Do We Really Need “Pharma Grade” Medical Cannabis?

Part one of a series of opinion pieces by Shane Le Brun, Coordinator, Medical Cannabis Awareness New Zealand

There is strong public support for significant reform of Medical Cannabis (MC) regulation. The system currently in place, which focuses wholly on pharmaceutically trialed cannabis-based medicines, removes patient and prescriber choice, and costs are prohibitive. New Zealand may have the highest priced MC in the western world – a side-effect of our remote location and small market.

Most other western countries are looking to grow and make their own products to expand treatment options while reducing costs. Australia in particular, with its solid experience in poppy cultivation, is looking to create an export market and has at least a dozen companies exploring the pharmaceutical route, pouring 10s of millions of dollars into trials for a product that they will likely have trouble holding patents on.

We have already proved with one patient, Dr Huhana Hickey, that a comparatively simple standardised extract made in grapeseed oil, can do a better job than the registered pharmaceutical alternative. This is compared to the ‘pharmaceutical grade’ product Sativex, which is essentially “2 strains of hash oil in a spraycan”. The alternative is available from Canada for a much lower cost. Imagine the cost reduction if such products could be produced in New Zealand with our proven scientific capabilities. Our issue with cost can be resolved without granting patients the individual freedom to grow their own.

At MCANZ we have introduced a small handful of products from 2 companies in Canada. These products are not Pharmaceutical grade, but are close to it, yet they cost 30-60% less than Sativex to the patient. I refer to these products as “near pharmaceutical” the quality is good, the product is clean. We have never had a request to prescribe one of these products declined by the MOH and we need to differentiate them from the negative connotations of “non pharmaceutical” in the applications scheme.

These products are not dirty hash oils made in a Californian garage by a “Ganjapreneur”, but are developed under a regime regulated and monitored by the Canadian MOH equivalent, “Health Canada”. For these products, the MOH has said nothing but yes (the trick is convincing New Zealand doctors to apply). These products have been safely prescribed to thousands of Canadian patients already, so why shouldn’t we also use these products?

The cost savings per patient can be immense for customers. However, this also matters for public expenditure as currently, WINZ, ACC and DHBs are funding Sativex on rare occasions. I estimate there are tens of thousands of dollars to be saved per annum by ditching the pharmaceutical only mindset. Naturally, starting from such a low number, the projections will only increase going forward as the evidence of cannabis’ effectiveness for conditions such as chronic pain shores up. (It is trending towards conclusive in general terms.) This has massive ramifications for the potential financial vulnerability/liability for the likes of ACC if they are increasingly asked to pay up for Sativex or other Pharmaceutical grade products in the future. It also matters for patients if they refuse access due to this cost burden.

After our next product roll out, we will reach a point where the only way to get products cheaper will be to make them ourselves in New Zealand. Canada’s system of licensed manufacturers would be ideal for New Zealand. It delivers relatively standardised and safe, sterilised products 80% cheaper than Sativex (the only relevant product preapproved by MedSafe for use in New Zealand) for similar-strength products. Products can double in price when getting shipped internationally, if we allow “near pharmaceutical” products to be made in New Zealand without trials, then we could make these products available as unregistered medicines. Trials cost big money, a cost that is then forwarded on to the patients. With plenty of generalised evidence emerging, there is no need to reinvent the wheel and prove that a balanced cannabis product that is in essence similar to Sativex does the same job.

Instead, lets make the products locally, and make them available to GPs and specialists, and let the medical professionals use their own common sense about when to prescribe. Additionally, by forgoing the insistence on trials, we can race ahead of Australia in getting the potential industry to the export stage, with cost advantages to boot. We snoozed and loosed with Opium production in the 60s, and now Tasmania leads the world in that multibillion-dollar industry, lets not make the same mistakes with Cannabis just because a few conservative MPs can’t differentiate between a medicinal crop and the cash crop down at their local tinny house.

Part 2 of this series of opinion pieces will be published next week and will cover the finer points on the workability of policy allowing patients to grow cannabis at home.

Cheaper medicinal cannabis product approved

The only legal medicinal cannabis product available in New Zealand until now has been Sativex, a mouth spray that has been prohibitively expensive for many people.

Another product that is less than half the price, Tilray, has just been approved by Associate Health Minister Peter Dunne after Dr Huhana Hickey applied to use it.

