In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.
Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon end, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.
“Are you kidding me that this is happening?” she thought.
But she also wanted to keep learning and growing in her remaining years, to dedicate them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.
“The last 2 years have kind of been this dance with Lady Death,” she said.
They have also been a dance with Lady Justice.
In March 2021, Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.
Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Baldeschwiler is seeking.
Psilocybin is illegal in the US, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the US Food and Drug Administration (FDA) but have passed phase 1 clinical trials.
This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.
The push to expand access to psilocybin is picking up steam in the US. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could also make psilocybin more widely accessible in the next few years.
It is also gaining momentum outside the US. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.
“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
Reverberations of Right to Try
The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.
After conventional therapies failed, Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was only available through colon cancer trials, she was denied access.
She died in 2001 at the age of 21.
Burroughs’ father, Frank, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.
Still, the case sparked a Right to Try movement.
“Right to Try laws swept the US in a firestorm,” Tucker said.
Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.
The movement intrigued Aggarwal, co-director of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Baldeschwiler could benefit.
“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”
He applied for the right to cultivate psilocybin mushrooms, but the fungus does not meet the right to try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.
Aggarwal joined forces with Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Tucker contacted the DEA about allowing dying patients, including Baldeschwiler and Bloom, to access psilocybin-assisted therapy.
The response, she said, was predictable.
“The DEA’s knee always jerks in the direction of no access,” Tucker said. So it said ‘no access.’ “
The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
Suing the DEA
Aggarwal and Tucker did not accept the DEA’s “no access” answer.
They decided to sue.
Aggarwal and 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 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 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, 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.
Tucker and her legal team also petitioned the DEA on behalf of 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, Tucker noted, “reflects that there is a currently accepted medical use.”
Nevertheless, in September, the DEA denied 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, 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, awake 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.
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,” 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 healthcare 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 healthcare 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 US. 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, Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s Department of Health that challenges the limited legal pathways to the use of psilocybin. The lawsuits 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.
An Uncertain Future
Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.
When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.
Although in clinical trials, psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds. .
That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.
In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to the potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.
“Oftentimes, we hear only the positive anecdotes,” Yaden said. “We don’t hear…neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”
A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”
But Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.
Keridwen Cornelius is a freelance journalist and editor based in Berlin, Germany. Follow her on Twitter @keridwen77.
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