Pharmac to consider cannabis spray funding

NZ Herald reports Cannabis spray considered for public funding:

A cannabis spray used to treat epilepsy, pain and multiple sclerosis will be considered for public funding next month.

Pharmac, the agency responsible for deciding which medicines get subsidised, plans to discuss the Sativex spray with its primary clinical advisory committee, according to a letter from Pharmac released on Friday.

Pharmac said Sativex contained cannabidiol with tetrahydrocannabinol, or THC, the main psychoactive component of cannabis.

The agency said consideration from the Pharmacology and Therapeutics Advisory Committee was the first step in assessing the funding of a new medicine.

According to Medsafe, Sativex was already approved for use in New Zealand as “an add-on treatment” for some patients with moderate to severe spasticity due to multiple sclerosis.

Specifically, it could be given to people who hadn’t responded adequately to other anti-spasticity medication and who showed improvement in spasticity-related symptoms during an initial trial of therapy.

Any other use of Sativex was currently banned.

One small step forward perhaps.

Historical Medical Cannabis Policy Briefing with New Zealand Healthcare Officials

From PRNewswire:

United Patients Group Participates in Historical Medical Cannabis Policy Briefing with New Zealand Healthcare Officials

The New Zealand Drug Foundation in conjunction with United in Compassion New Zealand call upon United Patients Group to contribute to a first-of-its-kind collaboration between US and international experts to further explore cannabis as a possible therapeutic treatment in New Zealand for a range of conditions

SAN FRANCISCO, July 23, 2015 /PRNewswire-USNewswire/ — United Patients Group, the leading medical cannabis information and education site, disclosed their participation in a history-making policy briefing held last week in Wellington, New Zealand with key members of the New Zealand Drug Foundation, United In Compassion New Zealand, world-renowned researchers and leading medical cannabis physicians.  United Patients Group will act in an ongoing advisory and consultative capacity to the New Zealand working group in conjunction with the Ministry of Health, to further explore and initiate potential phase 1 medical trials to examine cannabis as a possible therapeutic treatment in New Zealand.

The esteemed invitation-only panel are made up of experts from across the medical cannabis care pathway and included New Zealand and Australian participants, along with several key experts from the United States, including United Patients Group.

John Malanca, founder of United Patients Group commented, “We are honored to be a part of such a ground-breaking and historic effort and are incredibly impressed that the New Zealand government has listened to its constituents and are making a concerted effort to explore thoughtfully and swiftly the benefits of cannabis for medicinal purposes.”

Background
In May 2015, after intense petitioning by United in Compassion NZ, recent media coverage of high profile medical cases and resulting public pressure, New Zealand’s Associate Minister of Health, Peter Dunne, agreed to start a dialogue in order to become better informed about the process of bringing medical cannabis into New Zealand for potential research and development purposes.

Dunne set up a team to explore the current climate regarding medical cannabis in New Zealand and formed a Ministry of Health Working Group, led by Dr. Stewart Jessamine, current Director of Public Health for the Ministry of Health in Wellington.  Jessamine also heads up Medicines Control which functions as a regulatory team within the Ministry of Health that oversees the local distribution chain of medicines and controlled drugs within New Zealand.  Jessamine is also an executive board member for the World Health Organization.

With a marked shift in public opinion toward legalization of cannabis for medical purposes worldwide, New Zealand (like the US) is re-examining its long-standing policies toward the (currently illegal) drug.

Compassion Melds with Science
Malanca further commented, “Fundamentally, it’s difficult to ignore the daily barrage of stories coming from all over the world where medical cannabis is cited as having an effective impact on the relief and treatment for patients living with chronic and life-threatening conditions such as Dravet Syndrome to brain cancer.”

It was Malanca’s own personal experience with the devastating diagnosis of his father-in-law’s lung cancer (which had metastasized to the brain), that led he and co-founder, Corinne Malanca to medical cannabis as a last lifeline for their family member, Stan Rutner.  Five years later, Stan Rutner remains cancer free (both brain and lung scans are clear).  The duo formed United Patients Group in 2010 in order to provide reliable, comprehensive information on medical cannabis to individuals around the world.  The online site has expanded to include information for caregivers, physicians and treatment facilities throughout the US as well as online CME (continuing medical education) courses in medical cannabis .

New Zealand Seeks US Expertise
Toni-Marie Matich is a mother of a teenage daughter suffering from Dravet Syndrome.  Matich also has an early education in science and horticulture. They live in New Zealand, where like many other countries, cannabis is illegal.  She had heard the story of young Charlotte Figi, the Colorado child who was suffering from 300 grand mal seizures per week that was being successfully treated with medical cannabis.

