FDA Gives Psilocybin Clinical Studies Breakthrough Therapy Status
The FDA recognized psilocybin, the psychoactive compound in magic mushrooms, with “Breakthrough Therapy” designation for clinical trials studying its use for treatment-resistant depression by a company called Compass Pathways. The group plans to treat patients in Europe and North America over the next year in placebo-controlled studies to determine proper dosage and treatment methods.
Since hallucinogenic drugs were given Schedule I designation in 1966, psilocin and psilocybin have been villainized by the media and politicians who claim it has a high potential for abuse and no medical application. But recent studies from esteemed research institutions, including Johns Hopkins and London’s Imperial College, have helped ease misconceptions and stigma surrounding the drug, and now government regulatory bodies are seeing its potential.
Compass Pathways, a life sciences company founded in 2016 whose focus is to “accelerate patient access to evidence-based innovation in mental health,” specifically through research with psilocybin, was given the go-ahead by the FDA back in August, but the recent designation was an unexpected acknowledgment, according to some of those involved in its research.
According to the FDA, “Breakthrough Therapy” means it reviewed the findings of researchers it granted use of the drug to and viewed their results as:
“Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”
Once this designation is given, the FDA expedites the development and review of the drug, hopefully allowing medical professionals to soon begin implementing it as a legal, viable treatment and eventually change the scheduling of the drug.
Dr. Roland Griffiths, one of the foremost researchers in government-sanctioned studies of hallucinogenic drugs, told Inverse he’s hopeful the regulatory approval will change, though he doesn’t envision it becoming available from a pharmacy anytime soon, if ever.
Griffiths and his colleagues have mostly advocated for its use in controlled settings with guided sessions from a trained psychologist. He’s also stated he believes it can be a dangerous drug when taken by those with certain pre-existing mental illnesses, notably schizophrenia.
But now that studies have shown psilocybin to act as a “reset mechanism” in the brain for those suffering from severe forms of depression, this latest recognition from the FDA may allow psilocybin treatment to become available for those desperately needing it. This breakthrough may also pave the way for FDA trials with other psychedelic substances, such as LSD, currently studied by Griffiths and others in his field.
For more on Dr. Roland Griffith’s and other cutting edge work studying clinical treatments with psychedelic substances, check out this episode of Psychedelica:
About the Author
Comic Bill Hicks' Excellent Inter-Dimensional Adventure
Comic Bill Hicks was described as “irreverent, outrageous, shocking, angry,” and “genius.” He loathed media-entrained helplessness and consumerism, referring to America as the “United States of Advertising.” Called the “comedian’s comedian” by critics, Hicks performed in the U.S., U.K., and Australia until his death in 1994 at age 32.
But the adjectives above cannot fully describe Hicks, who waged war on the cultural trance, calling for a new, awakened consciousness. He was a rock n’ roll Gabriel on the razor’s edge, trumpeting a vision of a vast, human evolutionary shift. Look and listen between the lines and other descriptors will come to mind; “visionary,” “prophetic,” and yes, “dimensional traveler.”
One of Hicks’ alter egos, “Goat Boy,” was a startling stew of Pan, Dionysus, Bacchus, and any hedonistic diety you can think of. Goat Boy was the comic gestalt of Hicks’ libido — seriously explicit, but paradoxically wise and child-like. Gerald Nachman, the San Francisco Chronicle theater critic wrote, “However rough he gets, I felt my head opened up by Hicks. He’s not everyone’s cup of chicory, but If you like your comics witch’s brew-strong, Bill Hicks is the wit of choice.”
Harmonic Convergence 1987
As a teenager, Hicks and his friends discovered psilocybin mushrooms as a tool for spiritual insight. From an even earlier age, Hicks had explored eastern meditation traditions and subjects in the “Course in Miracles” genre. He earnestly and sincerely sought enlightenment, say his surviving friends. And he believed unshakably in UFOs and multi-dimensionality.
Laser-focused on a career as a comedian, Hicks began sneaking out of his parent’s house to perform in a Houston comedy club at age 14. By 1985, he was established as the leader of the pack of the Houston comedy scene. Hicks was living like a rockstar; drugs, alcohol, wild parties, etc., and over the next few years, he fell into addiction and behaviors that impacted his career and was losing credibility as an artist and performer.
“Bill knew he needed to get sober. From a career standpoint, it became apparent he needed to turn things around,” wrote friend Kevin Booth in his book. But according to Booth, now a filmmaker and producer, the 1987 Harmonic Conversion event was the turning point. The event was organized by author Jose Arguelles, the Aug. 16, 1987 date was chosen because of planetary alignments and the Mayan calendar. Hicks, Booth, and another friend prepared days in advance with meditation and clean diets.
