Regulators face new challenges over whether — and how — to allow people to receive mind-altering drugs to treat mental health conditions.
By Helen Collis
POLITICO
SEPTEMBER 28, 2022
LONDON — David was paralyzed by fear. The only thing stopping him from falling was his rigid fingers gripping to the rock face. The worst part was knowing he had to hold on for another five hours.
That was how long he knew it would take before his LSD trip would wear off and he could finally abandon the pretense of clinging on to some sense of his perceived self through what felt like an unbearable feat of endurance.
David, who asked that his true identity be concealed to allow him to speak freely, is not alone in having sought out illegal psychedelics to self-medicate a mental health condition. He’s also not alone in having had a bad trip.
His experience, and others like it, serve as cautionary tales, as drug companies develop psychedelics like magic mushrooms and acid to help people with some of the hardest-to-treat mental illnesses.
With clinical research into psychedelics in its early stages, and a rapidly growing and unregulated industry of therapeutic psychedelic retreats, there’s much researchers still have to learn about how to prevent harm from potentially paralyzing experiences like David’s.
“There’s way too much hype, way too much enthusiasm [for psychedelic therapies],” said George Goldsmith, executive chair and co-founder at COMPASS Pathways, which is developing a psilocybin therapy, derived from mushrooms, for mental health disorders. “It doesn’t help anyone.”
Still, Goldsmith believes psychedelics have the potential to help people with mental health disorders who have not responded to other treatments.
“What we’re really focused on is: what does preparation [for a trip] look like? And how do we know to the highest level of certainty that someone is really ready?” said Goldsmith.
Ultimately, with the right counseling and support before and after the trip, his company wants to prevent a bad trip from ever happening with its psilocybin treatment.
Wrong time, wrong place
Training society
SEPTEMBER 28, 2022
LONDON — David was paralyzed by fear. The only thing stopping him from falling was his rigid fingers gripping to the rock face. The worst part was knowing he had to hold on for another five hours.
That was how long he knew it would take before his LSD trip would wear off and he could finally abandon the pretense of clinging on to some sense of his perceived self through what felt like an unbearable feat of endurance.
David, who asked that his true identity be concealed to allow him to speak freely, is not alone in having sought out illegal psychedelics to self-medicate a mental health condition. He’s also not alone in having had a bad trip.
His experience, and others like it, serve as cautionary tales, as drug companies develop psychedelics like magic mushrooms and acid to help people with some of the hardest-to-treat mental illnesses.
With clinical research into psychedelics in its early stages, and a rapidly growing and unregulated industry of therapeutic psychedelic retreats, there’s much researchers still have to learn about how to prevent harm from potentially paralyzing experiences like David’s.
“There’s way too much hype, way too much enthusiasm [for psychedelic therapies],” said George Goldsmith, executive chair and co-founder at COMPASS Pathways, which is developing a psilocybin therapy, derived from mushrooms, for mental health disorders. “It doesn’t help anyone.”
Still, Goldsmith believes psychedelics have the potential to help people with mental health disorders who have not responded to other treatments.
“What we’re really focused on is: what does preparation [for a trip] look like? And how do we know to the highest level of certainty that someone is really ready?” said Goldsmith.
Ultimately, with the right counseling and support before and after the trip, his company wants to prevent a bad trip from ever happening with its psilocybin treatment.
Wrong time, wrong place
Researchers are working to fine-tune a suite of before- and after-care for those participating in clinical trials of psilocybin | Cole Burston/AFP via Getty Images
David’s experience with LSD took place about a decade ago when he was in his 20s, after a long period of social anxiety and depression that started in his teens and, despite trying antidepressants, persisted through university. He was looking for a magic bullet — and psychiatry had failed to deliver.
Fascinated by stories of psychedelics from South America, he finally plucked up the courage to try LSD with his friends.
“It was a really bad idea,” he said. “I had an absolutely horrible time, a really brutal time. And so much so that I thought afterward I had broken my brain.”
In the weeks and months that followed, he started having flashbacks and panic attacks “out of nowhere.”
Researchers at Kings College London (KCL) are working to fine-tune a suite of before- and after-care for those participating in clinical trials of psilocybin, to reduce the risk of harm. Some of these steps have been borne out of participant demand.
