At DEA’s Door: The Battle to Open Access to Psilocybin Therapy for Peace and Comfort at the End of Life

By Kathryn Tucker, JD[1]

On Mother’s Day 2022, my client Erinn Baldeschwiler, a young mother of two with Stage IV terminal cancer travelled from Seattle to Washington D.C. instead of spending the day with her children, even thought it was likely her last Mother’s Day given the inexorable advance of her illness.  Accompanied by her palliative care nurse, Erinn made the trip to the door of the headquarters of the Drug Enforcement Administration (DEA), a federal law enforcement agency which for more than 16 months has blocked her from access to psilocybin, an investigational drug shown in clinical trials to be enormously effective in relieving anxiety and depression in dying patients.  Provisions of state and federal right to try (RTT) laws intend for investigational drugs shown to have promise in early clinical trials to be accessible to patients with advanced illness. Patients like Erinn. But DEA has steadfastly refused Erinn access.

On the Monday following Mothers’ Day, bright, breezy and sunny, Erinn stood at a podium in front of the DEA high-rise building and told DEA employees shuttered inside: “I am running out of time.” The crowd, Americans from all across the United States who had also traveled to DEA’s door in solidarity with Erinn and the multitude of Americans confronted by advanced illness, chanted: “DEA stop the delay, DEA get out of the way”. Signs and posters held by demonstrators proclaimed what clinical trials show: “Immediate, Substantial and Sustained Relief.” Psilocybin provides relief from debilitating anxiety and depression in the face of imminent death and the loss the patient faces. For Erinn that loss includes missing out on seeing her children grow up. The unspeakably sad loss of not being able to be here for them. As her counsel, I spoke from the podium just before Erinn, to explain the efforts her legal team had made, what the RTT law provides, and how the DEA was thwarting the law and exceeding its scope of authority.

Erinn and her palliative care physician Dr. Sunil Aggarwal, Co-Founder and Director of Seattle’s Advanced Medical Science Institute, came to me in October of 2020 with the hope of gaining access to psilocybin, a drug currently sited on Schedule I of the Controlled Substances Act. This designation means no distributor would supply the drug without permission from the DEA. Our request for such permission detailed that the drug was an ‘eligible investigational drug’ under the terms of RTT laws. Nonetheless, our request was flatly denied:  DEA would permit no access for therapeutic use. I assembled a team of attorneys with special expertise to develop a lawsuit to be filed in federal court to compel the DEA to comply with the RTT laws.[2]  A multitude of amicus briefs were filed in support of our case, including by 8 States, leading psilocybin researchers, prominent palliative care physicians, and progressive and conservative think tanks alike.  DEA sought to avoid review by arguing its decision to deny access had not been “final”. In a ruling which did not reach the merits the court accepted that argument in a ruling issued on January 31, 2022 dismissing the case.

We immediately asked the DEA for a final determination, so that either access could be had or we could return to court.  Despite the fact that a year of legal briefing detailed the Agency’s clear obligation to accommodate RTT, several months later the Agency has yet to respond. The dynamic reality  of terminal illness means that the Agency’s delay means relief will be forever denied. This is what brought Erinn to the nation’s capital on May 9, 2022.

The idea of holding a public demonstration to shine a bright light of public scrutiny on the DEA’s failure to accommodate the law of the land was David Bronner’s. David is the CEO of Dr. Bronner’s Magic Soaps. David (for whom the CEO title stands for Cosmic Engagement Officer) is a well-known champion of opening access to psychedelics. David professes that the catalyst for him to get his team involved to  organize and host the demonstration was hearing me speak about Erinn’s case on the Psychedelics Today podcast.[3]

Hours into the demonstration, police arrived, arresting and handcuffing Erinn, arms behind her back, placing her in a police van. She, along with 16 other demonstrators (including David Bronner) engaging in peaceful protest of the DEA’s obstruction of the law of the land, was taken to jail. All the demonstrators were released that night, with summons for a future court appearance.

Next morning, notwithstanding the exhausting previous day, Erinn met me at the Dirksen Senate Office Building for a meeting with Senator Patty Murray’s staff. The meeting lasted more than an hour. This was our first in person meeting; we had met over Zoom several times, seeking Senator Murray’s involvement in ensuring that the DEA respect state and federal RTT laws and allow access to promising investigational drugs, in this case psilocybin.  Senator Murray, a 30 year Senate veteran, is Chair of the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP).

We urged that Senator Murray intercede urgently: Laws intended to benefit Erinn and others similarly situated are being thwarted by the DEA, leaving multitudes of patients to endure suffering which could be relieved with access to this drug. Having been one of the attorneys who successfully sued the Justice Department when then U.S. Attorney General John Ashcroft (and then his successor Alberto Gonzales)  attempted to thwart operation of Oregon’s pioneering Death with Dignity Act by invoking application of the federal Controlled Substances Act to override Oregon’s law, I felt particularly well suited to educate Murray’s staff that binding federal precedent of the Supreme Court of the United States forbids a federal agency from intruding into the regulation of the practice of medicine, a matter reserved largely to the sovereignty of the states.[4]  Washington State, Senator Murray’s home state, had enacted its RTT law in 2017 by unanimous vote. The US Congress had amplified that enactment in adopting the federal RTT a year later. It is incumbent on Senator Murray, I urged, for her to stand up for Erinn and other patients, and for the sovereignty of her home state; federal elected officials have the duty to oversee a federal agency overreaching the bounds of its authority. Especially when that overreach denies much needed relief to dying patients. Erinn, I told the Senator’s staff, was running out of time.

A short film about Erinn and  the demonstration at the DEA can be viewed at this link:  https://vimeo.com/713486783/8b7f4b4eda

For those interested in following Erinn’s case, and the continuing effort to open access to psilocybin therapy for peace and comfort at the end of life, visit:  https://righttotrypsilocybin.com/.  Join the petition and contact your federal elected officials to enourage them to ensure that RTT laws are respected and that dying patients are able to access this palliative care investigational medicine

The legal team leading the effort to forge a path to access pursuant to RTT laws will continue to press the DEA to issue a waiver allowing access, and/or to reschedule psilocybin from Schedule I to Schedule II of the Controlled Substances Act. Other strategies to ensure access are also being explored;  We will continue to move this advocacy forward until access is ensured.

[1] Special Counsel at Emerge Law Group, Co-Chair Psychedelic Practice Group. Founding board member of the Psychedelic Bar Association, Co-Chair, Litigation and Advocacy Committee.  Liaison to the American Bar Association. Founding Advisory Board Member, the Initiative on Psychedelics and Healing, Global Wellness Institute.

[2] Counsel joining me in representing Erinn and the other plaintiffs include Matt Zorn, Yetter Coleman LLP;  Shane Pennington, Vicente Sederberg LLP; and James Williams, Andrew Kline, Thomas Tobin and Holly Martinez, Perkins Coie LLP.

[3] Psychedelics Today webinar/podcast, “The Right to Try Act and the Battle for Psilocybin Access”, https://psychedelicstoday.com/2022/04/05/pt307/(4/5/22)

[4] Gonzales v. Oregon, 546 U.S. 243(2006)(landmark decision of the US Supreme Court which ruled that the United States Attorney General cannot enforce the federal Controlled Substances Act against physicians participating in Oregon’s Death with Dignity Act.)