Response Patient Access to Medicinal Cannabis in South Australia

The original paper this is referencing can be found here – http://bit.ly/SA-medcan-2017

 

Mr. Loren Paul Wiener
this week in weed tv (twiw.tv)
Cannabis Law Reform Australia
31 Jan 2017 

My Background –

• My brother died a few years ago of colon cancer in California as my father did only years prior. Prior to passing my brother discovered the wonders of what would later be called RSO (Rick Simpson Cannabis oil) this was 6 years ago when much was not known on dosages etc and how to use it for Cancer, as he was already in the late stage before it was discovered. Though a legal grower in California supplying legal dispensaries, he had given up smoking Cannabis recreationally years earlier. On discovering he was sick he investigated the oil and became a legal medical user. Doctors soon discovered he reacted well to the medical Cannabis oil and his tumors reduced dramatically. Selfishly, this gave me time to get to the USA to see my brother still strong.
• Unfortunately, he came off the oil too soon and the tumors came back and got him. Originally from California before becoming a proud Australian 11 years ago, I was a little involved in legalisation of Medical Cannabis in 1996 in the USA, talking to politicians, doctors, and law enforcement at the time. I had no interest in Australia law reform here, however, at the same time as my brother passed others in Australia in 2014 were going through the same struggles for the same oil. I was then encouraged by the words of Australian Government to get more involved. I set up various websites to aid in information and consulting to politicians and others, that are for and even those against the use of Cannabis for medicinal use, offering some views on bills laws acts etc. based on my experience and exposure to previous legislation. I was honored to be asked by MP Mary Wooldridge Victoria to consult on the Access for Medical Cannabis Victoria Paper in 2016 and had my amendment added/addressed with a kind thank you in the Senate. I also work across and assist with all activists groups where our ideologies match. Uniquely to some, we are a big fan of law enforcement, initial discussions with law enforcement unknown to many, helped progress the laws in California. We discovered then as now bad laws are bad for law enforcement also. I also consult on global Cannabis issues and in Australia when the government or others ask.

Overview

• Unfortunately, South Australia appears to be continuing the trend of 2016 and redefined the words “Medical Cannabis” and “Medicinal Cannabis”.
• On earth outside of Australia and even in Australia prior to 2016 Medical Cannabis was the same as Recreational Cannabis in definition with only the regulations and processes being different. (Typically, a cannabis plant with 10-15% THC and 1% or less CBD to increase the CBD and THC potency, oil is made creating a 6-7x increase in potency this is often referred to as RSO or Rick Simpson Oil.)
• Australia’s most recent Cannabis legal evolution dates back to 2014 with Australian governments promising medical Cannabis, then a survey in 2015 showed 94% of the population supports medical Cannabis. (http://bit.ly/Cannabis-Survey) The resulting period of 2015 to 2016, saw every bill with support from multiple “activists” and MPs in 2015 and 2016, change the definition of Medical Cannabis from a plant to a suite of pharmaceutical products, GMO, chemicals, and synthetics (as not even from a plant).
• The government and media took this further calling the pharmaceutical products “medical marijuana’ as well as “medicinal and medical Cannabis”. QLD was first in 2016 http://bit.ly/exp-QLD-Bill-Oct2016 to specify in Ch2  7c that “anything” that, “acts like Cannabis is cannabis” including synthetics (as not from a plant) and including in QLD documents also the synthetic opioid Fentanyl that killed the singer prince in 2016. – http://bit.ly/QLD-synthetics  (page 6)
• However, Victoria was the first state to introduce new laws against Cannabis in multiple bills but never mentioned the word “Cannabis, instead, they opted for an old reference “drugs of dependence”.

Specifics to the Paper

• There are various references in the Executive Summary, that require comment.

There is public interest in the medicinal use of cannabis and cannabis-derived products and their use is subject to ongoing debate among health professionals and representative organizations.

• I see no reference to the often referenced by government survey by Roy Morgan per above that showed there was a 94% support of the use of Cannabis (full spectrum) for medical use. – http://bit.ly/Cannabis-Survey

 

The available evidence supporting the efficacy of medicinal cannabis generally falls short of the standards required for approved medicines

If you search the phrase above you get over 1.3 million references, so common is this in papers from around the world as it was 21 years ago.

