When Erinn Baldeschwiler was diagnosed with stage 4 metastatic breast cancer in March 2020, the then 48-year-old mother of two knew she wanted to seek treatment—but not just for the cancer itself. She wanted to be able to deal with the emotional pain that comes with a terminal diagnosis. So she began investigating various therapies that might help her “make sense of everything and find peace,” as she put it at the time.
Baldeschwiler’s palliative care doctor, Sunil Aggarwal of the Advanced Integrative Medical Science (AIMS) Institute in Seattle, suggested that she might benefit from therapy with psilocybin, the main psychoactive ingredient in “magic mushrooms.” Baldeschwiler had only taken such mushrooms recreationally a couple times in her early 20s, but her interest in the therapeutic use of psilocybin was piqued.
However, there was a catch. Psilocybin therapy is being investigated and has not been approved by the Food and Drug Administration. However, it has shown promising results in addressing anxiety and depression in patients with terminal cancers. Psilocybin, itself, is also banned in the U.S.A as a Schedule I substance.
Aggarwal stated that Baldeschwiler could, theoretically, bypass these obstacles using the Right to Try ActA 2018 federal law allows people living with life-threatening diseases to access the. Investigative drugs are a good optionThese have passed phase 1 clinical trials. Washington, where Baldeschwiler resides, is one of the 41 states that have enacted Right to Try legislation at the state level.
Baldeschwiler isn’t the first cancer patient to make use of Right to Try to get access to an investigational medication. Michal Bloom, a cancer patient, is the first to make use of the law to access a Schedule I drug. Aggarwal needed permission from Drug Enforcement Administration in order to access and to administer psilocybin.
Getting the DEA’s permission to administer psilocybin therapy for a cancer patient should have been straightforward, because there is nothing in state or federal law that excludes scheduled drugs from the Right to Try Act, says Kathryn Tucker a Portland, Ore.–based lawyer at Emerge Law Group, who is lead counsel in a legal effort seeking to compel the DEA to open access to psilocybin under Right to Try laws. “But it turned out to be anything but simple.”
Baldeschwiler is stuck in a frustrating hold pattern of bureaucratic delays a year and a quarter after she first reached out to the DEA. Along with Aggarwal, Bloom and AIMS, she filed a ForensicsThe DEA was unable to resolve the case, so it was dismissed on a technicality. Baldeschwiler or Bloom have yet to receive a final decision from the agency that will allow them access to psilocybin therapy, or reopen their case.
Anne Milgram, DEA Administrator, did not respond to interviews for this story. Katherine Pfaff, spokesperson for the DEA, wrote a separate e mail to Scientific American that “we will respectfully decline this opportunity.”
The most frustrating part of the experience, Baldeschwiler says, is “knowing there are substances out there that can help but that they’re being taken off the table by some third-party agency that’s making my choice for me.”
For decades, all researchers involved in medical research were stopped by political vilification. Schedule IThere are many drugs such as MDMA, LSD, and psilocybin. In the last few years, however, support has risen dramatically for psychedelics. Studies increasingly demonstrate that certain strictly banned substances in this category can be safely administered and do have medical value—including for difficult-to-treat conditions such as severe post-traumatic stress disorder, substance use disorders Depression.
According to researchers, mind-altering medications have a long history of helping to ease death. “The use of these medicines to help with major life transitions is an extremely ancient, pan-cultural practice,” Aggarwal says.
Western science first took note of psychedelic substances’ ability to address complications surrounding death in the early 1960s, when Eric Kast, an assistant professor of medicine and psychiatry at Chicago Medical School, tested whether LSD could substitute for opioids to Relief from physical painLSD is used to treat cancer patients. LSD did not reduce pain during treatment, but it also reduced the pain for as long as two weeks.
Kast also noticed an unexpected side effect: LSD seemed like it could provide some relief from existential distress that can often accompany terminal illnesses. As he wrote in a 1964 study, “These patients displayed a peculiar disregard for the gravity of their situations, and talked freely about their impending death with an affect considered inappropriate in our western civilization, but most beneficial to their own psychic states.”
In the 1970s, LSD research was discontinued. However, LSD had been used in the treatment of more than 200 cancer patients. “People and their family members were saying it transformed the time before their death,” says Matthew Johnson, a professor of psychiatry at the Johns Hopkins University School of Medicine. “Their psychological suffering was attenuated.”