After exhausting all options available in New Zealand, and her daughter still suffering hundreds of seizures a day, Matich  began working behind the scenes for several years to try and raise the issue (and awareness) of medical cannabis, gaining the support of the NZ Children’s Commissioner, and the CEO of the NZ Drug Foundation along the way.  She became the New Zealand representative to United in Compassion Australia in 2014.

“Due to the laws criminalizing cannabis in New Zealand, it isn’t a treatment that our doctors or other health professionals are familiar with, therefore the ability for a doctor to have an open mind and discussion with their patient is non-existent and we would like that to change. I recognized that United Patients Group was leading the way in information across the entire spectrum of the medical cannabis movement in the US, as well as providing the educational resources for clinical and medical professionals, so I sought them out.”

Matich secured a meeting with (Associate Health Minister) Dunne, known for his vehement opposition to legalizing cannabis.  “Dunne listened and showed compassion.  To my surprise he immediately tasked a working group within the ministry to meet with us and engage in developing our initiatives.   A key component was to educate individuals on medical cannabis, so we immediately brought in United Patients Group.”

The policy briefing was hosted by the NZ Drug Foundation which functions as a charitable trust dedicated to advocating for evidence-based drug policies.  Ross Bell, Executive Director for the NZ Drug Foundation said, “Across the globe there’s a tremendous amount of new research coming up surrounding medical cannabis, and some of the research appears to be very promising.”  Bell stresses that at the core of the matter are the people of New Zealand, who are living with medical conditions that many of them feel may benefit from medical cannabis. “We’re thrilled to be working with experts from around the world, like United Patients Group, to address how to specifically deliver a medicine such as cannabis and to what type of medical condition while working through some of the political realities we face, just like any other nation at this time.”

In addition to United Patients Group, participants from the historic policy briefing included:

  • Toni-Marie Matich – Co-Founder and CEO, United in Compassion NZ Charitable Trust
  • Ross Bell – Executive Director of the NZ Drug Foundation
  • Dr. Russell Wills – The Children’s Commissioner (New Zealand)
  • Dr. Alan Shackelford  Harvard-trained physician and medical cannabis researcher who came to worldwide prominence as the doctor who successfully treated Charlotte Figi, the Colorado child suffering from 300 grand mal seizures a week
  • Dr. Bonni Goldstein – Medical Director of Canna-Centers, a medical practice in California devoted to educating patients about the use of cannabis for serious and chronic medical conditions
  • Lucy Haslam – Co-Founder and Director, United In Compassion Australia
  • Troy Langman –  Co-Founder and Director,  United In Compassion Australia and New Zealand
  • Knut Ratzeberg – Laboratory Director, Medical Cannabis Services (AU)
  • Dr. Helga Seyler – Liaison between The University of Sydney and Commonwealth Scientific and Industrial Research Organization (CSIRO)
  • Nevil Schoenmaker – Founded ‘The Seed Bank’ in Holland in 1984, and was one of the first legal producers of cannabis seeds

About United Patients Group
United Patients Group (UPG) is the unparalleled online resource and trusted leader for medical cannabis information and education for physicians, patients and health-related organizations.

Learn more about United Patients Group at www.unitedpatientsgroup.com

About United In Compassion NZ
United In Compassion is a non-profit charitable trust whose purpose is to educate the public on Medicinal Cannabis, supporting and facilitating NZ based research into the therapeutic effects of cannabinoid based medicines, as well as providing support to New Zealanders who would like to access legal medicinal cannabis, as well as to lobby government for legislation changes regarding the use of cannabis for medicinal purposes  http://unitedincompassion.org.nz/

About NZ Drug Foundation
A charitable trust dedicated to evidence-based alcohol and other drug policy.  http://www.drugfoundation.org.nz/

Curwen Rolinson and NZ First

Curwen Rolinson has been associated with NZ First – as Board member for six years so presumably longer than that. He has been reported as leading NZ First Youth.

It’s been reported today that Former NZ First youth leader on cannabis charge

The former president of New Zealand First’s youth wing has been charged with possession of cannabis for supply.

Curwen Rolinson’s always been a troublemaker for New Zealand First and now it seems he’s a law-breaker as well.

Police arrested the aspiring politician on April 15, and he since appeared in court charged with possession of cannabis for supply.

Former NZ First Youth president? A press release followed soon after this news under Winston Peters’ name:

Rt Hon Winston Peters
New Zealand First Leader
Member of Parliament for Northland
7 JULY 2015

Statement on Curwen Rolinson

A remit proposing to formalise a youth wing is coming before the New Zealand First Convention in August.

Mr Curwen Rolinson was told countless times never to call himself the president or leader of a youth wing. New Zealand First does not have a youth wing in its Constitution, and therefore does not have a former or present president of such an organisation.

