Failing Mental Health and ‘Vote for Medicine’ Models: Cannabis Conundrum Grows

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Failing Mental Health and ‘Vote for Medicine’ Models: Cannabis Conundrum Grows

August 1, 2024September 12, 2024By WRD News Team

Headlines, once not reported in our rush for the legalisation of the highly lauded (and to many advocates) panacea of most ills – cannabis – are now begrudgingly starting to emerge.

Doctors warn of significant increase in people hospitalised with psychosis after being prescribed medicinal cannabis (msn.com)

(North America reporting this more, Marijuana Overdoses on the Rise Among Elderly in Canada, Raising Concerns for the US – WRD News and Rising Rates of Cannabis-Related Disorders Seen in Older Adults – WRD News) The evidence of this growing public health disaster has always been gathering just not reported in the mainstream media. However, the pro-pot gag is starting to slip, and the many inescapable harms are now emerging more in the public square. It’s way past time that our community demands a better public health response to the ‘vote for medicine’ debacle that has facilitated much of this growing mess.

Recent reports have highlighted a concerning trend: a significant increase in hospitalizations due to psychosis among patients prescribed ‘medicinal’ cannabis. Doctors have observed that some patients, particularly those with pre-existing psychotic conditions, are experiencing severe relapses after using medicinal cannabis. This rise in psychosis cases has been attributed to the proliferation of “single-issue” cannabis clinics, which often prescribe cannabis without thorough patient evaluations.

‘Medicinal’ Marijuana and Self-Medication Outcomes

The debate over medicinal marijuana continues to evolve, with recent discussions focusing on the outcomes of self-medication. A key point of contention is whether medicinal cannabis truly benefits patients or if it leads to unintended consequences like cannabis use disorder (CUD). Studies have shown that while some patients report relief from symptoms such as pain and insomnia, others develop dependency issues ². This dichotomy underscores the need for more regulated and evidence-based approaches to prescribing medicinal cannabis ².

A recent 9-month follow-up study on medical cannabis users has provided valuable insights into the long-term effects of cannabis use. The study found that frequent cannabis use did not significantly improve symptoms of pain, anxiety, or depression. However, it did lead to the development of cannabis use disorder in a notable minority of participants. This finding highlights the importance of monitoring and regulating cannabis use among patients to prevent dependency and other adverse effects.

We could go into the mounting evidence of harms during pregnancy, the growing cancer risk related to the use of cannabis, and the now confirmed multiple journal published evidence-based research on the Genotoxicity and Neurotoxicity of this ‘medicine’.

Even before this growing and alarming research was published and it was becoming clear that cannabis as ‘medicine’ was falling spectacularly short of its propaganda promises, and sometime after the vote for medicine protocol had unleashed this unwisely ‘medically’ validated substance, the Royal Australian College of General Practitioners(RACGP)released its primer on this new ‘medicinal’ offering.

It’s important to note that this 2021 publishing is now three years behind the new concerning evidence about the harms of this recreational substance, turned medicine. Not least the new research revealing that CBD (Cannabidiol)is not the benign substance it was touted to be, even in this publication. It is research emerging in the last three years that have raised serious alarms about the long-term harms of this cannabis component and other cannabinoids.

The primary sentiment behind this generalised classification of CBD is ‘harmless’ was that around the fact that it it’s unadulterated form it doesn’t get you ‘high’; but that outcome is only one side-effect of this psychotropic toxin.

RACGP – A primer on medicinal cannabis safety and potential adverse effects

Even back then the somewhat muted concerns of the RACGP were clear. On reading their publication it is important to also note that this peak medical body made the very clear distinction between fully trialled pharmaceutical prescribable medicines, and the new more ‘holistic’ offerings allowed by the TGA.

While medicinal cannabis offers very few benefits other than mere temporary relief of symptoms of a small number of medical conditions, it more concerningly poses significant risks, particularly in relation to mental health. The increase in psychosis cases and the development of cannabis use disorder among users alone, call for stricter regulations and more comprehensive patient evaluations.

The very few positive benefits associated with medicinal cannabis are outweighed by the growing number of short- and longer-term harms of this highly engineered and increasingly under-performing therapeutic and they can no longer be ignored or easily dismissed as outliers.

