In the first of a three-part series, Cannabiz chief correspondent Steve Jones reports on the hurdles the industry still needs to jump to persuade politicians and physicians of its multi-million dollar, life-changing potential.
In late March, just a few days after Covid-19 began robbing us of our personal liberties and turning societal norms upside down, a hefty report landed in Canberra at the federal department of health.
It was desperately unfortunate timing.
With health minister Greg Hunt, his department, and pretty much everyone else in Government preoccupied with the pandemic, the report was largely forgotten, buried, in all probability, among a mountainous pile of papers in the non-urgent tray.
And there it has stayed, perhaps unsurprisingly given the wretched circumstances of this extraordinary year.
The report in question will be familiar to the medicinal cannabis industry and campaigners, if not the wider public. It contained the findings of the Senate inquiry into the accessibility of medicinal cannabis, conducted by the Community Affairs References Committee.
Ironically, as Covid-19 encroached on our lifestyles and restricted our choices, the 102-page report effectively called for greater freedoms in how we live our lives, and on the choices we make concerning our health.
After poring over 146 written submissions and listening to testimonies at a public hearing, the committee drew up 20 recommendations it believed would create a more open and equitable system around medicinal cannabis.
Barriers which restrict access to cannabis must be removed, or at least lowered, the committee concluded. Doing so, it argued, would potentially provide hundreds of thousands of Australians with access to cannabis-derived medications that, for a variety of reasons, have been frustratingly beyond their reach.
The problem, at least for critics of the existing system, is that few of the recommendations are likely to see the light of day.
The return of the independent regulator
Greens Senator Richard Di Natale, the politician who took up campaigners’ fight to legalise medicinal cannabis in 2014, suggested the Government didn’t even need Covid as a cover for inaction.
“The Government has a history of ignoring set reports and the recommendations that are included in those reports,” he told Cannabiz. “There is a strong appetite from the community to improve access, there are a lot of people who are frustrated at the current system and there are a number of groups who are advocating strongly for those recommendations to be adopted. But the Government’s track record on this is not very good.”
There is, according to the former Greens leader, a historical precedent which proves his point.
Casting his mind back to 2016 when medicinal cannabis was legalised in Australia, Di Natale recalled how the Government was dragged “kicking and screaming” to the table, before finally implementing legislation.
Critically, however, and to the enduring frustration of reformists, Di Natale among them, legislation excluded the core element of a 2015 Senate inquiry which recommended the creation of a regulator independent of government.
Instead, then health minister Sussan Ley insisted that medicinal cannabis would, like all other medicines, fall under the remit of the Therapeutic Goods Administration (TGA).
“It was a very conservative framework, and so far the TGA has shown little appetite to reform its processes,” Di Natale said. “The reason we went down that path of an independent regulator was that given its history and use, given the many therapeutic benefits, given there are so many formulations and preparations, given it is an emerging area and given how unique it is, we felt we should adopt what other jurisdictions have done around the world and create a separate regulator to focus specifically on medicinal cannabis.
“Instead the Government ignored our approach and tried to treat it as a pharmaceutical product. They tried to put a square peg into a round hole, and the TGA has been scrambling to give people access since.
“While I am hopeful the Government will implement at least some of the recommendations in the Senate inquiry, it’s not compelled to do so. It’s a case of waiting to see how they respond.”
In the report tabled in March, the formation of an independent regulator was again among the proposals. Recommendation five reads: “If after 12 months from the tabling of this report… the Therapeutic Goods Administration has failed to address the barriers to appropriate, regulated patient access to medicinal cannabis in Australia, a new Independent Regulator be considered.”
No-one is holding their breath.
While Di Natale remained hopeful – at least publicly – few in the industry believe any of the recommendations will materialise, beyond the down scheduling of CBD, a process that was already underway as the inquiry unfolded.
Rhys Cohen, principal consultant at Freshleaf Analytics, suggested any wait for a positive response will be a futile one.
Describing himself as a “realist”, Cohen said the Liberal National Coalition had no interest in the Senate inquiry in the first place.
“It happened in opposition to their wishes and was chaired by the Greens, and the recommendations reflect that. That’s not saying the recommendations are bad, they aren’t, they’re interesting. But they are ambitious when you compare them to the current policy. I don’t see them being implemented.”
It is a view widely shared across the medicinal cannabis ecosystem. Not that all 20 recommendations received universal backing. Opinion was split over the creation of an Independent Regulator to replace the TGA.