Scientists were finally able to resume medical research on psychedelics a decade ago, after decades of hard work. They began clinical trials of psychedelics (including psilocybin) to treat various diseases and provide mental relief to terminally ill patients. Three phases are involved in clinical trials. The first phase establishes safety for humans. The second and third test safety and efficacy. Researchers published the following 2011 research: Phase I double-blindThe study included 12 advanced-stage patients with cancer who were treated with psilocybin. The largest Phase II investigation was the one that followed. A 2016 study involving 51 cancer patients. All three studies revealed that psilocybin therapy can improve mood and last for several weeks to months after one session.
“The sense of unfairness, punishment, helplessness and uncertainty is particularly extreme with cancer, but there’s something about that existential distress that psilocybin really seems to get at the heart of,” says Johnson, who co-authored the 2016 paper. “It helps a lot of people and not just trivially.”
Phase III trials—the necessary next step to gain FDA approval—typically cost millions of dollars, however, and Johnson is not aware of any such study currently being conducted using psychedelics to treat cancer distress. Johnson says that the need exists. Johnson can’t count the number of family members and patients who reached out to Johnson in hopes of obtaining psilocybin treatment for conditions such as depression or nicotine addiction. “With cancer, I would certainly say it’s in the dozens of calls,” he says. “It’s just heartbreaking.”
Autonomy and Rights
Baldeschwiler used ketamine therapy as a psychological treatment to relieve the emotional distress that was triggered by her diagnosis. Although she experienced some positive results, Aggarwal (the therapist) agreed that she would benefit from a more prolonged and potent treatment. “There was still persistent spiritual and existential distress that needed addressing,” Aggarwal says. “I felt like there was more in this space that we could offer her.”
Tucker and Aggarwal joined forces to navigate the legal complexities of administering psilocybin therapy to Baldeschwiler, Bloom, Aggarwal’s patient. Tucker contacted the DEA in January 2021. It quickly became apparent, she says, that “the DEA had not familiarized itself with Right to Try laws.”
Subsequently, the DEA issued a “standard knee-jerk response,” Tucker says: the request was denied. Outlining the decision in a two-page letter, Thomas Prevoznik, a DEA deputy assistant administrator, wrote that the administration “has no authority to waive any of the [Controlled Substances Act’s] requirements.” Prevoznik did not respond to interview requests for this story.
The 1938 Federal Food, Drug and Cosmetic Act (FDCA) was amended by the Right to Try Act. However, the 1970 Controlled Substances Act contains a clause clarifying that the FDCA is not overridden in any of its provisions. “That’s an alphabet soup of acronyms, but at the end of the day, legal analysis would conclude that the Right to Try Act should not be thwarted or obstructed by the DEA,” Tucker says.
Tucker filed a lawsuit on Baldeschwiler and Bloom’s behalf in the U.S. Court of Appeals for the Ninth Circuit to seek judicial review of the DEA’s decision. After 10 months of arguments and legal briefings, the DEA claimed that the decision outlined in the two-page letter sent to Tucker was not “sufficiently final” to allow for judicial review, she says. The suit was dismissed by a three-judge panel.
This was January 2022. Bloom, Baldeschwiler, and Bloom still await a final decision from the DEA. “The name of the game for the DEA is delay,” Tucker says. “But we have the urgent reality that our clients are patients with inexorably advancing terminal illnesses, and they don’t have the time for the DEA to just stand there and do nothing.”
Baldeschwiler says she has Reached outTo ask for assistance, contact Senator Patty Murray from Washington State. In May Baldeschwiler also joined demonstrators at the DEA’s headquarters to protest the administration’s practices and was one of 17 people arrested for refusing to leave the premises.
Aggarwal continues to investigate other options to help Baldeschwiler, Bloom, and others get legal access. Underground psilocybin therapy remains illegal for those who have the financial resources. Baldeschwiler declined comment to say whether she was able to or plans to access underground psilocybin-assisted therapy.
If she and Bloom see their case resolved—and if the outcome is favorable—it could benefit not only them but other people with life-threatening illnesses or conditions who wish to seek relief through therapy with psilocybin, MDMAor any other scheduled drugs that are currently under investigation in clinical trials.
Baldeschwiler said that she will continue to devote her limited time and energy to pursuing her rights under law. She believes in autonomy for patients. “At the end of your life, when cancer’s taken over your body, my God, choice is all you have left,” she says. “This is my way of being of service.”