The leaders of a Seattle clinic for alternative medicine want the U.S. Drug Enforcement Administration to rethink its stance on psilocybin, the active ingredient in hallucinogenic mushrooms.
Dr. Sunil Aggarwal of the Advanced Integrative Medical Science Institute filed a petition for review with the U.S. Ninth Circuit Court of Appeals on behalf of two patients with life-threatening cancers.
Erinn Baldeschwiler is a 49-year-old mother of two with stage four metastatic breast cancer. She’s been given two years to live and would like to try psilocybin to alleviate emotional suffering, including anxiety and depression.
Michal Bloom is a retired attorney whose ovarian cancer has metastasized to her lymph nodes. Since being diagnosed four years ago, she’s had several major surgeries and multiple rounds of chemotherapy. She’d like to try psilocybin to improve her quality of life.
Research by some of the world’s leading academic institutions, including New York University and Johns Hopkins University, show promise for psilocybin therapy in relieving anxiety and depression for people with cancer.
Aggarwal says the DEA should allow his patients to take psilocybin under federal and state “Right To Try” laws. Such laws allow dying patients to try experimental therapies that have completed some testing, but have not been approved by the U.S. Food and Drug Administration.
“We know that patients with advanced cancer can have significant relief lasting in some cases up to more than a year ... from doing one series of sessions with psilocybin-assisted therapy,” Aggarwal said.
In a letter denying Aggarwal permission to prescribe the drug, DEA officials said they don’t have the authority to waive the federal Controlled Substances Act. Psilocybin is a Schedule I drug under federal law, meaning the government believes psilocybin currently has no accepted medical use and a high potential for abuse.
In the same letter, the DEA suggested Aggarwal apply to research Schedule I drugs such as psilocybin. But Aggarwal’s attorney, Kathryn Tucker, argues his patients don’t have time to wait for research.
“We had made very clear that the intention here was not to research the therapeutic use,” she said. “The research route is much more time consuming. The idea of ‘Right To Try’ is to respect the realities that the patients may not have much time.”
Over the last six years, 41 states and the federal government have adopted similar laws.
Tucker, a longtime patients’ rights lawyer, said medicine needs a better way to deal with anxiety and depression among people with terminal diagnoses.
“There has been a gap in the palliative care tool box ... anxiety and depression,” she said. “And that’s what this investigational drug, psilocybin, does.”
Baldeschwiler said the DEA decision frustrated her.
“My understanding is I have the legal right under these laws, and I personally get very angry when other external forces try to block my own choices and decisions and options,” she said.
Oregon is keeping a close eye on psilocybin rules after voters passed a measure last year to create a system of psilocybin-assisted therapy. The committee that will set up that system is about to be announced, and the program is expected to start in 2023.