Psilocybin approved for end-of-life care as momentum builds for psychedelic therapy

Four Canadians will soon become the first in the country to legally consume psilocybin since it was made illegal in 1974

By Samuel Riches

In early June, Thomas Hartle, a 52-year-old father of four from Saskatoon, who has been living with terminal cancer since 2016, sent a private video message to Patty Hajdu, Canada’s Minister of Health.

“People like myself are facing very real, very concrete, mental health issues,” he says in the video, which he shared with the National Post. “These are mental health issues and anxieties and depression that we feel could be addressed as easily as the stroke of a pen for you.”

Hartle was referring to an application he had sent to the minister weeks earlier for a Section 56 exemption to the Canadian Drugs and Substances Act. The exemption would allow Hartle to pursue psilocybin therapy for end-of-life distress. Psilocybin is a psychedelic drug derived from magic mushrooms.

This year, Hartle and at least three other Canadians  applied for the exemption. Earlier this week, more than 100 days after the first application was sent, they received good news. The exemptions were granted, meaning the four Canadians will soon become the first in the country to legally consume psilocybin since it was made illegal in 1974.

“Today is a good day,” Hartle said earlier this week.

Hartle completed his application with the assistance of TheraPsil, a B.C.-based, non-profit coalition of doctors and health-care professionals, policymakers, lawyers, researchers and advocates. Spencer Hawkswell, executive director of TheraPsil, says the need for psychedelic therapy is growing.

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“More individuals reach out every week, and I think many more across Canada would want to explore this option if they were aware of it,” Hawkswell previously told the Post.

“With so many Canadians diagnosed with terminal illnesses each year, and many choosing MAiD (medical assistance in dying), we hope to be another option for the patients who are experiencing end-of-life distress and want to try something like psilocybin,” Hawkswell says.

Hartle says that traditional anti-anxiety medications come with a range of unpleasant side effects and do not address the existential anxiety that he is feeling as he wrestles with the reality that he will be leaving his family behind. He believes psilocybin could help ease that pain and there’s no shortage of research to support his position.

A 2016 study from John Hopkins University demonstrated that psilocybin therapy led to significant and sustained decreases in depression and anxiety in patients with life-threatening cancer, in addition to improved quality of life and a renewed sense of optimism. Six months later, those changes persisted. About 80 per cent of participants continued to show substantial decreases in depression and anxiety.

Psilocybin-assisted psychotherapy is more than “just a trip,” Hawkswell explains. It begins with multiple preparatory sessions between the patient and therapist before the mushroom is consumed. The potential for breakthroughs comes in the moments of extreme anxiety, he says, as patients confront their negative emotions.

If we can do this the right way, and go through official channels, it will pave the way so other people can follow

“This is often where some of the most important psychotherapeutic work happens as patients let go of long-held negative beliefs.” The therapy concludes with multiple post-integration sessions, where the patient and therapist work through the experience.

“If we can do this the right way, and go through official channels, it will pave the way so other people can follow in my footsteps,” Hartle says. “I am hoping that, eventually, people like the Minister and Canadians in general, will see that people are benefiting from this, and it is not the harmful, non-beneficial substance that it has been portrayed as.”

Hawkswell says they’ve had a difficult time engaging the government in this discussion. In 2017, the organization’s founder, Dr. Bruce Tobin, applied for an exemption to treat dying Canadians with medically-supervised, psilocybin-assisted psychotherapy. After three years of limited communication with Health Canada, the application was denied.

Hawkswell hypothesizes that the original application was rejected because it was for a class of dying patients, not an individual. Since that ruling, they pivoted their strategy to focus on individual exemptions and, this week, the work finally paid off.

“We would like to extend our incredible gratitude to the Honorable Minister of Health, Patty Hajdu, and to our government,” Tobin said earlier this week. “Although it has taken a long time we are impressed with their willingness to listen to patients who have not been heard and to shift focus and policy to accommodate their interests and protect their needs.”Momentum for psychedelic therapy has been building across North America for the last several years.

In 2017, the U.S. Federal Drug Administration gave MDMA a breakthrough therapy designation for post-traumatic stress disorder. In 2018, they gave the same designation to psilocybin for treatment-resistant depression. In March of last year, the FDA approved a new antidepressant for the first time in decades, a nasal spray that mimics the effects of ketamine.

