Medicinal cannabis approved, but concerns remain


marijuana bud

The Federal Government has approved the sale of medical marijuana via GPs, but several issues remain for prescribers, patients and other stakeholders

Medicinal cannabis could be available under the new scheme in as little as eight weeks.

“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,” says Dr Scott Smid, a senior lecturer in pharmacology at the University of Adelaide.

“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.”

He says that it is critical, to ensure that the use of medicinal cannabis is safe and effectively targeted in the community, that it obtain acceptance within the medical community, whose 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,” says Dr Smid.

“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,” says Dr Smid.

“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.”

He says the vast scope for further research 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 David Caldicott, an emergency consultant and senior clinical lecturer in medicine at the Australian National University, says it is possible that the move could make life easier for patients in two months’ time.

However, “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.

“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.”

And Associate Professor David Allsop from the University of Sydney says the announcement is a welcome step, but some “potential flash points” remain.

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

“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,” explains A/Prof Allsop.

“There are some potential flash points that need to be considered also, such as whether allowing bulk importation and storage from overseas will in any way 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.”

Meanwhile, Medlab Clinical Limited has completed its final steps to start Australia’s first clinical trial using cannabis for oncology patients suffering intractable pain.

Medlab says it supports the Government’s initiative and also shares medical community concerns around safeguards and evidence based prescribing of cannabis products.

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7 Comments

  1. Ronky
    22/02/2017

    A couple of very misleading claims here.

    Far from “dithering”, because of political interference cannabis has been given an express magic carpet ride past nearly all of the regulatory requirements that apply to all other drugs for which a therapeutic benefit is claimed. There are literally thousands of other unregistered herbs, drugs and substances which have far stronger evidence for therapeutic benefit than cannabis, but they have to wait in the queue and are banned from supply until gold-plated proof of efficacy and safety is supplied.

    The claims that “access to medical cannabis was removed from the Category A route of the TGA’s Special Access Scheme” and that “Cannabis is the only scheduled drug to have been excluded from this route of access” are utter nonsense. All Schedule 9 drugs have always been totally excluded from Category A of the SAS. Cannabis was last year downscheduled to Schedule 8 on condition that it not be imported under the totally unsupervised Category A, so that there could still be at least some supervision of it.

    • pagophilus
      23/02/2017

      Aren’t overseas-sourced synthetic cannabinoids (eg Nabilone) available under SAS?

      • Ronky
        23/02/2017

        Yes but Nabilone is a registered medicine in the USA and some other countries and has always been S8 in Australia. It is not derived from Cannabis.

  2. pagophilus
    23/02/2017

    “….there is building anecdotal evidence of the effectiveness of medicinal cannabis for various conditions…”
    There is anecdotal evidence for lots of things. Access to dangerous drugs should not be based on anecdotal evidence. There is a reason Marijuana/Cannabis is illegal in the first place.

    • Andrew
      23/02/2017

      >>>>There is a reason Marijuana/Cannabis is illegal in the first place.

      Interested to hear what you think the reason is.

      >>>….there is building anecdotal evidence of the effectiveness of medicinal cannabis for various conditions…

      This line is regularly used in the Australian market context and it’s just not true. Israel is publishing some interesting and well designed studies as is the US. To claim that the level of evidence for any application is still within the “anecdotal” domain is disingenuous.

  3. PharmaC
    23/02/2017

    Really? ‘anecdotal’ is part of the cannabis discussion but not to be used in a conversation about CMs. Double standards for two sorts of therapy which both have evidence-based applications – or my CPD has been a waste of time

    • Ronky
      24/02/2017

      Yep, thanks to pressure from the politicians nearly all the rules that apply to everything else have been thrown out the window in the mad rush to legalise so-called “medicinal” cannabis. The medical and scientific experts have been told to shut up and not ask for evidence or any other questions, just make it legal immediately.

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