Hard News by Russell Brown

Public Address Word of the Year 2021: The Vote!

Welcome to to the voting stage of the Public Address Word of the Year 2021. Over the past week's korero phase, readers have been discussing and proposing words and phrases to sum up the year. I've made up a long list of  nominations and you can vote for those by clicking ...

HERE to go to the voting form.

As ever, you're asked to rank your top three choices. Do be sure to scroll down all the way before making your choices – the list is quite long.

There are prizes for playing. One prize will go to someone drawn at random  from everyone who votes. The other will be drawn from the readers who proposed each of the top 10 words in the vote.

And they're pretty good prizes!

I'm pleased and grateful that the good people at Nura are back again with the niceness (it's us and the All Blacks, really). They've given me two pairs of this year's NuraTrue wireless earbuds, which I think are their best product yet. (Not just me, to be fair: here's the five-star review from TechRadar and the 9/10 from Tech Advisor.)

I'm also delighted to welcome aboard my favourite little craft brewery North End Brewing of Waikanae, who make beer with love, enterprise and and originality. The law these days prevents us giving away alcohol as prizes, but you can be assured that by making me and our Chief Voting Form Officer Hadyn Green just a little little happier, North End is very much helping this thing get to air.


Public Address Word of the Year 2021: Discussion and nomination

It's that time again! Time to find the word or phrase that conjures, captures or sums up 2021. What'll it be? Last year's Public Address Word of the Year winner, "doomscrolling", made it all the way to The Guardian but is hardly heard now.

This is how it works: you, the readers, nominate words in this discussion. After two or three days of the korero, I’ll cull the nominations into a long list for the public vote.

As ever, there will be one prize drawn at random from everyone who votes. The other prize is for the people who nominate words and phrases in in this discussion. I'll draw the nomination prize from the top 10 words in the final vote, so you’ll have a chance to win even if you’re not in in the first few minutes of nominating.

I'm keeping the changes I made last year to the korero phase of Word of the Year: you’ll only be able to nominate one word per post. And three in total.

I'm pleased and grateful that the good people at Nura are back again with the prize niceness (it's us and the All Blacks, really). They've given me two pairs of this year's NuraTrue wireless earbuds, which I think are their best product yet. (Not just me, to be fair: here's the five-star review from TechRadar and the 9/10 from Tech Advisor.)

I'm also delighted to welcome aboard my favourite little craft brewery North End Brewing of Waikanae, who make beer with love, enterprise and and originality. The law these days prevents us giving away alcohol as prizes, but you can be assured that by making me and our Chief Voting Form Officer Hadyn Green just a little little happier, North End is very much helping this thing get to air.


More tales from the Medicinal Cannabis Scheme

You may have read last week that two years after the publication of regulations for medicinal cannabis – and three years after the enabling legislation – two local products from a local manufacturer have finally met the minimum quality standards for prescription. You may also be interested to know that it's not quite that simple.

The two products, both CBD oils and both from Auckland-based Helius Therapeutics, are indeed listed on the Medicinal Cannabis Agency website under the SubDrops brand. But their Active Pharmaceutical Ingredient (API) – the cannabidiol itself – is not produced in New Zealand, but imported as isolate from the Netherlands. The isolate powder is formulated – mixed with a carrier oil – at Helius's facility in East Tamaki.

It took some asking around to establish that, but not really because Helius is withholding the information. The rules around advertising of unapproved medicines are so strictly applied that Helius is not allowed to even put out a press release saying it has the products for sale, let alone provide background detail on them. (It did put a little announcement on its website.)

But the timing of the launch is extremely good news for cannabis patients, many of whom were facing sharply higher costs for prescribed CBD medicines after the twice-extended transitional period of the Medicinal Cannabis Scheme ended on October 1, meaning that imported products that had not met the minimum quality standards could no longer be prescribed. It's also a crucial face-saver for the Ministry of Health and Health minister Andrew Little, who are finally able to to point to a local company that has found a way through the regulatory thicket.

