Researchers expressed concern when Australia's traditionally conservative medicines regulator approved the use of psychedelics to supplement therapy sessions earlier this year.
Psilocybin, a substance present in magic mushrooms, will now be used to treat depression that is resistant to treatment. It will also permit the use of MDMA, also referred to as ecstasy, as a PTSD treatment.
Australia will be the first nation to officially classify psychedelics as medicines when the changes take effect on Saturday.
Although there will be limited and expensive initial access to the medications, many professionals and patients are hailing it as a historic moment.
Large health organizations, however, have also advised caution.
In 2017, a severe depression diagnosis was made for Marjane Beaugeois. She recalls, "Within two months, I lost my mother, my grandmother, my cherished pet dog, and my romantic relationship.".
She claims that taking antidepressants on a doctor's prescription left her feeling "zombie-like, unable to cry, self-soothe, or feel better." She was unable to eat, take a shower, or leave her Melbourne home.
The 49-year-old says, "I'd still pray before going to sleep not to wake up.
She was hesitant to visit an Amsterdam psilocybin clinic when her search for complementary treatments brought her there. .
"I don't use drugs or alcohol in the past. I was always strongly opposed to it as a counselor for addiction, she claims.
But in 2018, she made an appointment because she was desperate to get out of her treatment-resistant depression.
Psilocybin was ingested in tea. "The colors grew more vivid. I had a strong sense of being reconnected to the world; I felt cozy. It was a huge, beautiful experience of unconditional love, and just thinking about it makes me emotional. ".
She felt better after three sessions. She claims, "I could laugh, experience joy, and go about my daily activities with clarity.". "When I got home, friends reported seeing my eyes sparkle once more. " .
Glen Boyes' therapist was skeptical when he suggested using microdosing psychedelics to treat his incapacitating depression.
He says that although he couldn't stop me and would monitor my progress with brain scans, "he explained it wasn't something he does.".
The 33-year-old veteran claims that during Covid-19 lockdowns in Sydney, he first noticed "lingering PTSD" from his time in the army.
On his initial brain scans, however, red areas that indicated blockages had disappeared after 10 weeks of microdosing and therapy sessions. "My mental haze vanished. My mental clarity had returned. ".
The small cohort of people who have undergone psychedelic therapy is due to the fact that no other nation has rescheduled these drugs for clinical use on a national level.
Australia is "leading the world in this vital treatment innovation," said Professor David Nutt, Head of Neuropsychopharmacology at the Imperial College in the UK.
Dr. Ben Sessa, a psychiatrist and psychedelic researcher, called the approval groundbreaking. The BBC reported that "this is where the international psychedelic spotlight now shines.".
Dr. Sessa, who formerly oversaw the UK's main clinical organization for psychedelics, has given notice of his resignation and will now spend the next 18 months traveling to Australia to present a customized training course on psychedelic prescribing.
In other nations, such as Switzerland, Canada, and Israel, the use of psychedelics for compassionate purposes has been investigated. In these countries, regulators have reached similar conclusions, though not at the national level as in Australia. Jamaica and Costa Rica, among other nations, permit the legal operation of psychedelic clinics.
However, it will be closely observed how and at what cost Australia implements clinical prescriptions for both medications.
Ecstasy, which was initially created in 1912 as an appetite suppressant, was used in therapy sessions in the US up until the mid-1970s, when it was made illegal. Due to reports of its effects on increased energy, empathy, and pleasure, it was a party drug when it first arrived in Australia in the 1980s. It was made illegal in Australia in 1987.
Though little is known about how MDMA and psilocybin work to alleviate symptoms of severe depression, research slowly began to pick up again in the 2000s. Recent studies have found that both substances can quickly alleviate these symptoms.
A charity called Mind Medicine Australia (MMA), which advocated for psychedelic therapies, is aiding in the education of medical personnel who will be buying and prescribing the drugs.
Psychiatrists must submit an application to a drug regulatory agency in Australia, the Therapeutic Goods Administration (TGA), as well as an ethics committee, in order to be authorized to prescribe. Then they will have to find and supply both MDMA and psilocybin.
One psychedelics expert estimates that total costs, which include the drugs themselves, supervision from multidisciplinary teams, psychiatrist sessions, and hiring a private clinic, could reach A$30,000 (£15,700, $20,000) per treatment.
For the first 12 to 18 months, Dr. Stephen Bright, senior lecturer at Edith Cowan University, questions whether these treatments "will be very widely available at all" due to their prohibitive cost.
According to the BBC, patients should expect to pay between A$10,000 and A$15,000 for two psilocybin-assisted therapy sessions and three MDMA-assisted therapy sessions, respectively. Philanthropist Peter Hunt, chair of MMA, disputes those estimates. He explained, "We calculated the costs of the treatments with a mental health clinic.
The five-figure treatments are expected to remain out of reach for the majority of patients, however, because there are no planned government subsidies.
Among the most vocal opponents of psychedelic treatments are Australia's major medical and mental health organizations.
According to Kristen Morely, a professor of addiction medicine at the University of Sydney, "the scientific and medical community has been very cautious.".
The "weight of submissions from thousands of Australians whose current mental health treatments simply aren't working," according to MMA, helped the TGA approval cross the finish line. .
However, the Australian Medical Association (AMA) and the Royal Australian and New Zealand College of Psychiatrists (RANZCP) have expressed grave reservations.
Both organizations have demanded more thorough research and larger-scale studies into psychedelic therapies, warning of the unknowable dangers, long-term side effects, and "potentially very limited benefits" from their use in therapy.
"In cases where other treatments have been tried and failed, a small number of patients may find hope in psychedelic-assisted therapy. The head of the RANZCP's Psychedelic-Assisted Therapy Steering Group, Professor Richard Harvey, cautioned that it was not a miracle treatment.
The "potential for psychedelic substances to cause fear, panic, and re-traumatization" prompted him to advocate for a "cautious, considered, and informed" approach.
When a patient's therapy experience doesn't live up to their expectations, he explained, "vulnerable people can understandably feel distressed.".
Whether the effects of psychedelic treatments were more due to the drugs themselves or the psychotherapy is also unknown, he claimed.
Simply put, psychedelic-assisted therapy is a young field. We need to know more information.