Among the bodies backing the status quo was the Pharmacy Guild of Australia and the Medicinal Cannabis Industry Association (MCIA).
MCIA chairman and Cann Group chief executive Peter Crock told Cannabiz that taking oversight of medicinal cannabis away from the TGA would risk recent progress.
“We, as the MCIA, think it would be a step back to establish a different regulator,” he said. “You would lose a couple of years as you try and recreate what has already been done. But there is no doubt it [the current framework] can be modified.”
The association has previously voiced its backing for the TGA and Office of Drug Control (ODC), claiming the dual management structure is both familiar and respected by the medical community, and provides confidence to doctors and the wider healthcare sector.
Additionally, the MCIA said oversight by the TGA legitimises medicinal cannabis as a type of medicine and is the “most suitable structure to deliver the best outcome in terms of delivering patient access to trusted and quality products in a timely and effective manner”.
Carol Ireland, founding director of the Medical Cannabis Council and CEO of Epilepsy Action Australia, was among those arguing for an Independent Regulator back in 2014/15. But despite renewed calls for a shake-up, Ireland accepted the Government is not about to suddenly hand control of medicinal cannabis to a new entity.
Echoing Di Natale’s “square peg in a round hole” description regarding government oversight, Ireland lamented the absence of an Independent Regulator.
“I thought it would have been a very positive move, but it’s probably not going to happen now,” Ireland conceded. “The Australian Government, quite rightly, says it has an excellent system and that it’s managed every other issue very well. But it hasn’t been as open-minded to the argument from some sectors of the community that cannabis is different. It’s just not been receptive to that. But my instinct is that we need to work with what we have got.”
The TGA is not without its fan base. Far from reluctantly accepting the status quo, some within the industry believe the TGA should be recognised for the progress around medicinal cannabis.
One of them, Althea chief executive Josh Fegan, heralded the Government regulator as having done a “great job”.
“It’s a medication, it deserves to have belts and braces put around it,” he said. “They need to make sure it’s not abused and doesn’t end up in the wrong hands, that it’s safe, and that the right stakeholders are involved.
“Would I want to be further down the line, and our lives be a little easier so more patients could access these products? Absolutely. But I also think they have to see things evolve, and to get comfortable before that happens. And you can see in the numbers coming through the Special Access Scheme (SAS) that it’s starting to get serious.”
Better, but room for improvement
The numbers referenced by Fegan do present an encouraging picture. In June 2019, the TGA approved 1566 prescriptions through category B of the Special Access Scheme. Last month, it approved 4630, a record high and a near 200% year-on-year rise. Even the fiercest critics of the Government’s approach would recognise that as progress.
The reasons for the increase are varied, ranging from the creation of a streamlined online portal which removed the need for separate state and federal applications, the rise of medicinal cannabis clinics and growing awareness among patients of cannabinoids as a treatment for certain conditions.
Nevertheless, the number of approved prescriptions, while rising every month, are barely scratching the surface of the potential, and plenty of people are forced to illicitly source medicine having been knocked back by their GP.
Nor do application approvals correlate with patient numbers. That figure is not released by the TGA, with estimates of individual patients accessing medicinal cannabis via the SAS-B pathway ranging from 20,000 to 30,000.
As AusCann chief executive Ido Kanyon said: “Like every good forecaster I have a number, but it’s probably wrong. If you want to call it 20,000, 25,000 or 30,000, it’s still a fraction of the potential.”
The TGA’s reluctance to release more forensic analysis of medicinal cannabis usage is troubling to some, with the Lambert Initiative for Cannabinoid Therapeutics arguing that withholding such data from scientists hinders its understanding of the subtleties of current patient access.
“We have argued that a database should be established where detailed longitudinal data is collected from every patient given a TGA approval for medicinal cannabis,” it has said.
Lack of resources has been cited by the TGA as a reason for the dearth of information, a position described as “disappointing” by the research body.
It is also clear that doubts persist over the suitability of the TGA’s Special Access Scheme. As cannabis as a medicine continues to gain traction, and applications continue to rise, so does concern that the system will begin to creak.
Despite praising the TGA, Althea’s Josh Fegan warned: “The SAS is not designed for the type of volume where our sector is tracking. Pressure is building so at some point something will have to give.
“What does that look like? I’m hoping for a medicinal cannabis register that sits between the SAS and the Australian Register of Therapeutic Goods (ARTG) where products might not be authorised in the same fashion as a phase three clinically trialled drug, but if they meet safety and efficacy requirements they can sit on that register.
