Medicinal Marijuana: Experts Divided Over Federal Government Approval

The Federal Government has just approved the sale of medicinal marijuana in Australia, with the treatment (used for patients with conditions like with cancer, epilepsy and motor neurone disease) now available via prescription from a GP in as little as eight weeks.

But experts aren't in agreement about the new laws.

Associate Professor David Allsop, Associate Director the Lambert Initiative at the University of Sydney for research on cannabinoid therapeutics

"The announcement by Minister Hunt to allow the import and local storage of medical cannabis from overseas is a welcome step towards unblocking access to those patients who most need this medicine.

In having a local supply on hand, the timeline and costs of a patient getting access to medical cannabis products will be greatly streamlined.

Prior to this change, patients have faced a lengthy process of navigating federal and state level permissions and import permits, and overseas suppliers needing to organise export permits – all at significant financial and time cost to the patient.

These sourcing issues will now be dealt with in a faster more efficient manner.

There are some potential flash points that need to be considered also, such as whether allowing bulk importation and storage from overseas will in anyway interfere with the Federal Government’s November 2016 legislation, designed to encourage local Australian companies to establish growing and manufacturing operations for medical cannabis here in Australia.

It could be that allowing overseas importation lends significant competition to these emerging enterprises making it difficult to justify business models to investors.

The announcement also does not solve an issue installed by the Federal Government in November 2016, when access to medical cannabis was removed from the Category A route of the TGA’s Special Access Scheme. Cannabis is the only scheduled drug to have been excluded from this route of access – meaning that terminally ill patients cannot gain ready access in the timeframes appropriate to their dire situation, despite being arguably one of the patient groups most likely to benefit.

It also doesn't change the fact that in order to gain access, a doctor still needs to make the application, but most doctors either do not know how to apply, do not have the required training or expertise to apply, or are politically or philosophically against supporting a medical cannabis application."

David has a conflict of interest - he has received study drugs from GW Pharmaceuticals for Investigator led clinical trials.

Dr Scott Smid, Senior Lecturer in Pharmacology at the University of Adelaide

"It's a space that is moving fairly rapidly now. There is a strong advocacy from patient and community groups for improved access and The Government has responded to this with the recent announcement.

This is not without reason, for there is building anecdotal evidence of the effectiveness of medicinal cannabis for various conditions, but I see a critical next step as being to address more research into just how effective medicinal cannabis is and under which therapeutic context(s). It is cited as being effective in conditions ranging from epilepsy to neuropathic pain, arthritis and inflammatory bowel disease, but the clinical studies are either very few or ongoing and it will be the outcomes of these that medical practitioners ultimately look towards for guidance.

It's a critical point surrounding accessibility going forward - to ensure that the use of medicinal cannabis is safe and effectively targeted in the community, it will need acceptance within the medical community and their benchmark reference point will be the evidence from clinical trials.

Even in terms of basic research there is so much we still don't know about the bioactive components that make up the cannabis plant. We know a bit about THC, but even the pharmacology of another major cannabinoid, cannabidiol is still emerging. Add to that the 60-odd other cannabinoids and hundreds of plant terpenes and it becomes a tricky puzzle to tease out what works and where in the body, or even the added complexity of how they may all work together in the so-called ‘entourage effect’ to provide a potential therapeutic benefit.

The upside to this, as a basic researcher, is that there is so much scope for further research. This is exciting, as cannabinoids may reveal new insights into the biological basis of disease, for example some types of epilepsy, as well as open up new targets and avenues for disease treatment. This last point is one that may also ensure the longer term sustainability of the fledgling medicinal cannabis industry in Australia, in terms of providing new markets. So I see both the clinical and preclinical research as critical to informing the safe and effective use of medicinal cannabis in Australia."

Dr Delyse Hutchinson, Senior Research Fellow at the National Drug & Alcohol Research Centre (NDARC), Senior Research Fellow at Deakin University, Honorary Research Fellow at the Murdoch Children's Research Institute, Royal Children's Hospital Melbourne, Honorary Research Fellow at the University of Melbourne

"We know, based on sound evidence, that there are potential harmful consequences linked to (unregulated) cannabis use, particularly in terms of mental health, cognition and educational outcomes. These harms are most strongly linked to regular and/or heavy use of the substance. Scientific research is urgently needed to understand whether regulated provision of cannabis for medicinal purposes is harmful. This is an important health funding priority, if cannabis will be available through the health system."

Dr David Caldicott, Emergency Consultant and Senior Clinical Lecturer in Medicine at the Australian National University

"Working in this field for several years, you get to meet many extraordinary, strong people, frequently in terrible personal circumstance. One of these is Lucy Haslam, probably the single person most responsible for advancing the cause of medical cannabis in Australia. Her son, Dan, died last year, but while still alive, found great relief in the use of cannabis for his symptoms.

There have been many promises made to patients and loved ones about medical cannabis in Australia - most have been broken. We apply 'Dan’s Test' to any development or proposition floated by others: "If Dan, or someone in Dan’s position were alive today, would initiative ‘x’ help them, right now, in any pragmatic way?" This is the measure against which development in the field needs to be assessed - the provable benefit to the patient, without the harm to society.

It is possible that this might make life easier for patients in two months' time. There is very little information available to the medical profession about the strains being grown, and the intended formulation. The special access schemes in place to allow prescribing remain opaque and cumbersome. We are regularly advised by the (Australian) authorities that Australia is evolving as the best practice leader in this space. The global evidence remains overwhelmingly to the contrary. The most comprehensive review of the literature that has ever been undertaken has been recently published by the prestigious and formidable National Academy of Sciences in the USA. The Australian colleges and associations who have to date been selectively citing science to support their own conclusions, which differ wildly to the conclusions of this report, have remained curiously silent since its release.

It is clear that there are conditions for which medicinal cannabis has benefit, and should be made immediately available, as it is clear that there are conditions for which much more work is needed. Dithering because of political indecision, the tensions between Big Green and Big Pharma, and concerns regarding any threat to the Tasmanian opium market provides no reassurance to patients, nor security to the Australian public at large."

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