In a recent Medical Journal of Australia Insight blog on e-cigarette regulation, vaping promoter Colin Mendelsohn responded to a comment, writing “ecigs are consumer products. Medicines regulation is not appropriate. Why should they be regulated more strictly than cigarettes which can be bought at every corner shop?”

Then, without pausing for breath, in his very next sentence he goes on to tell us about how effective in smoking cessation they are, compared to nicotine replacement therapy (NRT), as one recent study reported them to be.  In case you missed it, NRT is a medicine regulated by the  Therapeutic Goods Administration, not a “consumer product” , whatever that might mean.  (see my previous blog and here for comments on the major limitations of the evidence that Mendelsohn cited)

Excitable News Corp journalist Joe Hildebrand puts it this way “How come it’s legal for me to walk into a convenience store and buy something that’s going to kill me but it’s illegal to buy the one thing that could save me?”

The one thing, eh Joe. Tell that to the 30% of Australia’s adult population who are ex-smokers who somehow managed to quit smoking without using an e-cigarette. About 5,440,800 of them, according to 2017-18 ABS data on smoking.

One problem with this trite comparison is that tobacco products are regulated in Australia in many ways that  Mendelsohn strongly opposes for ecigarettes.

• All advertising and promotion for tobacco products has been banned since 1994. Mendelsohn wants advertising for ecigarettes allowed
• the sale of fruit and confectionary flavoured cigarettes is prohibited in South Australia, New South Wales and Tasmania. He is strongly in favour of allowing many flavours, including those that may have high appeal to both adults and teens
• smoking is banned in all enclosed and several crowded outdoor areas like stadiums. He wants vapers to be allowed to smoke in areas where smoking is banned because he says this will add to the appeal of vaping and cause smokers to quit. The rest of us can just put up with clouds of vape like this is bars, restaurants and cinemas, apparently. When many vapers are present (and that would never happen of course), particulate matter levels can reach and exceed those that used to be recorded when smoking was allowed in crowded bars.
• Tobacco products are heavily taxed, depressing demand particularly among low income group and children. Mendelsohn supports reducing tax on ecigs, a policy that would make them more accessible to Australian children, of who only 1.9% smoke daily today.
• Retail display of tobacco products is banned nationally. Ecigarettes are on open display in retailers, something he fully supports
• All products are plain packaged, with large health warnings while packaging for ejuice is a cornucopia of beguiling images

Let’s repeat the same mistakes we made in allowing open slather sales and promotions with cigarettes

But more fundamentally, the galactic dangers of smoking were not fully understood for at least 40-50 years after mass consumption and the commerce that facilitated it had commenced in the first decades of the twentieth century. After mechanisation of cigarette production made them cheap as chips, it then took us 40 -50 years between the 1960s and today to fight for all the policies and campaign funding that have together taken smoking down to its lowest ever levels.

Out of ignorance and under sustained pressure from the tobacco industry, we began by making every regulatory mistake possible when cheap, mass produced cigarettes appeared. Our understanding of the health risks that may be posed by ecigarettes is in its early infancy, given the latency periods that apply with the development of chronic disease.

It is often said that if cigarettes were invented tomorrow, and we knew now what we didn’t know when they entered the market, no government in the world would permit their sale, let alone allow them to be sold in every convenience store.

With pharmaceutical products that save lives, treat illness and reduce severe pain, we allow only those with a 4 year pharmacy degree to sell them. And only to those with a temporary license issued by a doctor (a prescription) to use them. With cigarettes, we foolishly allow them to be sold everywhere.

Very few people (me included) are saying we should ban ecigarettes. But nearly every health and medical agency in Australia and many internationally, including the WHO, are saying that they should be strongly regulated through the TGA so that over time, as knowledge increases we could review whether looser or stronger regulation (perhaps including bans) was appropriate when that knowledge is available.

That’s the way nearly every country regulates pharmaceutical products. Strict, prescription-only regulation at first,  followed by evidence-driven loosening or tightening down the track.

Vaping advocates seem to have understood little from where we went so wrong in unleashing cigarettes and allowing them to be sold everywhere from the get-go. Today they are trying to walk on both sides of the street by insisting ecigs are not therapeutic goods, but in the next breath megaphoning claims about how good they allegedly are in helping smokers quit compared to other therapeutic goods.

Make up your minds?

