It’s possible that I shall make an ass of myself. But in that case one can always get out of it with a little dialectic. I have, of course, so worded my proposition as to be right either way (K.Marx, Letter to F.Engels on the Indian Mutiny)
Psychedelic-assisted therapies for patients with PTSD
The resurgence of research into psychedelic-based treatments is poised to benefit many people who face mental health challenges, such as post-traumatic stress disorder, but how do they feel about it?
IMAGE: MEDICAL UNIVERSITY OF SOUTH CAROLINA PSYCHIATRIST DR. JENNIFER JONES (LEFT) AND MELISSA MICHEL (RIGHT, RECLINING), LEAD THERAPIST FOR MUSC'S CENTERSPACE CLINIC, DEMONSTRATING PSYCHEDELIC-ASSISTED THERAPY.view more
CREDIT: MEDICAL UNIVERSITY OF SOUTH CAROLINA. PHOTOGRAPH COURTESY OF DR. JENNIFER JONES.
Psychedelic-based therapies are poised to change the treatments that psychiatrists can offer patients.
“I often talk about psychedelic treatments as catalysts for change, for both the individual and the field of psychiatry,” said Medical University of South Carolina psychiatrist Jennifer Jones, M.D., who conducts research on these treatments.
The highly anticipated approval of MDMA, or “ecstasy,” to treat post-traumatic stress disorder would be the first for a psychedelic drug, ushering in changes for patients, mental health providers and society. The Food and Drug Administration is expected to issue a decision on MDMA-assisted therapy for PTSD in early 2024.
How well this revolutionary research will be implemented into practice will depend on patients’ willingness to undergo psychedelic-based treatments and their ability to access those treatments, said Jones. Jones’ latest research, published in Frontiers in Psychiatry, examines these potential barriers in a population that stands to benefit greatly from psychedelic therapies for PTSD: individuals that use substances.
Changing treatments and outcomes
Approval of psychedelic therapies could help patients with mental illnesses, particularly those with multiple or treatment-resistant disorders. PTSD is an often severe mental disorder that can occur after being exposed to a traumatic event. Current treatments, while improving symptoms in some patients, leave many without any benefit at all.
For the many people who have PTSD and habitually use alcohol or other substances, rates of nonresponse to treatment are even higher. Jones thinks this is unacceptable, so she started researching new approaches to treat patients with both PTSD and a substance use disorder.
A promising ‘new’ treatment option for patients with both PTSD and SUD may come from an ‘old’ group of drugs called psychedelics. Psychedelics include both natural (psilocybin, mescaline, DMT) and synthetic (LSD, MDMA) drugs. Natural psychedelics have been used medicinally and spiritually in traditional cultures for centuries. However, they were described scientifically mostly in the 1950s and 1960s.
“It is really interesting – in these early studies looking at psychedelic therapy for one indication, like PTSD, they noticed improvements in symptoms of another mental health disorder, like depression or SUD,” said Jones.
Since 2009, approximately 80 clinical trials involving MDMA have been completed or are ongoing, according to Clinicaltrials.gov. These trials investigate the use of MDMA in a wide range of disorders, including anxiety, depression, obsessive compulsive disorder, SUD and PTSD. These diverse studies highlight the potential effects of MDMA across multiple disorders, something that prior treatments have lacked.
“This is really important,” said Jones. “It is very common to have concurrent mental health disorders, so having a treatment like MDMA that could, for example, improve both PTSD and SUD symptoms is really exciting for the field.”
Currently, drugs used to treat PTSD may be given with or without another form of therapy, broadly referred to as “talk therapy.” For MDMA-assisted therapy, the talk therapy component is a fundamental part of the treatment.
“In the context of MDMA-assisted therapy for PTSD, MDMA is thought to dampen the fear response around the traumatic memory, allowing the participant to engage with the therapy team to process this memory, sometimes for the first time in their lives,” said Jones. “Instead of running from it, they can process the traumatic memory and move past it.”
This processing may also apply to other mental functions, perhaps accounting for MDMA’s ability to improve symptoms for other disorders, like SUD.
“Participants in psychedelic clinical trials have lasting benefits that come from changes in their behaviors, their thought processes and their interactions with others,” said Jones. “Participants often point to these changes as what made the difference in their symptoms.”
The immediate effects of MDMA during therapy are not without concern, however. Jones is often asked whether the MDMA will produce feelings of “ecstasy.” “Ecstasy is a common descriptor for the effects caused by recreational MDMA, used so frequently that it became a nickname for the drug. However, because this therapy is a difficult process of self-healing, MDMA in this context does not usually produce ecstasy, Jones said. This common concern points to some of the possible barriers that Jones wanted to assess in her recent publication.
Changing minds
For some, reluctance to receive MDMA-assisted therapy is tied to negative views of psychedelics and their recreational uses. In the 1970s, all psychedelics were classified as Schedule I substances, drugs with high-abuse potential without clinical benefits, tarnishing political and public perceptions of these drugs. Their recreational use and representations in media have continued to perpetuate this stigma.
Negative views of psychedelics and increasing regulatory control halted early promising research on psychedelics in Western medicine in the 1970s, reported the Multidisciplinary Association for Psychedelic Studies. It wasn’t until the 1990s that officially sanctioned psychedelic research resumed on a small scale, only accelerating in the 2010s. New government policies allowed psychedelic clinical research to resume, but public perceptions of psychedelics will determine the success of these drugs as treatments.
In Jones’ study, approximately 70% of survey respondents indicated their support for MDMA-based research and belief that MDMA could be useful for treating mental health disorders. A smaller group, 59%, would be willing to receive an MDMA-based treatment if it were recommended by a mental health provider. The survey results suggest that most people who use substances are open to MDMA research and would be willing to try an MDMA-based therapy.
Jones also examined the role of race and ethnicity on opinions about MDMA-assisted therapy. Despite their underrepresentation in psychedelic clinical trials, racial and ethnic groups had similar levels of support for MDMA research. However, there were small, but potentially important, differences in willingness to try an MDMA-based therapy. “While largely a hypothesis,” said Jones, “differences in willingness to participate in clinical trials are probably related to prior use or cultural beliefs.”
While this research brings up additional questions for Jones and colleagues, she believes these results can help researchers and mental health providers to understand how to develop and implement treatments more equitably for different patient and ethnic populations.
By discussing these issues prior to the FDA decision, Jones hopes steps can be taken to address patient concerns.
“It is my heartfelt goal that everyone who might benefit from MDMA-assisted therapy is able to receive treatment once it is available, and that they will not be held back by worries or stigma about the treatment,” said Jones. “For that to be a reality, we have to seek input directly from those most likely to benefit from the treatments that we are developing.”
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About MUSC
Founded in 1824 in Charleston, MUSC is the state’s only comprehensive academic health system, with a unique mission to preserve and optimize human life in South Carolina through education, research and patient care. Each year, MUSC educates more than 3,200 students in six colleges – Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy – and trains more than 900 residents and fellows in its health system. MUSC brought in more than $298 million in research funds in fiscal year 2022, leading the state overall in research funding. MUSC also leads the state in federal and National Institutes of Health funding, with more than $220 million. For information on academic programs, visit musc.edu.
As the health care system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest-quality and safest patient care while educating and training generations of outstanding health care providers and leaders to serve the people of South Carolina and beyond. Patient care is provided at 16 hospitals (includes owned and equity stake), with approximately 2,700 beds and four additional hospital locations in development; more than 350 telehealth sites and connectivity to patients’ homes; and nearly 750 care locations situated in all regions of South Carolina. In 2022, for the eighth consecutive year, U.S. News & World Report named MUSC Health University Medical Center in Charleston the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.
MUSC has a total enterprise annual operating budget of $5.1 billion. The nearly 26,000 MUSC family members include world-class faculty, physicians, specialty providers, scientists, students, affiliates and care team members who deliver groundbreaking education, research, and patient
Perspectives on the therapeutic potential of MDMA: A nation-wide exploratory survey among substance users.