So NZ First are disowning Rolinson? He has certainly been connected with NZ First, but  in what capacity?

Searching the NZ First website on either his first or last name gets no hits.

He posts often at The Daily Blog and this one yesterday (6 July 2015) identifies him as a past Board member:

This piece has been a joint effort between long-serving former New Zealand First Board of Directors member Curwen Ares Rolinson, and a mysterious Southern gentleman known only as “Eduardo”.

There he is “former New Zealand First Board of Directors member” but in an earlier post on June 18:

Curwen Ares Rolinson was once, thanks to the Prime Minister, memorably investigated by the counter-terrorism branch of the NZ Police’s Special Investigations Group as a potential “Threat to National[‘s] Security”. He also blogs regularly at a variety of outlets; and heads up NZ First Youth.

This had changed to ‘former’ by June 27:

This piece has been a joint effort between long-serving former New Zealand First Board of Directors member Curwen Ares Rolinson, and a mysterious Southern gentleman known only as “Eduardo”.

On his Facebook ‘About':

Former Board of Directors; at New Zealand First

Here is his resignation from the NZ First Board on June 14:

The very first thing anybody learns about me – apart from, possibly, the fact I’m an Aries … is that my life is completely dedicated to New Zealand First.

Earlier this week, I tendered my resignation from NZF’s Board of Directors, in protest against what I considered to be unconscionable and dishonourable conduct from same.

Needless to say, this saddens me greatly. My service unto The Party, as delivered from that highest echelon, has been one of the highlights of my young life. The resounding recognition received for same from the thousands of Party members whom I’ve met at Conventions and in my travels across the land has been truly humbling. As has their supreme confidence in me by continually re-electing me to the Board for six years running. Who’d have thought a political party best known for its advocacy for the aged would EVER have entrusted a young lad of 20 with elevation to its highest body.

I’m truly pleased with what I’ve been able to accomplish as a Board member. NZ First developed a Youth Wing, a Social Media Presence, and numerous other 21st century innovations in no small part thanks to my efforts (although it is also VITALLY important to recognize that I didn’t do any of this alone, and that other people – in the case of NZ First Youth, DOZENS of other people – helped to make it all possible).

But regardless of whereabouts I wind up in the organization, my core belief – that New Zealand First represents the best, brightest, and blackest hope for our Nation’s future salvation – remains absolutely unchallenged.

There has therefore never even been the vaguest hint of a question about whether or not our fates remain intertwined.

To quote from my letter of resignation:

“Having said all that: I wish to make one thing perfectly and absolutely clear.

I am not going anywhere.

I still resolutely believe in this Party – its ordinary members, if not always its leadership; its Leader, if not always his martinets; and its principles if not always their practical applications.

My heart is still Black; and the linings remain – as ever – Silver.

I will therefore be continuing in my membership of New Zealand First, my activities in running the Youth Wing, and my public representations on our behalf through media such as The Daily Blog. […]

I hope by offering my Resignation […] that this allows us all to move forward in relative dignity; and get on with the serious business of protecting and saving our New Zealand, rather than wasting your breath and my sanity on continued factional infighting.

Our mission, here in politics, is bigger than each of us and any of us.

I look forward to continuing to play my part within it.

Yours faithfully,

Curwen Ares Rolinson. ”

The Age of Ares is over.

“Acta est fabula, plaudite!”

Curwen Ares Rolinson's photo.
Curwen Ares Rolinson's photo.

Oddly from the previous day:

On Sunday, at our Party Convention, I was once again re-elected to NZ First’s Board of Directors.

I believe my campaign promises included “levity” and “keeping the bastards honest”.

I thank the Party for its ongoing faith in me and what I do :D

They’ve voted for me en masse in each of 2010, 2012 and now 2014, so I must be doing something right :P

Confusing.

Rolinson was referring to NZ First Youth still on July 4 (last Saturday):

New Zealand First Youth meetup last night. We look like a goddamn boyband.

 — with Simon Oh Ionmhainèain and 3 others.

Curwen Ares Rolinson's photo.

The NZ First – Pakuranga Facebook timeline shows him as “Curwen Rolinson from the NZ First Youth Wing“:

NZFirstPakurangaFacebookIn March 2013: NZ First Youth denies pledge at odds with party

The president of NZ First’s youth wing has signed a pledge in favour of same-sex marriage.

It is a move that goes against the party’s opposition to the marriage equality bill, which is due for its second reading in Parliament on Thursday.

NZ First Youth president Curwen Rolinson was one of eight youth party representatives who signed a marriage equality certificate outside Parliament this morning.

