Where To Now?

6th June 2017: Glimmers of hope seen at UIC Symposium

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Argentina, Greece, Mexico – countries are falling like skittles before an overwhelming, consumer-driven surge to legalise medical cannabis or end pot prohibition outright (for stories on those places see here,  here and here).

With Poland, South Africa and others poised to follow, the trend is a global phenomenon – and Australia is very much part of the fray even as the United Nations and World Health Organisation call for recreational drugs to be decriminalised – a first in their respective histories.

But while some jurisdictions with fairly mature and established systems for getting the plant to the patient appear to be flourishing, here things do not, for the moment, go well.

The reason is by and large simple – composed for the most part of three letters known but not loved by advocacy groups and their members the length and breadth of the land.  Those letters are T.G. and A.

The Therapeutic Goods Administration is the Government’s all-powerful medical regulator, abetted by its specially created, smaller subsidiary known as the Office of Drug Control; together they more or less hold total sway over the lawful side of all use and production of cannabis and cannabis products.

We say ‘more or less’ because on top of this Federal command and control structure of legislation and regulation has been plonked an entire additional tier of hindrance to accessing cannabis medicines; each State and Territory has its own rules about who can obtain a prescription, for what indications and by whom the thing can be written.

Such a heavy-handed arrangement – described perspicaciously as ‘hyper-regulation’ by a member of one advocacy group – has accomplished much in the eight months or so since it came into effect at the beginning of November 2016.

But as ‘accomplishments’ go, most are not of the type you’d want to take home from school and proudly show your mum.

For a start the current scheme has placed patients and users of such products in direct confrontation with the Government which has managed to make the pipeline of availability so painfully thin barely anyone is able to get them. To make such a state of affairs seem less unpalatable, Ministers and their bureaucrats have, to boot, relied on underhand tactics, obfuscations and at times outright lies to give the impression things aren’t nearly as bad as some people have been making out.

Next, the plant has been forced into a regimen of cultivation, manufacture and supply for which it is clearly unsuited – a pharmaceutical model normally reserved for drugs based on a single agent for a single purpose and completely antithetic to a natural, botantical product.

It’s a set-up that has simultaneously (via both State and Federal legislation) left GPs – largely untrained in its use – both carrying the can for failing to prescribe the stuff yet prevented from doing so without approvals and / or supervision.

Predictably then, a nascent industry is now taking shape whose business models are, necessarily, predicated upon this kind of extreme governance – i.e. the premise that to make any money, cultivation and use of the plant needs to be more tightly restricted than ever and its ‘illicit’ use met with unrelentingly draconian measures. It is telling that one such operation publicly ‘applauded’ the Federal Government recently for adopting such an approach, taking an obvious gamble on the direction of  the cannabis wind legally speaking.

None of this of course is terribly good for the patient – a demographic systematically sidelined and ignored from the outset, rather than having been placed at the centre of policy-making.

The upshot, unsurprisingly, has been a massive growth in the black market which now offers most would-be users the only available source.

These and other issues were explored and discussed in depth at the United in Compassion Medical Cannabis Symposium which took place in Melbourne over the weekend before last.

Before the thing even started, UIC’s Founder and event organiser Lucy Haslam wrote in the programme brochure: ‘Initially I felt immense pride that Australian leaders saw fit to pass legislation on the basis of compassion for the sick, but what followed was a complete travesty. The Government failed to appoint an Advisory Council and set barricades and brick walls before genuine patients in distress. One can only conclude this was done wilfully to prevent patient access.

This set the general tone and whilst many of the presentations – online in a few weeks – gave fascinating glimpses into the science, research and development work around the herb – much of it from overseas but all now hopefully adding to the corpus of knowledge at home – it was in the areas of policy, politics and the effects of these upon patients and society generally that some of the most interesting and urgent remarks would be heard.

Most – but not all – came during the various panel discussions scattered throughout the proceedings – such luminaries as Dr Jeffery Hergenrather from the Cannabis Clinicians Society of the US, Deepak Anand, Executive Director of the Canadian National Medical Marijuana Association, Dr Ilan Linder from the Wolfson Medical Centre in Israel and Sue Sisley MD from the University of Arizona were included to bring an experienced outsider’s perspective on Australia’s cannabis ‘journey’. Native politicians and policy influencers such as former Federal Police Commissioner Mick Palmer, and MPs Adam Searle, Trevor Khan and Tammy Franks offered high-level critiques of the same. But of them all, two panelists in particular grabbed most of the headlines (at least as we see it) since their views and remarks, more than most, are likely to have the biggest and most immediate impact on the hole many sick Australians, some of whose lives depend upon accessing cannabis, now find themselves stuck in.

Enter then Mr Bill Turner from the above-mentioned Office of Drug Control and Dr Bastian Seidel, President of the Royal Australian College of General Practitioners – both pivotal to what is clearly an  ongoing and pressing debate.

Turner had, prior to his first group appearance, earlier given a talk – an ‘Update from the Commonwealth’ followed by a Q&A.

