Four years on from the legalistion of medical cannabis in Australia, record numbers of doctors are prescribing and access and awareness is at an all-time high, so why are hundreds of thousands of patients still self-medicating illicitly? Sarah Sinclair reports.
In 2016, following the legalistion of medical cannabis in Australia, the outlook was not a million miles away from the one facing the UK today.
It could offer a glimmer of hope for patients here then, that a recent analysis of the industry down under shows record numbers of doctors are now prescribing.
The latest report from FreshLeaf Analytics – including in-depth analysis of patients, products and pricing – was published in September, showing access to medical cannabis has never been more widespread.
The prescription market is expected to reach more than $150million by the end of 2012, with an estimated 30,000 patients now being prescribed cannabis-based medicines across the country – a significant jump from just over 10,000 in December 2019.
According to Professor Iain McGregor, academic director of the Lambert Initiative for Cannabinoid Therapeutics, based at the University of Sydney, the landscape has improved ‘exponentially’ in the last two years.
This is partly down to a more ‘streamlined’ Therapeutic Goods Administration (TGA) application process, removing the requirement for doctors to seek permission from the Federal and State Government. But also a change in views in the medical profession.
“In the early days patients couldn’t find a doctor to sponsor an application, because the doctors were quite rightly cautious, they hadn’t learned anything about cannabis in medical school,” says Prof McGregor.
“One of the key things that has promoted access is that the medical profession is becoming a lot more comfortable and better-educated around medicinal cannabis.”
The other factor is a significant drop in price. The cost of medicinal cannabis products has fallen by 75 percent since 2017, and according to the FreshLeaf report is now on a par with the black market.
Cassandra Hunt, managing director of FreshLeaf, told Cannabis Health: “The number of new products entering the market, and the degree of price drop is probably beyond levels we would have forecast 12 months ago.
“The report does not specifically track attitudes, however record numbers of doctors are prescribing, suggesting that acceptance of cannabis as a therapy is gradually increasing.”
The number of products available has doubled to 150 in the last year and is expected to exceed 300 by the end of 2021. This increase in competition has forced down prices.
According to the report, patients buying legal cannabis products are now spending the same as those accessing it illicitly, putting Australia in line with more mature markets such as Canada.
However, Cassandra added: “As medicinal cannabis products are not subsidised by the Government prices do appear expensive in comparison with subsidised medicine.”
This might go some way to explaining why, despite the increase in access, around 570,000 Australians are still self-medicating illicitly.
The results from the Cannabis As Medicine Survey (CAMS:18) conducted by staff at the Discipline of Addiction Medicine in conjunction with the Lambert Initiative, show that the majority of medical cannabis patients are using illicitly, with only 2.7 percent of respondents accessing legal products.
The Lambert Initiative itself was founded by philanthropist Michael Lambert, who was forced to break the law to access medical cannabis for his severely epileptic daughter.
“We can pat ourselves on the back and say that we’ve got more official patients than the UK does, but there’s still this huge unmet need in the community where people are using illicit products of unknown composition, often to treat very serious medical conditions,” Prof McGregor says.
“As well as trials, we have an advocacy role to try and promote access for patients to ensure that the needy and suffering can access these products without any problem.”
The CAMS:18 survey asks patients their reasoning for using cannabis illicitly, with many saying they can’t find a doctor to help them with an application.
Prof McGregor continued: “Traditionally, having a conversation with a medical professional has been very difficult, because we’ve had some of the leading colleges in Australia come out with very strong anti-cannabis messages.
“Our College of Physicians came out urging great caution about cannabis and our College of Anesthesiology and Pain Medicine specialists is also very dismissive.”
On the frontline
GP’s however, are more open-minded, with almost 2,000 now prescribing across the country.
“We carried out a survey of GPs a couple of years ago which showed the majority of them were in favour of medicinal cannabis,” he said.
“GPs are generally quite interested and more open-minded. I think that’s because they are the ones on the frontline of chronic unremitting illness. They see the carnage caused by opioids and all that all the prescription meds that they prescribed routinely.”
Chrissie Butler, is a palliative care support worker and assistant nurse in Queensland, as well as a medical cannabis patient herself.
“There is definitely a stigma still, especially in the medical profession although it is getting better,” she said.
“If a doctor won’t prescribe or listen to a patient about medical cannabis, I always tell them to find another doctor, because they are making a moral judgement not a clinical one.”
In her line of work Chrissie sees a broad spectrum of patients using both legally and illicitly.
“We deal with patients from all walks of life – I’ve got 90-year-olds using cannabis for cancer pain – and I see quite a few people who are legally prescribed medical cannabis, as well as black market users.”
She added: “I always encourage people to go the legal route, because you know you’re getting a quality product, but when people are desperate they will source it in any way they can.”
The devil’s in the detail
Where Australia could be seen to be lagging behind the likes of the UK, US and Europe, is in CBD products, with patients currently only able to access them through a prescription.
In September the TGA announced an interim decision to allow over the counter access to low-dose CBD products from next year. This has been welcomed by the sector, with around 20 percent of the products available falling into this category.
