Australia: Seven Years Of MMJ & The Debate Continues

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It’s been seven years since medicinal cannabis was legalised in Australia, yet debate over its usage, efficacy, availability, and cost continues.

More than 300,000 prescriptions for medicinal cannabis have been approved for conditions ranging from chronic pain to anxiety and depression since federal legislation passed in February 2016.

Demand for medicinal cannabis surged during the pandemic, with 296,804 prescriptions approved under the Therapeutic Goods Administration’s (TGA) SAS B scheme from 2020-2022 compared to less than 27,946 in the three years prior from 2017-2019.

Yet doctors are still calling for more scientific evidence showing therapeutic benefits and harms, and questions over how medicinal cannabis should be regulated and prescribed remain. Advocates for medicinal cannabis also hold concerns, not only about ongoing stigma, high cost, and barriers to access, but about patients being inappropriately prescribed the drug.

“There’s still so many things that are not working well in the medicinal cannabis world for patients,” Australian Medicinal Cannabis Association (AMCA) chair and co-founder Lucy Haslam told SBS News.

Quality care or a ‘shopping experience’?
As the market for medicinal cannabis booms, doctors and advocates are united in concern over commercial interests compromising patient care.

While the TGA allows authorised health care professionals to access medicinal cannabis products for their patients “where clinically appropriate”, all but two treatments available in Australia are “considered to be unapproved medicines” and have therefore not been assessed by the TGA for safety, quality or effectiveness. These “unregistered” treatments are accessed through the TGA’s Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme.

Ms Haslam was instrumental in the push for medicinal cannabis legalisation, and while she’s still fighting to remove stigma and barriers to access she’s also worried about commercial interests overriding what’s best for patients.

The rise of telehealth during the pandemic has allowed more patients to access medicinal cannabis through online clinics, and Ms Haslam is concerned about “some of the less ethical prescribing that’s going on”.

“[Some patients are] basically sold products and it’s based on making high numbers of sales versus making the correct clinical assessment and correct prescribing of the product that’s going to suit the patient,” she said.

“I never thought I’d be saying that access is almost too easy, but in some ways it is. I think COVID taught us that there was going to be an important role for telehealth. And at first I thought, well, this is actually going to be good for cannabis. But it’s almost gone the other way now with a lot of very profit-driven prescribing.”

Last year, the TGA issued more than $1 million in fines to medicinal cannabis companies, clinics and health practitioners for alleged unlawful advertising.

“Advertising of prescription-only medicines directly to consumers undermines the doctor-patient relationship and may create an inappropriate demand for particular medicines which may not be right for the individual,” the TGA said.

In Australia, medicinal cannabis products are only available via prescription but are not subsidised by Australia’s Pharmaceutical Benefits Scheme (PBS), with the full cost of the treatment borne by the patient. Costs can vary substantially, but according to a survey by the University of Sydney’s Lambert Initiative, prescribed users of cannabis spent an average of $79.20 a week on the treatment while those surveyed who were using illicit cannabis spent an average of $58.60 a week.

Ms Haslam wants to see “a really healthy industry” instead of one “that’s looking for customers rather than patients”.

“I think patients need to go to a doctor and have a clinical assessment and have their prescription made based on their clinical need. But it’s become a little bit more like a shopping experience,” she said.

Michael Vagg, director of professional affairs at the Faculty of Pain Medicine at the Australia and New Zealand College of Anaesthetists (ANZCA) cannabinoid companies are able to take advantage of “the gap in the market” created by “a lack of properly provided pain management”, including a lack of funding for comprehensive pain clinics.

AMCA board member and doctor Marc Russo said he was concerned about the intrusion of financial gain into clinical care when “prescription is occurring in these dedicated cannabis clinics” rather than through a primary GP.

“It is not ideal for cannabis prescriptions to be standalone and divorced from the ongoing holistic care of a patient as conducted by a patient’s general practitioner or by the patient’s primary specialist,” he said.

“This sort of separation and fragmentation is poor medical care for a start.”

