- Background Information
- The current situation in Australia
- The current situation in Tasmania
- The future of Medical cannabis in epilepsy treatment
- The use of Medical cannabis and driving motor vehicles
- Medical Cannabis Trials
- Medical Cannabis Trials – Status by State:
- Clinical trial results for Medical cannabis treatment in Dravet syndrome:
- Epilepsy Tasmania recognises the need for more effective and safe therapies to assist patients and their families facing severe, intractable seizures.
- A recent trial of medical cannabis published in the New England Journal of Medicine offers cautious optimism on the role of medical cannabis. Further trials are due to report.
- Overall, the effectiveness and safe use of medicinal cannabis products for epilepsy does not have a strong evidence base; however, there has been an increase in clinical trials of medicinal cannabis over recent years and new evidence will continue to emerge.
- Should evidence support that benefits outweigh adverse events, then best practice guidelines can be developed.
- The Australian Therapeutic Goods Administration (TGA) has recently released a guidance document regarding the use of medicinal cannabis in the treatment of epilepsy in paediatric and young adult patients. There is insufficient evidence to date regarding use in adult populations.
- Epilepsy Tasmania supports current clinical trials and seeks further clinical trials to be established to build the evidence base.
- The unregulated manufacture, supply or possession of cannabis, in any form, is illegal in all states of Australia.
- Pharmaceutical cannabis products available in the treatment of pain and wasting associated with HIV and chemotherapy, and in the treatment of spasticity in multiple sclerosis are not suitable for the treatment of severe refractory epilepsy or catastrophic epilepsy syndromes.
- Epilepsy Tasnania urges all people living with epilepsy, their families and carers to consult with an epilepsy specialist and explore the many existing treatment options, so that they can make an informed decision. An informed decision should take into account the possible risks and benefits of the different treatment options, including any participation in clinical trials of medicinal cannabis.
In 2016 Australian State and Federal governments responded to the calls from patients, families, their carers and clinicians for more effective therapies in severe, intractable epilepsies, by introducing legislation to facilitate the introduction of medical cannabis as a treatment for epilepsies as well as in other conditions.
Medical cannabis products remain an unapproved drug but now may be accessed via certain medical practitioners through the Controlled Access Scheme (CAS) or Authorised Prescriber Scheme1.
The unregulated manufacture of cannabis products, whether for medicinal or recreational purposes remains illegal in all Australian states. The Therapeutic Goods Agency (TGA) states: Cannabis remains a highly regulated drug in Australia and the use and supply of cannabis for non-medical purposes (for example, recreational use) is illegal in Australia, in accordance with applicable Commonwealth, state and territory laws1.
The active compounds found in the cannabis plant are referred to as cannabinoids. The cannabinoids that have attracted the most attention to date are cannabidiol (CBD), the major non-psychotropic compound, and tetrahydrocannabinol (THC) the compound that gives cannabis its psychotropic effect. Where the use of cannabis in epilepsy is concerned, CBD has been found by a number of small studies, as well as anecdotally, to reduce seizure activity. CBD use does not produce a ‘high’.
The American Academy of Neurology conducted a systematic review of the efficacy and safety of medical marijuana in selected neurological disorders and found that the use of oral cannabinoids are of unknown efficacy in epilepsy, that the risks and benefits of medical marijuana should be weighed carefully, and that the comparative effectiveness of medical marijuana versus already established therapies is unknown for epilepsy.2
In the United States in 2014, the Food and Drug Agency gave Orphan Drug Status to Epidiolex (cannabidiol) as an investigational drug therapy of Dravet and Lennox-Gastaut syndromes.3 Epidiolex was also given European Orphan Drug Status in 2017.4 There is an ongoing open label study (i.e. a clinical research study in which the participant, health care professional, and others know the drug and dose being given) that has recently released data for 27 patients treated for more than 12 weeks.4 Four patients were seizure free and approximately half the patients had a 50% reduction in seizures. Somnolence, fatigue, diarrhoea and altered appetite were each seen in more than 10% of these patients. These interim results look positive and we wait for further results to be published.
