Months after Australia found itself at the global forefront of work to treat mental illness using psychedelic substances found in illicit drugs like ecstasy and magic mushrooms, those working in the field say confusion is rife. 

A surprise decision by the country's drug regulator to approve the use of the substances, which caught even those working in the field unawares, came into effect on July 1.

Months after Australia found itself at the global forefront of work to treat mental illness using psychedelic substances found in illicit drugs like ecstasy and magic mushrooms, those working in the field say confusion is rife. 

A surprise decision by the country's drug regulator to approve the use of the substances, which caught even those working in the field unawares, came into effect on July 1.

Since then, public interest in the use of MDMA and psilocybin to treat conditions like PTSD and treatment-resistant depression has grown while mental health practitioners try to navigate the unexpected change — with some flagging "serious reservations".

As issues around how treatment should be administered, who should be able to access the tightly-controlled substances and how much treatment should cost remain unclear, a body of medical and health practitioners has called for an urgent industry meeting to help iron out the problems.

Some say 'premature' decision has led to 'virtually unworkable' system

Anthony Bloch chairs the Australian Multidisciplinary Association for Psychedelic Practitioners (AMAPP), a 160-member organisation formed in the wake of the decision by the Therapeutic Goods Administration (TGA).

He said the group understood the TGA decision was "both unexpected and perhaps premature" given "the lack of adequate research up until now into psychedelic medicines".

But Dr Bloch said in light of the decision having been made, the group is calling for an urgent meeting to be held with the TGA, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) and state health departments to help improve how things are working.

"The current regulatory system is virtually unworkable, overly cautious and cumbersome and needs to evolve with the help and input from those practitioners who have appropriate knowledge and experience working in the psychedelic field," he said.

The TGA said it was "always open to meet with stakeholders in order to help overcome points of confusion that may exist" and had met with stakeholders regarding the use of psilocybin and MDMA.

"The TGA welcomes an expression of interest to meet with any organisation should they wish to seek further discussion on these issues," they said.

RANZCP president Elizabeth Moore said guidance developed by the body regarding psychedelic-assisted therapy involved consultation with experts, "with patient safety as the primary concern and number one priority".

"Use of psychedelic-assisted therapy may carry its own unique risks that necessitate careful clinical judgement."

Dr Moore said the RANZCP was committed to safe practice and would meet with stakeholders as appropriate.

There is confusion about how treatment gets administered

For people who manage to access the treatment, the process is not a simple case of being handed a script.

Psychedelic-assisted treatment requires intensive preparation and supervision and trusting relationships with the mental health practitioners involved.

Experts say about 20 hours is the minimum requirement for a course of treatment.

Under the changes, only authorised prescribers — psychiatrists approved by the TGA — are able to access and administer MDMA and psilocybin.

Dr Bloch said he understood that less than 10 psychiatrists across Australia had been authorised as prescribers.

"While we understand the caution, limiting prescribers to that level of involvement in psychedelics does not add to safety, in our opinion," he said.

"All it does is completely restrict access."

He also said the level of involvement expected from the authorised prescribers was out of sync with the way mental health treatment worked on the ground.

According to the TGA, the authorised prescribers "must be directly involved in the immediate care of every patient undergoing treatment". That includes patient screening and consent, accessing the drugs for treatment and assessing the treatment.

Dr Bloch said the role supporting mental health practitioners could play in treatment was unclear, as were the settings for psychedelic-assisted therapy.

"Some state governments are now saying the clinics have to be inpatient facilities, while other state governments are saying they can just be day clinics," he said.

The research behind MDMA and psilocybin differs

Psychiatrist Nigel Strauss, who has been involved in psychedelic therapy for more than a decade, said the body of research behind the use of MDMA to treat PTSD is quite well established compared with the use of psilocybin to treat depression.

And he said the drugs worked differently.

"Psilocybin is a true psychedelic and I think there's a need for more research on who is suitable for this treatment, to discover outcomes and so forth," Dr Strauss said.

"Even though the TGA have announced that we can use it in treatment-resistant depression, I think there is some concern that there's still more to be learned about how we select people for this treatment, and how the treatment is carried out."

A Swinburne University study involving about 160 participants trialling the use of psilocybin for depression is about to begin.

Dr Strauss said such studies — the approval of which is separate to the TGA decision — were crucial to informing the use of the drug in one-on-one therapeutic settings.

"The results of that will tell us a lot about the effectiveness of the drug, but also to help to train a number of therapists," he said.

Public interest has geared up

Since the TGA's decision, public interest in psychedelic-assisted therapy (PAT) treatments has spiked.

One of the few psychiatrists authorised to prescribe the drugs, who wanted to remain anonymous, said they had a waiting list of 400 people interested in accessing the treatment.

"They won't all be eligible or ideal candidates — however, they are people who have tried every available mental health treatment and are interested in psychedelic-assisted therapy," they wrote.