The pricing implications are significant. The Helius 100mg product is wholesaling for $115 for a 30ml bottle, meaning that patients should be able to get it for as little $160 from a pharmacy. The comparable product from the Canadian company Tilray is wholesaling for $377 for a 40ml bottle – and selling to patients for $500 or even $600 after pharmacy markup. (I want to emphasise that I did not get this information from Helius and they would be in trouble if I had.)

This is good for Helius too – it's got them into the market at a time when thousands of patients have been cut off from products imported by companies like Medleaf and Nubu and are anxiously looking around for options. But Helius isn't making much money out of this pricing – possibly none at all.

Helius apparently expects to swap out its imported API for a locally-produced one next year and launch a wider range of products, once it can get something past the quality standards. But producing GMP-grade CBD isn't cheap. Helius has a great show at grabbing market share right now – how long it can sustain this kind of pricing isn't clear.

Like Rua Bioscience, the only other local company to have achieved a GMP licence, Helius will be relying on the European export market to stay viable in 2022. Things may get tough for the other New Zealand producers established under the law if they can't get their GMP licences soon.


Meanwhile, minister Little made a weirdly unhelful contribution to the debate after the transitional period ended by telling the Herald's Derek Cheng that the industry, or "some at least importers who frankly didn't get off their asses and get their applications in when they should have done."

This is unfair bordering on actionable. I know that Medleaf at least has tried repeatedly to get products through the standards, and that when its application for one producer failed because its EU GMP licence wasn't recognised by our ministry, it offered to pay for a remote audit with a telepresence robot. The ministry said no. Medleaf has also repeatedly sought a meeting with Little to discuss its issues. The minister's office said no.

This all wound up in a fairly spectacular radio segment where the minister insisted that our regulations were no different those of countries like Germany. He was followed on air by Medleaf's Shane Le Brun, who explained various ways in which products accepted by Germany have been rejected here.  Short version: New Zealand's regulators have taken the most maximal and least pragmatic path available to them at every step.

The regulations have been eased in a couple of ways recently, most notably in that local producers will no longer be required to do their product testing at GMP labs that literally don't exist in New Zealand. Turns out, ISO-accredited labs are fine. But a broader regulatory review has stalled and won't report until next year.

Little also said in the radio interview that individual prescribers would still be able to import the now-banned CBD products as unapproved medicines for individual patients under Section 25 of the Medicines Act (anything containing THC needs case-by-case ministry approval). Then Medsafe's Chris James went to the press to warn that this right should be used only "sparingly" and bulk imports would be investigated. It's just a bit of a mess.

But that's what's happening. One clinic is using Section 25 to prescribe its own-brand CBD products. Medleaf has also set up an offshore company to supply prescribers under Section 25.

Medleaf's CBD product will be broad-spectrum, which means it contains other compounds, such as terpenes and very low levels of other cannabinoids. Some patients and prescribers regard broad-spectrum products as important for their needs, so there's probably a battle looming over that. The MCS effectively doesn't recognise any role for terpenes or differences between strains, so it's not just a matter of interchangeable isolates.


The differences between the establishement approach to prescribing cannabis and the broader understanding of cannabis therapeutics are also evident in the long-awaited BPAC guidelines for prescribing cannabis, which are currently up for feedback.

The advice suggests chronic pain, spasticity and childhood epilepsy (CBD only) as primary indications, but warns that "in the absence of large and robust RCTs comparing medicinal cannabis with established treatments, medicinal cannabis products cannot currently be considered a first- line option for any indication." For neuropathic pain, it recommends that at least three other medications should have been tried before cannabis is prescribed and for malignant pain, two others.

Notably absent is any consideration of how patients might feel: as I've written recently, some pain patients simply find prescription opioids and gabapentinoids, which can be freely prescribed, unbearable and feel strongly that cannabis has helped them reclaim their lives. Dr Graham Gulbransen calls prescription cannabis an "exit drug" for that reason.