However, Prof McGregor has warned that the ‘devil will be in the detail’.
“We have our suspicions that it’s going to be difficult to get products registered for over the counter access, but in principle, it’s a very welcome development,” he said.
“At the moment it’s estimated that around 20 percent of patients having to get CBD prescriptions are in that low-dose range that can be quite easily serviced by over the counter products.”
While the regulations could be viewed as ‘nannyism’ by some, they have made Australia a favourable place for clinical trials, with around 60 ongoing trials, many with overseas sponsors.
Equally, many products are now being derived from raw materials that are increasingly being cultivated and produced on a large scale.
According to the FreshLeaf report, 2021 could be ‘significant in defining what a healthy medical cannabis industry looks like’.
“The last 12 months has seen huge change in the industry. Record numbers of new products, rapid price declines and new regulations that will improve access and reduce patient prices,” Cassandra commented.
“In the next 12 months we expect the market to continue to grow, generating in excess of A$150M in sales next year.
“We also expect significant consolidation as the number of players and product companies in the sector is excessive for the size of the market. Some Australian players will start to report meaningful revenues from overseas sales, mostly to Europe.”
Looking towards full legalistion?
FreshLeaf also speculated that a need for new taxable revenues could lead to a discussion about the legalisation of cannabis for recreational use.
As well as having recently been awarded $1.7 million to study the effectiveness of cannabidiol for treating chronic pain, the Lambert Initiative currently has ongoing studies into the impact of cannabis use on driving.
Is this in anticipation of a future where cannabis is fully legalised?
Prof McGregor added: “In Australia we still arrest something like 70,000 people a year for petty cannabis offences and there’s a lot of concern about the damage that does to people’s wellbeing, and ultimately who benefits from arresting small time users and people growing for compassionate purposes?
“It’s inevitable that something has got to give, but let’s solve the problems in the medical cannabis sector first and then we can go down the recreational path.”
CBD dominant cannabis does not influence driving skills – study
Participants showed no signs of impairment when it came to driving but they did test positive for trace levels of THC
A study suggests that CBD-dominant cannabis does not influence the skills associated with driving such as reaction time, concentration, time perception or balance.
The Swiss study examined CBD and THC dominant cannabis flowers to see if they impacted on neurocognitive or psychomotor skills.
Some of the participants were given a CBD dominant strain that had a 16.6:0.9 per cent ratio, and others were given a placebo.
After inhaling the cannabis, participants were asked to undergo the Vienna Test System TRAFFIC. This measures reaction time, behaviour in stressful situations, concentration and performance. They also took further tests to determine their fitness to drive, three separate balance tests and coordination along with vital signs such as blood pressure and pulse.
Driving and cannabis
The participants showed no signs of impairment when it came to driving but they did test positive for trace levels of THC in their blood. The blood tests were taken 45 minutes after consuming the CBD dominant cannabis.
The authors noted that the slight change in THC levels within the system would potentially place patients in violation of traffic safety laws.
The researchers noted: “This finding suggests that higher CBD concentrations cause a negative allosteric effect in the endocannabinoid system, preventing the formation of such symptoms. Nevertheless, it is recommended that consumers refrain from driving for several hours after smoking CBD-rich marijuana, as legal THC concentration limits may be exceeded.”
Driving and THC tests
When it comes to THC and roadside testing, new research revealed that THC levels in blood and saliva are poor measures of impairment.
Researchers analysed a range of studies on the relationship between driving performance and Tetrahydrocannabinol (THC) concentrations in blood and saliva.
The researchers took data from 28 different publications that involved ether ingested or inhaled cannabis. They characterised the relationships between blood and saliva THC concentrations, driving performance and skills such as reaction time or concentration.
When it came to infrequent cannabis users, there were some significant correlations between blood and oral levels of THC and impairments were observed. However, It was noted that these relationships were ‘weak.’
There was no significant relationship noted for the more regular consumers.
CBGA may be ‘more potent’ than CBD against seizures in Dravet syndrome
Dr Lyndsey Anderson said there is more to explore when it comes to creating more treatment options for Dravet syndrome.
Scientists say they have found the ‘Mother of all cannabinoids’ which may help to reduce seizures in Dravet syndrome.
A new study on mice from the University of Sydney found that three acidic cannabinoids found in cannabis reduced seizures in Dravet syndrome, an intractable form of childhood epilepsy.
The three cannabinoids are cannabigerolic acid (CBGA), cannabidivarinic acid (CBDVA), cannabigerovarinic acid (CBGVA). All three but CBGA in particular “may contribute to the effects of cannabis-based products in childhood epilepsy” noted the researchers and were found to potentially have ‘anticonvulsant properties.”
The study marks the first time that three acidic cannabinoids were found to potentially help reduce seizures for Dravet syndrome.
Speaking with Cannabis Health News, the lead author of the study, Dr Lyndsey Anderson, said: “We found that CBGA exhibited both anticonvulsant and pro-convulsant effects. CBGA was more potent than CBD against febrile seizures in a mouse model of Dravet syndrome. We also found that a combination of CBGA and clobazam was more effective than either treatment alone. Additionally, we found that CBGA was anticonvulsant in the maximal electroshock acute seizure model, a model for generalized tonic-clonic seizures.”