This 2016  Lancet meta-analysis of smoking cessation and ecigarettes concluded that  ecigs were associated with less quitting among smokers. The 2018 report of the US National Academies of Science, Engineering and Medicine on ecigarettes concluded “Conclusion 17.1 Overall, there is limited evidence that e-cigarettes may be effective aids to promote smoking cessation.” NASEM rated limited evidence four rungs below “conclusive” evidence and just two above “no available evidence”.

[updated 27 March, 2020]

Since I published this blog this time last year, I’ve seen a further critique written by  Prof Matthew Peters, a respiratory specialist from Sydney’s Concord Hospital and former chair of Action on Smoking and Health Australia.  Here it is, with the original blog following below)

Electronic cigarettes vs NRT for smoking cessation – the sting is in the tale.

In February 2019, Hajek and others published results of a randomised trial of nicotine replacement therapy (NRT n=446) vs use of a second-generation refillable e-cigarette device (n=438) in the New England Journal of Medicine. Subjects were all self-selecting attenders at U.K. National Health Service stop-smoking services.

The  paper attracted considerable attention as it was a randomised study with an active control arm and used modern e-cigarette (EC) devices. Compared to the few previous randomised trials which used earlier generation ECs, it had a substantially greater effect size with relative risk of 1.75-1.84, (depending on adjustments and exclusion of certain subjects) for the primary outcome variable of continuous abstinence at 52 weeks. In media discussions since, this  effect was commonly rounded up to a doubling of smoking cessation compared to NRT.

Three other smoking cessation outcomes were also reported or calculable from data in the paper and the associated supplement. 

1. Intention to treat (ITT) allocation to EC was not associated with reduced risk of relapse beyond 4 weeks after the target quit date. This was so even though EC use continued at a rate of 40% vs 4% for NRT.
2. The relative risk (RR) for 7 days point-prevalence abstinence at 52 weeks was 1.52 for EC vs NRT
3. The RR for continuous abstinence and being smoke and nicotine free at 52 weeks was approximately 0.5 for EC vs NRT. The ITT e-cigarette arm had 14 (3.1% smoke-free/nicotine free subjects compared to 31(6.9%) in the NRT arm.

If the beneficial effect is based on factors within the first 4 weeks, it is critical to exclude biases in the administration of the intervention and control treatments and to consider whether there may have been participant biases. Here, it is a problem that the control intervention was poorly applied. In the first 4 weeks, only 10% reported use of NRT daily vs 53% for those randomised to e-cigarettes. 25% of the NRT subjects used it on 19 or fewer days.

The investigators sought per protocol to exclude potential participants who may not have been equally disposed to one or other treatment but probably did not succeed. 91 NRT subjects did not complete 4-week follow-up compared with only 63  with e-cigarettes and these were counted as continuing or relapsed smokers as is standard practice in trials. Reinforcing the probability that the participating subjects were more favourably disposed to EC than NRT, crossover from NRT to e-cigarettes occurred around three times more often than e-cigarettes to NRT. In contrast, there was no difference for varenicline.

Critically, a statistical oddity underpins the high relative risk for continuous abstinence at 52 weeks. Continuous (CA) or prolonged abstinence and CO-confirmed 7-day point prevalence abstinence (PPA) are equally valid, highly correlated smoking cessation study end-points. CA cannot, by definition, exceed PPA. Hughes and others found a ratio of 0.74 from a systematic review of smoking cessation intervention studies. Viewing consolidated data from the paper and supplement in one table provides the best insight into the problem.

	PPA- EC (n)	CA-EC(n)	CA/PPA Ratio	PPA-NRT(n)	CA-NRT(n)	CA/PPA Ratio	RR for PPA (unadjusted)	RR for CA (unadjusted)
4 weeks	195	192	.985	136	134	.985	1.46	1.45
26 weeks	158	155	.981	115	112	.974	1.39	1.40
52 weeks	146	79	.541	98	44	.449	1.52	1.83 (Primary comparison)

Abbreviations used: CA continuous abstinence; PPA point prevalence abstinence; RR relative risk

What is clear that a dramatic fall at 52 weeks in CA/PPA for e-cigarettes and an even greater fall for NRT were required to achieve the headline relative risk for continuous abstinence with both ratios being well outside Hughes’ mean estimate. It is possible that the standard for continuous abstinence (not more than 5 cigarettes after quit date) contributed to CA/PPA being so different at 52 weeks compared to 26 weeks but this does not explain why the decline for NRT was so much greater.

