Politics
Federal Court Hears Doctor’s Dispute With DEA Over Giving Psilocybin To Terminally Ill Cancer Patients
A federal appeals panel heard oral arguments Monday in the case of a Washington State doctor seeking to legally use psilocybin to treat cancer patients in end-of-life care.
The lawsuit from Dr. Sunil Aggarwal and his clinic, the Advanced Integrated Medical Science (AIMS) Institute, centers on whether the federal government must allow certain patients access to psilocybin under state and federal right to try (RTT) laws, which intend to give people with terminal conditions the opportunity to try investigational medications that have not been approved for general use.
Aggarwal and AIMS believe the laws should open a path to legal use of psilocybin and other controlled substances. But attorneys for the Drug Enforcement Administration (DEA) have argued in the case that the federal RTT law, signed into law in 2018 by President Donald Trump, “does not provide any exemptions” from CSA restrictions.
“What we’re faced with is a categorical view of the world from the DEA, and that categorical view of the world is that there is no path to access Schedule I substances for therapeutic use,” Shane Pennington, an attorney for Aggarwal, told judges on the U.S. Court of Appeals for the Ninth Circuit at Monday’s hearing.
That view, he argued, is at odds with a plain reading of the Right to Try Act.
“Congress said what an eligible investigational drug is,” Pennington said. “Neither the government nor DEA disputes that. If you look at that definition and you just do textualism like you do so well, there’s no way to say that it doesn’t cover psilocybin.”
Aggarwal and AIMS have been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care, initially seeking to win permission from regulators under state and federal RTT laws.
When DEA rebuffed that request, Aggarwal sued. In early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action.
The current Ninth Circuit case stems from Aggarwal’s responses to that ruling. In February 2022, the doctor filed a formal petition with DEA to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA)—the denial of which is a reviewable action. He also applied for a regulatory waiver to obtain psilocybin.
DEA denied Aggarwal’s petition in September 2022 and rejected the waiver request the next month. The doctor’s Ninth Circuit cases challenge both decisions.
A separate lawsuit by Aggarwal seeking to reschedule psilocybin under the federal Controlled Substances Act (CSA) was ordered to mediation earlier this year under a joint request from his institute and DEA.
“The core of this case,” Pennington said at Monday’s 9th Circuit hearing, “is whether DEA has the tools to be able to accommodate this request at all.”
Judges Marsha Berzon, Aaron Bress and Lawrence VanDyke had critical questions for Pennington about Aggarwal’s waiver request, saying the scope of the proposed psilocybin activity was vague and noting that it was unusual to bring the rejection directly to an appeals court rather than filing suit at the district court level.
“The odd thing here is that you went to the agency and then came to us as a review of the agency decision,” Berzon said. “In most instances, what litigants do in this context, you should bring a district court case.”
Pennington contended that DEA has in the past granted similar requests, for example in the context of reverse distributors and, separately, allowing an individual patient access to medical marijuana.
Judges also pushed back against the government’s lawyer, however, saying DEA could have better justified its rejection of Aggarwal’s waiver request.
“It didn’t explain anything about whether accommodating the RTT’s scheme, even though it wasn’t directly applicable, was a good or bad idea, or why it didn’t do it,” Berzon said of the agency.
“Well, I think it did,” replied DEA attorney Thomas Pulham. “The agency first noted the features of the substance in question, which is that it has no currently accepted medical use, high potential for abuse and a lack of accepted safety.”
“Those are all the statutory criteria for why it’s Schedule I to begin with,” Berzon shot back, suggesting DEA didn’t sufficiently explain why that meant the agency couldn’t accommodate Aggarwal’s request.
“The agency could have granted some kind of waiver by rule here,” the judge added. “It could have done that, is that right?”
“Yes,” acknowledged Pulham, “the agency never said it lacked authority.”
DEA argued in a filing in the case in April, however, that “the Right to Try Act does not ‘provide any exemptions from the CSA or its implementing regulations. And it does not ‘give the DEA authority to waive CSA requirements.’”
Pennington argued that if Aggarwal had mislabeled his request as research, rather than providing access to terminally ill patients, DEA likely would have granted the psilocybin waiver under government’s expanded access program. Indeed, the DEA attorney said that in the case of the patient who received a federal medical marijuana waiver, his condition was “constantly monitored” by FDA and improved investigators.
“You’re saying these were…researchers?” asked Bress of the marijuana patient’s doctors. “Is that your position?
“It’s a little unclear,” Pulham responded.
During rebuttal, Pennington explained that Aggarwal has worked to find any legal pathway whatsoever that would allow him to obtain and dispense psilocybin to terminally ill patients.
“Dr. Aggarwal is knocking on every door,” the lawyer said. “The house has a front door, a side door, a back door. He’s trying to get through the door any way he can, because he has patients who are dying and he wants to be able to give them an eligible investigational drug.”
“There is no registration available under the regulations for this particular activity,” he added, “so he asked [DEA] to do what they’ve done in the past: either create that through a regulation or grant him an exemption, like you did in these other cases.”
“Why can’t they do that to help these patients get this drug,” he asked. “Why can’t they do that to facilitate Congress’s will here? There’s no explanation. They don’t address it. And that’s why we think it’s important.”
