Hospice providers are navigating an evolving landscape of laws opening up pathways of access around psychedelic utilization at the end of life.

Despite mounting evidence that psychedelics can improve experiences and reduce symptom burden in some terminally ill patients, these drugs remain difficult to access for those wishing to utilize them.

Some states and the federal government have considered legislation that would establish a “right to try” psychedelics and other experimental interventions for certain seriously ill patients. Though right-to-try laws have expanded in the last few years, greater progress is needed to improve access and quality outcomes among patients with unmet needs, Kathryn Tucker, director of advocacy at the National Psychedelics Association (NPA).

“There’s been tremendous progress in a relatively short amount of time that has yielded improvements in end-of-life care,” Tucker told Hospice News. “But there’s been a glaring gap in a provider’s toolbox for relief of nonphysical suffering. There’s a recognition that dying people don’t have time to wait for the long, slow process of drug approvals.”

State of right to try laws

Most recent data available show that 41 states have adopted some type of laws permitting the use of “investigational drugs” since the passing of the Right to Try Act of 2017, as has Congress. These laws allow patients with serious or terminal illnesses to utilize drugs prior to approval by the U.S. Food & Drug Administration (FDA) and those that are “off-label” or unapproved, that have gone through clinical trial studies.

Congress introduced the Breakthrough Therapies Act in 2022, which widened opportunities to utilize certain controlled substances. The laws allowed for the classification of drugs or other substances that are part of approved breakthrough therapies as schedule II controlled substances. It also expedited controlled substance registrations through the U.S. Drug Enforcement Administration (DEA) for researchers whose work involves investigational drugs.

A large aim of these legislative moves was to develop a standardized system for terminal patients who have exhausted other options to access investigational treatments that could help alleviate their symptoms.

These laws come with limited access to controlled substances, with restrictions around medical cannabis utilization and psychedelics such as ketamine, psilocybin and methylenedioxymethamphetamine (MDMA), among others, Tucker stated.

“The entire function of these right-to-try laws is being thwarted by regulators like the DEA, which should stay in its lane of law enforcement and prevention of diversion and not swim into evolving scientific and medical expertise,” Tucker stated. “Right-to-try laws should open a path of access for therapeutic use of controlled substances for dying patients, especially those with proven effects like psilocybin. One of the perverse things that can happen is that lack of access drives medically fragile people into the ‘underground,’ to find these substances without therapeutic or medical guidance.”

Calls are growing louder for regulatory and legal change that will expand access to controlled substances among terminally ill populations.

Recent legal moves have two cases moving their way through the federal court system related to expanded utilization of psilocybin. The Advanced Integrative Medicine Science (AIMS) Institute in concert with the NPA filed a series of lawsuits seeking both the rescheduling of and expanded right to try access to psilocybin.

These cases could be “groundbreaking” in creating paths of access and establishing mandates that could help improve end-of-life outcomes nationwide, according to Dr. Sunil Kumar Aggarwal, AIMS co-founder. Aggarwal is an integrative palliative physician, scientist and medical geographer.

Despite clinical trials showing evidence of improved mental health outcomes and physical relief, patients wishing to try these drugs often face complicated legal paths toward utilization, Aggarwal said.

“The research is clear on these as far as studies of psilocybin involving patients with life-threatening illness,” Aggarwal told Hospice News. “Even in the 60s patients were finding significant relief from severe pain, serious depression, existential distress, demoralization and a whole psychometric scale of positive changes. That translates into increased quality of life during such a critically important time for patients.”

Impact on end-of-life care

Research has shown that serious and terminally ill patients who have utilized psilocybin-assisted therapy have found alleviation of anxiety, depression and psycho-spiritual benefits, Aggarwal stated. Others have found psychedelics to help reduce physical pain.

Patients that have reported positive results have included those with various conditions such as cancer, neurological diseases and brain injuries, neurodegenerative disorders and behavioral health issues, among others. Psychedelic-assisted psychotherapy has also been found to help address grief for families coping with recent loss.

Navigating the utilization of controlled substances takes careful consideration of their risks, as they are not beneficial to everyone, he added.

A lack of provider awareness and education are main barriers to increased access alongside regulatory factors. Case in point, inadequate provider knowledge was a deterrent for psychedelic utilization among nearly half (49%) of participants in a recent study published in Psychiatric Times. A separate study found that only 5% of people using psychedelics viewed their health care providers as an information source.

Hospice and palliative clinicians are increasingly seeking out information and education around psychedelic therapies, but regulatory factors pose another barrier to access, according to Aggarwal.

Expanded right-to-try laws could help break down barriers on both the provider and patient side, he stated.

“The fact that these right-to-try laws exist at all is an additional public health framework we have in the United States of caring for patients with terminal illness,” Aggarwal said. “People with life-threatening illnesses have special needs and they may not live long enough to benefit from the innovations that their own tax dollars are funding to treat conditions that they have themselves. It’s a matter of the government helping to facilitate the development of drugs that help with suffering. The whole basis that these laws exist upon is that these people deserve to have special privileges that help them in a safe and effective way.”