Yet the BPAC advice declares there is "no evidence that adjunctive use of medicinal cannabis reduces the use of opioids in patients with chronic non-malignant pain", citing a large four-year observational study that did indeed find "no evidence that cannabis use improved patient outcomes." But that study was included in a more recent evidence review that did find quite plentiful evidence of opioid use reduction with cannabis in qualifying studies, but failed it on some familiar basics of evidence quality: not least, what is a dose of cannabis anyway? See also: exactly which cannabis are we talking about?

 The emphasis on clinical trial evidence is inevitable – and it does turn up something interesting. A graphic in the draft advice compares the efficacy of several treatments. For all the problems with funding and conducting high-quality cannabis research, gabapentin and pregabalin actually wash up only slightly better than cannabis does.

There's a kind of cultural gap here too. Anyone who has used cannabis understands that different strains do different things and it's reasonably well established that the respective effects of, say, cannabis sativa and cannabis indica strains are related to their respective terpene profiles, which are thught to modulate the effects of cannabinoids. But the advice to prescribers covers just two isolated molecues, CBD and THC. No other cannabinoids are mentioned, nor terpenes. The gulf between cannabis science and the clinical world still seems hard to bridge.

So it's a baseline for wary GPs, one with a creditable emphasis on conversations with patients and jointly-agreed treatment plans. But I suspect regular prescribers will look more to next year's Helius-sponsored MedCann summit, which will have a prescriber day. Helius is also a sponsor of the mcinfo.com site published by DataPharm, which provides a somewhat gentler introduction for prescribers and their patients.


Finally, I'm aware that the regulatory battles tend to drown out any good news stories the fledgling industry might generate. So let's focus on a really good news story.

Growing Dope, Wednesdays on Prime TV, tells the story of Rua Bioscience over four years (beginning as Hikurangi Enterprises) with warmth and authenticity. It's striking to grasp how much hope rides on this company and it only increased my respect for Manu Caddie and Panapa Ehau to see how patiently they've worked towards their kaupapa.

You can watch it on your TV and online if you have Neon. Or you can go to SkyGo and sign up for a free account and watch it there. I heartily recommend you do.

PS: Thanks so much to everyone who clicked the support button below the last cannabis issues post and kicked in a little via PressPatron. This stuff is important, but there's a limit to how much I can get in mainstream publications.


Pearl, prescriptions and patient experts

As I've noted here before, for various reasons, the clinical evidence for cannabis as a teatment for pain and other conditions is not yet compelling. This doesn't mean it won't be, but as the International Association for the Study of Pain put it in a recent position statement, "promising" advances in the science of cannabis as a therapeutic "are yet to be fully translated to efficacious and safe medicines."

"High-quality research is required to elucidate the types of pain, and characteristics of individuals, where there is benefit or harm from particular cannabinoid compounds (personalised medicine). Improved understanding of the clinical pharmacology of cannabis and cannabinoids in a pain relief setting is needed," the association's taskforce concluded.

But as I point out in a story for the Listener this week, there's another way of looking at it: observational studies. These can't prove or disprove any cannabis product as a treatment. But the large patient surveys conducted by Otago and Massey universities in the past couple of years do point to quite a consistent outcome: a substantial group of patients who use cannabis are able to give up or reduce their use of onerous prescription medicines – typically opioids and gabapentinoids – and their lives improve as a result.For the Listener story I also noted two recent Canadian studies that showed the same thing.

And I spoke to three pain patients, one who was using an illicit cannabis balm and two who had more or less found a way through the troubled medicinal cannabis scheme. At least one had been recklessly prescribed to, two had been flagged as drug-seekers for merely enquiring about prescription cannabis, and two had found life on their prescribed pain medications so unbearable that they considered suicide.

I also mentioned Pearl Schomburg, who is the first person I heard this kind of story from. For Pearl, the tipping point was seeing her reflection in a chemist shop window with two full shopping bags of medications for her auto-immune conditions and the pain they caused. She could not, she realised, go on living like this.

Pearl became a patient advocate and medicinal cannabis activist. I couldn't fit most of what we talked about in a recent interview into the Listener story but it warrants airing.

