Informing the Public or the Public informing?

In April 2019 headlines trumpeted that, Medicinal cannabis supply to reach new high with first-ever pot factory in NSW, so goes all such cannabis focused by lines these days, unhelpfully painting cannabis in a ‘health’ light. Of course, click bait phrases are engaged for further reading. However, it was the announcement of a research facility to develop our own Cannabis Medicines – even though GW Pharma in England was just putting their decade long clinically trialled epilepsy medicine into the market.

As of this August the facility is producing.

One tabloid outlet, Channel 7’s news program The Latest, made a story of this on the evening of 20th of August. The segment went, as most tabloid news goes, with shallow data and then lathers of personal, and clearly uniformed, commentary.

The host Michael Usher was quick to recount his experience of the ‘miraculous’ transformation he saw in a fitting child when plied with one of Colorado’s ‘home brew’ cannabis tinctures (most likely the now infamous Charlottes Web). Then after further endorsing comments about people illegally importing the substance in desperation, was critical of authority’s perceived lack of action.

Then he crossed to two ‘social commentators’ – not cannabis clinicians, or medical experts – just ‘influencers’ who then waxed lyrical about the need to not let ‘big pharma’ hijack this new wonder drug, and to top off this – Big Marijuana Playbook’ pitch – the statement came; “We seem to forget that parents know more often that not what is best for their children.”

There you have it! What more is needed?

Tabloid news endorsement – personal anecdote, and a parent grieving heart, is all we need for a product to be declared a ‘medicine’ and then self-prescribed for whatever ailment you believe it will help with. However, any ‘science’ that disagrees with this new manufactured consensus, is at best ignored, as ‘my gut feeling’ is far better than evidence-based clinical research.

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In recent announcements too, Victoria and Tasmania are also to have/have new Cannabis Facilities of some kind – As nationally, other ‘industry’ permission is being granted for this apparent ‘science skipping’ policy progress.

The headlines pealed forth that Australia’s biggest medicinal cannabis plant is to be built in Melbourne! (unintentional and amusing double entendre aside) It always remains a little tragic when our long-submitted warnings about ‘thin end of wedge’ policy creep emerges.

Of course, the relentless propaganda (disguised as ‘health marketing’) on the purported panacea properties of pot, combines with a doubling down on all efforts in the ‘we have to make this weed thing work for us somehow’, mentality lend themselves to an ever blinding (at the very least, myopic) bias that largely ignores not only minor ‘side effects’ of this unpredictable product, but the real and often irreparable long term harms.

Sure, at the moment, other than the pro-pot pushers, and their ‘addiction for profit’ financiers, no credible voice in the scientific and policy space is suggesting cannabis should attain the protected status of alcohol (not yet, anyway) but the every noisy clamor to validate this product as ‘medicine’ is enabling creative, if not fallacious means, to give it even a spurious legitimacy in those important echelons.

State governments are trying to be the first to get big farms and processing plants up, believing a ‘boon’ in the faux pharmaceutical space will emerge – it hasn’t anywhere else – but that isn’t stopping the equity rescue pursuit of bad investment.

The most disturbing thing in this process, is that legitimate, thorough, and best practice clinical trials have been, if not negated, then massaged to fit a new approval mechanism.

Not a clear authoritative pre and proscription model – one that only thorough and exhaustive trials can produce – rather a ‘recommendation’, based on analysis of some evidence-based data, and a plethora of anecdotal testimonials.

It appears on the weight of the (often celebrity endorsed and pop-culture lauded) stories, long term impacts on consumers is of little regard if the ‘felt need’ is being met, even if only subjectively, and if only for the interim.

The message being sent to the most vulnerable of those consumers – Children is, ‘as long as any symptom is managed, it matters little what may come next.’

The Potential Thalidomide Parallel and Big Tobacco Playbook

What is of grave concern is that the Thalidomide disaster that Australia could have avoided if it followed the USA lead back in the 1960’s, is consistently being ignored in the reviewing and research space.