However, Mr Rolinson says his youth wing’s stance is not at odds with the party and his signing of the pledge was on the condition of a referendum.

He has an unofficially connected blog called Putting NZ First:

PuttingNZFirstblog

NO COMMENTS:

So it’s curious that NZ First seem to be trying to distance themselves from Rolinson’s party Youth wing activities when he has been a Board member for six years.

And if he’s been reported as NZ First Youth president for years why deny it now? Of course Rolinson’s arrest could be seen as embarrassing for the party but a belated cutting adrift won’t change much.

Related post: NZ First youth wing

Alex Renton dies

Very sad to hear that Alex Renton died yesterday. Prior reports had been of improvement as he was gradually allowed to come out of a drug induced coma as cannabis oil treatment increased.

His family posted on Facebook – Support for Alex’s Journey – last night:

This evening our beautiful warrior Alex passed peacefully away. He was surrounded by his family, listening to his own music with a tummy of mums food. We thank you all from our hearts as you kept us strong during this journey. His spirit is amongst us all as he taught us so very much. We love you dear Alex (aka Ratty) xxxxxxx

Two days earlier (June 29) they had posted:

Alex is holding his own maintaining his own breathing! He shows courage, strength and fortitude as he battles towards better health. Keep prayers flowing. We are now feeding Alex our own meals with support from Hospital. This continues to be the most challenging event of our lives as a family, support around NZ is incredible, thank you xx. Rose

Stuff reports Nelson teenager Alex Renton dies despite treatment with medical cannabis.

Alex, 19, has been in hospital since April 8 in “status epilepticus”, a kind of prolonged seizure. It was not known what caused the seizures.

He had been put in an induced coma and his family petitioned the Government to allow him to be treated with a medicinal cannabidiol oil, Elixinol. They gained national support and Associate Health Minister Peter Dunne approved it to be used last month.

Alex was given his first dose of the oil on June 16, after it arrived from America.

His sedation medication treatment was reduced and he regained consciousness and his seizures stopped in that first week.

There will possibly be an inquest into Alex’s illness and death to explore the complex medical issues involved.

Gareth Jones, dying and cannabis oil

Gareth Jones is dying of cancer. He was told he had only a few months to live (last October). He producing his own cannabis oil and self medicating with it. He says it helps his pain and thinks it may have extended his life. But it’s illegal.

3-D (3 News): Cancer patient says NZ needs law change on medical cannabis

His pain is substantial. He’s doing his best to manage it with pharmaceutical drugs administered through this “pain patch”, but he’s adamant the cannabis oil is playing a lead role in fighting the pain and improving his quality of life.

He says the benefits are sleeping, pain relief and appetite.

Mr Jones also believes his homemade medicine is extending his life. Last October he was told he had just three months to live.

“The way the oncologist was talking it was more like I’d have a month of good and maybe a month or two after that, maybe three months tops, and he was talking six months as the extreme side of it and I’m over that now,” says Mr Jones.

Regardless of whether the cannabis oil is providing any real medical benefit – even if it is just having a placebo effect – surely there is nothing wrong with a dying man from using it. It’s hard to see what harm can be done by it.

Without fail, every night Mr Jones takes two capsules – a measured combination of his home-cooked cannabis oil mixed with coconut oil.

“Yes [I get high], but that’s why I take it at night, so I sleep off the effects, so I don’t really feel anything. So that’s why I take a good dose at night then wake up in the morning and it’s gone and I carry on the day like normal.”

He needn’t get high – if the law allowed him to use cannabis oil that was low in intoxicants. Cannabis low in THC can be grown although it isn’t readily available in New Zealand.

But so what if he gets high?

What makes it even more frustrating for Mr Jones is seeing the recent legalisation of medical cannabis across the United States; in many states what he’s doing is totally legal.

“It’s pretty average really. For trying to extend my life and spend more time with my family I get made a criminal for it.

“Something needs to change in New Zealand. Most other countries have woken up to it. And using it for medicinal use anyway, they’ve been doing it for a long time with good results now, so it’s about time New Zealand finally caught up.”

Overseas, studies have found cannabis works well on chronic pain, especially for people like Mr Jones with late-stage cancers.

But this family can’t wait for New Zealand to catch on. Mr Jones is determined to see his daughter turn three. If that means breaking the law, then that’s what he’ll do.

“I guess I’ll just keep taking my nightly pills and go from there I guess. I don’t really have back-up plans now.

I suppose there’s a risk that now Gareth has gone public the police could arrest him. What then – put him in a prison hospital and does him up on morphine?

Morphine is often legally provided for pain relief and that is highly intoxicating. It seems nuts that a milder and far safer intoxicant can’t be legally used, especially as it might provide other medical benefits as well.

