Hard News by Russell Brown
7

ASA: Let's not talk about this

Last week, major newspapers carried a full-page ad as part of the campaign for a "No" vote to the referendum question about supporting the Cannabis Legalisation and Control Bill. The ad was authorised by the SAM NZ Coalition, which takes its name from a controversial American anti-cannabis group and includes members of two Scientology front organisations.

I took a photo of the ad in the Herald that morning.

It would be fair to say I was furious about it – my immediate reaction on social media included the words "lying liars". I wasn't alone.

The most obviously misleading elements of the ad are:

- The signs. These would never be permitted under Section 157 of the Cannabis Legalisaton and Control Bill, which prohibits advertising both generally and specifically, including any notice or sign "outside of the place of business of a person who offers cannabis products for sale". A retailer who breached the advertising ban would be fined up to $240,000. The advertising ban has been fundamental to the proposed reform since the original Cabinet paper.

– Under Section 159, a licence-holder would be allowed to display the name of the business outside, but not "any word or expression signifying that any cannabis product is available in that place for purchase" or "the trade mark of a cannabis product or the company name of a cannabis product processor". The name of the retail business itself would also be subject to regulations on "unsuitable names".

– Licensed cannabis retail outlets would not be "everywhere, like dairies". The bill requires the new Cannabis Regulatory Authority to take into account the proximity of "kindergartens, early childhood centres, schools, tertiary institutions, places of worship, parks, sports facilities, swimming pools, playgrounds, and other community facilities" in drawing up local licensing plans, and to further consult with local residents and businesses and consider "whether the amenity and good order of the territory would be likely to be reduced" by the presence of a licensed premises. Practically speaking, there would not be licensed premises with open doors raced past by kids on bikes and scooters.

– The more-than-400 cannabis outlets comes from an estimate by the economic consultancy BERL in its speculation of a likely regulated market, and relates to the least restricted licensing option – albeit the one BERL favoured as offering the best prospect of supplanting the existing criminal market. (The actual figure is 420, so someone was perhaps having a quiet joke.) But there are ten times that many dairies and convenience stores, so licensed outlets will not be "everywhere like dairies" in that respect either. Or, for that matter, like liquor outlets– there are at least 14,000 of those.

So the depiction of a dairy – which is a manipulated image of a real-life dairy whose local customers aren't happpy about its use – is wholly misleading. But there are other, more subtly misleading elements to the ad. The claim about "drug usage increasing by almost 30%"  relates to the other BERL paper, which does not predict a sustained increase in cannabis consumption. The figure equates to BERL's guess of an initial "short-term spike" as people try out the novel experience of buying cannabis legally, and what effect that might have on the Regulatory Authority's cap on annual cannabis production:

While consumption will drop back down to a long-term average, the legal cannabis market will need to be able to supply this short-term spike, or risk allowing the illegal cannabis market to maintain a sizable share of the market.

But that could be argued, and the 30-odd complainants to the Advertising Standards Authority regarding the ad presumably looked forward to just such an argument. As it turns out, the argument will not be had.

In an extraordinary decision, ASA chair Raewyn Anderson has blocked the complaints from reaching the ASA's Complaints Board, on the basis that there are "no grounds to proceed". It appears the advertiser was not asked to respond to any of the complaints, so that response will not be relayed to complainants, as might usualy happen. Instead, Anderson has chosen to devise a defence on her own (it's a more able one than the Say Nope to Dope spokesman was able to summon himself when challenged).

The defence on the signage issue effectively amounts to "what do words mean anyway?".

The Chair said the scenario depicted in the advertisement is a subjective interpretation of what a possible future could look like if the Cannabis Legalisation and Control Bill becomes law, and therefore comes under the category of opinion.

The Chair noted that while certain provisions are currently in the Bill, many changes could potentially be made during the Select Committee process, and it is not possible to predict with any accuracy what the final outcome might be. The Chair noted that while the signage on the shop in the advertisement might not comply with the provisions in the Bill, it assisted with conveying the Advertiser’s view of what cannabis retail outlets may look like and how the New Zealand way of life might change if the Bill is passed.

