MEDICINAL cannabis is back in the news, after a surprise Senate vote earlier this month eased Therapeutic Goods Administration (TGA) restrictions on prescribing the drug for terminally ill patients. The Greens initiative – opposed by the federal government, but passed with the support of Labor, One Nation and independent senators – sees medicinal cannabis rescheduled from Category B to A under the TGA’s Special Access Scheme.

Previously, under Category B, prescribing doctors had to seek approval from the TGA, nominating the cannabis product to be used and showing evidence that the patient had tried all other possible treatments while continuing to suffer from intolerable symptoms. But under Category A, doctors don’t need the TGA’s approval. They simply have to notify the TGA after they have supplied the drug to the terminally ill patient.

Pushback from the government and peak medical bodies was immediate and unequivocal. Federal Minister for Health Greg Hunt called the move “deeply concerning and disappointing”. He said it was “a dangerous step because the quality of what can now come in can no longer be regulated”.

The Australian Medical Association (AMA) also came out strongly against the new legislation. In an interview with Sky News, AMA President Dr Michael Gannon said that he was concerned about the potential for the diversion of medicinal cannabis into the general community.

“We’re talking about a substance that is a major source of mental illness in our community. It’s absolutely essential that we’re assured that whatever’s being brought into the country is safe – even if we’re talking about its use in the palliative care setting.”

Dr Gannon said that Australians would be “outraged” if prescription medication was rushed in, or foodstuffs imported without appropriate safety checks.

“Why would we possibly have a different rule when it comes to cannabis?” he asked.

The key criticism, it seems, is that under the old rules the government maintained control over cannabis products coming into the country, and had an established stockpile of tested drugs. But with Category A, doctors can contact a supplier directly, with little oversight from the TGA, which means that the government loses some control over what is being imported.

Supporters of the new legislation say it will speed up the process, getting drugs more quickly to patients for whom time is very much of the essence.

However, the speed at which prescribing doctors can get hold of medicinal cannabis may depend on where they live. The problem that is not addressed by the federal legislation is the second layer of bureaucracy involved in medicinal cannabis approval, at state level, which can vary substantially. In NSW, for example, the state-based process can be lengthy, while in South Australia doctors don’t need state approval and can get medicinal cannabis to their patients more quickly.

Dr Judith Lacey, who is Head of Supportive Care and Integrative Oncology at the Chris O’Brien Lifehouse in Sydney, has prescribed medicinal cannabis under Category B for two patients with cancer who did not meet criteria for a medicinal cannabis trial. The treatment was prescribed for refractory nausea and anorexia in one case, and for chemotherapy-induced nausea and vomiting in the other.

“I’m hoping the new legislation will eventually make a huge amount of difference,” she told MJA InSight.

As for the drug’s efficacy, Dr Lacey said she had seen significant improvements with medicinal cannabis for severe, refractory nausea in some patients with cancer under her care.

“When you go through all the drugs we have available, including the ones with known side effects, such as levomepromazine, it’s a question of working out the limitations of each drug. I’ve got patients who are self-prescribing cannabis through compassionate access pathways, and they have found it amazingly effective for short periods of time.”

But many doctors harbour doubts about the way medicinal cannabis has been introduced in Australia. Professor Jennifer Martin, Chair of Clinical Pharmacology at the University of Newcastle, has concerns about the new federal legislation for similar reasons to those of the government and the AMA. She says that it doesn’t appear to offer any benefit for patients who can already access locally stored products and that it potentially opens the floodgates for uncontrolled importation without safety checks.

And she adds that, in any case, palliative care may not be the place to start with products lacking standard pharmacology and clinical data, such as medicinal cannabis.

“This our most vulnerable group. Palliative care patients don’t have much reserve and you can really make them quite sick. If you’re going to start with anyone, it should probably be a younger, more robust group,” she told MJA InSight.

Professor Martin is involved in several cannabis trials, including an ongoing trial measuring improvement with medicinal cannabis in end-of-life patients.

“We’re learning things about dosage and the relationship between dose and symptoms such as development of mental health symptoms. I think it’s worth waiting until we get that data, so we can have an idea about which doses seem effective and which ones may be toxic. I’m just not sure why we have to rush things.”

Professor Martin noted that if the clinical data were not available, the other issue was that the drugs would have difficulty getting listed on the Pharmaceutical Benefits Scheme, and patients would end up out of pocket.

But Dr Lacey said that while getting the data was critically important, it didn’t follow that patients shouldn’t get the treatments in the interim.