The Ministry of Health told 3D as part of a wider review of the Medicines Act it’s looking into the legislation around the use of controlled drugs, including cannabis. The results of the review will be released next year.

It seems likely Gareth will be dead by next year. Because our Government is paranoid about sick and dying people getting high using cannabis – already one of the most widely used drugs in New Zealand.

Studies on medical cannabis “mostly poor quality” but prospects for change

It was interesting to see this posted on the United Future Facebook time line – Studies Supporting Use of Medical Marijuana are Mostly Poor Quality, Researchers Find.

The White House has just announced that it will be relaxing some of its strict regulations on marijuana research, making it easier for scientists to conduct clinical studies on the drug.

This could not have come at a better time, it seems, as a comprehensive review of 40 years of human trials that examined its potential use in treating a variety of ailments has suggested that high-quality evidence supporting its therapeutic use is lacking.

With its increasing popularity, now is the time to critically evaluate its effectiveness in clinical settings, which is precisely what a team of researchers from the University of Bristol recently set out to do.

As described in the journal JAMA, the team set out to review the benefits of cannabinoids in the treatment of various diseases or symptoms. Almost 80 randomized clinical trials were included in the study, which revealed that the majority found an improvement in symptoms with the use of cannabinoids. While this may sound positive, they actually found that most of these associated health improvements were not statistically significant.

Some study successes:

Of those that were considered to be of moderate quality, support was found for the use of cannabinoids in the treatment of chronic pain and spasticity due to multiple sclerosis.

And some failures:

But for sleep disorders, weight gain in HIV infection, Tourette’s syndrome, and nausea due to chemotherapy, studies reporting improvements with cannabinoid use were considered to be of low quality.

An obvious need for more comprehensive studies.

So if the studies aren’t good enough, why is medical marijuana so widely used to treat certain diseases? The FDA actually requires a minimum of two randomized clinical trials of adequate quality before a drug can be approved for a specific medical condition, but it seems that many cannabis studies have slipped through the net. But as pointed out by anaccompanying editorial, this arguably reflects difficulties in conducting clinical studies on the drug due to its classification as a Schedule 1 drug.

It’s difficult to adequately study drugs that are illegal and use of them is prosecuted.

The take-home message from this review is therefore not that marijuana has no place in modern medicine, but that there is a clear need for more robust studies into its use, especially given the fact that more governments are now contemplating its legalization as a medicinal or recreational drug.

Shane responded to this on facebook:

Part of the issue is that public policy has outstripped the science due to restrictions in place. Many people are now well aware of its medical potential for things such as intractable epilepsy, Crohn’s disease, neuro degenerative conditions such as MS and MND, and my particular interest, chronic pain. The science is coming in to back up these conditions, but if we wait for 100% certainty of the science, people will needlessly suffer, Charlotte Figi would be dead without MC, of that we can be nearly certain, As well as as the countless chronic pain patients in the USA who have avoided overdosing on opiates with medical cannsbis as a safer alternative. A middle ground must be found to serve the public interest while those suffering wait impatiently for the science to catch up.

If there’s relatively low risk (especially compared to other drugs) and the chances of some benefits then more liberal controls make sense.

Dunne: find a doctor who is open to medicinal cannabis

Peter Dunne has been reported as effectively encouraging patients wanting to use medicinal cannabis to find a doctor who will consider this in their interest.

This is in Mum desperate for medicinal cannabis for her sick son:

Associate Minister of Health Peter Dunne has made it clear to GPs and the Medical Association that conservatism about using medicinal cannabis isn’t always in the best interests of their patients.

If a doctor wasn’t open to medicinal cannabis then families had the option of finding another doctor, he said.

“I’m not going to encourage or discourage that because it’s not my role, but it’s an option for them to consider.”

This looks like a carefully worded but significant statement from Dunne. This was in response to discussion about other parents wanting to try medical cannabis for their children because other drugs weren’t helping and follows the approval of the Ministry and Dunne to allow Alex Renton to be treated with Elixinol.

His family’s fight to get doctors to apply to the Ministry of Health has triggered another mother, Julie Dixon, to share her experiences battling for CBD for her son, Matthew.

The Christchurch 27-year-old has suffered from refractory epilepsy since he was aged 3 and has spent much of his life in and out of a hospital.

“We’re desperate,” Dixon said.

Matthew’s seizures are uncontrolled by medication and he too has spent time in hospital in an induced coma.

The Government allows oral treatment of a drug called Sativex, which contains cannabis extracts that include CBD and requires ministerial approval.

When Dunne approved Elixinol for Alex Renton it was the first time that particular product had been approved.

“The last time we visited the specialist we asked about Sativex and the doctor’s response was, why would you want to try that when it hasn’t been proven to work,” Dixon said.

