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 be ending, 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 devote 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, Ms. 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 Ms. Baldeschwiler is seeking.
Psilocybin is illegal in the United States, 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 Food and Drug Administration 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 United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.
It is also gaining momentum outside the United States. 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, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.
She died in 2001 at age 21.
Ms. Burroughs’ father, Frank Burroughs, 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 U.S. in a firestorm,” Ms. Tucker said.
Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.
The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. 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 doesn’t meet 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.
Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.
The response, she said, was predictable.
“The DEA’s knee always jerks in the direction of no access,” Ms. 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.