In March, Mind Medicine Inc., which received financial backing from Kevin O’Leary and Bruce Linton, began trading on Toronto’s NEO Exchange. The company’s first drug, 18-MC, is a derivative of ibogaine, a naturally occurring psychedelic from the root and bark of Iboga, a rainforest shrub that grows across West Africa. Ibogaine has shown promise in treating some of the world’s most destructive and damaging addictions: heroin, alcohol, methamphetamine and opioids.

Later this month, Paul Manly, the Green Party’s MP for Nanaimo-Ladysmith, will present a petition, initiated by the Canadian Psychedelic Association, that calls for the decriminalization of psychedelic plants and fungi. The petition has been signed by nearly 11,000 Canadians.

“There is a rapidly growing body of evidence that medicinal plants containing psychoactive ingredients can provide therapeutic benefits,” Manly previously told the Post. “They have been safely used to treat people suffering from addictions, common mental health issues such as depression and anxiety, as well as for end-of-life care.”For Hartle, and other Canadians living with a terminal diagnosis, this week’s decision is a welcomed one, and potentially, the beginning of a much larger movement. The legalization of cannabis, after all, can be traced back to a Section 56 exemption.

“This is the positive result that is possible when good people show genuine compassion,” Hartle says. “I’m so grateful that I can move forward with the next step of healing.”

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Research shows psilocybin — a Schedule I narcotic — to be of great help to patients with end-of-life problems


Guided LSD session at Johns Hopkins University.

“People in this country don’t talk about death. When I would talk about it sometimes with people they would say, ‘Oh be optimistic! Don’t talk that way. You’re gonna be fine.’ You really need to look at it (death) and this is the perfect way to do it.”
Ann Levy – psilocybin-assisted psychotherapy study participant

I remember the ride home being really quiet. Typically, my mom would be driving me nuts, loudly singing old Methodist hymns, rather than letting us listen to music on the radio. But this time she just drove silently as my grandmother, Lillian Brustad, stared out the window of our well-traveled station wagon. We had just left my grandmother’s oncology appointment in Rochester, New York and we were heading back to her home in Hamilton. There was no discussion about the appointment, no talk about any diagnosis, no ‘next steps’ and no ‘why me’s?’ What was said was said in a meeting with my mother, my grandmother and her doctors.

I’d break the silence with my repetitive pre-teen complaints as to why we should have stopped in Rochester, rather than waiting until Syracuse to pull into a Friendly’s restaurant for a Jim Dandy sundae. I’d debate from the back seat that stopping in Rochester would have made me full and happy. Stopping would have better allowed me to finish this book report on Mickey Mantle that I was putting off.

When I wasn’t complaining; there was silence…

We made many more trips to Rochester over the next few years. My grandmother remained stoic in her battle against cancer, despite it wreaking havoc on her physical body, eventually taking her life.

The final months of life are often marked by increasing physical and emotional suffering. As one approaches death, we often experience varying degrees of depression, hopelessness, anxiety, and a desire to hasten death. The prospect of our loved one’s looming death can lead to feelings of defeat, helplessness, and despair in family members and within the patient’s medical team.

How do you want to die? Most people hope to die at home, with their loved ones, but sadly an overwhelming majority of us die in a hospital or extended care home surrounded by beeping equipment.

What would a good death look like? Anthony Bocelli, PhD, is a palliative care psychologist and investigator in a study conducted at the NYU School of Medicine on the use of psilocybin-assisted psychotherapy to help patients and families deal better with end-of-life distress.

“Death needs to be humanized,” he says. “Although the end-of-life can be profoundly difficult, it can also trigger a search for meaning and an openness for the sacred.”

Maria Sabina called psilocybin mushrooms her ‘saint children.’ Sabina was the Mazatec curandera/healer that banker Gordon Wasson sought out to learn the secrets of ‘magic mushrooms.’ Sabina introduced Wasson and his wife Valentina to teonanácatl; the Psilocybe mushroom. ‘nti-ši-tho in Mazatec, meaning the ‘Little-One-Who-Springs-Forth’.

Wasson went on to famously detail his psychedelic experience in Life Magazine, introducing these sacred mushrooms to the Western world. Albert Hofmann, discoverer of LSD and chemist at the Swiss Sandoz Laboratories, isolated psilocybin in 1957 from mushrooms collected by Wasson’s team on their second trip to Oaxaca.

