Home Education Two cancer patients are fighting to make psilocybin available for palliative care

Two cancer patients are fighting to make psilocybin available for palliative care

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When Erin Baldeshwiler 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 also wanted to do something about the emotional pain that comes with a terminal diagnosis. So she began researching different treatments that might help her “make sense of it all and find peace,” as she put it at the time.

Baldeshwiler palliative care physician Sunil Aggarwal of the Advanced Institute for Integrative Medicine (AIMS) in Seattle suggested that she might benefit from therapy with psilocybin, the main psychoactive ingredient in “magic mushrooms.” Baldeshwiler had only used such mushrooms recreationally a couple of times in her 20s, but her interest in the therapeutic use of psilocybin was piqued.

However, there was a catch. Although psilocybin therapy has shown promising results in treating depression and anxiety in patients with life-threatening cancer, the treatment remains investigational and has not yet been approved by the Food and Drug Administration for any purpose. Psilocybin itself is also strictly prohibited in the US as a Schedule I substance.

In theory, Agarwal explained, Baldeshwiler could work around these obstacles The right to try to acta 2018 federal law that allows people with life-threatening illnesses try experimental drugs which have completed phase 1 clinical trials. Forty-one states, including Washington, where Baldeshwiler lives, have also adopted the law at the state level.

Baldeschwiler is not the first cancer patient to use the right to try to access an experimental drug. But she and another cancer patient, Michal Bloom, appear to have been the first to try to use the law to treat with Schedule I drugs. Because of this, Agarwal had to try to get some sort of Drug Enforcement Administration approval to access and administer psilocybin.

Getting DEA approval for psilocybin therapy for cancer patients should have been easy because there’s nothing in state or federal law that exempts regular drugs from the Right to Try Act, says Kathryn Tucker, an Emerge lawyer in Portland, OR. Are. Law Group, which is lead counsel in a legal case seeking to compel the DEA to open access to psilocybin under right-to-try laws. “But it turned out that everything was not simple at all.”

A year and a half after she first approached the DEA, Baldeshwiler found herself in a frustrating pattern of bureaucratic delays. She and Blum, as well as Aggarwal and AIMS, went so far as to file a lawsuit against the DEA, but it was dismissed on a technicality. The agency has yet to issue a final decision that will allow Baldeschwiler and Bloom to either access psilocybin therapy or reopen their lawsuit.

DEA Administrator Ann Milgram did not respond to interview requests for this story. DEA spokeswoman Kathryn Pfaff wrote in a separate email Scientific American that “we will respectfully decline this opportunity.”

Baldeschwiler says the most frustrating part of the experience is “knowing that there are substances that can help, but that they’re being taken away by a third-party agency that’s making my choices for me.”

Existential relief

For decades, political embarrassment prevented all but the most determined researchers from conducting medical use research Schedule I drugs, including marijuana, MDMA, psilocybin, and LSD. But over the past few years, support for psychedelics has grown dramatically. Research is increasingly showing that some of the banned substances in this category can be used safely and have medical value, including in difficult-to-treat conditions such as severe post-traumatic stress disorder, substance use disorders and depression.

According to some researchers, in addition to treating certain diseases, mind-altering drugs have also long facilitated the process of death. “Using these medicines to help with major life transitions is an extremely ancient cross-cultural practice,” Agarwal says.

Western science first drew attention to the ability of psychedelics to reverse complications related to death in the early 1960s, when Eric Kast, an assistant professor of medicine and psychiatry at the Chicago Medical School, tested whether LSD could replace opioids. relieve physical pain in cancer patients. LSD not only reduced pain while taking the drug, but also for two weeks afterward.

Cust also noticed an unexpected side effect: LSD seemed to provide some relief from the existential distress that often accompanies terminal illness. As he wrote in a 1964 study, “these patients displayed a peculiar disregard for the seriousness of their situation and spoke freely of their impending death with an affect considered inappropriate in our Western civilization but most beneficial to their own mental states.”

Psychedelic research was discontinued in the 1970s. But before that, more than 200 cancer patients were treated with LSD. “People and their families said it changed the time before death,” says Matthew Johnson, a professor of psychiatry at the Johns Hopkins University School of Medicine. “Their psychological suffering was alleviated.”

