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Warning of “history repeating,” researchers list ten problems with psychedelic research that make conclusions about efficacy and safety uncertain. March 20, 2023
Drugs like ketamine, psilocybin (mushrooms), LSD, and MDMA are at the forefront of a new wave of overhyped treatments for mental health problems that may fail to deliver on their promises, according to a new article by researchers Michael van Elk and Eiko Fried at Leiden University, the Netherlands. They write that psychedelic research is plagued by methodological problems that make the efficacy and safety of these drugs uncertain.
Despite the minimal research and its limitations, the drugs have been hyped as “miracle” drugs, with some, like esketamine, even receiving FDA approval—despite failing to beat placebo in five of its six initial efficacy trials (the sixth trial reached statistical, but not clinical, significance). In fact, last year, researchers wrote that the promotion of ketamine/esketamine treatments poses “a significant risk to the public.” In their new article, published before peer review on the preprint server PsyArXiv, van Elk and Fried focus on the top 10 methodological problems rampant in psychedelic research, how these issues undermine the evidence base, and how researchers can avoid them in the future.
“These problems threaten internal validity (treatment effects are due to factors unrelated to the treatment), external validity (lack of generalizability), construct validity (an unclear working mechanism), or statistical conclusion validity (conclusions do not follow from the data and methods),” the researchers write.
Worse, they add, most psychedelic studies feature more than one of these problems, which makes the studies far more unreliable: “These problems tend to co-occur in psychedelic studies, strongly limiting conclusions that can be drawn about the safety and efficacy of psychedelic therapy.”
First TGA gives non-clinically trialled or fully vetted cannabis ‘medicines’ a short cut, now they just give a pass to Psilocybine, because this drug users group demand it – Science and Evidence be Damned?
"Members agreed that there was little additional evidence presented in this application … As such, the main barrier to down-scheduling psilocybine was therefore still a lack of established therapeutic value.
"Members expressed several concerns, including the broadness of the indication included in the proposal (treatment-resistant mental illness), the lack of phase III trials, and the problems associated with the translation from a clinical trial setting to clinical practice.
"The Committee agreed that the risk of diversion is low in a controlled medical environment, but noted that, contrary to the assertions of the applicant, there are significant risks of diversion at other points in the supply chain. In addition, not dispensing from a pharmacy would bypass the real-time prescription monitoring system, hence limiting oversight and governance. "There remains no approved therapeutic product containing psilocybine anywhere in the world."TGA Board Minutes
The committee's advice for MDMA echoed these concerns. The committee also noted the Australian Medical Association's continued opposition to the down-scheduling. So, it was little surprise that the secret TGA decision-maker known as "the delegate" made the interim decision in October to keep the drugs prohibited.
For most drugs, that would be the end of the story — TGA insiders told Background Briefing it's uncommon for a final decision to diverge from the interim decision. But this time was different. In the intervening months, Mind Medicine Australia doubled down on its campaign.
The group called for supporters to put in submissions opposing the TGA's interim decision, and more than 3,000 heeded the call. That's on top of the more than 13,000 public submissions the TGA had received before the interim decision.
The TGA delegate noted how few submissions came from actual psychiatrists or relevant organisations (submissions from the Royal Australian and New Zealand College of Psychiatrists and the Australian Psychological Society supported the interim decision not to down-schedule the drugs). The delegate said the submissions — largely corralled by MMA — were brief, and most failed to address any of the reservations expressed in its interim decision.
High-profile psychiatrist and Orygen CEO Patrick McGorry tweeted: "It is premature to allow psilocybin to be used beyond research trials. Can we be reassured that approval is not due to intense private lobbying/special pleading by a zealous private group?"
McGorry is conducting his own trial in the space, much like psychiatrist Nigel Strauss, who, despite long advocating for the potential of psychedelic therapy, felt the decision was premature. "We're doing the research here, but it's early days still," said Professor Strauss. "And when you look around the world at all the research that's available, there hasn't been that much.
