In January 2021, Tucker wrote a letter to the DEA requesting access to psilocybin under the Right to Try Act (RTT), intended for terminally ill patients who do not have time to wait for the drug to be approved.
Washington State approved RTT in 2017 to allow patients to try to preserve their own lives by gaining access to affordable experimental drugs. The state has stated that the decision to use these drugs should be made by the patient and their physician.
Dr Sunil Aggarwal said his patient, Erinn Baldesweiler, has the legal right to get this medicine immediately. Although the RTT was signed at both the federal and state levels, and Aggarwal was registered with the DEA to prescribe controlled substances, he was still denied registration with the DEA.
At that point, the team decided to take the DEA to court to reverse its decision. I follow the rules and I expect the DEA to follow the rules, Aggarwal said.
Providing high-quality care to patients with life-threatening illnesses can not only relieve pain and symptoms, but also prolong life. As quality of life improves, depression and anxiety decrease. The immune system is strengthened so that it can fight the cancer and increase tolerance to other treatments that may be needed to cure the cancer.
Tucker has been advocating for better end-of-life care for 30 years and says there is a gap in the ability to treat non-body suffering, anxiety and depression.
I want to have that opportunity not only for myself, but to keep it open for others who are suffering, said Baldeshwiler, who was diagnosed with stage IV breast cancer and had only two years to live.
Despite research by leading academic institutions such as Johns Hopkins University, psilocybin is classified by the DEA as a List I substance, prohibiting its medical use and severely restricting research.
Studies have shown that psilocybin can provide emotional relief to patients with advanced cancer. According to a study : People who take a psychedelic trip often experience a sense of oneness with the world, even with the universe. It’s like they’re dead and have gone somewhere else.
A patient said: I’m not a religious person, and I’d be hard-pressed to say I was even remotely spiritual, but I felt like I was living it, experiencing the afterlife almost like a glimpse, and I felt completely calm, completely relaxed, completely at peace. So that when the time comes, I won’t be afraid of it at all.
In all 50 states, a patient with a terminal illness can choose palliative sedation, in which controlled substances are administered to remove consciousness so that the patient is no longer aware of his or her suffering. Tucker said: In these jurisdictions, one would certainly think that patients with advanced disease should have access to controlled substances to increase and broaden awareness.
Tucker still doesn’t know why the DEA refused to help him. We have no explanation. In a letter to Tucker, the DEA rejected the therapeutic use and suggested that Aggarwal become an investigator.
We’ve made it clear that it’s not about research, it’s about therapeutic applications, and those two things are definitely very different, Tucker said: If we go down the road of research, we lose the purpose of the application in the first place, because patients only have a limited time to get a good quality treatment.
Tucker plans to request an expedited hearing, which could take several months. They also do not rule out the possibility that the DEA will come to its senses and discuss a decision on granting access, as has happened in Canada.
In 2020, Canada approved access to psilocybin for terminally ill patients receiving end-of-life care. Tucker said: We are confident that we can achieve the same experience in Canada with this trial.
Whatever time I have left, I want to have the best quality of life possible, Baldesweiler said.