Pearl continues to go through surgeries related to her condition, as her joints erode and need rebuilding. She manages her post-operative recovery with cannabis products from her green fairy, Gandalf, and says she recovers more quickly and without the side-effects (including vomiting) she used to suffer from post-op pain medication.

Until now, she has taken in her products into hospital and used them unobtrusively, but she realised that for her most recent surgery, that wouldn't work.

"This was a hand surgery – and I knew it would be much more difficult for me to manage to do this on my own, which is what I've had in the past. It's a nightmare, you know, fumbling around, trying to get your little bottles and balms, terrified that somebody was going to walk in."

So she fronted it.

"The first appointment was with the anaesthetist and I just said to him, look, you know, this is what I did last time and my response was phenomenal. They kicked me out of rehab in the first week because I had already reached the levels that they required at the end of the six weeks. I didn't have to use any of the medications at all for pain relief.

"I told all this to the anaesthetist and he said that he would be supportive of me doing that on the ward. And he said, if you just wait here, I'll go up and I'll speak to the head of the nursing on that ward and and I'll come back and talk to you. He came back and he said that the nurse was going to come down and talk to me.

"So the anaesthetist, myself and the head of the nursing staff of that ward sat in his office and spoke about what that looked like. And I just said, I use oils and drops under my tongue. I might bring a couple of them and I would do it, depending how I am, something like every two to four hours initially, then easing off over time."

Pearl's surgeon wasn't opposed, so the plan went ahead.

"I was really pleased that there wasn't a policeman waiting for me and there was a nurse waiting! The first nurse that came on when I got back to my ward introduced herself and she did a few of the machine things. Then she said, is there anything else I can help you with?

"And I said, yes, there is. You probably know that I'm a medicinal cannabis patient and I've got my own products to use. Her face lit up in this big grin and she said, 'I was so pleased to get you to nurse on my shift, I really love what you're doing, you know? I think it's really important'.

"So I asked her to get the bag out and I had three oils, all indicas of varying THC strength, and a balm. And each time the nurse helped me, I would ask for a specific one and I'd talk about why I chose that strain, what its ratios were and what I expected out of it. And I did that for every nurse or person that helped me.

"There was one nurse on the ward who I could tell was a little concerned, but part of my talk with the staff was about my belief that this is part of patient safety and harm minimisation and not only for me, but for them. They want to know what patients are using and patients need to feel supported in that environment. And it's better to be open and honest about these things.

"Just before I left the ward at the end of my stay there, the nurse who was very nervous came back to me and she said, 'I really want to thank you for helping me understand this. I have to admit I was really worried at the beginning, but I really appreciate the way you were concerned about my safety as well. And I've learnt a lot, and I really appreciate that'."

This doesn't mean that doctors at Auckland District Health Board are going to routinely prescribe cannabis products for post-op recovery, or even that they should. The products don't really exist in the system anyway. But having Pearl come in and be able to talk about what she was using, when and in what dose, will have been enormously helpful.

Doctors are understandably wary of using medicines they don't know how to dose. People like Pearl (and Gareth Duff and Dan Salter, whose stories I tell in the Listener feature) are not doctors, but they have become, at the least, experts in what works for them

There may also be, as the IASP position statement suggests, a yet-to-be-understood dimension of personalised medicine here – different things work for different people. But Pearl modelling the thoughtful use of green fairy products isn't a bad thing for medical professionals to be able to see and take notes on.

One day, the system, however it looks, will work a lot better than it does now, but until then, it's wrong to criminalise or increase harm to people who are doing the right thing for themselves.

You may be asking: isn't any hospital knowingly allowing the use of Class B controlled drugs putting itself in legal peril? Not in this case.

Pearl was among stakeholders interviewed as part of a review of the statutory defence provided under the medicinal cannabis legalisation. That allows a patient with a doctor's letter saying they are in palliative care to possess and use cannabis. A Supplementary Order Paper late in the process removed the requirement that the patient must be six months from death. The amended Section 4 of the Misuse of Drugs Act requires only that "in the opinion of a medical practitioner or nurse practitioner, the person has an advanced progressive life-limiting condition and is nearing the end of their life."

