The U.S. Drug Enforcement Administration has been delaying access to psilocybin mushrooms under the Right to Try law for two palliative patients since November 2020. Now, an advocacy group is prepared to carry out civil disobedience outside its headquarters in Virginia on May 9 to protest against the federal agency’s efforts to block access.
Two years ago, a Seattle-based palliative care clinic, Advanced Integrated Medical Sciences (AIMS), reached out to the federal agency with a request to access psilocybin for its two patients — Erinn Balderschwiler and Michal Bloom — both suffering from terminal illnesses.
After the request was denied, the clinic sued the DEA in early 2021. But the case was dismissed a year later due to a lack of response from the federal agency. Meanwhile, patients continue to struggle with end-of-life distress, losing time that could’ve been used in healing.
In a protest led by David Bronner, a philanthropist and cosmic engagement officer (CEO) of a soap company Dr. Bronner’s, advocates are now planning to peacefully block DEA headquarter entrance, saying that delay and obstruction in compassionate care with psilocybin is unacceptable.
“The DEA is very much disobeying the law,” Bronner tells Microdose, adding that the Right to Try Act (RTT) is clear on accessing the drug under trial.
A federal law enacted by the Trump Administration in 2018, RTT allows patients with life-threatening conditions to try “eligible investigational drugs”, which include those that have successfully cleared a Phase I trial.
So far, 41 states and the federal government have adopted RTT laws, allowing terminally ill patients access to treatments, which should also include psilocybin as a drug in the investigational stages.
Although psilocybin is a Schedule I drug under the Controlled Substances Act, several studies have proven its therapeutic benefits in curing mental health issues like treatment-resistant depression and end-of-life distress.
Bronner remains resolute in his pursuit to seek a response from the DEA, knowing he might “get arrested” for blocking the DEA headquarters entrance. Although, this wouldn’t be his first time if he gets arrested.
Could the Senator Help?
Earlier this year, the issue was brought to US Senator Patty Murray (D-WA), who also sits on the Health Committee, asking for support in accessing psilocybin for terminal patients. The Senator’s staff members held two meetings with Dr. Sunil Aggarwal of AIMS, Balderschwiler and Bloom.
Katherine Tucker, the lead attorney for AIMS, Balderschwiler and Bloom, tells Microdose, “(Murray) is one of the senators from the state of Washington where my clients are dying of cancer, and my client (Dr. Aggarwal) is trying to provide the palliative care, so she should care about the plight from this particular constituent.”
Tucker added: “She’s a very powerful senator. She did make a public record comment that she is investigating how the DEA is handling these requests.”
The struggles of Balderschwiler and Bloom have garnered support from other prominent figures like Congressman Earl Blumenauer (D-OR) — supporting their request for access to psilocybin. A bipartisan group of attorneys general representing eight U.S. states and the District of Columbia also filed an amicus brief against the DEA, saying the federal agency “overstepped the limits of its authority” by not recognizing the RTT law and its status under the U.S. Controlled Substances Act. So did the Goldwater Institute, and ACLU.
Fight for psilocybin access
Balderschwiler, a mother of two, was diagnosed with stage IV metastatic breast cancer two years ago. Knowing there’s no cure for the illness, she decided to come to terms with her “finite amount of time,” and reached out to Dr. Sunil Aggarwal of AIMS for medical assistance to deal with end-of-life sufferings.
“It’s a life and death issue,” Dr. Aggarwal tells Microdose, adding that patients don’t have the luxury of time to keep fighting for access to psilocybin.
Balderschwiler told Microdose that constant delays have been frustrating for her. “I’m not going to lie. It pisses me off!”
“Ultimately, my question is who is holding the DEA accountable? Who gets fired? We’ve asked for a waiver, and we still have received zero responses,” Balderschwiler said.
The U.S. Court of Appeals for the Ninth Circuit dismissed the case, sending it back to the DEA. The court ruled that they cannot make a decision until a final response is received from the DEA on the request to access psilocybin for compassionate care.
Tucker noted the case “could go in two directions.”
“(The DEA) could grant access, and that would be great. Everyone would win,” she said. “Or it could deny access with a final decision and we could go back to court.”
The team hasn’t heard a response from the agency despite follow-ups. “Delay is the tactic of this agency.”
Tucker and Dr. Aggarwal have also filed a petition to reschedule psilocybin to Schedule II in February to reduce barriers to psilocybin access, but haven’t received a response from the DEA yet.
“Again, unacceptable delay,” Tucker said. The group has also filed a FOIA request, enquiring into what the agency has done so far on multiple requests for psilocybin access.
Advocates are now choosing to demonstrate against the DEA’s unresponsiveness.
“(The protest would) highlight the issue of prioritizing with our elected officials and others who can be inside the Biden Administration, and hopefully pressure to stop blocking access,” Bronner tells Microdose, who has long extended support and advocated for psychedelic medicines.
Tucker said the effect of the demonstration is to bring the issue into the public eye “in a bigger way so that citizens across the country demand their federal elected official to get the DEA back in its lane,” while allowing the state and federal law “to operate as intended and to create a pathway to access (psilocybin) which brings immediate substantial and sustained relief of anxiety, depression and dying patients.”