"I'm not really aware of what drove the TGA to make this change decision. All I can say, is that it's definitely not research because there hasn't been any great change … particularly in Australia. Professor Strauss is concerned about how the decision was reached.
Regardless of the purported opinions and postures around the failing harm reduction ‘vehicle’ that is e-cigarettes, our children’s health, well-being and future should be the priority; motivating the political will to push the QUIT and PREVENTION mandates and mantras in all key Education, Legal and Social arenas.
The following excerpt from a recent ABC article is the real issue that should be the key informing element in prevention endeavours to this now emerged public health nightmare. Professor Skerritt told a Senate Estimates committee last week, the growth in vaping is reversing what had been a very consistent trend. "While we're seeing smoking levels dropping in this country, the total nicotine use in this country is doing something it hasn't done for 50 years. And that's going up," Nicotine for the developing brain (let along cannabis or any other psychotropic toxin) is one of the most harmful substances in short-circuiting that vulnerable brain. The attending harms of this alone should send the same ‘anti-smoking’ policy makers into a vaping nicotine preventative legislation frenzy… But will they? If not, why won’t they?
How many people are vaping? Hard data on the current use of vapes is hard to come by. According to the Australian National University, as of 2019, a little over one in 10 Australians aged over 14 had ever tried a vape. There are concerns about how easily accessible vapes are. And the numbers skew strongly toward younger people — over one third of regular e-cigarette users were under 25, and half were under 30. The Cancer Council's Generation Vape study looked particularly at teenagers aged 14-17 in New South Wales, who shouldn't legally be allowed to acquire a vape with or without nicotine. Nearly a third had tried a vape at least once, and more than half of those had never tried a cigarette. Over half had also knowingly used a vape containing nicotine, and another quarter could not be sure. By comparison, daily smoking rates have steadily fallen in recent decades, down to 11 per cent in 2019. People aged between 40 and 60 are the most likely to be smoking each day. Professor Skerritt told a Senate Estimates committee last week, the growth in vaping is reversing what had been a very consistent trend. "While we're seeing smoking levels dropping in this country, the total nicotine use in this country is doing something it hasn't done for 50 years. And that's going up," he said. (Source: Australia has a vaping problem, but no easy health or political solution - ABC News)
It’s crystal clear from this data alone that vaping as a ‘harm reduction’ vehicle has not only failed in reducing smoking cessation rates, but worse, has been hijacked by the addiction for profit industry to bring an entire new cohort into nicotine (and other) harmful substance use.
This cohort is the most vulnerable to both short and long-term harms – harms to the brains ‘wiring’ that can take a long time to unravel. And whilst they are unravelling this avoidable mess, the other attending passive harms of failed potential, capacity, and productivity, take a toll on their immediate economies and inevitably the national budgets – Health and welfare systems already buckling under the weight of substance harms – both legal and illicit.
Failure to interdict the industry and sector over this intentional recruitment of the young to harm will be one of the worse kinds of ‘expensive’ for both personal and economic futures. The tobacco industry and the willing and unwilling collaborators in the National Drug Strategy policy interpretations may feign innocence or declare ‘incidental’ over these disturbing outcomes. Yet even the most naïve of us could but scratch the surface of that narrative to see how faux it is.
A National Drug Educators Experience. Overwhelmingly what we are seeing in the schools right now is predominantly Nicotine based Vapes or Nicotine containing vapes that are not listed on the packaging to circumvent the Federal Govt ruling on any Vape product with Nicotine in it must have a prescription. Nicotine Poisoning (Nic Sic) is a real issue within our schools. Vapes are being sold to children at corner shops with no identification required and no prescriptions. They believe it’s just sweet flavoured nothingness that looks cool with the tricks, shapes and veritable fruit salad of flavours available to them. Active promotion via Social Media to our youth is promoting hiding your use behind the back of your teacher/ parent, Vaping in unauthorised areas using deceptive techniques (Stealth Vaping), myths around contents in Vapes & health benefits (especially mental health) and also encouragement to Hack the vapes themselves and create their own bespoke e-juice. Items Youth listen to:
Actual ingredients found in Vapes and what physical damage these cause EVALI, e-cigarette & vaping acquired lung injury being one. Thus far the reports I have seen on Australian youth lung injuries has been due to Nicotine based Vapes not THC - however Jan’s Lung Specialist that she has coming up in a DACA Webinar on Vaping may have more up to date information from behind the medical curtain than what limited information we see through media.