Until this anomaly is explained, we are left with the more solid smoking cessation data being 7-day point prevalence CO-confirmed abstinence. That figure of about 1.5 at 52 weeks could still suggest that high nicotine delivery systems outperform older generation e-cigarettes for cessation outcomes but this finding would still need to be considered in the light of sharp differences in the application of e-cigarettes and NRT control in the critical first 4 weeks.

Behavioural support

Importantly, all trial participants also received “weekly behavioural support for at least 4 weeks”, with the authors noting in their conclusion that “E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support.”. This support “involved weekly one-on-one sessions with local clinicians, who also monitored expired carbon monoxide levels for at least 4 weeks after the quit date.” Eighty one percent of participants received 4 or 5 support sessions.

However, in real world use of either NRT or ecigs for smoking cessation, only a very small proportion of smokers would receive such support. Important questions therefore arise about the relative contributions of NRT and ecigs, to that of the support which all received. A study of a national English prospective cohort of 1560 smokers found “the adjusted odds of remaining abstinent up to the time of the 6-month follow-up survey were 2.58 (95% CI, 1.48-4.52) times higher in users of prescription medication in combination with specialist behavioral support”. However “The use of NRT bought over the counter was associated with a lower odds of abstinence (odds ratio, 0.68; 95% CI, 0.49-0.94).” This suggests that real world use of NRT without support may be ineffective.

Serious adverse events

The notion that new-generation e-cigarettes would be able to deliver more of the “good stuff”, nicotine, and not more of the bad stuff – toxic products of superheated vehicle solvents and flavourants was always questionable. This study reports numerically more serious adverse events in the e-cigarette arm than the NRT arm – 27 vs 22. Excluding malignancies, there were 7 potentially smoking related serious adverse events (SAEs) – one fatal- in the e-cigarette arm and 4 in the NRT group even though smoking rates remained higher in the NRT arm. Of the 5 respiratory events with e-cigarettes (vs 1 with NRT), the investigator concluded in each case that e-cigarette use was unrelated. The risk disparity 1.1% vs 0.2% was in the authors’ published conclusion – “likely a chance event”. This would suggest that there is a lack of objectivity and/or openness to emerging risks of e-cigarettes.

These safety findings are consistent with the failure of e-cigarette use, whether as complete or partial substitution for smoking, to reduce potential smoking-related disease or to meaningfully improve general health in a 4-year prospective study. Here with no reduction in potentially smoking related serious adverse events and an imbalance in respiratory SAE’s, serious doubts are created in relation to claims that use of latest generation e-cigarettes is 95% safer than smoking; if it is safer at all.

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Original blog

The New England Journal of Medicine has just published the results of a randomised controlled trial on the relative efficacy of e-cigarettes v nicotine replacement therapy.

Here are the results and conclusions from the abstract (the full article is paywalled).

Results A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.

Conclusions E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support.

This study is already causing the predicted outbreak of gushing hyperbole from e-cigarette interests and their urgers.

Professor Martin McKee, from the London School of Hygiene and Tropical Medicine, has shared the following comments about the paper that are very useful.

“The subjects were people who had already decided to attend a stop smoking service. Then, randomisation only began after they had set a quit date. In other words, they were very far from a random sample of smokers. They also excluded existing dual users. [note dual e-cig and cigarette use is by far the most common way that e-cigarettes are used].

Outcome was self-reported use of less than 5 cigarettes from 2 weeks post enrollment to 1 year, and validated, but only by 1 biochemical (CO) test at 1 year, which would only capture very recent smoking.

Among those who did give up, 80% in the e-cig group were still using them, but only 9% of the NRT group were using NRT. Given evidence from other studies, such as the US PATH study, that over longer periods quite a lot of e-cig users relapse, it will be important to look at longer term follow up. (The authors say 80% is “fairly high”!)

They say “Provided that ongoing e-cigarette use has similar effects to long-term NRT…” but then refer to 1988 study. And they say nothing about health risks of e-cigs.

Finally, as they note, this study is inconsistent with 3 previous ones.

So, in summary, I would say:

“This study differs from previous ones in finding that e-cigarettes do seem to be better than NRT at maintaining abstinence, at least for one year, in a highly selected group of people who have already decided to quit and have taken steps to get help with it. Of course, the vast majority of those who quit do so unaided, but, nonetheless, these findings are interesting, although it will be important to see what happens in the longer term. It is, however, important to recognise that it only relates to those who are using e-cigarettes when linked to face-to-face support from a smoking cessation service. It tells us nothing about their use in the wider population of smokers, which is where many of the concerns lie.”