“That would enable a doctor to write a prescription and avoid the application process. I don’t think I’m out of my mind to believe that’s possible, it’s realistic. It’s going to come down to the numbers.”
As with estimating the number of current users, assessment of the potential market size involves a forecasting model of the finger-in-the-air variety, sitting at anywhere between 250,000 up to one million. The top end of that range was the calculation of Cannatrek chief executive Tommy Huppert, who identified the over 50s as a potentially “massive market”.
“You’ll hear companies come out with different numbers, but I believe there will be this new demographic – the over 50s – who will come out of nowhere and it could become the major part of the market,” he told Cannabiz.
Meanwhile, MCIA’s Peter Crock suggested the patient base could sit somewhere between 300,000 and 600,000, a figure consistent with international markets on a per capita basis.
The reluctant GP: show me the data
While forecasts differ over the likely scale of the local market, there is overwhelming agreement that GPs, and the broader medical community, remain the major roadblock to wider access, at least under existing regulations. The moment medicinal cannabis was legalised – through access to unapproved drugs – it was practitioners who, by default, were appointed gatekeepers.
Yet GPs would argue they do not hold the keys to the medicine cabinet. That is the TGA, and to a lesser extent, the states and territories who must approve GP applications. But probably more pertinent is the widely-articulated view of practitioners, and their industry bodies, that their hands are tied by a lack of robust evidence.
Inevitably, that has created friction between medicinal cannabis advocates and the medical community, with the former insisting there is an ever-expanding body of real-world data.
Furthermore, advocates argue the high safety profile is undeniable.
Carol Ireland, from the Medical Cannabis Council and Epilepsy Action Australia, said gathering the “gold standard” level of research required by Australian doctors – double blind, placebo-controlled trials – will take “years and years”. And it’s time many families don’t have.
“Putting my consumer hat on, there are thousands of people in this boat,” she said. “The condition they or their child has is devastating and they don’t have 10, 15 or 20 years to wait. If you look at it from the medical profession and research point of view it’s probably moving incredibly quickly. But not so from the consumer side, and that’s where the tension is.
“Having spoken to doctors in the US, they seem to be willing to learn almost as they go. They have accepted the safety profile, whereas the culture in Australia is ‘no, we want all the evidence first’. That’s the way they’re used to working.
“What the consumer movement is calling for is a more pragmatic approach. We know the risk is low, we know there’s not a high risk of harm, so we want the right to try, and we want that right now.”
Ireland suggested medicinal cannabis prescriptions are currently being written in hospitals, within a trial setting, and by GPs working in collaboration with specialist cannabis clinics.
“In terms of the number of doctors that are prescribing, it’s not moving fast at all. We’re a long way from having our local GPs all able and willing to prescribe,” she said. “And when it comes down to attitudes, my goodness, I think I’ve come across them all. If you’re perhaps an older medical professional, you’ve probably never even heard of the endocannabinoid system. It certainly wasn’t in any of the medical training, and it’s still not in most of the medical training. All you learned about was cannabis as a product of harm.
“I still hear, mainly third hand, of doctors telling patients: ‘Oh that’s a lot of rubbish. That’s a lot of nonsense. I’m not going to talk to you about that.’ We still hear that quite a bit.”
The only medicinal cannabis drug included in the ARTG – although not available under the Pharmaceutical Benefits Scheme – is Sativex, a treatment for spasticity in MS patients.
Deidre Mackechnie, chief executive of MS Australia, said there is “pretty clear clinical evidence” to suggest medicinal cannabis can also aid with pain management associated with spasticity, along with other symptoms such as incontinence.
But part of the problem lies in the guarded approach of the GP governing bodies, the Australian Medical Association (AMA) and the Royal Australian College of General Practitioners (RACGP).
“If you’re getting advice suggesting that you need to be careful, and to maybe avoid medicinal cannabis, of course many doctors will take the safer path,” she said. “What we need to do is improve their education and understanding and present medicinal cannabis as an alternative path.”
According to Bod Australia chief executive Jo Patterson, medicinal cannabis has the potential to become ARTG registered without the need for multi-million dollar trials. While accepting GPs operate in an environment where clinical data is paramount, the amount of real-word information could provide the necessary evidence for a specific indication.
Patterson also anticipated the market could become consumer-driven, particularly by patients who have failed to respond to more traditional treatments.