The bill might well be amended in the legislative process, although as constitutional law professor Andrew Geddis has observed, the moral imperative to pass it essentially as voted on would be considerable. But to declare that it is "not possible to predict with any accuracy" whether a central facet of the bill, the advertising ban, becomes law is a hell of a call to make.

And apart from anything else, this is the bill we're voting on. If we can't discuss its text as meaningful, to use it as a point of reference, what's the point of a discussion? By the logic of this decision, SAM NZ could depict 14 year-olds lining up to buy weed at the school tuck shop as its "interpretation" of what could happen if the "Yes" vote carried. 

On the "short-term spike" issue, Anderson acknowledges that the ad presents a 30% increase in consumption without noting that on the same basis as it expects the spike (the experience of other jurisdictions) and in the very next sentence, BERL expects a fall to the long-term average. But:

The Chair said while the Advertiser has chosen to refer to the first statement from this quote, and not the second, this is allowable in the context of advocacy advertising.

Hmmm. 

Anderson also addresses the presence of children in the ad, and observes that premises would be strictly R20:

The Chair said that if cannabis is available for purchase at shops children will be able to walk, scooter and bike past these shops, as shown in the advertisement, and this is not misleading.

There is at least a significant discussion to be had about whether these licensed outlets would actually even look like shops "as shown in the advertisement", given that shopfronts would be effectively banned.

Anderson responds to complaints that the ad was "scaremongering, sensationalist and exaggerated", by writing that:

... while the advertisement did have shock value, which is likely to have been deliberate, it did not reach the threshold to cause serious or widespread offence or cause fear without justification. The Advertiser is using provocative imagery to draw attention to the debate about an important social issue.

Is the advertiser really "drawing attention to the debate", or simply misrepresenting what's being debated? It seems notable that Anderson hasn't included even a cautionary word for referendum advertisers to be mindful of the facts. It's all just fine.

If the complaints board, with its representatives from the public and from the advertising industry, had been given the opportunity to discuss the complaints and declined to uphold them, that would have been something. Complainants and commentators would have grumbled and perhaps opted to take the decision to the review board. But there was no discussion permitted.

It's proper and a matter of practicality that the Chair should have the power to weed out complaints in this way – otherwise the board would be bogged down in trivia.

But this isn't trivia. Misinformation about cannabis reform is clearly as much part of the debate as the bill itself. Last November, Justice minister Andrew Little expressed concern about a likely barrage of misinformation about the referendum, appealed to the public to call it out and specifically underlined the role of the Advertising Standards Authority. The complaints board chair's decision that the board should not even discuss it seems extraordinary, the more so when you look at many of the complaints to board has been allowed to discuss.

In a way, this does speak to the different purposes and philosophies of the the "Yes" and "No" campaigns. The "Yes" people – and I am one – are generally, sometimes painfully, focused on making a good-faith evidential case for reform. Say Nope to Dope/SAM-NZ's role is to raise fear, uncertainty and doubt about that reform.

This isn't necessarily the end of the road – the ASA has a separately-constituted appeals board – but having been dismissed in this way, the complainants may simply lose faith in the authority. The advertisers in this case will doubtless be considerably emboldened.

7

ASA: Let's not talk about this

Last week, major newspapers carried a full-page ad as part of the campaign for a "No" vote to the referendum question about supporting the Cannabis Legalisation and Control Bill. The ad was authorised by the SAM NZ Coalition, which takes its name from a controversial American anti-cannabis group and includes members of two Scientology front organisations.

I took a photo of the ad in the Herald that morning.

It would be fair to say I was furious about it – my immediate reaction on social media included the words "lying liars". I wasn't alone.

The most obviously misleading elements of the ad are:

- The signs. These would never be permitted under Section 157 of the Cannabis Legalisaton and Control Bill, which prohibits advertising both generally and specifically, including any notice or sign "outside of the place of business of a person who offers cannabis products for sale". A retailer who breached the advertising ban would be fined up to $240,000. The advertising ban has been fundamental to the proposed reform since the original Cabinet paper.

– Under Section 159, a licence-holder would be allowed to display the name of the business outside, but not "any word or expression signifying that any cannabis product is available in that place for purchase" or "the trade mark of a cannabis product or the company name of a cannabis product processor". The name of the retail business itself would also be subject to regulations on "unsuitable names".

