Do dying patients have the “right to try” illegal drugs like psilocybin and MDMA if they can relieve their end-of-life suffering from anxiety and depression?
That issue is now before one of the nation’s highest courts, with a Seattle-based hospice doctor appealing a U.S. Drug Enforcement Administration ruling barring him from prescribing psilocybin to his patients with advanced cancer.
Dr. Sunil Aggarwal says he has the right to prescribe psilocybin – the hallucinogenic compound found in “magic mushrooms” – under state and federal “right to try” laws, which give phased patients terminal access to experimental drug therapies before they are approved by the US Food. and Medication Administration. More than 40 states, including Washington and California, have such laws in place, and Congress passed a federal version in 2018.
“I have patients who want to try psilocybin-assisted therapy to relieve their existential distress,” Aggarwal said in an interview with The Times. “And there are many studies that support that.”
The DEA denied Aggarwal’s request, arguing that the therapeutic use of psilocybin remains prohibited – even for terminally ill patients – under the Controlled Substances Act of 1970, which classifies the drug as a narcotic. “Annex I” without recognized medical use. The agency said Aggarwal could only work with the drug if he received a license to do so as a researcher, not as part of his regular palliative care practice.
The case is one of two cases currently pending before the 9th Circuit in Aggarwal, each pitting the DEA’s law enforcement authorities against the state’s powers to regulate medicine. In the second case, Aggarwal is asking the DEA to simply reprogram psilocybin, making it available for therapeutic purposes – not just research.
Doctors and medical experts across the country are closely monitoring the “right to judge” case, and eight states and the District of Columbia have directly thrown their support behind Aggarwal.
In February, the coalition of states filed a brief accusing the DEA of going far beyond its law enforcement role of preventing the illegal diversion of powerful narcotics. They said the DEA’s assertion that the Controlled Substances Act trumped state right-to-try laws posed a “threat to state sovereignty.”
“If accepted, the DEA’s interpretation would ratify federal involvement in some of the most wrenching decisions a person can make, based on the most ‘attenuated’ relationship to any federal interest imaginable,” he said. wrote Washington Deputy Attorney General Peter Gonick on behalf of the coalition. .
Gonick said there is no reason to believe that allowing psilocybin to be administered to terminally ill patients under the supervision of a physician “will materially affect any interstate market for these substances or otherwise contribute to manner to illicit use, even in the aggregate.”
The same problem will soon arise with other drugs, Gonick said, notably with MDMA – commonly called ecstasy or molly – which is being studied as a treatment for anxiety in terminally ill patients.
Alongside Washington and DC are Delaware, Illinois, Michigan, Minnesota, Nevada, Oregon and Pennsylvania. State officials and the DEA 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 on the litigation.
Last year, Gov. Gavin Newsom vetoed a bill that would have decriminalized psilocybin and other natural psychedelics, and a more recent effort to put decriminalization on state ballots failed. However, advocates continue to push for state approval of therapeutic treatments using the drug.
Aggarwal’s case comes at a pivotal moment for medical research into psychedelics and other mind-altering substances. Clinical trials increasingly suggest effectiveness in treating depression, anxiety, and trauma-related disorders. With psilocybin, “microdosing” has become fashionable as a way to slightly alter or improve a person’s mental state without causing hallucinations or intense effects.
The use of these drugs is increasing, raising some concerns about unintended consequences.
Aggarwal, a University of Washington faculty member, national leader in hospice and palliative medicine and co-director of the Advanced Integrative Medical Science Institute, said he simply wants to give his dying patients the best care possible in the safest way possible – which is not the case. This is not happening right now.
Aggarwal said he’s seen it again and again: A terminally ill patient desperately wants to enjoy his final days with loved ones, but is overwhelmed by the “debilitating” anxiety and depression associated with his diagnosis.
“When you are told that you suffer from an incurable illness, that all we can do is extend your life expectancy for a while but there is no cure, the psycho-spiritual toll that it imposes on a person’s mind is very high,” he said. said.
Some of his patients have told him they are already taking illegally sourced psilocybin, which is concerning. The dosage and purity of illicit drugs are impossible to know, Aggarwal said, and his patients take them in uncontrolled settings without proper medical guidance — which studies show poses a greater risk of a bad reaction than when they are administered in a clinical setting.
Right now, all Aggarwal can do in such situations is offer his patients “harm reduction strategies,” he said, “but I don’t think that’s sufficient “.
In his brief to the 9th Circuit, Aggarwal notes that psilocybin “showed tremendous promise in early clinical trials for relieving the debilitating anxiety and depression suffered by terminally ill patients,” receiving “breakthrough” status. as a promising medical therapy by the FDA, and is in the final stages of clinical trials before approval.
It has shown promise not only in treating direct symptoms of anxiety and depression related to terminal illness, he said, but can also help patients make clearer and sometimes better decisions regarding the rest of their treatment plan.
“Getting this kind of relief could change the way you deal with the cancer itself and the types of treatments you accept or don’t accept,” he said.
However, when he began considering obtaining the drug under the “right to try” scheme a few years ago, it became clear that no manufacturer would supply it without DEA approval.
Since setting up a real research project to give his patients access to the drug would be too expensive and time-consuming, especially for his patients, he said, he asked the DEA clarified that no registration or special exemption was required for it to prescribe psilocybin under the “right to try” law, or to grant a waiver.
He refused to do that either.
“Unfortunately, we feel like we’re facing a situation where the government is restricting things for its own bureaucratic reasons,” Aggarwal said, “and not for sick or dying patients.”
Kathryn Tucker, director of advocacy at the National Psychedelics Assn. and one of Aggarwal’s lawyers, said she hoped the 9th Circuit would issue a strong opinion telling the DEA it was “out of its way.”
“The DEA has stepped in to nullify the effect of duly enacted state and federal laws, and the result is that dying patients suffering from anxiety and depression over death continue to suffer when they could get relief ” Tucker said. “It’s heartbreaking.”
Courts, including the U.S. Supreme Court, have been deferential to doctors in applying the law in other recent cases related to prescribing drugs, including powerful opioids. The DEA is preparing to reclassify marijuana as a less dangerous drug with recognized medical uses.
David Olson, director of the UC Davis Institute for Psychedelics and Neurotherapeutics, said Aggarwal’s case raises “extremely interesting” questions in a growing and extremely promising medical field.
Evidence suggests that psychedelic drugs not only offer patients potential spiritual and existential peace and acceptance in the face of difficult terminal diagnoses, but may also help physically repair the brain’s neural circuits linked to depression – opening up possibilities astonishing.
“How we think, how we feel and how we behave really depends on the totality of the circuitry in your brain,” Olson said.
Olson believes it is only a matter of time before such drugs are approved as therapeutic drugs by the FDA. However, the process of getting to that point is unpredictable, with no clear timeline, he said — which is why Aggarwal’s arguments on behalf of his dying patients are so compelling.
“As a society, we spend a lot of time trying to help people live well, but we should also help them die well,” Olson said. “It’s sad if someone has to go through that kind of anxiety and terror without any kind of release.”
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