14 August 2015
Australian Cavy and the Cannabis Pharmaceutical
In 2009, Graham Irvine* became (and remains) the first patient in Australia with Parkinson’s Disease (PD) symptoms to legally obtain and use a purportedly 'revolutionary' cannabis-based medicine in a three-month clinical trial. Sativex® was not legal in Australia and its importation from Britain cost him AU$1,000. But it did little to ease his symptoms, which was unfortunate he said, not only for him but for the other 80,000 or so PD sufferers who could have potentially benefited from the drug.
Graham discovered that there were two glaring problems with this pharmaceutical. First, the psychoactive effects of its 55% Tetrahydrocannabinol (THC) content were claimed to be balanced by its other active ingredient, Cannabidiol (CBD), which is not psychoactive but has other medicinal properties. However, Graham's experience was that he became 'stoned' every time he took it. And that led to the second major problem, the method of administration, which is inherently flawed.
Although it is supposed to be squirted onto the inner cheeks from a pump action sprayer, Graham found it difficult to achieve. For one thing, he wrote, it was hard to spray accurately as there was no marker on top of the sprayer to indicate direction of the spray. Also, the position of the ampoule blocked ones vision of the open mouth. Unlike aerosol sprayers, pump action sprayers such as Sativex® require the user to use some force to ingest the correct dose. Graham reported that because the pump often got stuck the amount of spray generated was never an accurate or consistent dose. This was particularly problematic for PD patients whose symptoms often include atrophy of fine motor skills, making it awkward for them to manipulate the sprayer.
Graham continued, stating that even if all these obstacles were to be overcome, there still remained the problem of most of the medicine sprayed onto the cheeks running down into the floor of the mouth, being swallowed and ending up in the stomach. Graham reported it took some four hours before the effects kicked in and then it produced a 'high' lasting several hours, rendering the patient incapable of any sustained cognitive activity. So, instead of acting when the need was greatest, the drug’s efficacy was highest when it is least needed.
Graham thought this information about Sativex® was important news for thousands of PD patients, so he sent a letter to the British Medical Journal, the Australian Medical Journal and the Parkinson’s Disease newsletter. None of them did anything.
British biopharmaceutical company, GW Pharmaceuticals first cannabis-based medicine, Sativex®, is an oromucosal spray which most recently failed Phase III Trials for 'cancer pain'. Patients in the UK report other nasty side effects, like mouth ulcers. Some patients ended up incapable of eating anything, and this mouth spray is alcohol-based (imagine spraying that on ulcers)! The following information will hopefully be an eye-opener for those who still believe cannabis can be synthesised and turned into a huge money-spinning 'pharmaceutical'. Cannabis sativa L., is an annual herbaceous plant that is best used raw, dried, but not turned into a pharmaceutical. In April 2015, Professor David Pennington wrote; "Cannabis is a herb, not a conventional pharmaceutical agent." But sadly that's where his understanding stops and most Australian elected officials (public servants) are way behind Professor Pennington.
Each 100 microlitre spray contains: 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD).
Each ml contains: 38-44mg and 35-42mg of two extracts from Cannabis sativa L., folium cum flore (Cannabis leaf and flower) corresponding to 27mg delta-9-tetrahydrocannabinol and 25mg cannabidiol.
Extraction solvent: Liquid carbon dioxide.
Excipient(s): each 100 microlitre spray also contains up to 0.04 g ethanol (Ethanol anhydrous) along with Propylene glycol and Peppermint oil.
Adults are advised to shake the spray container before use and spray at different sites on the oromucosal surface changing the application site each time. Patients are also advised that it might take up to two weeks to find the optimal dose and that undesirable effects can occur during this time, most commonly dizziness but that these undesirable effects are usually mild and resolve in a few days. But, as Graham pointed out, this is far from the truth.
The table shows the adverse effects GW Pharmaceuticals were prepared to admit to occurring in patients who take or are given this pharmaceutical and their frequency. Why would anyone put someone who is already suffering (a lot) through this kind of torment when it is so unnecessary? Nature has presented us with a most efficacious herb that works; why do these corporations think they can do better when they repeatedly fail dismally? So-called 'alternative medicine' has been fighting this for years. Science cannot replicate successfully the natural synergies that occur within plants, in particular. Cannabis sativa L., has been successfully used by millions over thousands of years without the interference of science and will continue to be used regardless of the legality or otherwise because it WORKS and saves lives! To quote young inspirational American Coltyn Turner, “I'd rather be illegally healed than legally dead”.
Thank you Graham and thanks to Coltyn too, in fact, thanks to ALL the brave cannabis patients, their carers, healers and also to those who fight tirelessly to keep spreading the truth. Namaste.
*Graham Irvine, Law Lecturer and Broadcaster, completed a Ph.D. on the legalisation of medicinal cannabis in New South Wales, Australia. Because university theses do not usually attract the attention of the media he wrote a piece for Crikey in 2010 called 'The Guinea Pigs Tale of Cannabis Based Medicine' to stimulate debate.