NZ Herald: Medicinal cannabis costs set to tumble after cheaper product gets green light

It is estimated the marijuana-based tincture called Tilray will cost at least 50 per cent less than the existing legal product Sativex, a UK mouth spray made by GW Pharma.

Multiple sclerosis sufferer, Dr Huhana Hickey, who applied to use Tilray, said: “I’m so relieved. It’s going to save me $700 a month.”

The AUT academic says she has spent $9000 on prescriptions since she started taking medicinal cannabis in February. Hickey says the results have been remarkable.

“I’m living my life again. I’m back to work, I am fully-functioning”

She started using the spray to replace pain killers such as morphine, codeine, tramadol and other opiates which she had been prescribed for years.

“At the start I was sceptical I didn’t think it was going to work that well, but I can’t believe it. I haven’t had opiates for seven months. It really works and I have no side effects.”

Hickey says she doesn’t get high, just a little dozy at nights.
“And I sleep, which is great because I’ve been an insomniac for 40 years.”

Medicinal cannabis is being used to treat diverse conditions such as chronic pain, terminal cancer, Tourette’s and child epilepsy. Patients say it reduces the severity of their symptoms.

Sativex, which is not funded by the drug buying agency Pharmac, has been available in New Zealand since 2008. Medical marijuana campaigners say fewer than 40 patients use it, largely because of the price. A prescription through a district health board costs patients around $1200 a month, or $1500 if it is ordered with a chemist.

Hickey’s success follows the rejection of a similar application by trade unionist Helen Kelly. She wanted to use a cannabis product to alleviate symptoms of terminal lung cancer. Kelly, 52, died on Friday.

Kelly’s application was rejected and she didn’t try again, instead choosing to illegally use medicinal cannabis, openly flaunting the law.

The campaigning charity Medical Cannabis Awareness NZ supported Hickey’s application for the new concentrate.

Spokesman Shane Le Brun said: “There are many people suffering while waiting for legal access, who balk at the price of Sativex. We hope that Tilray products will be recognised over time as a ‘close enough’ equivalent to Sativex to spare patients the exorbitant cost.”

Le Brun says the other reason for the lack of uptake of Sativex the difficulty in finding an anaesthetist who will agree to prescribing medicinal cannabis. He hopes this decision will change things.

“Once we have a few more approvals through then specialists will have less room to squirm and avoid the issue.”

Le Brun hopes that eventually new cannabis medicines will not require ministerial sign off.

Dunne would not comment but his office indicated that in the future approval for recognised products such as Tilray was likely to become routine.

“Hopefully this will open door for others in need,” says Hickey.

It’s a toe in the door. Now Hickey’s application has succeeded expect more people to apply to use Tilray.

Seeking support for new, cheaper medicinal cannabis

A silly headline but a useful article from NZ Herald: Medical marijuana: Is NZ dazed and confused?

A conservative lobby group is seeking support for new, cheaper medicinal cannabis for chronic pain relief.

Kat Le Brun, by her own admission, is a “grumpy” Christian student teacher from Nelson, and Jacinta, a tiger mother with a quickfire voice.

What do they have in common? Pain. Not bang-your-thumb-with-a-hammer pain, but the sort of pain that lasts as long as you do.

Chronic pain.

Many people suffer from chronic pain and legal pain relief products are not always effective – and can be addictive, like  morphine.

“I believe we have to focus on the medical at this stage. It might be selfish but it’s all getting muddled up. We need to look at one issue. This is too much for the politicians to deal with.”

This conflation of medical marijuana and general legalisation may be one reason why New Zealand seems stuck, while our neighbours and allies are moving quite fast.

Medical marijuana is legal in 25 states of the United States, half the country.

In Australia, Victoria and ACT are preparing to join the party.

Ross Bell from the NZ Drug Foundation says after all these years railing against the evils of marijuana our Government is in a bit of a quandary.

“They think they are the drug warriors. Medical marijuana is confusing them, ‘we should do something but we don’t know what’. Something’s not computing. They don’t know what to do to meet the needs of the 75 per cent.”

New Zealand is certainly lagging behind the US and Australia on enabling the legal use of medicinal cannabis products.

Like Kat, Nichola’s tried marijuana and finds it transformative.

“It works and it’s a crime that it’s not available to us,” says Nichola. But just like Kat she refuses to turn herself into a criminal.

