Does the federal “Right To Try” Act, passed by the U.S. Congress, signed into law by President Trump, with 41 state enactments, give terminally ill patients access to experimental medicines still in development? Yes. But the Drug Enforcement Agency is barring access to one such experimental medicine: psilocybin, also known in its fungal form as “magic mushrooms.”
Erinn Baldeschwiler, a Washington state mother of two in the final months of metastatic breast cancer, has been denied access to psilocybin by the DEA, even though she is suffering with the knowledge she won’t live long enough to raise her children. The door to this treatment was closed to her despite the “Right to Try” Act and well-documented medical research showing psilocybin provides relief from the debilitating anxiety and depression that many terminally ill patients experience.
A lawyer representing Baldeschwiler and her palliative care physician sought judicial intervention to help her access the drug as allowed by state and federal law. The attorney, Kathryn Tucker, lodged the challenge to the DEA’s response with a petition for review before the United States Court of Appeals for the Ninth Circuit. The filing, she explained, was to clarify, “Is the DEA going to comply with duly enacted state and federal law and allow access to psilocybin therapy?” Baldeschwiler’s doctor, Sunil Aggarwal, M.D., co-founder of an integrative oncology clinic in Seattle, had requested the psilocybin for Baldeschwiler and another patient with advanced cancer under the terms of state and federal “Right to Try” Acts. The other terminally ill patient in that court case is Michal Bloom, a Department of Justice attorney, forced to leave work because of advanced ovarian cancer and multiple complications.
But on January 31, 2022, the legal effort hit a dead end. The court dodged the issue by dismissing the case, holding that the DEA’s refusal to allow the dying women’s integrative oncology clinic access to psilocybin was insufficiently “final” for purposes of judicial review.
The DEA did not respond to multiple requests for comment.
Now Aggarwal, Baldeschwiler and their attorney have reached out to U.S. Senator Patty Murray, (D-WA) who represents Baldeschwiler, Bloom and Aggarwal’s home state, urging her to help to secure DEA cooperation with the federally mandated access for her dying constituents. “Who can secure oversight of a federal agency unless it is a federal elected official?” observed Tucker.
In a series of recent virtual meetings, Senator Murray’s staff heard from Aggarwal and Tucker, Erinn Baldeschwiler, the mother denied therapeutic access to psilocybin by the DEA as well as other Washington State women with stage IV terminal cancer, and a representative from the conservative think tank, the Goldwater Institute. As the chair of the Global Wellness Institute’s Psychedelics & Healing Initiative, one of the authors of this article, Mary-Elizabeth, was invited to participate in two meetings with Murray’s office as a resource who can speak to current research and findings. Goldwater filed an amicus brief in support of Dr. Aggarwal’s filing as did the ACLU, the conservative Cato Institute, the attorneys general of Washington State and seven other states.
“My name is Erinn Baldeschwiler and I’m dying,” the Washington state native told Senator Murray’s staff. At the start of Covid, in March of 2020, she was diagnosed with a pernicious form of triple negative Stage IV breast cancer and given a prognosis of about two years to live. Her treatment options are exhausted, she said and the tumors have spread throughout her body.
“I have a 15-year old and an 18-year old. It’s my son’s birthday tomorrow and I am sitting here facing the real fact that for me, it may be the last one,” said Baldeschwiler, “It’s devastating.”
Her doctor’s suggestion that psilocybin-assisted therapy could ease her feelings of desperation and anxiety motivates her to speak about her search to find “some emotional ease and mental clarity” during this time of “increased physical pain.” Baldeschwiler added, “I am sad. And now I am out of time.”
Two of Senator Murray’s staff appeared to openly weep during Baldeschwiler’s statement. The Senator herself was not present for the meetings.
“Justice delayed for people like Erinn is justice denied. Permanently,” said attorney Tucker in the meeting.
“It is excruciating,” stated Lynda Weatherby, a Washington State resident with stage IV breast cancer who has experienced metastasis to her brain and throughout her bones. Initially diagnosed when her children were ages three and six, she hosts a podcast about metastatic breast cancer. She also mentors young mothers who struggle with a terminal diagnosis, sometimes while they are nursing infants and caring for small children. At that stage of life, Weatherby said, mothers are “constantly battling the darkness of what this disease means” and would benefit from access to medicinal psilocybin. Weatherby observed, “the patients who really struggle have young families and they need to be present in the days that they have with their family.”
Another Stage IV Washington State resident, Lisa Laudico, introduced herself along with her prognosis: four-and-a-half years into a three-to-five year survival window, “my situation is not good,” she said. Laudico, who hosts the podcast with Weatherby, explained, “I’m on my seventh line of treatment, I’ve no more treatments or clinical trials available to me. . . so my life expectancy is quite short.”
Laudico explained, “that is the norm with metastatic breast cancer. That makes it super tough to keep your mental health strong and to be able to be present for your families, for yourself.” This is why, she said, she is joining in asking Senator Murray to hold the DEA accountable for blocking experimental medicines such as psilocybin that are supposed to be made available under the “Right to Try” Acts. Although neither she, nor Weatherby are requesting access to therapeutic psilocybin for themselves personally, each spoke of the challenges other mothers face as terminally ill patients.
“The existential distress that comes, makes it tough to be present for your family and for yourself”, said Laudico. “Access delayed to psilocybin is access just denied for people like myself.”
“The point of “Right to Try” is to create an avenue for terminally ill patients to access promising investigational drugs outside of the clinical trial process for therapeutic use. Congress, and 41 states, recognized this need in passing the law,” said Tucker, noting that “these terminally ill patients do not have the luxury of time.”
Beyond the medical issue, care for the dying is a “human right” said Aggarwal, “I am a palliative care physician. . . my patients are qualified under every measure that those laws indicate.” The absence of compassion for his terminally ill patients once they reach end of life, has left him “very upset” he said. “Quality of life throughout the entire life spectrum matters,” he said. “Everyone realizes, including the World Health Organization that [care for the dying] . . . is essential human rights care.”
“The question now: Is the DEA going to comply with duly enacted federal law and allow access to psilocybin? And if the DEA is going to continue to obstruct access, what is Senator Murray going to do about it?” asks Tucker.
Psilocybin has been deemed an “eligible investigational drug” by virtue of having already completed an FDA-approved Phase 1 clinical trial, as well as other criteria outlined in the legislation, which enjoys bipartisan support.
“The DEA has chosen not to permit [psilocybin] access, even though duly enacted federal and state federal Right to Try laws provide for that access,” Tucker said to Murray’s staff. “The clock is ticking for patients burdened with debilitating anxiety, and depression who could get immediate relief if the DEA would get out of the way.”
Senator Murray this week responded to Lucid News, “I understand how personal this issue is and how hard it can be to talk about, and I appreciate the patients speaking up about the unimaginably challenging experience they are going through, sharing their stories, and advocating for support to help them deal with end of life anxiety and depression.”
Murray, Chair of the Senate Committee on Health, Education, Labor and Pensions (HELP) added “I am committed to making sure people in Washington state have their voices heard and concerns addressed when they speak out—that’s why I became a Senator, and it’s how I approach my work every day.”
“After hearing from these patients, my office asked the DEA directly about the issues they are raising—and I am going to keep pushing the DEA and Biden Administration for answers,” declared Murray.
Image: Erinn Baldeschwiler, mother of two with terminal breast cancer. Courtesy of Erinn Baldeschwiler.