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Bye Bye, Prozac! FDA Approves Psilocybin for Depression Clinical Trials

Here’s another great news that shows the times, they are definitely a-changing: The FDA has granted Compass Pathways –“a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health”– a license to conduct what is said to be the largest clinical trial involving psilocybin (the psychoactive ingredient found in ‘magic mushrooms’) in which 216 patients with treatment-resistant depression will be given the compound combined with psychological support. The phase-2 trial will be conducted across 12 to 15 research sites in North America and Europe, and was said to start in the U.K. by the end of this month –regulatory approvals for the trial have already been given in the UK, the Netherlands and Canada.

Tracy Cheung, from Compass Pathways, told Newsweek the clinical trial will be the largest ever conducted into psilocybin therapy.

“If our studies are successful, we could be applying for marketing authorization in two to three years,” she said, describing depression as “a huge unmet need with 300 million patients worldwide; 100 million of these have treatment-resistant depression and don’t respond to existing treatments.”

With one in six Americans taking some sort of antidepressant, according to NBC news, to say this study is long overdue is the understatement of the century. Incidentally, almost exactly one year ago we also reported on how MAPS had also achieved a huge milestone by obtaining another FDA license to conduct phase-3 trials for MDMA-assisted therapy –MDMA, popularly known as ecstasy, has been shown to be incredibly helpful in the treatment of veterans suffering from post-traumatic stress disorder.

There’s a reason why psilocybin and MDMA have become the ‘weapon of choice’ for these type of clinical trials, and that is because they don’t carry the stigma of other psychoactive substances (like LSD or ketamine), even though people who regularly ingest doses of LSD so small they do not elicit any kind of psychedelic state –what is popularly known as “microdosing”— for its purported potential to increase creativity, also report an improvement in their mood. For the time being, though, it seems as if MDMA and psilocybin will be the ‘trojan horses’ that will help vanquish the current anti-psychedelic paradigm, paving the way for other substances like LSD, Ayahuasca and Ibogaine.

Because, at the end of the day, it seems the chemical is NOT the real healer, meaning it doesn’t really matter what kind of compound you take. What matters most is the kind of ‘set and setting’ you manage to prepare for the patient, so they can attain that ‘entheogenic state of consciousness’ (safely!) in which they will be able to heal themselves. This not only would defuse the dreams of all who only want these chemicals to be legally available to anyone, but it would undoubtedly require a major overhauling of our current medical infrastructure, and the way Big Pharma conducts business.

In this interview for the Tangentially Speaking podcast, Dennis McKenna talks precisely about that, and speculates on how pharmaceutical companies could shift from a drug-selling model to a more holistic one: He envisions the kind of spa-like treatment centers that are already beginning to appear in countries like Costa Rica, in which patients would go for a weekend to get the psychedelic under the supervision of a trained counselor, who would also provide advice with regards to nutrition, exercise, etc –alas, those kind of centers remain only accessible to wealthy individuals; but that could change once psychedelics attain full legalization for therapeutic purposes.

Regardless on whether Pfizer will be able to make that shift once Prozac goes the way of bloodletting and trepanation, what is clear is that the end to the War on Drugs is short at hand, and ours will no longer be the only human civilization which demonizes psychedelics –whereas others always regarded them as the greatest gifts from the gods. Who knows? Perhaps as a bonus these chemicals will also help us prove once and for all our brains do not generate consciousness, but only mediate it  –of course, once that happens we’ll sure need all the mood-altering drugs we can get, just to cope with the major paradigm change that will come crashing down on us…



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