Death and psychedelics

— How science is reviving this ancient connection

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In November 1963, the writer and psychedelic explorer Aldous Huxley laid in bed, unable to speak. He was dying of cancer. One of his final acts was to pass a handwritten note to his wife Laura. 

His famous last words: “LSD, 100 µg, intramuscular.”

It was Huxley’s dying wish: a large dose of acid, please. Laura Huxley fulfilled the request twice during her husband’s final hours.

First synthesized 25 years before Huxley’s death, LSD was still legal in 1963. Scientists were studying it as a potential treatment for alcoholism and other ailments, as well as investigating its similarity to other psychedelics. It wasn’t until 1968 that the federal government outlawed these drugs due to their association with the cultural turbulence of the 1960s.

Today, several decades later, terminal cancer patients are once again taking psychedelics. This time around the drugs are being administered by doctors and scientists in controlled settings—and they are not microdoses. The results of this research have been nothing short of remarkable.

Laura Archera Huxley, 40-year-old musician and filmmaker, and husband Aldous Huxley, 61-year-old British novelist, pictured at their Hollywood home in Hollywood in 1956. On his deathbed seven years later, Huxley asked his wife for a massive dose of LSD.

Alleviating anxiety and despair

Terminal patients often suffer from feelings of intense anxiety and despair after receiving their diagnoses. For many, this is just too much to bear. The overall suicide risk for these patients is double or more compared to the general population, with suicide typically occurring in the first year after diagnosis.

Terminal patients have twice the suicide risk of the general public. Psychedelics may help reduce their fear and suffering.

That’s where psychedelic therapy may help. After a single large dose of psilocybin, taken in a curated space and supervised by a pair of doctors, many patients report feeling reborn. It’s not that the underlying physical disease has been cured. Rather, the drug prompts a shift in the theme of their emotional self-narrative—from anxiety and despair to acceptance and gratitude.

It may seem curious to think about psychedelic drugs, often associated with hippies and the Grateful Dead, as clinical-grade tools for overcoming our primordial aversion to death. But maybe it shouldn’t be. Maybe this is only surprising if your window of historical perspective is too narrow. Maybe these “novel findings” are, in a sense, a return to somewhere we’ve been before.

Psychedelics at the dawn of civilization

In late 2020 I spoke to Brian Muraresku, author of The Immortality Key: The Secret History of the Religion With No Name, about the use of psychoactive plant medicine throughout antiquity. Our podcast conversation covers this history in more detail, but it’s clear that humanity’s relationship with psychoactive plants extends back at least to ancient Greece—if not further. It’s hard to look at prehistoric cave paintings like the Tassili mushroom figure and not wonder if psychedelics played a part in their creation.

Western philosophy may have developed with help from psychedelics as well. In Plato’s well-known allegory of the cave, a group of prisoners live chained to a cave wall, seeing nothing but the shadows of objects projected onto it by fire. The shadows are their reality; they know nothing outside of it. Philosophers, Plato states, are like prisoners freed from the cave. They know the shadows are mere reflections, and they aim to understand deeper levels of reality.

Plato’s philosophical ideas might have been influenced by psychedelic experiences.

Was Plato tripping?

If that sounds like someone who’s explored those deeper levels with psychedelic assistance…well, maybe it was. In his book, Brian Muraresku explores the significance of the Eleusinian Mysteries, secret ceremonies that involved death and rebirth. For centuries, philosophers and mystics traveled to the Greek town of Eleusis to partake in a ritual that involved an elixir known as pharmakon athanasias, “the drug of immortality.”

“Within the toolkit of the archaic techniques of ecstasy–plant medicine just being one among many–something you find again and again, in Ancient Greece and other traditional societies, is this sense that to ‘die’ in this lifetime, or achieve a sense of timelessness in the here and now, is the real trick.” -Brian Muraresku

Contemporary archaeologists, digging outside Eleusis, have unearthed ancient chalices containing a residue of beer and Ergotized grain. Ergot is a fungus that grows on grain. It produces alkaloids similar to LSD. It’s possible, then, that influential thinkers like Plato were inspired by genuine psychedelic experiences.