Another practitioner said they received about 10 enquiries a week, with that figure jumping to about 30 "immediately after any news/Netflix special, etc".

Amid the increased interest is also a lack of understanding about the strict criteria that means many will not be eligible.

One practitioner reported that their client had told them that when they saw a psychiatrist the next month for their ADHD "they were going to ask … for a script of psilocybin so they could start microdosing".

The cost is still prohibitive for individuals

Given the intensive nature of psychedelic-assisted therapy, and the lack of subsidies in place for access to the drugs, the cost can run into thousands of dollars, making it too expensive for most people to access.

Dr Strauss said as well as the long-term goal of attracting a "meaningful" Medicare rebate, there were opportunities for other funding sources to help individuals access care as the use of the drugs becomes more established.

"Ideally, we want to see the Department of Veterans' Affairs, other first responder organisations starting to fund their members' PTSD treatments," he said

"We want to see private health insurers jumping in and realising that funding a person's treatment-resistant depression for a lifetime is more expensive than a psychedelic assisted therapy which may put them in remission for years, or longer, from a single treatment."

(Source: The use of psychedelic drugs to treat mental illness is allowed in Australia, but confusion remains (msn.com)

Further Reading

• Psychedelics: The New Panacea – Just Like Cannabis, it will Fix Everything, Won’t it?
• Psychedelics: The Hype, The Hope, The Harm? – Is the therapeutic potential of hallucinogens risky and overhyped?
• History repeating: A Roadmap to Address Common Problems in Psychedelic Science
• Problematic Psychedelics – Prescribing Harm? Researchers Warn of Major Threats to the Validity of Psychedelic Research
• We don’t want to run before we walk

“We don’t want to run before we walk”: the attitudes of Australian stakeholders towards using psychedelics for mental health conditions

Conclusions: Stakeholder representatives and politicians agree that insufficient evidence exists to support the widespread clinical implementation of psychedelics in Australia. Politicians also perceive the stigma associated with psychedelics might negatively influence progressive legislation. Additional research and a clear presentation of this research are needed before the clinical use of psychedelics can be supported. (Source: Public Health Research & Practice)

Psychedelics, much like cannabis, has been touted by activists as a new panacea for many ills. However, as with all such activism and a new 'vote for medicine' wedge into our pharmaceutical system, we are seeing less, not more thorough, double-blind, placebo accounted for clinical trials. The hyped promises and now wielded 'anecdata' of subjective testimonies are thinly draped over the growing body of evidence that these substances are not only under-delivering, but in growing numbers of cases, very damaging.

See Also

Abstract: Research in the last decade has expressed considerable optimism about the clinical potential of psychedelics for the treatment of mental disorders. This optimism is reflected in an increase in research papers, investments by pharmaceutical companies, patents, media coverage, as well as political and legislative changes. However, psychedelic science is facing serious challenges that threaten the validity of core findings and raise doubt regarding clinical efficacy and safety. In this paper, we introduce the 10 most pressing challenges, grouped into easy, moderate, and hard problems. We show how these problems threaten internal validity (treatment effects are due to factors unrelated to the treatment), external validity (lack of generalizability), construct validity (unclear working mechanism) or statistical conclusion validity (conclusions do not follow from the data and methods). These problems tend to co-occur in psychedelic studies, limiting conclusions that can be drawn about the safety and efficacy of psychedelic therapy. We provide a roadmap for tackling these challenges and share a checklist that researchers, journalists, funders, policy makers, and other stakeholders can use to assess the quality of psychedelic science. Addressing today’s problems is necessary to find out whether the optimism regarding the therapeutic potential of psychedelics has been warranted and to avoid history repeating itself.

Download Paper here

As the medicinal use of psychedelics gains mainstream attention, fears remain over their effect on mental health and the need for safe administration

Guardian’s David Cox 19 Aug 2023 

In June 2021, 32-year-old actor Kate Hyatt travelled to a farmhouse near Great Malvern in Worcerstershire for a plant medicine retreat that she hoped would improve her mental health after a difficult time during the pandemic lockdowns. While there, she is believed to have taken a substance called wachuma, or San Pedro cactus, a powerful hallucinogen used by Indigenous people in the Andes for thousands of years.

But Hyatt did not experience relief; instead, her mental health worsened. Three months later, she described being in “some sort of psychotic break” and feeling as if her brain was going to explode. Later that autumn she took her own life. At the subsequent inquest, the coroner’s report linked her worsening symptoms to the hallucinogens she had consumed.

Such tragedies represent the darker side of the psychedelics renaissance. These cases are often forgotten amid the feverish anticipation surrounding the therapeutic potential of these drugs, combined with exhaustive media coverage, the rapid rise of a billion-dollar industry – ranging from venture capital-backed startups to wellness retreats – and the hype around last year’s Netflix series How to Change Your Mind (based on Michael Pollan’s bestselling book).

