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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.
For complete story
Also see
- Cannabis as ‘Medicine?’: Pot Propaganda, Emotive Anecdote, Marketing Manipulation, and the Side Stepping of Science
- IS THE PSYCHEDELIC THERAPY BUBBLE ABOUT TO BURST?
Shane W. Varcoe
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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 collaborations 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.
(click image to play video)
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.
Tanya Cavanagh, Executive Director of Not Even Once ®
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.
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Today February one, The Australian Newspaper release an article tiled, Exposed: big tobacco’s links to vape research. They report led with…“one of the world’s largest tobacco companies funded research into vapes and e-cigarettes that had positive findings and have since been promoted by Australian researchers”.
The Australian went onto report that,
Philip Morris infiltrated academia through the Foundation for a Smoke Free World, which launched four years after the tobacco giant announced it would move into the e-cigarette market. One Italian researcher, who made a submission in support of vaping to the federal inquiry into e-cigarette use in Australia, has worked on at least 17 papers commissioned by the foundation.
Philip Morris – the maker of Marlboro and Peter Jackson cigarettes – is the sole funder of the Foundation for a Smoke Free World. It has financed more than 70 academic papers on topics…The foundation has commissioned at least six projects with researchers from Yale University.
The research, some of which does not disclose the foundation is funded by the tobacco company, is published in legitimate academic journals …After the research is published, it is then cited by other researchers and becomes part of academic literature. Some of the articles have been cited dozens of times, with that research then relied on by other researchers, sometimes hundreds of them and occasionally thousands.
One paper on patterns of tobacco use over the pandemic published in Nicotine and Tobacco Research, which is run by Oxford University Press, was cited 82 times. Those 82 research papers were cited more than a 1000 times. That research was then used in more than 6700 papers. The original paper did not disclose the link to Philip Morris but disclosed funding from the foundation. Oxford University Press did not respond to a request for comment.
Exposed: big tobacco's financial links to vape research – The Australian 1/2/23
Well, if one is going to actively manipulate ‘science’ to, if not find, then generate confirmation bias, this all makes perfect sense.
However, if truth telling and fact-finding, evidence-based objective science is the right process, then this mechanism is nothing short of… we’ll leave you to conclude that sentence – which will perhaps depend on your bias?
In the article Professor Proctor commented that “cigarette makers liked supporting science when it helped them sell cigarettes… and also support science to make it seem like they are acting as responsible corporate citizens.”
Of course, this is not unexpected at all! Big tobacco has a long and recorded history of ‘muddying the waters’ of science that took a serious, concerted and sustained multi-government effort to finally unravel and remove their ‘smokescreen’. Everyone takes for granted the ‘lies’ told by Big Tobacco, but we forget, or worse, wilfully ignore that history. Consequently, this ‘history’ has a good shot of repeating itself.
It kind of makes sense, in a perverse way, Big Tobacco make and promote an addictive product, and when that is railed against, they buy into a vehicle that is supposed to help people stop smoking – or keep it going in a different form?
Cash-in on the addiction! Cash-in on the exit or maintenance of addiction.
The Australian Financial Review in February 2021 reported on the start of some of lobbying games for e-cigarettes and the courting of governments to partner with their manipulatively cynical messaging around smoking cessation. How these games were being found out and then starting to get some serious ‘push back’ against Big Tobaccos involvement in e-cigarette promotion.
Just how deeply big tobacco is entwined in the push to legalise vaping has come to light because one of the country’s largest industry groups decided it had had enough. The Australian Retailers Association confirmed to AFR Weekend that it cancelled a contract last August with global PR firm Burson Cohn & Wolfe (BCW) worth hundreds of thousands of dollars to promote and lobby to get e-cigarettes legalised.
