Dr Norman Swan: The Australian Government is yet to approve most medicinal cannabis products but they are becoming available under what’s called the special access scheme and from approved prescribers. The conditions which have been allowed under the special access scheme include epilepsy, chronic non-cancer pain, multiple sclerosis, palliative care and chemotherapy-induced nausea and vomiting.
But it’s important to appreciate that medicinal cannabis is not yet a first line therapy for any condition.
As the publicity about medicinal cannabis increases it’s important that doctors and patients have the right information.
The cannabis plant – Cannabis sativa is cultivated to produce two distinctive products – industrial hemp and cannabis. The difference is based on the level of cannabinoids – that’s the family of chemical compounds that the cannabis plant naturally produces. There are over 200 chemical compounds but the two main players are cannabidiol or CBD and tetrahydrocannabinol or THC. CBD is not psychoactive – it doesn't make you high, whereas THC can make you high.
Plants can be grown to produce higher levels of CBD or THC. Medicinal cannabis may use both CBD and THC – the dose and ratio are very much still in trial stage and vary depending on the condition it’s prescribed for and what someone can tolerate.
Adjunct Professor Richard Chye, is a palliative care specialist in Sydney and has prescribed medicinal cannabis to 60 of his patients.
Adjunct Professor Richard Chye: Yes it can help improve appetite in some of my patients – not all my patients. It can help with nausea in some of my patients, but not all. It can help patients with nerve pain, but not arthritis and bone pain.
If patients have tried every other medication to help their nausea, to help their appetite, to help their nerve pain and it is not working then I'm comfortable with trying medicinal cannabis, but I do it in a very controlled way, making sure that patients are taking the medicinal cannabis that has been deemed to be free of bacteria, to be free of heavy metals, to be free of pesticides, Then I know that the medicinal cannabis that you're taking is relatively safe. And I carefully monitor for the efficacy to make sure it works. I monitor for side effects and make sure that medication has not made people too sleepy. For example, I also make sure that if it doesn't work, then I say to patients, “We've given it a good go.” And we stop.
Dr Norman Swan: Paediatric neurologist, Professor Ingrid Scheffer cautiously prescribes cannabidiol or CBD to her patients with severe epilepsy syndromes.
Professor Ingrid Scheffer: It takes quite a bit of expertise to know which patient will be suitable for CBD. There's so much hype around this in the media and with families that it's very hard to dissect out to families so that the expectation is at the right place. Yes, we should try it, but it may not be any better than the other anti-epileptic drugs we use.
Dr Norman Swan: There’s particular concern around patient access to safe doses of medicinal cannabis.
Adjunct Professor Richard Chye: It's all about safety for patients – about making sure that I know what they're taking and that they're not going to cause themselves harm.
Dr Norman Swan: Warren has had chronic pain for twenty years caused by degenerative changes in his lumbar spine. He has been on a cocktail of drugs for many years including the opioid Fentanyl.
Warren: What happened was we’d been away to the states for holiday and everywhere we went – on TV shows in newspapers – they were talking about medicinal cannabis for pain for chronic pain management.
Dr Norman Swan: Early in 2018 Warren’s GP got an introductory email from the Cannabis Access Clinic. The CAC provides expert advice to GPs and patients who are deemed appropriate to trial medicinal cannabis. Each patient is thoroughly screened and must have exhausted all other treatments.
Warren: You have to have the support of your GP and any other medical specialists that do you have been you know treated by.
Dr Norman Swan: After seeking approval from the TGA for the prescription Warren started on CBD oil on 1st August. He takes half a mil (ml) under his tongue every day and so far the results have been promising.
Warren: The pain now is just, there's none. Previously I couldn't even stand at the sink and peel vegetables.
Dr Norman Swan: And this is his first visit to see Dr Nijhawan after starting the CBD medication. Warren’s treatment is progressing well, and Dr Nijhawan, is cautiously optimistic.
Dr Sanjay Nijhawan, Medical Director, Cannabis Access Clinic: I've been a GP for the last 28 years in Australia and obviously I've dealt with chronic disease, chronic pain. It's not the only avenue, but it's an adjunct therapy which may help a lot of people with pain.
Dr Norman Swan: Professor Richard Chye has a similar opinion.
Adjunct Professor Richard Chye: I think a lot of our patients are already on cannabis whether we like it or not, whether we think they are on it or not. And I would prefer those patients to be on medications that we know about, that we know are relatively safe and I want to be able to monitor patients carefully for any side effects from the medicinal cannabis. I want to know that they are actually getting effect from it.
Professor Ingrid Scheffer: But we have a problem here, in that the industry is not producing drug at the right level for all the other drugs we give our patients to ensure that each time the patient gets the same drug, the same dose, the same extra things in the tablet or in the liquid. At the moment, the industry is sort of going wild.
Dr Norman Swan: Medicinal cannabis may use both CBD and THC the dose and ratio are very much still in the trial stage. For some conditions the prescription will be higher in CBD while for others THC will be higher, or it could be 1:1 dose. But there is still so much to learn about what works for different conditions and how individual people respond.
Marion has had a bilateral mastectomy resulting in chronic pain, and also lives with a rare condition called PERM causing limb rigidity, twitches and seizures.
Marion: I’m on a Canadian product: at the present time it's a 50:50 one to one dose of the THC to CBD.
It's been successful for me because it treats two parts of me: one treats pain that comes and goes and there’s also a persistent pain that I have because the muscles have locked down and the pain of that is excruciating. We had to work to find which was a stable dosage for me, which means that I’m comfortable. I’m not necessarily pain free all the time but I'm comfortable pain wise, not having the seizures or twitches, etc. that leads onto spasm and anaesthesia.