– Licensed cannabis retail outlets would not be "everywhere, like dairies". The bill requires the new Cannabis Regulatory Authority to take into account the proximity of "kindergartens, early childhood centres, schools, tertiary institutions, places of worship, parks, sports facilities, swimming pools, playgrounds, and other community facilities" in drawing up local licensing plans, and to further consult with local residents and businesses and consider "whether the amenity and good order of the territory would be likely to be reduced" by the presence of a licensed premises. Practically speaking, there would not be licensed premises with open doors raced past by kids on bikes and scooters.

– The more-than-400 cannabis outlets comes from an estimate by the economic consultancy BERL in its speculation of a likely regulated market, and relates to the least restricted licensing option – albeit the one BERL favoured as offering the best prospect of supplanting the existing criminal market. (The actual figure is 420, so someone was perhaps having a quiet joke.) But there are ten times that many dairies and convenience stores, so licensed outlets will not be "everywhere like dairies" in that respect either. Or, for that matter, like liquor outlets– there are at least 14,000 of those.

So the depiction of a dairy – which is a manipulated image of a real-life dairy whose local customers aren't happpy about its use – is wholly misleading. But there are other, more subtly misleading elements to the ad. The claim about "drug usage increasing by almost 30%"  relates to the other BERL paper, which does not predict a sustained increase in cannabis consumption. The figure equates to BERL's guess of an initial "short-term spike" as people try out the novel experience of buying cannabis legally, and what effect that might have on the Regulatory Authority's cap on annual cannabis production:

While consumption will drop back down to a long-term average, the legal cannabis market will need to be able to supply this short-term spike, or risk allowing the illegal cannabis market to maintain a sizable share of the market.

But that could be argued, and the 30-odd complainants to the Advertising Standards Authority regarding the ad presumably looked forward to just such an argument. As it turns out, the argument will not be had.

In an extraordinary decision, ASA chair Raewyn Anderson has blocked the complaints from reaching the ASA's Complaints Board, on the basis that there are "no grounds to proceed". It appears the advertiser was not asked to respond to any of the complaints, so that response will not be relayed to complainants, as might usualy happen. Instead, Anderson has chosen to devise a defence on her own (it's a more able one than the Say Nope to Dope spokesman was able to summon himself when challenged).

The defence on the signage issue effectively amounts to "what do words mean anyway?".

The Chair said the scenario depicted in the advertisement is a subjective interpretation of what a possible future could look like if the Cannabis Legalisation and Control Bill becomes law, and therefore comes under the category of opinion.

The Chair noted that while certain provisions are currently in the Bill, many changes could potentially be made during the Select Committee process, and it is not possible to predict with any accuracy what the final outcome might be. The Chair noted that while the signage on the shop in the advertisement might not comply with the provisions in the Bill, it assisted with conveying the Advertiser’s view of what cannabis retail outlets may look like and how the New Zealand way of life might change if the Bill is passed.

The bill might well be amended in the legislative process, although as constitutional law professor Andrew Geddis has observed, the moral imperative to pass it essentially as voted on would be considerable. But to declare that it is "not possible to predict with any accuracy" whether a central facet of the bill, the advertising ban, becomes law is a hell of a call to make.

And apart from anything else, this is the bill we're voting on. If we can't discuss its text as meaningful, to use it as a point of reference, what's the point of a discussion? By the logic of this decision, SAM NZ could depict 14 year-olds lining up to buy weed at the school tuck shop as its "interpretation" of what could happen if the "Yes" vote carried. 

On the "short-term spike" issue, Anderson acknowledges that the ad presents a 30% increase in consumption without noting that on the same basis as it expects the spike (the experience of other jurisdictions) and in the very next sentence, BERL expects a fall to the long-term average. But:

The Chair said while the Advertiser has chosen to refer to the first statement from this quote, and not the second, this is allowable in the context of advocacy advertising.

Hmmm. 

Anderson also addresses the presence of children in the ad, and observes that premises would be strictly R20:

The Chair said that if cannabis is available for purchase at shops children will be able to walk, scooter and bike past these shops, as shown in the advertisement, and this is not misleading.

There is at least a significant discussion to be had about whether these licensed outlets would actually even look like shops "as shown in the advertisement", given that shopfronts would be effectively banned.