Thursday, February 01, 2024
MDMA 'outperforms' expectations in trial as medicine for PTSD
BETTER LIVING THROUGH CHEMISTRY
Rob Waugh ·Contributor Mon, 29 January 2024 MDMA could soon be used as a medicine, researchers say (Getty)
MDMA is better known as the dancefloor hallucinogen Ecstasy, but it may have important uses as a medicine, a new study has shown.
The research found that - when paired with therapy - MDMA significantly outperformed therapy alone when it came to dealing with PTSD (post-traumatic stress disorder).
The difference was particularly stark when it came to people dealing with traumas from early childhood, which are especially hard to deal with through therapy.
The researchers said: "MDMA may be particularly effective for enhancing treatment efficacy by improving a range of problems with self-experience that are associated with treatment resistance."
In particular, the drug may be able to help patients who have been traumatised during childhood confront their issues and deal with problems such as alexithymia - an inability to recognise emotions.
The study found people who took MDMA responded better to therapy. (Getty)
The researchers added: "Even though the MDMA-assisted therapy experimental sessions often occurred in relative silence as participants focus largely on their inner experience, MDMA-assisted therapy was associated with a significant improvement in emotional self-awareness and loss of alexithymia.
"This suggests that MDMA-assisted therapy can facilitate accessing painful memories and experiences that under ordinary conditions are too overwhelming and terrifying to confront, even in the presence of trained therapists." Recommended reading
Speaking to Vox, researcher Bessel Van derk Kolk, author of The Body Keeps the Score, Brain Mind and Body in the Healing of Trauma, said he was initially reluctant to include people with childhood trauma in the study.
In the end, the study, which aims to legitimise the use of MDMA-assisted therapy, included 84% people with early childhood trauma.
The subjects were split into two groups, one of which had therapy, and one which had 36 hours of MDMA-assisted therapy.
Van der Kolk said: "We had the best outcome data here with MDMA that I’ve ever seen for any study." Can psychedelic drugs really treat illnesses?
Research has shown that certain psychedelic drugs such as psilocybin (the ingredient in magic mushrooms) and MDMA can have an impact on problems such as depression and post-traumatic stress disorder.
On LSD, the picture is less clear.
A small trial in 2018, funded by the Beckley Foundation and led by the 'first lady of LSD', Amanda Feilding, the Countess of Wemyss and March, saw 20 volunteers take the drug and fill in psychological questionnaires.
Feilding said: "I took it in the 1960s when it was legal and it improved my wellbeing."
A systematic review of studies into LSD in Frontiers in Psychiatry in 2020 found that the drug was a "potential therapeutic agent", with the strongest evidence around using LSD to treat alcoholism. Will MDMA really be legal a medicine?
In 2017, the US Food and Drug Administration awarded the drug 'breakthrough status', so it could be fast-tracked as a potential treatment.
MDMA is often illegally sold on the street. (Getty)
Studies have shown that patients with PTSD – where it's difficult to deal with painful memories – can overcome their traumas, long-term, with the aid of MDMA.
Several successful trials have shown the drug's potential with PTSD, and some believe approval could come this year.
Saturday, February 04, 2023
Australia Becomes First Country to Legalize Therapeutic Use of MDMA and Psilocybin
One expert called the move a "very welcome step away from what has been decades of demonization."
Trisha Suppes, founder of the Bipolar and Depression Research Program at the Palo Alto VA Medical Center in California, points during a November 4, 2022 presentation to what she called "stunning" results showing a reduction in treatment-resistant depression among patients undergoing psilocybin therapy. (Photo: Steve Jurvetson/flickr/cc)
After decades of criminalization, Australia's government said Friday that it will legalize the prescription of MDMA and psilocybin for the treatment of two medical conditions, a historic move hailed by researchers who have studied the therapeutic possibilities of the drugs.
Australia's Therapeutic Goods Administration (TGA) said in a statement that starting July 1, psychiatrists may prescribe MDMA (3,4-methylenedioxy-methamphetamine), commonly called "Molly" or "ecstasy" by recreational users, to treat post-traumatic stress disorder (PTSD) and psilocybin—the psychedelic prodrug compound in "magic" mushrooms—for treatment-resistant depression.
"These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients," TGA said, adding that the drugs must be taken "in a controlled medical setting."
Advocates of MDMA and psilocybin are hopeful that one day doctors could prescribe them to treat a range of conditions, from alcoholism and eating disorders to obsessive-compulsive disorder.
David Caldicott, a clinical senior lecturer in emergency medicine at Australian National University, toldThe Guardian that Friday's surprise announcement is a "very welcome step away from what has been decades of demonization."
Caldicott said it is now "abundantly clear” that both MDMA and psilocybin "can have dramatic effects" on hard-to-treat mental health problems, and that "in addition to a clear and evolving therapeutic benefit, [legalization] also offers the chance to catch up on the decades of lost opportunity [of] delving into the inner workings of the human mind, abandoned for so long as part of an ill-conceived, ideological 'war on drugs.'"
MDMA—which has been criminalized in Australia since 1987—was first patented by German drugmaker Merck in the early 1910s. After World War II the United States military explored possibilities for weaponizing MDMA as a truth serum as part of the MK-ULTRA mind control experiments aimed at creating real-life Manchurian candidates. A crossover from clinical usage in marriage and other therapies in the 1970s and '80s to recreational consumption—especially in the disco and burgeoning rave scenes—in the latter decade sparked a conservative backlash in the form of emergency bans in countries including Australia, the United Kingdom, and the United States. The U.S. Drug Enforcement Administration classifies MDMA and psilocybin as Schedule I substances, meaning they have "no currently accepted medical use and a high potential for abuse."
Patients who've tried MDMA therapy and those who treat them say otherwise. A study published last year by John Hopkins Health found that in a carefully controlled setting, psilocybin-assisted psychotherapy held promise for "significant and durable improvements in depression."
The California-based Multidisciplinary Association for Psychedelic Studies (MAPS)—the world's premier organization for psychedelic advocacy and research—interviewed Colorado massage therapist Rachael Kaplan about her MDMA-assisted therapy for PTSD:
For the majority of my life I prayed to die and fought suicidal urges as I struggled with complex PTSD. This PTSD was born out of chronic severe childhood abuse. Since then, my life has been a journey of searching for healing. I started going to therapy 21 years ago, and since then I have tried every healing modality that I could think of, such as bodywork, energy work, medications, residential treatment, and more. Many of these modalities were beneficial but none of them significantly reduced my trauma symptoms. I was still terrified most of the time...
In my first MDMA-assisted psychotherapy session I was surprised that the MDMA helped me see the world as it was, instead of seeing it through my lens of terror. I thought that the MDMA would alter my perception of reality, but instead, it helped me see... more clearly... The MDMA session was the first time that I was able to stay present, explore, and process what had happened to me. This changed everything... There are no words for the gratitude that I feel.
Jon Lubecky, an American Iraq War combat veteran who tried to kill himself five times, toldNBC's "Today" in 2021 that MDMA therapy—also with MAPS—enabled him "to talk about things I had never brought up before to anyone."
"And it was OK. My body did not betray me. I didn't get panic attacks. I didn't shut down emotionally or just become so overemotional I couldn't deal with anything," he recounted.
"This treatment is the reason my son has a father instead of a folded flag," Lubecky said in a message to other veterans afflicted with PTSD. "I want all of you to be around in 2023 when this is [U.S. Food and Drug Administration]-approved. I know what your suffering is like. You can make it."
MAPS' latest clinical research on MDMA—which is aimed at winning FDA approval—is currently in phase three trials. The Biden administration said last year that it "anticipates" MDMA and psilocybin would be approved by the FDA by 2024 and is "exploring the prospect of establishing a federal task force to monitor" therapeutic possibilities of both drugs.
Like MDMA, psilocybin—which occurs naturally in hundreds of fungal species and has been used by humans for medicinal, spiritual, and recreational purposes for millennia—remains illegal at the federal level in the U.S., although several states and municipalities have legalized or decriminalized psychedelic mushrooms, or have moved to do so.