The BCW revelation torpedoes the argument by vaping promoters that legalising e-cigarettes will hurt tobacco companies. Not only are they putting submissions supporting legalisation, they have a secret money trail to make it happen. (Australian Financial Review – The Secret Money Trail Behind Vaping)
The Lung Foundation of Australia also chimed in on the ever-morphing tactics of Big Tobacco in the Vaping space. In August last year they posted the following,
Lung Foundation Australia are urging pharmacists to not engage with the tobacco industry giant Philip Morris International (PMI) backed patient support scheme for nicotine vaping products. In Australia, nicotine vaping products can only be obtained by prescription through a doctor as a last-line smoking cessation aid. Details of the controversial program, outlines PMI’s plan to give pharmacists payments for referral of patients to get prescriptions for nicotine containing vaping products, providing education about vaping and dispensing fee associated with sale of their product.
Tobacco Industry has no place in healthcare – and should have not have the ability to provide incentives (financial or other) to healthcare professionals, directly or indirectly. All current evidence states nicotine vaping products do not have substantial evidence to be used as smoking cessation aids. There is no e-cigarette, regardless of nicotine content, that is approved as safe to use, and in Australia we have many other proven safe and effective smoking cessation aids that smokers who are wanting to quit should speak to their doctor about. Lung Foundation 2022
These are just samples of the shenanigans in play.
Coming or going, Big Tobacco continues to have its hand in any vehicle or mechanism that keeps punters ‘inhaling’… whatever they can sell or enable and it’s our kids who are going to pay the highest price.
According to the Australia Bureau of Statistics the demographic that arguably ‘smokes’ the least is the one vaping the most with nearly 22% of 18-24 y.o. using. More disturbingly, 7.6% of children (15-17) are vaping, and heavens knows what. We can declare almost categorically that engaging with e-cigarettes in these demographics is not for smoking cessation, but for uptake of…?
Prescription only models is just one starting point to rein in this public health disaster, but much more needs to be done.
Your pressure will help this. Keep pushing back in your schools, communities, and homes on this issue.
Communications Team @ Dalgarno Institute
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How ‘cool’ is vaping the ‘harmless’ weed? Hmmmm?
Vaping can transform the Cannabinoid known as CBD – a typically non-intoxicating substance into THC – the psychotropic compound in cannabis that gets you ‘high’. If that’s not enough to warrant a significant level of precaution, vaping cannabis can lead to creating a respiratory poisoning gas called Ketene, which can fill your lungs with fluid and kill you.
The aim of our study was to investigate the effect of temperature on the composition of pyrolysis products of CBD. The experiments were performed in the typical operating temperature range of e-cigarettes (250–400 °C) and at 500 °C under both inert and oxidative conditions, and the pyrolysis products were identified and quantified by GC–MS. Depending on the temperature and atmosphere, 25–52% of CBD was transformed into other chemical substances: Ä9-THC, Ä8-THC, cannabinol and cannabichromene were the predominant pyrolysates in both conditions, all formed by cyclization reaction. THC was the main pyrolysis product at all temperatures under both oxidative and inert conditions. Our results point out that CBD in e-cigarettes can be considered as a precursor of THC, thus it bears all the dangers related to this psychoactive compound. Our findings are fundamental contributions to the safety profile of CBD-based e-cigarettes. (Source: https://www.nature.com/articles/s41598-021-88389-z )
Vaping Cannabinoid Acetates Leads to Ketene Formation Ä8-THC acetate is a relatively new psychoactive cannabis product that is available online and in vape shops across the US since it is currently unregulated. Because it contains a similar substructure to vitamin E acetate, which has been shown to form the poison gas ketene during vaping, we investigated potential ketene formation from Ä8-THC acetate, as well as other cannabinoids acetates, CBN acetate and CBD acetate, under vaping conditions. Ketene was consistently observed in vaped condensates from all three acetates as well as from a commercial delta-8 THC acetate product purchased online. (Source: Department of Chemistry, Portland State University, Portland https://pubs.acs.org/doi/10.1021/acs.chemrestox.2c00170 )