“It’s just my hypothesis but this market has the potential to be led by patients who drive their doctor to seek out the research,” she explained. “You build trust and a dialogue with your doctor. And if the patient is not getting relief from opioids or their dosage continues to rise, they will increasingly ask for cannabis.”
The MCC has advocated N-of-1 trials be used by the TGA as a source of evidence when considering ARTG applications. Had such trials been adopted at an earlier date, the industry would be armed with rich data that could have better shaped policy, Ireland claimed.
“If we had been trialling a cannabis product with individuals, and been using that data, we would be much further advanced,” Ireland said. “From the small number of people I have monitored, and our nurses have monitored, there have been some amazing results. So I would love to have switched those people from illicit to licit product and had them monitored from way back.”
As it stands though, patients are confronting a largely sceptical and suspicious GP network that, as MS Australia suggested, reflects the positions of the AMA and the RACGP.
According to Di Natale, a former GP, the AMA and RACGP are subject to the same bias as practising doctors.
“There is still that stigma around cannabis and a lack of knowledge and understanding,” the politician said. “My message to them is firstly ensure the people who are making decisions about medicinal cannabis through their own policy framework understand the issue better. What they should be advocating for is structured accredited training for all doctors so they can learn more about it, we can address the stigma and start prescribing it to more people.”
Medicine, he added, remains a “very conservative institution”.
“It takes a long time to steer the ship. Achieving change in established practices takes time, takes education and takes investment and it’s just not happening with medicinal cannabis.”
The RACGP declined interview requests from Cannabiz.
Despite the reluctance of doctors to prescribe medicinal cannabis, GP and associate professor Vicki Kotsirilos, who became Australia’s first authorised prescriber in 2018, believes the fundamental interest is there. But there is undeniable nervousness, and few GPs are willing to prescribe it just yet.
The reasons for the limited uptake are varied, Kotsirilos said, with the SAS-TGA application process too lengthy for some time-sensitive doctors.
Others, she explained, are simply unconvinced by the evidence or “not philosophically comfortable” prescribing something they feel has a potential for addiction.
“There is hesitation because we’ve gone through an opioid crisis and doctors are wary about cannabis being another drug of addiction and jumping from opioids to medicinal cannabis,” Kotsirilos said.
“I can understand the concern and the hesitation among the medical profession and authorities and the need for more high-quality research.
“So we do need more of the gold standard research such as that being conducted by the Lambert Initiative. GPs would like more scientific evidence to assist them with understanding what the clinical benefits are, what the risks are and the side effects.”
Yet that does not mean studies are not out there – it’s just that some in the medical community appear oblivious to them, Kotsirilos said.
“I recently went to a lecture about the potential use of steroid injections into the spine for relief of chronic back pain. There was a question from the GP audience about medicinal cannabis and the lecturer asked if anyone in the audience used it.
“I put my hand up but even the lecturer said ‘oh, there’s no evidence’. I said there was a recent review and he asked if I could email it to him. So there is the perception out there that there is a lack of evidence when in fact there is research, and it’s evolving.”
A further incentive for GPs to look more closely at medicinal cannabis would be the removal of the ‘drug of last resort’ policy adopted by the TGA.
Under the TGA framework, only after exhausting all other traditional options should medicinal cannabis be considered.
“My personal view is that this needs to be changed,” Kotsirilos said. “It’s unreasonable because there are other drugs that are more addictive and harmful than medicinal cannabis. There is also the patient right to treatment argument.”
She told Cannabiz of a recent case where the parents of a child suffering from a severe autistic disorder wanted to try CBD rather than antipsychotic medication.
“I provided low-quality research to the TGA demonstrating CBD alone can help with behavioural problems in autistic children, and explained that the paediatrician supported the line of treatment, and was willing to watch and observe,” Kotsirilos explained. “But I was further questioned by the TGA to justify the choice of treatment, and it took me extra time to write an additional report.
“The TGA eventually gave us the permit but it’s an example of how time consuming it can be. And this was for a CBD-only product.”
The patient, Kotsirilos added, was reacting well to the CBD. “The parents are really happy,” she said.
In a statement to Cannabiz, while the AMA recognised that medicinal cannabis will have a role to play “in treating difficult cases”, it will only be suitable for a “tiny proportion of patients”.