Psychiatrist James Rucker, of KCL, worked on a safety study — of psilocybin in healthy volunteers — for Compass in 2018.
The researchers did some preparatory work with the participants beforehand, and offered some support after their trip, “but it wasn’t enough for some people,” said Rucker. Some participants needed more support in the weeks after their treatment, even though they did not have a mental health diagnosis.
So Rucker set up monthly “integration” sessions, open not only to trial participants but also members of the public who are curious about psychedelics or who wanted to share their own experiences.
“We wanted a forum for people to be able to get advice and to talk about their experiences in a safe and confidential way,” said Rucker. This allowed people to speak openly about an activity that was otherwise shrouded in stigma, he said.
Every month, new and old faces join the sessions, opening up on the often life-altering experiences they have had — and have struggled to comprehend. People listen and then offer their thoughts.
For many, it’s the support they need to move on
Letting go
David was one of the participants of Rucker’s integration sessions who had not taken part in a study. He participated virtually in a session in 2020 and found it to be a breakthrough.
“What would have happened if you’d let go of the cliff?” he recalled another participant asking him.
This is how psychedelics differ from other psychotherapies, he concluded. They’re not supposed to suppress your emotions and numb the pain; you’re meant to let go and explore them.
Scientists have learned that during psychedelic trips, the brain becomes more neuroplastic, opening up neurological pathways that have been dormant, or suppressed, for years. This flexibility can endure for weeks — even months. It allows people to see things differently, and often in a more positive light.
But even as they develop these chemicals for treatment-resistant depression and other mental health disorders, researchers admit frankly that they are not a miracle cure.
Still, in COMPASS’s Phase 2b clinical trial testing psilocybin therapy on people with depression for whom no other treatments had worked, the company found that 24 percent of participants responded well. That’s a significant outcome in a particularly hard-to-treat illness.
It’s that type of result that has ignited an explosion of interest in these chemicals from a much wider audience.
Each reported study has lifted an ingrained taboo slightly more, inspiring people who are simply curious or who are desperate to find a healing therapy to give them a try. Psychedelics are becoming so mainstream that author Michael Pollan, best known as a food writer, has presented a Netflix series that delves into LSD, psilocybin, MDMA and mescaline.
Wild West
David’s experience with LSD took place about a decade ago when he was in his 20s, after a long period of social anxiety and depression that started in his teens and, despite trying antidepressants, persisted through university. He was looking for a magic bullet — and psychiatry had failed to deliver.
Fascinated by stories of psychedelics from South America, he finally plucked up the courage to try LSD with his friends.
“It was a really bad idea,” he said. “I had an absolutely horrible time, a really brutal time. And so much so that I thought afterward I had broken my brain.”
In the weeks and months that followed, he started having flashbacks and panic attacks “out of nowhere.”
Researchers at Kings College London (KCL) are working to fine-tune a suite of before- and after-care for those participating in clinical trials of psilocybin, to reduce the risk of harm. Some of these steps have been borne out of participant demand.
Psychiatrist James Rucker, of KCL, worked on a safety study — of psilocybin in healthy volunteers — for Compass in 2018.
The researchers did some preparatory work with the participants beforehand, and offered some support after their trip, “but it wasn’t enough for some people,” said Rucker. Some participants needed more support in the weeks after their treatment, even though they did not have a mental health diagnosis.
So Rucker set up monthly “integration” sessions, open not only to trial participants but also members of the public who are curious about psychedelics or who wanted to share their own experiences.
“We wanted a forum for people to be able to get advice and to talk about their experiences in a safe and confidential way,” said Rucker. This allowed people to speak openly about an activity that was otherwise shrouded in stigma, he said.
Every month, new and old faces join the sessions, opening up on the often life-altering experiences they have had — and have struggled to comprehend. People listen and then offer their thoughts.
For many, it’s the support they need to move on
Letting go
David was one of the participants of Rucker’s integration sessions who had not taken part in a study. He participated virtually in a session in 2020 and found it to be a breakthrough.
“What would have happened if you’d let go of the cliff?” he recalled another participant asking him.
This is how psychedelics differ from other psychotherapies, he concluded. They’re not supposed to suppress your emotions and numb the pain; you’re meant to let go and explore them.