These sacred mushrooms have been used for millennia by indigenous cultures around the globe for healing and insight. Psilocybin-assisted psychotherapy melds this ancient sacred wisdom with modern day scientific technology. I am not talking here about eating a bag of ‘shrooms and tripping at a rock concert; this is about the therapeutic use of this valuable tool in a controlled setting under supervision by trained guides to help combat depression, addiction, and existential distress.

So why psilocybin mushrooms and why now? It has been said that psychedelics could be to psychiatry, what the microscope is to biology or the telescope was to astronomy. Bear in mind that telescopic science was prohibited in 1616 for over 100 years, in fear that people may discover that planet Earth was not the center of the universe.

Alicia Danforth, Ph.D, served as investigator on a psychedelic research study at Harbor-UCLA Medical Center examining the safety and efficacy of psilocybin as a treatment for advanced-cancer anxiety. She remarked, “It’s very important not to lose sight of the fact that research with psychedelic medicines has been going on for thousands and thousands of years. As long as there has been humans really. What’s new is when you get into the Western medical model.”

Dr. Danforth worked with Dr. Charles Grob on an important pilot study at Harbor-UCLA Medical Center on 12 patients who were facing end-of-life from advanced stages of cancer. Subjects were administered a placebo (niacin) during one session and the other session they received psilocybin.

I had the pleasure of discussing the study and their findings with Dr. Danforth. “Our participants were really near death. Some did not survive the six-month follow-up period,” she said.

Dr. Danforth detailed that they administered “one session at a low-to-moderate dose because we were the first cancer-treatment study in a new wave of psychedelic-assisted therapy and the FDA was really conservative. The main purpose for these little pilot studies is to establish that they are safe and is it even achievable. Does it work?”

The other studies that I will cite in this article worked with higher doses of psilocybin. However, Danforth stated that, ‘even with one session of preparatory psychotherapy session before (treatment day), then a really supported session on the day of treatment, then therapy afterwards, our study found a reduction in anxiety and a trend toward a reduction in depression.” She continued, “It’s more important to look at the trending that leads to larger studies so you can make stronger claims. We saw positive trends and there was a significant difference in the anxiety scores. The qualitative outcomes were good; the safety data were good. We didn’t have any serious adverse events and everything was green light go for the larger studies.”

As Danforth mentioned, humans have been conducting research for thousands of years on psychedelics. Prior to prohibition of these substances in the late sixties, there were more than a thousand studies conducted with more than 40,000 subjects and many showed positive trends.

During the 1960’s, Dr. Eric Kast, from the Chicago Medical School utilized LSD for a series of studies working with cancer patients encountering death. Several hundred advanced-stage cancer patients were administered LSD. Findings showed trends toward pain reduction for several weeks, relief of depression, improved sleep, and a lessened fear of death. Dr. Kast noted that some of these individuals showed a striking disregard for the gravity of their personal situations. They frequently talked about their impending death with an emotional attitude that would be considered atypical in our culture.

Another important study by William Pahnke from the Maryland Psychiatric Research Center, in Baltimore conducted a study that was published in the Harvard Theological Review in 1969. His work examined the psychedelic mystical experience in the human encounter with death. He found, “The most dramatic effects came in the wake of a mystical experience.” He reported a decrease in fear, anxiety, worry and depression. Often the need for pain medications was lessened, because the patient was able to tolerate pain more easily. There was a profound increase in serenity, peace, and calmness, with a marked decrease in the fear of death.

Roland Griffiths, Ph.D., is a Professor in the Departments of Psychiatry and Neurosciences at the Johns Hopkins University School of Medicine. He is the principal investigator of the Johns Hopkins Psilocybin Project. He and his team have been studying the effects of psilocybin and its ability to bring about mystical experiences. Their team conducted the largest and most rigorous study in this new wave of psychedelic research involving fifty-one patients who had received a potentially life-threatening cancer diagnosis.

“We found that the response was dose-specific,” Dr. Griffiths said. “The larger dose created a much larger response than the lower dose. We also found that the occurrence of mystical-type experiences is positively correlated with positive outcomes. Those who underwent them were more likely to have enduring, large-magnitude changes in depression and anxiety.”