Pearl says she was told by her interviewer for the review, "your rheumatoid arthritis, which can never be cured, it's only ever going to be managed, that would be one of the many conditions that which would come under that palliation exemption."

The system may have been more compassionate than it meant to here, but Pearl has a letter from her doctor based on this template.

Dr Graham Gulbransen has frequently used the template in presentation and told me he originally sourced it from a page on the Ministry of Health website. I couldn't find it there, so it may have been removed.

Anyway, I've just received a response to my Official Information Act request for advice and communications around the decision not to further extend the transitional period under the Medicinal Cannabis Scheme – you can read my deep dive about that here on Matters of Substance – so I'll be back next week with some thoughts about that.

In the meantime, if you felt able to chip in a little via the supporter link below this post, I'd be very grateful. I tend to do a lot more work on this topic than I can find a paying home for ...


Testing the fairies

A new paper by ESR scientists, published in the Australian Journal of Chemistry, has confirmed what close observers of the local cannabis community already knew, or at least suspected: the cannabinoid contents of local "green fairy" products vary widely, ratios in many products are not as claimed – and most products claiming to be high in CBD are not.

But, short of real regulation, a solution is in the wings – via the drug-checking law currently making its way through Parliament.

In 2019, the ESR scientists collected and tested a hundred green fairy products, most of them passed on via the Auckland patient advocate Pearl Schomburg. They included cannabis flower, FECO (fully extracted cannabis oil), carrier oil preparations, balms, tinctures and even vape liquids.

The results in this subsequent paper, Medicinal Cannabis – The Green Fairy Phenomenon, are not entirely news: ESR Forensic toxicology and pharmaceuticals manager Mary Jane McCarthy, who led the project, warned in February 2019 about a "product administered to an epileptic child, which "should have been high CBD and low THC – in fact it was the opposite. I would be very worried about a child taking a product like that." She presented the testing results last November at the inaugural MedCan Summit in Auckland – and said that the testing ended because its funding ran out.

I noted at the time that there was "a compelling harm reduction rationale for continuing to test these products and sharing the results." It now seems likely that will happen, via the Drug and Substance Checking Legislation Bill (No 2), which replaces the temporary legislation introduced to allow drug-checking at events last summer and is now at select committee. Like the temporary version, the bill aims to "try to minimise drug and substance harm by allowing drug and substance checking services to operate legally in New Zealand."

I have spoken to the Auckland businessman who has spent $50,000 on cannabis analysis equipment to do just that in the cannabis market. It would be fair to describe him as mild-mannered. He prefers to be known simply as "Tester Guy" (we'll call hm TG) until he secures a licence under the new law (currently, the only organisation licensed to carry out testing is Know Your Stuff) but he has already had discussions with Ministry of Health officials.

"We've been working with them so they know what the processes are to check a product," says TG. "They're writing the legislation, so they need to see what the processes are. But they did say, if you are currently testing illegal flower, stop instantly. That was detailed to me quite abruptly."

It's very likely that ministry officials won't be taking any new licence applications until the permanent law is enacted and accompanying regulations are written, but you can expect to see applications to test for safety outside the purview of Know Your Stuff, including for meth, opioids and potentially synthetic cannabinoid products, where dosage is literally a matter of life or death. Peer relationships are crucial to this form of harm reduction, so it makes sense for testing to be done within the respective user communities.

For TG, this new project is a matter of reaching out to help the community that helped a family member.

"My wife's mother has terrible migraine headaches. She's been on mainstream medicines for a long long time, with awful side-effects – and then taking another pill to offset the side-effects from the first one. It wasn't doing her any good at all.  She's been to every possible facility in the greater Auckland area to try and sort the migraines out, for years. Then she happened across cannabinoids and started to try some of the different [green fairy] products. She's off all mainstream medicines now, completely."