This connection between psychedelics and death didn’t end with Eleusis. It survived, often repressed and hidden from view, right through the time of Aldous Huxley.

The connection re-emerges in the 1960s

In the 1960s, Timothy Leary co-wrote a book called The Psychedelic Experience: A manual based on the Tibetan Book of the Dead. Leary, the exiled Harvard professor and psychedelic guru, dedicated the book, “with profound admiration and gratitude,” to Aldous Huxley. It opens with a passage from The Doors of Perception, Huxley’s essay on the psychedelic experience. Huxley is asked if he can fix his attention on what the Tibetan Book of the Dead calls the Clear Light. He answers yes, “but only if there were somebody there to tell me about the Clear Light.”

It couldn’t be done alone. That’s the point of the Tibetan ritual, he says: You need “somebody sitting there all the time telling you what’s what.”

Huxley was describing a trip sitter, someone who guides a person along their psychedelic journey. Sometimes it’s an ayauasquero in the heart of the Amazon. Sometimes it’s a doctor holding your hand in a hospital.

Timothy Leary, shown at home in California in 1979, was deeply influenced by Huxley’s work.

Seeking rebirth within the mind

In his book, Leary grounded Eastern spiritual concepts in the understanding of neurology we had at the time. The states of consciousness achieved by meditation masters and those induced by three hits of Orange Sunshine, he wrote, may actually be the same. Both involve dissolving the ego (“death”) and allowing it to recrystallize as the default mode of consciousness returns (“rebirth”). 

Leary wasn’t talking about magic. Scientists know these as “non-ordinary brain states,” inducible by rigorous attentional practice (meditation), pharmacological intervention (psychedelics), and organic decay (dying).

The ability of psychedelics to induce these remarkable brain states may also be why they’re showing such promise in alleviating the very ordinary fear of death.

Today’s psychedelic treatments: Coping with death

So what, exactly, has recent research on psilocybin as an end-of-life anxiety treatment involved?

A few small studies have seen psilocybin administered to dozens of cancer patients. They’ve been conducted in a randomized, double-blind, placebo-controlled fashion. In general, a large majority of patients showed sustained, clinically significant reductions in measures of psychosocial stress and increased levels of overall well-being.

For example, in one study, 80% of the patients found that a single dose of psilocybin quickly relieved their distress. Remarkably, in some patients that positive effect lasted for more than six months.

Sprouting new physical connections

What’s going on at the neuronal level to produce those changes? We don’t know for sure, but some preclinical research has given us a hint. Both psilocybin and LSD have been shown to induce rapid and lasting antidepressant effects in lab animals.

Early studies hint at how psychedelics may produce positive changes in the brain.

Early indications are that psychedelics may allow brain circuits to rapidly sprout new physical connections. This is exciting, but again: These are non-human studies, and it’s early.

It’s gratifying to see any of these studies happening, frankly. This is research that’s been stalled by the Schedule I status of psychedelics for half a century. Much of this work requires obtaining a special federal waiver to study banned substances, which slows progress.

Potential help for end-of-life patients

Fortunately, the FDA recently designated psilocybin therapy as a “breakthrough therapy” and the DEA has proposed increasing the supply of psilocybin for research. This should speed up the rate at which we understand the clinical efficacy of psilocybin and related psychedelics.

Here’s more good news: In terms of psilocybin’s efficacy as a treatment for end-of-life anxiety, larger human trials are already underway.

Dr. Stephen Ross, one of the field’s leading researchers, has described the significance of this work: “If larger clinical trials prove successful, then we could ultimately have available a safe, effective, and inexpensive medication—dispensed under strict control—to alleviate the distress that increases suicide rates among cancer patients.”

Huxley: Ahead of his time

In one sense, Aldous Huxley was ahead of his time. More than a half-century before today’s renaissance in psychedelic research, his own experiences had evidently brought him to the conclusion that the best way to experience death was in a psychedelic trance.

In another sense, though, Huxley was one in a long line of creators stretching back to ancient Greek philosophers and perhaps even to prehistoric cave artists. They may all have used psychedelics to catalyze their outward creativity and comfort their inner distress.

Huxley titled his famous introspective essay, The Doors of Perception, after a quote from the English poet, William Blake: “If the doors of perception were cleansed everything would appear to [us] as it is, infinite.”

