A team of seven attorneys is fighting on behalf of a Seattle physician and his two cancer patients who wish to access psilocybin to treat the mental health impacts of their terminal illnesses. These lawyers have been involved in an extensive battle attempting to prove to a federal judge that psilocybin should be removed from its classification as a Schedule I substance so that more individuals with life-threatening conditions can seek the therapeutic use of psilocybin.
Back in 2020, Dr. Sunil Aggarwal, a palliative care physician at the Advanced Integrative Medical Science Institute (AIMS), wanted to use and grow psilocybin mushrooms to treat his terminally-ill cancer patients who suffered from severe symptoms of anxiety. As a specialist in end-of-life care, he recognized the potential of psilocybin as a significantly more effective treatment than traditional anti-anxiety medications for his dying patients. He made a request to both the Washington state government and the federal government via the Drug Enforcement Administration (DEA) for a permit to use the psychedelic substance in his treatments. Despite his reasonings to use psilocybin, Aggarwal’s application was ultimately denied. The DEA claimed that the agency had no power to waive the Controlled Substances Act (CSA), which labels psilocybin as a Schedule I controlled substance under federal law. The agency declared that the only way Dr. Aggarwal could legally dispense psilocybin was through a federal research permit that was inaccessible to him at the time.
Aggarwal did not take the rejection lightly as he saw no reason why there could not be an exception to using psilocybin for his patients. He argued that special cases could be made under the government’s “right to try” laws which allow the use of investigational medicines for terminally ill patients. In a report from Marijuana Movement, Aggarwal believed that the DEA had no grounds to deny the application. Hence, his attorneys sued the United States Court of Appeals for the Ninth Circuit to “expeditiously reconsider and accommodate valid requests made from qualified health providers for the therapeutic use of the eligible investigation drug psilocybin.”
The lead attorney of the lawsuit, Kathryn Tucker from Emerge Law Group, argued that the substance meets the requirements of the right to try laws as an “eligible investigational drug”; therefore, terminal patients should be able to access psilocybin while it remains under investigation. However, Tucker’s arguments had legal limits that the DEA had no authority over. Once again, the appeal was dismissed because Congress has not yet made any changes to the CSA, which allows only specified exclusions regarding certain laws. The DEA asserts that they have no legal means within their agency to allow psilocybin for therapeutic purposes since it remains a Schedule I drug. Even the attorney of the DEA agreed that their lack of guidance was unfair to patients, yet there is currently nothing they can do to bypass the requirements of the CSA, even with the new right-to-try laws.
The Senate and former President Trump signed the Federal Right to Try (RTT) Act in 2018. As stated by the U.S. Food and Drug Administration (FDA) site, “patients with serious or immediately life-threatening diseases or conditions” are allowed “access to eligible investigational drugs.” Among the eligible treatments or drugs, the law specifies that they should have completed an FDA-approved Phase 1 clinical trial or is in an active clinical trial filed with the FDA and in ongoing development. Psilocybin has undergone an FDA-approved Phase 1 clinical trial and has been granted the status of a “breakthrough therapy” for treatment-resistant depression as of October 2018. This status indicates that the substance has significant clinical benefits that are more effective than other currently available drugs. Since then, several more studies have been conducted which concluded that psilocybin works as a novel treatment option for those struggling with a mental health condition who have not responded to traditional medications and therapies.
Regardless of its status as an FDA-approved breakthrough therapy, psilocybin remains a Schedule I drug, which makes it difficult to bypass any new laws, such as the RTT Act. The DEA’s hands are apparently tied until psilocybin is reclassified as a Schedule II substance instead.
