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:
New Gene Discovery May Explain Rapid Human Brain Evolution
A revealing new study on human evolution and brain development has just been published. Could this lend credence to the stoned ape theory of brain evolution?
About 300,000-800,000 years ago the human brain experienced a massive and accelerated growth spurt. Scientists have offered many explanations for how and why this may have occurred, but a new study out of Boston Children’s Hospital focused on a fast-evolving set of the human genome called human accelerated regions (HARS). Previous studies have found about 3,100 HARS during brain development, but the team at Children’s Hospital determined one HAR gene PPP1R17 could be responsible for or play a significant role in, rapid brain development. Further, they discovered this works differently in humans than in other animals.
Ben Stewart, the host of Gaia’s Limitless series, said,”[T]hese regions of the human DNA may hold some kind of an answer at the rapid explosion of human neo-cortex because if you think of it evolutionarily, there’s not been one creature, at least on planet Earth, that has been studied that had any organ increase in size as large and as rapidly as the human brain did, so there’s definitely some unanswered questions there.”
“I’m pretty sure that these HARS regions are being looked at for something very unique in the evolution of the brain, and my own personal twist on it is this also might be important when we start looking at brian-machine interfaces and how the brain can potentially cause mutations to adapt to some kind of technology in the brain to enhance or evolve the human brain,” Stewart said.
How could this new discovery be related to the Stoned Ape theory?
“There’s a possibility that the Stoned Ape theory could lead into this. Now, the Stoned Ape theory was really popularized by Terence McKenna,” Stewart said. “Over time, you would have some of our ancient ancestors, hominids, that would be following behind bovine creatures, cows, and in the cow patties in the fields that would naturally, having followed these creatures around for hundreds of thousands of years or whatever it might have been, that they would have started eating the mushrooms, the psilocybin mushrooms that grow naturally in cow patties. These experiences tickling the language centers and other parts of the brain, bringing down the rigidity of the default mode network, and activating other communication hubs within the brain, that could actually explain the rapid explosion of the human neocortex.”
“In this article, they’re saying that these human accelerated regions act differently in humans than they do in primates or creatures like mice and ferrets that they’ve looked into now. So, potentially if there is some connection with the Stoned Ape theory, that psychedelics or psychotropics helped in the expansion of the human neocortex, and made us as, at least psychologically, so much different than the rest of the creatures on Earth, then there may be something to look at here.”