Prowling the stage like a captive tiger under stress, he delivered a selection of messages few could have wanted to hear. Speaking in solitary splendour – a colleague from ‘parent company’ the TGA having failed, at the last minute, to show up – Turner gamely but quite defensively took the flack on behalf of both outfits. For this alone, and for the fact that of his own free will he remained at the Symposium for the majority of its three days, he is to be roundly applauded.

Less welcome though were some of comments he made, in particular the suggestion his organisation had done all it could to make cannabis medicines available and that somehow doctors were to blame for failing to dish it out. ‘We get criticised,’ he admitted, ‘for the small number of applications,’ referring to the fact that only 145 of them had been granted since 1992, but this, he claimed, was because medicos did not wish to prescribe. ‘A need exists to convince the medical community,’ he said, noting uptake of the much-lauded ‘bulk imports‘ of cannabis products into Australia had been ‘somewhat slow,’ i.e. next to none at all. ‘We approve almost every application we get. If we had a thousand, we’d approve a thousand, if we had ten thousand….‘ and so on was the lavish claim.

What he did not say was that of the requests received, a significant number, while not refused, are returned to the offending physician with the diktat that more information be given – until such applications are eventually withdrawn.  Cynics see this as a deliberate ploy among Ministers and their functionaries to diminish access further still.

More than once over the duration Turner also stressed that ‘if cannabis really is as great a drug as everyone keeps suggesting, it should hold its own‘ in the TGA’s approval processes – failing to acknowledge the organisation is only geared up to evaluating ‘population medicines’. Cannabis though, to work properly or work at all, needs to be personalised and based on individual need- the right strain for the right patient in the right dose, and as such requires a different approach. And it’s one the TGA seems unable to accommodate – a fact Turner strongly disputes. ‘We have treated it differently,’ he insisted. ‘We’ve changed legislation so it can be cultivated here, we’ve organised importations during the interim, we’re writing a guidance document – we’ve never done any of these things for any other medicine.‘ In this he is totally right. The trouble is though none of it has eased patient access although apparently the INCB – the Swiss-based body responsible for overseeing the UN Convention on drugs – has written in glowing terms of Australia’s efforts.

The Therapeutic Goods Administrations Special Access Scheme Category A pathway – ‘SASCAT-A’ as its shorthand seems now to have become – that was touched on too; a vote in the Senate last month reversed a regulatory tweak preventing the dying and seriously ill from getting hold of cannabis via a fast-track ‘notification’ rather than approvals process. It had, Turner said, caused ‘great excitement from a public servant’s point of view’ forcing him and his colleagues into ‘deep consultation with Border Protection’ about personal importation which the vote also affected. Health Minister Greg Hunt had said at the time ‘we cannot accept this,’ so instead of tackling the issue head on, the Ministry now apparently plans to make it its mission to run thorough ‘safety checks’ on all products ordered through the Category ensuring the process ends up taking even longer than its detested counterpart Category B.

Given all this, still the ‘tone of the conversation needed to be raised’, Turner ‘gently warned’,  citing a list of aspersions – cast mainly by this website with one or two choice ones by Lucy Haslam – which he felt constituted ‘uncivil discourse.’  We post this offering today duly chastened and unreservedly add Bill is a nice fellow, but….

Less uncivil perhaps was the impish question from the floor, UIC’s David Caldicott clearly in leprechaun mode: ‘Is it possible that we just have the wrong Framewework for cannabis?‘ he innocently wondered. Bill Turner paused. ‘Anything’s possible,’ he said with (we thought) a knowing grin.

Other than annoying some with his claim there was evidence of deaths caused by weed (we are aware of none) this initial talk set out the stall for his own and his Department’s position, offering a place of departure for further, perhaps meatier comments during the panel discussions.

In these, where Turner was concerned, there were moments of genuine concord, such as his assertion, on the final day, that ‘some of the stories’ he’d heard would be be useful to him and his TGA colleagues. And though he ‘wasn’t a fan of all the science’ (and disliked the ‘Colorado model’ of cannabis use) ‘as a public servant, engaging with people is one of the job’s greatest joys‘. It’s a statement that should perhaps be accepted at face value – as we’ve mentioned, no-one forced him to stay for the entire three days…

What didn’t astonish however was how well he thought everything was going here in relation to medical pot. When Chairman David Calidcott asked guests taking part in a session called ‘Optimising Medicinal Cannabis Policy’ what they thought Australia was doing right, the Canadian Deepak Anand could only manage ‘you call the plant by it’s proper name rather than ‘marijuana’,’ while the good doctor Hergenrather more optimistically held that ‘you’re conducting a dialogue, you’re having a real debate.’ Despite these and the politicians insisting otherwise, Turner himself remained adamant: ‘I don’t think we’ve done anything wrong – cannabis has not made a case for itself as a medicine,’ though the general consensus was that this was far from the case. ‘The biggest mistake,’ observed one panel member, ‘was not taking heed of the Senate Inquiry into the Regulator of Medicinal Cannabis Bill back in 2015‘, which, had it not been derailed by the Government, would have avoided many of the problems seen now. Others blamed ‘lack of leadership’ on the part of the medical profession and spoke of the drug’s ‘fictional availability.’