“For us there is an absence of any other treatment options. We are regularly advised there is nothing left.”

Dixon said doctors have never discussed anything outside of conventional treatments with her and it was only when she started doing her own research she came across Sativex and Elixinol.

She and her husband, Kelvin, have written to Dunne asking for approval but without the support of Matthew’s doctor, Dunne is hamstrung by the procedure, which isn’t one he plans to change.

“At the end of the day cannabis oil is just another drug – no different from the powerful drugs being used to keep Alex comatose and the powerful drug that our son Matthew takes every day of his life, which does not control his seizures,” she said.

And Dunne seems to be following these cases and recognises the difficulties the families are having with treatments.

While Dunne said he had considerable sympathy for the families involved, “I’m not a clinician and I’m not in any position to override the clinical judgment.”

But he is open to broadening access to medicinal cannabis despite Prime Minister John Key saying he wouldn’t support a parliamentary debate on the matter.

“We are watching closely the trials that are being undertaken in Australia. Essentially if they prove to be effective we would obviously seek to take advantage of them in New Zealand.

“But the real issue beyond that is manufacturers being prepared to make those drugs available, in some cases they’re not interested because they don’t see the market as big enough.”

For it to go beyond a case by basis a manufacturer would have to apply for interim or general approval of use of their products here.

Perhaps the New Zealand market isn’t big enough – but if a manufacturer had their products approved in the New Zealand market and proved their worth here that would do a lot to help them establish wider markets.

Pressure on Dunne – another mother wanting medicinal cannabis

There is pressure on Peter Dunne with another mother applying pressure to be able to use medicinal cannabis to treat her 7 year old daughter.

The Rotorua Post (via NZH) reports: Hope for Zoe in cannabis oil

Zoe has neurodevelopmental disorder and refractory seizure disorder, due to her brain being deprived of oxygen during birth.

Mrs Jeffries said doctors had given her 24 hours to live but, seven years on, Zoe was still fighting. “It’s the ups and downs that make it hard. You can only live each day as it comes … As a family, we are extremely happy Mr Dunne has shown considerable compassion and approved the use of Elixinol for Alex (Renton).

“In regards to Zoe, she has had a list of seven pharmaceuticals to trial this year. There is one left to try and she still continues to have hundreds of seizures daily”.

Dunne has made it clear that approval for Alex didn’t set a precedent:

Mr Dunne stressed the use of Elixinol in Mr Renton’s situation wasn’t a precedent and shouldn’t be seen as a “significant change in policy”.

But that is contradicted.

Mr Dunne said doctors had been able to apply for medicinal cannabis products for many years but it was the first time that avenue had been used for that product.

More products are available now, and more testing is being done, and more anecdotal evidence is becoming available. And there’s quite a bit of research pending.

What Mrs Jeffries will need to do is apply to the Ministry for approval to use a product.

Ministry of Health advice was “50/50 saying that there’s no compelling evidence that this product will work. On the other hand there’s no compelling evidence it will do significant damage to him”.

She needs to show that there is reasonable evidence the product might work, and that there is no compelling evidence it will not do any damage to Zoe.

Ideally approval for the product in general can be obtained to save parents from going through procedures and more stress.

It will help if more doctors and specialists ask for these relatively safe products too.

Mrs Jeffries said UICNZ was working constructively with the Ministry of Health to change that. “We hope to be able to implement a methodical regime here in NZ. Ideally compassion for one can equate to compassion for all in need.”

” Zoe is my inspiration for becoming a trustee with United in Compassion NZ (UICNZ), a sister branch of the Australian organisation who worked with Rose Renton on Alex’s case. As a non-profit we are working towards the goal of medical cannabis in NZ, and doing so from an angle highlighting education, compassion and logic.”

UICNZ now has charity status and has set up a Givealittle page to raise funds. For more information visit unitedincompassion.org.nz/2015/06/13/united-in-compassion-is-officially-registered-and-seeking-donations/

Karen Jeffries is far from the only parent desperate for something that will effectively treat their child.

Australian medicinal cannabinoid research could benefit NZ

A $33 million dollar research grant towards medicinal cannabinoid research in Australia could have a successful spin-off for New Zealand if it proves successful.

New Zealand is unlikely to do much if any research on this so a major initiative in Australia is probably the best we will get to add to the currently limited knowledge base here.

News release:

Lambert donation puts Australia at forefront of medicinal cannabinoid research

A $33.7 million gift to the University of Sydney places Australia at the forefront of medicinal cannabinoid research.

“Our vision is to make Australia a world-leader in researching how to realise the powerful medicinal potential of the cannabis plant,” said Barry Lambert, who together with his wife Joy, has funded the Lambert Initiative.

