Posted by Hugh on March 11, 2022, at 12:57:15
The second coming of psychedelics heralds a new model of mental health treatment.
By Hara Estroff Marano
Psychology TodayIt's scarcely 2022, but mark your calendar for 2023. If all goes as many people and billions of investment dollars expect, the first treatment will be made available to do what no other has been able to accomplish -- peel away an intractable mental health disorder and do it without the need for a lifetime prescription.
It's not just that the prospect of a cure -- for PTSD -- centers on the use of a psychedelic agent, specifically MDMA, or 3,4 methylenedioxymethamphetamine, also called Ecstasy or Molly. If the dollars don't outdazzle the data and trigger a backlash, the possibilities include a brightened outlook for numerous psychiatric afflictions, a new way of delivering drugs, and pharmacology that comes with compassion.
Although medical interest in psychedelics flared in the 1950s and '60s, research and clinical use were forced underground in the '80s by criminalization statutes. But plant-derived hallucinogens such as psilocybin and mescaline have a long history of safe use, largely in traditional cultures, in ritualized release from the constraints of the prefrontal cortex.
Perhaps no person has done more to restore them and their synthetic siblings, including MDMA, to respectability than Rick Doblin, who founded the Multidisciplinary Association for Psychedelic Studies (MAPS) as a nonprofit pharmaceutical company in 1986 and then got a Ph.D. in policy administration at Harvard in order to make psychedelics mainstream-credible. Enamored of MDMA since trying it in college, Doblin recruited scientists, developed protocols for studying psychedelics, and compiled evidence until MDMA-assisted psychotherapy for PTSD was granted a rare Breakthrough Therapy Designation by the FDA in 2017. MDMA is expected to be the first true hallucinogen legally prescribable. Results from a first set of randomized, placebo-controlled Phase 3 clinical trials for safety and efficacy, the prelude to official new-drug approval, published last June in Nature Medicine, show that after three large doses of MDMA, with therapy, spaced a month apart, two thirds of patients no longer meet the criteria for a diagnosis of PTSD. Patients are still getting better a year after their treatment has stopped.
"This is the opposite of what happens with pharmaceuticals," says Doblin. "We think people learn how to process trauma. They don't run from intrusive memories or trauma triggers; they're able to work through them," he explains. Evidence shows that MDMA reduces hyperactivity in the amygdala and increases connectivity between the amygdala and the hippocampus so that memories can be processed and put into storage and the past doesn't constantly invade the present. It also releases oxytocin, boosting social reward areas of the brain.
Also in development around the world: ibogaine for treatment of cocaine and opioid addiction; MDMA for social anxiety and couple therapy; psilocybin and LSD for Alzheimer's and other dementias; DMT for stroke recovery. At the furthest edge of psychedelic research lies the hope that the drugs not only improve quality of life but actually extend it.
Persuasive evidence there'd be few regulatory obstacles to psychedelics, MDMA's "breakthrough" designation set off a gold rush: A whole psychedelic sector arose on financial markets, with about 400 for-profit companies angling for a niche by the end of 2021. They're bringing mushrooms to market, searching for patentable molecules, establishing clinic networks for treatment delivery, creating trippy media for clinical settings, and more.
One of the earliest, Compass Pathways, set on establishing psilocybin as with-therapy treatment for resistant depression, was the first psychedelic stock to hit $1 billion valuation after the company, backed by PayPal's Peter Thiel, went public in 2020. Thiel also put millions into starting Berlin-based Atai Life Sciences in 2018; it's now the biggest psychedelic player of all.
Between 2019 and 2021 alone, investors unleashed $3 to $5 billion, says venture capitalist Richard Skaife, who set up The Conscious Fund in 2019 to expedite what many expect to be a paradigm shift in mental health treatment -- the end of the "drug treadmill."
"The vast majority of people who have supported the psychedelic space so far," says Skaife, "are ultra-high-net-worth individuals who have had either a very negative experience with general health care after some trauma in the family or a positive interaction with psychedelics, usually in a nonmedical setting. We don't have to do a lot of convincing." Doblin says MAPS's roster of donors includes some of the wealthiest families in America -- Rockefellers, Buffetts, even a Koch. Skaife says he doesn't just deploy capital but identifies conditions for which there is scientific plausibility for psychedelic treatment, then breeds a business based on that.
The delivery -- under direct supervision by specially certified therapists -- remains as important as the drug. It's the intense psychotherapy that transforms MDMA, psilocybin, and other hallucinogens from an amusement (or a bad trip) into a medicine. Patients report that they get something deeply meaningful out of the altered consciousness -- a sense of unity, of connection. Therapy allows them to incorporate that into an enduring shift in identity and to build a better self.
That accounts for one of the liveliest areas of investment: setting up networks of cushy clinics to administer the anesthetic ketamine now while awaiting approval of MDMA and psilocybin. New York-based Nushama has staked out the Northeast and opened "journey centers" that mix luxe settings with psychedelic-inspired accoutrements. The journey psychedelics make possible is deep into the self, says medical director Steven Radowitz. "They free you of who you think you are and catalyze your own healing power." Private "journey parties" have become popular among the affluent, often inspiring psychedelic snobbery.
The "psychedelic space" now abounds with hucksters and hype. But at its core is a new therapeutic model that depends on just a few drug doses, delivered with extreme care. What has investors still salivating are reports of a billion people on the planet in need of help. No one fears running out of patients anytime soon.
poster:Hugh
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URL: http://www.dr-bob.org/babble/20220128/msgs/1118973.html