The Therapeutic Goods Administration (TGA) of Australia has made a surprising announcement allowing for the limited use of two controlled substances, 3,4-methylenedioxy-methamphetamine (MDMA) and psilocybin, as medicines.
This move marks Australia as the first country in the world to officially recognize these substances as medicines.
Despite being illegal to possess or supply in Australia, MDMA and psilocybin have been found to "have dramatic effects on conditions considered refractory to contemporary treatments," says Dr. David Caldicott, a clinical senior lecturer in emergency medicine at Australian National University
As a result, millions of dollars of funding have been poured into clinical trials to assess the safety and efficacy of psychedelics, and deepen our understanding of how to best apply them to our lives.
Caldicott asserts that “the safe ‘re-medicalization’ of certain historically illicit drugs is a very welcome step away from what has been decades of demonization.”
“In addition to a clear and evolving therapeutic benefit, it 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’.”
Controlled use of MDMA and psilocybin.
“These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients,” the TGA said.
The decision will amend the Poisons Standard, reclassifying the drugs — for these specific uses — as “controlled drugs”.
This will allow authorized psychiatrists to access and supply a specified “unapproved” medicine containing these substances to their patients, and for these substances to be used “therapeutically in a controlled medical setting”.
“There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety, and efficacy,” the TGA said.
The medicines containing these medicinal psychedelics are scheduled to be authorized for prescription starting July 1, 2023.
Caution and further research are needed.
Cognitive neuropsychologist Professor Susan Rossell, from Swinburne’s Centre for Mental Health, still has “a significant degree of caution” about the decision, pointing out the lack of data on long-term outcomes as a concern.
As the lead researcher on Australia’s largest clinical trial on psilocybin’s effectiveness for treatment-resistant depression, she emphasizes the need for further research.
Dr. Stephen Bright, senior lecturer and director of Psychedelic Research in Science and Medicine (PRISM) at Edith Cowan University, acknowledges that the announcement is an “important step in drug policy reform” in Australia, but stresses the need for extensive training for the approved psychiatrists to ensure safe use. He also warns that the decision may lead to more people accessing the drugs illegally, “through desperation”.
The TGA acknowledges the vulnerability of patients during psychedelic-assisted psychotherapy, emphasizing the need for controls to protect them.
The decision to allow the use of MDMA and psilocybin in Australia acknowledges “the current lack of options for patients with specific treatment-resistant mental illnesses,” and allows for their use in a controlled medical setting.
In conclusion, while the approval of MDMA and psilocybin as medicines marks a positive step forward in drug policy reform, caution and further research are necessary to ensure their safe use.
What's with the stigma around MDMA and psilocybin?
MDMA was initially used in the 1970s as an adjunct to psychotherapy.
It was believed that the drug's ability to enhance empathy and emotional openness could help therapists build trust with their patients and facilitate deeper therapeutic connections.
However, by the end of the 1970s, the drug had become popular for recreational use, leading to concerns about its potential for abuse and negative side effects. In response, the U.S. government classified MDMA as a Schedule I controlled substance, meaning it was deemed to have a high potential for abuse and no accepted medical use. This made it illegal to use, manufacture, or distribute the drug.
As a result, research into the therapeutic potential of MDMA effectively came to a halt, and it wasn't until recent years that clinical trials started to investigate its efficacy in treating mental health conditions such as PTSD.
Similarly, the criminalization of psilocybin mushrooms was not driven by scientific evidence or medical research, but rather by cultural and political factors.
The anti-drug sentiment of the 1960s and 1970s was characterized by moral panic about the perceived dangers of drug use, particularly among young people. This led to a political climate in which strict drug laws were enacted and drugs were criminalized with little regard for their actual effects or potential benefits.
Additionally, the criminalization of psilocybin mushrooms was not based on a comprehensive understanding of their effects or the context in which they were being used. Many indigenous cultures have used psilocybin mushrooms for centuries as a sacrament in religious or spiritual ceremonies, but these cultural traditions were largely ignored in the drive to criminalize the drug.
In conclusion, the recent announcement by Australia's TGA to allow the limited use of two psychedelics — MDMA and psilocybin — for the treatment of mental illnesses has sparked a renewed interest in the potential benefits of these substances.
Despite the cautiousness of some experts and the need for further research, the move marks a significant shift in the perception of these drugs and their potential to heal the mind.
The question that now arises is where this change in policy will lead us in our journey toward better mental health.
Will we continue to explore the use of psychedelics in therapy, or will we revert back to the "war on drugs" mentality?
As the late pioneer of psychedelic therapy, Stanislav Grof, once said, "psychedelic substances have the potential to revolutionize our understanding of the human mind and its relationship to nature."
The future of mental health and psychedelics remains to be seen, but one thing is for sure — this is just the beginning of a new and exciting chapter.
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