" ABC Website - Sunday 19 October 2014 8:05AM - Di Martin
http://www.abc.net.au/radionational/pro ... 19/5816112
It’s estimated thousands of Australians are risking arrest by using cannabis for medical reasons. A national clinical trial has been announced but legalisation could be many years away, and then for expensive pharmaceutical drugs only. Di Martin investigates the science and the politics of medical cannabis.
National cannabis trials were announced this week, but they may have nothing to do with smoking the drug.
The Australian Medical Association says the raw plant, and any oils or tinctures made from it, should not be trialled or legalised.
‘We are in no form ... looking at the crude plant and legalising the plant for medicinal purposes,’ says Dr Tony Bartone, head of the AMA’s Victorian branch.
Dr Bartone is concerned about the different sources of street cannabis and their different chemical compositions.
‘We know that the composition between leaves can vary, depending on where it’s sourced, how it’s grown, and what time of year it’s harvested.’
The AMA is now lobbying governments to only consider a fully tested medicine, one that has been approved by the Therapeutic Goods Administration (TGA).
‘What we are seeking to do is exactly what any other new medicine would be required to do coming onto the market,’ Dr Bartone says.
Advocates for legalising cannabis without further trials say that taking the pharmaceutical route is both expensive and unnecessarily time consuming, however.
Dr David Caldicott runs the emergency department at Canberra’s Calvary hospital.
He’s one of the few senior Australian clinicians who say medical cannabis should be legalised now for use by the terminally ill and those with profound conditions which are not responding to conventional medication.
Dr Caldicott says cannabis has hundreds of different active ingredients, posing significant challenges for pharmaceutical companies.
‘These are complex compounds, difficult to prepare, and that greatly increases the cost of any commercial product,’ he says.
‘There is an argument by some people that we should just wait until the pharmaceutical companies take control of this, own it and sell it, but this will be at an enormous cost to the Australian taxpayer and to the poor individuals who need to consume these (drugs).’
‘This is a plant that can be grown. This can be grown like a tomato at roughly the same price.’
Dr Caldicott specialises in illicit drugs and toxicology and says the side effects of cannabis are benign compared to many of the medicines he now prescribes.
Dr Bartone, however, says the harms are not known from one batch of street cannabis to next.
He’s welcomed the news that national clinical trials will be held, a collaboration led by NSW. The AMA wants these trials to only use cannabis-based pharmaceutical products already on the market overseas, but not available in Australia.
There are two types of these drugs. One contains a synthetic version of THC, the main mind altering molecule in cannabis and includes drugs called dronabinol and nabilone.
The other type is new on the market, and is an extract of the cannabis plant called Sativex. It contains equal amounts of THC and another key molecule, CBD. It is the only cannabis-based medicine approved by Australia’s TGA, but only for the treatment of spasticity in muscular sclerosis.
Dr Bartone says that leaves a lot of scope for trials to be held around Australia into the use of Sativex for different medical conditions.
Clinical trials are expensive, however. A recent nine day Australian trial of Sativex involving 51 people cost more than a million dollars.
If Sativex needs to be paid for, costs will balloon. In New Zealand, where it is already available, medical cannabis users say an average prescription costs the equivalent of $1000 a month.
Advocates for legalising cannabis say further trials are unnecessary. They point to a 2012 German study reviewing 100 clinically controlled trials on cannabis.
‘There is now clear evidence that cannabinoids are useful for the treatment of various medical conditions,’ concludes the study.
The Victorian ALP, tipped to win next month’s state election, agrees that there’s already more than enough cannabis science to warrant changing the law.
‘Look around the world. There is an enormous amount of literature, there is an enormous amount of peer reviewed work, where there have been clinical trials in lots of other parts of the world,’ says Opposition Leader Daniel Andrews.
‘I think there is an undeniable momentum to make this change because it is changing lives, saving lives, it is exactly the sort of law reform we should be into.’
If the ALP wins office, it will ask the Victorian Law Reform Commission to investigate the best way to legalise cannabis. Mr Andrews says the main complexities that need to be considered are about the supply and distribution of medical cannabis.
Mr Andrews welcomes the AMA’s suggestion of holding more clinical trials of pharmaceutical cannabis based products, but not before the drug is legalised for medical use. He believes the association’s concerns about safety are overstated.
‘I think there are ways in which you can safeguard the public without being as limited as what they might put forward. I think that is a legitimate point of disagreement.’
Cannabis has now been legalised for medical use in more than 20 US states, Canada, Israel and several European countries.
In the Netherlands, a leading international cannabis researcher says the AMA’s objection about the variability of plants is outdated.
‘Right now we have six standardised varieties that are all grown indoors and they are quality controlled. They are checked for all sorts of quality parameters by an external laboratory,’ says Dr Arno Hazekamp, head of product development for Bedrocan BV.
Bedrocan BV is a Dutch company that sells five gram containers of cannabis flower heads in Canada, the Netherlands and other European countries. The company says their plants are cloned, and the flowers have standardised amounts of THC, CBD and other cannabis molecules.
‘I think the only part which is missing here compared to a standard conventional medicine is that it's not turned from a plant into something that is more familiar to us, like a standard pill,’ Dr Hazekamp says.
There are thought to be 800 different strains of cannabis. Each one has more than 100 different active chemical compounds, and each compound is believed to have a medical application.
Cannabis is now being investigated to treat conditions as varied as Alzheimer’s, epilepsy, PTSD and obesity. Dr Hazecamp says the great complexity of cannabis, and its illegal status, have deterred traditional pharmaceutical companies from researching this plant.
‘I think natural sources they have always been a little bit of a challenge for the pharmaceutical industry,’ he says.
Dr Hazekamp suggests more epidemiological work needs to be done on the discoveries made by cannabis users to supplement pharmaceutical company research.
‘These people have a lot of experience and if you look at these patients in the thousands and you ask the proper questions, I think there's a lot to be learned that will provide you with information that is clinical trial-like.’
‘I know that is not the way that modern science thinks, but that is why I am very interested in cannabis, because it is a kind of democratising medicine. It forces modern medicine and legislators to approach medicine in a different manner.’
Dr Caldicott agrees, and has volunteered to run a trial of current ACT users.
‘This is an act of civil disobedience that is occurring already all over Australia. There are thousands of people doing this already. Sso what we should probably look at it is recruiting those who are already using it and seeing what effects it has on them.’
‘What I don't think it's useful is to put it in the hands of the pharmaceutical companies and to allow them to make enormous profits out of a product that actually probably can be consumed safely without detriment to the Australian taxpayer.’"
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