There have also been bipartisan congressional efforts to allow patients access to both drugs. Legislation introduced last year by U.S. Sens. Cory Booker (D-N.J.) and Rand Paul (R-Ky.) would permit therapeutic use of certain Schedule I drugs for terminally ill patients. Meanwhile, Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Dan Crenshaw (R-Texas) passed amendments to the 2023 National Defense Authorization Act providing more funding for psychedelic research and making it easier for veterans and active-duty troops suffering from PTSD to try drug-based treatments.
MDMA and Psilocybin Are Approved as Medicines for the First Time
Many are celebrating Australia’s decision to pave the way for these psychedelic therapies, but questions around accessibility remain.
In a world-first, Australia has announced it will officially recognize MDMA and psilocybin as medicines.
On February 3, Australia’s Therapeutic Goods Administration (TGA)—the government authority responsible for regulating medicines—announced that starting July 1, 2023, authorized psychiatrists will be able to prescribe MDMA for the treatment of post-traumatic stress disorder (PTSD), and psilocybin, the active ingredient in magic mushrooms, for treatment-resistant depression. Because the TGA has yet to approve any actual medicines that contain MDMA or psilocybin, patients will initially be receiving “unapproved” medicines containing the substances.
The decision came as a big surprise. At the end of December 2021, the same regulatory body decided against down-scheduling the drugs for use in a medical context. “When I woke up, my email was completely flooded with people saying: ‘Have you heard what’s happened?’ I was shocked by the decision,” says Simon Ruffell, a psychiatrist and senior research fellow at the Psychae Institute at the University of Melbourne.
Before advocates celebrate, experts warn that there are still many questions around just how many people will be actually able to access these treatments come July 1, as well as whether Australia has jumped the gun before gathering enough evidence on how to roll out these treatments effectively and safely.
“I think it will take a while to ramp up,” says Daniel Perkins, adjunct associate professor at the Centre for Mental Health at Swinburne University and a senior research fellow at the University of Melbourne. This is wise, he says: Let it gradually open up to see what works well and what does not. “They’ve probably intentionally done it this way.”
The path for a psychiatrist to get the all-clear to dole out the drugs could be lengthy and twisted. First, psychiatrists will need to be approved under Australia’s Authorised Prescriber Scheme, which means being endorsed by a human research ethics committee and then the TGA. For this, they’ll need to prove that they can clinically justify the treatment regime, that they will have proper governance over the treatment process, and that they will be using suitable measures to protect patients. What exactly these measures look like in practice have yet to be laid out in detail by the TGA.
Plus, the TGA has yet to provide any detail regarding the minimum training standards required for psychiatrists to become authorized prescribers. This makes exactly how these treatments will be prescribed ambiguous, considering the bedrock of evidence to support them involves patients receiving therapy from trained professionals alongside the drugs themselves. Because of this—and because the TGA has put the onus on the psychiatrist to demonstrate that their prescribing practices are appropriate—providing therapy in conjunction with the drugs will likely be required, says Rhys Cohen, who is on the non-executive advisory board of the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney and consults for the medical cannabis industry.
And not just any psychiatrist or psychologist can safely administer these kinds of therapies. Ruffell points out that in well-established Indigenous psychedelic practices around the world, people spend five to 10 years, at least, training to be able to work with these kinds of substances. “I think that a grave error would be to think that psychiatric and psychological qualifications are transferable to psychedelic substances without additional training.”
Another barrier to access will likely be cost. The treatments won’t be covered by health insurance, “so it’s probably initially going to be a therapy for relatively well-off people who have these conditions,” Perkins says.
Some worry that Australia may be putting the cart before the horse in terms of the safety and long-term effects of these treatments. “We haven’t even looked at any longer term data yet,” says Ruffell. “The longest data that we have is 12 months. We don’t really know what happens later down the line.”
But on the other hand, “the benefit, particularly for the treatment-resistant conditions that they’re talking about—PTSD and depression—could be really huge,” says Perkins.
Mostly, there’s a sense of surprise that Australia is first off the mark. At the beginning of 2023, Oregon became the first US state to allow adult use of psilocybin “under the supervision of a state-certified facilitator,” though the substance remains an unapproved investigational drug in the US for now. It’s been predicted that the US Food and Drug Administration will approve MDMA for the treatment of PTSD in 2024. Switzerland allows a limited number of psychiatrists to use LSD and MDMA to assist psychotherapy. How the scheme unfolds in Australia will likely impact whether other countries choose to offer the drugs for therapeutic purposes in the future—and that includes if it goes wrong and people get harmed. “I think the eyes of the world will be watching Australia now,” Ruffell says.
For Ruffell, the optimist in him is excited that psychedelic medicine is finally getting somewhere. “And then the pessimist is like, could this have a negative outcome?” he says. “I hope not. But that will be determined in the future.”
Mark Walkey, left, and Matthew Piggott look over samples at a University of Western Australia lab, where they are trying to shorten the duration of MDMA effects and eliminate a weak addictive property.
(Frances Vinall/The Washington Post)
PERTH, Australia — The scientist held up the container of clear liquid and examined it. At a rave, it could be sold by its street names “ecstasy” or “molly.” But here, in a university lab in one of the most remote cities in the world, experts are harnessing MDMA with a therapeutic purpose in mind.
The team of chemists at the University of Western Australia have been working to modify the chemical compound so it can be better used for mental health treatments.
It’s a mission that has suddenly became more urgent, after Australia announced it would become the first country to allow psychiatrists to widely prescribe MDMA to treat post-traumatic stress disorder.
“We will have a lot of attention on us as this rolls out,” said Michael Winlo, the chief executive of Australian biotech company Emyria, which is partly funding the lab’s work.
Australia’s drug regulator, the Therapeutic Goods Administration, surprised just about everybody — including the country’s health institutions — when it ruled that from July, MDMA would be rescheduled from a prohibited to a controlled substance. It will also allow psilocybin, the active ingredient in magic mushrooms, to be used in therapy for treatment-resistant depression.
In doing so, the regulator has turned Australia into a countrywide experiment for other jurisdictions, including the United States, to observe. That is especially the case for MDMA, which no nation has made accessible as a mental health treatment except in limited special circumstances, and which has been of increasing interest to the Food and Drug Administration.
Some experts believe the law change in Australia has happened too quickly and could put patients at risk. But the drugs’ advocates say the move could offer recovery to people with debilitating mental illnesses.
Part of the chemical process to isolate an MDMA analog at the University of Western Australia. (Frances Vinall/The Washington Post)
MDMA floods the brain with feel-good chemicals it produces naturally: serotonin, norepinephrine, oxytocin and dopamine. Meanwhile, fear is curtailed: the amygdala, the brain’s threat response system, quietens down.
It’s a cocktail that, practitioners say, allows a patient to examine past traumatic experiences while typical responses like avoidance, defensiveness and shame are blocked.
A 2021 clinical trial published in Nature of people with severe PTSD found 88 percent showed significant improvement after three sessions of MDMA-assisted therapy. More than two-thirds no longer met the criteria for PTSD two months afterward.
The U.S.-based Multidisciplinary Association for Psychedelic Studies (MAPS), the organization that has applied for FDA approval, sponsored the research.
There is also ongoing research into MDMA’s potential in the treatment of addiction, social anxiety and, in the case of the UWA-Emyria lab, Parkinson’s disease. In all, the global psychedelics market is projected to be worth more than $10 billion by 2027.
“It’s a pretty hot area,” said Matthew Piggott, associate professor of medicinal chemistry and the head of the lab at the University of Western Australia.
His team is working on shortening MDMA’s half-life (the length of time the drug is in effect) and eliminating a weak addictive property. In the lab, a chemist carefully pours a clear solution into a flask from a series of test tubes. Inside, each contains an analog of the drug. Nearby, a colleague handles a small jar filled with crystalline yellow precursor, while another switches off a contraption with a spinning sphere.
The work has helped turn the state capital Perth, a city with thousands of miles of desert on one side and the Indian Ocean on the other, into an unlikely vanguard of the nascent psychedelic therapies industry.
The state’s favorable regulatory approach has meant Australian-based biotech companies working in MDMA and psilocybin have set up there, said Suzy Madar, an intellectual property lawyer who specializes in health.
But the companies were still surprised when the drugs were rescheduled in February.
