Do dying patients have the right to “try” illegal drugs like psilocybin and MDMA if they may suffer from anxiety and depression at the end of life?
That question is now before one of the nation’s highest courts, with a Seattle-based palliative care physician appealing a U.S. Drug Enforcement Administration ruling that barred him from prescribing psilocybin to his end-stage cancer patients Has gone.
Dr. Sunil Aggarwal says he has the right under state and federal “right to try” laws to prescribe psilocybin – the hallucinogenic compound in “magic mushrooms” – to terminal patients before it is approved by the U.S. Food and Drug Administration (FDA). Provides access to. and drug administration. More than 40 states, including Washington and California, have such laws, and Congress passed a federal version in 2018.
“I have patients who want to try psilocybin-assisted therapy for existential crisis,” Agarwal said in an interview with The Times. “And there are many studies that support this.”
The DEA has denied Agarwal’s request, arguing that therapeutic use of psilocybin is prohibited – even for terminal patients – under the Controlled Substances Act of 1970, which prohibits the drug from being used as a recognized therapy. Lists as a “Schedule I” narcotic of use. The agency said Aggarwal can work with the drug only if he is licensed to do so as a researcher, and not as a routine part of his palliative care practice.
Aggarwal’s case is one of two now pending before the 9th Circuit, each pitting the DEA’s law enforcement authority against state powers to regulate medicine. In the second case, Agarwal is asking the DEA to reschedule psilocybin, making it available for therapy — not just research.
Physicians and medical experts across the country are closely following the “right to try” case, and eight states and the District of Columbia have directly voiced their support for Agarwal.
In February, a coalition of states filed a brief accusing the DEA of overreaching its law enforcement role of preventing the illegal diversion of powerful narcotics. He said the DEA’s claim that the Controlled Substances Act preempts state jurisdictional laws is a “threat to state sovereignty.”
Washington Deputy Solicitor General Peter Gonick wrote on behalf of the coalition, “If accepted, the DEA’s interpretation, based on the most ‘tenuous’ connection to any potential federal interest, would make some of the most difficult decisions an individual can make.” “Will confirm federal participation.” ,
Gonick said there is no reason to believe that allowing psilocybin to be given to terminal patients under doctor’s supervision “would substantially affect any interstate market in such substances or otherwise contribute to illicit use, even That overall too.”
The same issue will soon arise with other drugs, Gonick said, particularly with MDMA — commonly known as ecstasy or molly — which is being studied as a treatment for anxiety in terminal patients. .
Joining Washington and DC are Delaware, Illinois, Michigan, Minnesota, Nevada, Oregon and Pennsylvania. State officials and the DEA both declined to comment on the case.
California is not part of the coalition, and California Atty. Gen. Rob Bonta’s office did not respond to a request for comment on California’s position in the lawsuit.
Governor Gavin Newsom vetoed a bill last year that would have decriminalized psilocybin and other natural psychedelics, and a more recent attempt to decriminalize state ballots failed. However, advocates continue to press for state approval curative treatment using medication,
Agarwal’s case comes at a critical moment for medical research on psychedelics and other mind-altering substances. Clinical trials have suggested efficacy in treating depression, anxiety, and trauma-related disorders. With psilocybin, “micro-dosing” has come into vogue as a way to mildly alter or improve one’s mental state without producing hallucinations or acute effects.
use of medicines is increasing, which is raising some concerns About unintended consequences.
Aggarwal, a faculty member at the University of Washington, a national leader in hospice and palliative medicine, and co-director of the Advanced Integrative Medical Sciences Institute, said he wants to give his dying patients the best possible care in the safest way possible — that’s what it’s like. It’s happening right now.
Aggarwal said he has seen it again and again: A terminal patient wants to enjoy his or her last days with loved ones, but is overwhelmed by the “debilitating” anxiety and depression associated with his or her diagnosis.
“When you are told that you have a terminal disease, all we can do is extend your lifespan for a certain amount of time but there is no cure, the psycho-spiritual impact on one’s mind is enormous. It happens,” he said. Said.
Some of his patients have told him that they are already taking psilocybin that they obtained illegally, which is worrying. It’s impossible to know the dosage and purity of street drugs, Agarwal said, and his patients are taking them in uncontrolled settings without proper medical guidance — which studies have shown is worse than when given in a clinical setting. The risk of reaction is high.
Right now, Agarwal can only offer “harm reduction strategies” to his patients in such situations, he said, “but I don’t think that’s enough.”
In his brief to the 9th Circuit, Aggarwal wrote that psilocybin “has shown enormous promise in relieving debilitating anxiety and depression in terminally ill patients in early clinical trials”, adding that the FDA It has been rated “breakthrough” by the FDA as a promising medical treatment. And is in the final stages of clinical trials before approval.
It has shown promise not only in addressing the direct symptoms of anxiety and depression related to terminal illness, he said, but may also help patients make clearer and sometimes better decisions about the rest of their treatment plan.
“Having this kind of remission can change how you really cope with cancer and what kind of treatments you accept or don’t accept,” he said.
However, when they began to consider obtaining the drug under the “right to try” framework a few years ago, it became clear that no manufacturer would supply them without DEA approval.
Since it would be too expensive and time-consuming to set up a real research project for their patients to have access to the drug, he said, he asked the DEA to clarify that no special registration or exemption is required for them. Prescribe psilocybin under “right to try” laws, or it grants him immunity.
It also refused to do so.
“Unfortunately we feel like we’re dealing with a situation where the government is restricting things for its own bureaucratic reasons, and not for sick and dying patients,” Agarwal said.
Katherine Tucker, director of advocacy at the National Psychedelics Association. And one of Agarwal’s lawyers said he hopes the 9th Circuit will issue a strong opinion and tell the DEA that it is “far out of its lane.”
Tucker said, “The DEA has interfered with itself to subvert the operation of duly enacted state and federal laws, and the result is that patients suffering from anxiety and depression in the face of death continue to suffer even when they receive relief. Can get.” “It’s heartbreaking.”
Courts, including the US Supreme Court, have shown deference to doctors over law enforcement Other recent cases Relates to prescribing medications, including powerful opioids. DEA is preparing to reclassify marijuana a less dangerous drug With recognized medicinal uses.
David Olson, director of the UC Davis Institute of Psychedelics and Neurotherapeutics, said Aggarwal’s case raises “extremely interesting” questions in an emerging field of medicine that has tremendous potential.
Evidence suggests that psychedelic drugs not only provide patients with potentially spiritual and existential peace and acceptance in the face of a challenging terminal diagnosis, but may also help physically repair neural circuits in the brain associated with depression—which Creates amazing possibilities.
“How we think, how we feel, how we behave really depends on the totality of the circuits in your brain,” Olson said.
Olson believes it is only a matter of time before such drugs are approved by the FDA as therapeutic drugs. However, the process of getting to that point is unpredictable, with no clear timeline, he said — which is why Agarwal’s case for his dying patients is so compelling.
“As a society we spend a lot of time helping people live well, but we also must help people die well,” Olson said. “It’s sad if someone has to go through that kind of anxiety and terror without any kind of release.”