Scientists have learned that during psychedelic trips, the brain becomes more neuroplastic, opening up neurological pathways that have been dormant, or suppressed, for years. This flexibility can endure for weeks — even months. It allows people to see things differently, and often in a more positive light.
But even as they develop these chemicals for treatment-resistant depression and other mental health disorders, researchers admit frankly that they are not a miracle cure.
Still, in COMPASS’s Phase 2b clinical trial testing psilocybin therapy on people with depression for whom no other treatments had worked, the company found that 24 percent of participants responded well. That’s a significant outcome in a particularly hard-to-treat illness.
It’s that type of result that has ignited an explosion of interest in these chemicals from a much wider audience.
Each reported study has lifted an ingrained taboo slightly more, inspiring people who are simply curious or who are desperate to find a healing therapy to give them a try. Psychedelics are becoming so mainstream that author Michael Pollan, best known as a food writer, has presented a Netflix series that delves into LSD, psilocybin, MDMA and mescaline.
Wild West
No one should be prevented from choosing to expand their consciousness, but the world of retreats can become “the Wild West” | Brent Lewin/Getty Images
That surge in demand has been met with a range of offerings, despite the limitations of the early data.
Psychedelic retreats have sprung up in Portugal, Spain and the Netherlands, countries where the rules on their use are lax.
Portugal decriminalized possession of all drugs in 2001, allowing individuals to consume and possess small quantities of psilocybin mushrooms. The Netherlands allows personal consumption of psilocybin truffles that have a similar effect to the mushrooms, which remain banned. And in Spain, possession, production and distribution of psilocybin is illegal, but its consumption in private places is decriminalized.
People are also traveling to Jamaica, where psilocybin is legal, as well as seeking ritualistic experiences with indigenous tribes in South America.
To Goldsmith, at COMPASS, no one should be prevented from choosing to expand their consciousness, but he cautioned that the world of retreats is like “the Wild West.”
Some retreats are set up with ethically sound intentions and run by trained therapists — including those with advanced research experience and academic qualifications. But others are run by profit-hungry opportunists with little training to help people navigate through challenging experiences. They promise to transform lives, misappropriating early clinical trial data from companies as evidence that psychedelics work.
While COMPASS’s Phase 2b data is compelling, it also showed that “well over 50 percent didn’t respond,” Goldsmith said. “I don’t quite hear those numbers when I look at retreats.”
According to Rucker, at KCL, the retreats industry needs checks and balances. And currently, there are none.
“I’ve had some reports of people over the years who’ve had terrible times at retreat centers but also reports of people who’ve had wonderful times,” he said. The main concern is the promises made: “There’s a fine line here between what is personal development and what is treatment.”
Share the love
Others, like Myles Katz co-founder of the Synthesis Institute, a Dutch center offering psilocybin therapy with truffles, argue that retreats are vital to expanding access to people who need it.
“The only place psychedelic medical treatment is currently available is in clinical trials, which are incredibly rare and notoriously difficult to get into,” said Katz. Retreats are a more accessible option, he said, “for people wanting to have a legal, professionally facilitated, psychedelic experience.”
Synthesis “thoroughly” screens applicants prior to accepting them, he said. Many retreats in Europe are attempting to align their screening protocols with the medical research that is available on psychedelics, Katz added. This in itself is an evolving process given the limited research available.
With so much variation across the sector, a lack of transparency over the benefits and the risks of the experience, and little data, if any, on the rates of traumatic trips and how they are managed, some people would like to see retreats formally regulated.
One idea being floated is for retreats to vet people who are most vulnerable, and to exclude those with a history of treatment-resistant mental health disorders — those who may be most vulnerable to bad experiences without the right support, but also most likely to seek to cure their illness through psychedelics.
Kirk Rutter was one of the few who got accepted onto a psilocybin study in the U.K. after being diagnosed with treatment-resistant depression. Before his mental health deteriorated, he had tried ayahuasca, a South American plant-based psychedelic, at an underground retreat in England. He didn’t enjoy the experience but nonetheless has no regrets.
“I didn’t feel as safe,” he said. “I didn’t know the people who were going to be looking after me. We were basically out in the middle of nowhere.” Compared with his psilocybin trip, “it was a much darker experience,” he said.