We will never know what he experienced in the final hours before his death, after handing that note to his wife. I like to think that for him, the last breath seemed to last forever.

Complete Article HERE!

‘The End In Mind’ Conference Answers Questions About Psychedelics For End-Of-Life Patients

By Benjamin Adams

As they say, “memento mori.” The end is inevitable to all of us, but we have tools available to provide comfort—even in death. With psychedelics’ growing promise in therapies for trauma and grief, there are endless questions. Take the similarities between near death experiences and psychedelics, for instance.

End Well recently announced it will host “The End in Mind,” the largest-to-date annual virtual conference dedicated to the future of psychedelic medicines in care for people facing serious illness or end-of-life situations, taking place on October 14.

The conference will include panelists such as Melissa Etheridge as well as Dream Corps founder and political commentator Van Jones, along with a roster of healthcare, policy, culture, business and psychedelic leaders.

Conference tracks will cover psychedelic medicines and their uses—from Indigenous practices to recent clinical trials—and the current and future role of psychedelics in care for serious illness, grief and end of life. The science behind psychedelic drug development will also be pored over in detail.

End Well Founder Dr. Shoshana Ungerleider, MD, said that psychedelics could be a “paradigm shift in modern medicine,” creating new possibilities for end-of-life patients.

The event is sponsored by Palo Santo, a U.S.-based psychedelic investment fund that recently launched with $35 million in capital raised and an active portfolio of 20+ companies. Daniel Goldberg, cofounder of Palo Santo will be among the panelists, discussing the opportunities and concerns about the future of psychedelic medicine for people seeking to improve the quality of life at the end. Goldberg founded the diversified venture fund last year with Tim Schlidt and Tony Eisenberg. He noted the variety of voices that are expected this year.

“Our panel at this year’s End Well annual symposium is made up of an interdisciplinary group of professionals that are all psychedelic medicine advocates but with very different perspectives: Dr. Jerry Rosenbaum, Director of Harvard Mass General’s new Center for the Neuroscience of Psychedelics; Dr. Julie Holland, a renowned psychiatrist and psychopharmacologist who has been an advocate in the space for decades; and Shelby Hartman, a talented journalist who founded DoubleBlind, a media business focused on psychedelics,” says Goldberg.

The conference will provide interactive breakout sessions to answer questions and provide a deep-dive into the cultural, regulatory and industry shifts. “The four of us have very different vantage points yet all of us have unique exposure to the psychedelic private sector,” Goldberg says. “We will be exploring the rapid pace of innovation happening in psychedelics and what we are most excited about (and concerned about).”

Also on the panel will be Rick Doblin, Ph.D., American drug reformist, advocate and the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS) as well as Ira Byock, MD, a leading palliative care physician; and Patricia James, Cheyenne pipe carrier, among others.

The conference will also investigate the stigma attached to psychedelics. “Finally, we seem to be moving past the stigma around plant medicines,” said Etheridge, who tackled tragedy and cancer, “and into a whole new era of understanding that will hopefully enable more of us to experience the benefits of these powerful medicines—especially in the most dire times of need when we are confronting illness, grief, mortality, existential fear and death.”

The conference is also sponsored by Reset Pharma, biotechnology company Cybin, the first psychedelics company to be listed on the New York Stock Exchange; atai Life Sciences, a biopharmaceutical company aiming to transform the treatment of mental health disorders; and Microdose, a psychedelic-focused media platform.

“I’m also excited to share a bit about why our Psychedelic VC fund made a huge bet on Reset Pharma, which is developing and commercializing a novel psilocybin-based therapy to address mental health in patients with cancer and other life-threatening diseases,” Goldberg shares. “For its lead asset, the company is using the licensed research of Dr. Stephen Ross’ (NYU) seminal 2016 phase 2 clinical trial data. We believe this could help pave the way to change how we address end-of-life care as a society.”

Psychedelic medicines continue to evolve at a rapid pace. As a fund manager, Goldberg says he’s concerned when he sees valuations get bid up for certain early-stage psychedelic businesses that are based on hype. His fund, for instance, passed up on more than a few deals in the event that his scientific advisory board couldn’t get comfortable with the science—or lack of—behind some deals in the marketplace.