The United States FDA (Food & Drug Administration) never authorized this experimental drug for ‘morning sickness’ and consequently saw less than 50 babies born with deformities, whilst in Australia, thousands of casualties were had, whom all still live with disabilities today. Even the long fought for settlement for damages changed little to the permanent and ignored (or played down harms) of this purported panacea for morning sickness.

The caution exercised by the US Federal government is being worn thin by the predatorial nature of Pot promotors, consequently concerns about cannabis being a potential new Thalidomide threat are being largely and, it would appear, willfully ignored.

What vexes even more, is the same willful ignorance is being exercise around Big Marijuana’s unabashed plagiarizing of the Big Tobacco marketing playbook. They are, arguably, following it to the letter, and somehow the authorities that took four decades to wake up to the con of the tobacco industry, are swallowing the pitch, hook, line, and sinker. It is as if they have never seen this before and in their newfound naivete are blithely embracing the strategy as fiscally wise and harm limited.

The Australian Push

In very recent weeks another license was granted. Medicinal cannabis producer and developer MGC Pharma (ASX: MXC) will see its logistics processes streamlined following the granting of a new import licence.

According to news reports… “Issued by the Australian Office of Drug Control (ODC) the import licence will enable MGC to directly import Schedule 4 (prescription only medicine) and Schedule 8 (controlled drugs) medicinal cannabis products into Australia from its European production facility.”

This Canadian company, along with others have long looked to target Australia as a possible source of renewed revenue, as that nations burgeoning legalization experiment is failing to produce even a modicum of the cornucopian realities it promised and in current reality is just plain failing.

Perhaps the most concerning issue we see emerging is, as we opened here, in the policy, practice and regulation space around this unpredictable and highly engineered product.

The Therapeutic Goods Administration (TGA) have, laudably, been reining in the misuse of another plant-based drug – opiates – as the harms from this misappropriated and misused pain manager exploded.

You would think this would act as a profound cautionary tale when it comes to releasing further ‘medicines from nature’, particularly the ones that have been so engineered that there is little resemblance to their natural state.

The fervency to unleash ‘cannabis’ as a medicine has been fueled by the relentless propaganda machine and the anecdotes, they engage to promote this product. Yet, the scientific bodies charged with ensuring not only efficacy, but safety – the AMA and TGA – seem (for the most part) to be bowing to public pressure and now we appear to be ‘voting’ on medicine, and that not via democratic political process, but ‘social media consensus’.

The TGA ‘Pass’?

Under the ‘Accessing Unapproved Products’ the TGA have listed the following ‘caveat’.

Medical Cannabis Guidance Documents

This new ‘category’ of allowance by the TGA, is not a recommendation, as no exhaustive clinical trial evidence exists to do so. Anecdotal and placebo effect data cannot pass for best practice science, that is why this new ‘category’ has been included and is it simply another step toward ‘rescheduling’ this drug?

Even the wording on the TGA site under ‘Why are these Guidance Documents developed?’ is indicting.

Many prescribers and dispensers know very little about medicinal cannabis because there has been little research on medicinal cannabis for many years and there is not much information on medicinal cannabis provided in most medicine and pharmacy courses.

Dr Kevin Sabet, former Drug Czar for three US Presidents, and Co-Founder and President of Smart Approaches to Marijuana (SAM) writes insightfully and compassionately in warning against rescheduling of Cannabis in any context, no less for the ‘potential of medical use’.

So, back to the grand new industry announcements; they are investing millions to produce what exactly in Victoria (or elsewhere for that matter)?

• National inquiry into CBD producers is currently in play with no findings handed down,
• The Victorian Enquiry into Cannabis seeking submissions but will not commence review until September.
• TGA have only approved Cannabis based pharmaceuticals, Sativex ® and very recently Epidiolex ®

So, what information does Cannvalate who are promoting pot product as if it was a clinically trialed medicine have that gives them confidence to invest so heavily?