How effective is medicinal cannabis?
Doctors and expert bodies in Australia say more scientific evidence is still needed to support medicinal cannabis therapies.

Medicinal cannabis is a catch-all term for a wide range of different cannabinoid products that vary in formulation, strength, and how they are administered – with methods ranging from oral liquid to dried herb, capsules and spray. In Australia, the term mostly refers to naturally occurring compounds tetrahydrocannabinol (THC) and cannabidiol (CBD) that are derived from plant cannabinoids, usually from the sativa cannabis plant, which are then formulated for use in a medical context.

In Australia, medicinal cannabis has been prescribed for a range of conditions, most commonly chronic pain, followed by anxiety and sleep disorders.

ANZCA’s Faculty of Pain Medicine does not support the general use of cannabis to treat pain, echoing the International Association for the Study of Pain’s 2021 position statement, which cites a “lack of evidence from high quality research” and calls for trials to improve understanding of cannabis harms and benefits.

Dr Vagg said there is little clinical evidence that medicinal cannabis is effective in relieving pain.

“The evidence would suggest that they are very limited in their effectiveness as an analgesic, that it may have a range of other effects, which are helpful in people who have pain, but it doesn’t seem to be a very effective pain reliever as such,” Dr Vagg said.

“If you talk to people who use it you will find that usually they’re saying it either makes them less anxious or it helps them sleep or it does something indirectly that improves their ability to manage their pain. But not that many people actually say that it reduces their pain per se.”

Dr Vagg said he is concerned about patients being given “false hope” that medicinal cannabis will cure their pain based on anecdotal stories and media hype.

“We have rigorous standards for the type of treatments that we accept as being effective in pain medicine, and there are not that many treatments which we know to be really genuinely effective in the long term of people’s lives,” he said.

“So we need to focus first on providing those in the good way before we get too distracted with other areas.”

Chronic pain is “an extremely complex thing, and everybody has it in a slightly different way”, Dr Vagg said, and the best way to treat it is with a “multi-disciplinary, comprehensive clinical approach”.

“You need to have that capacity to tailor a smorgasbord of treatments to the particular individual patient needs. And that’s how you get the best result,” he said.

Dr Russo is a specialist pain medicine physician and a fellow of ANZCA’s Faculty of Pain Medicine who has been working in the field for more than 20 years and has treated more than 45,000 patients. He runs a large multi-disciplinary private pain clinic in Newcastle, NSW, and has been prescribing medicinal cannabis “selectively, to certain patients” for the past four years.

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“As the clinical data is evolving for medicinal cannabis, mostly we should be reserving the prescriptions of that for patients who fail to respond to conventional medical approaches,” Dr Russo said.

“Mainstream medical approaches often have a very mature data set of knowledge. So we can be certain about whether it does or doesn’t work.”

While the jury is still out on medicinal cannabis it “should be restricted to those patients who failed other avenues of medical treatment”, Dr Russo said.

“What we need is granularity of data, and we need very defined population groups to answer very specific questions. And if we do that, then we can take that information, know whether it’s appropriate or not to translate that to the clinic,” he said.

Australian Medical Association (AMA) President Steve Robson said medicinal cannabis “must be treated like all other medicines in this country – medicines must meet TGA approval before becoming registered”.

“Australians have the right to expect that all medicines are safe and effective,” Professor Robson said.

“At the moment only two medicinal cannabis products are registered. They are Nabiximols, for patients with moderate to severe spasticity due to multiple sclerosis and Epidyolex, for seizures associated with Lennox-Gastaut Syndrome or Dravet syndrome.

“The AMA has confidence the TGA will continue to consider the evidence base for the use of medicinal cannabis and make appropriate decisions regarding the registration and scheduling of medicinal cannabis as a medication.”

Ms Haslam became involved in the fight for medicinal cannabis law reform after her son turned to the drug as a last resort to help improve his quality of life while suffering through bowel cancer.

In 2010, aged 20, Ms Haslam’s son Dan was diagnosed with stage four bowel cancer. For four years he suffered through gruelling therapy and treatments, and by 2014 he was gravely ill, she said.

