7th March 2017: Time politicians were called to account
:: Terminally Ill Woman’s Prescription Cannabis – Her Dying Wish – Snatched By Government;
:: Labor Refuses To Support Access To Cannabis Medicine By Terminally Sick Patients;
:: Public Consultation on Special Access Scheme Category B / Authorised Prescribers;
:: What’s The Argument About Anyway?
You don’t get much more vulnerable than a hospitalised, terminally ill mother with cancer who’s been given a fortnight to live.
But you’d expect, wouldn’t you, someone like that to be be provided with every conceivable comfort, every amenity, every available medication to make their final days as bearable as they could possibly be.
That is unless you work for the Government’s medical regulator, the Therapeutic Goods Administration which has just stopped such a person from obtaining medicinal weed on prescription – a dying wish, to help with the pain from her illness and accompanying nausea and vomiting.
Few are more law-abiding and respectable than Sydney-based Mrs Lynda Lawrie who, until her diagnosis with breast cancer three years ago, spent the better part of her career – 26 years of it – working for NSW Police.
Mrs Lawrie’s story – some of it at least – was covered by 7 News last Friday (3rd March) – a 90-second segment worth watching.
Essentially, Mrs Lawrie’s doctor prescribed her such medication under Category A of the TGA’s Special Access Scheme. He was apparently unaware or did so in spite of the fact the Government has removed the drug (and only that one) from the Category, making it unavailable to patients like Mrs Lawrie. And once the TGA received the application, somehow it was passed without incident by someone themselves unaware of the changes – which are being challenged in the Senate through a Motion by the Greens in three weeks.
The cannabis was shipped without effort but as soon as the TGA – in the shape of its adjunct organisation the Office of Drug Control – realised its ‘error’ Mrs Lawrie was immediately prevented from getting it – and the organisation is refusing to budge.
Mrs Lawrie is reportedly devastated, telling 7 News the Government’s recent plan to import and warehouse cannabis products was a ‘hollow promise.’
As mentioned, her plight is a direct result of changes to the Special Access Scheme snuck in by former Health Minister, the disgraced Sussan Ley, using a Statutory Instrument – meaning Parliament was not consulted. Green’s Leader Richard Di Natale has a Motion to Disallow the change and prevent it from become law – it will, as we’ve said, be voted upon in the Senate on 23rd March.
Shockingly however, AMCSignpost has learned (and verified) that, thanks to Bill Shorten, Labor will not be supporting di Natale, and will instead kowtow to the Government, in effect signalling the Party believes it is right to deny such medication to patients like Mrs Lawrie and ending any chance of those like her obtaining it in future.
It is a kick in the teeth for campaigners who might be forgiven if they feel moved to telephone Shorten’s office (on (02) 6277 4022) or email (Bill.Shorten.MP@aph.gov.au) to register their distaste at a supposed opposition behaving more like a lapdog (with no offence meant to such creatures).
Those same campaigners might also be interested to learn the TGA, very quietly, two weeks ago, opened up a Public Consultation about Category B – the Category within the Special Access Scheme medics are meant to use if they wish to prescribe cannabis or cannabis products – as well as its Authorised Prescribers (AP) Scheme – the other ‘pathway’ in theory open to doctors.
It appears the TGA wishes to ‘streamline’ Category B Applications by producing a list of ‘notifiable products’ that will not need individual approval each time an application is made and has produced a ‘consultation document‘ to this effect which also discusses APs.
‘To enable notification of unapproved therapeutic goods via the SAS B access pathway, a criterion to help identify an unapproved therapeutic good’s suitability for notification rather than being subject to an approval process is proposed,’ the TGA says.
But cannabis will not be among them. It goes on:
‘Schedule 8, 9 or Schedule 10 substances in the Poisons Standard and medicinal cannabis preparations at this stage will not be eligible for SAS B notification‘.
In other words such products will still need individual approval from the TGA.
Where Authorised Prescribers are concerned, the TGA says it plans to forego the ‘need to approve the clinical justification for use of products’ but ‘instead will rely on HREC/college expertise.’
By this it means ‘expertise’ offered by the Human Research Ethics Committee or by the Specialist Colleges (most of which aren’t in favour of cannabis) and says it will offer those bodies ‘increased guidance to assist in the delivery of those roles,’ though what such ‘guidance’ might entail is unknown.
Since however – as we reported last week (comm. 27th Feb.) – only 34 SAS approvals using Category B were granted between 01/06/16 to 17/2/17 and a small but unconfirmed number of Authorised Prescribers have been named, all in paediatric epilepsy, such proposals are largely academic.
If up to 100,000 people in Australia are using cannabis medicinally those doing so legally account for an almost statistically irrelevant fraction (around 0.04%?) – not what activists had mind when they worked so hard to get the stuff legalised for that purpose a few years ago.
What then has gone so horribly wrong? Why is the Government hampering things it the mystifying way that it is?
