When it comes to mitigating the pain and depression suffered by patients with terminal cancer, some people argue no potential treatment should be off the table. The Drug Enforcement Agency (DEA), tasked with enforcing the nation's drug laws, might not agree with that assessment.
On February 13, 2025, a panel of judges on the Ninth Circuit Court of Appeals ruled not to overturn a DEA decision concerning a Schedule I drug. Doctor Sunil Aggarwal and the Advanced Integrative Medical Science Institute (AIMS) had petitioned the court to instruct the DEA to allow them to use psilocybin, a hallucinogen, as part of a cancer treatment regimen.
Far Out Treatment
Psilocybin is produced by over 200 different types of mushrooms, also known as "magic mushrooms." While ingestion of psilocybin can cause euphoria, giddiness, and pleasant hallucinations, a fair number of negative reactions have been documented among users as well, including nausea, vomiting, and agitation.
In 1970, psilocybin was given a Schedule I classification under the Controlled Substances Act (CSA), banning its use under federal law. Drugs under Schedule I are considered to have a high potential for abuse and no accepted medical use.
While psilocybin's federal classification hasn't changed, the past decade has seen it decriminalized in two states (Colorado and Oregon) and several cities. Oregon allows legal use through a therapist or licensed facilitator.
AIMS is an outpatient clinic and research facility located in Seattle, Washington. Dr. Aggarwal is a co-founder and co-director. Since 2021, he's tried to secure the right to give his terminal cancer patients psilocybin to mitigate their pain and provide relief. Unable to secure a supplier, he requested that the DEA either grant him a waiver for usage under the CSA or rule that it didn't require registration.
Courting Failure
When the DEA declined to grant permission, AIMS appealed the decision. Supported by an amicus curiae brief from several states, they cited the federal Right To Try Act as justification for being allowed to use psilocybin.
The Right To Try Act is designed to allow patients who have exhausted all other types of treatment access to drugs that have cleared Phase 1 clinical trials. However, it doesn't apply to drugs under the CSA.
In its 10-page opinion denying AIMS' appeal, the panel of judges from the Ninth Circuit listed a number of issues they had with the request by Aggarwal and AIMS. Practitioners and researchers who wish to administer drugs with a CSA schedule must register with the DEA, but Aggarwal wanted to use right-to-try laws to gain a waiver instead.
The panel also noted that Aggarwal and AIMS hadn't provided a treatment plan associated with the use of psilocybin or information about any safety protocols that would be in place. While the institute said that using psilocybin had shown "enormous promise" in early trials, the court found proof of these claims lacking.
The panel ruled that the DEA's decision was neither arbitrary nor capricious. They'd provided a reasonable explanation for their refusal.
It's a Kind of Magic (Mushroom)
This case highlights the dichotomy between state and federal laws. While Aggarwal and AIMS find themselves denied access to psilocybin, it's an approved medical option in Oregon, 173 miles to the south.
Should nearly all treatment options for patients with late-stage or terminal illnesses be allowed? After all, the argument goes, what is there to lose? With an unpredictable drug like psilocybin, however, the DEA felt that the approach offered by Aggarwal and AIMS was trying to cut too many corners. As evidenced by their opinion, the Ninth Circuit agreed.
Related Resources
- Drug Enforcement Agency (DEA) Overview (FindLaw's Learn About the Law)
- The Controlled Substances Act: Overview (FindLaw's Criminal Charges)
- Psilocybin (Magic Mushroom) Law (FindLaw's Criminal Law)