Given the opportunity of taking a psychedelic again, he would opt hands-down for the controlled clinical approach, “for the feeling of safety.” That’s because he knows exactly what would happen, what dose he would receive, who would be with him, and where he would be. He underwent extensive medical vetting and questionnaires before and after the trip and had doctors and psychotherapists on hand throughout the experience. “I got a lot of reassurances,” he said.
For Rutter, the treatment also worked. Seven years after the trial he remains free of depression. He’s even become a poster child for COMPASS’s research — albeit reluctantly.
Imperial College, which led the trial, asked him to talk to the press about his experience. His immediate reaction was: No! “Talk about depression? And psychedelics? They’re both really taboo, really uncomfortable subjects,” he said.
But then he realized, if he couldn’t share his experiences, then society would never get over this stigma and others wouldn’t have the opportunity to benefit like he did. So he relented.
That surge in demand has been met with a range of offerings, despite the limitations of the early data.
Psychedelic retreats have sprung up in Portugal, Spain and the Netherlands, countries where the rules on their use are lax.
Portugal decriminalized possession of all drugs in 2001, allowing individuals to consume and possess small quantities of psilocybin mushrooms. The Netherlands allows personal consumption of psilocybin truffles that have a similar effect to the mushrooms, which remain banned. And in Spain, possession, production and distribution of psilocybin is illegal, but its consumption in private places is decriminalized.
People are also traveling to Jamaica, where psilocybin is legal, as well as seeking ritualistic experiences with indigenous tribes in South America.
To Goldsmith, at COMPASS, no one should be prevented from choosing to expand their consciousness, but he cautioned that the world of retreats is like “the Wild West.”
Some retreats are set up with ethically sound intentions and run by trained therapists — including those with advanced research experience and academic qualifications. But others are run by profit-hungry opportunists with little training to help people navigate through challenging experiences. They promise to transform lives, misappropriating early clinical trial data from companies as evidence that psychedelics work.
While COMPASS’s Phase 2b data is compelling, it also showed that “well over 50 percent didn’t respond,” Goldsmith said. “I don’t quite hear those numbers when I look at retreats.”
According to Rucker, at KCL, the retreats industry needs checks and balances. And currently, there are none.
“I’ve had some reports of people over the years who’ve had terrible times at retreat centers but also reports of people who’ve had wonderful times,” he said. The main concern is the promises made: “There’s a fine line here between what is personal development and what is treatment.”
Share the love
Others, like Myles Katz co-founder of the Synthesis Institute, a Dutch center offering psilocybin therapy with truffles, argue that retreats are vital to expanding access to people who need it.
“The only place psychedelic medical treatment is currently available is in clinical trials, which are incredibly rare and notoriously difficult to get into,” said Katz. Retreats are a more accessible option, he said, “for people wanting to have a legal, professionally facilitated, psychedelic experience.”
Synthesis “thoroughly” screens applicants prior to accepting them, he said. Many retreats in Europe are attempting to align their screening protocols with the medical research that is available on psychedelics, Katz added. This in itself is an evolving process given the limited research available.
With so much variation across the sector, a lack of transparency over the benefits and the risks of the experience, and little data, if any, on the rates of traumatic trips and how they are managed, some people would like to see retreats formally regulated.
One idea being floated is for retreats to vet people who are most vulnerable, and to exclude those with a history of treatment-resistant mental health disorders — those who may be most vulnerable to bad experiences without the right support, but also most likely to seek to cure their illness through psychedelics.
Kirk Rutter was one of the few who got accepted onto a psilocybin study in the U.K. after being diagnosed with treatment-resistant depression. Before his mental health deteriorated, he had tried ayahuasca, a South American plant-based psychedelic, at an underground retreat in England. He didn’t enjoy the experience but nonetheless has no regrets.
“I didn’t feel as safe,” he said. “I didn’t know the people who were going to be looking after me. We were basically out in the middle of nowhere.” Compared with his psilocybin trip, “it was a much darker experience,” he said.
Given the opportunity of taking a psychedelic again, he would opt hands-down for the controlled clinical approach, “for the feeling of safety.” That’s because he knows exactly what would happen, what dose he would receive, who would be with him, and where he would be. He underwent extensive medical vetting and questionnaires before and after the trip and had doctors and psychotherapists on hand throughout the experience. “I got a lot of reassurances,” he said.
