hopkins Medicine published a study in the Journal of Psychopharmacology that found that two doses of psilocybin in conjunction with psychotherapy drastically decreased major depressive disorder symptoms for most participants.