Self-medication is a particular concern, encouraged by the relentless promotion of the possible benefits of psychedelics

Yet without careful monitoring and scrutiny of who receives them, this class of drugs – which includes LSD, MDMA (commonly known as ecstasy or molly) and psilocybin (the active ingredient of magic mushrooms) – can be dangerous. There is evidence that they can destabilise vulnerable individuals who have experienced a previous psychotic episode or have a family history of psychosis.

“Psilocybin affects serotonin and it’s been known for some time that drugs which do this can set off a manic episode in people with bipolar disorder,” says Andrew Penn, a psychedelics researcher at the University of California, San Francisco. “What we worry about with somebody with underlying psychotic illnesses is that the drug might wear off, but the illness symptoms persist, or even that the drug has helped them emerge.”

Self-medication is a particular concern, encouraged by the relentless promotion of the possible benefits of psychedelics. While clinical studies will use precisely controlled doses and patients will be supervised by trained staff, this does not necessarily happen when people take psychedelics alone or at retreats. “People using it out there in the wild, as we say – that’s rapidly increasing,” says Haley Dourron, a researcher at the University of Alabama at Birmingham. “We’re seeing more instances of people having bad experiences, especially those with questionable mental health histories, or use in unsafe circumstances.”

When Compass Pathways, a London-based biotechology company, published the results of a phase 2b trial of psilocybin for treatment-resistant depression, it reported that three patients demonstrated suicidal behaviour for at least a month after receiving the drug.

Penn has heard first-hand how tragedy can happen when the drug is taken in the wrong settings. “One recent case was very concerning,” he says. “A 21-year-old woman tried to treat her own depression through self-medicating with a high dose of psilocybin. She got very distressed, and apparently tried to go to the office the next day before deciding she wasn’t in a fit state to work. She turned around, stopped in the middle of the Golden Gate Bridge [in San Francisco] and jumped off.”

While independent researchers are optimistic, they still urge caution. Dourron feels that there needs to be a more concerted scientific effort to look for potential risks in the wider population, particularly in vulnerable patients.

Matt Butler, an academic psychiatrist at King’s College London, is concerned that the substantial commercial interest in psychedelics will lead to them being ushered into the mainstream prematurely.

“There are pressures to get things pushed forward,” he says. “The results are promising, but I think we need to do more research. There are lessons from the 50s, 60s and 70s, when psychedelics were pushed through quite quickly and things didn’t end well.”

The placebo problem

The psychedelics revolution is progressing at pace. Regulators in Australia gave psychiatrists the green light from last month to prescribe MDMA and psilocybin for PTSD and depression.

“Maybe it’s a decision based on their perceived lack of risk versus the potential for usefulness,” says Rachael Sumner, a pharmacy researcher at the University of Auckland in New Zealand. “But there are these issues that are well known.”

Sumner’s surprise stems from the question marks that still exist regarding how to measure the benefits of psychedelic-assisted treatment. Most medicines are assessed by giving one group of patients the active drug and another a placebo, before comparing the two. Ascertaining whether a new drug performs better than a placebo is particularly imperative in depression, where patients commonly experience a short-term psychological boost from receiving a new treatment.

But this works only if patients cannot guess whether they have received the drug or not, and with psychedelics, most can tell. While scientists have tried various placebos – from the vitamin supplement niacin, which causes flushes, to the sedative remifentanil – Sumner says that in her experience the majority of participants can guess.

This can cause an additional problem. The crushing disappointment from realising they have not received the psychedelic can cause a patient’s condition to deteriorate. Both Butler and Sumner have published papers speculating that some of the large differences between psychedelic and placebo groups in trials is not just because patients on the drugs have improved, but because those on the placebo have worsened. “I think we’re probably overestimating how effective they are at the moment,” says Butler.

“In the media, a lot of ink gets thrown about this topic,” he says. “People read that and say: ‘I have depression and my buddy grows mushrooms. Maybe I’ll just take this and see if it makes me better.’ But what those narratives are overlooking is that there’s a lot more to psychedelic treatment than just the drug, and there’s this whole context and safety container that makes it safer.”

(For complete article Is the therapeutic potential of hallucinogens risky and overhyped? | The Guardian)

Also see Psychedelics: The New Panacea – Just Like Cannabis, it will Fix Everything, Won’t it?

‘Street Drugs – The New Addiction Industry’ is a long awaited and vital resource for those who cannot see through the thinly veiled ‘War FOR Drugs’ hiding in plain sight. Elaine Walters OAM is a veteran in the arena of drug education and a relentless advocate for best practice Demand Reduction and drug use exiting recovery. The truths reasserted in this work are an imperative for those who care about the well-being, safety, dignity and potential of our communities and their emerging families. And to remember the words of Aldous Huxley quoted in the book… “Facts do no cease to exist because they are ignored or eclipsed by a thrilling falsehood.”