“We stay very focused on due diligence in order to assess a company’s ability to navigate the regulatory path and ultimately the likelihood of successful commercialization,” Goldberg says.

Based on Goldberg’s experience, not all of these psychedelic pharma startups are going to make it, regardless of the positive press they receive or the names on their board. “Clinical trials are incredibly expensive and while it might be easy for start-ups to raise $10-50 million, it’s tougher to come up with $100-300 million for trials unless you have the right product and team, as well as validating investors that have access to downstream capital,” he says.

Given that psychedelics were stigmatized for so many decades, Goldberg stressed the need for a focus on the science.

“Unless we can continue to prove safety and efficacy, doctors will be slow to move patients off of SSRI’s and give these new treatments a go,” Goldberg said. “Ultimately, we hope that patients will be able to try psychedelic therapy before being put on SSRI’s, which are hard to get off of and often have nasty side effects. Currently, psychedelics are still often viewed as a “last resort” but I believe eventually they will become the standard of care for many indications. We need that to be the case in order for insurers to get on board, which is critical as it relates to affordability.”

If we truly want to make these new drugs and treatments accessible to more people, developers need to jump through the regulatory hoops. That process has already been put into motion, for some substances. “The good news is that, even though psychedelics might have a colorful history and backstory, the FDA doesn’t really see psilocybin and MDMA any differently than amoxicillin or penicillin, in the sense that they are just drugs that have to go through the same arduous process to get approved,” Goldberg says. “In fact, because some of the ‘generic’ psychedelics, like psilocybin, have been around so long and have been proven to be safe, they have been granted ‘breakthrough therapy’ designation, which speeds up the process.”

Currently, the Palo Santo fund is invested in more than 20 businesses across the psychedelic ecosystem—with a focus on biotech and drug development. Given the range of early-stage investment, Palo Santo will have the ability to lean into the most promising companies in our portfolio and support them with downstream capital as they progress. “We are also in tech and service businesses related to the space, and we see quite a bit of cross pollination within our portfolio,” Goldberg says.

“We have a very exciting pipeline of opportunities centered around ‘2nd and 3rd generation’ psychedelic compounds,” he adds. “The innovation, accelerated by the incredible scientific talent jumping into psychedelics, is astounding. We see ample room for improvement in psychedelics and do not subscribe to the point of view that innovation is at odds with the broader psychedelics movement.”

Goldberg says it’s possible to respect the rich history of plant medicine while also supporting legalization measures at the same time. By investing heavily in the private sector, it’s possible to achieve improved versions of MDMA, LSD and create new chemical entities.

Psychedelic experiences vary widely, especially when used improperly. There is a vast range of intentions. “I want everyone who wants to go on an expensive ayahuasca retreat to Peru to do so, but I also want safe, prescription drugs—that are reimbursed by insurers—available to those who are more comfortable with that route. We need to meet people where they are with all of this,” Goldberg says.

The End in Mind will take place on October 14, from 11:45am to 5:00pm EDT/8:45am to 2:00pm PDT. Registration is free until September 26. It’s free and open to the public.

Complete Article HERE!

Can Psychedelics Help Make Dying Easier?

“I need to be in a space where I am not hopeless,” says one terminal cancer patient who is suing the Justice Department and the DEA for her right to use psilocybin

By &

Erinn Baldeschwiler had already been having a rough go of it. A mother of two teens, she was going through a divorce, moving out of her house, and splitting from her business partner all as the severity of the Covid-19 pandemic was becoming a reality. Amid it all, she was diagnosed with stage four, triple-negative metastatic breast cancer. The doctors told her that even with chemotherapy every week — something which she knew would severely impact her quality of life — and immunotherapy every two weeks, she likely had about two years to live.

“It was devastating,” says Baldeschwiler, 49. “I thought, what if I’m not going to be here for my kids? A dear friend passed very suddenly, unexpectedly from cancer a few years back and I just know the pain that it leaves behind. It was really, really heavy.”

