The use of psychedelics for PTSD and drug-resistant depression has gained attention in recent months following the reclassification by Australia’s Therapeutic Goods Administration (TGA) from category nine to category eight.
The reclassification has meant that from July 1 this year, authorised psychiatrists can prescribe MDMA (or ecstasy) and psilocybin (or “magic mushrooms”) to treat some mental health conditions along with control measures.
These mental health conditions are post-traumatic stress disorder (PTSD) and treatment-resistant depression.
While the reclassification by the TGA has been described as a “world first,” there have been some criticisms of the move, particularly by peak bodies such as the RANZCP, which have said that further research is needed along with adequate screening measures.
“Australia has a chance to lead—we’ve become the first nation in the world to reschedule these medicines,” Ms. de Jong told The Epoch Times.
“And the reason for the TGA doing that is because they acknowledge the huge amount of suffering, intractable and immense suffering, in this country.”
Ms. de Jong and Mr. Hunt’s charity, Mind Medicine Australia, launched their “world-leading” training in psychedelic-assisted therapies in 2021. An estimated 350 clinicians will have been trained by the end of this year, of whom 30-40 percent are psychiatrists who will screen patients with the specified mental health conditions and prescribe them psychedelics and psychedelic-assisted therapies.
These psychiatrists will have the option of providing such services by the December quarter of this year, Mr. Hunt said.
Treatment Carries ‘Unique Risks,’ ‘Safety First’ Approach Needed: RANZCP
Meanwhile, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) released a memorandum in June outlining “safety first” guidelines for psychiatrists treating patients with PTSD and treatment-resistant depression.In it, the RANZCP states that the use of psychedelic-assisted therapy (PAT) is only recommended for those “whom established psychiatric treatment methods have been attempted without lasting success.”
“Patient safety is paramount, and PAT carries unique risks that necessitate careful clinical judgement and clear communication with potential patients,” the RANZCP said.
Such risks include acute sensitivity and adverse psychological reactions or negative experiences, i.e., fear, panic, and re-traumatisation.
Hence, “proper preparation and support” and an “appropriate setting led by clinicians with appropriate training and experience in PAT” will help mitigate this risk, the RANZCP states.
Additionally, psychiatrists must obtain approval for the use of the substances for patients under their care from a human research ethics committee (HREC) that is registered with the National Health and Medical Research Council (NHMRC).
Ms. de Jong and Mr. Hunt agree with the control measures but do not agree that there is limited research.
“Hundreds of trials have been conducted post the War on Drugs when you could no longer effectively use these medicines,” Mr. Hunt said.
“The trials have been occurring since the early part of this century … for the last 20 years. Psilocybin was used extensively in the 1960s for therapy, and MDMA was used as part of therapy into the 1980s.”
Mr. Hunt argued that bodies such as the RANZCP have had “plenty of time” to consider the trials for MDMA and psilocybin for mental health conditions and claimed that the RANZCP is not “looking forward.”
“Everything involves risk in our lives. The issue with any medicine is that they can be abused, but the whole purpose of having a medical system and trained professionals is to minimise the risks of that abuse taking place,” he said.
In an emailed statement, Professor Richard Harvey, Chair of the RANZCP Psychedelic Assisted Therapy Steering Group, told The Epoch Times that PAT is “not a miracle cure,” but an “experimental and emerging field” that may offer hope to “a small number of people where other treatments have been attempted without success.”
“More research is needed to find out which people will respond best, and which people may be at risk when using the treatment, as well as the longer term safety and efficacy,” Mr. Harvey said.
In response, Ms. de Jong said that while each patient case is unique, hundreds of research trials have shown remission rates for psilocybin-assisted therapies are between 50 and 80 percent after two treatments with psychotherapy. This compares to remission rates of around 30 percent from existing treatments for depression.
Remission rates for MDMA with psychotherapy are at 67 percent after just 3 medicinal sessions alongside a short course of psychotherapy in the current phase 3 trials taking place, Ms. de Jong said.
“In the case of PTSD, the existing treatments lead to remission for only about 5 to 10 percent of patients.
“Antidepressants are being given out at the rate of one to every four Australians at the moment, which shows you that (appropriate screening) and full discussion of benefits and side effects is probably not happening properly at the moment.
No Evidence of Addiction, Founders Say
Mr. Hunt said that there is no evidence of addiction or addictive qualities coming from this treatment.“You’re only talking about 2-3 doses, and you’re talking about taking it in a medically controlled environment,” Mr. Hunt said.
For instance, one course of psilocybin is indicated for two doses over two months, and MDMA for three doses over three months. These include psychotherapy, which must be delivered by two health professionals, one of whom needs to be a medical practitioner, according to RANZCP guidelines.
Ms. de Jong said that for any treatment, particularly for psychedelic-assisted therapy, psychiatrists should be discussing the risks and benefits of the treatment and ensuring there is informed consent.
“In this case, there is really about zero chance of [fatal risks] because the checks and balances are so high for this treatment. In thousands of patients who have participated in trials globally, there has never been any serious adverse events occur,” she argued.
Internationally, there are a handful of places where psychedelic-assisted therapies have been approved for very limited use outside of clinical trials, and Australia is the first jurisdiction to have altered the way these are formally classified at a national level.
National Registry Formed
Ms. de Jong and Mr. Hunt’s charity, Mind Medicine Australia, which was founded in 2019, is part-financing a national registry that is being kept by the ANU School of Medicine and Psychiatry. The registry will keep data from any clinical treatment with psychedelic-assisted therapies that takes place in Australia and will provide valuable information on these treatments and their effectiveness.That being said, the cost of therapy can range anywhere from $10,000 to $15,000 for a course of treatment.
But Ms. de Jong gave a price comparison.
“For an Australian patient it might cost $100,000 to $200,000 over their lives for the cost of various psychiatric medications and psychotherapy, over a course of decades. During that time they may still remain unwell”, she said.
“But if that patient gets well in that four-month period through the treatment of psilocybin or MDMA, then that means that they can lead a meaningful, healthy, and happy life immediately and hopefully for the rest of their lives, which is pretty significant. That amounts to enormous cost savings and significantly less burden on our mental health and medical system and a lot less suffering.”
She added that various health insurance companies have approached MMA for more information on the therapy.
“These treatments offer enormous potential cost savings for their clients as well as a far greater chance of the patients getting well,” she said.