“The number one objective is do no harm, and I don’t think cannabis, with good monitoring and prescribing, is going to do a lot of harm in these patients. In palliative care we try to reduce suffering, we look at what may work and then we try and back it up with evidence. One example would be ketamine and octreotide, which we started using to reduce suffering in patients with advanced cancer and then later we were able to get the numbers to run a reasonable randomised controlled trial to evaluate efficacy.”

Even if the treatment is effective in palliative care, there’s also the wider issue of whether more easily available medicinal cannabis may open the door to its use in ways not intended by the legislation. Professor Martin points to the example of US state of Colorado, where medicinal cannabis is considerably easier to obtain than here in Australia.

“I was talking to the head of the Colorado program just a few months ago. They desperately want to do the research, but no one wants to because they’ve already got the product. There’s a sense that people are just using cannabis to treat a whole lot of things, many of which have more effective therapy available than adding another drug. And we know from years of recreational cannabis use that those products may take away motivation and have other social problems. Even though it’s ostensibly medical, there’s a feeling that they’ve legalised a drug and it’s very difficult to pull back from that.”

Australia would do well to take note, she says.

 

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Poll

I am more convinced about the benefits of medicinal cannabis than I was 6 months ago
  • Strongly agree (32%, 60 Votes)
  • Agree (23%, 43 Votes)
  • Neutral (17%, 32 Votes)
  • Disagree (16%, 31 Votes)
  • Strongly disagree (13%, 24 Votes)

Total Voters: 190

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10 thoughts on “Cannabis legislation: a new can of worms

  1. David Caldicott says:

    Actually, quite a great deal is known about dosing. The Department of Health in Israel has published guidelines- not guidances- on dosing in their ‘Green Book’, and have very generously provided them to their counterparts in NSW. The fact that they have not been released more widely in Australia doesn’t negate their existence- merely that those in receipt haven’t felt the need to make their existence known in Australia.

    I would imagine that Professor Marten’s perception of the need for a ‘rush’ is substantially different to that to the view of patients, who stand to benefit from a product that when used appropriately, has a very wide therapeutic index. It’s not clear to me how witholding an effective therapy on the grounds that it might interfere with the ability to recruit ‘clinical material’ is one that holds up to strong ethical scrutiny.

    The National Academies of Science from the US has published their excellent review in only January of this year, in which they find compelling evidence for it’s use in the management of pain. Despite knowing this, The Minister of Health has commissioned a further Australian review of evidence, before issuing any guidance.

    We rolled out Australia’s first independent medical cannabis course for clinicians last Thursday, and such was the immediate demand, we now need to run 4 more before the end of the year. In a collaboration between the ANU and United in Compassion, the course is not-for-profit, strictly scientific, and perhaps most important, apolitical. In the absence of any alternative information, it was inevitable that such a course would emerge from academia- we welcome the emergence of others. It represents a counter-narrative to the one currently being pressed in Australia, one which is losing traction in a global environment where patients can share information and experiences from all quarters of the world.

    The end game in the global narrative has already been decided. The elegance or otherwise of how Australia plays into that endgame is entirely up to those who have the power to make the decisions that can affect the health of thousands.

  2. David Penington says:

    David Caldicott is right. We need to move based on much evidence from the US with outcomes in 10 States with established med. cannabis programs (JAMA Int. Med 2014) compared with others.

  3. Anonymous says:

    Would love to see the AMA president back up his comment with data. Not sure that’s possible and not sure someone in his position should be making sweeping statements that are factually unfounded.

  4. David Caldicott says:

    I would be delighted to invite the AMA President to come along to one of our courses, if he’d like to learn more about the topic

  5. Sue Ieraci says:

    Previous commenters appear to be confusing efficacy with regulation and supply.

    “Professor Jennifer Martin, Chair of Clinical Pharmacology at the University of Newcastle, has concerns about the new federal legislation for similar reasons to those of the government and the AMA. She says that it doesn’t appear to offer any benefit for patients who can already access locally stored products and that it potentially opens the floodgates for uncontrolled importation without safety checks.”

    We know that opiates are enormously useful, especially at the end of life, but we also have to manage the complications of misuse in the wider community.

    Why not use similar caution to introduce rational, evidence-based use of cannabis products under controlled conditions?

    Cannabis is no “miracle drug” – just another addition to the therapeutic toolbox that can help many people with symptomatic relief, while causing side-effects and complications in others – like any mixture of chemicals with pharmacological activity.

    The AMA President’s comments are don’t merit the flippant response – he is looking at the wider ramifications of the legal change – not just the clinical application.

  6. David Caldicott says:

    Sue, my comments were not meant in any flippant manner. It was meant absolutely straight down the line; we met with the AMA Public Health team, at their request, last year to discuss it. They are very in favour of our course, but have concerns regarding the politics in this space at the moment.