• Is it because they already know they will be the key wholesaling enterprise so a ‘Big Pharma brand’ may start developing medicines, and such manufacturers have better access to primary product, without ‘middle-men’ and less potential for contamination/degradation in shipping processes? That certainly has a legitimate tone, but there is still no legislative pass to guarantee this, or this there?
• Are they aware that this new TGA ‘rework’ is just an echo of the U.S. Food and Drug Administration’s lack of resources to act in accordance with best practice as the following reveals…

The FDA occasionally sends Warning Letters to online CBD dealers telling them to stop making unsupported medical claims for their products. For the most part, the dealers are quick to comply as their customer base is well-schooled in knowing precisely what it wants. Even here, however, there are legislative initiatives presently being considered that would redefine these products to exempt them from these FDA regulations.

If motivated to do so, the FDA could stop sales of CBD and THC. Pursuant to the FD&CA, when a substance is identified as a drug and approved as such by the FDA, all subsequent producers of the drug must obtain prior FDA approval before the drug can be marketed in food or medicine. Thus far, the FDA has shown little interest in enforcing this provision. Instead, the agency seems satisfied that warned CBD sellers have complied with the agency’s letters and deleted unsupported medical claims, as ordered. One of the warned CBD dealers actually posted the FDA Warning Letter on its website and added a link to the agency’s lab report to show customers just how high the CBD content was in its products.

Nominally, the DEA and Federal Bureau of Investigation (FBI) retain authority to enforce the marijuana and THC provisions of the CSA, but the actions of the 115th Congress in passing the Farm Bill weakened this authority and virtually eliminated it with respect to finished products containing hemp-based ingredients. When it comes to marijuana law enforcement, federal efforts are now focused mostly on cartel-related cross-border and maritime bulk smuggling operations. Oddly, success in reducing imported marijuana drives up consumer demand and increases the value of domestic supplies.

More so, we must ask,

• Who is ‘prescribing’ cannabis ‘medicines’ and in what formulation? If Sativex and Epidiolex, then fine, we don’t need ‘cannabis clinics’ for this?
• Where are these patients coming from?
• How does one define the term ‘patient’ and as actual cannabis based medicines have no curative properties, and very limited symptom management value, what is this being ‘prescribed for’?
• To repeat, the science is clear – cannabis as properly trialed pharmaceutical grade medicine is limited to two (perhaps three) current clinically trialed formulations – Sativex, Epidiolex and the rest is not medicine, at best is a poorly vetted ‘supplement’.
• What are the unwitting public being led to believe and who is driving the decision making on this? Science, due process, and government? Or, are Anecdotes, celebrities and sentiment driving policy on medicine now?

Victorian Legislative Council called earlier this year for submissions from the public on how cannabis should be managed in Victoria, with a focus on what assisting Young People stay away from Cannabis may look like.

If one where skeptical – and we most certainly need to be with the momentum of the marijuana marketing machine driving perception, not fact or science – one could deduce this looks a lot like another preemptive ploy by the state government to back their unleashing of ‘weed’, as if it were a fait accompli? For instance, they maybe intimating that they have a campaign of ‘protective elements’ for young, whilst they enable the ‘grown ups’ to enjoy the weed, with impunity?

Of course, my cynicism could be entirely misplaced and no under handed blanket permission for cannabis use be given to the ever more ‘cannibidazzled’ public.

One thing will remain, and only time will bring our collective awareness to the inevitable and sad conclusion; increased use of this unvetted drug will only increase harms to individuals, families, communities, and the governments that foster this. That, as with Thalidomide and Tobacco, is a guarantee.

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For a genuine investigative journalistic examination of the Cannabis issue, both ‘medicinal’ and ‘recreational’, the exemplary report was SBS Insight – Marijuana  It is a must view for anyone serious about the health and well-being of citizens.

For those interested in understanding the ‘underbelly’ of the broken marijuana market and the egregious misuse of medical marketing then you must view the important documentary Smokescreen

The Research and Communication Team @ Dalgarno Institute