For Rutter, the treatment also worked. Seven years after the trial he remains free of depression. He’s even become a poster child for COMPASS’s research — albeit reluctantly.
Imperial College, which led the trial, asked him to talk to the press about his experience. His immediate reaction was: No! “Talk about depression? And psychedelics? They’re both really taboo, really uncomfortable subjects,” he said.
But then he realized, if he couldn’t share his experiences, then society would never get over this stigma and others wouldn’t have the opportunity to benefit like he did. So he relented.
Training society
As the anticipated arrival of the first medical psychedelics nears, no one yet knows what impact this will have on the retreats industry | Fabrice Coffrini/AFP via Getty Images
On top of the calls to regulate retreats, some are also concerned about the need to prepare health systems and society for the anticipated arrival of the first psychedelics in Western medicine.
Medicines regulators in the U.S., the European Union and the U.K. are working with companies to ensure that the development of these therapies fits within the parameters of tried and tested measures demonstrating that the benefits outweigh the risks. The U.S. said this summer that it anticipated the first psychedelic medicine to be approved within two years.
One major hurdle however is the critical suite of before- and after-care to minimize potential harm from traumatic trips. The COMPASS trial showed that 3.8 percent of participants had suicidal behaviors in the aftermath of the study — a behavior the company noted could be more likely among people with treatment-resistant depression.
“The regulatory authorities … were set up to regulate drugs,” said Rucker at KCL. “They were not set up to regulate psychotherapy, and they are not interested in regulating psychotherapy … Our point is that you can’t give the drug without the psychotherapy.”
Companies are in talks with regulators over the possibility of licensing a package that defines that the drug must come with preparation, dosing, day support and integration, “because otherwise, the therapeutic effect you’re looking for is in jeopardy,” said Rucker.
Adding to the complexity, “that package of care, if licensed, would require optimization over time,” said Liam Modlin, psychology and psychotherapy lead in psychedelics, also at KCL. “That’s an ongoing, long-term process.”
Health systems also need to prepare for such a step change in psychiatric treatment. “Psychiatrists and psychotherapists are going to be administering psychedelics if they are licensed,” Modlin said, adding they would need governance bodies to provide professional, standardized training and oversight.
Some people are working with patient groups to try to raise awareness and cut through the stigma of these therapies, ingrained by decades of illegality.
Chris Jenkins, at consultancy OEV, is working with police and firefighters who have among the highest rates of post-traumatic stress disorder in any profession, at around 20 percent. He’s hoping to break down the multiple stigmas that might prevent them from seeking treatment with psychedelics: from speaking about mental health, perceptions of masculinity and weakness, and taking psychedelics.
“We’re working to try and engage with the police and say, ‘Look, this is something that can really benefit you,’” said Jenkins. But overcoming these multiple stigmas requires work and preparation now, he said.
Fork in the road
On top of the calls to regulate retreats, some are also concerned about the need to prepare health systems and society for the anticipated arrival of the first psychedelics in Western medicine.
Medicines regulators in the U.S., the European Union and the U.K. are working with companies to ensure that the development of these therapies fits within the parameters of tried and tested measures demonstrating that the benefits outweigh the risks. The U.S. said this summer that it anticipated the first psychedelic medicine to be approved within two years.
One major hurdle however is the critical suite of before- and after-care to minimize potential harm from traumatic trips. The COMPASS trial showed that 3.8 percent of participants had suicidal behaviors in the aftermath of the study — a behavior the company noted could be more likely among people with treatment-resistant depression.
“The regulatory authorities … were set up to regulate drugs,” said Rucker at KCL. “They were not set up to regulate psychotherapy, and they are not interested in regulating psychotherapy … Our point is that you can’t give the drug without the psychotherapy.”
Companies are in talks with regulators over the possibility of licensing a package that defines that the drug must come with preparation, dosing, day support and integration, “because otherwise, the therapeutic effect you’re looking for is in jeopardy,” said Rucker.
Adding to the complexity, “that package of care, if licensed, would require optimization over time,” said Liam Modlin, psychology and psychotherapy lead in psychedelics, also at KCL. “That’s an ongoing, long-term process.”
Health systems also need to prepare for such a step change in psychiatric treatment. “Psychiatrists and psychotherapists are going to be administering psychedelics if they are licensed,” Modlin said, adding they would need governance bodies to provide professional, standardized training and oversight.