    We had Bastien Siedel on one of our panels at the Medical Cannabis Symposium, demonstrating true compassion for a patient. He emphasised the importance of education in this space, and his interest in learning more. THIS is the sort of leadership that Australian’s should expect of their doctors- not a buy-in to any new fad, but a willingness to investigate if it holds any worth.

    I completely agree with your assessment, for what it’s worth. Medicinal cannabis is NOT a panacea- but the global experience is that when it is used for the right patient, with the right condition, in the right dose, it can sometimes be the best medicine to use.

    I would like to take the opportunity to also invite you to do our course- we pride ourselves that it provides those with an interest in emerging therapies the science to justify witholding it’s use in any given patient, as much as to prescribe it.

    Let us know if you’re interested.

  7. Anonymous says:

    Medicinal cannabis must be tightly regulated and controlled by the Government because at every turn it will be exploited by private enterprise and criminals organized or not. The slippery slop is already known let us not be stupid again.
    We do not need the police to be attending to medicinal Cannabis and doctors do not need to question quality.
    Anybody promoting lessoning control is self seeking and socially negligent.

  8. Sue Ieraci says:

    Thanks, David. I’m sure your course contains much valuable information, but, to maintain my skills on the management of chronic pain, or end-of-life-care, I am more likely to attend courses or talks in each of these clinical situations, by a speaker in the area who can give the pros and cons of the broad range of pharmaceutical and non-pharmaceutical tools for managing different symptoms, I also look forward to seeing a lot more good quality trials, especially investigating the benefits and risks of specific cannabis products against existing alternative therapies. Courses that look at the full range of options for spedific clinical situations, citing relevant evidence, would be ideal (much as we might now do for the NOACs).

    While I’m not accusing you or your course of this, the public debate about so-called “medicinal cannabis” has been muddied by many false claims about alleged therapeutic effects for everything from cancer to “wellness”. Just like the opiates, we need to distinguish useful symptomatic relief from “cure”. Much of this discussion in the community is also about the right to cultivate and consume one’s own crop of the “healing herb”. While there are pros and cons to liberalised use of the whole plant, this should not confuse the evidence for legitimate use to assist with symptom control in specific conditions.

  9. David Caldicott says:

    Completely agree with much of what you say, Sue.

    It is critical for advocates for a botanical product to limit their claims to that which can be substantiated. Our colleagues and collaborators in Israel are very strict on this, and in our course, we take our lead from them.

    Over half of what our course is devoted to discussing the endocannabinoid system, about which a lot is emerging, every week, and about which clinicians, especially Australian clinicians, know next to nothing. I don’t think that any doctor should be asked to make a future prescribing decision about a physiological system- an important one, at that- which didn’t even appear on their undergraduate medical syllabus.

    One of the most important issues about using medicinal cannabis is knowing what is actually in it. We differentiate between ‘therapeutic cannabis’ which many folk use, to give some apparent benefit, and ‘medicinal cannabis’ which is a known product, of known dose, given to an appropriate patient, under medical supervision.

    I think your position of how you want to spend your hard earned TESL is the norm. In the diffusion of innovation model, medical practitioners tend to be ‘late-adapters’- it’s safer that way. Our role is more to provide the education to make an informed decision, rather than spruik any position. The literature is catching up with paractice, and at the moment, supports use for symptomatic relief of a narrow range of indications. There is very promising, robust work on animal models coming out of Spain, on apoptosis and cancer, which correlates with some radiologically proven ‘miracles’, but human trials are still some way off.

    I sense that you are maintaining an open mind, and await persuading, which I think is the best approach in this space- there are too many of our colleagues who have chosen a more conservative route than this.

  10. Sue Ieraci says:

    Thanks, David. You say “medical practitioners tend to be ‘late-adapters’ “, and yet, it has been the (apparently) too-early adoption of new medications – such as the COX2 inhibitors – that has led to mistrust of the conventional medical system.

    It’s true that our physiological knowledge continues to develop – it has done so significiantly since my training days. I now know a lot more about the serotonergic system, for example, which is also widespread throughout the body. We also know that there are widespread opiate receptors, and that both endogenous and exogenous opiates produce a wide range of effects, and yet they are not “cancer cures”. Similarly, the endocannabinoid system is widespread and stimulation has different effects in different sites.

    Original research into the physiology, and well-controlled clinical trials, need to progress before we can expect widespread incorporation into medical use. Reassuringly, there are currently many alternatives for all the proposed uses of cannabis extracts – including pain, nausea and vomiting, anxiety and cancer chemotherapy. If good evidence emerges that cannabinoid extracts, in dose-standardised form and of reliable and cost-effective supply, are equal to or superior to existing alternatives for specific symptoms, they should be incorporated into appropriate use.

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