Now Baldeschwiler, along with Michal Bloom, another cancer patient diagnosed with stage 3 ovarian cancer in 2017, their palliative care physician, Dr. Sunil Aggarwal, and his clinic, AIMS Institute, are suing the Department of Justice and the Drug Enforcement Administration. Baldeschwiler and Bloom want to try psilocybin, the psychoactive component in psychedelic mushrooms, in a therapeutic context for what’s sometimes called “end-of-life distress,” depression, anxiety, and other mental health challenges that can come along with a terminal diagnosis. 

Kathryn Tucker, one of seven attorneys on the case, says Baldeschwiler and Bloom have the right to access psilocybin under Washington state’s Right to Try law, a law which permits patients with a terminal illness to access drugs that are currently being researched, but not yet approved. The federal government, she says, is wrongfully interfering with that right.

According to Tucker, who has devoted much of her career to helping pass and reform legislation meant to ease the suffering of those at the end of their lives, states are the primary authority for the regulation of medicine. And yet, in January, Tucker says, when she wrote to the Drug Enforcement Administration, on behalf of  Aggarwal, Baldeschwiler, and Bloom, asking them how they should go about accessing psilocybin, the administration wrote back saying they couldn’t because psilocybin is a Schedule I drug on the Controlled Substances Act, the most restrictive category defined as drugs with “no medical use” and a “high potential for abuse.” (Typically, physicians with terminal patients would go straight to a manufacturer to get access to a drug under a state’s Right to Try law, but they needed to write to the Drug Enforcement Administration about the process for access since psilocybin is federally illegal.)

In addition to Washington state, 40 states have Right to Try laws, although they’re all worded slightly differently. (Some use language like “terminally ill” while others say “life threatening,” which could change who qualifies.) Overlaid on top of these state Right to Try laws is a federal Right to Try law, which President Trump signed in 2018. In this case, Tucker and the fellow attorneys are primarily focused on patients’ rights under Washington’s Right to Try law, but are using the federal Right to Try law to bolster their argument.

Both the Washington law and the federal law state that terminal patients can access drugs that are not yet approved by the Food and Drug Administration so long as they’ve successfully made it through the first phase of an FDA-approved clinical trial and are currently being investigated. Psilocybin is currently in the final phase of research before FDA approval, and has shown so much promise for treatment-resistant depression and major depressive disorder that it’s been granted “breakthrough therapy” status by the FDA.

“The DEA just did not know about or did not understand Right to Try and this lawsuit is something of an educational vehicle,” Tucker says. Yes, she says, psilocybin is on the Controlled Substances Act, but in the hierarchy of legislation, The Federal Food, Drug, and Cosmetic Act, which Right to Try falls under, trumps the Controlled Substances Act. Tucker says DEA officials just don’t understand that or are behaving as though they don’t. (The Department of Justice declined to comment for this story.)

“I don’t want my diagnosis to be upsetting and dark and hopeless for my kids,” says Baldeschwiler. “So I need to be in a space where I am not hopeless and there is peace. I know for certain if I’m negative and ‘woe is me,’ and desperate and have feelings of like ‘I just want to check out,’ that’s going to make it a hundred times worse.”

Baldeschwiler first got the idea to do psychedelic-assisted psychotherapy from Aggarwal, who she’d found after looking around for more holistic treatment plans in the Seattle, Washington area. Aggarwal discovered what he says is the extraordinary potential of psilocybin to help cancer patients when working with the psilocybin research group at New York University.

Researchers, going back to the late 1950s, found psychedelics such as psilocybin and LSD showed promise for end-of-life distress as well as a host of other mental health conditions, from alcoholism to trauma. Much of this research, however, is not considered valid by the Food and Drug Administration because it did not follow their current protocols.

After Richard Nixon signed the Controlled Substances Act into law in 1970, there was essentially a decades-long ban on psychedelic research. It was a landmark study, published in the Journal of Psychopharmacology, in 2006 — showing psilocybin holds promise for end-of-life distress in cancer patients — that largely jumpstarted what’s now known as the “Psychedelic Renaissance,” the second wave of psychedelic research in the U.S. since the 60s. The study found that after two or three psilocybin sessions, a majority of participants had significant and positive changes in their mood, while 33 percent rated the experience as the most spiritually significant experience of their life, comparable to the birth of a first child or the death of a parent. Since then, this research has continued with the same results in trials at Johns Hopkins and New York University.