Some people are working with patient groups to try to raise awareness and cut through the stigma of these therapies, ingrained by decades of illegality.
Chris Jenkins, at consultancy OEV, is working with police and firefighters who have among the highest rates of post-traumatic stress disorder in any profession, at around 20 percent. He’s hoping to break down the multiple stigmas that might prevent them from seeking treatment with psychedelics: from speaking about mental health, perceptions of masculinity and weakness, and taking psychedelics.
“We’re working to try and engage with the police and say, ‘Look, this is something that can really benefit you,’” said Jenkins. But overcoming these multiple stigmas requires work and preparation now, he said.
Fork in the road
Psilocybe mushrooms at the Numinus Bioscience lab in Nanaimo, British Columbia, Canada | James MacDonald/Bloomberg via Getty Images
As the anticipated arrival of the first medical psychedelics nears, no one yet knows what impact this will have on the retreats industry.
The pharmaceutical sector is highly regulated and will provide treatment for a narrow cohort of people with mental health disorders; retreats are an unregulated sector providing broader access but at greater risk and cost.
“I would hope that this is one of those situations where there’s coexistence,” said Goldsmith, at COMPASS, as opposed to fueling conflict between the two.
For Tadeusz Hawrot, founder and policy lead at the Psychedelic Access and Research European Alliance (PAREA), it could be an opportunity for the two industries to work together.
He sees a day when doctors could triage patient care based on the severity of mental health concerns. The most serious, treatment-resistant cases could be referred for clinical therapy with psychedelics, in a controlled setting, with standardized before- and after-care, and doctors and psychotherapists on hand. People with less severe mental health worries could be referred to a retreat and might prefer to seek help outside of the medical model.
This would require retreats to be regulated, he said, underscoring the importance of accurate data collection and transparency. “Perhaps there could be a network of licensed retreats,” he said, providing real-world evidence to add to the body of knowledge on these therapies.
For people who, like David, have experimented independently with psychedelics, this approach would provide more of a safety net in case of a bad trip.
As it happened, it would be a decade after his LSD experience before David would experiment again, in a second attempt to self-medicate for his mental health conditions. This time it was with psilocybin and just one close friend. It was a much better experience, but there’s still more work to be done to let go, he said.
With the support of the integration sessions and armed with a new understanding of psychedelics’ effect on the mind, he’s confident they can now help him, not least in opening his eyes to how he needs to change his life.
It’s a process that for the Davids of the future may come with less trial and error: a licensed, safe treatment and more professional and peer support.
As the anticipated arrival of the first medical psychedelics nears, no one yet knows what impact this will have on the retreats industry.
The pharmaceutical sector is highly regulated and will provide treatment for a narrow cohort of people with mental health disorders; retreats are an unregulated sector providing broader access but at greater risk and cost.
“I would hope that this is one of those situations where there’s coexistence,” said Goldsmith, at COMPASS, as opposed to fueling conflict between the two.
For Tadeusz Hawrot, founder and policy lead at the Psychedelic Access and Research European Alliance (PAREA), it could be an opportunity for the two industries to work together.
He sees a day when doctors could triage patient care based on the severity of mental health concerns. The most serious, treatment-resistant cases could be referred for clinical therapy with psychedelics, in a controlled setting, with standardized before- and after-care, and doctors and psychotherapists on hand. People with less severe mental health worries could be referred to a retreat and might prefer to seek help outside of the medical model.
This would require retreats to be regulated, he said, underscoring the importance of accurate data collection and transparency. “Perhaps there could be a network of licensed retreats,” he said, providing real-world evidence to add to the body of knowledge on these therapies.
For people who, like David, have experimented independently with psychedelics, this approach would provide more of a safety net in case of a bad trip.
As it happened, it would be a decade after his LSD experience before David would experiment again, in a second attempt to self-medicate for his mental health conditions. This time it was with psilocybin and just one close friend. It was a much better experience, but there’s still more work to be done to let go, he said.
With the support of the integration sessions and armed with a new understanding of psychedelics’ effect on the mind, he’s confident they can now help him, not least in opening his eyes to how he needs to change his life.
It’s a process that for the Davids of the future may come with less trial and error: a licensed, safe treatment and more professional and peer support.
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