“It’s not common for the TGA to take a lead in this kind of area,” said Winlo of Emyria. “This puts a lot of attention on the various players in this space to see how we proceed.”
Some experts are concerned Australia has not designed an adequate regulatory framework for this type of treatment.
“Those of us at the coalface doing this research can see how there are going to be very few guardrails in place,” said Paul Liknaitzky, head of clinical psychedelic research at Monash University and co-founder of psychedelic therapy business Clarion Clinics.
“The safety and quality of what is provided is going to depend in large part on the goodwill and competence of the providers, not on authorities and governance,” he said.
The TGA, the drugs regulator that operates at arm’s length from government, made the rescheduling decision. It provided some guidance, but its involvement in overseeing MDMA and psilocybin therapies has now largely ceased.
Instead, human research ethics committees — of which there are about 200 in Australia — will be responsible for assessing psychiatrists’ applications to become authorized prescribers, with final TGA sign-off.
One concern expressed by experts is equality of access: Treatments are initially expected to cost about $17,000 for those incorporating standard therapy sessions before and after the drug is taken and multiple dosing sessions lasting about eight hours each.
Another concern is the potential for boundaries to be crossed. Australian clinics planning on offering MDMA therapy for PTSD said they would be adapting from the treatment manual published by MAPS, the organization that has applied for FDA approval.
This method includes “nurturing touch” between the therapist and patient. That could include the patient being “held” by the therapist, or the therapist placing their hand “on an area where the participant is experiencing pain, tension or other physical symptoms.” Withholding touch could be perceived as “abuse by neglect,” it says.
It bars any sexual behavior between therapist and patient and requires prior and ongoing consent for touch. It recommends two therapists, generally one female and one male, be in the room for each dosing session, and that sessions be recorded.
The TGA said it was satisfied appropriate safeguards could be established in the existing system.
But Hester Wilson, alcohol and drug spokesperson for the Royal Australian College of General Practitioners, said the use of “nurturing touch” in an MDMA-assisted treatment worries her.
“If you’ve seen or been with people who are on MDMA, their boundaries are really blurred. They’re so emotionally vulnerable, and just telling everybody that they love them,” Wilson said.
Still, the apparent potential of MDMA to help people who have not responded to other treatment is attractive to many.
At the Pax Centre, a trauma-focused clinic in Perth, co-founders Claire Kullack and Jon Laugharne have undertaken training, along with 18 staff members, and received ethics committee approval for the therapy, using a clinical trial model with recorded, two-therapist sessions and partnering with Emyria, the biotech firm.
About 20 to 30 percent of their clients with PTSD showed little improvement with available treatment methods, Laugharne said. The clinic is cautiously optimistic they may now be able to give some of those people a fuller life.
“We’re at the forefront of something — for once,” he said dryly, referring to Australia. “It’s exciting, and it’s also a big responsibility.”
Sunday, July 30, 2023
The Return of MDMA
Some doctors are itching to prescribe ecstacy again. How do we avoid the regulatory mistakes of the '80s?
In 2006 a Florida man named Zulfi Riza reached out to Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies (MAPS). Riza was suicidal. He was suffering from PTSD, anxiety, depression, and anger issues. He had tried countless remedies, and he felt that Doblin was his last hope. Riza had heard that an underground network of psychiatrists practiced therapy using the illegal drug MDMA, better known as ecstasy or molly. And Doblin knew of such a therapist.
But Riza also suffered seizures. Should a medical emergency take place during a session, the therapist would be exposed and could lose their license, or worse.
Doblin told him he couldn't help. Riza killed himself the very same morning.
The Drug Enforcement Administration (DEA) had unilaterally outlawed MDMA in 1985 under emergency powers granted to it by Congress. To back up the ban, the agency cited flimsy evidence about MDA, another drug entirely. It was a catastrophic case of government overreach. Zulfi Riza was just one of many people whose lives may have been saved had they not been forced to seek help in secret.
The DEA isn't the only villain in this story. In 2002, a senator from Delaware named Joe Biden proposed the Reducing Americans' Vulnerability to Ecstasy (RAVE) Act. This eventually passed, in somewhat watered-down form, as the Illicit Drug Anti-Proliferation Act. It basically made party organizers liable for drugs consumed on the premises. This made it much more complicated to organize services such as testing partygoers' drugs for dangerous ingredients, as it would implicitly admit there was drug-taking on-site.
At a time when Americans are dying in record numbers from accidentally ingesting substances such as fentanyl, a de facto ban on drug checking in places where Americans take drugs—clubs, festivals—seems especially criminal.
Now that the war on weed is all but lost—federal legalization of marijuana feels like a matter of when, not if—the next battlefront will be over MDMA and other psychedelics. This year Australia allowed licensed therapists to give patients the drug. (It did the same as well for magic mushrooms.) Meanwhile, the Biden administration expects MDMA and psilocybin to be approved therapeutically within the next few years.
Rachel Nuwer's book I Feel Love arrives just in time for the debate. It exhaustively chronicles MDMA's journey from a therapeutic tool to an underground party pill and back to therapy. Although many drug books dwell on the criminal element—killer kingpins, sophisticated smugglers—Nuwer, a respected science journalist, mostly prefers to explore the positive potential of ecstasy and the forces, such as MAPS, seeking to unleash it.
As illicit narcotics go, ecstasy is relatively benign. It does not, as an infamous episode of Oprah suggested, turn your brain into Swiss cheese. Instead, it floods you with an overwhelming sense of love, joy, and empathy—the kind of feeling you get, as Nuwer puts it, "if you were suddenly reunited with a good friend that you hadn't seen in years, and you stayed up all night talking because you were so happy to see each other."
It's precisely these properties that make MDMA such a useful tool for addressing trauma, anxiety, and other mental health issues. Since it's virtually impossible to feel bad while on it, patients can dive deep into traumatic events without being overcome with emotions, and open up to their therapists about things they'd normally keep bottled up.
But as any seasoned tripper will tell you, it's not just the drugs; it's how and where you use them—the set and setting. Someone undergoing MDMA-assisted therapy will get support and guidance from trained professionals. Likewise, someone spending all night pumping his fist in the air at a warehouse party in Brooklyn is unlikely to walk away with any psychological breakthroughs.
Rick Doblin's quest to legalize ecstasy features prominently in the book. Doblin has been fascinated with psychedelics ever since his time studying at New College in Florida, in those days an open-minded institution where students took acid and hung around a clothes-free swimming pool. When the DEA announced its intent to outlaw ecstasy in 1984, Doblin led the counterattack, rallying lawyers, shrinks, and scientists. When that failed and the ban was soon to go into effect, Doblin sold ecstasy pills that had been donated by one of the drug's first kingpins, Michael Clegg, to fund experiments on rats and dogs. Doblin then enrolled at Harvard and interned at the White House to become an insider in government policy.
MAPS has been behind several promising studies showing MDMA's potential in treating combat veterans, sexual assault survivors, and others. Less happily, Doblin and MAPS have been criticised recently for how they handled a sexual abuse case during one of their clinical trials. While creepy therapists are hardly unique to psychedelics, tossing mind-altering chemicals into the mix leaves patients particularly vulnerable. Doblin also has a reputation as a psychedelic evangelist who sometimes gets ahead of himself, which has hurt the cause at times. To her credit, Nuwer doesn't shy away from Doblin's flaws, which will likely get more attention as the debate around psychedelics heats up.
Although Nuwer does an excellent job of breaking down the scientific studies of ecstasy and how exactly it works on the brain, there are still gaps in the research. Some experts have questioned whether enough is known about those for whom MDMA-assisted therapy doesn't work. Could it actually make things worse? Certainly, there are accounts of patients feeling suicidal after a session, a point which Nuwer perhaps covers a little too briefly.
Still, most people aren't taking ecstasy in a clinical setting to cope with survivor's guilt after surviving an IED blast in Fallujah. They're doing it to let loose at boisterous jamborees like Coachella and Burning Man. Nuwer feels no shame describing herself rolling on molly at house parties.
As for ecstasy's alleged dangers: Millions of people have taken the drug since the late '80s, but there hasn't been a corresponding epidemic of brain damage. An infamous study that seemed to show that it caused brain damage in monkeys turned out to be bogus after it was discovered the monkeys had been injected not with molly but with meth.