It’s all about a conversation that was supposed to have happened – in fact did happen, several times over, throughout 2014-15.
It’s one this website has accorded an entire section to – and from what we’ve seen lately, it’s probably needed again.
It’s the dispute between two main schools of thought on the matter of medical weed – and until it’s resolved, patient groups and Government are likely to remain in a deadlock.
The opposing positions are these.
On the one hand there are those who believe cannabis works best as a ‘full-spectrum’ plant and that while individual constituents are useful, these are more effective in combination. And because there are so many active ingredients involved (they run to three figures) studying them individually doesn’t replicate what they do together either in ‘botanical’ form or with natural extracts made from it. Moreover, such people say, cannabis is one of the least toxic medicines known. Overdosing is, to all intents and purposes, impossible and their own experience or that of their loved ones is walking proof that it works. Add to this the 250 or so ‘cannabis clinicians‘ in California alone, successfully treating in the region of 100,000 patients for a wide variety of illnesses, along with others like them in Canada and (particularly) Israel and you have all the evidence you need to demonstrate the plant offers a safe and powerful medical option. The argument becomes even more persuasive if you take into account the fact that those US States where it’s been legalised, prescriptions for dangerous, addictive pharmaceutical products like opioid painkillers as well as anti-depressants and other drugs have dropped.
The problem with this position though – if it is a problem at all – is those from this school insist that, because of the nature of the plant, normal regulatory systems such as those of the Food and Drug Administration in the US and the Therapeutic Goods Administration here are unsuited to something as natural as cannabis and that trying to impose such regulations is like forcing a square peg through a round hole.
The other argument however – that of drug companies, some in the medical profession such as the AMA and RACGP and apparently politicians like Greg Hunt and other Ministers, is that the only acceptable form of cannabis is standardised, heavily regulated industrially-produced cannabinoid products with exact and recognised effects. And only bodies such as the FDA (in the US) and TGA here are able to make sure this occurs.
Cannabis, they say, must be treated like any other drug and products derived from it should put through their regulatory paces.
It is between these two opposing views therefore that the battle lines have been drawn – and is the cause of the tension between the authorities and patients who want (and in some cases absolutely need) to use medical cannabis. Senior politicians, bureaucrats, Big Pharma and some medics meanwhile insist they can only have it in the form of properly regulated pharmaceutical products.
In Australia, the arguments on either side have been laid out in enormous detail no fewer than seven times, with Public Inquiries about the matter conducted in the ACT (details of which have been removed from the web), Queensland (details here), Victoria (details here), Tasmania (details here), NSW (details here) as well as by the TGA when it consulted about the rescheduling of cannabis (details here).
But it was at Federal level, when the Regulator of Medicinal Cannabis Bill was being considered that the clash between the two opposing sides appeared settled.
The Regulator Bill – a piece of Senate legislation introduced by the Greens with wide cross-bench support in November 2014 – recognised the fact that in many ways cannabis is unique, does not fit into the ‘normal’ regulatory procedures of the TGA and requires its own specialist body to oversee all aspects of the plant’s use – from cultivation through to prescription.
And this, had it been enacted, would have provided just such an body, side-stepping the TGA and in so doing avoid many of the problems faced now.
Cases for and against such a move were put to the Senate’s Legal and Constitutional Affairs Legislation Committee which took nearly a year to scrutinise it, holding three days-worth of Public Hearings and poring over hundreds of public submissions.
The point to be made here is, after all that, the Committee recommended – with some minor amendments – the Bill be passed into law.
For campaigners, the battle had been fought and won (or so they thought) the wants of big business and conservatives within the medical profession had been placed second to patient need.
All of it is summed up in the Committee’s Report on the matter – a document which is now, probably, once again key.
Because the Government, rather than pass the original Bill, did something different and amended existing law in relation to weed – hurriedly passing the Narcotic Drugs Amendment Act in February 2016.
The rest, as they say, is history, with Ministers then deciding – against all the evidence that had persuaded the Senate Committee otherwise – that cannabis should be treated like all other drugs and undergo the TGA system.
The trouble was – and remains – the fact that campaigners and the public believed they were getting one thing – legalised, regulated cannabis – when what they were given was quite the opposite. And the Government cheerfully let them and the media believe it – until patients realised they couldn’t access the medicines they needed in the forms that were most effective.
It’s the cause of all the rancour today, and it’s likely to worsen unless the Health Minister is prepared to re-visit those same discussions held from late 2013 on.
To do otherwise would be akin to insanity.
AMCSignpost has had sight of testimonials from medical cannabis users provided by a compassionate supplier.
Under the Minister’s very nose there are tumours being held at bay, seizures controlled, chronic pain relieved – and instead of celebrating this he persecutes and punishes the individuals concerned. And there are hundreds of these if not thousands.
An excellent opportunity to do something truly remarkable in Australia is being offered to him on a plate – unless he takes it he’ll find himself on the wrong side of history.