Suing the DEA
Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.
They decided to sue.
Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.
The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.
In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.
In late June, the DEA provided its final answer: No access.
In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”
In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”
The government’s response is due in January 2023.
Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.
The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”
Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.
Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.
In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.
And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
The fight north of the border
In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.
After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.
Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.
In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.
“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”
TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.
But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.
Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”
As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.
“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”
Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.
In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.