WWhen Helen was diagnosed with fibromyalgia at age 40, her doctor prescribed a series of opioids. He tried morphine, meperidine, and a few more, but none helped alleviate the constant pain caused by his chronic illness.
Long before medical cannabis was legal in Australia, while Helen was traveling in North America, a doctor at a dispensary suggested she try cannabidiol oil. “He gave me this bottle of tincture and taught me to use one or two drops under my tongue,” Helen says. “My pain decreased dramatically. I was shocked.”
But once he returned from his trip, his only option was the black market.
Helen is one of hundreds of thousands of Australians who have resorted to medicinal cannabis to treat numerous conditions, which they believe have not been helped by traditional therapies. But as the industry grows after its legalization in 2017, the evidence remains inconclusive and the costs, for many, prohibitive.
Today in Australia, cannabis medicinal products are only available by prescription. Data from the Therapeutic Goods Administration reveal that more than 172,000 people have been granted access to medical cannabis through its special access regime.
Only two products have received TGA approval and are registered in the Australian Register of Therapeutic Products. One is Epidyolex, prescribed for rare but severe and drug-resistant forms of epilepsy in children. The other is Sativex, approved in 2012 to treat muscle spasticity associated with multiple sclerosis.
Doctors may request access to 224 different medicinal cannabis products not registered through the TGA scheme or as an authorized prescriber. These products can be capsules, oils, nasal and oral aerosols containing THC (delta-9-tetrahydrocannabinol) or CBD (cannabidiol) or a combination of the two. Some of them are of plant origin. Others are of synthetic production.
Along with the increasing demand for medicinal cannabis, there has been a growing interest in research around its use, with many clinical trials attempting to demonstrate its effectiveness for various medical conditions.
However, there is often no solid evidence and many products remain unregistered, making it difficult to prescribe with confidence for many GPs.
A cannabis felling in 2017: one of 50 cloned “mother plants” for future generations of crops for Australia’s medical marijuana industry. Photography: Saeed Khan / AFP / Getty Images
Professor Vicki Kotsirilos, a GP and Australia’s first licensed prescriber of medical cannabis, says the process for prescribing medical cannabis is “much easier” than it was four years ago.
The main challenge facing GPs is to choose the right product from more than 200 unregistered, of whom no clinical trials are available. “Choosing the right product is a real challenge,” says Kotsirilos.
Professor Iain McGregor leads the Lambert Initiative for Cannabinoid Therapy, a research center at the University of Sydney founded by a donation from former medical cannabis entrepreneur and financial steering Barry Lambert.
“It’s pretty mind-boggling to try to match a patient’s condition with the right product and dose because often this evidence from a clinical trial isn’t there,” McGregor says.
However, the number of medical cannabis users has increased over the past five years. This year alone, more than 86,000 applications have been submitted, with the forecast to exceed 100,000 next year.
Like Helen, the vast majority of patients turn to prescription cannabis to control chronic pain. However, last March, the Faculty of Pain Medicine of the College of Anesthetists of Australia and New Zealand issued a statement recommending health professionals not to prescribe the cannabis medicinal products available to treat pain. chronic non-carcinogenic unless they are part of a registered clinical trial.
“There is still no clinical trial to show that CBD does anything useful for chronic pain,” says McGregor. “The prescription continues, though, and that’s not an evidence-based prescription.”
Common uses of medical cannabis include treating cancer pain and sleep and mood disorders. Anxiety is now the second most common condition for which patients request medical cannabis.
Larry, a 43-year-old carpenter living on the Gold Coast, has been using it to deal with anxiety and depression for the past 18 months.
A lover of surfing, an artist and the father of five children, Larry has struggled with his mental health since he lost his father at a young age. “I used to use a lot of cannabis in my late teens and 20s,” he says. “It just took that advantage out of anxiety and depression.”
Then Larry bought on the black market. He now goes to a specialist clinic and uses CBD in low doses with 2% THC. “The best [medicinal cannabis being] regulated is that it is grown in controlled environments; it’s not just someone cultivating it in the backyard or cultivating it yourself. You know exactly what you’re getting. “
Larry says medical cannabis is a tool he uses to control his anxiety, along with staying active, eating well and having a healthy lifestyle. “[Medicinal cannabis] it’s not a silver bullet, but it just gives you a little relief, ”he says.