“The experience of our granddaughter, who suffers debilitating epilepsy, has opened our eyes to the extraordinary possibility of cannabinoids treating not only her condition but a range of chronic illnesses that often don’t respond to conventional treatments.

“We believe this investment in the future of Australian science and medicine will provide the much-needed evidence to rapidly advance the use of medicinal cannabinoids in the treatment of childhood epilepsy and other serious illnesses.”

The donation is the largest gift ever made to research at the University of Sydney.

“The Lamberts’ unprecedented gift holds the promise of achieving innovative and effective new medicines to alleviate the suffering of countless numbers of people,” said Dr Michael Spence, Vice-Chancellor of the University of Sydney.

“It enables research across a broad range of applications from addiction, cancer, obesity, childhood epilepsy and chronic pain to dementia and mental health disorders. Their generosity recognises the University’s commitment to cross-disciplinary research that can achieve life-changing outcomes. It is our privilege and responsibility to respond.

“A world-first in the extent of its support for medicinal cannabis research, it places Australia in the front rank of countries, such as the Netherlands, the United States and Israel, leading the world in this new era of cannabinoid science.”

The Lambert Initiative funds a multi-year program to build on the University’s extensive clinical and scientific cannabinoid-related expertise to ultimately produce cannabinoid-based medicines.

NSW Premier Mike Baird has congratulated the University of Sydney on the significant initiative and applauded the generosity of the Lamberts.

“NSW is breaking new ground in terms of medical cannabis research and this major investment confirms our state’s leadership in this area,” Mr Baird said.

“The Lamberts’ investment gives our cause enormous momentum and my hope is it dramatically increases the cross-sector knowledge sharing required to ultimately produce cannabinoid-based medicines that are safe, reliable and affordable.

“I recently met with the lead investigators of the Lambert Initiative and am pleased that they are already embedded in our clinical trials.”

A priority of the Initiative will be to understand how cannabidiol (CBD) works to treat paediatric epilepsy and to explore the potential of the nine other cannabinoids, currently identified as of greatest therapeutic interest, to address the condition.

The strategy will go on to determine which of these cannabinoids hold the greatest promise in treating specific diseases and, using rigorous, high-quality evidence, move them towards human clinical trials.

From the start the Initiative will undertake medicinal chemistry to drive the creation of new highly targeted medications based on its emerging understanding of how cannabinoids treat disease. At the heart of the program will be sharing such knowledge with the public, government and medical professionals with both outreach and education.

The lead investigators of the Lambert Initiative, from the Faculty of Science and Sydney Medical School, with decades of cannabinoid research between them, are Professor Iain McGregor,Associate Professor Nicholas Lintzeris and Dr David  Allsop.

“We have all devoted our careers to cannabis science, one of the fastest moving frontiers in pharmacology. We now know there are more than 100 different compounds we call cannabinoids, many of which have incredible therapeutic properties that we are only beginning to understand,” said Professor Iain McGregor.

“The Lambert Initiative allows us to gather the key science researchers and clinicians from Australia and worldwide to work within, or in association with, the Lambert Initiative. Much of the research will happen on-site at the University of Sydney but it will also support and promote specialist researchers throughout Australia to encourage them to undertake collaborative cannabinoid-related research.

“We have also made a flying start by becoming embedded in the NSW government’s sponsored clinical trials of medicinal cannabis, offering our unique cannabinoid clinical trials expertise, including exploring its safety and effectiveness for treating paediatric epilepsy.”

Cannabis treatment concerns

Cannabis oil treatment has been approved for Alex Renton after having a severe seizure and a subsequent two month coma.

Cautious concerns have been expressed by experts about the cannabis product approved as it is virtually untested in this situation, and it has more of an industrial background than a medical background.

One expert says “this is uncharted territory”

The biggest concern is for Alex’swell being, and whether any cannabis oil treatment will help him. We have to hope.

It will have been an awful and very stressful time for Alex’s mother (and sister). Any mother in her position would be desperate for something to help her son. She has pushed hard for approval for alternate treatment, as nothing the hospital could do seems to have worked.

But what is going to be tried now has virtually been untested, and some concerns have been expressed about the particular product that has been chosen and approved. It’s a risk – but any new treatment would be a risk, and doing nothing would also be a major risk.

There’s been a post on this at the Science media Centre: Cannabidiol as a seizure treatment – Expert reaction where they ask:

Health authorities have approved the use of hemp derived medication Elixinol – on a one-off basis – to treat a coma patient suffering ongoing seizures. But does it work?

I don’t think anyone knows whether it will work.

The drug was approved on compassionate grounds by Associate Minister of Health Hon Peter Dunne, to be administered by clinicians treating Wellington patient Alex Renton.

