“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.

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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.” 

Adding menthol flavoring to electronic cigarettes may damage your lungs more than regular e-cigarettes do, a new study reveals.

A number of studies have suggested that e-cigarette vapor can cause lung inflammation, oxidative stress, DNA damage and airway hyper-responsiveness that can trigger asthma, Benam said. Vaping these substances can cause lung damage that impairs lung function. Menthol, he added, is such a toxic substance.

The common mint flavoring helps deliver lots more toxic microparticles, compared with e-cigarette pods that don't contain menthol. It's those microparticles that damage lung function, researchers say.
"Beware of additives in the e-cigarettes, if you vape, they can make you inhale more particles into your lungs. Don‘t assume that since menthol is a substance naturally found in mint plants and added to some food and beverages, it would be fine to inhale…Menthol flavoring leads to a significantly higher number of particle counts that one would take into their lungs by vaping them…E-cigarette aerosols are known to contain many harmful substances, such as nicotine and formaldehyde.”

Associate Professor Kambez Benam, Senior Researcher in the division of pulmonary, allergy and critical care medicine at the University of Pittsburgh's School of Medicine

(Source: Menthol Vapes Could Be Even More Toxic to Lungs (webmd.com))