She added: “CBGA did, however, present some proconvulsant effects. The frequency of spontaneous seizures in the mouse model of Dravet syndrome was increased with a high dose of CBGA. Also, CBGA was proconvulsant in the 6-Hz acute seizure model, a model of focal, psychomotor seizures.”
Although CBGA shows promise, Dr Anderson also stressed that it needs more research before it can replace CBD. She cautioned that Dravet syndrome patients may still need to proceed with caution.
“Artisanal cannabis-based products are believed to reduce seizures in Dravet syndrome patients,” she said. “As these oils contain rare cannabinoids like CBGA, it is possible CBGA then contributes to the anticonvulsant effects of these artisanal cannabis oils. However, there were proconvulsant effects observed with CBGA, suggesting that Dravet syndrome patients may need to proceed with caution. The proconvulsant liability of CBGA would need to be addressed before it replaced CBD as an anticonvulsant.”
What is CBGA?
Sometimes referred to as ‘the mother of all cannabinoids,’ CBGA is the precursor molecule to many different cannabinioids including CBD and THC. It is thought to help some diseases such as colon cancer, metabolic disease and cardiovascular disease. It is a non-intoxicating cannabinoid much like CBD.
Dr Anderson explains that more research is needed to explain how the three cannabinoids work together.
“We don’t know how they work together yet,” she said. “We found that CBGA, CBDVA and CBGVA were all individually anticonvulsant against thermally induced seizures in the mouse model of Dravet syndrome. We did not investigate whether a combination of these three cannabinoids would result in a greater anticonvulsant effect than either cannabinoid alone. Future work will definitely explore this possibility.”
CBGA future research
This isn’t the end of the research into CBGA for Dravet Syndrome. Dr Anderson said there is more to explore when it comes to creating more treatment options for Dravet syndrome.
She said: “Next on the horizon for this research is to explore whether the anticonvulsant properties of CBDVA and CBGVA translate to other seizure types including spontaneous seizures in the mouse model of Dravet syndrome. Additionally, we have extensively interrogated the anticonvulsant potential of individual cannabinoids and identified ten with anticonvulsant properties.”
“We are now interested in investigating what happens when we combine these anticonvulsant properties. It remains an open possibility that greater anticonvulsant effects are achieved when the cannabinoids are administered in combination.”
CBD-enriched cannabis oil may reduce seizures in children with West syndrome
Four of the eight children had less than half the seizures they had before the trial.
A new study on CBD-enriched cannabis oil for seizures involving eight children revealed that electroencephalogram (EEG) abnormalities improved by 20 to 80 percent.
The study on seizures, published online, examines if CBD-enriched cannabis oil used as an add-on therapy could help children with condition that causes spasms. It found that four of the eight children in the trial had less than half the seizures they had before the trial.
The researchers reviewed the experiences of eight West syndrome children who were refractory to anti-seizure medications between May 2020 and March 2021. The children were aged between sixteen to twenty-two months and each received a dose of 25:1 CBD to THC as an add-on therapy.
The participants record a mean of 63 seizures per day with the lower rate recorded as 31 and the higher amount recorded as 79.
At the follow-up appointment, two of the patients reported a 75 percent to 99 percent decrease in frequency. A further two children recorded a 50 percent decrease while one patient did not experience any changes at all.
The authors wrote: “The index of EEG (electroencephalogram) abnormalities improved between 20 per cent and 80 per cent in seven patients concurrently with the reduction in seizures.”
“Tolerability among those patients experiencing fewer seizures was good and, overall, “adverse effects were mild and transient.”
West syndrome is a form of epilepsy. According to Epilepsy Action UK, West syndrome happens in about one in every 2,5000 to 3000 children. This means that about 350 to 400 children will develop the syndrome each year in the UK.
In 9 out of every 10 children, the first seizures will take place in the first year between three to eight months of age. They may happen in clusters or runs rather than singularly. The children may go on to develop learning difficulties as a result of the syndrome.
A new study published this month shows that CBD transdermal gel may help to reduce seizures and improve children’s quality of life.
The study, Safety and Tolerability of Transdermal Cannabidiol Gel in Children With Developmental and Epileptic Encephalopathies, was conducted in Australia and New Zealand. It involved 40 children with Developmental And Epileptic Encephalopathies (DEE). The authors noted that the DEEs were the most severe type of epilepsy typically beginning in childhood.
The non-randomised, clinical trial involved CBD gel being applied twice a day for six and a half months on children aged three to eighteen. The gel had a CBD content of 125 to 500 mg.
The researchers found that the gel helped in response to facial impaired awareness seizures potentially reducing them to 44.5 percent. It also helped to reduce tonic-clonic seizures where the muscles violently contract by 22.5 percent. Overall, the seizures in 33 participants were reduced by 43.5 percent.
The children also recorded improvements in alertness, alongside the seizure reduction.
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