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)
BRETT WILKINS
Feb 03, 2023
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.
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)
BRETT WILKINS
Feb 03, 2023
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.
Many are celebrating Australia’s decision to pave the way for these psychedelic therapies, but questions around accessibility remain.
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GRACE BROWNE
WIRED.COM
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.”
03.02.2023
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.”
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