The Minister said that  “despite the absence of clinical evidence supporting the efficacy of CBD in patients with Mr Renton’s condition status epilepticus, my decision relies on the dire circumstances and extreme severity of Mr Renton’s individual case”.

The Science Media Centre contacted New Zealand experts for comment.

There is a lot of interest in what is happening with Alex and whether cannabis products will help or not.

Dr John Ashton, Senior Lecturer, Department of Pharmacology and Toxicology, University of Otago, comments:

“There is some evidence that enriched CBD oil may help reduce seizures in specific kinds of hard-to-treat childhood epilepsy, but much of this evidence is anecdotal, and relies on parental reports. Controlled experiments have yet to be completed, though one product “Epidiolex” which is 98% CBD and produced by GWPharmaceuticals (who also make Sativex) is showing promising interim results in an ongoing experiment.

“However, there is no evidence that CBD can treat status epilepticus nor encephalitis, so this is uncharted territory. Also, the product Elixinol is an industrial hemp oil product, not from medicinal cannabis; hemp and medicinal cannabis are distinct variants of the same species. Elixinol only has 18-19% CBD, and contains a range of other compounds, and has not been tested in any kind of seizures under controlled conditions.”

So there is no evidence that the product, Elixinol, has had any beneficial effect for the type of seizure Alex has had. A significantly different product, Epidiolex, “is showing promising interim results in an ongoing experiment”.

Assoc Prof Michelle Glass, Head – Department of Pharmacology, University of Auckland, comments:

“The reports that we have seen in the media today strongly imply that the government has approved cannabis for the treatment of Alex Renton, it is important that people recognise that this is not the case.  What has been approved is oil made from industrial hemp, which is not marijuana, it is not a drug that will make the user experience any of the “high” generally associated with cannabis based products.  Instead, these are plants with a very high fibre content and a negligible THC content (less than 0.2%).  THC is the component of cannabis that generates a high.

“The use of high cannabidiol (CBD)  strains of cannabis or hemp have recently garnered a lot of public attention, particularly in pediatric seizure disorders such as Dravets syndrome, where there have been some dramatic results in individual patients (see the media coverage around Charlottes Web).  The strength of these individual results was such that the FDA awarded a pharmaceutical preparation of CBD – Epidiolex (from GW pharmaceuticals) orphan drug status, helping to drive the progress of clinical testing.

“These larger scale clinical trials are currently underway, and early reporting of the initial results looks very promising, with good seizure control being achieved and the drug being well tolerated, but it’s important to note that these are still in quite low numbers of patients (around 150) and a limited number of seizure disorders, meaning it is difficult to generalise at this stage.

“The compound that has been approved for Alex Renton is not Epidiolex which is a pure 98% CBD oil – but Elixinol, this is reported on the manufacturers web site to be 18% CBD hemp oil, which to the best of my knowledge has never been tested in clinical trials – however, there are some anecdotal reports of similar products proving useful in seizure disorders.  There is even a suggestion from animal studies that less pure products with a range of plant based cannabinoids in them might be preferable to a highly pure product.

“This is really a tragic case, and given that this is a compound which appears to be well tolerated, it is certainly worth a try, we can only hope in the future that there will be stronger clinical evidence as to what composition and dose of medicine is most likely to succeed.”

So the use of CBD for Alex looks like a bit of a medical punt.

And the particular product approved is also a punt.

As nothing else has worked for Alex then trying anything is probably better than nothing, as long as the risks are relatively low and that would seem to be the case here.

If Elixinol works and Alex’s condition improves that would be great, but there will be no way of knowing whether it was the best product to use or not. A different cannabinoid may have had more or less effect. There’s little way of knowing.

Epidiolexis mentioned above.

If there is no improvement then it will leave many questions unanswered. It wouldn’t prove that Elixinol was ineffective in general as it’s possible Alex’s condition is simply untreatable. And it wouldn’t prove that cannabinoids wouldn’t help Alex.

If Elixinol has no effect on Alex, or has little effect, then perhaps an alternative like Epidiolex could be tried to see if it is more effective for him.

Another product that’s been suggested is from StateWide Dosed Medicines.

This all seems like hit or miss experimentation, and that’s pretty much what it is. Nothing else has worked for Alex so there seems little to lose – CBD could have an adverse effect but so could any other treatment.

It seems to be a risk worth taking – if Alex was my son I’d want to try anything that gave me hope of success.

I hope that the medical advice behind the decision to try Elixinol is sound – there are criticisms of this product online.

And I hope Alex gets better. It would be a major for him and his family, obviously. It would also be significant in the use of CBD as a treatment for seizures.

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