“We were really desperate to try and get him some relief.”

When a fellow cancer sufferer suggested cannabis, Ms Haslam and her husband encouraged him to try it. “That was a big thing for us, because my husband had been in the drug squad for most of his 35 years in the police. And I was very opposed to recreational cannabis use. But we were desperate. And he tried it,” she said.

The drug helped Dan with “quality of life measures like appetite, the ability to sleep, to rest, to feel less anxious, and later on for pain”, Ms Haslam said. Medicinal cannabis was illegal in Australia at that time, but Ms Haslam’s research led her to believe “the reasons for it being illegal were not valid reasons”. She began to agitate for medicinal cannabis to be legalised. While it came too late for Dan, who died in 2015, in February 2016 the Australian government legalised the cultivation, production and distribution of the drug for medicinal purposes.

“That came on the first anniversary of Dan’s death, so he didn’t get to do that. But he was very much the reason for it,” Ms Haslam said.

She has continued to be at the forefront of advocating for medicinal cannabis reform in Australia. AMCA’s inaugural Medicinal Cannabis Awareness Week began on 20 February, with the central theme ‘it’s about being well, not about being high’.

When it comes to breaking down stigma around the drug in Australia, Ms Haslam credits the late entertainer Olivia Newton-John, who will be honoured with a state memorial service in Victoria on Sunday. World famous for her singing and acting, Newton-John was also an advocate for medicinal cannabis, crediting the drug with helping her in her battle with breast cancer. Ms Haslam remembers the day she heard Newton-John go public about her medicinal cannabis use.

“I was just so excited … I just thought wow, this is the breakthrough that we need, because you had to be quite brave to come forward and say that you were using cannabis,” she said.

Ms Haslam met Newton-John in 2017, and they became friends and kept in contact over the years. Together, the pair “tried to give a voice to medicinal cannabis patients”.

“Hers was probably the strongest of all, being so well known, and being so well respected,” Ms Haslam said.

What’s the future of medicinal cannabis in Australia?
Seven years on from legalisation, the fight is not over for medicinal cannabis advocates.

Ms Haslam is lobbying the Australia federal government to support a compassionate access scheme for those who can least afford medicinal cannabis. She hopes a newly formed Parliamentary Friends of Medicinal Cannabis group, co-chaired by Labor senator Anne Urquhart and LNP MP Warren Entsch, will help drive further change.

In a statement to SBS News, a spokesperson for the TGA said the Australian government is “aware of compassionate access programs being offered by some companies and also the Australian Medicinal Cannabis Association”.

“Companies providing medicinal cannabis products are private businesses and make individual decisions about pricing of their medicines,” the spokesperson said.

“Each company is able to offer compassionate access schemes for patients should they wish to do so. Support for a medicinal cannabis compassionate scheme would be a decision of Government.”

There is also an ongoing push to have a ban on driving for those taking medicinal cannabis lifted, with advocates arguing that the laws are not in line with the way in which other prescription medicines that can also impair driving in some circumstances are treated.

Ms Haslam said the driving laws are an example of ongoing “stigma” and “discrimination” faced by medicinal cannabis users, who are prevented from driving when taking “legally prescribed products containing THC, even though they may be completely unimpaired”.

In Victoria, members of the Legalise Cannabis party this week introduced a Bill to the state’s parliament that seeks to allow medicinal cannabis patients to drive with detectable levels of THC in their system, provided it is safe for them to do so.

Medicinal cannabis is still in its infancy as a therapeutic treatment, Dr Russo said.

“Right now we’re in the very first stage of this as a therapy. Therapies often go through three or four stages before they reach maturity. We are in the baby steps,” he said.

In five to ten years, Dr Russo expects that “we will have determined what combination of the different cannabinoids that exist is optimal for [a patient’s] specific condition”.

“A patient will receive a condition-specific prescription instead of this generic one size fits all prescription,” he said.

“It is highly likely that the results will be far more effective as a result. So we have a long long way to go in optimising this.”