• Simply put where a medicine is illegal federally, doing research is difficult if not impossible unless the government is attempting to do research to prove a negative. One definition of efficacy is defined as, ‘the ability to produce a desired or intended result’. Where that desired effect is for Cannabis to be ineffective, then its proof of effectiveness is also a failure of efficacy.
• However, with Cannabis being legal since 1996 in the USA and later in Canada and with over 200 million citizens, now able to access Cannabis legally in the United States alone without a single death, it is safe to say Cannabis (the plant is safe).
• Unfortunately, tests on pharmaceutical extracts of Cannabis such as pure CBD such as GW Pharma product Epidiolex has shown many serious side effects including 2 deaths during trials – http://bit.ly/epidiolex-serious . It can also be argued that the suggested criteria to meet efficacy for Cannabis the Cochrane or Gold Standard test do not work for Cannabis. This is because the human body contains a group of receptors in the brain and thought-out the human nervous center called the endocannabinoid system (ECS). A runners high is believed to be the result of a stimulated ECS. Though the efficacy is proven in various studies. The fact that human dosage required varies greatly, it was noted in a study 80% benefited when Cannabis was used for pain management. Pain 112 (2004) Berman, Symonds, Birch –
• This is complimented by most if not all Cannabis doctors that have patients with legal access, where approximate 90% is for pain management and 66% of those for arthritis pain specifically. This mirrors the Australian OTC (over the counter) sales and prescriptions as well per recent reports.

However, there are various references to efficacy available.

• 2017 – American Academy of Neurology – https://www.aan.com/Guidelines/Home/GetGuidelineContent/651
• 2016 – Efficacy of a Cannabis-Based Medicine at Advanced Stages of Dementia https://www.ncbi.nlm.nih.gov/pubmed/27567873
• 2014 – Medical Marijuana how the evidence stacks up http://bit.ly/can-eff-2

Medical Cannabis and use of Cannabis as a Medicines  – Steps are being taken to facilitate availability of high quality “medicinal cannabis” products

Again, of those using Cannabis legally medically 90% of the world that use medical Cannabis do so for pain. This only works with real Cannabis. Unfortunately, the new pharmaceuticals, being created do not work well for that and failed phase 3 trials as well (GW Pharma Sativex failed trials).

Appendix 1

Other trials are a preference by the department, with many SAEs (serious adverse effects) being your definition of Cannabis seems to indicate the new dangerous pharmaceutical Cannabis chemicals those side effects are typical and why they should not be approved in favor of natural Cannabis products.

What is Cannabis, medicinal Cannabis, hemp, industrial hemp, and recreational Cannabis?

Unfortunately, with the inconsistent definitions of Cannabis in Australia, illustrated above any reference to the word “Cannabis” in this paper has to be vetted for their meaning. Medical Cannabis everywhere but Australia is the same as recreational Cannabis with just different regulations. In Australia, Medical Cannabis need not include Cannabis at all.

Aligned with the national initiatives, the Department is developing a patient access pathway for medicinal cannabis.

Again, in this context, Cannabis is something other than Cannabis the plant, and very dangerous.

 

While legally produced medicinal cannabis products are currently not readily available in

Australia, the national intention is that eventually there will be access to high-quality Australian-grown and manufactured pharmaceutical products on prescription. It is anticipated that access to medicinal cannabis products produced to TGA standards may be possible in 2017. 

Australia Creates Multiple New Government Backed Black Markets for Cannabis in Australia 

• With the new licensing regime created by the TGA and ODC, the false demand created for new pharmaceutical Cannabis and “new” medicines to be grown per above, has criteria where demand must be quantified. Demand is based on not what is needed, but what is lawful, and for what conditions they are lawful. Demand in Australia as in the rest of the world is based on the efficacy of medicine that works. This is Cannabis a full spectrum plant, not isolated chemicals from Cannabis or synthetics that need not come from a plant at all. The result of this is that many hemp growers looking to capitalize, on this new black market, (some funded by government) are offering thousands of dollars in Australia for lists of names of potential patients. Where those lists are hard to come by, they pretend to be looking to supply medical Cannabis (the plant) hoping to engage more names and addresses for a demand for a placebo no one wants. This is similar to lawsuits in the USA in 2014, where the Hemp industry purposely confused Cannabis users with hemp users and medicines. Unfortunately, this is being done via the government in Australia, not industry currently and one of the likely legal challenges in 2017.
• The current black market for illegal Cannabis for medical users is also growing due to the government repeating sound bites in the media that states medical Cannabis is now legal in Australia. A search reveals 861,000 references to this with many from Australia government web sites.

South Australia Government Endangering Public Safety with New Pharmaceuticals Hidden in New Cannabis Laws –

• With the department choosing to consider new and untested and cannabis chemicals versus the real Cannabis products legal in the USA, Canada, Jamaica, Israel etc it is endangering the community.
• A simple dialogue recently, where the government was asked if the Synthetic Cannabis they were using for trials is the same Synthetic Cannabis that they were reporting on the same day as being dangerous, highlights the confusion.

 

Likely Australia legal challenges in 2017 for not allowing Cannabis to be used as medicine.