“I have quite strong values. I don’t want to blur the lines.”

In the blurry world of right and wrong all these women have had more experience with hard drugs than any of the dodgiest-looking characters on the protest.

Tramadol, OxyContin, morphine. You name it. Nichola is even taking heroin substitute methadone. She longs for medical marijuana to be legal.

“That’d be incredible. I’d be burning all my drugs my methadone and fentanyl patches.”

Patient frustration at the fringe nature of the movement has birthed a new conservative pressure group.

The co-ordinator is Kat’s husband Shane Le Brun.

“It’s been a long journey. Before my wife was injured we chucked flatmates out for drug use once upon a time. Now the tables have turned,” says the former soldier and National Party voter.

It’s called MCANZ. Medical Cannabis Awareness New Zealand.

They are trying to normalise the health benefits only of cannabis products.

A report to Health Minister Jonathan Coleman obtained under an Official information request says “there is a lack of robust clinical data and evidence of patient benefit”.

Kat, Nichola and Jacinta’s daughter have carried out their own personal trials and believe it works for chronic pain. For them anyway.

Not a cure or anything but a great alternative to opiates.

“It means pain relief that doesn’t affect me in a bad way,” says Kat. “A natural solution without all these massive side effects.”

With one in five kiwi adults suffering from chronic pain, Shane believes there are thousands out there who could benefit from medical marijuana.

But he’s careful not to suggest that it’s a panacea.

“At one end conservatives say it gives you schizophrenia and is so addictive and horrible. Then you’ve got those who say it will cure all ills and you never need another drug again. The truth lies somewhere in the middle.”

Getting New Zealand to catch up with that middle is a challenge given the current Government’s unwillingness to change the law.

Revelations that Martin Crowe and Paul Holmes used marijuana to mitigate the effects of chemotherapy has no doubt bolstered public opinion in New Zealand.

Since 2003 the number of people in favour of medical marijuana has doubled.

“We have people like Sir Paul Holmes using it in his dying days,” says Shane.

“You don’t have to be a hardcore lefty for that to strike a chord.”

Helen Kelly is another high profile user of medicinal cannabis, the difference being she is going public while she is still alive (albeit dying).

Shane agrees there’s a lot of compassionate cultivation going on.

“Some people will just grow and do it on the sly to self-medicate.”

But as Ross Bell warns, if you are treating kids with seizures you probably don’t want just anyone boiling up cannabis oil, you probably do want pharmaceuticals.

MCANZ is supportive of Rose Renton’s work, but as a conservative charity can’t support home-growing.

“As the only patient-led group playing within the rules we hope to be taken a little more seriously. All we care about is getting medicine into patients hands and getting rid of the background noise.”

To that end MCANZ is trying to make two cannabis-based medicines from a Canadian company called Tilray available for patients.

But there are hoops.

First they have to be assessed by the Ministry of Health, then personally signed off by Associate Minister of Health Peter Dunne.

The MCANZ applications are expected to land on Dunne’s desk in the next few weeks.

In the meantime, Kat and Shane are contemplating a second baby.

They hope medical marijuana might be available by the time it arrives. Their first child was born addicted to narcotics because of all the painkillers Kat had been prescribed.

“What my son went through because of the medication … For two weeks he had to go through withdrawals. I would not wish that on anyone. That’s what opiates do.”

What is currently available legally has major drawbacks, generally and compared to cannabis products.

They are sharing this personal story in the hope the decision makers will listen.

“They should come and sit with us and see what goes on with our families on a daily basis,” says Shane.

“There’s so much suffering our people go through. All behind closed doors. The only way is to open it up.”

Seeking support for new, cheaper medicinal cannabis seems the sensible, logical, relatively safe and compassionate way to go.

Helen Kelly Backs Medical Cannabis Charity

Medical Cannabis Awareness New Zealand Press Release:

Today Helen Kelly published a post supporting of others making meaningful contributions in support of Medical Cannabis, including a supporting video of our #MC410 fundraiser, aiming to fundraise for Sativex for 10 Patients.


MCANZ is grateful for the public endorsement from Helen Kelly, who is the only notable public figure tackling this issue from a genuine personal need. We hope in future that other public figures and Charities will join us in publicly taking a positive stance on this issue, as charities representing MS, Cancer etc have been largely silent, to the detriment of the patient groups they purport to represent.

