Lawyers representing a Washington State doctor who wants to use psilocybin legally for end-of life care argue that the Drug Enforcement Administration failed to explain a crucial decision when they denied him access to psychedelic. They are asking judges to reverse this decision, calling it arbitrary, capricious and to order the government review the matter again.
The opening brief submitted in the U.S. Court of Appeals, Ninth Circuit, last week is part of a long-term effort by Dr. Sunil Aggarwal of the Advanced Integrative Medical Science Institute for treating terminally ill patients with cancer using psilocybin.
The new action is aimed at the DEA decision to deny Aggarwal access to psilocybin in 2022 under state and federal Right-to-Try (RTT) legislation, which gives patients with terminal illnesses the chance to try investigational medicines that are not approved for general usage.
Washington State passed a Right to Try law in 2017 and the federal Right to Try Act was signed by then-President Donald Trump the following year. Dozens of states have adopted their own right to try policies.
Aggarwal, over the years, has made multiple proposals to the DEA in order to either legally cultivate or obtain psilocybin for his patients. He argues that the federal Controlled Substances Act must include a way to access the substance legally under RTT laws.
The new brief states that “DEA has refused each request, but has never addressed arguments raised by Dr. Aggarwal in support of them.”
In 2022, DEA denied a regulatory exemption that would have allowed Aggarwal to legally obtain psilocybin. The brief states that the agency has granted similar waivers before, but that “DEA did neither consider his arguments based upon the agency’s prior precedent nor provide a rationale for treating his request in a different way than similar ones in the past.”
The report continues: “If DEA wishes to disclaim its authority to give Dr. Aggarwal psilocybin access under the CSA or RTT,” the report states, “it must explain how this decision is in line with the CSA as well as the agency’s precedent.”
The brief states that DEA’s “decision denied Petitioners’ requests on the grounds that allowing Dr. Aggarwal access to psilocybin in the manner requested by the Petition would not be consistent’ with public safety and health'”. As support for this contention, DEA cited the statutory features of schedule I drug and claimed that allowing psilocybin therapeutic use with dying patients in RTT’s terms presented a ‘too large a departure from the current law.’ ‘”
In the brief, it is noted that in October, the Ninth Circuit ruled in Aggarwal’s favor in another matter relating to a separate and related petition to reschedule. The court ruled that DEA had failed to give a complete explanation of its decision to deny the petition. It then ordered the agency to provide a better justification.
It says that “for the same reasons this Court remanded DEA’s inadequate denial letters in Agarwalless than four months ago,” “it must remand DEA’s Final Decision in This Case as well.”
In their opening brief, lawyers for the AIMS Institute state that the court should “grant the petition for review and declare DEA’s Final Decision illegal, set it aside and remand the matter to the agency, with instructions to either grant Dr. Aggarwal’s Petition or explain why it was denied” as required by law.
The brief argues that “DEA denied Dr. Aggarwal’s Petition, without addressing the key arguments and reasoned he raised. This includes ones based on statutory text and DEA precedence.” “Was DEA’s Final Decision Arbitrary and Capricious?” Yes.”
According to Kathryn Tucker one of the attorneys who represents plaintiffs in this case, AIMS v. DEA 22,-1568, Amicus Briefs are expected in the case later this week on Thursday. The DEA response deadline is April 8. Aggarwal’s attorneys will reply the following month.
Aggarwal began working on a solution to obtain psilocybin legally for palliative patients as early as 2020. Initially, he tried to gain permission from the regulators in accordance with state and federal RTT legislation.
Aggarwal filed a lawsuit when DEA rejected his request. In early 2022, a federal appeals panel dismissed this lawsuit. They argued that the court lacked the jurisdiction, because DEA’s refusal to grant Aggarwal his administrative request did not constitute a reviewable action by the agency.
Aggarwal’s response to the ruling is what led to the current Ninth Circuit cases. The doctor submitted a formal petition to DEA in February 2022 to reschedule psilocybin to Schedule II, under the federal Controlled Substances Act. The denial of this action is reviewable. He also requested the regulatory waiver in order to obtain psilocybin.
The DEA rejected Aggarwal’s petition in September 2020 and the waiver request in the following month. Both decisions are being challenged by the doctor’s Ninth Circuit cases.
Aggarwal’s legal battle has been fought in court, and a number studies have supported the use of psilocybin for medical purposes. As a response, Congress sent President Joe Biden’s (D) a defense measure late last year that included provisions to fund studies on the therapeutic use of psychoedelics like psilocybin or MDMA by military servicemen.
The American Medical Association published a clinical study in which it found that the psilocybin had “strong and persistent antidepressant properties” among people with bipolar disorder. “There was no sign of mood instability or suicidal thoughts increasing.”
Researchers at Johns Hopkins University and Ohio State University published a report in September last year that linked the use of psilocybin with “persisting decreases” in anxiety, depression and alcohol abuse as well as an increase in emotional regulation and spiritual wellbeing.
The authors of the study stated that these results “are highly consistent with an increasing body of clinical trials, behavioral pharmacology and epidemiological data about psilocybin.” These data are a valuable window into the current resurgence in public interest in classic psychoactives, and the results of concurrent increases in naturalistic use of psilocybin.
a study by the American Medical Association in August last year found that patients with major depression saw a “clinically significant sustained” reduction of their symptoms even after taking just one dose.
A survey conducted by Canadian researchers in October found that psilocybin use can ease psychological distress among people who experienced adverse childhood experiences. Researchers found that psilocybin seemed to have “particularly strong benefits for those who experienced more severe childhood adversity.”
Canada’s minister of health granted the permission to four cancer patients to possess psilocybin for the first time in decades. In the same year, some healthcare professionals were also granted the right to possess and use psilocybin .
In a survey conducted earlier this year, approximately 8 out of 10 Canadians believed that psilocybin was “a reasonable option” to help end life care.
Below, you can read the entire petitioners’ Opening Brief: AIMS v. DEA .
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