Here’s another comment

“E-cigarettes may be better than the nicotine replacement alternative in the [NEJM] study — but they only helped a minority of participants in the vaping group quit. “In spite of the concerted effort and encouraging findings, it is still disappointing,” said David Liddell Ashley, the previous director of the office of science in the Center for Tobacco Products at FDA [Food & Drug Administration]… So this randomized controlled trial might — and probably should — encourage health professionals to consider e-cigarettes, at least the type shown to be effective in the study, as a tool for their smoking patients. But it also shows e-cigarettes are far from the panacea some suggest they might be.” [Julia Belluz. Study: Vaping helps smokers quit. Sort of. Vox] 

Behavioural support: little real world relevance

To this I would emphasie that the participants in the trial received not only e-cigarettes or NRT, but they self-selected to attend a quit smoking service and received “behavioural support”.  This means these subjects were very different to random e-cigarette or NRT users in the English community, the great majority of whom do not elect to attend such services.

In Australia, despite the quitline phone number being on  every cigarette pack and it being hammered in many quit smoking campaign ads, only 3.6% of smokers ever called the quitline over a year. Far fewer are interested in attending “behavioural support” sessions. So this paper has very important limitations in its relevance for debates about whether e-cigarettes (or NRT) can assist people to quit under conditions of real world use.

We know from recent real world longitudinal studies of people who vape in the USA that e-cigarette users actually do worse with quitting than those who use other forms of smoking cessation aids, and particularly those who quit unaided. I covered this in an earlier blog here.

We also know that over-the-counter NRT, used without support in the normal way that nearly all users use it, is not effective. See for example here  (“The use of NRT bought over the counter was associated with a lower odds of abstinence (odds ratio, 0.68; 95% CI, 0.49-0.94).). In other words, using NRT like this might actually prevent quitting. Big Tobacco, now with major investments in e-cigs and heat-not-burn products, will be praying the same thing is true for e-cigs. And if they are wise investors, also very confident that the net effect of e-cigarette proliferation will be to keep far more people in smoking than are tipped  out of it, and that it will provide nicotine addiction training wheels to many children who have never smoked and probably never would have.

This week’s Menindee fish kill is third major kill in the upper Darling River  in five weeks. It reportedly involves hundreds of thousands of fish, coming on top of an estimated “up to a million” three weeks ago. On January 15, the ABC reported that contractors would start  the next week on the task of cleaning up the fish carcasses and that they had a window of five days to remove them before most would have sunk to the bottom to rot.

With the wait that occurred to appoint the contractors, it is plain that huge numbers would have sunk into the mud where the bacteria that causes putrefaction would have massively added to the oxygen depleted water problem initially caused by algal blooms. Ecosystem disaster language is being used without exaggeration.

A Central Darling Shire Council spokesman said that there were “very few contractors with the resources to deal with a problem of this scale.”  But the task they would face with a million floating dead fish is of galactic proportions.

Removing a million fish in five days before they sink means 200,000 a day. If contractors worked eight hours a day at the task, that would require 25,000 per hour or 417 a minute. If the average fish weighed 2kg, that would mean 50 tonnes per hour would need to be hauled in from drag nets, then removed into dump trucks and transported to landfill.

The figure of a “million” dead fish has been repeated in nearly every news report of the biggest kill. It remains a guesstimate because no one knows with any accuracy how many fish are actually in our rivers. It could be less, but with many thousands of fish having already sunk, it may well have been even more.

Drag netting a river as narrow as the Darling, with its river bank vegetation, tree roots and dead wood often blocking your way is a totally different proposition to unimpeded ocean net fishing where massive numbers can be scooped up quickly. The disruptions and entanglements this would cause would mean untold thousands of fish will need to be painstakingly removed with scoops and gaff hooks where nets can’t be used.

Source: Sydney Morning Herald

If this Armageddon scale clean-up was in fact proceeding on schedule, embattled politicians would have surely lost no time in having the flotilla of boats, the armies of workers, the convoys of dump trucks laden with carcasses and the squadrons of bulldozers burying the bodies shown on every news bulletin, just like we saw with the unforgettable pictures of the 1996 gun buyback.  So where are they? “Porcine aviation” is a likely apposite comparison.