That isn't to say ecstasy is harmless. Nothing is—even caffeine can kill you in heroic doses. But most of the drug's dangers exist precisely because of the DEA's decision to ban it all those years ago. Nuwer tells the story of Martha Fernback, a 15-year-old English schoolgirl who died in 2013 after swallowing half a gram of 91 percent pure MDMA powder. Like almost everyone else who wants to feel the euphoric bliss of molly, she purchased her gear from an underground pusher, not a licensed pharmacist. She had no idea what dose she was taking, or even if it contained MDMA at all.
Imagine if we played the same stupid games with liquor or beer. Actually, you don't have to imagine. Certain parts of the world have banned booze, so the people there aren't sipping fine wine; they're drinking moonshine or bathtub hooch. Many of them then go blind or die. Rather than crusade against the evils of drugs, Martha's mother joined a campaign called Anyone's Child, calling for a reform of British laws and the legalization of ecstasy.
The ancient Greeks had a word, pharmakon, that can mean either "poison" or "medicine." It's too bad we can't always tell which is which.
Sunday, March 15, 2020
'Psyched': First Psychedelics Company Lists Publicly, Phase III Clinical Trials On MDMA For PTSD Natan Ponieman,Benzinga•March 15, 2020
Welcome to the first edition of Psyched, a bi-monthly column covering the most important developments in the industry of medicinal psychedelics. We hope you follow us periodically as we report on the growth of this exciting new industry.
MindMed Became the First Psychedelics Company to List Publicly on NEO Stock Exchange, Created New Committee
Mind Medicine Inc. (OTC: MMEDF) (NEO: MMED) received clearance by Canada’s NEO Exchange to list under the symbol MMED on March 3. This makes it the first psychedelic-focused company to go public on a North American exchange.
MindMed is a neuro-pharmaceutical company that researches and develops psychedelics-inspired medicine. The company is researching 18-MC, a non-hallucinogenic drug derived from the psychedelic plant ibogaine and is setting the ground for Phase 2 clinical trials on LSD microdosing.
After completion of a Phase 1 clinical trial to prove 18-MC’s safety in humans the company is now moving forward to Phase 2 trials, which will assess efficacy and side effects. The 18-MC molecule has been floated as a possible alternative to treating substance addiction, including opioids and tobacco.
The company also announced on March 12 it has formed a technology evaluation, acquisition and scientific integrity board committee, that will be headed by Matthew Johnson, Ph.D.
Johnson is a Johns Hopkins professor of psychiatry and behavioral sciences, who has been one of the leading figures of psychedelic research and treatment development in the past decade. Dr. Miri Halperin Wernli, a psychiatry clinician and a director on MindMed's board, will chair the committee.
Former Canopy Growth Exec. Joined Psychedelics Company Board
Jon Cooper, former Canopy Growth (NYSE: CGC) Deputy Managing Director of U.S. Operations, was named Director of the Board at CaaMTech on Feb. 26.
Cooper founded Ebbu, a Colorado-based cannabis company in 2013. The company was acquired by Canopy Growth in 2018 by CA$429 million ($330 million), which were paid CA$25 million in cash, and the rest in Canopy Stock.
Israel Completed Phase III Clinical Trials on MDMA for PTSD
Two Israeli participants were the first to complete a Phase III clinical study using MDMA as a treatment for Post-Traumatic Stress Disorder, announced the Multidisciplinary Association for Psychedelic Studies (MAPS) on Feb. 26.
The study will be complemented with patients from the U.S. and Canada, and is expected to be completed by 2021. Dr. Keren Tzarfaty, Clinical Investigator, Training Supervisor, and Director of Israeli Projects and Collaborations with MAPS said that MDMA-assisted psychotherapy can have a great impact on patients who suffer from traumatic experiences such as war or sexual assault. Given Israel’s current and historical condition of political instability, it is believed that over 10% of the Israeli population experiences PTSD in relation to war and war-related violence.
In February 2019, Israel became the first country to give financial support to MDMA-assisted therapy, with the granting of $500,000 in medical and hospital services to MAPS. The country was also the first to approve a Compassionate Use program for MDMA therapy for PTSD.
Psychedelic-Enhanced Psychotherapy Clinic Opens In Toronto
The center will be dedicated exclusively to the administration of psychedelic-enhanced psychotherapy. This means that the clinic’s professionals will use psychedelics as tools to improve psychological treatment.
The first psychedelic that will be administered to patients at the clinic is ketamine, a dissociative drug that the former director of the National Institute of Mental Health described as “the most important breakthrough in antidepressant treatment in decades.”
His statement was based on evidence showing Ketamine is safe, provides almost immediate and enduring relief from depression symptoms, and improves neuroplasticity.
The opening follows Field Trip’s announcement of an oversubscribed Series A financing round that raised $8.5 million for the company. Those funds will be used to execute the initial stages of Field Trip's strategic plan to build out its network of medical centers in Toronto as well as in the U.S. with clinics in New York and Los Angeles set to open later this year.
Additionally, the financing will help fund the final construction of its research and cultivation facility at the University of the West Indies in Jamaica that is dedicated to the study of psilocybin-producing mushrooms and the discovery of novel therapeutic molecules.
Prohibition Partners Released its First Psychedelics Report
The European-based cannabis research firm Prohibition Partners released its first report on psychedelics as medicine. The report introduces the language and established categories for the nascent industry, including the drugs psilocybin (‘magic’ mushrooms), LSD, ketamine, MDMA and ibogaine.
The report reviews legislation and regulation around these drugs, their market potential and consumer trends and attitudes. Also included is a profiling of the different compounds in terms of their therapeutic possibilities, a timeline of key events in the history of these drugs and the status of psychedelics as medicine around the world.
Photo by Valentin Salja on Unsplash
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Monday, January 01, 2024
Bringing psychedelic medicine from the margins to the mainstream
BY ROBERT BAUER, THE HILL OPINION CONTRIBUTOR - 12/31/23
Getty Images
Research into the therapeutic benefits of psychedelic drugs is nothing new. In fact, research extends back 80 years with the discovery of lysergic acid diethylamide (LSD), when the Swiss chemist Albert Hofmann, looking to synthesize a migraine treatment, created the derivative of the ergot fungus. It wasn’t until several years later that he accidentally dosed himself and realized LSD’s psychedelic effect.
This initial research kicked off a wave investigating the therapeutic potential of psychedelics, but with the emergence of the secretive and unethical research by the Army and CIA and the rise of the counterculture, the federal government stepped in. The Controlled Substance Act subsection of the Comprehensive Drug Abuse Prevention and Control Act of 1970 classified LSD, heroin, marijuana and a few other drugs as having “a high potential for abuse, no current medical use, and a lack of safety for use under medical supervision,” classifying them as Schedule I substances and effectively killing research because of the hoops scientists would need to jump through, with both the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
It would be nearly three decades before psychedelic medicine research re-emerged in a meaningful way, when researchers at Johns Hopkins obtained regulatory approval to reinitiate research in healthy, psychedelic-naïve volunteers. A subsequent study examining psilocybin administered in a supportive setting is widely recognized for igniting the current period of psychedelic research. This seminal study, which demonstrated long-term benefits of psilocybin (e.g., positive mood, life satisfaction, prosocial behavior) in healthy participants, is just one of many studies that have since confirmed the low toxicity and minimal addiction potential of psychedelics.
In the intervening years, legislative reform regarding psychedelics began to gain momentum. According to a study in JAMA Psychiatry, from January 2019 to September 2022, 25 states considered 74 bills to reform existing laws restricting access to psychedelic drugs or proposed further research into reform legislation. Ten of those bills were signed into law by seven states, with the vast majority (90 percent) specifically referring to psilocybin and 36 percent of the bills also including 3,4-methylenedioxy-methamphetamine (MDMA).
The foundation laid by Johns Hopkins has, over the last 20 years, spurred a wave of interest — and progress — into the benefits of psychedelic medicines.