The Johns Hopkins group reported that psilocybin decreased both clinician and patient-rated depressed mood, anxiety, and death anxiety. The results showed increased quality of life, sense of connectedness, and optimism. Participants expressed an increased belief that death is not an ending, but rather a transition to something even greater than this life. About 70% reported the experience as one of their top five spiritually significant lifetime events, including the birth of a child or death of a loved one.”

He continued, “There are potential risks associated with these compounds. We can protect against a lot of those risks through the screening and preparation procedure in our medical setting. About 30 percent of our people reported some fear or discomfort arising sometime during the experience. If individuals are anxious, then we might say a few words, or hold their hand. It is really just grounding them in consensual reality, reminding them that they have taken psilocybin, that everything is going to be alright. Very often these short-lived experiences of psychological challenge can be cathartic and serve as doorways into personal meaning and transcendence.”

Dr Charles Grob, the principal investigator on the UCLA study reported similar results, “Psilocybin facilitates a greater likelihood of achieving a psycho-spiritual state of consciousness — a mystical kind of experience. The old research literature from the 50’s and 60’s very strongly indicated that individuals in psychedelic research studies, who experienced a spiritual epiphany during the course of their many hour treatment sessions, were more likely to have a long-term positive therapeutic outcome.”

Why does psilocybin appear to efficacious, while modern pharmaceutical efforts are largely ineffective?

Dr. Griffiths explains, “Psilocybin acts very selectively at serotonin-2A receptors, which are a neurotransmitter that promotes positive feelings. Acting like a ‘lock and key’, so psilocybin can click in to this receptor site and activate a variety of processes.” With all of the classical psychedelics; LSD, psilocybin, mescaline; the thing that they have in common is that they activate serotonin-2A receptors.

Dr. Danforth added, “Sometimes when we are in a challenging situation in life, our thoughts can get stuck in a loop. Negative thoughts just continue and continue and continue and psilocybin in a therapeutic setting can function like a big hand coming in and jiggling the needle on a skipping record, so that a tune can resume.”

Yet another study — this one conducted by NYU Langone Psilocybin Research Project — examined the effects of psilocybin on the psychosocial distress with patients with advanced cancer. This trial was led by Stephen Ross, M.D. and Anthony Bossis, Ph.D. Their study included 29 patients facing end-of-life. In their sessions, subjects were either given either a moderate dose of psilocybin or a placebo (niacin), cross-switching to the other after about seven weeks after the first session. Findings were very similar to the studies at UCLA and Johns Hopkins. They found that psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression leading to decreases in cancer-related demoralization and hopelessness, improved spiritual well being, and an increased quality of life. At the six-month follow-up, psilocybin was associated with enduring anxiolytic and antidepressant effects.

The NYU researchers further reported sustained benefits in existential distress and quality of life, as well as improved attitudes towards death.

There is growing anticipation that psilocybin could be rescheduled and open up further opportunities for psychedelic research. Decriminalization of psilocybin is going to the voters in the city of Denver on May 7.

“I look forward to a day, that if it were clinically indicated to be able to offer that service to certain clients,” Dr. Danforth said. “Expanded access is not available yet; no one in the United States is able to legally work with Schedule I substances in a clinical setting,”

She continued, “It’s possible in the near future that some in the MDMA (ecstasy) world we will have expanded access for PTSD therapy. It’s hard to anticipate what’s going to happen with MDMA and psilocybin, but I don’t think it’s going to happen overnight. Everybody’s kind of waiting to see what happens in Denver and what that’ll mean… There are a ton of opportunists rushing in trying to make a buck, but in terms of real clinical work, that process moves at a snail’s pace, as it should.”

I asked Dr. Danforth on additional prospects for psychedelic-assisted psychotherapy. “My private practice is almost exclusively adults on the autism spectrum and some of them have very severe social anxiety and MDMA would be a real powerful clinical tool.”

She continued, “Others are very interested at looking at psychedelics for the betterment of well people. Two streams of effort working here — treating people that are unwell or providing guidance for those that are well, like we have been doing for thousands of years. They may have spiritual reasons for altering consciousness. It’s not all about getting a competitive edge in Silicon Valley, but it’s about how do we make our community healthy. For me it just happens to be the healing aspect. For people that are really suffering is where my interests lie.”

So what are the most promising areas in psilocybin research?