Anderson responds to complaints that the ad was "scaremongering, sensationalist and exaggerated", by writing that:

... while the advertisement did have shock value, which is likely to have been deliberate, it did not reach the threshold to cause serious or widespread offence or cause fear without justification. The Advertiser is using provocative imagery to draw attention to the debate about an important social issue.

Is the advertiser really "drawing attention to the debate", or simply misrepresenting what's being debated? It seems notable that Anderson hasn't included even a cautionary word for referendum advertisers to be mindful of the facts. It's all just fine.

If the complaints board, with its representatives from the public and from the advertising industry, had been given the opportunity to discuss the complaints and declined to uphold them, that would have been something. Complainants and commentators would have grumbled and perhaps opted to take the decision to the review board. But there was no discussion permitted.

It's proper and a matter of practicality that the Chair should have the power to weed out complaints in this way – otherwise the board would be bogged down in trivia.

But this isn't trivia. Misinformation about cannabis reform is clearly as much part of the debate as the bill itself. Last November, Justice minister Andrew Little expressed concern about a likely barrage of misinformation about the referendum, appealed to the public to call it out and specifically underlined the role of the Advertising Standards Authority. The complaints board chair's decision that the board should not even discuss it seems extraordinary, the more so when you look at many of the complaints to board has been allowed to discuss.

In a way, this does speak to the different purposes and philosophies of the the "Yes" and "No" campaigns. The "Yes" people – and I am one – are generally, sometimes painfully, focused on making a good-faith evidential case for reform. Say Nope to Dope/SAM-NZ's role is to raise fear, uncertainty and doubt about that reform.

This isn't necessarily the end of the road – the ASA has a separately-constituted appeals board – but having been dismissed in this way, the complainants may simply lose faith in the authority. The advertisers in this case will doubtless be considerably emboldened.

44

An unhelpful column about cannabis

The bar to get a opinion published about legalising and regulating cannabis is, you'll know, not terribly high at the moment. Anyone can have a crack. But there's a column published on Stuff that I want to take a closer look at because it's by someone who should bring a degree of expertise.

It's by Dr Mark Hotu of Green Doctors in Ponsonby, which bills itself as "the ONLY [cannabis] clinic that has actual medical specialists". I presume that doesn't mean the only one with medical doctors, but with a specialist on staff. 

Acccording to the Green Doctors website, Dr Hotu himself himself has been prescribing cannabis products for "over a year" and visited a cannabis clinic in Canada last year. His colleague Dr Anne Craig joined the practice last year. They both have have backgrounds in treating pain and Dr Craig is a pain specialist. Like all New Zealand doctors, their history of prescribing cannabis is a very short one.

UPDATE: In the comments below, Dr Waseem Alzaher of Cannabis Clinic says Dr Craig "works solely for Cannabis Clinic and not Green Doctors. She has requested her name be removed for 2 months now."

Dr Hotu says this in his column:

As a GP I feel a duty to help ensure the public is properly informed when they cast their vote, they should know about the existing availability of medicinal cannabis and the potential risks of self-prescribing cannabis for health reasons.

I’m concerned that many voters have been led to believe a cannabis referendum ‘Yes vote’ equals a ‘Yes’ for medicinal cannabis. This is not the case; patients already have access to medicinal cannabis. It’s legal under the Medicinal Cannabis Scheme and currently available via prescription from doctors who can identify any potential drug interactions and adverse effects that may affect a patient.

At present, that means that they prescribe a lot of CBD, which they've been allowed to do since September 2017. Green Doctors bills itself as offering "the cheapest CBD products in the country". There are nine of them listed on its website, but the Ministry of Health's regulations are such that no one's allowed to tell you what they are.

Currently, doctors can readily prescribe exactly one product containing THC: Sativex, which was approved in 2010. Sativex is approved by MedSafe for treating the symptoms of multiple sclerosis, but since April 1 this year, doctors have been allowed to use their clinical judgement prescribe it off-label, for pain and other conditions. It's not funded by Pharmac and costs around $900 + GST a month, although for some patients it's considerably more.

Another, functionally similar, product, Tilray 10:10, is often cheaper, but it's unapproved, which means a specialist must write the prescription, which has to be approved on a case-by-case basis by the Ministry of Health. (Having a pain specialist like Dr Craig on staff is an obvious advantage.)

The situation will gradually improve as products are approved under the April 1 regulations, but no product has been submitted for approval yet.

Moving on ...

Admissions to psychiatric hospitals for marijuana induced psychosis will go through the roof. Over the last few years we’ve put millions of dollars into the prevention and treatment of mental illness. Speak to any health professional that works in this field and they’ll tell you the impact that marijuana has on psychosis. Increasing access will undoubtedly result in a surge in mental health admissions. 

"Through the roof" and "undoubtedly result in a surge" are big claims – and they're not supported by evidence. If they were, you couldn't imagine the directors of our two most important public health research projects, the Dunedin and Christchurch longitudinal studies, being supportive of  careful legalisation. Or for frontline mental health staff consulted for the 2018 Report of the Government Inquiry into Mental Health and Addiction to repeatedly emphasise the way crimianlisation makes ther work more difficult.

The rate of Cannabis Use Disorder, which is assessed with a DSM checklist asking about tolerance, dependence and various social impairments, is a good thing to look at here, because it can lead to more serious mental health problems.

One study last year showed small but significant increases in CUD in legal US states among past-year users in 2008-2016 – effectively covering the first two years of legal availability in Colorado and Washington state – but the researchers speculated that the teen rate was influenced by unmeasured confounders.

Another, published at the same time but using the same dataset over a longer period and a slightly different case definition (frequent users, rather than past year users), found a substantial fall in CUD incidence among young people and the authors speculated that "as the cannabis market becomes increasingly regulated, better information about cannabis use risks may be available." In other words, bringing cannabis out into the light may be facilitating better choices.

A new study, published last week and using 2008-2017 data, found the same nationwide decline in adolescent CUD - and that "compared to other states, the rate of admission declined more rapidly among adolescents in Colorado and Washington following the legalization of cannabis."

We may not yet be at the stage of conclusive evidence, but claiming as a fact that legalisation would send psychiatric admissions "through the roof" seems pretty reckless for a doctor.

Dr Hotu continues:

Last year I was in Montreal at a medicinal cannabis summit and spoke to one of the clinical directors of Spectrum Therapeutics, the medical arm of Canada’s largest medicinal cannabis company. Prior to 2019, they increased production of their oral oils and capsules in preparation for the recreational market. When cannabis was finally legalised they ended up having to dump all those products because no one wanted them. Why? Because all people wanted to do was smoke. 

Such is the transition from a permissive medical regime to one in which people have access to regulated retail. Spectrum is a medicinal brand launched last year by Canopy Growth – which is increasingly viewed as the Big Cannabis example regulators should do anything possible to avoid.

Although Canopy began in Canada's medicinal regime, its primary shareholder now is Constellation Brands, a booze company. What actually happened last year is that Canopy completely misread the market for cannabis oils, medicinal or otherwise. Now, despite a staggering $4 billion investment from Constellation, Canopy is floundering because the booze barons wanted to focus on cannabis beverages – and it's really only its medical divisions that are making any money.

 So Dr Hotu's pretty off-beam there.

He continues:

Home-grown cannabis is not medicinal grade, the THC and CBD levels are unknown making effects on users unpredictable. A patient of mine experienced unexpected and unwanted side-effects from cannabis oil obtained from a green fairy. They were informed the cannabis oil had a high-CBD, low-THC ratio but described effects suggesting it contained much higher amounts of THC.

Even if suppliers provide a cannabis plant’s likely pharmacological characteristics, how the seed is grown and refined into a consumable form can affect the final product. Whereas medical-grade cannabis products receive Medsafe approval following proper testing and certification showing analysis of the CBD and THC levels.

He's right to say (the occasional back-door test at ESR notwithstanding) that green fairy products aren't tested and that many may not be true to label. But the good green fairies would really, really like access to testing. It's actually dangerous that they are denied that access. As the Cannabis Legalisation and Control Bill stands, it would not legalise their products, but it would open the way to creating a safer niche for them – and the people they supply – to occupy. That's what we would do if we wanted to reduce harm. Perhaps the green fairies will gradually fade away as prescribable products appear in the system, but for now, there's a straightforward way to reduce the potential for harm for thousands of people.

Also, the referendum bill would require the THC and CBD content of dried cannabis flower to be listed at retail, and set quality standards. The medicinal regs go further by requiring GMP production standards – the same as other pharmaceutical drugs – which is expensive to do. But it's misleading to imply there would be a lack of information about the products themselves.

Then there's this:

Essentially we’re letting five million non-medically trained New Zealanders decide whether a controlled drug should be sold at the corner store.

Whoa there, doc. No one's going to be selling anything at "the corner store" and it's ridiculous to say so. Licensed cannabis retailers wouldn't even be able to have a storefront, let alone advertise.

It may not have been his intention, but this column does read as if Dr Hotu is rather clumsily trying to defend his market. It's not going to help with the frustrating problem of doctor distrust in the cannabis community and it ignores the public health problems related to criminalisation. Apart from anything else, Dr Hotu would benefit from a little humility. He could learn some things from the green fairies who have been dealing with cannabis patients for years, as much as they could learn from him.

Finally, he writes in conclusion:

Right now there’s a lot of smoke being blown about and as a GP and medicinal cannabis specialist I want to equip Kiwis with the facts.

Those facts need some work.

7

More on the repurposed hepatitis C drugs and their potential as a Covid-19 treatment

Back in April, I wrote about trials in Iran of a fixed-dose combination of two existing anti-viral drugs used to treat hepatitis C – sofosbuvir and daclatasvir –  that could point to an effective treatment for Covid-19 symptoms.

At the time, data from those trials was not available outside the hospitals that conducted them and their identification was a matter of some detective work at a distance by the Australian doctor James Freeman.

Overnight, per the press release below in the names of doctors in Iran, Brazil and the UK, those results were formally presented to the International Covid-19 Conference.  It's important to note that the three trials were small – totalling only 176 patients – and open-label. They do not confirm that   "sof-dac" is an effective treatment. But, in the words of the doctors, patients given the combination showed "significantly faster rates of clinical recovery and improved survival for patients hospitalised with COVID-19 infection."

In particular, as a Financial Times story this morning notes, the death rate for patients given the drug combination was 5% versus 20% for those who were not. The FT also quotes Dr Anthony Fauci:

Anthony Fauci, the head of the US National Institute of Allergy and Infectious Diseases and a member of the coronavirus task force, told reporters the results were “really quite interesting and provocative and encouraging”.

“We desperately need antivirals that can be given early on in the course [of the disease] to prevent individuals from requiring hospitalisation,” he said. “I’d encourage that we do further studies to nail this down.”

That's happening. There are now five randomised trials involving 2000 patients in Iran, Brazil, Egypt and South Africa, which should by October give a better idea of the viability of the treatment. If the results are positive, it would be good news for the world. The two drugs are generically manufactured as Hep C treatments in several countries and, if shown to be effective, would represent a Covid treatment that could be provided cheaply ( $US7 per 14-day treatment) and at scale.

That remains to be seen. But how we got to this point is interesting. There is no pharmaceutical company money behind the new trials and the key one in Brazil, representing half the total patients, only got off the ground because Dr Freeman personally provided some funding. A further $500,000 from the NGO Unitaid let it go ahead.

By contrast, huge resources have gone into the global Solidarity clinical trial project overseen by the WHO, which last week announced that its trials of hydroxychloroquine and an HIV antiviral combination have been discontinued. Only Gilead's remdesivir antiviral remains in active trials under Solidarity.

That doesn't mean there are no other treamtent trials in progress – to take the most notable example, dexamethasone has emerged as an effective treatment in trials in the UK. But it does raise real questions about the allocation of the really major resources.

New Zealand Hep C activist Hazel Heal, a longtime collaborator with Dr Freeman, also brought in donations from her colleagues in the Edmund Hillary fellowship. She's strongly of the view that the international research effort into Covid treatments is broken – and focused too much on vaccine development and too little on treatment options.

"Treatments have been starved of research dollars and patients to try them on because all the eggs are in the vaccine basket, which is a long way off giving us a solution. There are 150 funded vaccine trials around the world at the moment – and for treatment, just Solidarity, which was for three drugs and is now only for one.

"Even if remdesivir is shown to be effective at ICU, the US has bought up all the global production for the next several months. So the world has given up its ICUs and its research dollars to research one drug that's not very good which will only be available to Americans."

Even after Brazilian researchers conducted in vitro research that showed that daclatasvir was active against the SARS-CoV-2 virus and published the results as a pre-print three weeks ago, efforts to have their work replicated in the US were stymied because all necessary resources were committed to vaccine development.

She says in the longer term, the sof-dac combination is probably "an answer, rather than the answer," comparing it to AZT in the early days of HIV treatments, but adds:

"Repurposing small-molecule drugs that come in tablets is the important work that shoud have been done methodically around the world– and it just hasn't been. It's a failure at the international organisational level."

––––

Hepatitis C Treatment shows promising efficacy against COVID-19 in first studies.

Definitive results expected in October

Results presented today at the International COVID-19 conference show significantly faster rates of clinical recovery and improved survival for patients hospitalised with COVID-19 infection given two Hepatitis C drugs - sofosbuvir plus daclatasvir.  These results are from three relatively small, open-label clinical trials in a total of 176 patients.  These trials were conducted in three cities in Iran (Abadan, Tehran and Sari), during their first wave of the COVID-19 epidemic.

After 14 days of treatment, 94% of patients taking sofosbuvir/daclatasvir showed clinical recovery versus 70% on control treatment.  The death rate for people taking sofosbuvir plus daclatasvir was 5%, versus 20% for people taking control treatment.  One of these trials was not properly randomised, but clinical recovery rates were still significantly higher for sofosbuvir/daclatasvir in the two randomised trials (96% versus 80%).  Small, open-label trials could be prone to biases, so these results need to be seen as preliminary, unless confirmed with larger double-blinded placebo controlled trials.  

“Laboratory studies have shown that daclatasvir has antiviral activity against SARS-CoV-2.  Daclatasvir also penetrates well into the lungs, where COVID-19 infection can be concentrated.  In laboratory studies, sofosbuvir has only marginal antiviral activity against SARS-CoV-2.  Sofosbuvir plus daclatasvir already has a well-established safety profile in the treatment of Hepatitis C.  Worldwide, millions of people have been cured of Hepatitis C using this treatment.”  Dr Thiago Souza, Laboratório de Imunofarmacologia, Rio de Janeiro, Brazil.

“This treatment is being developed with no support from the large pharmaceutical companies.  All our funding is from governments, Universities, or donor agencies such as Unitaid. If this treatment proves to be effective, it could be made available worldwide as a cheap generic treatment costing approximately $7 per 14-day treatment course.  Sofosbuvir plus daclatasvir is already available at these prices in India, Pakistan, Iran and Egypt.  There is already enough generic sofosbuvir and daclatasvir mass produced to treat millions of people if this drug proves effectiveness in large trials.  We want this treatment to be affordable for anyone with COVID-19 infection, in any country.”  Dr Andrew Hill, Liverpool University, UK. 

“In spite of the encouraging initial results, we believe it is too early to reach a verdict.  Larger, well-designed studies are required to confirm our results.  A network of 5 randomised clinical trials has been set up, to test sofosbuvir plus daclatasvir in over 2000 patients with COVID-19, in Iran, Brazil, Egypt and South Africa.  The largest of these trials is double-blinded and placebo controlled.  By October, we should know from the trial results if this treatment could be approved for worldwide use.  Conducting research amidst a pandemic with overwhelmed hospitals is a challenge and we cannot be sure of success.  Sometimes treatments look promising in early trials but then fail later on.  

In the future, we will also be evaluating daclatasvir at higher doses and as part of dual or triple combination treatments.”  Professor Shahin Merat, Tehran University of Medical Sciences, Iran. 

Dr Andrew Hill, Senior Visiting Research Fellow, Liverpool University

Dr Thiago Souza: Laboratório de Imunofarmacologia, Instituto Oswaldo Cruz (IOC), Fundação Oswaldo 10 Cruz (Fiocruz), Rio de Janeiro

Professor Shahin Merat: Digestive Disease Research Institute, Tehran University of medical sciences

8

The cannabis referendum: the evidence

If the government has not lined up behind a "Yes" vote in this year's cannabis referendum the way some reformers would have liked, one entirely laudable thing it did do was commission some science around the public's choice.

That science landed today, in the form of the report from an expert panel convened by the Prime Minister's Chief Science Advisor, Professor Juliet Gerrard. The panel was specifically not asked to make a recommendation, but instead to summarise the evidence on legalising and regulating cannabis.

The result is some quite admirable science communication, with evidence available in at-a-glance summaries and FAQs, and in detail. There's even an accompanying 25-minute video by Shirley Horrocks:

It would be redundant to go through all of it here, but it would be fair to say the panel seems to have found more common ground on the social harm caused by the current criminalisation of cannabis than on the public health consequences of legalisation and regulation, as observed in other jurisdictions, although it does indicate that on balance, legalisation will make it easier to get help with use problems and also make research easier to conduct.

Indeed, that's what Professor Gerrard focused on in an interview ahead of today's release. 

"Instinctively when people hear the word harm, they think about the medical harm. Less well documented is the social harm - people getting kicked out of school for a drug offence, a drug conviction on a record which could affect employment prospects and cascade into a series of social harms.

"The people in that situation are disproportionately young, disproportionately male and disproportionately Māori."

The panel has, however, found a consensus that cannabis is less harmful overall than the two currently legal social drugs, alcohol and tobacco – and on most measures at that. Whether legalising cannabis leads to a substitution of cannabis for alcohol is less clear.

 The at-a-glance page correctly notes a "progressive softening of the law" on cannabis in New Zealand, culminating in last year's Misuse of Drugs Act  amendment directing police discretion away from prosecution and towards a health-based response. It also observes that "enforcement may continue to discriminate against Māori and young men."

Cannabis arrests have already declined sharply over the past decade, and the panel says that the number of convictions "is also likely to decrease over time". Yet within this slow slide into de facto decriminalisation, leaving production and supply as criminal enterprises is "likely to continue to give rise to and boost organised and opportunistic crime."

What the panel doesn't canvas, but which I fret about sometimes, is some evidence that under decriminalisation (and permissive medicinal schemes) in US states, public health outcomes – and rates of youth use especially – were worse than under legalisation.

New Zealand Police are increasingly disinclined to prosecute cannabis possession – and the courts are granting discharges for people caught with as many as 20 plants, especially if there is some evidence of medicinal intent. I do worry about sliding into a messy, unregulated space the way Canada did. Youth use climbed right up to legalisation there, then stabilised and declined. Remember last year when Patrick Gower agonised on TV about the dab bars of Vancouver, where people were inhaling powerful concentrates? They actually predated legalisation by years and the new federal law is being used to close them down.

In Horrocks' video, Dr Irene Braithwaite of the Medical Research Insitute of New Zealand draws a distinction between "recreational" use and the medicinal use permitted and regulated under last year's Misuse of Drugs (Medicinal Cannabis) Regulations. On one level, this is just clearing up the dfference between two laws, but as we know from research conducted in the past year by both MCANZ and Massey SHORE, there is a large group of  New Zealanders using cannabis illegally in ways that are at least as much therapeutic as "recreational". Adult use of cannabis isn't just one thing.

As controversial as it's proving to say, that community isn't necessarily going to switch wholesale to prescribed GMP-standard cannabis products – and certainly not before there are many more products and GPs willing to prescribe them. The referendum is about whether we should continue to criminalise those people too.

My impression overall is that there's more in the expert panel's consensus to please reformers than the people who favour continued prohibition of cannabis, especially in the area of social harms. To be honest, that was to be expected.

Whatever any of us takes from this exercise, I think the government is to be commended for requesting it and the PMCSA for delivering it in the way it has. Bravo.

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There's another new presentation on the implications of cannabis legalisation – and in a place where you might not expect it.

Auckland Transport has just published a swathe of cannabis-related papers presented to its board last month and it while most of those are external documents attached for the reference of the board (including health and safety advice from Canada) , the discussion document presented by AT staff is solid, sensible stuff.

What's missing for now is active consideration of a switch from urine to saliva testing within AT itself. Saliva testing offers a much better measure of actual impairment, it will be fairer for employees and there's now a New Zealand Standard for it. AT should be talking about this to its employees and their unions.

But there's time for that. For now, AT deserves plaudits for getting out in front of the issues. Other organisations could follow suit.

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