Terminal Cancer Patients Deprived of Right to Try Psychedelic-Assisted Therapy

In multiple clinical trials, individuals with life-threatening conditions suffering from anxiety and depression experienced meaningful and lasting relief after a single therapeutic session with psilocybin — an investigational psychedelic drug derived from mushrooms.

However, despite these promising findings, using psychedelic drugs does entail risks, and it is expected to take years before psilocybin is FDA approved.

Recognizing that patients with a terminal illness don't have time to wait for the long FDA approval process, federal and state Right To Try laws were enacted so that patients with no other options could try an eligible and promising investigational drug under their doctor's supervision.

In 2020, Dr. Sunil Aggarwal, a Seattle-based palliative care specialist, exercised the right to try and requested authorization to receive psilocybin on behalf of two late-stage cancer patients.

In an email, Aggarwal explained the rationale behind his action: "High-quality research and a very long history of traditional use suggest there is great potential for psilocybin-assisted therapy to relieve the suffering of my patients and many others like them."

Psilocybin has passed Phase I studies evaluating safety and dosage, making it an eligible investigative drug under the Right To Try (RTT) law. And yet, despite its demonstrated benefits and security, psilocybin still falls under Schedule I of the federal Controlled Substances Act. 

Dating back to the 1970s and President Richard Nixon's War on Drugs, psilocybin was lumped together with cannabis, heroin, and LSD and labeled as highly dangerous and of no medical value.

But because of psilocybin's restricted status, Aggarwal knew that no manufacturer would supply this experimental drug without prior approval from the Drug Enforcement Administration (DEA).

Thus, in 2021, he applied to the DEA for permission to receive psilocybin on his patients' behalf. The request was denied, but in an inconclusive manner, it left the appeal hanging.

The DEA's decision was confounding and deeply frustrating for Aggarwal, his patients, and observers of the current psychedelic renaissance. With the well-being of seriously ill patients across the country at stake, Aggarwal and attorney Kathryn Tucker decided to appeal the decision in federal court.

After ten months of deliberation, the court ruled that the DEA hadn't given a sufficiently final decision. This sent Tucker back to court seeking a definitive answer from the DEA. As the stalling continued, patience had run out by May this year.

Erinn Baldeschwiler, one of the patients in the appeal, and her nurse, Kim Larsen, traveled to Washington, DC, to participate in a protest at DEA headquarters. The goal was to bring attention to Baldeschwiler's plight and the DEA's obstructive tactics and hopefully get a waiver allowing her access to the drug.

Tucker explained at the DEA: "Erinn doesn't expect to see her children reach adulthood or even be here a year from now. So she's eager to have this therapy, and the law intends her to have it."

"The DEA has no role in regulating the practice of medicine. So it's acting way outside its lane by intruding into the operation of these laws intended to make these investigational drugs available to patients with advanced illness."

Addressing the crowd, Baldeschwiler emphasized: "I am one of the millions of patients with legal access to these medicines, and it's shameful that this agency is blocking my way."

And from Larsen, a nurse who is also trained in psychedelic-assisted therapy: "Nothing is coming even close to the efficacy of these medicines to alleviate the fear, the pain. Psilocybin gives people their life back in a way that allows them to enjoy what time they have left. So why are we not granting access?"

MDMA, also known as ecstasy, is another investigative psychedelic drug classified as a Schedule One controlled substance. In clinical trials, MDMA demonstrates impressive outcomes in relieving and resolving severe and intractable PTSD. 

Thanks to strong advocacy by politicians and veteran groups, MDMA is now being administered to veterans through the VA system, and FDA approval is expected soon.

Tucker hopes that advocacy groups working on behalf of cancer patients will rally behind the cause of making psilocybin therapy available under the Right To Try laws.

Speaking to members of the MBC network of activists working on behalf of metastatic breast cancer survivors, Tucker emphasized:

"Our frontline objective here is ensuring that patients with advanced illness, no matter how long they live, are at peace with what's unfolding for them. If we are successful, patients nationwide will have access to psilocybin therapy." 

The MBC's podcast featured three episodes on psychedelic-assisted therapy for those with breast cancer; Tucker and Baldeschwiler explain the Right To Try initiative in the third episode.

Tucker and Aggarwal received a substantive answer from the DEA on June 28, doubling down on its refusal to abide by the RTT laws and allow access for Baldeschwiler and others to receive the drug. They plan to return to court but are also trying other approaches.

According to Tucker, "one of the things we've discussed with Senate offices is to make a small clarification that will make it abundantly clear that Schedule I substances are subject to the Right-To-Try law. 

In mid-July, Senators Cory Booker (D- New Jersey) and Rand Paul (R- Kentucky) introduced a bipartisan bill clarifying that Schedule-1 substances passed Phase I trials are included under Right-To-Try laws.

At the same time, Tucker and others filed a lawsuit against the DEA over their stalling tactics in complying with Freedom of Information requests related to their Right To Try cases. 

After that, they will return to federal court to seek judicial review of DEA's failure to accommodate RTT laws. But these processes are slow, and for Baldeschwiler and others, time is running out.

The Right To Try advocacy effort is time-consuming and costly. Tucker and her team provide their legal services' low bono', and expenses are covered mainly through philanthropy. However, additional philanthropic support is needed.

Anyone who supports this cause is urged to sign the petition on the Right To Try website, write to newspapers or reach out to federal elected officials, informing them that the DEA is thwarting duly enacted state and federal laws to the detriment of patients with advanced illness. 

Interested individuals can also urge federal elected officials to support the Booker/Paul Right To Try Clarification Act and call on the DEA to allow the law to operate as intended.