Assembling the puzzle
Like THC, CBD binds to the brain’s cannabinoid receptors, controlling the release of chemicals that regulate functions and processes such as mood, emotions, sleep, appetite, and pain. Low serotonin levels in the brain can cause anxiety, depression and other mood disorders. Researchers suggest that high doses of CBD could help regulate serotonin levels in the brains of some people.
“There are a whole host of receptors that we know CBD interacts with,” McGregor says. “But the whole picture is very complicated and we still don’t have the complete puzzle assembled.”
The ability of CBD to act on many different receptors does not translate into significant therapeutic benefits. “Because it opens so many doors, you’d think it would have profound effects, but it’s just the opposite,” McGregor says.
A woman taking drops of CBD oil. Not all patients experience the same benefits. Photo: Drop of ink / Alamy
While some people continue to report experiencing huge benefits with CBD oil, he says, clinical studies have found that low doses of CBD show no difference compared to placebo.
“Paradoxically, the vast majority of patients use CBD oil at doses of which we do not yet have any evidence,” he says.
Late last year, the TGA approved CBD products at a maximum dose of 150 milligrams a day to sell them over-the-counter as three scheduled medications. But unlike prescription-only cannabis medicines that can be prescribed even if they are not registered, over-the-counter CBD products must be included in the Australian Register of Therapeutic Products.
Everyone’s response is different. Some people are more sensitive than others Vicki Kotsirilos, GP
To register their products, companies must demonstrate that they have clinical benefits and, to date, there are no low-dose CBD products on the register.
“There are many companies that claim they are pursuing over-the-counter registration,” says Rhys Cohen, Cannabiz’s general editor and non-executive advisory member of the Lambert Initiative for Cannabinoid Therapy.
“There are a smaller number of companies that are really trying this job. It’s not known if they will be successful or not because no one has proven before that CBD at these low doses is effective in treating a disease.”
Although clinical trials have shown the efficacy of some high-dose cannabis-derived drugs such as Sativex and Epidyolex, the evidence remains anecdotal for low-dose CBD products.
Complex and individual
“CBD has a very complex pharmacological action that we still don’t fully understand, ”McGregor says.
Kotsirilos says that in his experience, not all patients experience the same benefits: “Everyone’s response is different. Some individuals are more sensitive than others. “
Starting only with low-dose CBD oil is their preferred strategy for most patients, slowly increasing to higher doses if necessary, and finally considering the introduction of THC. But in patients with severe pain or chemotherapy-related nausea and vomiting, such as those in palliative care, he says, it makes no sense to give CBD alone.
“Unfortunately, not all GPs are familiar with CBD products and feel safe enough to prescribe them to patients,” he says. “This is a gap we need to address through a balanced education in Australia.”
Costs and risks
But while the evidence for its effectiveness remains inconclusive, for many Australians looking for the drug in hopes of alleviating their pain and other conditions, the costs can be formidable.
The access system harms less wealthy Australians who are more likely to suffer from those conditions for which more medical cannabis is requested. More than half a million people still turn to the black market for self-medication, and that carries great risks.
In general, unregulated products sold on the black market are not pure compounds, but contain an indefinite amount of CBD and THC and a mixture of other substances, with unknown effects on the body. And home growers often use a number of pesticides that can cause serious side effects.
When Helen could not find a GP willing to give her a prescription, she sought out a clinic specializing in medicinal cannabis.
While these clinics allow patients access to CBD oil products, they are not affordable for most. “These clinics charge outrageous prices,” says Helen, who has paid up to $ 350 for a 15-minute telehealth consultation.
This adds to the cost of the products, which are on average $ 0.14 per milligram, with prescribed doses ranging from 50 to 200 mg per day. The government does not subsidize cannabis medicinal products under the pharmaceutical benefits regime.
For many patients like Helen, this equates to spending hundreds of dollars every month.
“I’m 70 now and I’m still working to pay for my medications,” he says. “In the future, I would like to see a better education for people and doctors; I would like the costs to go down; I would like to see a fairer access process for everyone. “