Manufacturing consensus – The Start of ‘Vote for Medicine’ Protocol

Where did this very concerning and inevitable public health issue begin?

I’ll start the journey here back in December 2014, the Victorian Law Reform Commission Consultation on ‘medicinal’ cannabis released its report. It drew from a miniscule 9 very poorly attended public hearings in Victoria and a mere 99 submissions, mostly from then illicit cannabis users.

This exceedingly small sampling of a community largely unaware, and arguably disinterested in, this issue was to become the basis for simply ‘rubber stamping’ (as we’ll see) a fait accompli of predetermined government decision. A being ‘seen to do the due diligence’ pantomime.

As mentioned, these ‘town halls’ drew very small numbers, with the major one in the city of Melbourne, having less than one hundred people attending, and all but a few clearly pro-cannabis delegates.

At this particular consultation, the Dalgarno Institute was represented by Drug Free Australia Research Fellow who was deeply concerned, but not surprised, by this small Melbourne consultation. Prepared evidence-based research on the harms of cannabis was ready to be shared, but our representative was quickly marginalised and/or managed, by the facilitators when they noted his voice was a dissenting one.

Repeated attempts to have his well-prepared evidence tabled were no less than stifled. However, our affiliate in the room experienced, observed and noted the following,

Emotive tone seemed not merely permitted but set for meeting by facilitators. The meeting was facilitated by representatives of the VLRC who appeared to have a bias toward the legalisation of ‘medical marijuana’ in manner that suited the self-medicating option, regardless of evidence-based science.

When attempts were made to present evidence contrary to the seemingly predetermined agenda of these facilitators, he was either quickly shut down (after daring to speak in the first place) or continually ignored; apparently, dissenting opinions were not welcome. Whilst at the same time, proponents for ‘self-medication’ use of cannabis were given complete and unfettered access to the floor, producing statements such as:

–“Many, many people have been cured – from just about anything and everything.”

–“What would you rather have – infertility or 35 seizures a day?”

–“Random workplace drug testing is wrong.”

Not only are these statements (now on record) outrageous, but they are also utterly unsubstantiated by any legitimate clinical research, as the overwhelming evidence from the last 10 years has utterly confirmed. This small contingent of pro-cannabis lobbyists was permitted to simply spruik anecdotes with no evidence-based presentation yet also had their evidenced-deprived opinions affirmed and validated by the consultants.

The facilitators inferred that the Government (of Victoria, at least) already has legislation in place with this current ‘consultation’ process simply in play to validate those changes and therefore it is in essence a forgone conclusion.

Beyond these confirmation-bias laden gatherings, there was also a strong indication that either the A.M.A. or T.G.A. recommendations or processes would be side-stepped and/or negated wherever possible by simple legislative changes.

So, to assist with framing these potential science negating changes, new language and concepts had to be introduced by these lawyers. The following ideas and terms were introduced to help leverage the consensus manufacturing process.

The idea of ‘exceptionality’ and of ‘compassion as a basis for action’.

Not science, or best practice, but sentiment, anecdote and impassioned pleas, as we saw in our live snapshot of the community consultation shared above.

Cowboy Legislation in a Cowboy State?

Once this box-ticking ‘consultation’ was completed, it was then time to introduce the already drafted – Access to Medicinal Cannabis Bill 2015

The Victorian Labor Government had decided, against better practice national option and instead to create its own Medicinal Cannabis industry, even after assurances from the Federal Health Minister at the time that a National Scheme under T.G.A. purview would be a better option. The Labor government, at the taxpayers’ expense, was setting up another bureaucracy and self-styled pharmaceutical practice/process that will, if not run parallel to T.G.A., most likely negate it. Dalgarno Institute raised many concerns directly with Health Minister and was systematically acknowledged and then ignored.

Dalgarno Institute was able to liaise with Opposition Health Minister and through several correspondences and evidence/concern exchange, she was able to be part of a group that saw seven hours of debate in the Senate resulting in over 400 Government amendments (believed to be a new record according to Clerk of Court) the revised bill was passed. One such amendment is that at no point or occasion will cannabis be prescribed for delivery via ‘smoking’.