Disposable Vapes have incredibly high levels of Nicotine in the
Mental Health impacts - Vapes are being promoted to our youth to help them with their Anxiety & Depression (does this sound like Cigarettes story with health professionals) especially to young girls. So many nod their head when I ask them if they’ve heard that being spoken of amongst friends or on Social media, a few weeks ago a large percentage of Grade 5 & 6 girls told me they had heard this - Dakota Stephensons example here in Australia in Oct 2021 shows how that ends up. Complete opposite with lung damage thrown on top for good measure at 16
Symptoms - Nicotine Poisoning & EVALI - what to look for
Second Hand & Third Hand Vaping (especially 3rd Hand carcinogenic substances like Formaldehydes being found on clothing, bathrooms etc) when they realise they are vaping around their friends that are not vaping and understand the health impacts which to a degree are next level on Cigarettes it gets very real in the classroom. I have many coming up talking to me about this point. They genuinely don’t want to hurt their friends or little brothers & sisters.
Who is behind Vaping products - follow the money - marketing strategies - Juul is a fantastic example - They are a commodity to BIG TOBACCO & now BIG MARIJUANA (if they are actually different the correlation is they are one and the same - ALTRIA is just one example)
Vaping is NOT an effective cessation device for smokers - think the Cigarette companies didn’t know that? They stated Nicotine wasn’t addictive publicly! Well we know the sad truth about that More and more research is proving this everyday - Adolescents are 7 times more likely to take up smoking if they Vape
How to quit - our young people are addicted to these products, the Nicotine and the Habit forming Hand to Mouth - rewiring of their reward systems in their brains
I understand the mentality behind prescription only Vapes - its managing the damage methods. Cities in the US are trying to ban them or in fact are banning them. The FDA has JUUL in their sights if they can bring this one down then that sends a big message, but reality it will take years before any real change probably happens here. Vapes are Addictive no matter what’s in them. They harm people no matter what’s in them. They are a delivery device purely aimed at producing a whole new Customer base targeted predominantly at youth and they are doing a stellar job at it. Mass producing customers that will jump on board with whatever liquid product their brand affiliated company offers them, Nicotine, THC, CBD, LSD, GHB, Ketamine etc.
The need to act decisively and thoroughly on all and every vaping prevention model is now.
It took decades upon decades to finally out the truth on tobacco and nicotine harms. Not to act with decisive and relentless prevention, supply and other demand reduction processes and policies would not only be negligent, but arguably with what we already know – culpable.
The addiction for profit industry and those in the health sector that deliberately or inadvertently collaborate with them should be brought to account.
ustralia have done even less than a No War on Drugs in the past near 40 years of drug policy. Prohibiting dangerous, health and safety harming activities in the public, more importantly in private when it comes to psychotropic toxins, is the purview of any responsible government – Federal and down. “Governments should aim to… a) Protect their citizens from harm. b) Provide environments that enable its citizens to reach their full productive potential.” Gus Jaspert The Deputy Director of UK Home Office speaking at the 3rd World Forum Against Drugs
Author: Alex Berenson Publisher: Free Press (January 8, 2019)
An eye-opening report from an award-winning author and former New York Times reporter reveals the link between teenage marijuana use and mental illness, and a hidden epidemic of violence caused by the drug—facts the media have ignored as the United States rushes to legalize cannabis
It’s crystal clear from this data alone that vaping as a ‘harm reduction’ vehicle has not only failed in reducing smoking cessation rates, but worse, has been hijacked by the addiction for profit industry to bring an entire new cohort into nicotine (and other) harmful substance use.