Talking to members of the cannabis community he discovered there was a problem with simply knowing what was in each batch. Patient advocates have been asking for safe access to product testing for at least five years, but for so long as the products have been illegal, that has not been possible.

"I thought, hey, what can we work out? What's in these amazing medicines and flowers? That led me to spend six months investigating the instruments worldwide. I put together a 50-page report on the different instruments available and narrowed it down to the one I purchased."

The equipment, from a North American company, can already provide detailed assays of cannabinoid contents, but TG plans to expand that capability.

"One of the major decision factors with the instrument I've brought in is that it's future-proof. We're working on methods and standards for detecting toxins, including the main pesticides. We're working on 11 terpenes at the moment. You need a gas chromatography instrument for the terpenes, while the best way of testing for cannabinoids is an HPLC instrument, which I have."

One area where TG's service could help curb a real health risk is in plant growth regulators, or PGRs. These are prohibited for use in food crops, but are readily available in grow shops, as "bud hardeners" and the like. They make plants appear more productive, but often at the expense of cannabinoid levels – and they're associated with organ damage and elevated cancer risk in humans.

"That's coming," says TG. "PGRs are so cheap and they're heavily promoted. Buy the 10 different bottles for $400 and that's all you need. All the amateur growers think it's brilliant."

These are all things organisations like ESR could do, but don't have the workflow for. The same is doubly true for Know Your Stuff, which has been turning away people who want to check plant matter almost since it began testing. TG sees his plans as complementary to what Know Your Stuff does.

"I want to help out the green fairies, so they're sure about what they're administering, and the growers to know what they're actually growing before they put it into their tinctures and oils. We want to go right back to the coalface of growing."

The government is unlikely to stand in the way. Health minister Andrew Little, who has been under fire for perceived inaction on medicinal cannabis, told the recent Parliamentary drug symposium that harm reduction via drug-checking would not be limited to festivals, but should be available through the community.

This kind of community testing falls short of the GMP standard decreed under our embattled medicinal cannabis scheme – which is so high that no New Zealand company has yet been able to get a product past the ministry's "minimum quality standard" and only four products, all from the Canadian company Tilray, have passed. But the gulf between no testing at all for quality and contents and our high official bar is very, very wide. There are perhaps 3000-4000 New Zealand patents being prescribed cannabis products (although many of them will be receiving CBD products allowed under the current transitional regime but not meeting the minimum quality standard). The number using illicit cannabis therapeutically is likely 10 or 15 times greater.

The ESR paper acknowledges "frustration at the restrictions to access prescribed cannabinoids in New Zealand" as a key reason for the growth of "a black market of home-made cannabis-based products for medicinal use", but it also seems that public attitudes towards these products have changed in the past couple of years and they are being used in some cases by people who would not have countenanced cannabis previously.

It also notes that product consistency is easier to achieve through a conventional pharmacological process of isolating individual cannabinoids, typically THC and CBD, than in whole-plant extracts, but that this may mean "the loss of potential benefits of the many other cannabinoids and terpenes in the cannabis plant (the entourage effect)."

There's also the simple fact that the transition from a high-THC recreational market established over decades to one where different attributes are sought from cannabis just isn't easy. It can be challenging to grow for CBD levels, let alone for potentially useful minor cannabinoids, especially when the growers are flying blind and can't test what they produce. This doesn't necessarily mean the products are inactive (although a small number seemed to be), but it makes consistent dosing difficult for people who need it.

The paper makes the point that even where CBD was present in the green fairy products, it was often at a level less than that thought to be a therapeutically useful dose (which is typically greater than that for THC). Reliably high levels of CBD are still largely the preserve of imported products, whether they meet the minimum quality standard or not.

It's also worth observing that nearly all the samples which closely matched their claimed contents came from one producer: the Northland green fairy Gandalf. Global investors are already sniffing around New Zealand genetics and our medicinal cannabis law allows New Zealand companies to bring in  illegally-developed strains. This would seem to be an area to watch.