According to the then Shadow Minister for Health, Mary Wooldridge, the bill also provides that if the T.G.A. down schedules Medicinal Cannabis from a Schedule 9 drug to Schedule 8 (which is proposed to happen) that it will not be down scheduled in Victoria. The Victorian Government argues that they would rather regulate it via our State specific, purpose-built scheme than participate at a national level. ‘I am concerned that the opportunity to ultimately be part of a national scheme will be missed if Victoria insists on going it alone’ the Shadow Minister stated.

However, launch their own trial they did and with great expense, and all but zero positive outcomes for the Victoria Taxpayer. The following newspaper article revealed just how fruitless this cowboy action proved to be.

MORE than a third of children receiving medicinal cannabis from the Victorian Government have discontinued their taxpayer funded treatment after the drugs failed to work.
It was revealed this week that 13 out of 34 children have left the Government’s subsidised medicinal cannabis program since it began in March last year.
The Opposition’s health spokesperson, Mary Wooldridge, said the dropouts are proof the policy — which the Government says costs around $35,000 per child — has not delivered good value for Victorian taxpayers.

Herald Sun/The Age/SBS , 7^th June 2018

What highlights the cowboy culture even more, was that the fully clinically trialled pharmaceutical grade cannabis-based medicine Epidiolex® epilepsy drug had been approved by the Food and Drug Administration in the US in the very same month. This product went through a near 10-year full clinical investigation. This medicine had been thoroughly, double-blind, placebo accounted for trial giving it a full understanding of its capacity, limitations and its shortcomings. They followed the complete quality of evidence research pyramid to the very top as outlined in the following graphic.

Western Australia was to soon follow suit in this new Vote for Medicine protocol, with the State government there, becoming the actual ‘pusher’ of this now untrialled substance.

In 2017, when freshly minted vote for medicine legislation let non-clinically trialled cannabis products off the leash as ‘medicine’, there was no clinical takers. Get this, it is important to note that not a single one of the 10,000 plus Doctors in W.A would prescribe cannabis, as revealed by the following news article…

West Australian patients are finding it almost impossible to obtain medicinal cannabis more than eight months after it was legalised, advocates say.
By May, no health professional had applied to prescribe the drug, despite it being made legal in November.
The Department of Health confirmed this week it has granted permission to three doctors to prescribe cannabinoid-based drugs and is in the process of assessing two more applications.
“The AMA is certainly not supportive of shortcuts, and instead of avoiding all the regulatory steps, we should be investigating cannabis-based products, how good they are, how safe they are, and once that’s been done, they should available just like any other drug,” AMA WA president Omar Khorshid

The then State Premier, Mark McGowan, was very vocal about this unacceptable scenario and effective became the government ‘pusher’ of this drug as they try to create an ‘industry’ from this now voted for medicine, despite clinicians serious concerns.

The New Vote for Medicine TGA Play Book

One of the further consequences of the ‘anecdata’ driven socio-political sentiment in medical legislation making, has seen our peak medicine approving body the Therapeutic Goods Administration (TGA) fall in line with said sentiment. In this context, again, science and best-practice research are not the cornerstone of this new procedural approval system, but, as with the Victorian consultation it appears that compassion now becomes the preferred basis for action, regardless of any unforeseen side-effects.

So, for all intents and purposes, a loophole for ‘medicinal’ cannabis was created in this regulatory setting. A caveat that enables concoctions to be made and dispensed outside the long-held gold-standard of clinical pharmaceutical research process. This then enables side-stepping the need for full double-blind, placebo accounted for and exhaustive clinical trials, like the ones conducted by G.W. Pharmaceuticals on their Epidiolex® product.

The following is an excerpt from recent correspondence sent from the Prime Minister’s office to the Taskforce for Drug Prevention to clarify this new TGA cannabis protocol.

“The Therapeutic Goods Administration (TGA) also administers several mechanisms to enable access to therapeutic goods which are not registered on the Australian Register of Therapeutic Goods (ARTG) and are otherwise termed as ‘unapproved’ therapeutic goods.

These mechanisms include the Special Access Scheme (SAS), the Authorised Prescriber (AP) pathway, the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme. It is a condition of TGA approval or authorisation that the prescribing health practitioner (applicant) assumes responsibility for any adverse outcome associated with use of any ‘unapproved’ therapeutic good. Any Australian registered medical practitioner can make an application under these schemes.”

