A congressman is asking his fellow lawmakers to join him in requesting that the Drug Enforcement Administration (DEA) allow terminally ill patients to use psilocybin as an investigational treatment without the fear of federal prosecution.
A new Dear Colleague letter that’s being circulated by Rep. Earl Blumenauer (D-OR) notes that there are state and federal right-to-try (RTT) laws that should make it so certain patients can obtain the psychedelic given that it’s shown early potential in ongoing clinical trials.
Yet DEA has denied access, resulting in a lawsuit that was filed in March by a Washington State doctor who sought federal guidance to treat terminal patients with psilocybin mushrooms and was told there wasn’t a legal avenue for him to do so.
“There has been a growing body of evidence in recent years pointing to the safety and effectiveness of psilocybin assisted therapy as a potential method to provide care to individuals with treatment-resistant depression and/or anxiety,” Blumenauer wrote to fellow lawmakers.
“However, even with these promising advancements, the pace of regulatory approval has been far too slow for a naturally occurring substance that has evidence of having been safely used by humans for therapeutic uses for thousands of years,” the congressman said. “This is even more true when the quality of care and treatment for terminally ill individuals is resultingly limited and impacted.”
Congress and 41 states have adopted right-to-try laws, which allow patients with terminal conditions to try investigational medications that have not been approved for general use. The letter says DEA has “has failed to abide” by the law.
“I hope you will join me in urging that the DEA takes quick action to remediate these concerns and end their obstruction of access to end-of-life care,” Blumenauer said.
The lawsuit against DEA is currently before the U.S. Court of Appeals for the Ninth Circuit, which heard oral arguments in the case in September. Washington State’s attorney general’s office joined the plaintiffs in support of psilocybin access. DEA argued that the court should dismiss the suit because it lacked jurisdiction.
Blumenauer is asking his colleagues to sign onto a letter addressed to DEA Administrator Anne Milgram, who was appointed by President Joe Biden and confirmed by the Senate over the summer.
“We strongly believe that our constituents suffering such illnesses should have access to this investigational drug should they decide to pursue such a course of treatment and we urge you to take quick action to ensure that the DEA accommodates federal and state RTT laws and allows terminally ill patients to receive psilocybin for therapeutic use,” it says.
The lawsuit—which was brought by an oncology clinic, the Advanced Integrative Medical Science (AIMS) Institute—”can, and ought to be, quickly settled in a manner which addresses DEA’s legitimate concerns about ensuring adequate security to prevent diversion, while enabling dying cancer patients such as those in the AIMS case access to psilocybin,” the letter says.
“Urgent action is needed to ensure that patients currently suffering terminal illness can elect treatment involving psilocybin,” it concludes. “We urge you to take quick action to ensure that the DEA accommodates enacted RTT law and allows terminally ill patients to receive psilocybin for therapeutic use. We appreciate your attention to this urgent matter.”
Sunil Aggarwal, the AIMS doctor behind the lawsuit, told Marijuana Moment that he is “so heartened and grateful for Representative Blumenauer’s leadership here to help my patients who have advancing serious and life-threatening cancer to try psilocybin-assisted therapy, as is their right, to palliate and relieve suffering.”
“High quality clinical evidence has shown that psilocybin-assisted therapy can help generate awe, connection, and joy, and these can impact immune function, mood, demoralization, and potentially prognosis,” he said. “The time is now for all members of Congress in Washington State and beyond to sign onto this letter that implores the US DEA to respect and protect the right to try law’s promises for my patients and others like them. It is the right thing to do, and this is an urgent and time-sensitive matter.”
The Blumenauer-led letter to DEA closes for signatures on Friday. It’s not clear when it will be sent to the agency, but it’s currently dated for some time in December.
Blumenauer separately told Marijuana Moment on Thursday that he’s “excited” about advancements in psychedelics research, as well as the implementation of a psilocybin therapy program that’s being set up in his home state of Oregon, where voters approved the historic reform during last year’s election.
Oregon’s initiative is “a model about how to take advantage of the this therapy for people who desperately need it,” he said. “There are a number of opportunities to demonstrate the power of this therapy. And we are, in a very thoughtful and systematic way, implementing that in Oregon to show how it can result.”
“I think this discussion needs to take place on Capitol Hill—and it’s something that I would like to occur early in the new the new year,” Blumenauer said. “Let people understand the potential, using opportunities now for people in the late stages of life to be able to try this using federal legislation.”
Read the full text of the letter to DEA on psilocybin access for terminal patients below:
Dear Administrator Milgram,
We write with concern about the U.S. Drug and Enforcement Administration (DEA) obstructing access to psilocybin for therapeutic use consistent with the letter and intent of Right to Try (RTT) laws. The DEA has failed to allow patients access to psilocybin treatment under RTT laws and as a result, litigation has been brought against the agency in Advanced Integrative Medical Science Institute (AIMS), et al v. USDEA that seeks to force the agency to allow access to psilocybin treatment consistent with RTT law (Pub. L. 115-176). We strongly believe that our constituents suffering such illnesses should have access to this investigational drug should they decide to pursue such a course of treatment and we urge you to take quick action to ensure that the DEA accommodates federal and state RTT laws and allows terminally ill patients to receive psilocybin for therapeutic use.
Research demonstrates that psilocybin provides immediate, substantial, and sustained relief from debilitating anxiety and depression in patients with terminal illnesses. Patients with advanced cancer that are also suffering from treatment-resistant anxiety or depression have been found to experience significant reductions in anxiety and depression, and improvements in mood, following a single guided session of psilocybin-assisted therapy. Further, these studies show no safety concerns or clinically significant adverse effects. Of note, researchers have also found that the benefits from such a treatment are sustained, with patients experiencing improvements in quality of life, life meaning, death acceptance, and optimism six months after treatment. We are excited by this research and the implications it has for our constituents suffering terminal illness.
Recognizing that terminally ill patients do not have the luxury of time to await the slow approval process for new drugs, in 2018 federal lawmakers enacted the Right to Try Act (Pub. L. 115-176), following 41 state legislatures that provided patients access to drugs in investigational stages. Psilocybin qualifies as an investigational drug under the terms outlined in applicable state and federal statutes. Notwithstanding, suffering dying patients seeking treatment with psilocybin are prohibited from receiving such a treatment because of the DEA’s refusal to accommodate RTT.
This refusal has led AIMS, an outpatient oncology clinic and research institute that has been denied access to psilocybin for therapeutic use with terminally ill patients, to file suit against the DEA (AIMS, et al v. USDEA). This case can, and ought to be, quickly settled in a manner which addresses DEA’s legitimate concerns about ensuring adequate security to prevent diversion, while enabling dying cancer patients such as those in the AIMS case access to psilocybin. Urgent action is needed to ensure that patients currently suffering terminal illness can elect treatment involving psilocybin.
We urge you to take quick action to ensure that the DEA accommodates enacted RTT law and allows terminally ill patients to receive psilocybin for therapeutic use. We appreciate your attention to this urgent matter.
Image courtesy of Kristie Gianopulos.