Access to psilocybin – psychedelic mushrooms – stalled, but doctors find evidence of clinical benefits

Erinn Baldeschwiler has been battling stage four metastatic breast cancer for two years.

Two months after her diagnosis, the 50-year-old writer and patient advocate began immunotherapy. But in October, her cancer became treatment-resistant and she received a six-month prognosis.

“When you’re actually a person physically sitting with that, it can bring out an immense amount of emotions, you know, sadness, melancholy, anxiety, fears,” said Baldeschwiler, who lives in North Bend, Washington.

Baldeschwiler is seeking access to psilocybin – the main psychoactive compound in psychedelic mushrooms – to help treat her end-of-life depression and anxiety.

“I find that, you know, medicine is anything that will aid me in feeling more connected with life itself and take my mind out of the picture and really alleviate any fear surrounding death and passing,” she added.

The Food and Drug Administration designated psilocybin a breakthrough therapy in 2018 and 2019 for treating drug-resistant depression and major depressive disorder.

But the Drug Enforcement Administration classifies psilocybin as a Schedule I substance under the Controlled Substance Act, meaning it cannot be prescribed, administered or dispensed for medical use. The law also sets strict limits on a medical professional’s ability to conduct further research on the drug.

“If we make something illegal and then cut off the option to even research it, it’s like how can you even know if there’s medical benefits to it or not?” Baldeschwiler said.

Bladeschwiler said she is dissatisfied with the options currently available to her. She said traditional chemotherapy has side effects including reduced blood cell counts and increased risk of infection.

“I’m all about let’s find modalities, let’s find options that can actually help relieve symptoms for good as opposed to just, ‘Here, take this. It’s going to wear off in 12 hours. Now take another one.’ That to me is masking the issue,” she added.

Baldeschwiler and her Seattle-based palliative care physician, Dr. Sunil Aggarwal, sued the U.S. Drug Enforcement Administration in March 2021, after the agency sent a letter denying Aggarwal’s permission to disperse psilocybin under state and federal right-to-try laws. Those allow patients with terminal conditions to try investigational medications that have not been approved for general use. The U.S. Court of Appeals for the Ninth Circuit dismissed the lawsuit on Jan. 31.

In January, state Sen. Jesse Salomon, D-Shoreline, introduced a bill that would have allowed anyone 21 or older to access psychedelic mushrooms, even if they are not a doctor or licensed counselor. The Senate Health & Long Term Care Committee did not consider the bill before Feb. 28, so it did not pass during this legislative session.

In Spokane, an initiative was filed with the city clerk last year that would effectively end citywide enforcement of laws against the possession of psilocybin. The city’s hearing examiner, however, determined the initiative to be “invalid” because it conflicts with state law. The leaders of that effort have since switched their focus in support of Initiative 1886, a proposed state initiative, in the signature-gathering stage that would “allow licensed persons to provide psilocybin products and services to persons age 21 and older and require state agencies to license and regulate the manufacture, sale, and use of psilocybin.”

A study from John Hopkins University found psilocybin was associated with clinically significant decreases in depression and anxiety in about 80% of participants after six months. Another study from New York University showed a similar result.

A study at Imperial College London testing the impacts of taking daily escitalopram pills, an antidepressant, against two doses of psilocybin in patients with major depression showed that, after six weeks, twice as many psilocybin patients were in remission as in the antidepressant group, even though both groups received the drugs in combination with psychological counseling.

Baldeschwiler acknowledged that there are ways she could access psilocybin illegally, but she would prefer to try it in a clinical setting. In 2020 Oregon voters decided to legalize psilocybin in clinical settings. Using it, however, won’t be legal until the end of the year, which is the deadline for the state to finish writing regulations for the drug.

“I know that there’s these medicines available. I know I have a doctor that is willing to provide them in a clinical setting. And then I have this government, nonelected agency that is making choices for people,” Baldeschwiler said.

She believes there is a stigma against psilocybin because of its popularity for recreational use in the 1960s and ’70s in hippie culture and its subsequent demonization by the government. She said she thinks other substances with high potential for abuse, like alcohol and nicotine, are legal because they are “billion-dollar industries.”

Her doctor, Aggarwal, is a board-certified physician in hospice and palliative medicine and physical medicine and rehabilitation at the Advanced Integrative Medical Sciences Institute. He said some of his colleagues are trained to facilitate psychedelic-assisted therapy with psilocybin.

“We have it set up, it’s just a matter of getting legal permission – if we can – to do it,” Aggarwal said.

He said he would “without a doubt” want to expand his practice to include psilocybin-assisted therapy if it was rescheduled.

“There are no interventions that are available in medicine today that have that level of efficacy, and the safety is very good too,” Aggarwal said.

“It’s an idea whose time has come,” he added.

Dr. Greg Carter, clinical professor at the Washington State University Elson S. Floyd College of Medicine in Spokane, also said stigma played a large part in psilocybin’s Schedule I status.

“You know, we criminalize addiction, we put drug addicts in prison, so it’s really more societal norms,” he said.

Carter supports rescheduling psilocybin so scientists and physicians can more easily get funding for, and conduct, clinical research.

“It’s very, very difficult to do research on (Schedule I) compounds,” Carter said. “I mean, people have managed to do it, myself included, but it’s not easy. And no pharmaceutical companies are going to be interested in anything that is Schedule I because it won’t go to market.”

“There’s a lot of people that say ‘Hey, this stuff helps me,’ but that’s not research,” Carter added.

Carter said researchers need to conduct more randomized, double-blind, placebo-controlled trials in which researchers treat one group with a placebo drug and another with psilocybin to have reliable results that would allow them to decide whether to endorse psilocybin for clinical use.

Matthew Johnson has conducted these trials at Johns Hopkins University. A professor in psychedelics and consciousness, he told Ethan Nadelmann, on Nadelmann’s podcast, “Psychoactive,” that the fact psilocybin remains on Schedule I is “absolutely absurd.”

“We know very, very well that psilocybin and the other classic psychedelics like LSD, mescaline, DMT, are not addictive,” Johnson said.

“Accepted medical value has come to be defined as explicit FDA approval. So by definition, regardless of the science, until (psilocybin) has FDA approval for a disorder, it has no accepted medical use,” he added.

But there are some risks associated with psilocybin. In rare instances it can cause a lasting psychotic reaction, more often in people with a family history of psychosis, according to the journal Nature.

Like Baldeschwiler, some people say they don’t have time to wait for the FDA to reschedule psilocybin.

Spokane resident Darren McCrae, 53, said he needs the drug in order to feed himself, stand or drive. He eats one gram of mushrooms containing psilocybin every five hours to stop severe tremors associated with his Parkinson’s disorder, which causes gradual stiffness or slowing of movement by attacking the nervous system. He was diagnosed with the disease in September, but has had tremors his entire life.

A doctor recommended that McCrae do deep brain stimulation, a procedure in which doctors implant electrodes in the brain by drilling holes in a patient’s skull. The procedure has a 10-year survival rate of 51% for patients with Parkinson’s disease. Without psilocybin, McCrae would have no choice but to get the surgery.

“The reason I get so choked up when I talk about this is that that’s the only thing for people like me, all over the world,” McCrae said. “There’s nothing out there but deep brain stimulation to help us.”

“I know there’s people right now like me that these mushrooms could be the key to being able to care for themselves,” McCrae added. “The ’shrooms could break those chains and let them have their life back like they’ve given me.”

Without the psilocybin, McCrae can’t walk, but with it he said he takes 2- to 3-mile walks five to six days a week, which has helped combat his depression.