Helen Kelly:

“Its Prime goal is to make sure that families that have got legal access to Medicinal Cannabis are able to afford to fund it.”

“We need a proper medical cannabis law in New Zealand to make this accessible, to have it funded but in the meantime there are families with desperate people missing out on what has been a fantastic drug for me, the best drug available, for pain relief, for Nausea, for the Stimulation of my appetite..”

“I have got cancer everywhere, and it has enable me to have a full night’s sleep, to be comfortable, to be pain free”

Medical Cannabis Awareness New Zealand Coordinator Shane Le Brun:

“It’s important to realize that not everyone is in a position to flout the law as Helen does, some, like a patient we are fundraising for are in care facilities, while others, with severe disabilities relating to Multiple Sclerosis, are in no position to get stuck into the gardening as it were.”

“We have 1 legal option Pharmaceutical grade option, which while not suitable for everyone, and almost unobtainable, it is proving possible to access for those with the most extreme need”.

“We are fundraising for 10 of these patients with extreme need from up and down the country under our #MC410 campaign, in these cases the Medical Profession and the Ministry are not a barrier to access, only the cost”.

“we hope with the support of New Zealanders we can continue to support these 10 needy patients receive a potentially life changing treatment, as already one of our patients has had improvements in Seizure activity, reduction in pain relief and dramatic improvements in sleeping patterns, additionally giving the family caring for him an improvement in their lives, easing the burden of several people”.

About MCANZ: http://mcawarenessnz.org/our-mission/

Medical cannabis charity coverage

The Medical Cannabis Awareness charity has just been launched – see Medical Cannabis Awareness. Shane le Brun is been heavily onvolved with this – he has posted here at Your NZ in the past and still pops in to comment.

Use of medical cannabis in particular and use of cannabis generally is getting a lot of attention in New Zealand and in other parts of the world. Peter Dunne along with a New Zealand contingent is currently attending the United Nations General Assembly Special Session on the World Drug Problem (UNGASS) in New York.

The media have picked up medical cannabis as a topic and have been giving it a lot of coverage over the last few months, helped by high profile stories involving Paul Holmes, Martin Crowe and Helen Kelly.

So the launch of MC Awareness is well timed to pick up on this interest, and they are getting some good coverage.

One News: Kiwi medical cannabis charity registered

An organisation looking to fundraise for New Zealand’s medical cannabis users has become a registered charity.

Radio NZ: NZ’s first medical cannabis charity

New Zealand’s first medical cannabis charity want to help pay for patients to get legally available medical cannabis.

Stuff: NZ’s first medicinal cannabis charity fundraising for 10 patients to get treatment

New Zealand’s first medicinal cannabis charity is fundraising to provide patients with the unfunded drugs.

Medical Cannabis Awareness New Zealand (MCANZ) became a registered charity on Friday. Coordinator Shane Le Brun said it had launched a fundraising campaign, initially to fund Sativex for 10 patients.

NZ City: Medical cannabis charity registered

An organisation looking to fundraise for New Zealand’s medical cannabis users has become a registered charity.

Medical Cannabis Awareness New Zealand launched this week with the goals of raising awareness and advocating for the treatment, along with getting together funds for those already using it.

The charity – the country’s first for medical cannabis – says about 30 Kiwis currently have a prescription to one cannabis treatment, Sativex, but it can cost more than $1000 a month to acquire because it’s not Pharmac-funded.

“The cost of Sativex is a huge barrier. Already, many people have had successful crowd funding campaigns for this medicine, and MCANZ will promote and assist such fundraising through its tax-deductible status,” MCANZ co-ordinator Shane Le Brun said.

The group wants to initially raise enough money through its Givealittle page to support treatment for 10 new patients.

Newshub: Desperate families get behind marijuana charity

Pressure is mounting on the Government to cut red tape for those who want to access medicinal marijuana.

A group of desperate families are speaking out as they launch a charity to raise money and awareness in the battle for Sativex.

Newshub: Medicinal marijuana charity launched

Momentum is growing in the battle for access to medicinal marijuana, with a group of Kiwis launching a new charity.

Shane Le Brun founded “MC Awareness” to raise money and support for those who want Sativex, the only approved medicinal cannabis product, after watching his wife suffer for years with chronic back pain.

