Helen was diagnosed in her 40s with fibromyalgia. Her doctor prescribed a variety of opioids. Although she tried meperidine, morphine and other opioids, none of them helped her manage the chronic pain.
Helen was traveling across North America when a doctor suggested that she try cannabidiol oil. This was long before medical cannabis was legalized in Australia. Helen says that he gave me a bottle of the tincture and instructed me to put one or two drops under each tongue. The pain went away quickly. I was stunned.
After she returned from her trip, the only thing that was left for her was to go to the black market.
Helen is just one of many thousands of Australians who have used medicinal cannabis to treat a variety of conditions that they believe are not being treated by traditional therapies. Despite the fact that the cannabis industry is growing after it was legalized in 2017, there are still inconclusive evidence and high costs.
Today, medicinal cannabis products in Australia are only available for prescription. The Therapeutic Goods Administration has data that shows more than 172,000 people have been granted access to medicinal cannabis under its special access program.
Only two products were approved by the TGA and registered on the Australian Register of Therapeutic Products. Epidyolex is prescribed to treat severe and drug-resistant epilepsy in children. Sativex was approved in 2012 for the treatment of muscle spasticity related to multiple sclerosis.
The TGA scheme allows doctors to request access to unregistered medical marijuana products. These products can be capsules, oils, nasal and oral sprays containing either THC (delta-9-tetrahydrocannabinol) or CBD (cannabidiol) or a combination of the two. Some of these products are plant-derived. Some are synthetically manufactured.
There is a growing demand for medical cannabis. Many clinical trials are being conducted to prove its effectiveness for various medical conditions.
However, there is not always strong evidence and many products are still unregistered. This makes it difficult for many GPs to prescribe with confidence.
One of the approximately 50 mother plants for Australia's future cannabis industry was cloned in 2017. Photograph by Saeed Khan/AFP/Getty Images
Assoc Prof Vicki Kotsirilos is a GP who was Australia's first authorised medicinal marijuana prescriber. She says that the process of prescribing medicinal cannabinoids is now much simpler than it was four year ago.
The biggest challenge for GPs is choosing the right product from more than 200 that are not registered. Clinical evidence is difficult to find. Kotsirilos states that choosing the right product can be a difficult task.
Professor Iain McGregor is the head of the Lambert Initiative for Cannabinoid Therapeutics at Sydney University. This research centre was established by Barry Lambert, an ex-finance high-flyer who also became a medicinal cannabis entrepreneur.
McGregor states that it can be quite difficult to match patients to the right product or dosage, as often there is no clinical trial evidence.
Yet, the number of medical cannabis users has increased over the last five years. More than 86,000 applications were filed this year, and the number is expected to rise to 100,000 next year.
Helen is not the only one who uses prescription medicinal cannabis for chronic pain. The Australian and New Zealand College of Anaesthetists issued a statement last March urging health professionals not to prescribe medicinal cannabis products for chronic non-cancer pain, unless they are part of a clinical trial.
McGregor states that there is no clinical trial that has shown CBD can be used to treat chronic pain. Despite this, the prescribing of CBD continues. This prescribing is not based on evidence.
The most common uses of medicinal cannabis are for treating pain from cancer, as well as sleep and mood disorders. Patients who suffer from anxiety are the most frequent users of medicinal cannabis.
Larry, a 43 year-old carpenter who lives on the Gold Coast, uses it to manage anxiety and depression for the last 18 months.
Larry is a father of five children, a surfer lover and an artist. He has struggled with his mental well-being since the death of his father when he was young. He says that he used cannabis extensively in his late teens and early 20s. It took the edge off of anxiety and depression.
Larry was a black market buyer back then. He now attends a specialist clinic and uses low dose CBD with 2% THC. It is not illegal to grow medical cannabis in your backyard. You are fully aware of what you're getting.
Larry states that he uses medicinal cannabis to manage his anxiety. He also eats well, keeps active and has a healthy lifestyle. He says that although medicinal cannabis isn't a miracle cure, it can give you some relief.
Piece the puzzle together
CBD, like THC, binds to the brain's cannabinoid receptors. This controls the release of chemicals that regulate mood, emotions and pain. Low levels of serotonin can lead to anxiety, depression, and other mood disorders. Some researchers believe that CBD may help to regulate the brain's serotonin levels.
McGregor states that CBD interacts with a variety of receptors. The whole picture is complex and we don't have all the pieces.
The CBD's ability to interact with many receptors doesn't translate into significant therapeutic benefits. McGregor claims that CBD opens up many possibilities, which would lead you to believe it will have profound effects.
A woman using CBD oil. Every patient will experience different benefits. Photograph: Almy/Ink Drop
He says that while some continue to experience tremendous benefits from CBD oil and others are still reporting them, clinical trials have shown that CBD oil in low doses doesn't show any difference when compared to placebo.
He says that CBD oil is used by a large majority of patients in doses for which there are no evidence.
The TGA approved CBD products containing a maximum of 150 mg per day for sale over-the-counter as schedule three medications at the end of 2013. Over-the-counter CBD products cannot be prescribed even if they are not registered, unlike prescription-only marijuana medicines.
Everyone's reaction is different. Vicki Kotsirilos: Some people are more sensitive than others Vicki Koutsirilos GP
Companies must show clinical benefits to register products. Currently, there is no low-dose CBD product on the register.
Many companies claim they are seeking over-the-counter registration. This is according to ays Rhys Cohen (editor at Large for Cannabiz) and a nonexecutive advisory member of the Lambert Initiative for Cannabinoid Therapeutics.
A smaller number of companies are actually trying to do this work. It is not clear if they will succeed or fail, as no one has ever shown that CBD in low doses can be used to treat a medical condition.
Clinical trials have shown the effectiveness of high-dose cannabis-derived drugs like Epidyolex and Sativex, but the evidence is still limited for CBD products with low doses.
Complex and personal
McGregor states that CBD's pharmacological actions are very complex and we don't fully understand them.
Kotsirilos states that not all patients experience the same benefits. Every patient's reaction is unique. Some people are more sensitive than others.
For most patients, she recommends starting with low-dose CBD oil. If necessary, she will gradually increase the doses and then consider adding THC. She says that CBD oil alone is not recommended for patients suffering from severe pain, nausea or vomiting due to chemotherapy.
She says that not all GPs are comfortable prescribing CBD products to patients. Balanced education in Australia is needed to close this gap.
Risks and costs
While the evidence for its effectiveness is still inconclusive for many Australians, it can prove costly for those who seek relief from pain or other conditions.
Access to medicinal cannabis is more expensive for the less wealthy Australians. There are still more than half a million people who use the black market for self-medicating, which comes with many risks.
Unregulated products on the black market generally do not contain pure compounds, but they can have undefined amounts of CBD and THC, as well as a mixture of substances with unknown effects. Home growers may use pesticides that could have severe side effects.
Helen was unable to find a GP who would give her a prescription so she searched for a clinic that specialised in medicinal cannabis.
These clinics offer CBD oil products to patients, but they aren't affordable for the majority. Helen says that these clinics are outrageously expensive and she has paid as high as $350 for a 15 minute telehealth consultation.
This is in addition to the price of the products which average $0.14 per milligram. Prescribed doses range from 50 to 200mg daily. Under the Pharmaceutical Benefits Scheme, medicinal cannabis products are not covered by government subsidies.
Helen is one of many patients who spend hundreds of dollars each month.
She says that although I am in my 70s, I still work to pay my medicine bills. In the future, I want to see more education for doctors and patients; I want to see lower costs; I would love to see fair access for everyone.