More recent reports of a Phase III, double-blind randomised placebo controlled trial of Epidiolex with 171 patients with Lennox-Gastaut Syndrome has shown a reduction in seizures frequency but increased treatment- related adverse events for those on the Epidiolex compared with the placebo.5 The results of a 2017 double-blind placebo controlled trial in 120 children and young adults with Dravet Syndrome were reported in the National English Journal of Medicine. Those in the CBD group demonstrated a decrease in seizures compared to the placebo group, but also reported increased adverse events. Commonly reported adverse events included drowsiness, ataxia and diarrhoea, and while more serious side effects were less common, some patients did experience a worsening of their seizures. Some of these adverse events were controlled by dose reduction but 8 patients on CBD withdrew from the trial.6
Small clinical trials have therefore provided some evidence for the efficacy and safety of CBD for children with severe epilepsy. Despite these encouraging early findings, research data on the use of medicinal cannabis for epilepsy is limited. A 2014 Cochrane Review on Cannabinoids for Epilepsy examined published studies to assess the efficacy and safety of cannabinoids when used as monotherapy or add-on treatment for people with epilepsy. This review found that, overall, no reliable conclusions could be drawn at present regarding the efficacy of cannabinoids as a treatment for epilepsy. Only four studies from 1978 to 1990 met the selection criteria of randomized control trials (the best level of evidence for new medications), whether blinded or not. Other difficulties with studies to date have included, small patient numbers, varying reports of seizure frequency and/ or freedom, a lack of information on the cannabis compounds used, and a lack of longer term studies (most studies run between 4 weeks to 18 months), preventing an understanding of the long-term safety of these compounds.7,8,9,10 Furthermore, it should be noted that recent guidance documents released by the TGA state that “evidence is unavailable for first line or sole use of medicinal cannabis or cannabinoids in epilepsy.”11
The current situation in Australia with medical cannabis and epilepsy
The situation in Australia is changing at a very fast pace.
Much has been put in place by the TGA to provide the basis for prescribing medical cannabis. Medical cannabis is imported at the moment but is regulated by the TGA. Patients will need a prescription from the treating doctor to obtain medical cannabis. This will come under the Controlled Access Scheme (CAS). If the prescribed medicine is more than 2% THC (the part of cannabis that creates a “high”) then it is considered very restricted and the doctor needs to apply for an additional Schedule 8 permit. This is unlikely to impact on people with epilepsy as medical cannabadiol here will contain 2% or less THC and is then a Schedule 4 drug and does not require anything more than then SAS permit.
In Victoria the government is providing access to cannabidiol on a compassionate scheme for some 29 young children with uncontrolled seizures. This is being closely monitored by their treating specialists and data is being collected on the results. In Queensland medical cannabis is available for a number of conditions including uncontrolled epilepsy and can be prescribed by both specialists and general practitioners after applying through the TGA SAS and to the Queensland Dept. of Health. Similar arrangements are enacted in other states.
In October 2016 Federal parliament passed legislation to enable applications for licences and permits for the cultivation, production and manufacture of medical cannabis products in Australia. This industry will be highly regulated. It will also mean a new pharmaceutical industry for Australia and a consistently high standard of medical cannabis products. Barriers to the use of all medical cannabis products in Australia at present are the shortage of supply of imported product and their cost.
Recent guidance documents released by the TGA include a number of recommendations for individuals considering medicinal cannabis for epilepsy, multiple sclerosis, chronic pain, palliative care and nausea and vomiting related to chemotherapy or HIV/AIDs.12 The guidance document for people with epilepsy includes the following recommendations (among others).11
- Epilepsy treatment with medicinal cannabis or cannabinoids is only recommended as an adjunctive treatment – that is, in addition to existing anti-epileptic drugs.
- There is insufficient evidence to provide recommendations for adults aged over 25 years.
- Patients and prescribing clinicians should be aware of likely adverse events such as diarrhoea, drowsiness, and changes to appetite. Adverse events such as a worsening of seizures, convulsions, severe diarrhoea or behavioural difficulties may affect the aims of the epilepsy treatment and increase the likelihood of treatment withdrawal, and should be evaluated on a case by case basis. If treatment is likely to be long-term, it is important that any side-effects from medicinal cannabis are not greater than side effects experienced with other anti-epileptic drugs and that their response to treatment is regularly assessed.
- In the absence of strong evidence for dosing and specific preparations of medicinal cannabis in epilepsy treatment, it is recommended that CBD be used and re-evaluated after twelve weeks of therapy, to ascertain whether there has been any benefit from its introduction.
- Prescribing clinicians should also be aware of the potential drug-drug interactions with CBD and anti-epileptic drugs.
The current situation in Tasmania
Epilepsy Tasmania welcomed the Tasmanian government announcement of a Controlled Access Scheme (CAS) from 1 September 2017, to allow Tasmanians with serious, unresponsive medical conditions to access medical cannabis when prescribed by a specialist doctor.
The CAS is not decriminalisation but allows Tasmanians with serious, unresponsive medical conditions to access medical cannabis products when grown lawfully under Commonwealth licenses and prescribed by a specialist doctor.