Shane Le Brun says there’s still a lot of stigma attached to prescribing Sativex, as doctors don’t want to be seen as dope enthusiasts.

This story has featured ongoing on the Paul Henry show this morning.

Shane and his team have put a lot of effort into establishing a practical means of achieving something practical to help people who would benefit from the use of Sativex.

Their Givealittle page: Medical Cannabis for 10 Patients

Fundraising for Sativex for 10 needy people in New Zealand. Conditions such as Epilepsy, Cancer, and Chronic Pain.

A fundraising pool of 10 patients, who will be revealed in due course,

First up is Jamie,

At 5 weeks of age Jamie O’mara suffered a massive intracranial hemorrhage. This left him severely brain damaged and in need of constant care. This was attributable to Jamie not receiving a Vitamin K injection at birth.

As a result of his brain damage Jamie developed severe epilepsy, which was poorly controlled by numerous anti-epileptic drugs.

At 24 years of age, in 2008, with no other avenue in sight, Jamie finally underwent hemispherectomy (removal of half his brain) This finally rid him of some seizures & as a result, a better quality of life but a lot of seizures still remained day & night.

Jamie is now 32 years old. He recently began to suffer massive aspirations during tonic clonic seizures prompting medical staff to tell the family Jamie wouldn’t make it through one night. Jamie defied all odds and survived this massive aspiration on his own, even after doctors refused him life support. Jamie is a true battler.

The only remaining option is to try Medical Cannabis. After a lengthy wait, Jamie had his first spray of Sativex this week. Time is needed now to show how effective it will be. Please seriously consider this family’s plea for help. For a family who has been so desperate to alleviate their son’s seizures that they even agreed to partial removal of his brain, their request for financial support with Sativex can only be seen as reasonable.

 

Medical Cannabis Awareness

Medical Cannabis Awareness New Zealand co-ordinator  Shane Le Brun is put out a launch press release:

Medical Cannabis Awareness New Zealand

Medical Cannabis Awareness New Zealand (MCANZ) is pleased to announce its registration as a charity has been approved.

MCANZ is devoted to “putting patients before politics”, and intends to help patients who may benefit from access to medical cannabis under existing laws. As a charity, MCANZ cannot advocate for any specific law changes. However, we can take a role in increasing public awareness of medical cannabis use in New Zealand.

Medical cannabis is legally available in New Zealand. Approximately 30 Kiwis now have active prescriptions for Sativex, but MCANZ believes many more New Zealanders could benefit from this medication.

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The Three Goals of MCANZ

* to assist fundraising for legally-available medical cannabis for patients

* To promote knowledge on medical cannabis to the medical profession

* to advocate for patients’ access to the best medicine available for them

The cost of Sativex is a huge barrier. Already, many people have had successful crowd funding campaigns for this medicine, and MCANZ will promote and assist such fundraising through its tax-deductible status. MCANZ will seek donations and bequests directly, and network to help Kiwis in need meet potential benefactors. Initially, a crowd-funding campaign will support 10 additional patients.

https://givealittle.co.nz/cause/legalmcfor10/donations

Improving knowledge on medical cannabis would empower and assist the medical profession to use current legal options for prescribing / requesting access to medical cannabis for their patients.

A reputable American online course will be offered, that is recognized for 12 AMA PRA Category 1 Credits. We have duly confirmed that these credits are transferrable for Nurses, GPs and Anaesthetists in New Zealand to be recognized as part of their continuing education programs. Other relevant specialties may be added, and in future we hope to bring medical cannabis experts from the USA to offer this course locally.

Where medical cannabis may be an appropriate treatment, MCANZ will support individual patients’ efforts to research their situation and to apply for access to this medicine through their GP and/or specialists.

The MCANZ team includes a Registered Nurse who is undertaking further medical cannabis education. This will enable us to provide up-to-date information on the benefits, risks and success rates possible. Having a medical professional assisting with these applications (such as those made for Alex Renton and Helen Kelly) could, we believe, greatly help with the applications process in a variety of ways.

Our long term goals are to become a recognized centre of knowledge on Medical Cannabis in New Zealand, to promote the research and development of MC products here in NZ, and to advocate for improvements in the availability and affordability of Medical Cannabis.

Website: www.mcawarenessnz.org

Facebook: https://www.facebook.com/MCANewZealand/