Doctor Challenges DEA For Cancer Patients’ Right To Use Psilocybin
A physician from Seattle is fighting the DEA (Drug Enforcement Administration) for the legal right to provide terminal cancer patients with psilocybin.
Dr. Sunil Aggarwal has been petitioning the DEA to reschedule psilocybin from a Schedule I to Schedule II drug. This allows terminally ill patients to legally access psilocybin to manage their depression and anxiety.
This has been a long and arduous battle for Aggarwal who initially started a petition in February 2022, seeking permission from federal regulators under federal “right-to-try” laws. This would allow terminally ill patients to use investigational new drugs that aren’t Federal Drug Administration (FDA) approved.
When his petition was denied, Aggarwal requested instead that the DEA do a review to reschedule psilocybin to a Schedule II drug. The request was subsequently denied without any analysis or reasoning behind the decision. The issue was brought to court under Aggarwal v. DEA and on October 27, 2023, the Ninth Circuit Court of Appeals ordered the DEA to reconsider its denial of petition.
According to Ninth Circuit notes, ‘DEA neglected to define “currently accepted medical use with severe restrictions,” the standard for transferring a drug from Schedule I to Schedule II. The DEA didn’t clearly explain how psilocybin doesn’t meet the criteria for “accepted medical use” according to their five-part test or any other method that would allow them to make that call.
Arguments in front of the Ninth Circuit Court of Appeals were held on August 19 in San Francisco. Updates will be shared when it is available.
Cannabis rescheduling review delayed due to election
The DEA announced earlier this year that it was considering rescheduling cannabis from a Schedule I to Schedule III drug. This recognizes its legal status for medical usage, research and softening penalties for possession and recreational use. In addition to cannabis, other substances will include ketamine, anabolic steroids and some acetaminophen-codeine combinations.
The review was due to go before the White House Office of Management and Budget but has been delayed until after the upcoming elections. According to the Federal Register website, the hearing is set to commence on December 2, 2024.
Despite strong evidence that cannabis and psychedelics can have positive effects on those suffering with depression, dementia and anxiety, clinical studies are notoriously difficult to conduct in the U.S. Because of the legal barriers, researchers have to rely on participant’s anecdotal reports instead of administering the cannabis to participants, observing them and recording the data. Which is why most research tends to come from scientists outside the U.S.
Dr. Aggarwal has always been a proponent of cannabis and psychedelics as part of a patient’s pain and symptom management.
“There are so many chances to enhance and grow palliative care. I really think cannabinoids can play a significant role in oncologic palliative care. This role will likely expand as more people become knowledgeable and accepting of these agents again, just like in North America and Europe during the 19th and early 20th centuries,” Aggarwal notes in his 2016 research.
“Regardless of source, all cannabis-related medicinal products have yet to be well-integrated into healthcare, indicative of the translational gap between available scientific evidence on cannabis and cannabinoids, and current practices. The benefits of bringing CIM (cannabinoid integrative medicine) into palliative care have faced challenges due to conflicting regulations, ongoing stigma, research hurdles, and limited product availability—most of which come from a lack of awareness and knowledge among patients, clinicians, and other stakeholders.