Under the CAS, a medical specialist doctor will be able to seek approval to prescribe a medical cannabis product for a specified medical condition, for example a child suffering severe epilepsy. Importantly, the decision of whether or not this is an appropriate treatment for a particular condition for a particular patient will be initiated by specialist doctors.
Tasmania’s state Budget, released in May 2017, allocated $3.75 million to enable the comprehensive clinical assessment of patients with severe epilepsy who may be eligible for medical cannabis, due to being non-responsive to mainstream medications.
Specialists will consider the scheme’s rules, including patient safety and appropriateness for the individual case. This funding should improve the treatment of children and young people with severe epilepsy by recruiting more expert staff to support neurology specialists and increasing the testing and treatment options available.
“There is potential for medical cannabis to help some people control their epileptic seizures when all other options have failed,” said Epilepsy Tasmania Board Member Dr Elizabeth Lord. “Until now, people with severe refractory seizures or catastrophic epilepsy syndromes have been unable to access and trial medical cannabis as an anti-epileptic treatment option.”
Commonwealth law means that Therapeutic Goods Administration (TGA) approval will still be required to access medical cannabis products approved under the CAS. The Department of Health and Human Services will establish an expert panel of clinicians to assess applications.
At present, risks relating to medical cannabis are the lack of legally available products, and no oversight by appropriate health professionals. Black market products such as oils, tinctures and plant matter may contain unknown ingredients that can put people at risk. It is also difficult to monitor appropriate dosages, and there are risks of interactions and reactions with other medicines.
Epilepsy Tasmania hopes the CAS will result in ongoing scientific trials and research into the use and efficacy of medical cannabis. CEO Wendy Groot said “The new Controlled Access Scheme is a leap forward for Tasmanians because the efficacy of medical cannabis can now be trialled in a safe and controlled manner under the supervision of prescribing specialist doctors.”
Epilepsy Tasmania continues to be a strong supporter of clinical trials and the work being done by the NSW Government following a memorandum of understanding signed last year on a range of issues and opportunities for Tasmanian patients.
The Tasmanian Government is working with local businesses to maximise opportunities to cultivate medical cannabis and manufacture products, under the nationally-consistent licensing scheme operated by the Commonwealth Government.
Tasmanian Alkaloids, with their partner AusCann, an Australian medical cannabis stock supplier, have been granted a medical cannabis licence, and a research and development licence. This is a significant step towards cultivating, growing and processing medical cannabis in Tasmania.
Epilepsy Tasmania supports the use of medical cannabis under specialist medical supervision for the management of epilepsy and the ongoing scientific trials and research into the use of medical cannabis.
The future of medical cannabis in epilepsy treatment in Australia
In the future, Australia will have a safe consistent supply of medicinal cannabis for a number of conditions including epilepsy. As the Australian industry develops there will be more trials conducted which will be of particular importance to encourage in the case of children and young people with epilepsy as this ensures the highest standards of care.
Epilepsy Tasmania urges all people living with epilepsy, their families and carers to consult with an epilepsy specialist and explore the many existing treatment options, so that they can make informed decisions with their specialist that weighs the risks and benefits of the different treatment options, including any participation in clinical trials of medicinal cannabis.
While these results are encouraging we need to exercise caution because of the lack of evidence around the efficacy and safety of using medicinal cannabis in children and the potential impact it can have on the developing brain in regard to memory, cognition, and the potential for psychosis in later years. Even more caution should be exercised with regard to using marijuana bought illicitly since the ingredients in it will be unknown and untested. Patients and families need to give careful consideration to such issues.
The use of medical cannabis and driving motor vehicles
This section refers to CBD, THC and non-prescribed cannabis products. While prescribed medicinal cannabis products in epilepsy are limited to children at present, this situation will change and cannabis is likely to be prescribed to people of driving age.
Prescribed CBD is not an illicit drug under the Road Safety Act in Victoria. However, CBD would be considered a drug by the Road Safety Act if it deprives the person consuming it of any of his/her mental or physical capacities, in other words being impaired by the CBD. This is the case with any drug, prescribed or not. Prescribed THC is an illicit drug for the purposes of the Road Safety Act and any presence of THC in blood is a driving offence. CBD does not necessarily show up in any of the standard roadside tests, however THC does.
When being prescribed a medicinal cannabis product it is important to use it in accordance with the prescribing doctor’s directions and to seek advice as to driving a motor vehicle while using that specific product. There are discussions taking place amongst the States to develop a nationally consistent approach to driving and medicinal cannabis but at this point in time each State has some variations about which drivers will need to inform themselves.