• Australia has referenced the Canadian Cannabis model many times especially via the ODC. Canada was sued in 2016, for being in violation of their own constitution preventing safe and access to Cannabis for medicinal use (the plant). This has merit in Australia as well.
• Canada was also sued by the people in 2008, for not allowing those other than government to provide Cannabis for medical use (the plant)
• Many companies were sued in 2014 in the USA for misrepresenting hemp products as Cannabis. The same is true for the Australian government as is referenced in this paper.
• In the Royal Commission, South Australia on Drug Use. The chairman Ron Sackville wrote in 1984 that Australia was misinterpreting and incorrectly enforcing the UN Single Use Act, as it was about trafficking and not personal use or medical use. This was ignored and the lowering of the benchmark for what trafficking is continues with tougher laws today. In light of these and other factors especially the legalizing of Cannabis in countries that have jurisprudence with Australia, it is anticipated a new interpretation of constitutional elements are justified and likely forthcoming.

Paper Questions –

1. Should a medical practitioner be required to hold a section 18A authority before prescribing an unregistered schedule 8 medicinal cannabis product?

No. A Cannabis GP in the USA when asked how he can suggest Cannabis with no training. He asked if we have Panadol or Paracetamol in Australia? I said yes. He reminded me that they work on the human endocannabinoid system (ECS) just as does Cannabis. If they cannot suggest Cannabis then they should not be suggesting Panadol or similar drugs that work on the ECS. Especially as people dies from Panadol but never from Cannabis though there is a rumor a bale fell on someone on 20 April 2005.

2. Should a medical practitioner be required to hold a section 18A authority before prescribing an unregistered schedule 8 medicinal cannabis product for patients over 70 years of age and Notified Palliative Care Patients?

No, Per above with over 200m with legal access to Cannabis, globally, making anything more complicated to any patients that can benefit patients is not in their best interest.

3. Should there be consideration of a provision for a general practitioner to be able to hold a section 18A authority to continue treatment initiated and overseen by a specialist medical practitioner?

Again why make this more complicated, new specialists to access medicine that has been used in the Australia pharmacopeia for decades until prohibition is nonsensical, and to in the public interest.

4. Should there be different requirements (compared with the usual requirements that apply to sale or supply of drugs of dependence) for pharmacists in relation to dispensing medicinal cannabis on prescription or supplying medicinal cannabis on order and recording such supply? If so, please detail what requirements should apply.

 

Drugs of dependence as a definition include hundreds of other drugs all more dangerous than Cannabis. Regulation and supply of Cannabis for medicinal use should be no more difficult than the USA,  Canada, Netherlands etc.

 

5. Should there be different requirements (compared with the usual requirements that apply to administration and supply of drugs of dependence) for recording administration or supply of medicinal cannabis by a registered health practitioner, including when the drug is administered in a health service facility? If so, please detail what requirements should apply.

Yes, it should be easier, again with reference to the over 200m with access to legal Cannabis, it is unclear why Australia takes a perspective reminiscent of the early prohibition reefer madness.

 

6. Should there be different requirements for the destruction of medicinal cannabis products? If so, what requirements should apply?

Again depends on what you mean by medicinal Cannabis. If the full spectrum plant then confiscation should be allowed to be used for research if nothing else.

 

7. Are there any factors unique to medicinal cannabis products that need to be taken into account in relation to the storage and transport requirements for these products? If so, please provide details of any relevant factors.

Again depends if referring to cannabis the full spectrum plant (and products) or medical cannabis the dangerous pharmaceutical. If the plant in Canada most sales are online and delivered by post avoiding the issue.

8. Are there any other matters that need to be considered in developing the access pathway? If so, please provide details.

If patients’ rights, needs, the SA department obligations, and a move away from creating bigger black markets, are a consideration, then Australia needs to move beyond arresting their way out of the need for a medicine from the Cannabis plant. Australia either embraces the black market and risking the public health in having to use it or evolves to a more mature model similar to any of the countries that have an evolved model especially Canada and the USA.

Summary

• If a health and safety manual said that for a gas fire you need to use a certain fire extinguisher, but that fire extinguisher may also be a petrol container, it would seem nonsensical.
• The government, the department and this paper are doing this by re-defining the word Cannabis multiple times in this paper and away from global definitions.
• With Cannabis already re-defined in some references from being a plant to being a suite of pharmaceutical products and synthetics that need not include Cannabis, adding a further definition as the drug of dependence is not in the public interest.
• Two bills passed in the Victoria in 2016 introducing new penalties and laws against The words Cannabis were never used in favor of drugs of dependence. Both laws passed with little debate and have still not been notified to the public.
• By South Australia saying and the department saying legal Medical Cannabis will not contain Cannabis offers no value for patients. Patients to date have not addressed their rights, on the promise that government would fulfill their obligations to do so.
• Creating new Black Markets and increasing the validity of existing ones by saying medical Cannabis is legal, as it is not, is not in the public interest.
• Empowering black markets that sell Cannabis, as well as ICE, cocaine, weapons and other things, is not in the public interest.
• “Considering” cannabis to be used for very rare cases and with very hard to get approved circumstances is not in the public interest, and empowers the black market further.
• Creating a process as Qld, Vic, and NSW has done that results in no supply of medicine, enforces the black market, and also the need for legal action and is not in the public interest.