In October 2022, mental health company Compass Pathways announced initiation of the first Phase 3 program of psilocybin therapy globally for treatment-resistant depression. Initiation of the program followed positive results from the company’s Phase 2b study, presented at the American Psychiatric Association annual meeting in May 2022. Likewise, earlier this year, the Multidisciplinary Association for Psychedelic Studies announced results of its Phase 3 clinical trial of MDMA-assisted therapy, which demonstrated statistically significant improvements in PTSD symptoms after three sessions.
This past June, the FDA published a new draft guidance to highlight considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions. This represented the first draft guidance that presents considerations for designing clinical trials for psychedelic drugs. It recognizes the interest in exploring their therapeutic potential, but also the unique challenges throughout the drug development process, including clinical trial conduct, data collection, subject safety and new drug application requirements.
Further, the draft guidance notes that, for psychedelics that are currently Schedule I controlled substances, activities associated with investigations under an Investigational New Drug Application must comply with applicable DEA regulatory requirements. Importantly, in providing a pathway for the research, this is a tacit signal that the FDA is also indicating to the biopharmaceutical industry that there is ultimately a pathway to approval. With the first approval possibly coming as soon as 2024, there will surely be increased interest in the space, even if it doesn’t translate into an immediate wave of approvals.
Yet, challenges remain.
These challenges are often logistical in nature. Given the psychedelic experience that accompanies treatment, which can last up to 12 hours in some cases, conducting clinical research is labor and resource intensive. FDA’s guidance requires two people to monitor clinical trial participants. One of these monitors needs to be at least a Ph.D.-level researcher and the secondary monitor still needs to have experience in the mental health space. This is something that will likely extend into treatment once these medicines are approved. Uptake could be a similar challenge, as it could require two people to guide patients through their psychedelic experience to make sure they remain safe, and if there are any adverse effects, that they can support them along their journey.
This is also new ground for the FDA, and the agency will likely take a very cautious approach to safeguard patients and minimize the risk for unforeseen treatment-emergent safety concerns. Compounding the challenge of uptake is that manufacturers and investigators will need to go through the process of securing DEA clearance to be authorized to administer these drugs in the research setting.
Despite decades of research, the FDA’s draft guidance is finally bringing psychedelics research into the light. As the space continues to progress, there could be a move toward fine tuning the experience for patients. That may mean minimizing the psychedelic effects of these drugs without compromising their therapeutic benefits or being more selective in the receptors researchers target to reduce their adverse potential. Along with this evolution, a meaningful step that could bring us closer to realizing the full potential of these important therapeutics would be for the Department of Health and Human Services (HHS) to initiate a review to consider recommending rescheduling of the individual drugs or the entire class. The precedent for such a move was recently set when HHS recommended in August 2023 to have cannabis moved to Schedule III from its current Schedule I. Doing so would greatly ease access for further research and eliminate the administrative burden on prospective researchers and the DEA that is currently required to review the paperwork from each researcher for each trial they plan to conduct.
In researching her new book, about the therapeutic applications of MDMA, author Rachel Nuwer dove into MAPS. She discovered the group was supported by some surprising benefactors.
This includes Elizabeth Koch, the daughter of Charles Koch of Koch Industries, which is one of the largest private American companies. Besides their massive fortune, Charles Koch and his brother David are known for funding conservative movements, like the Tea Party.
Nuwer explained in her book that though it may be counterintuitive, many public figures with conservative ties, like Elizabeth Koch, invest in socially liberal groups like MAPS. Advertisement
Read below for the story of how Elizabeth Koch came to support psychedelic therapy in an excerpt from Rachel Nuwer's new book "I Feel Love."
When it's sold on the street, MDMA is sometimes distributed in pills like these.
Reuters/ DEA
The moment I walked through the door of the loftlike space, the slender forty-five-year-old greeted me with a hug, a blanket, and not one but two very LA-appropriate canned drinks ("energy booster" and "prebiotic popping soda") from the office's meticulously organized fridge. Elizabeth's bubbly enthusiasm and disarming warmth immediately put me at ease, and within minutes I felt as though I were chatting with an old friend.
Elizabeth's uncanny ability to endear herself to others is a skill she has been cultivating nearly her entire life, and it's actually a symptom of her trauma. In hearing her story, I would learn that MAPS's fundraising success doesn't just boil down to Doblin's prowess as a salesman, or to wealthy people simply loving MDMA, but to the fact that trauma and suffering are universal.
Not even the most privileged individuals in the world are immune to mental anguish, and they can face the same limitations as the rest of us in finding relief for that pain. Elizabeth's "fall from Eden," as she described her index trauma, occurred when she was five years old.
After a close friend of her parents severed his spine by diving into a shallow pond, the family went over to pay their respects to the now wheelchair-bound man. The atmosphere in the house was oppressively somber, so to lighten the mood for her little brother, Elizabeth began singing the Humpty Dumpty song.
In one refrain, though, she absentmindedly replaced "Humpty Dumpty" with the name of the paralyzed man. Suddenly, all the tension in the room was directed at her. "I see my dad looking over his shoulder and giving me this death stare," she recalled.
Charles Koch, Elizabeth Koch's father, who owns Koch industries. At the time of writing, his estimated net worth is $62.5 billion USD.
When the family got home, Elizabeth's father sat her down. "You kids don't get it," she recalled him saying. "You have everything that everyone wants, and you'll be hated for it your entire life. Your job, always, is to be the nicest person in the room, and the hardest worker in the room — the one who picks up garbage that everyone leaves behind. You have to be aboveboard because if you aren't, you'll not only be hated by everyone else but also by yourself."
Looking back on this incident with an adult's perspective, Elizabeth now understands that her father was trying to protect her. "He was absolutely terrified that my brother and I would grow up to be spoiled, piece-of-shit monsters," she said. As a five-year-old, however, she interpreted his lecture to mean that she could only be loved if she were good.
That pivotal message came to hold sway over nearly every facet of her personality and life.
It started with a nightly ritual: before bed, she would review everything she had said and done that day to make sure she had been the nicest person and the hardest worker, and that she hadn't accidentally hurt anyone's feelings. If something bad happened to her — say, she tripped and skinned her knee — she would tell herself that it was because the universe was punishing her for not being good enough.
In classrooms, during extracurricular activities, or on sports teams, she would always beeline for whichever kid she thought would hate her the most — usually the one who appeared to have the least money, or the one who looked the least like her — and try to win them over by telling them funny stories about her family's dysfunction.
Over the years Elizabeth rose to the top of her class, won competitions for her writing, and made many friends, but she lacked joy. "I have to do this to prove that I deserve to be alive," she would tell herself each time she accomplished something.
"I have to earn my existence."
Her paranoia about what others thought of her intensified, as did her unhappiness. She realized she needed help and began trying various mental health solutions, including yoga, silent meditation retreats, and, briefly, medications. Advertisement
She read books about Buddhism and neuroscience and gained glimpses of insight. But no amount of knowledge, learning, or practice brought genuine relief.
MDMA, also known as ecstasy, initially became popular as a club drug.
When a friend suggested in 2016 that she try psychedelic-assisted therapy with a "consciousness cowboy" he knew — an ex-military man who called himself Doug the Lovebunny — she agreed. Doug filled a silver balloon full with "some kind of vapor smoke," Elizabeth recalled, and instructed her to breathe in and hold it.
She had no idea what she was in for: he had given her 5-MeO-DMT, a short-acting but incredibly potent tryptamine. The ego-abolishing drug dissolved Elizabeth in totality. It was terrifying.
Doug the Lovebunny hadn't prepared Elizabeth for this harrowing and destabilizing experience, and he did not provide any support or integration for her afterward. For weeks, she would wake up in the middle of the night, she said, "scrambling to try to grab hold of my body."
She wanted to know more about what she was going through, and research led her to MAPS. She attended a psychedelics conference in Los Angeles, where she was moved and inspired by the firsthand accounts shared by war veterans who had taken part in the MDMA-assisted clinical trials for PTSD.
"I Feel Love" by Rachel Nuwer was published in June and describes the fascinating transformation of how we've come to use the psychedelic drug MDMA.