“The AMA supports properly conducted and evaluated clinical trials of medicinal cannabis to test the evidence of its benefits in treating a range of conditions,” a spokesperson said. “There is evidence that it may assist in some specialised neurological conditions, including paediatric epilepsy, in multiple sclerosis, and the body wasting that goes along with HIV and chemotherapy, but is is not the panacea for all.
“The public has been led to believe that medicinal cannabis is available, and patients can go to any doctor and it will be prescribed. This creates many problems, both for the GP and for patients.”
The need for improved training
What was made abundantly clear during the Senate inquiry, and remains as legitimate now and it did then, is the need for a more structured education and information program for general practice. Anecdotally, patients keen to discuss medicinal cannabis are often casually dismissed or met with uninformed responses.
Resources are available – and manufacturers have their own educational strategies for potential prescribers – but many feel the overall education piece is delivered in haphazard fashion.
It is something the industry is attempting to address.
Peter Crock, from the MCIA, diplomatically stopped short of saying doctors need “educating”, but said a collective industry approach was required to provide “balanced access to information”.
To that end, the MCIA has begun collaborating with the MCC in order to supply medicos with data, and “some explanation as to where and how medicinal cannabis is applicable”, Crock said.
“Medicinal cannabis is not a silver bullet, it’s not for everyone, but there are clearly areas where it’s of use, and understanding how to access product, and be able to prescribe it to patients, that’s where we’re aiming. That’s a role for the industry to play as opposed to an individual company promoting their own product.”
Once provided with information, GPs can “make an informed decision and support the patient”, Crock added.
The MCIA’s new bedfellow, the MCC, said training and information does exist, but it is unaccredited and largely supplied by organisations with “vested interests”.
“There is a lot of scepticism among doctors about undertaking that training,” Carol Ireland said. “There hasn’t yet been a situation where, say, the Government has said, ‘here’s some endorsed training, and we’re going to put some funding towards it’.”
The AMA also called on training to be stepped up, arguing that while modules are being created, the information is “not being effectively communicated”.
“There is insufficient information regarding the additional training general practitioners require to become an ‘approved’ cannabis dispenser,” a spokesperson said.
Doctors, the AMA said, must be informed about the types of products available, their strength, use and dosage.
“As the Senate Inquiry recognised, the current system is so convoluted and complicated for patients and prescribers that it isn’t fulfilling the reason it was established,” it added.
“The AMA has called for increased investment in education and training for doctors on medicinal cannabis. There is a constant flow of new reports and findings related to medical cannabis and therefore up-to-date information and education for GPs is paramount. “
For Deidre Mackechnie, providing GPs with more nuanced training of MS, coupled with an education program on medicinal cannabis and where that fits in with MS symptom management, would benefit patients.
“We’ve had discussions with the GP college to try and find ways we can improve the understanding of MS in general, as well how we can improve the understanding of symptom management,” she said. “Most people with MS have a neurologist, but if they experience a change in their specific circumstances in terms of the manifestation of symptoms, it’s not going to be the neurologist they see, it’s likely to be their GP. So what we think is key is providing general practitioners with enhanced education around a whole range of things to do with MS.
“From a medicinal cannabis perspective, it’s a much broader education program. GPs need to get a better understanding of the varieties of medicinal cannabis, where it works, where it doesn’t, and start to see it as a viable option.”
Fleta Solomon, chief executive of Little Green Pharma, described GP engagement as one of the most pressing challenges, both for her company and the industry. And while applauding the progress, she acknowledged the task remained a tough one.
“Access is definitely improving,” she told Cannabiz. “When you look where we’ve come from in the last couple of years, the demand and the access have improved greatly. But there is always room for improvement and that will come with the education that we’re doing and the industry is doing as a whole.
“We have a huge role to play and a long path ahead of us to educate doctors. It’s about bringing them out of the woodwork and being open to learning about the endocannabinoid system and how cannabis as a therapy can be prescribed.
“When you look at it, cannabis was a prohibited substance just a few years ago. It was this big ugly drug that caused many issues, and it’s hard for doctors who have been educated about the dangers of such a substance to be now told it has a role to play for medicinal purposes.”
As of now, Solomon said, a small percentage are open to medicinal cannabis, while around 10 to 20 per cent will never alter their negative views. In between sit the majority.
“They are on the fence but could be – and I think will be – persuaded because enough time will have passed and their peers are doing it. They’re also getting pressure from patients.
“That’s when they will start to reach out to a company like LGP, or any other producer, and say ‘I am ready to learn, how do I do it?'”
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