Though psilocybin remains a Schedule I controlled substance, it’s been granted “breakthrough therapy” status by the Food and Drug Administration (FDA).
Aggarwal and AIMS have spent years pursuing various legal and regulatory pathways to allow the clinic to use psilocybin in palliative care. The clinic has presented DEA with multiple proposals to legally cultivate or otherwise obtain psilocybin to treat patients under RTT. The agency has denied them all.
“DEA has rejected each request,” the clinic argued in its opening brief earlier this year, “but has never addressed the arguments that Dr. Aggarwal has raised in support of them.”
“If DEA wants to disclaim authority to grant Dr. Aggarwal access to psilocybin under the CSA and RTT,” AIMS continued, “it must provide a reasoned explanation for how that decision comports with the CSA and the agency’s own precedent.”
Washington State and eight other jurisdictions—Delaware, Illinois, Michigan, Minnesota, Nevada, Oregon, Pennsylvania and Washington, D.C.—filed an amicus brief in support of the clinic’s position earlier this year, arguing that CSA doesn’t prohibit the use of controlled substances under RTT.
Many of the same states filed a previous amicus brief in 2021 that said DEA’s rejection of the patients’ application amounted to overreach by the agency
“The CSA was intended to combat drug trafficking and abuse,” says the latest amicus brief, led by the office of Washington State Attorney General Bob Ferguson (D).
“It is irrelevant whether a Schedule I substance has a ‘currently accepted medical use’ under the CSA in the context of uses authorized by the RTT Act,” the brief adds. “The RTT Act’s purpose is to provide a unique, targeted exemption from such requirements.”
Washington State, for its part, adopted its own right to try law in 2017, and dozens of other states have enacted similar policies.
The case is AIMS v. DEA, 22-1568.
As Aggarwal’s efforts have made their way through the courts, a number of studies have strengthened the case for psilocybin’s legitimate medical use.
A federal health agency earlier this year acknowledged on its website the potential benefits the psychedelic substance might provide—including for treatment of alcohol use disorder, anxiety and depression. Officials also highlighted psilocybin research being funded by the federal government into the drug’s effects on pain, migraines, psychiatric disorders and various other conditions.
As for anxiety and existential distress, the agency said a “small amount” of research has studied psilocybin as a treatment for distress in people with serious medical illnesses, like advanced cancer.
“A 2020 analysis of 4 small studies in 117 people, most with life-threatening cancer, concluded that psilocybin combined with psychotherapy may be safe and effective for improving anxiety, depression, and existential distress, as well as quality of life,” it says, adding that “Because of limitations in the design of the studies and the small number and health status of the people involved, the authors note that the conclusions may have been biased.”
Just this month, the head of the National Institutes of Health (NIH) said there’s “growing evidence” that psilocybin could represent a novel therapy option in the treatment of substance misuse, depression, anxiety and other mental health conditions.
Findings of another recent study suggested that the use of full-spectrum psychedelic mushroom extract has a more powerful effect than chemically synthesized psilocybin alone, which could have implications for psychedelic-assisted therapy. The findings imply that the experience of entheogenic mushrooms may involve a so-called “entourage effect” similar to what’s observed with cannabis and its many components.
A separate study recently published by the American Medical Association (AMA) found that single-dose psilocybin use was “not associated with risk of paranoia,” while other adverse effects such as headaches are generally “tolerable and resolved within 48 hours.”
That study involved a meta-analysis of double-blind clinical trials where psilocybin was used to treat anxiety and depression from 1966 to last year.
AMA published another recent study that similarly contradicted commonly held beliefs about the potential risks of psychedelics use, finding the substances “may be associated with lower rates of psychotic symptoms among adolescents.”
Also, results of a clinical trial published by AMA in December “suggest efficacy and safety” of psilocybin-assisted psychotherapy for treatment of bipolar II disorder, a mental health condition often associated with debilitating and difficult-to-treat depressive episodes.
The association also published research last August that found people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin.
In September of last year, researchers at Johns Hopkins and Ohio State universities published a report that linked psilocybin use with “persisting reductions” in depression, anxiety and alcohol misuse, as well as increases in emotional regulation, spiritual wellbeing and extraversion.
Those results were “highly consistent with a growing body of clinical trial, behavioral pharmacology, and epidemiological data on psilocybin,” authors of the study said. “Overall, these data provide an important window into the current resurgence of public interest in classic psychedelics and the outcomes of contemporaneous increases in naturalistic psilocybin use.”
Last August, a separate study from the American Medical Association (AMA) found that people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin.
And a survey by Canadian researchers published in October said psilocybin use can help ease psychological distress in people who had adverse experiences as children. Researchers said psilocybin appeared to offer “particularly strong benefits to those with more severe childhood adversity.”
Canada, for its part, allowed four cancer patients in 2020 to become the nation’s first people in decades to legally possess psilocybin after being granted permission by the country’s health minister to use the substance for end-of-life care. Later that year, some healthcare professionals also gained the ability to legally possess and use psilocybin themselves.
A survey published earlier this year found that roughly 8 in 10 Canadians believe psilocybin is “a reasonable choice” for end-of-life care.
Photo courtesy of Wikimedia/Workman.