“Many, many patients come to me wanting this,” says Aggarwal of psilocybin-assisted psychotherapy. “They read about it in the news or in Michael Pollan’s book.” He says it’s hard to predict, but there’s surely millions of terminally ill patients who could benefit from psilocybin therapy. In 2021 alone, an estimated 1.9 million Americans will be diagnosed with cancer, according to the National Cancer Institute. That doesn’t even take into account, says Aggarwal, all the other terminally ill patients, such as those with Lou Gehrig’s disease, whom he also works with.

Susan Patz, a 62-year-old woman with Lou Gehrig’s disease, filed an Amicus brief, a statement which can be filed to the court by someone in favor of a particular side of a case, for this lawsuit. Patz lives in the town of Monroe, Washington, where her husband John is now her caretaker as she slowly loses agency over her body and even her ability to breathe and swallow. 

“Because of the ALS, I have had to give up a lot of the activities I was passionate about,” she wrote to the court in a brief filed on May 24th. “I loved gardening, and I used to delight in driving the tractor around our property. I loved to swim at the YMCA five days a week. I loved cooking and trying new recipes. I can no longer do any of those things.” She often stays up until 3 or 4 in the morning, because she can’t sleep; she used to be “foodie,” but now doesn’t want to eat or even see friends for fear that they’ll see her as a “sick person.”

“I am desperate to try something that will work, something that will enable me to experience joy and pleasure again,” she wrote to the court. “If the Right-to-Try laws don’t allow someone like me the chance to try something that may help alleviate my suffering, then what good are they?”

On June 21st, the Department of Justice will file a brief on behalf of the Drug Enforcement Administration. On July 12, the petitioners — Aggarwal and his patients — will be given the opportunity to reply. And then, likely in September, the oral argument will take place in which, Tucker says, they may get their first insights into where the court stands on the case. She’s hopeful that perhaps they won’t even get that far, though, because the Drug Enforcement Administration will reach out with the intention of finding a resolution.

Either way, Tucker says, if the case passes, the next doctor and patient who want access to psilocybin for end-of-life distress shouldn’t need to take it to court again. If they succeed in Washington, then, she says, doctors and patients in states with Right to Try laws should be able to access psilocybin.

There’s many unknowns, however, about how doctors and patients would go about notifying the DEA when they’re going to conduct psilocybin therapy — and how they would access the psilocybin itself. Currently, under Right to Try laws, doctors don’t need government approval at all — they can go straight to manufacturers to request access to a drug that’s under investigation for their patient. But the process might be different for psilocybin and a host of practical issues exist, too, such as that it’s difficult to find federally-licensed labs making synthetic psilocybin as there’s no publicly available directory. At this point, Tucker says, they’re just focused on taking things in “small bites.”

“It kind of kills me that I have to be dying to even possibly have access to this medicine when I think it could be incredibly helpful for so many people that maybe don’t fall into that category,” says Baldeschwiler. “I truly, truly am hoping that we have some open minds and open hearts with regards to the DEA and that they honor the intent and the letter of the law because we fall within it.”

Complete Article HERE!

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.”

Complete Article HERE!

What if psychedelics could revolutionize the way you die?

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My story begins eight years ago, when I was approached by my first client requesting that I supervise her in a therapeutic session with a psychedelic medicine.

She had debilitating depression and anxiety brought on by a breast cancer diagnosis. Although she had survived her cancer, she couldn’t shake her terrible emotional distress. She had tried therapists, pills and a residential program. Nothing had worked.

Then she came across stories in the media about research at UCLA using psilocybin (the active ingredient in magic mushrooms) with cancer patients suffering from what was called “end-of-life distress” and how this new treatment was showing really promising results.

She was desperate to try it for herself.

Well, as a licensed therapist and academic, could I help this woman? Reading the research literature, I learned that psychedelic research was becoming well-developed as a treatment for the psycho-spiritual depression and “existential anxiety” that often accompany the diagnosis of a life-threatening illness.