Bloomsbury Publishing
MDMA sounded a lot more user friendly than 5-MeO-DMT — and perhaps, Elizabeth thought, it could help her, too. So in spring 2018, she found "someone off grid" who agreed to give her MDMA-assisted therapy following the MAPS protocol.
Elizabeth wound up doing three sessions, and through that process, she saw the vast amount of pain she had been harboring throughout her life.
"I had been terrified of joy," she said. "The medicine showed me the degree to which all this buried stuff that I hadn't even been able to see was causing me to be reactive and feel constantly trapped, overwhelmed, and miserable."
The MDMA sessions (one of which she also paired with psilocybin) helped Elizabeth let go of the "intense self-hatred" she had been burdened with since she was five years old, she said, and to feel sympathy and love for herself. She's since become one of MAPS's top five donors.
"MDMA is not going to save the world," Elizabeth said. "But together with conversations and experiences of going inward and self-investigating, I think it can help."
Following that thread, in 2018, Elizabeth founded a company, Unlikely Collaborators, that aims to bring people together who seem like they're on opposite sides of an issue, and then work with them to reveal their shared humanity and commonalities.
If and when MDMA-assisted therapy gains FDA approval, Elizabeth also envisions Unlikely Collaborators providing community-oriented group integration services.
Peyote is the darling of the psychedelics renaissance. Indigenous users say it co-opts ‘a sacred way of life’
Flowering peyote plant (Photo: Hans B | CC BY-SA 3.0)
BY ANNETTE MCGIVNEY, THE GUARDIAN
On the first day of autumn, evening temperatures near Window Rock, Arizona, were brisk. Beneath the late September sky, a traditional round hogan in this remote corner of the Navajo Nation was enveloped in darkness. Ten tribal members gathered inside.
This article was originally published in The Guardian and is used with permission.
“When this is over, you will feel like a washrag with all the gunk wrung out of it,” the man’s grandmother told him.
Tonight, the ritual would be no different from what it was a century ago. There would be peyote songs and drumming. Margie Whitney-Silva, a certified spiritual leader known as a roadman, would supply the peyote in the form of a tea brewed from the cactus, carried in a large pickle jar. Eagle-feather fans and gourd rattles would be used as the jar was passed around.
During the 19th and first half of the 20th centuries, Indigenous Americans risked being thrown in jail for participating in such ceremonies because peyote was illegal under US law. Today, it is just the opposite. Peyote and mescaline – the hallucinogenic substance found inside the cactus – have become a darling of the psychedelic renaissance.
Peyote, mescaline and other hallucinogenics such as LSD, MDMA, ayahuasca and magic mushrooms are being touted for their capacity to revolutionise the treatment of PTSD, addiction and other health problems. In recent years, progressive politicians, doctors, community groups and Silicon Valley investors alike have thrown their weight behind decriminalization bills in dozens of US states and cities.
Their concerns are multifold. Decriminalizing peyote could fuel poaching and a black market for the slow-growing cactus, whose limited habitat is already threatened by climate change and development. A sudden surge in demand might completely wipe out peyote from its natural environment, traditional practitioners say.
Then there are the deeper concerns about turning peyote and mescaline into an on-demand drug. Members of the Native American church of North America, an inter-tribal religion that revolves around the ancient practice of peyotism, are alarmed by pharmaceutical ventures seeking to create mescaline in a lab, in much the same way opium from the poppy flower was synthesized to create fentanyl.
Non-Indigenous leaders in the psychedelic space insist they are respecting Native American spirituality by using synthetic mescaline instead of the real thing. Dozens of Indigenous Americans interviewed for this story see it otherwise.
At its core, the push to medicalize and mass-produce peyote and mescaline goes against the Indigenous American worldview of interconnectedness. There are no English words that describe how the spiritual character of peyote is inextricably intertwined with its hallucinogenic properties, the land where it grows and the Indigenous Americans who consume it, says Jones. In the Navajo language, Jones describes this harmonic oneness as azee’ hinááh binÃÅ‚ch’idiyin, be’adÃnÃdÃÃn.
Creating synthetic mescaline in a lab or growing peyote in a greenhouse is a violation of natural law, and interrupts the unique symbiotic relationship with the plant. “What western scientists call mescaline is for us the essence of the medicine,” said Jones. “It is the soul of it and what makes it holy.”
Traditional peyote practitioners emphasise that they are not against the use of all psychedelics to innovate new treatments for addiction and PTSD. After all, their experiences prove just how powerful a healing tool these substances can be.
But they question why peyote and mescaline need to be used when a variety of other tools – especially psilocybin and MDMA – have proven effective. In rushing to medicalize peyote, which has a unique history and a sacred role for tribes, the decriminalisation movement risks perpetuating more harm in the name of doing good, they say.
“I’m all for healing,” said Cora Maxx-Phillips, a social worker, member of the Navajo Nation human rights commission and board member of the Council of Peyote Way of Life Coalition, a grassroots group in the Navajo Nation.
“But don’t do it at the expense of our people, who are trying to survive the multigenerational trauma inflicted upon us. Please, leave us alone.”
A fight for tradition
The ceremony near Window Rock was a private, emotionally grueling ritual that lasted all night.
Before the ceremony, Boyd Tsosie, another roadman who led the ritual, said the experiences of ancestors from three or four generations prior might surface. There would be little discussion; the goal was for each person to embark on their own inner journey in a kind of spiritual vision quest where the plant itself was the guide.
Tsosie emphasized that the practice of peyotism is as much about the ceremony as it is about the psychological effects. “We don’t view peyote as a substance the way non-Natives think about drugs,” said Tsosie. “There is no hallucination, no trip. The medicine is not used to numb the body like with other drugs, but to teach us.”
Fear and anger about what outside forces might do were palpable inside the hogan. Synthesizing, commodifying and enriching oneself at peyote’s expense is no way to treat a relative.
“We just have a sliver left of what we hold dear,” said Tsosie. “And we are praying and fighting to hang on to it.”
The way modern tribal members tell it, their ancestors were drowning in sorrow as a result of federal policies to seize their homeland and sacred sites, force their children into boarding schools and forbid the practice of traditional ceremonies. Peyote was sent by the creator as a kind of life raft that traveled from tribe to tribe, and those who jumped on, survived.
Then in 1883, Congress passed the Religious Crimes Code, outlawing Indigenous American spirituality on the grounds that it hindered the federal policy of forced assimilation. In addition to peyote ceremonies, the sun dance and ghost dance were only practiced in secret, with violators subjected to jail time and the withholding of food rations.
Frank Dayish, 65, grew up on the north-western corner of the Navajo reservation and is descended from generations of peyote practitioners. He remembers how, when he was a young boy, tribal law enforcement would show up at his home and seize his community’s supply of peyote.
“The Navajo Nation police put all the peyote in a pile and poured gasoline on it and burned it,” said Dayish. “After they left, my father and his brothers would try to salvage what was too green to burn.”
The religious crimes law would not be repealed until 1978, when Congress passed the American Indian Religious Freedom Act (Airfa). But Airfa did not specifically address the use of peyote, which the federal government still classified as a highly addictive, schedule 1 drug. To distinguish themselves from the experimental hippies in the 1970s, Indigenous American peyote practitioners banded together to form a religion called the Native American church, demanding the same protections for their religious beliefs as anyone else in the US.
After decades of lobbying by Native American church groups, a 1994 amendment to Airfa finally gave protections to Indigenous American peyote users by stipulating that peyote can only be consumed by a “federally recognized tribal member” and “in connection with a traditional Indian religion”. The amendment also authorized tribal members to legally transport peyote across state lines.
“That was a huge victory for us,” said Dayish, who was president of the Native American church of North America at the time and heavily involved in lobbying for the amendment.
However, the hard-won exemption soon had unintended effects. Non-Indigenous New Age groups, such asJames Mooney’s Oklevueha church and the Peyote Way Church of God,began offering access to the sacred cactus by claiming to follow the Native American church religion or their own brand of peyote religion.
In a precedent-setting 2004 case, the Utah supreme court ruled that Mooney was allowed to distribute peyote to his church members under the Religious Freedom Restoration Act. The result was to embolden psychedelic activists, who established plant-medicine churches on the grounds of religious freedom and to invigorate the decriminalization movement.
