Compassionate access to cannabis for kids


Pharmaceutical cannabidiol is being used to treat children with severe, treatment-resistant epilepsy as part of three wider trials

A few children with severe, treatment-resistant epilepsy have already begun treatment at John Hunter Children’s Hospital in the Hunter New England region of NSW, confirms a state government spokesperson.

During the course of the trial, up to 12 children will receive doses of a pharmaceutical-grade, cannabis-derived medicine called Epidiolex to treat their condition.

The children will access the medicine through the Compassionate Access Scheme for Epidiolex at John Hunter Children’s Hospital, as part of a wider trial of the drug involving up to 40 children.

“The [Compassionate Access] Scheme will see some of the sickest children in NSW – who have not responded to available epilepsy drugs and treatments – gain access to a regulated pharmaceutical supply of the promising medicine, cannabidiol, at an earlier date than was expected, and before it is accessible in many other countries,” says lead trial researcher Dr John Lawson, from Sydney Children’s Hospital in Randwick, NSW.

“These children suffer from such severe, treatment-resistant epilepsy – some with hundreds of seizures a day – that they are too sick to take part in clinical trials. This Scheme fills that gap in the hope of providing some relief to them and their families,” he says.

Epidiolex is an oral pharmaceutical formulation of pure cannabidiol (CBD), a non-psychoactive component of the cannabis plant, which is manufactured by British company GW Pharmaceuticals.

Currently, because it is an experimental medication, Epidiolex has not been considered by the TGA for routine use in Australia.

A palliative care trial is also set to enrol patients in the coming months. This trial will use a vapourised cannabis flower bud to compare tetrahydrocannabinol (THC) alone, or THC combined with cannabidiol (CBD), and placebo, in their ability to improve appetite in terminally ill cancer patients.

The first part will be conducted at the Calvary Mater Newcastle Hospital and Sacred Heart Health Service in Sydney, while the second part of the trial will enrol a larger number of patients in major hospitals across NSW that are yet to be confirmed.

Meanwhile, a trial for chemotherapy patients is progressing through ethics and regulatory approvals and is expected to being towards the end of this year, confirms the NSW Health Department. This research will aim to treat chemotherapy-induced nausea and vomiting using oral cannabis-derived capsules containing THC and CBD, developed and supplied by Canadian medicinal cannabis company Tilray.

Doctors in NSW are also now able to apply to prescribe a broader range of cannabis-based medicines as a result of state regulatory changes, the state government announced in July.

“This change increases the options available for doctors as it means a broader range of cannabis-based medicines can be prescribed – while we continue our evidence-based research looking further into the role medicinal cannabis can play,” says Premier Mike Baird.

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9 Comments

  1. Loren Wiener
    29/09/2016

    Per the NSW government, they have redefined hemp as being less than 1% THC. Epidiolex as mentioned in this article, has no THC so is medical hemp per the government definition not “medical cannabis, cannabis derived, or Cannabis anything”. The media needs to be vigilant on the truth please, as others of us working with government and on legislature only have it tougher when the media is sloppy. #WordsMatter

    • Sheshtyn Paola
      30/09/2016

      Hi Loren
      If you have an issue with the wording then you need to take it up with NSW Health’s Centre for Medicinal Cannabis Research and Innovation, the group behind the trials. It is their wording and description to refer to Epidiolex as a ‘cannabis-derived product’. See http://www.medicinalcannabis.nsw.gov.au
      Kind regards,
      Sheshtyn Paola (Journalist, AJP)

      • Loren Wiener
        30/09/2016

        Thanks for the prompt reply. I just needed to get it on record you were printing a lie and knew it was a like and chose to do nothing about it. I have some folks standing by.

        Regards

        Loren Paul Wiener
        Senior Australia Editor – The Law Report

        • Sheshtyn Paola
          30/09/2016

          Did you even read my story Loren? Please take your vendetta elsewhere.

        • Ronky
          05/10/2016

          You are clearly profoundly ignorant of pharmacology and are unable to comprehend relatively simple legal definitions. Or else perhaps you are deliberately circulating lies because of some personal grudge or mental health issue.
          If it is in fact true that you hold a position as a senior journalist in the field of law, and that you “consult to government”, that would indeed be very frightening.
          In the unlikely event that any reader of this journal may be misled by your extremely inaccurate claims:
          Fentanyl is a synthetic opiate-like drug that has no relation whatsoever to cannabis and certainly could not be claimed to be included in any legal definition of cannabis!!
          There is a 1% THC cut-off in the definition of “low-THC hemp” (which can be used for industrial, not therapeutic use, e.g. manufacture of rope, clothing, tents etc.) This does not by any means mean that low-THC hemp is the only kind of cannabis or cannabis product!!

    • Andrew
      30/09/2016

      Semantics.

      The genus of the plant is Cannabis. “Cannabis” is appropriate regardless of THC/CBD ratio.

      • Loren Wiener
        30/09/2016

        Gosh andrew you would think so wouldn’t you?. That is the definition on the rest of earth. Australia does things differently. Since 2015 when a poll said 94% of Australians support medical Cannabis, the government in various bills has redefined Cannabis from a plant to a “suite of products? and in the state of Queensland the bill at the moment, defines “Anything that acts like cannabis as Cannabis” this includes the synthetic opioid fentynal that killed the singer Prince recently, not from a plant and not Cannabis. It is defined as cannabis per the bill. Specific to this story, the government (ODC, TGA, and NSW) have specifically redefined hemp as being less than 1% THC and Cannabis above 1% THC. With drugs being tested with ZERO THC this makes it per the specific new definitions by the government as Medical Hemp not medical Cannabis. Unfortunately the lack of ethics in journos is saddening. – here is the link to the NSW change in specific definitions of hemp (the result of this is legal hemp growers have to destroy crops above 1% THC) – Cannot make this stuff up – the government cannot have it both ways. – http://bit.ly/hemp-nsw-changes

        • Andrew
          30/09/2016

          >>>”Anything that acts like cannabis as Cannabis”

          Yes, the analogue laws.

          >>>>this includes the synthetic opioid fentynal that killed the singer Prince recently, not from a plant and not Cannabis. It is defined as cannabis per the bill.

          I think you may be confused here.

          Bad laws should be challenged – good luck to you and your cause.

          • Loren Wiener
            30/09/2016

            lol – You must be a journo – http://bit.ly/QLD-Cannabis-10-may-2016 Pge 13 –
            Article 7 – ITEM (c) Meaning of cannabis product
            A cannabis product is any product—
            (a) that is or was any part of a plant of the genus Cannabis,
            whether living or dead; or
            (b) otherwise derived, wholly or in part, from any part of a
            plant of the genus Cannabis, whether living or dead; or
            (c) that has, or is intended by the manufacturer of the
            product to have, a pharmacological effect that is
            substantially similar to the pharmacological effect of a
            product mentioned in paragraph (a) or (b). – We are just trying to help sick folks get legal medicine.

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