E48-year old rinn Baldeschwiler has metastatic breast cancer and is currently suffering from depression and anxiety as she nears her untimely death. “The last thing I want is to be terrified and scared and anxious, especially when I pass,” she says.
Her disease will not be reversed by any treatment. But she’s fighting for access to a different kind of therapeutic: psilocybin-assisted therapy, which past research has found can ease anxiety for depression in advanced cancer patients.
Psilocybin (the active component in magic mushrooms), and other potential life-changing psychoedelic drugs for treating mental conditions like depression, anxiety and trauma are all being investigated. Advocates are optimistic that psilocybin and MDMA—which clinical trials have shown may be effective against post-traumatic stress disorder (PTSD)—could be approved by the U.S. Food and Drug Administration (FDA) within the next few years. But Baldeschwiler and other people with terminal illnesses can’t wait that long.
“I’m going to be dead by then,” she says. “It’s a time issue. It would be great if you could give an alternative that would immediately relieve anxiety, depression and bring about a feeling of calm. [someone is] going through their final days—why would you not want that as an option?”
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Some argue that MDMA as well as psilocybin should already be accessible to eligible patients via the federal Right to Try law. The 2018 law states that patients with life-threatening illnesses who have exhausted all treatment options can access drugs that have passed through Phase 1 testing—the first phase of clinical trials that tests drugs in humans—but have not been approved by the FDA.
Baldeschwiler and MDMA also fit these criteria. But the drugs’ Schedule 1 status—meaning the DEA deems them to have “no currently accepted medical use and a high potential for abuse” (a characterization that advocates for psychedelics dispute)—is keeping them back from patients.
Baldeschwiler’s palliative care physician, Dr. Sunil Aggarwal, reached an agreement with a drug manufacturer to receive psilocybin. Aggarwal had applied to Drug Enforcement Administration (DEA), to be granted a waiver for the supply of the drug. However, in February 2021, the DEA denied Aggarwal’s request, declaring that the agency was not authorized to waive the Controlled Substances Act.
Baldeschwiler and Aggarwal are now working with Kathryn Tucker, a lawyer focused on expanding access to psychedelics for groups including terminally ill people, to compel the DEA to allow use of psilocybin under the Right to Try law, which Tucker argues should supersede the Controlled Substances Act establishing the U.S.’s drug policy. The DEA is “thwarting operation of duly enacted federal law,” says Tucker. “If a physician deems their patient to have a life-threatening condition that could be addressed with one of the eligible investigational drugs, then that physician can seek [Right to Try] access, and should be granted it.” Advocates argue that the law has a particularly broad mandate. “The lack of an exclusion makes it clear that there is no exclusion” for Schedule 1 substances, Tucker says.
The DEA declined TIME’s request for further comment, citing ongoing litigation.
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Psychedelic medicine is still an unsettled science that will require much more research before scientists fully understand how well it works, and for whom—especially given that many of the clinical trials that have tested psychedelic drugs are very small. There are risks associated with psychedelic drugs. Patients who take part in clinical trials must meet specific health requirements. For example, patients in clinical trials of psilocybin are not allowed to be involved if they have close relatives who have had a history with schizophrenia or bipolar disorder. Advocates for expanding access claim that MDMA-assisted and psilocybin psychotherapy fall within the Right to Try law’s founding principle: Patients who are facing death should be able to test new drugs.
The advocates’ case has won them some powerful bipartisan allies. On July 20, Senators Cory Booker (D-NJ) and Rand Paul (R-Ky.) introduced the Right to Try Clarification Act, to make it clear that the legislation encompasses Schedule 1 substances so long as they’ve been through Phase 1 clinical trials.
Many supporters, including retired Marine Corp Lieutenant General Martin Steele, think that suicide risk individuals should have the option to access psychedelic-assisted treatment. Steele co-founded Reason for Hope, an activist group that promotes psychedelic treatments access and research. Recently, he testified to support a Connecticut law, which established a pilot program that allows veterans, former first responders and retirees to access MDMA and psilocybin. Nationally, people are exposed to “unprecedented levels of stress and trauma,” he says. “We all know the current treatments are inadequate, and things are only getting worse.”
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In the battle to increase psychedelic accessibility, veterans with PTSD is a key focus area. “Currently, even in the best circumstances, our treatments probably help about half of the patients with PTSD,” and many also have treatment-resistant depression, says retired Brigadier Gen. Dr. Stephen Xenakis, a psychiatrist who served in the Army and volunteers with Reason for Hope. According to him, the U.S. owes them a moral obligation to help. Given that about 17 U.S. veterans die by suicide every day in the U.S., “too many people are going to die” if veterans are forced to wait for FDA approval.
“All of us should be shouting from the rooftops that something has to change,” says Lynnette Averill, an associate professor of psychiatry and behavioral sciences at Baylor College of Medicine who has studied how psychedelics can help special-operations veterans and is part of Reason for Hope. “Given the crisis that we are in, we cannot wait another year—or 2, 5, or 10—for these to be fully approved.”
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