“Two of the most promising areas are Palliative Care; reducing the stress near the end of life and addiction studies,” Danforth replied. “I’ve always been really fascinated with the smoking cessation studies at John Hopkins and with Michael Bogenschutz M.D. (NYU) studies on alcoholism. I think that was one of the most promising areas of study from the first wave of psychedelic research in the sixties. I’d like to see more funding and research around treating addiction.”

Danforth said it’s frustrating not being able to use all the tools she’d like when treating patients. “I feel a bit like a firefighter who’s still allowed to fight fires, but I just can’t bring my hose,” she said. “The answer isn’t, ‘well let’s just give everybody fire hoses,’ because a lot of people could be hurt in an uncontrolled setting. I hope that we can find a middle ground.”

Dr. Danforth advises, “Psilocybin was used as a sacrament for sacred rituals, with a lot of reverence, wisdom, tradition, and mentoring. I’m not sure we are grown up enough as a culture to just have widespread access.”

Dr Danforth’s associate on the UCLA study, Gurpreet S. Chopra, emphasized, “I think it’s kind of ridiculous to be a scientist and a doctor and not investigate and try to understand how we can use these tools in a Western Culture safely.”

I posed a similar thought to local clinical psychologist and founder of the Alaska Psilocybin Society, Dr. William Kerst. Dr. Kerst finds that psilocybin being a Schedule I substance to be ridiculous. “It clearly has potential medical benefit as demonstrated by the studies that are ongoing and not only is it not necessarily addictive, but it tends to be anti-addictive.”

“Working with the Alaska Psychedelic Society, I have had several patients that are struggling with end-of-life anxiety, which is one of the primary uses of psilocybin in some of these studies and they don’t have time for legalization efforts to get pushed through. They need relief and it looks like these substances may be able to do that, and right now we have to say, ‘no’ to these patients and that’s terrible. It’s heart-wrenching, honestly.”

Should you have further interest in investigating psychedelic substances, the Alaska Psychedelic Society is holding their monthly meeting on Saturday, April 27 from 2 to 4 pm at Uncle Leroy’s Coffee, located at 701 West 36th Avenue in Anchorage. Also visit the Society’s Facebook page to keep updated on future meetings as well as recent studies and articles regarding psychedelics.

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Patients in end-of-life care to be treated with magic mushrooms

A spokeswoman for Palliative Care Australia said anxiety is a common and distressing symptom for those entering the final stage of their life.

By Benjamin Ansell

Palliative care patients will be treated with the psychoactive ingredient in magic mushrooms in a bid to reduce their anxiety during end of life care.

The first of 30 patients in Melbourne’s St Vincent’s Hospital trial will be treated with psilocybin in April after a year-long battle to have the study approved by the ethics committee, as well as state and federal authorities.

Patients will be given a single dose of the psychedelic drug, which stimulates feelings of euphoria and is believed to be able to ease anxiety, fear and depression for up to six months.

Applicants will be screened, requiring a state government permit to take the medication, and will be closely monitored by two clinicians on the ‘dose day’ while the initial high wears-off.

“With therapists in the room providing therapy it will allow people to have a heightened awareness of their situation, see the problem and work through it,” Mark Bowie, director of Palliative Medicine at St Vincent Hospital, said.

St Vincent’s clinical psychologist Dr Margaret Ross said patients in the study will be given a single dose of the drug in capsule form.

A similar trial conducted at New York University found 70 per cent of patients later reflected on the psilocybin experience as one of the top five most spiritually significant experiences of their entire lives, while 87 per cent reported increased life satisfaction overall.

Vice President of Australia’s Psychedelic Research In Science and Medicine Association Dr Stephen Bright told 9News that the study “sets a precedent” for more research into the medical application of psychoactive substances.

Patients will be treated with the psychoactive ingredient in magic mushrooms.

“I think it’s fantastic this study has been able to obtain the requisite approval, there have been multiple attempts to use psychedelics which have all been knocked back,” Dr Bright said.

“The fact that this has been able to secure approval is very encouraging.”

Dr Bright, also a senior lecturer at Edith Cowen university, is currently attempting to secure funding and ethics approval for another study on the potential of MDMA to be used in the treatment of Post-Traumatic Stress Disorder.

A spokeswoman for Palliative Care Australia told 9News.com.au anxiety is a common and distressing symptom for those entering the final stage of their life.

“This can be triggered by concerns and fears about how they will die, how their families and loved ones will cope as well as existential or spiritual concerns,” the spokeswoman said.

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