Adjunct Professor Richard Chye: There’s actually very, very little guidance about what is the right dose, what is the right combination and what I've been doing is starting low build up very slowly and look for those side effects and look for those benefits and look for benefits in many, many different domains.
Dr Norman Swan: High levels of CBD seem to work for people with severe epilepsy.
Professor Ingrid Scheffer: The only part of the cannabis plant that we know is effective for children and adults with epilepsy is called “cannabidiol”.
The problem is that CBD, whilst it's been shown to be useful in two of the very severe epilepsy syndromes, and they're called Dravet Syndrome and Lennox Gastaut Syndrome, it is really no better than the other drugs we use in those syndromes. It doesn't mean we shouldn't use it. I think we should use it, but I don't think it's a magic bullet.
We published the first evidence last year in the New England Journal [of Medicine] in about May 2017. We found there was a 43% responder rate in Dravet syndrome. A responder is defined as a 50% seizure reduction.
There have been two papers on Lennox Gastaut Syndrome and the results are almost the same. Around a 40% of patients will reduce by 50%.
Dr Norman Swan: Monitoring patients and noting any side effects is important for the care of individual patients but also for research.
Professor Ingrid Scheffer: So CBD can be associated particularly with sedation and with diarrhoea. Sedation is very common – all the anti-epileptic drugs can cause that.
Adjunct Professor Richard Chye:: I also talk about the possibility of hallucinations, psychosis, because we know THC can do that, but I also explain by starting low, the chances of that happening at a low dose is very very low.
Professor Ingrid Scheffer: The other thing about CBD, which I think we're yet to flesh out is that it can help learning, behaviour, maybe sleep as well. It's not surprising it helps sleep, but if these children are able to learn a bit more or their behaviour is better, that can be life-changing for a family. So, I think it'd be great if everyone could access it, but I think we have to do it in a very thoughtful way so that we ensure we're not just dealing with placebo effect.
Dr Norman Swan: So how do patients access medicinal cannabis?
Adjunct Professor Richard Chye: Like any referral to a doctor or specialist, their GPs need to write a letter referral document – exactly what the illness is now, what the symptoms are, what they've tried to improve their symptoms. Medicinal cannabis doesn't have a lot of evidence behind its use, behind its efficacy, but the Government and myself recognize that we should be trying medicines that have been shown to be effective.
And if those medicines don’t work for the appetite; if those medicines don't work for the nausea; or don't work for the pain, then they have to be carefully documented that it doesn't work and medicinal cannabis is used as a drug of last resort.
Dr Norman Swan: Carol Ireland is the CEO Epilepsy Action Australia & the director of Medicinal Cannabis Council. She believes medicinal cannabis needs to be made more accessible for doctors and their patients.
Carol Ireland: The Medicinal Cannabis Council actually operates to pull together the various disparate, sometimes, voices in the field of medicinal cannabis in this country. It seeks to be a peak body, an industry body that can actually work on issues of access, education, and indeed medical research. Really, access is all about opening up the legal market for people who really don't want to be doing something illicit and making it very available.
Dr Norman Swan: Although there are still uncertainties surrounding the use of medicinal cannabis and its effects, the Royal Australia College of General Practitioners is supportive … The College argues that a consistent national regulatory framework for prescribing medicinal cannabis products should be developed. The college also argues that patients' welfare is at the centre of this difficult and rapidly evolving area of medicine.
Marion: I'd like to see the government – yes I've been on trial – that they open it up there's a lot of people out there that 1) need to be able to access this and 2) the cost – it's ridiculous.
Dr Norman Swan: As with all new medications the cost is often prohibitive for many patients and it may be some time before medicinal cannabis is covered by the Pharmaceutical Benefits Scheme – the PBS.
Marion: We pay 1600 dollars – that's $1,600 for five bottles – five of these bottles and this one lasts me eight days.
Warren: My prescription is for 25 ml; at half a ml a day that should last 50 days and it's $235. It's a lot more expensive than normal medications on the PBS, but it has not got the side effects and it works.
Dr Norman Swan: But for Prof Scheffer’s patients it’s a different story. She prescribes 98% pure CBD to some of her patients.
Professor Ingrid Scheffer: One of the companies was quoting that CBD for one year for an adult would be between $75,000 and $150,000 a year.
Now, the reason it's so expensive is that it needs a lot of purification of the cannabis plant. To get the pure CBD is expensive, but that's the part that we know is effective.
Dr Norman Swan: The law is yet to catch up with the legalisation of medicinal cannabis.
Professor Ingrid Scheffer: The access has been a real issue and continues to be an issue. At the moment in Victoria, you can't get it for adults with severe epilepsy.
Adjunct Professor Richard Chye: Currently, I understand the law says that if you have a trace of cannabis in your blood, you're driving, then you are driving under the influence of cannabis, even if you've had taken that cannabis three weeks ago
Dr Norman Swan: The field of medicinal cannabis is an exciting one but there are still many unknowns.
Carol Ireland: I think it's going to be quite a number of years before we really understand the potential of cannabis and the different compounds and how they can help. The problem being, we also have a lot of sick people who want the opportunity to try now. And you know, those people have usually come to the end of the treatment options available to them. And they've heard that cannabis may be a treatment option, and they don't have the time – a lot of these people don't have the time for 10 or 20 years worth of research.
Professor Ingrid Scheffer: The landscape has changed and I think that we all have to take it on board and start thinking about which patients can access it, but it also needs engagement with government around the funding, but I also think we need to be careful about making sure it's really doing something.
Dr Norman Swan: If you or a person you know would like to know more about medicinal cannabis view the links at the top of this page. And the Therapeutic Goods Administration guidance for the use of medicinal cannabis in Australia.