Endorsed by Epilepsy Australia, January 2018
Medical Cannabis Trials
Epilepsy Tasmania fully supports the current interest in these trials and the leadership at the political level to progress research via clinical trials whilst addressing legislative changes to decriminalise use in certain circumstances.
The Office of Drug Control (ODC) provides information about the Australian Government moves towards legalisation of medical cannabis and also provides information about cultivators, manufacturers and patient access. See the ODC website for more information.
The Australian Government Department of Health has issued a Medical Cannabis Fact Sheet which provides a lot of information about access to medical cannabis in Australia.
Read here the statement released by the TGA regarding guidelines for consumers, health professionals and sponsors of Access to Medical Cannabis Products.
Medical Cannabis Trials – Status by State:
- Victoria: Read the latest news from the Victorian Premier’s Office
- New South Wales: Read the latest news from the New South Wales Government
- South Australia: Read the latest news from the Premier of South Australia
- Queensland: Read the latest news from the Queensland Government
- Tasmania: Read the latest news from the Premier of Tasmania
- Western Australia: Read the latest news from the West Australian Government
Read the medical cannabis statement published by the Epilepsy Society of Australia. The Epilepsy Society of Australia is a professional organisation for clinicians, scientists and technologists involved in the diagnosis, treatment and research of epilepsy in Australia.
Clinical trial results for medical cannabis treatment in Dravet Syndrome:
The first randomised, double-blind, placebo controlled trial using medical cannabis for the treatment of a form of epilepsy known as Dravet syndrome, has been completed. Read a summary of the trial results here.
- Australian Government Department of Health Therapeutic Goods Administration. Access to Medicinal Cannabis Products https://www.tga.gov.au/access-medicinal-cannabis-products accessed 21 June 2017
- Koppel, B.S., Brust, J.C., Fife, T., Bronstein, J., Youssof, S., Gronseth, G. et al. (2014) Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology, 82; 1556-63
- GW Pharmaceuticals announces physician reports of Epidiolex treatment effect in children and young adults with treatment-resistant epilepsy from physician-led expanded access treatment program (2014; 2015) https://www.gwpharm.com/about-us/news/gw-pharmaceuticals-announces-new-physician-reports-epidiolex%C2%AE-treatment-effect-0 and https://www.gwpharm.com/about-us/news/gw-pharmaceuticals-announces-new-physician-reports-epidiolex-treatment-effect-children Accessed 10 January 2018
- GW Pharmaceuticals Announces Epidiolex® Receives Orphan Drug Designation from the European Medicines Agency for the Treatment of Lennox-Gastaut Syndrome* (2017). https://www.gwpharm.com/about-us/news/gw-pharmaceuticals-announces-epidiolex%C2%AE-receives-orphan-drug-designation-european (2015). Accessed 10 July 2017
- GW announces new Epidiolex (CBD) positive phase 3 data in Dravet Syndrome and Lennox-Gastaut Syndrome. (2016). https://www.gwpharm.com/about-us/news/gw-announces-new-epidiolex%C2%AE-cbd-positive-phase-3-data-dravet-syndrome-and-lennox Accessed June 2017.
- Devinsky, O., Cross, H.J., Laux, L., Marsh, E., Miller, I. & Nabbout, R. et al. (2017). Trial of cannabidiol for drug-resistant seizures in the Dravet Syndrome. N Engl J Med, 376; 2011-2020
- Maa, E. & Figi, P. (2014). The case for medical marijuana in epilepsy Epilepsia, 55:783-6
- Cilio, M.R., Thiele, E.A. & Devinsky, O. (2014) The case for assessing cannabidiol in epilepsy. Epilepsia. 55:787-90.
- Australian National Council on Drugs. Medicinal use of cannabis: Background and information paper. August 2014
- Gloss, D. & Vickrey, B. (2014). Cannabinoids for epilepsy (Review). Cochrane Database of Systematic Reviews, Issue 3. Art.No.: CD009270.
- Australian Government, Department of Health, Therapeutic Goods Administration (2017). Guidance for the use of medicinal cannabis in the treatment of epilepsy in paediatric and young adult patients in Australia. Version 1, December 2017. https://www.tga.gov.au/publication/guidance-use-medicinal-cannabis-treatment-epilepsy-paediatric-and-young-adult-patients-australia Accessed 10 January 2018
- Australian Government, Department of Health, Therapeutic Goods Administration (2017). Access to medicinal cannabis products; Medicinal cannabis – guidance documents. https://www.tga.gov.au/access-medicinal-cannabis-products Accessed 10 January 2018