Today, one of the largest groups behind this movement is called Decriminalize Nature. The organization has 50 chapters across the United States, each comprising grassroots plant-medicine activists who advocate for legislation at state and local levels. Their logo features a peyote button, with a website that urges humanity to “draw upon the ancient wisdom of all our ancestors who lived from the Indigenous Worldview upon this Earth”.
Aikutzi Valadez, a member of Decriminalize Nature’s board, believes anyone should be allowed to grow peyote in private greenhouses for their personal use in order to increase supply and protect the cactus from being depleted in its native habitat. Valadez resides in California but is a member of the Huichol tribe in Mexico, which practices peyotism. She said that because she is not enrolled in a federally recognized tribe in the US, current drug laws prevent her from being able to engage in traditional peyote rituals where she lives.
“Native American church members need to look at the big picture,” she said. “If they are concerned about peyote becoming commodified, the solution is to make it widely available so it’s not just the pharmaceutical companies that have access. We are trying to liberate peyote because it is Mother Nature’s plant and should not be criminalized.”
This anti-corporate, nature-based ideology is appealing to many liberal-minded activists. But the philosophy of Decriminalize Nature, and groups like it, illuminates a tension at the heart of the peyote debate. Native American church leaders say groups describing themselves as culturally progressive are not only ignoring the requests of tribal governments but have done little to consult them on how peyote should be used by non-Indigenous people – if at all.
While the group’s policy is positioned as a “working plan” to help Native American church members and other Indigenous peyote practitioners protect their sacred medicine, Kevin Feeney, a cultural anthropologist at Central Washington University, sees echoes of the US’s colonial past in such efforts.
“There is the sentiment within the movement that decriminalizing these plants will result in this rosy, kumbaya situation where we all get to take peyote,” said Feeney, who has written extensively on peyote issues. “They are saying, let bygones be bygones … But, really, they are only asking Native people to be OK with this history.”
An $11bn industry
The psychedelics drug market is expected to be worth more than $11bn by the end of the decade. And while the use of psilocybin and MDMA in a clinical setting are farthest along, mescaline is the dark horse that some of Silicon Valley’s biggest investors are betting on.
One company riding the wave is Journey Colab, a pharmaceutical startup that’s developing psychedelic drugs and therapies. Since its founding in 2020, the company has raised more than $12m from high-level investors including Sam Altman, the founder of ChatGPT and an avid psychedelic proponent.
Journey Colab’s founder, Jeeshan Chowdhury, says people describe him as a “Silicon Valley tech bro”. He’s also a physician and the son of Indian immigrants.
He says he was intrigued by mescaline when he started the company. “The elders and respected leaders in the psychedelic space all told me mescaline was their favorite,” he said.
Peyote has long had a certain cachet in the psychedelics world. The English writer and philosopher Aldous Huxley first coined the term “psychedelic” in his 1954 essay The Doors of Perception to describe a mescaline trip. The perpetually intoxicated gonzo journalist Hunter S Thompson further popularised the drug in works like Fear and Loathing in Las Vegas.
While mescaline was studied for its therapeutic benefitsin the 1950s and 1960s, it became overshadowed by LSD, which was cheaper and more accessible. Today, multiple companies, including several in Canada – where there are fewer restrictions on mescaline – are developing mescaline-based products and growing peyote in greenhouses.
The Canadian company Lophos Pharma, for instance, describes itself as “North America’s largest cultivation and research facility for peyote cactus” and is working on genetically modifying peyote to “decrease the peyote growth timeline from 13 years to as low as 3 years”.
Chowdhury says he set out to do things differently, and was influenced by Altman’s OpenAI model, which strives to share technological benefits with society at large. Alongside its drug development, Journey Colab set aside 10% of its founding equity for Indigenous groups, such as the peyote practitioners in the Native American church, as part of what it calls the Reciprocity Trust. Journey Colab has also signed a “patent pledge” that promises to use only synthetic mescaline in its products, and to not directly utilize any Indigenous resources.
Chowdhury says the fund is about respecting Indigenous American use of peyote and sharing financial benefits with Indigenous populations. “I believe if you have used any psychedelic personally or they are in any part of your professional career, we all owe our relationship to these medicines to the Indigenous communities who have stewarded this knowledge for generations,” Chowdhury said.
Native American Church prayer tipi near Potomac Park on the National Mall in Washington, D.C. (Photo by Darren Thompson for Native News Online)
However, he admits he did not consult with US Indigenous American peyote practitioners or leaders of the Native American churchbefore establishing the Reciprocity Trust. Nor did he get their opinion about creating a company that revolves around synthetic mescaline. He says he wants to give back because he believes it is the right thing to do, but he also believes that because Journey Colab’s synthetic mescaline product is not directly derived from peyote, it is not appropriating Indigenous Americans’ sacred medicine.
“There is absolutely no use of peyote or any botanical material in the construction of our synthetic mescaline,” he explained.
This is of little comfort to peyote practitioners. Aside from the spiritual implications, there is no guarantee other companies won’t try to obtain patents for mescaline that may contain some degree of organic material, or attempt to patent aspects of Indigenous American ceremonies as part of clinical treatments.
According to Chowdhury, establishing how and when the Reciprocity Trust will distribute company profits is currently on hold. Leaders of both the Peyote Way of Life Coalition and the Native American church of North America have been reluctant to engage with Journey Colab regarding the Reciprocity Trust, which is featured prominently in the company’s marketing material.
“Our unwritten spiritual laws don’t allow us to receive benefit from the extraction of our holy medicine or from our sacred heritage molecule that the pharmaceutical companies are trying to appropriate,” said Ryan Wilson, a peyote practitioner with the Oglala Lakota tribe and chair of the Native American church of North America’s legislative committee. “We don’t sell our way of life.”
While psychedelics have created a new gold rush, cultural anthropologist Feeney says the drive is about more than money.
“If someone’s goal is to have a psychedelic trip, then why do they need to use peyote or mescaline when there are so many other equally effective options like LSD or psilocybin?” he said. “I think it comes down to what non-Natives in the United States associate with the American Indian. They want a psychedelic trip and they want something that feels traditional, authentic and Earth-based.”
The proliferation of non-Indigenous ayahuasca ceremonies and plant-medicine retreats show just how mainstreamed Indigenous spirituality has become. Ayahuasca used to be largely off-limits to tourists and required an arduous trip into the South American jungle with the permission of a tribal community. Today it’s possible to attend luxury ayahuasca retreats in places like New York, New Mexico and Florida that cost thousands of dollars and promise access to Indigenous wisdom and sacred ceremonies alongside yoga, massage and other perks.
As a white person who is disconnected from his own European ancestry and Catholic religion, Feeney says he understands the desire to find meaning through Indigenous spirituality.
“There is a common emptiness among the European diaspora in this country,” Feeney added. “But, we can’t continue to perpetuate the harms of colonization by trying to fill that hole with Indigenous people’s culture.”
Coals from the woodstove that had burned all night were used to form a giant heart on a square of dirt inside the structure. It was a testimony to the 12-hour spiritual marathon the participants had completed.
Hostess cupcakes and coffee were passed around. A rooster crowed. Eventually people made their way outside, where Native American church volunteers were cooking breakfast. Navajo was spoken more than English.
The student struggling to overcome alcohol abuse reported that he felt “energized and happy” as he held his girlfriend’s hand. They said the power of the experience was not just about ingesting peyote but also receiving support from their community and connecting to a tradition passed down by their ancestors.
Margie Whitney-Silva stood outside the hogan hugging the pickle jar to her chest. About half of the peyote tea had been consumed.
Having inherited the role of Native American church roadman from her father, Whitney-Silva takes the responsibility of “protecting the medicine” very seriously. She has been facilitating peyote ceremonies on the Navajo Nation for nearly two decades, ever since she first heard the sacred cactus singing to her from inside her deceased father’s medicine box.
When Whitney-Silva had arrived at the ceremony the night before, she said, she had been filled with grief. Her husband had died suddenly just a few weeks prior.
“I thought I was going to collapse, but then I heard the singing,” she said. “Our medicine is like a beating heart. As long as you have it, you will be OK.”
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