Come Sunday and another discussion, some real surprises were to be had. Not least was Bill Turner’s affirmation – and here explicitly speaking on behalf of the Department of Health – that, when completing a Category B SAS Application ‘The TGA would be willing to accept previous experience of patients’ use of medicinal cannabis’ as ‘evidence’ when undertaking the process. Which is definite headway of sorts – but for the fact that, unless provided with the means to test such ‘artisanal’ (a.k.a. ‘black market’) products, nobody knows quite what they are.

The biggest astonishment of all though were remarks made by Bastian Seidel, the current RACGP President, whose presence was in itself a major coup. Rather than following the well-trodden path of citing lack of evidence for the drug’s use as a medicine and calling for more clinical trials, Seidel shocked the audience somewhat by taking the opposite view.

Lashing out at the Government’s handling of the matter he decried the excessive red tape surrounding patient access.

He would be, he said, ‘really angry as a doctor’ if the ‘law or regulation’ stopped him from prescribing a medicine such as this and insisted ‘GPs were specialists’ and should be the chief initiators and prescribers of their patients’ treatment as well as the main monitors of it.

The comments came in response to another panelist who’d described having been recommended the medicine by her GP only to have the prescription knocked back by an ‘Expert Advisory Panel’ in her home state of New South Wales.

As mentioned earlier, legislation related to cannabis means this country now operates a two-tier system with permission required first from the Therapeutic Goods Administration then – in many states – further authorisation from the local Department of Health. In some instances, such as in Queensland, GPs cannot prescribe it at all and a treating specialist is required to do so.

That’s a story I didn’t want to hear,’ said Seidel after hearing his fellow guest’s account.

He was though less enthusiastic about the recent Senate move to relax how doctors can help patients obtain the drug through the TGA’s Special Access Scheme Category A pathway. This, he said, was likely to put undue pressure on members – ‘I’ve not been trained in things like import and export,‘ he said, ‘and we’d be responsible if anything went wrong with the treatment.’

But, refreshingly he did agree that random controlled trials were of limited value, especially for medicines like cannabis.

Calling for more n=1 trials, where individuals rather than patient populations are involved in the gathering of data, he said where cannabis treatments were concerned the medical profession ‘should generate evidence as we go along.’

Such exegeses mark a radical departure from the College’s previous stance and, though possibly adopted for political reasons to differentiate itself from the AMA which is its major competitor, nevertheless are to be welcomed.

The same can be said of a speech by Senator Richard Di Natale who struggled through Canberra fog to deliver a rousing and encouraging oration. He would, he said, be calling on the Government to grant amnesty for medical cannabis uses and also introduce a new Bill to Parliament allowing locally grown product to be accessed through SAS Category A (the route is currently available only for imports – except for the ones already here). Whatever your impression of the Greens, their stance on this matter at least has remained steady and constant throughout; he was unsurprisingly rewarded with healthy cheering and applause.

The day before the Symposium itself, UIC launched its first ‘Medical Cannabis Course‘ delivered by the ubiquitous Dr David Caldicott. Pulling heavily on the bardic tradition of the Gaels he somehow managed not so much to breeze through a staggering eight hours of data, documentation and clinical evidence as storm through it as if throwing a day-long ceilidh with stethoscopes chucked in for good measure. The affair attracted lots of delicious press with dozens of healthcare practitioners attending, among them at least fifteen GPs. The Course we are told is currently with the RACGP for accreditation with another such shindig scheduled to take place in South Australia. Drs Caldicott and Hergenrather meanwhile, along with some of the medics who were present that day are discussing convening an Australian Chapter of the Cannabis Clinicians Society.

If it could be said there were major take-aways to be had either from the Course or proceedings as a whole, there would, we suggest, be mainly three – irrefutable and already well-known to anyone who’s been around cannabis medicine for any length of time.

These are firstly that use of the whole whole plant is proving more effective than compounds made from it – the ‘entourage effect’ is alive and well in most other countries, though in Australia the Government is loathe to admit this. ‘Some herbs don’t want to be drugs,’ one keynote speaker emphasised – hitting the nail on the head. The next we’ve already mentioned – that cannabis demands individual, personalised treatment – a fact reiterated time and again in a multitude of presentations – though the Government alas won’t see that either, as it quite obviously doesn’t the final point. Which is that this country is getting the whole shooting match wrong over cannabis – hideously, painfully, almost criminally wrong. And lives are being put at risk or have already been lost because of it.

Last week,’compassionate supplier’ Jenny Hallam posted a powerful and moving video on Facebook listing those she had tried to help and who had died – by implication a result of public policy. It is something the Health Minister would do well to watch:  right now lawyers are beginning to circle, either looking at bringing cases against Canberra for its atrocious handling of the situation or ready to assist those who’ve been busted for the drug. This ‘pincer’ movement of legal attack and defence might, in the fullness of time shift things a little, while at this rate the issue will once again become an election issue come 2019.

For the reality is, the TGA is unlikely to change its ways or Ministers be moved to act unless forced to do so. And as advocates are acutely aware, politics and institutions are set up to maintain ‘business as usual’ even if ‘business as usual’ does not mean what’s best for the public.

 

 

 

 

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