“Importantly, unapproved therapeutic goods accessed through these pathways have not been evaluated by the TGA for safety, quality and efficacy. As such health practitioners who engage in the prescribing of an unapproved therapeutic good are required to do so in accordance with Good Medical Practice and the code of conduct published by the Medical Board of Australia (MBA).

It is expected that prescribing health practitioners will have considered clinically appropriate treatment options that are included in the ARTG before applying to access unapproved therapeutic goods. These considerations apply to accessing any ‘unapproved’ product, not just medicinal cannabis.”

(Prime Minister’s Office 18^th June 2024)

REMS – The Minimum Filter for Public Health Protection

Making plain here just some of the catastrophic medical flaws of this vote for medicine debacle is not difficult, nor is it the fix, if the political will isn’t there to conform with best-practice medicine.

For any substance to be properly considered for release as medicine in the public square, requires – well at least it SHOULD require – not only rigorous testing, but on review by public health watch dogs, should at the very least go through what is known as a REMS review Risk Evaluation and Mitigation Strategies.

What is a REMS? A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program implemented by the U.S. Food and Drug Administration (FDA) for specific medications with serious safety concerns. Essentially, REMS are designed to reduce the occurrence or severity of particular serious adverse events associated with these drugs.

REMS a Minimum Imperative: When a medication poses significant risks, the FDA may require a REMS to ensure that the benefits of the drug outweigh its potential harms. These risks could include severe allergic reactions, dangerous side effects, or other safety concerns. REMS are particularly relevant for prescription drugs and biologics. Without a REMS, some medications might not be approved or would even be withdrawn from the market due to known or potential risks.

How Do REMS Work? REMS involve various interventions to support the safe use of a medication. Here are a couple of examples:

Controlled Administration Settings: For drugs that can cause severe allergic reactions immediately after administration, a REMS might mandate that the drug be administered only in healthcare facilities with trained personnel who can manage such reactions. These facilities would have immediate access to necessary treatments and equipment.
Lab Testing Requirements: Another scenario involves ensuring that specific lab tests are completed, and their results checked before a medication prescription is refilled. This helps monitor patient safety and tailor treatment appropriately.

REMS as a Safeguard Involves:

Healthcare Providers: They receive education and guidance on safe prescribing practices.
Patients: They may receive educational materials about the risks and safe use of the medication.
Pharmacists: They play a crucial role in dispensing medications according to REMS requirements.
Healthcare Settings: These settings must adhere to specific protocols for administering the drug safely.

In summary, Risk Evaluation and Mitigation Strategies should be a minimum and vital part of ensuring that anything promoted as medicine or medications with serious risks are used safely or not at all. These protocols can bridge the gap between medical innovation and patient well-being, emphasizing the importance of balancing benefits and risks in the realm of public health.

Epilogue – The Final Diagnosis?

These growing public-health predicaments (and arguably culpable failings) around this super-hyped substance are beyond concerning. We have labelled this propagandized ‘medicinal’ promoting as the new Reefer Madness. All this was foreseen by anyone who refused to buy said cannabis culture and cannabis industry palaver – such as those medically trained and not on the pocket of big cannabis physicians of Western Australia some seven years ago.

What the average ‘Jo Public’ is unaware of, is that there has been a fifty plus year war for this drug. It was only the Trojan Horse strategy of the ‘Medicinal Marijuana’ campaign, introduced by such actors as NORML, in the early 1990’s that saw more people be drawn and this new tactic of ‘medicalising’ cannabis to shift momentum back in favour of the pro-cannabis recreational use lobby.

What is also essentially unknown by almost all, is that since around 1997 up until March 2024 there have been 11,420 studies conducted on Cannabis THC alone, (not including Cannabis CBD or other cannabinoids) at a cost of $4.877 billion (USD) and the very best we can come up with from all this promised panacea of all ills is essentially the same therapeutics that were already available for prescription, with the exception of the newest pharmaceutical Epidiolex ®

In this brief expose, we have not spelunked the thousands of published research on the environmental, community and productivity harms of this psychotropic toxin, parading as medicine, but we do seriously encourage, no, goad you into looking at this issue and discover the unrobust nature of pro-cannabis literature and the short-cuts being taken to promote this addiction for profit enterprise – You, your family and your community deserve to know what is really happening and get the heads up you need for what ramifications this will mean for public and community health in the future.

Shane Varcoe – Executive Director, Dalgarno Institute.