As a result of these legal hurdles, Aggarwal’s attorneys filed a waiver request and a petition to reschedule psilocybin as a Schedule II substance in 2022. The petition aimed to provide the DEA with an alternative for granting psilocybin access to patients with terminal illnesses. They hoped that the DEA would recognize the inconsistencies with their denial of the requests concerning the purpose of the RTT laws. Similarly, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act the same year, with companion legislation from representatives Earl Blumenauer and Nancy Mace. The bipartisan bill was meant to amend the current RRT Act by clarifying that terminal patients could be allowed access to Schedule I drugs that have passed a Phase 1 clinical trial. Therefore, removing “any obstacle presented by the Controlled Substances Act with respect to Schedule I substances when they are used by doctors and patients in accordance with the federal Right to Try law.” Both requests were shot down as the DEA formally refused to reschedule psilocybin or reconsider the terms of the RTT Act.
The DEA defines a substance as Schedule II when the “drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.” Among the list of substances on the Schedule II list are drugs that are proven to be more toxic and addictive, such as fentanyl, codeine, oxycodone, and morphine. Still, the DEA refuses to reschedule psilocybin despite its evidence as an effective drug for medical treatment. Regardless of the DEA’s disapproval of Aggarwal and his attorney’s petitions, his team is still fighting for reconsideration.
In May of 2022, several demonstrators gathered outside of the DEA headquarters to protest for patients’ access to psilocybin to treat life-threatening conditions. Many of the protestors were arrested for not leaving the premises, one being a patient of Dr. Aggarwal, Erinn Baldeschwiler.
Baldeschwiler, a mother of two, has been fighting Stage 4 metastatic breast cancer since 2020. Because of her terminal diagnosis, she has been struggling with debilitating mental health concerns that make it difficult for her to be present during her last stretch of life with her family and loved ones. Erinn discussed her disapproval of the DEA’s handling of the appeals, insisting that she has the right to try psilocybin:
“My cancer is progressing and I am running out of time to access this promising medicine. It is not just the DEA’s refusal to grant access, but the fact that they have yet to confirm receipt and/or respond to our waiver request from early February is inhumane, unjust, and downright shameful. This agency is not above the law, and in this instance a law that was passed with overwhelming unilateral support from our legislators.”
Cases like Erinn’s are precisely why Aggarwal and his attorneys continue to fight against the DEA’s denial of allowing psilocybin access to individuals with terminal illnesses. According to a report by Double Blind Magazine, his attorneys have summarized their arguments to a judge as to why psilocybin should be reclassified in a recently filed 13,000-word merits brief. They have also called for “amicus briefs,” which are documents submitted by parties not directly tied to the case (otherwise known as the amicus curiae). The documents will provide further arguments and information to the court to help influence the judge’s decision-making process. The lawyers hope that this route of opposing the DEA will humanize their case and add an emotional aspect to the legal arguments in the court battle. Along with firsthand accounts, individuals and organizations are invited to share their bipartisan support for psychedelic research or explain why the drug scheduling laws should not apply to psilocybin.
Shane Pennington, an attorney working in partnership with Tucker, believes the firsthand accounts from individuals who have benefitted from psilocybin may sway the judge in their decision and open their mind to the overwhelming personal anecdotes. “I’d like to see the veterans come in and share their powerful voices in the context of the lawsuit,” explains Tucker, “they may not realize how many veterans, children with rare diseases, elderly people with terminal illness are watching this case.”
While psilocybin remains illegal on a federal level, several lawmakers across the U.S. have been filing legislation to make psilocybin legal for medical use in their states. So far, only Oregon and Colorado have passed laws that have not only decriminalized many psychedelic drugs in small amounts but also made psilocybin entirely legal for medical treatment via psilocybin-assisted therapy clinics that follow a strict framework of rules and guidelines to ensure proper regulation and treatment with the substance. Many states, such as California, New Hampshire, and Massachusetts, are attempting to follow in the footsteps of decriminalizing psilocybin and potentially legalizing it for psilocybin-assisted therapies, demonstrating that multiple states nationwide have similar stances to Aggarwal’s views on psilocybin as a treatment. Perhaps in the future, with more statewide support, the federal government may change its perspective on psilocybin’s use as a medicine for terminal patients. Until then, studies and accessibility on the substance will remain limited until the DEA reschedules psilocybin as a Schedule II substance.