I also found myself in a bind: The science was telling me that psilocybin is the treatment most likely to benefit patients with existential anxiety when other treatments have failed; my ethical code from the B.C. Association of Clinical Counsellors tells me to act to my client’s benefit; federal law forbids me to use this treatment.

This is why, together with colleagues in the Therapeutic Psilocybin for Canadians project, I filed an application with Health Canada in January 2017, seeking a so-called “Section 56 exemption” — to permit us to provide psilocybin-assisted psychotherapy to patients with terminal cancer.

Immediate decrease in death anxiety

Dinah Bazer found relief from cancer anxiety by being treated with a dose of psilocybin administered by a New York University study.

Recent research at Johns Hopkins Medical Centre and New York University indicates that treatment of this end-of-life distress with psilocybin-assisted psychotherapy is safe and effective.

The research indicated it led to immediate, substantial and sustained decreases in depression, death anxiety, cancer-related demoralization and hopelessness.

It resulted in increased quality of life, life meaning and optimism. And these changes had persisted at a six-month follow-up.

Patients attributed improved attitudes about life and death, self, relationships and spirituality to the psilocybin experience, along with better well-being, life satisfaction and mood.

It is heartening to see research moving into Phase 3 clinical trials that will involve many more research participants. However, the foreseeable future for Canadians who need this game-changing therapy is not especially rosy.

At our current rate of progress, it may well still be years before psilocybin successfully completes Phase 3 trials and becomes available as an orthodox medicine.

Therapists risk criminal penalties

In the meantime, many Canadians with terminal cancer are also suffering from end-of-life distress, and are in dire need of relief — now.

They face serious and life-threatening illness. Their condition is terminal, so concerns about long-term effects of psilocybin are not relevant. They suffer from serious end-of-life psychological distress (anxiety and depression) to the point that it interferes with their other medical treatments. And this distress has not successfully responded to other treatments.

Psilocybin is currently a restricted drug, meaning that therapists risk criminal penalties if they aid or abet its possession. That means that we cannot recommend or encourage its use.

My professional Code of Ethics, however, states that our ethical duty is to act in a way that serves our clients’ “best interests.” The service we provide has to be “for the client’s benefit.” We must “take care to maximize benefits and minimize potential harm.”

A compassionate, humanitarian death

I agree with the Canadian medical establishment that, in ordinary circumstances, new medicines should be made available to Canadians only when they have successfully completed Phase 3 clinical trials.

In the New York University study a pill, containing either a placebo or psilocybin, was presented to the subjects in a chalice.

But I contend that the patients described here are not in ordinary circumstances. They have terminal cancer. All other treatments have failed them; they have nothing left to lose. They have the right to die; surely they have the right to try!

These patients deserve access to a still-experimental but promising medicine on compassionate and humanitarian grounds. Because of their extraordinary medical straits, psilocybin now for them represents a reasonable medical choice; it is necessary to them for a medical purpose.

Our application to Health Canada seeking a “Section 56 exemption” will be ruled on very shortly.

We fully expect that it will be denied — for political, not scientific reasons. Justin Trudeau’s Liberal government is likely in no mood to loosen up on psychedelics before the dust from the legalization of cannabis has fully settled. I think the government would like it if someone else made that decision.

Violation of our rights and freedoms

If our application is denied, we intend to file for a judicial review, and if necessary, a lawsuit in Federal Court challenging that denial.

We believe that prohibition of access to psilocybin for a legitimate medical purpose violates a citizen’s Canadian Charter of Rights and Freedoms Section 7 right to “life, liberty and security of person.”

This clause has already been interpreted by the Supreme Court to imply that a citizen has the right to autonomy in making health-care decisions. Charter-based arguments have already led to success in three recent landmark medical cannabis cases.

We argue that what applies to cannabis also applies to psilocybin:

The prohibition of … cannabis “limits the liberty of medical users by foreclosing reasonable medical choices through the threat of criminal prosecution. Similarly, by forcing a person to choose between a legal but inadequate treatment and an illegal but more effective one, the law also infringes on security of person.” Supreme Court of Canada, R. v. Smith, 2015

One thing that unites all of us human beings is that we will die. Imagine if, when our time comes, we could all have the option to die peacefully, with acceptance, without anxiety.

Complete Article HERE!