Doctor’s Lawsuit Over Psilocybin For Cancer Patients Will Be Argued This Summer, With Separate Rescheduling Case Headed To Mediation

Two separate lawsuits on legal access to therapeutic psilocybin are advancing toward next steps in federal court.

An appeals panel this week scheduled oral arguments for later this summer in the case of a Washington State doctor seeking to legally use the psychedelic to treat cancer patients in end-of-life care. A dispute over attorneys’ fees in the doctor’s separate challenge to the scheduling status of psilocybin, meanwhile, is heading to mediation.

Regarding the former case, the U.S. Circuit Court of Appeals for the Ninth Circuit this week scheduled arguments for August 19 in a San Francisco courtroom.

The underlying lawsuit, brought by 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. The laws intend to give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use.

Aggarwal and AIMS contend those laws should allow a legal way for end-of-life patients to access psilocybin, but lawyers for the federal government disagree.

In a brief filed to the court in April, attorneys for the Drug Enforcement Administration (DEA) argued that the federal RTT law, signed into law in 2018, “does not provide any exemptions” from CSA restrictions.

“As DEA explained, 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,’” the government’s brief says. “Indeed, the Right to Try Act does not even mention the CSA or controlled substances at all.”

Washington State, for its part, adopted its own right to try law in 2017, and dozens of other states have enacted similar policies.

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.”

Eight U.S. states as well as Washington, D.C. have filed a friend of the court brief in support of AIMS’s effort to use psilocybin under state and federal RTT laws.

A separate lawsuit by Aggarwal seeking to reschedule psilocybin under the federal Controlled Substances Act (CSA) was recently ordered to mediation under a joint request from his institute and DEA, with the parties set to discuss a possible settlement over attorneys’ fees.

As for the case around right-to-try laws, 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.”

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. But 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 cases 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 the 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.

As Aggarwal’s efforts have made its way through the courts, a number of studies have strengthened the case for psilocybin’s legitimate medical use.

As a result, a federal health agency late last month acknowledged on its website the potential benefits the psychedelic substance might provide—including for treatment of alcohol use disorder, anxiety and depression. The agency 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.”

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.

Read the mediation order in the psilocybin rescheduling case below: