Australia’s anti-vaping activists and bureaucrats working together to harass citizens and protect the cigarette trade

I remember back when I was Director of Action on Smoking and Health in the UK (1997-2003), we used to glance across hemispheres and admire what they were doing on tobacco in Australia. Australia’s anti-smoking coalition was engaged in a feisty battle for genuine public health, defending the little guy from predatory tobacco companies. At that time, it was the David of the story taking on the giant.

No longer.

What a pitiful spectacle they make now.  Now they are the predatory giants, harassing and bullying the little guy.

Thousands of ordinary Australians want a better and longer life by switching from smoking to vaping but an unaccountable cadre of public health activists, apparently with unshakable convictions untempered by evidence, humility or empathy, believes the government should use its powers to obstruct them.  On what basis? And how have they managed to get the Minister for Health to go along with their weird and dogmatic opposition to pro-health innovation and progress that is working well elsewhere?

In June, Australia’s Minister for Health, the Hon. Greg Hunt MP announced new measures to make access to vaping products even more difficult in Australia: Prescription Nicotine Based Vaping. This is an astonishingly poor act of policymaking and this blog takes a hard look at his proposals.

I am pleased there is to be a Senate inquiry into Tobacco Harm Reduction – this blog is my initial take on how Australian policymakers, consumers and businesses should navigate these issues – it’s quite long so please dip in.

Contents

1. Relative risk: the simplest starting place from which all else flows
2. The rest is sophistry… and the burden of proof rests with the anti-vaping activists
3. The basic liberal argument
4. The absurdity of protecting the cigarette trade from vaping
5. Beating smoking by battering smokers
6. The ethical imperative to link painfully high taxes to quitting smoking by any means possible
7. Vaping is working well in Europe and North America
8. Australians give good reasons for vaping
9. Harassing Australian citizens by intense bureaucratic attrition
10. The purpose is to impose bureaucratic blockage, not to enable a new or improved pathway
11. What new behaviours will this bureaucratic blockage stimulate?
12. Where is the regulatory impact analysis for this prescription nicotine idea?
13. The case for action – a line-by-line look at the Health Minister’s press release
14. The issue of vaping by adolescents and non-users
15. Lessons from the United States: drill down into the youth vaping numbers and the story changes.
16. Addressing youth vaping while maintaining benefits for adults

Updated: Submissions to Parliament of Australia Senate inquiry into tobacco harm reduction

1. Relative risk: the simplest starting place from which all else flows

Vaping is, beyond any reasonable doubt, far safer than smoking and may not be harmful at all. We know this from the basic physics and chemistry of the processes involved (combustion versus heated aerosol formation); the toxicology of the vapour (far fewer hazardous agents are detectable and at much lower levels), and much lower concentrations of key toxins found in the blood, urine or saliva of vapers compared to smokers. This is not the place to go into this in detail – but here’s an example from  Shahab et al., 2017, showing vaping exposures as low as found with NRT users and much lower than for smoking – this is figure 2 from this study reproduced below with my annotations.

We also have to treat claims of harms projected heroically from test-tube (in vitro) or animal studies or from observable changes in the human body with a great deal of scepticism. Recall that people who smoke cigarettes for 20 years avoid almost all of the severe harms of smoking if they quit by age 35-40 [discussed here]. Many of the anti-vaping activists approach vaping risks as if the human body is somehow without defences, resilience and repair mechanisms – like warning people to stay indoors in case they are blown over by a gentle breeze.

I have written several posts about science and health risks.  These two will probably suffice.

• Vaping risk compared to smoking: challenging a false and dangerous claim by Professor Stanton Glantz
• Vaping is still at least 95% lower risk than smoking – debunking a feeble and empty critique

2. The rest is sophistry… and the burden of proof rests with the anti-vaping activists

Once you have accepted the relative risk finding above, as you must if you take a professional and reality-based approach to your work, much else becomes clear.  Most importantly, there is no case to obstruct people from accessing these products while the dominant incumbent products, cigarettes, are available everywhere. You will hear a great deal of sophistry [see my blog on anti-vaping sophistry] designed to distract from this straightforward reading of the situation.

It’s fine to ask: does it work as a smoking cessation treatment for most people?  Is there a gateway effect? What about the long term risks? etc.  Yes, policy considerations may arise from these questions – but the much lower risk to the individual means that the burden of proof changes: the anti-vaping activists need to show (1) there are clear harms arising from population effects; (2) restricting access to the much safer product will not cause more harm than it prevents, and (3) the harms involved justify state intrusion in personal risk decisions.

But let’s help out here.  On 14th October, the world-renowned Cochrane collaboration published an updated review of the smoking cessation efficacy of e-cigarettes.

More people probably stop smoking for at least six months using nicotine e‐cigarettes than using nicotine replacement therapy (3 studies; 1498 people), or nicotine‐free e‑cigarettes (3 studies; 802 people).

Nicotine e‐cigarettes may help more people to stop smoking than no support or behavioural support only (4 studies; 2312 people).

For every 100 people using nicotine e‐cigarettes to stop smoking, 10 might successfully stop, compared with only six of 100 people using nicotine‐replacement therapy or nicotine‐free e‐cigarettes, or four of 100 people having no support or behavioural support only.

Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, Begh R, Theodoulou A, et al. Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev. 2020;(10). [link]

Excellent and informative comments on the assessment were made to the Science Media Centre. For example, Professor Peter Hajek of Queen Mary University of London, note how the RCT data triangulates with other data:

The results of this new review of randomised trials of vaping tally with other evidence from cohort and epidemiological studies, suggesting that for many smokers, e-cigarettes represent an effective tool for quitting smoking.

When, in the face of evidence, a government simply assumes that state intrusion in a citizen’s options to protect their own life is justified, the basic liberal argument is worth restating.

3. The basic liberal argument

If someone wants to switch from a dangerous if widely practised habit to one far safer, even if not entirely safe, in what world does it make sense for the Minister for Health to intervene to prevent them or to make it impossibly difficult?  What is the policy goal that somehow overrides the basic freedom of voluntary exchange in the mutual interest of a consumer and producer? Approximately 1 in 7 (14.7%) Australian adults were smokers in 2019 – about 2.9 million Australian citizens. What is it that motivates activists in public health to try to stop these ordinary people, weighted to the more deprived in Australian society, from doing the right thing for their health, wellbeing and family budget? And doing this on their own initiative and at their own expense and with no harm to anyone else?

The main argument of principle should end there. From that position, every action restrictive action of the government needs a credible justification.

4. The absurdity of protecting the cigarette trade from vaping

Though nicotine vaping has already been made difficult and the Minister plans to make it even more difficult,  the Australian government permits cigarettes to be sold legally and with ease on any street corner – apparently without irony. There it is, written bluntly into Poisons Standard: as part of Schedule 7: nicotine is a subject to poison control unless…

“in tobacco prepared and packed for smoking.”

In what may be one of the world’s most beneficial regulatory protections of the cigarette trade, the Minister for Health and the Therapeutic Goods Administration have determined that this exemption should be strictly reserved for smoking products and not extended to e-cigarettes or heated tobacco products, despite applications to change this made in 2016-17 and 2019-20 respectively. These went to consultation, and many experts from around the world responded urging liberalisation, but minds were closed.

• TGA Final Decision on nicotine liquids. March 2017. [40 international experts submit evidence calling for reform – here (September 2016) and another 21 international experts followed up here (February 2017) – see blog: Australian medicines regulator intends to continue to protect the cigarette trade – we challenge its bizarre reasoning]
• TGA Final decision on heated tobacco products. August 2020.  [Submission by David Abrams, Clive Bates, Ray Niaura, David Sweanor – here]

5. Beating smoking by battering smokers

So Australia’s tobacco control activists have an answer to their apparently absurd exemption for cigarettes: raise the tax on cigarettes to eye-watering levels with a series of annual 12.5% increases over from 2013 – 2020.  According to Tobacco Reporter, 2 Sept 2020.

Successive tax hikes from April 2010 have made Australian cigarettes among the most expensive in the world. Following the [1 September 2020] increase, a 25-stick pack of Marlboro Gold cigarettes now costs AUD48.50 (US$35.63) while the average 20-pack costs around AUD35.  That means a pack-a-day smoker will spend AUD12,500 [US$9,182] over the course of a year.

Australia has the highest cigarette prices in the world – see Numbeo – on this reckoning, an incredible 76% higher than the UK.  Australia also has a sharp socioeconomic gradient in smoking – smoking prevalence in the most disadvantaged quintile is 21.3% but just 8.3% in the most advantaged quintile.

Okay, let’s not have an argument about whether this ‘tax-em-til-their-last-gasp’ strategy is a good idea. Let’s avoid comparison with creeping prohibition.  Let’s not ask whether it works (one in seven still smoke, after all). Or whether it is sharply regressive and excessively punitive for those who will not or cannot quit, especially those who are poor, with mental health conditions or other forms of disadvantage.  Let’s park the arguments about whether this stimulates a giant black market – or even whether a black market may even be a good thing given the impact on poverty. Let’s not look at the welfare costs to the family budget for a couple of regular smokers.

Let’s leave all that, and take this tax regime as a given, which it is.

What does a tax policy like that need to be workable and fair – or at least less unfair?

6. The ethical imperative to link painfully high taxes to quitting smoking by any means possible

Here’s my proposition:

If the government raises the price of a product that the same government says is “addictive” and that quitting “can be one of the most difficult, yet rewarding things a person can do“, then it has a clear ethical obligation to make quitting smoking as easy as possible and certainly not to place bureaucratic barriers in the way.

In my view, the policy of aggressive tax-raising and stigma-inducing tobacco control measures must be linked to maximising the opportunities to quit.  Vaping products add to the number and type of options that people have available to quit smoking. It works through growing familiarity confidence over time, not in the traditional abrupt cessation with treatment for withdrawal and craving (and usually, relapse shortly after).  It works well with people who don’t necessarily want to quit nicotine and may not even want to quit smoking, at least initially.  It is not a stop smoking aid, it is a rival consumer proposition available to smokers that appeals to them in some ways that are similar to smoking (nicotine, flavour, throat sensation, hand-to-mouth movement, behavioural ritual and identity). This is why it works.

Short aside. Maybe this is also why so many in Australia’s public health cadre really loathe vaping and vapers: precisely because it isn’t a smoking cessation approach (even if that is the result). Vaping represents an alternative paradigm for quitting smoking: replacing one pleasure with another at greatly reduced risk.  The Australia tobacco control paradigm has a more Old Testament feel: it is about penitence, purging and redemption.  We will hurt you with financial pain, social marginalisation and personal stigma. We will treat you like a patient with a psychiatric illness.  And when finally you do as we say, the pain will stop. 

The option to move to vaping does not close down other options (many smokers will still use them and many have tried and failed with the other options), it extends the options available to smokers and may reach smokers who do not find the conventional alternatives appealing. There is no right way to quit smoking, only the way that works for each individual.  In the UK, vaping is increasingly integrated into stop smoking programmes run by the National Health Service [see here] and annual Stop Smoking drives [see Stoptober], including government-funded TV advertising for vaping.

I often wonder what would happen if Australia’s public health cadres were paid by results [e.g. for reducing smoking-related disease or for increasing wellbeing]. Would there be the same hostility to vaping? I somehow doubt it.

7. Vaping is working well in Europe and North America

The situation was already pretty Byzantine in Australia, with vapers required to obtain a prescription from a willing doctor and then import nicotine from New Zealand or China,  jumping through various hoops to do what is easily done legally in shops and online by millions of vapers in Europe and North America, with no great drama or ill-effects. What is the disaster that Australia is supposedly protecting its defenceless citizens from? Would it be so bad if people quit smoking in large numbers, even if they use a method that various anti-tobacco crusaders don’t like? Though it is difficult to draw causal inferences, the rate of decline in smoking in Australia appears to be slower than in the United States and England where smokers have turned to vaping in their millions:

8. Australians give good reasons for vaping

According to the National Drug Strategy Household Survey 2019 (Tobacco section), Australia now has more than 500,000 vapers (2.5% of adults), and they give commendable reasons for trying and continuing with e-cigarettes:

More than half of people (54%) tried e-cigarettes out of curiosity.  This was especially the case for never smokers (85%) and young adults aged 18–24 (72%). Other reasons included:

• to help me quit smoking (32% in 2019, similar proportion to 2016, 31%)
• I think they are less harmful than regular cigarettes (23%, up from 19.2%)
• to try to cut down on the number of cigarettes smoke/smoked (22%, up from 18.7%)
• to try to stop me going back to smoking regular cigarettes (17.8%, up from 14.5%)
• they are cheaper than regular cigarettes (17.7%, up from 10.5%)
• I think they taste better than regular cigarettes (16.1%, up from 10.0%).

I really cannot see any argument for thwarting any of these ambitions or motivations. Of course, people try things because they are curious – they want to find out whether it might do something good for them, and for many it does.  If it doesn’t do something good for them, why would they continue with it?

9. Harassing Australian citizens by intense bureaucratic attrition

The existing level of state-harassment of Australian vapers was apparently not enough for Minister for Health, Greg Hunt.  He has decided that from 1 January 2021, it will no longer be legal to import nicotine into Australia for personal use. Vapers will have to locate, waste the time of, and someone will have to pay for a sympathetic doctor to issue a script and then find a pharmacy willing to supply vaping products from overseas via a licensed importer and wholesaler.

If they go ahead, the new restrictions would be implemented through two changes:

1. changes to the Customs (Prohibited Import Regulations), which are due to enter force on 1 January 2021.  This will block the personal import scheme, meaning imports can only be made to a wholesaler licenced for drug imports with an import permit from the Office of Drug Control (ODC).  There are huge fines – up to AU$222,000 [US$160,000] – for unlawfully importing nicotine liquids.
2. changes to Poisons scheduling – with the TGA shifting nicotine liquid from Schedule 7 to Schedule 4 (a prescription-only medicine) of the Poisons Standard.  This would mean that all nicotine liquid for human use requires a prescription as before (though exceptions for smoking and patches and gum are maintained). This is due to start on 1 April or 1 June 2021.

The Therapeutic Goods Administration explains these new restrictions here: Prohibition on importing e-cigarettes containing vaporiser nicotine 

This creates major barriers to access. Vapers would have to go through all this and just hope it works. But there are hardly any doctors or pharmacies that want this trade, and even if there were, it would be missing the point.  These are not smoking cessation treatments.  They are consumer products that create a rival proposition to smokers. (also see ATHRA flyer: Liquid nicotine. Prescription or consumer product?)

This is how it is supposed to work, according to the TGA’s graphic.

To be honest, this still needs a bit of work… let’s start with a reality-based view of how the prescription regime works. Not all pathways on the revised chart have the happy ending envisaged by the TGA.

Then add in the additional supply chain complexity created by customs changes and it gets even more messy and improbable…

Let’s walk through it:

• The patient (that’s a smoker or vaper) visits their doctor.
• If the doctor is signed up to supply nicotine (meaning they have applied to be an authorised prescriber to prescribe drugs not listed in the official formulary ), then they may be able to prescribe a nicotine liquid
• The doctor may be willing to prescribe nicotine for vaping – or if he or she knows best, they may not be willing and press the patient towards licensed smoking cessation medications.
• The doctor may issue a prescription script for an e-liquid. If the patient is lucky they might have a choice and it might be one they like. But they won’t be able to try first.
• The patient takes the prescription script to a pharmacy.
• If the pharmacy is willing to supply nicotine liquids, the pharmacy can place an order with a wholesaler and importer
• The medical wholesaler and importer must be licensed and hold a permit from the Office of Drug Control for importing and storing prescription drugs
• The wholesaler supplies the pharmacy – let’s hope it arrives at a predictable time and without excessive delay
• The patient returns to the pharmacy to collect the prescribed liquid.

That compares with, say, the UK.

• Vaper or smoker goes to a local shop and buys preferred liquid, or may try new ones, or obtains advice from helpful staff, or perhaps goes online and places an order for delivery to home.

10. The purpose is to impose bureaucratic blockage, not to enable a new or improved pathway

The point is that at each stage in this procedural labyrinth marked in red above there is friction, delay, cost, travel, and uncertainty.   At each point, there is the option for a potential user to declare the whole endeavour pointless and to give up or never start.  It’s not as if the bureaucrats that designed it don’t realise this. Anyone who has spent more than a day working in the public sector would know that this will defeat all but the most determined and capable users. One can almost sense a kind of sadistic pleasure at the cruelty built into the design.  The point is that this bureaucracy is a feature, not a bug for the Minister for Health. It is intentional: an attempt to constrict the legal pathway to vaping to the point where it functions as a de facto prohibition, but without having to use that ugly word while allowing its proponents to pretend they are doing something responsible.

11. What new behaviours will this bureaucratic blockage stimulate?

But actually, things don’t work out always as Ministers expect.  So how to analyse the effects…?  Imagine taking the diagram above and drawing on all the pathways and transitions that might be altered by this change of regulation.

• Take 100 representative vapers including adolescent vapers. How many will: (i) return to smoking; (ii) move to black-market finished vaping products and liquids; (iii) import high strength nicotine and mix their own liquids; (iv) buy from someone importing nicotine and mixing liquids as a commercial enterprise; (v) mix and sell illicit liquids to friends or on a more commercial basis; (vi) quit nicotine altogether – (a) without substituting another substance use or risk behaviour – (b) substituting other substance use of risk behaviours?
• Take 100 representative smokers including adolescent smokers. How many will: (i) stick with smoking who might otherwise have quit with vaping; (ii) gain confidence and seek out a doctor and switch to vaping when they would otherwise have continued to smoke; (iii) try a quit smoking method less effective than vaping and fail; (iii) as adolescents, stick with smoking?
• Take 100 representative non-users including adolescents. How many will: (i) try smoking instead of trying vaping; (ii) not try vaping when they otherwise would have; (iii) want to try vaping and seek out black-market vape products or illegally sourced nicotine; (iv) try smoking and stick with it instead of switching to vaping.

Further enhancements to the diagram above would need to include the following reality-based pathways. How does it work for:

• a vaper who runs out, loses or spills their e-liquids? [Return straight to smoking?]
• a smoker who wants to try vaping but doesn’t vape already?  [An impossible barrier to getting started?]
• a potential black market vape supplier? [A considerable opportunity?]
• a vaper that considers importing nicotine illegally for home use? [An unfortunate but justifiable necessity – albeit at the risk of an outrageous fine?]
• an illegal drug supplier to add nicotine to their illicit product range? [A way of bringing new consumers into the main business? A gateway created by the Minister for Health?]
• a black-market cigarette supplier? [an opportunity to supply low-cost consumer nicotine products to cost-conscious vapers]
• an adolescent? [Something to defeat as a matter of principle in order to frustrate patronising adults and senescent professors and an opportunity to become a supplier?].
• a vape shops that sell devices and nicotine-free liquid? [Go out of business and stop providing expert support to smokers and novice vapers?]

For those unfamiliar with this idea, it is called:

thinking through the effects of your actions before the perverse consequences come around and bite you on the ass

But it also has a more formal name: regulatory impact analysis.

12. Where is the regulatory impact analysis for this prescription nicotine idea?

Like all modern governments, Australia imposes some disciplines on policymakers when it comes to regulation – goals should be clear and justified, the regulation should be proportionate, options considered and consultation held.  The Department of the Prime Minister and Cabinet Office publishes the Australian Government Guide to Regulatory Impact Analysis (2nd Edition PDF, March 2020).  This aims to protect Australian citizens and businesses from the regulatory excesses of politicians and officials.

The government describes the purpose of this:

The Government’s rigorous approach to policy making seeks to ensure that regulation is never adopted as the default solution, but rather introduced as a means of last resort. Regulation can have benefits, but businesses, community organisations and families pay the price of poor regulation.

Regulation can’t eliminate every risk, nor should it. We therefore seek better regulation, not more regulation. Policy makers must seek practical solutions, balancing risk with the need for regulatory frameworks that support a stronger, more productive and diverse economy where innovation, investment and jobs are created.

The Australian regulatory impact analysis framework is structured around seven questions:

1. What is the policy problem you are trying to solve?
2. Why is government action needed?
3. What policy options are you considering?
4. What is the likely net benefit of each option?
5. Who did you consult and how did you incorporate their feedback?
6. What is the best option from those you have considered?
7. How will you implement and evaluate your chosen option?

The Minister for Health needs to go beyond his sketchy 26 June 2020 press release (see below) and get some answers to these questions down on paper: it’s his policy and he needs to assess the plausible impacts – as they would be in reality – and then own the foreseeable perverse consequences.  In particular, he needs to explain how he would evaluate the effects of his measure and know whether it needed to be corrected or withdrawn.

The public health activists in Australia tend to dismiss vaping as if it is a minor issue, a distraction from bludgeoning smokers into obedience. But it involves 500,000 people as vapers – with rapid growth since there were 280,000 in 2016 –  and a potential out for 2.9 million smokers.  If the decisions made by the Health minister adversely affected just 1% of vapers and 0.1% of smokers, that would be 5,000 + 2,800 = 7,800 harmed by the Minister for Health.  If this means smoking instead of vaping, then that means these people are exposed to life-threatening risk – that’s a non-trivial human impact.  And who seriously thinks as few as 1% of vapers and 0.1% of smokers would be adversely affected?

So how robust is the case for doing this?

13. The case for action – a line-by-line look at the Health Minister’s press release

It’s hard to divine any coherent rationale in the Minister’s case for making nicotine vaping a prescription-only drug. To the extent that any case is made in his announcement press release of 26 June 2020: Prescription Nicotine Based Vaping we should look hard at the rationale.  I will take the statements made one-by-one.

Australia’s medical experts, including the AHPPC, have warned of the health dangers of e-cigarettes.

Response: what matters is the risk relative to smoking (very much lower) and the absolute risk compared to other benchmarks of comparable risk in society, such as occupational health exposures (much lower). Talking about ‘dangers’ without discussing magnitude and context is meaningless and does not provide a policy rationale.  How dangerous matters a great deal.

This is consistent with the existing ban in all states and territories on the sale of e-cigarettes containing vaporiser nicotine.

Response: no it isn’t. The existing ban is inconsistent with the widespread availability of cigarettes, for which these products are a much safer alternative. The existing ban, especially if intensified as proposed, will stimulate the black market or informal economy responses and these will create additional risks arising from vapers relapsing to smoking or not switching, and from lower standards of product stewardship.

Smoking rates in Australia have declined significantly over the past two decades, from 22.3 per cent in 2001 to 13.8 per cent in 2017-18. But the latest statistics show tobacco use still contributed to an estimated 21,000 deaths, or more than one in eight, in 2015. This is why we need to drive down those smoking rates further.

Response: the decline in Australia’s smoking rates has slowed and vaping products offer an additional way to drive down smoking rates without taking away any of the existing options. Even if smoking rates were falling sharply, there is every reason to try to accelerate the trend by increasing the ways available to quit.

In particular, around the world we have seen strong evidence of non-smokers being introduced to nicotine through vaping for the first time.

Response: this reasoning is a mixture of non-sequitur, over-simplification and falsehood.  We have seen the “youth vaping epidemic” narrative emerge mainly in the United States.  But this needs to be unpacked more carefully.  In the United States, (1) most adolescent vapers are infrequent users and of little public health concern given vaping is a minor risk in the landscape of youth risk behaviours; (2) most frequent/daily vapers have been smokers, and for them vaping may be beneficial; (3) very few tobacco-naive vapers show signs of dependence to nicotine.  This is discussed in the section below:  Lessons from the United States: drill down into the youth vaping numbers and the story changes. Trying to create a world where no young people copy any adult habits is futile – adolescents will do what adults do

Therefore the Government is responding to the advice by ensuring that nicotine based e-cigarettes can only be imported on the basis of a prescription from a doctor. This will help prevent the introduction of non-smokers to nicotine via vaping.

Response: are you sure you’ve thought this through?  This takes no account of the actual at-risk population, namely adults who smoke (mentioned by the Minister just two lines before) and vapers who have quit or are quitting smoking using vaping products.  It also has nothing to say about how youth non-users will respond – it only takes a few more to start smoking instead of vaping for the ledger of benefits and detriments to move into the red.  What if a subset of young people starts to access the vaping black-market or engage in informal supply?  What if they shift their ‘sin portfolio’ to try other, more dangerous risk behaviours.  The Minister for Health must be assuming that these young people will somehow turn away from vaping and take up piano lessons, do more homework and practice yoga instead.

However there is a second group of people who have been using these e-cigarettes with nicotine as a means to ending their cigarette smoking. In order to assist this group in continuing to end that addiction we will therefore provide further time for implementation of the change by establishing a streamlined process for patients obtaining prescriptions through their GP.  For this reason, the implementation timeframe will be extended by six months to 1 January 2021.

Response: not a single pro-vaping organisation or, to my knowledge, a single vaper thinks this is a good idea.  All are united in condemnation.  All see it as an assault on their own personal health strategy, and to my mind, the Minister is baiting them with insincere interest in their wellbeing.   The measure increases costs, delays, search time, complexity and practical difficulty.  It is far from clear how many doctors and pharmacies are willing to play ball and what sort of gaps in coverage it would create.  There is a third group that he ignores: that is a potentially large subset of Australia’s 2.9 million smokers who would switch to vaping in future if it wasn’t made so hard (by which I mean impossible) to get started. Who will use this method to try for the first time?

People should always be consulting their GP on these health matters and ensuring this is the right product for them. This will give patients time to talk with the GP, discuss the best way to give up smoking, such as using other products including patches or sprays, and if still required, will be able to gain a prescription. We note that the RACGP’s Supporting smoking cessation – A guide for health professionals stipulates that nicotine-containing e-cigarettes are not first-line treatments for smoking cessation.

Response: the main merit of this section of the press release is that it shows the Minister for Health does not really understand the products and behaviours he is trying to regulate.  Vaping products are not smoking cessation aids. I know that may be hard to grasp, given that people use them to stop smoking.  But that is because vaping works by replacing one consumer habit with another that is similar in many respects other than the risks to health. This is a very different paradigm from a medical intervention to reduce the cravings and withdrawal from becoming completely abstinent, and it is also why it works for many smokers. Of course, it makes sense for a vaper to discuss vaping with their GP (and to be proud and confident that they have found a way to quit smoking or are on the way there).  But this is very different from a GP being appointed to police and approve the options a smoker/vaper decides to take. Being, well, medics, it is likely that many GPs will be more inclined to a medical model and affinity with pharmaceuticals and pharma companies that to a consumer model that is unfamiliar to them. Medics medicalise.

During this time, the Therapeutic Goods Administration will undertake a formal review and consultation process regarding the classification of nicotine in the Poisons Standard which will inform the implementation.

Response: the Therapeutic Good Administration is a hammer and to the TGA every problem is, therefore, a nail.  It deals in medications and poisons, not in consumer products, behavioural science, or tobacco policy (other than allowing the most dangerous consumer products while banning the least dangerous).  Institutionally, it does not understand the products it is dealing with and how consumer factors like appeal, flavour, branding etc contribute to creating a successful low-risk alternative to smoking.  In fact, the TGA functions economically as a huge barrier to entry to competitors to cigarettes and is a major player in protecting Australia’s cigarette oligopoly from a competitive market.  Not only a stout defender of the cigarette trade, the TGA and its advisory committees have also set out their stall against the alternatives by rejecting proposed amendments to the poison standard to allow vaping and heated tobacco products (discussed above). Like all bureaucracies, they are conflicted by the pressure to show consistency over time and therefore they will be inclined to interpret the factual record in a way that confirms they were right all along.

The Victorian Poisons Centre reported a near doubling of nicotine poisons between 2018 (21 cases) and 2019 (41 cases), primarily caused by imported products of dubious safety and quality. A Victorian toddler died from nicotine poisoning in July 2018.

Response: and the Minister concludes by jumping to a classic self-immolating argument. Firstly, the poison call cases went up probably for two reasons: (1) the total number of users went up; (2) worldwide baseless hysteria about a US lung injury outbreak in 2019. An FOI request by ATHRA showed the numbers were both exaggerated and referred to calls, not poisoning episodes.  But to return to the reasoning in the press release. I have four comments.

• First, look at the scale of the problem in context: Victoria Poisons Information Centre received 41,714 calls in 2018, an average of 114 calls per day (Annual report, 2018) and the top reason for calling was Paracetamol (2,718) followed by Ibuprofen (1,326) . That brings perspective to the 21 and 41 cases reported by the Minister for the whole of 2018 and 2019 respectively. And these are not ‘poisonings’ but calls to a poisons phone line.
• Second, take a look at the accidents arising from smoking.   According to one summary on smoking and accidents: In Australia between 2003 and 2017, there were 900 deaths due to preventable residential fires; the most common causes of death were smoke inhalation and burns. For one-third of these fires, the cause was unknown. Of those with known causes, over a quarter of deaths were caused by smoking-related materials (around one third started in bed).¹² A recent report estimated the total annual cost of smoking-related fire damage in Australia to be $81 million.¹³
• Third, the Minister’s lamentation on the “imported products of dubious safety and quality” is plainly absurd. What does the Minister for Health think will happen if he makes it even harder for vapers to access vaping products from legitimate sources in Australia? If you want a safe and secure industry, the right may to do it is to make it easy for Australian vapers to access well-regulated vaping products from convenient Australian sources at affordable prices.
• Fourth, in the case of the tragic poisoning of the 18-month-old baby, the Minister for Health has some contributory negligence. Because of the Minister’s policy, the parents had imported high strength nicotine solution from the United States.  They had therefore brought a much more toxic substance into their home than any vaper would normally encounter if they were using regular commercial vaping products.  See the Coroner’s report on this awful case:

I’d be surprised if there is a more poignant counter-argument to Greg Hunt’s argument for prescription-only access to vaping products than the case study highlighted in his own press release.

Conclusion: the press release is a poorly-reasoned cover story for what is essentially state-sponsored harassment of thousands of Australian citizens trying to do the right thing.  To the extent there is any rationale here, it is something to with the protection of young people and non-smokers. But how much risk is there here?

The youth vaping is more complicated than it appears to be at first sight and we turn to that now.

14. The issue of vaping by adolescents and non-users

In summary, vaping among young people is at a low rate though, to some extent, some vaping is inevitable. Adolescents will always find a way to do what adults do – at least that has been the case with smoking, illicit drugs and many other risk behaviours. Even though illicit drugs are banned outright, young people can access them and there is no reason why that would not be the case with nicotine.  Because vaping is not particularly harmful, the risks to young people are not that serious compared to other youth risk behaviours. But the risk to adult smokers from an excessive policy response intended to protect adolescents from a relatively minor risk is the perpetuation of smoking and severe ill-health in adults.   However, even for young people,  the data needs unpacking: vaping, and especially frequent vaping, are concentrated in smokers or would-be smokers: for these young people vaping may be a beneficial diversion from smoking or other risk behaviours.

Now let’s take a look at some of the data behind this.

Vaping is one among many adolescent risk behaviours – we should focus on harm reduction, not abstinence. It goes without saying that no-one wants young people to vape. Or to smoke. Or to use illicit drugs. Or to drive dangerously. Or to drink and get drunk. Or to have sex before they are ready or the age of majority. Or to join gangs and carry weapons. Nor do we want to see bullying, sexual harassment, violence or mental health problems.  The point is that we do see all of these in young people, and as long as adults do these things, so will adolescents. In reality, the role of adult society is to reduce the harms caused to young people as they are and as they will grow up. It is not to strike unrealistic postures about abstinence and while being blind the perverse consequences of excessive interventions to control risks to youth.  Even totally outlawing something doesn’t make it go away:   according to the National Drug Strategy Household Survey, 15.9% of 14-19 year-olds used some sort of illicit drug in the previous 12 months.

Note: vaping was not included in the original table 1.14.  However,  Table 2.24 from the same survey shows that 2.8% of 14-19-year-olds reported the use of electronic cigarettes “daily, weekly, monthly or less than monthly”.

The lesson here is that youth risk behaviours are quite widespread and that even outright prohibition does not prevent them.  What is to stop whoever is supplying cannabis to this age group branching out into nicotine? What is to stop whoever supplies nicotine to young people under the Hunt reforms also offering other drugs?

Over time more non-users will start vaping having never smoked.  As vaping and other non-combustible products advance the obsolescence of smoking, we should expect more users to start without ever having smoked.  That is a good thing.  There is no virtue in a nicotine user having to become a smoker first before the public health establishment deems their vaping acceptable.  We should also not worry too much if adults who would never have become nicotine users try vaping: it isn’t especially dangerous once isolated from smoking and should have about the same level of concern as other recreational drug behaviours… caffeine and moderate alcohol consumption.  I explore these issues in The endgame revisited.

Some risks are more serious than others – a sense of proportion is important. Some adolescents indulge in risk behaviours whatever adult society tries to do to stop them – the law is rarely a barrier. These behaviours can be relatively harmful – opioids, drink-driving, binge-drinking, smoking, carrying weapons, teen pregnancy, texting while driving – or relatively benign – vaping or moderate drinking.  It is important to retain a sense of proportion about the landscape of youth risk behaviours.  Vaping is towards the benign end of the spectrum of risks and harms confronting young people.

Never consider youth vaping without also considering adults. A sense of proportion is important because in adult society vaping represents a major public health opportunity: it can displace the single most important modifiable risk factor for cancer, cardiovascular disease and COPD – and much else.  So if we are to shut down or severely curtail access to vaping to protect young people, then we need to weigh that possible benefit against the detriment to adults who would use vaping to quit smoking.  Middle-aged adult smokers who have been smoking for two decades or more are the real at-risk population.

Recognise that the interests of adults and adolescents cannot be separated.  It is not possible or desirable to separate the interests of adolescents and adults as if they are separate populations – the two are deeply entwined.

• Adolescents growth into adults and they have a stake in their options in the adult world – for example, young smokers have an interest in access to smokefree alternatives later in life
• Young people are hurt by smoking-related harms to a parent or other significant adults – through loss and grief or care burdens
• Young people are harmed by the drain of parental smoking costs on the household budget
• Parental smoking is a strong predictor of  youth smoking – there is an intergenerational transfer of smoking propensity that may be interrupted by parental diversion to vaping
• There are possible collateral harms associated with secondhand smoke, fires and parental stigma

Never consider youth vaping without also considering young smokers. According to the National Drug Strategy Household Survey (2019 date) by the Australian Institute of Health and Welfare, by 2019 current smoking among 14-17 year-olds was down to 3.1% from 15.4% in 2001 (Data Table 2.7).  But this low level is not as much cause for celebration as it may seem – the smoking prevalence is rising sharply through this age range and by age 18-24, it has reached 14.9% (down from 32.1% in 2001).

The decline is proportionately lower in the older age group (18-24) because initiation starts later – but it still starts. For adolescents and young adults, we should not overlook the importance of vaping as a diversion from smoking – and an option to prevent smoking from becoming an entrenched habit as they progress to adulthood.

Always look at the smoking patterns of young vapers.  The National Drug Strategy (Data Table 2.24) shows that just 1.8% of 14-17 year-olds are vaping.  But it also shows that youth vaping is concentrated in young people who smoke or previously smoked. For them, vaping may be beneficial.

The more frequent youth vapers are likely to be smokers.  There is quite a difference between someone who vapes every day and starts soon after waking and someone whose vaping experience is messing around at a party and blowing silly clouds a couple of times a month. Yet both are counted equally in the same headline statistic. To understand youth vaping statistics, it is important to understand the frequency distribution behind the headline figures.   We should be less concerned about the occasional users and focus more on frequent or daily users. But here we are likely to find that that the frequent users are those who are or would also have been smokers, and for whom vaping may be beneficial.  The National Drug Strategy Household Survey does not provide data tables for vaping frequency stratified by both age and smoking status. For all ages, Data Table 2.22 shows that daily use is concentrated in smokers and ex-smokers.

15. Lessons from the United States: drill down into the youth vaping numbers and the story changes

This data has, however, been produced for the United States.  Most of the worldwide concern about a “youth vaping epidemic” has been generated in the United States, notably when high school past-month vaping prevalence reached 27.5% (NYTS 2019) though its has since fallen back to 19.6% (NYTS 2020).  Yet, a closer examination of the headline numbers suggest that (1) most vaping is infrequent; (2) frequent vaping is concentrated in young smokers or former smokers; (3) very few never-smokers show signs of dependence.

Conclusions: While use of e-cigarettes in US high-school students increased sharply between 2017 and 2019, frequent use and signs of e-cigarette dependence remained rare in students who had only ever used e-cigarettes and never any other tobacco product.

We find a gaping chasm between the vision of an epidemic of e-cigarette use threatening to engulf a new generation in nicotine addiction and the reality of the evidence contained in the NYTS.  As patterns of youth nicotine and tobacco use continue to evolve, careful surveillance of survey findings will remain of critical importance.

Jarvis MJ, West R, Brown J. Epidemic of youth nicotine addiction? What does the National Youth Tobacco Survey reveal about high school e-cigarette use in the USA? (Preprint). Qeios. 2019 Oct 2; [link]

I have taken a similar cut of this data and segmented the 2019 ‘youth vaping epidemic’ past-30-day total prevalence of 27.5%, confirming that most adolescent vaping is infrequent (18.1% or two-thirds of high school vapers) and most adolescent frequent vapers are prior tobacco users (8.0% students or 85% of high school frequent vapers0 .

Finally, though US data prompted panic in the United States that spread beyond its borders, comparisons with other countries tell a different story.  In fact, when smoking and vaping are considered together, the position in the United States in 2019 looks better than Canada or England.  This could be because vaping is displacing smoking among young people in the United States, though this data cannot show there is that causal relationship.

Source:  Hammond D, Rynard VL, Reid JL. Changes in prevalence of vaping among youths in the United States, Canada, and England from 2017 to 2019. Vol. 174, JAMA Pediatrics. American Medical Association; 2020. p. 797–9. [link]  Annotations in red by me.

The chart shows that when the data are taken together, the nicotine use is broadly similar in this age group (16-19). However, the mix of nicotine use is different and weighted in favour of the less harmful vaping in the United States.  If the pattern of nicotine use is characterised by harm-weighting, then the real focus becomes smoking and vaping starts to look like a harm-reduction benefit rather than a detriment.

16. Addressing youth vaping while maintaining benefits for adults

Despite its possible role in reducing or displacing youth smoking, increased youth vaping is hardly a vote-winner or popular with the public or parents.

The challenge is to intervene in a way that does not make things worse for other at-risk groups – adult or adolescent smokers or would-be smokers.

Anti-vaping activists cannot even assume that if they are successful in preventing adolescent vaping, that these adolescents will not just shuffle their “sin portfolio” of risk-taking behaviours and start to do something else as risky or more risky – it may be smoking, it may be something else.

I would advise one over-arching approach: adopt a risk proportionate regulatory philosophy.  This means burdens and restrictions are imposed in proportionate to the risk, and in inverse proportion to opportunity. Alas, we are some distance from this rational approach in Australia.

Measure	Cigarettes, hand-rolling tobacco and other combustibles	Vaping, heated tobacco smokeless and oral nicotine
Taxation	Relatively high taxes	Low or zero tax (sales tax only)
Illicit trade	Track and trace (FCTC protocol)	Complaint-driven
Advertising	Prohibit other than within trade	Control themes and placement
Warnings	Graphic warnings depicting disease	Messages encouraging switching
Public places	Legally mandated controls	Up to the discretion of the owner
Plain packaging	Yes	No
Ingredients	Control reward-enhancing additives	Blacklist material health hazards
Flavours	Prohibit	Allow, subject to health hazards
Flavour descriptors	Not applicable if flavours banned	Control appeal to youth/trademarks
Age restrictions	No sales to under-21s	No sales to under-18s
Internet sales	Banned	Permitted with age controls
Product standards	Control risks and reduce the appeal	Control risks

Updated: Submissions to Australian Parliament Senate Inquiry into Tobacco Harm Reduction

Responses to the Australian Parliament Senate Select Committee on Tobacco Harm Reduction.

Clive Bates’ submission, 3 November: download PDF

Also submissions by prominent experts:

• Australian Tobacco Harm Reduction Association (ATHRA)
• Ron Borland
• John Britton
• Chris Bullen & Natalie Walker
• Coral Gartner & Wayne Hall;
• Peter Hajek
• David Sweanor
• Ken Warner