After decades of fighting to revive research into the medical use of psychedelics, scientists were able to return in earnest to this promising area of ​​research about a decade ago. They began making their way through clinical trials of psychedelics, including psilocybin, to treat various illnesses and provide mental health care to terminally ill patients. Clinical trials include three phases; the first establishes human safety, while the second and third further test for safety and efficacy. In 2011, researchers published a a double-blind phase I study involving 12 advanced cancer patients receiving psilocybin therapy. Two Phase II studies followed, the largest of which was 2016 study with the participation of 51 cancer patients. All three studies showed that psilocybin therapy improved mood and that the benefits lasted for weeks or even months after a single session of active treatment.

“Feelings of injustice, punishment, helplessness, and uncertainty are especially strong in cancer, but there’s something about that existential distress that seems to really underlie psilocybin,” says Johnson, who co-authored the 2016 paper. “It helps a lot of people, and not just like that.”

Phase III trials — the necessary next step for FDA approval — typically cost millions of dollars, and Johnson is unaware of any such research currently underway using psychedelics to treat cancer. But the need is there, he says. Johnson has lost count of the number of patients and family members who have come to him in hopes of accessing psilocybin therapy for ailments ranging from depression to nicotine addiction. “With cancer, I would certainly say it’s in the dozens of calls,” he says. “It’s just heartbreaking.”

Rights and autonomy

Before targeting psilocybin therapy, Baldeschwiler sought psychological relief from the suffering associated with her diagnosis through ketamine therapy. But while she enjoyed some success, both she and Aggarwal, who administered the therapy, agreed that she could benefit from longer, stronger treatment. “There was still spiritual and existential anguish that needed to be addressed,” Agarwal says. “I felt like we could offer her more in this space.”

Aggarwal teamed up with Tucker to navigate the legal intricacies of administering psilocybin therapy to Baldeshwiler and Bloom, who is also his patient. DEA officials seemed confused when Tucker contacted them in January 2021. It quickly became apparent, she said, that “the DEA was not familiar with right-to-try laws.”

Afterward, the DEA issued a “standard reflex,” Tucker says: The request was denied. Outlining the decision in a two-page letter, Thomas Prevoznik, the DEA’s deputy assistant administrator, wrote that the administration “does not have the authority to waive any of [Controlled Substances Act’s] requirements”. The carrier did not respond to interview requests for this story.

However, the Right to Try Act is an amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) of 1938, and the Controlled Substances Act of 1970 contains a provision explaining that nothing in its text repeals the FDCA. “It’s an alphabet soup of acronyms, but at the end of the day, the legal analysis will conclude that the DEA should not impede or interfere with the Right to Trial Act,” Tucker says.

Tucker filed a lawsuit on behalf of Baldeshwiler and Bloom in the U.S. Court of Appeals for the Ninth Circuit seeking judicial review of the DEA’s decision. After 10 months of arguments and legal briefs, the DEA said the decision, set out in a two-page letter sent to Tucker, was not “final enough” to allow for a judicial review, she says. A three-judge panel dismissed the lawsuit.

It was January 2022, and Baldeshwiler and Bloom were still awaiting a final decision from the DEA. “The name of the game for the DEA is delay,” Tucker says. “But we have the stark reality that our clients are patients with inexorably progressive terminal illnesses, and they don’t have time for the DEA to just stand by and do nothing.”

Baldeshwiler says he has stretched out to Senator Patty Murray of Washington state for help in the case. In May, Baldeshwiler also joined demonstrators at DEA headquarters to protest the administration’s practices and was one of 17 people arrested for refusing to leave the premises.

As the delays continue, Aggarwal is considering other options to help Baldeschwiler and Bloom gain legal access to psilocybin, including through a possible religious exemption. For those with the resources to seek it out, underground psilocybin therapy is also an option, but remains illegal. Baldeshwiler declined to comment on whether she has had or plans to access psilocybin therapy underground.

If she and Blum 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 seeking relief through psilocybin therapy. MDMA or other planned drugs currently being investigated in clinical trials.

In the meantime, Baldeshwiler says she will continue to invest her limited time and energy in advocating for her rights under the law because she believes in the importance of giving patients autonomy. “At the end of your life, when cancer has taken over your body, oh my God, choices are all you have left,” she says. “This is my way of serving.”

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