These unplanned incidents should give us alarming pause at the still-active plans to release carp herpes virus into Australian rivers in the hope that this will eradicate these maligned river rabbits. Championed by Barnaby Joyce, the National Carp Control Plan has not yet been abandoned, despite its leader resigning last year  The same blithe assurances we have just seen with the Menindee mass kills have also been given about clean-up teams whisking away the millions of dead carp.

Yet in all that has been said about the herpes release plan, no detail has been provided about clean-up, beyond vague talk about paying local Dad’s Army groups to remove and dispose of dead fish. The task here would be more than daunting. The Lachlan river is 1,440 kilometres long, the Murrumbidgee 1,600 and the Murray-Darling, 2,507km.  Huge stretches of these are sparsely populated.

The unplanned clean-up “death rehearsal” in real world conditions we are now seeing shows that herpes cure for the carp problem may well be far worse that the concerns it now poses. To cap off the folly, last November, aquatic zoologists from the University of Sydney concluded that the carp virus plan would not work anyway, saying there was little evidence to suggest that repeated carp virus outbreaks would recur at a magnitude to counter the reproductive potential of surviving, resistant carp.

Disclosure: I am patron of the Australian Koi Association. See previous writing on this issue here:

Chapman S. Plan to kill carp with herpes could prove as foolish as the cane toad. Sydney Morning Herald 2018; May 4.

Chapman S. Carpageddon is coming, but we’re not prepared. Sydney Morning Herald 2017 Apr 11

Chapman S. Stinking dead fish portend major problem with carp herpes release. The Conversation 2017; Jan 18.

Chapman S. Should we release the deadly carp virus into our rivers and water supplies? The Conversation April 18, 2016

The first mobile phone in Australia was switched on in 1987. Since then, their use has grown to become almost universal among teenagers and adults for 15 years. There are millions of Australians who have used the phones many times daily since the mid 1990s (24 years). WiFi has been spreading massively in Australia since 2002 (17 years).  If I look at the WiFi neighbourhood networks visible to my home computer, there are 13. If you do the same in a Hong Kong hotel room, pages and pages of network addresses point to a EMR bath you are living in.

If mobile phones really caused brain cancer, today we are in a very good position to test that hypothesis because of the massive numbers who have been exposed, the duration of that exposure and the very high reliability of the outcome endpoint: brain cancer incidence.

If you are diagnosed with any cancer (including brain cancer) in Australia (and many high income nations) your doctors have long been legally obliged to notify cancer registries of the fact. It is not like a diagnosis of  back pain, a bad cold, or migraine where your medical records will contain that information, but only sampling studies of such records can be used to estimate national incidence.

In 2016, three colleagues and I published a study designed to test the proposition that the proliferation of mobile phones and transmitter towers since the late 1980s, as well as  WiFi, cordless phones, Bluetooth and smart meters, may have been “causing” an increased incidence of brain cancer. Brain cancer is the usual focus of alarmist groups pointing the finger at the alleged risks of these devices.

We found no increases for any age group except the very oldest age group, and that increase commenced before mobile phones were even available in Australia, and so clearly could not be explained by their introduction. It was almost certainly due to the introduction of advanced medical diagnostic scanning equipment which likely saw some events once diagnosed as cerebrovascular, reclassified as brain cancers.

Where are all the bodies?

So the teensy-weensy problem-ette with mobile phone alarmists central claim is that there has been no increase in brain cancer incidence (ie: the age-adjusted rate of newly diagnosed cases per 100,000 population) in Australia since cancer registry records began being kept in 1982. This has now been the exclusive focus of two papers: ours plus a 2018 reworking of the same data to also consider sub-types of brain cancer.  Similar results have been reported for England, the USA, the Nordic countries  and New Zealand.

The most elementary test of the hypothesis that your mobile phone and other appliances may give you brain cancer has now repeatedly fallen at the first and most obvious hurdle. If they cause brain cancer, where are all the bodies?

When the 2018 paper was published, we saw some of the same usual suspects reprising their favourite arguments on social media. Several of these were thrown at out 2016 paper, which we rebutted  here (reader warning: barely restrained academic bloodsport).

Mobile phone alarmists are a relentless (small) lobby group who are risk-phobic about almost every new form of communication. Every time there’s a new generation of cell phone or electronic technology, they crank out the same fear-mongering stuff.  Cult-like, they wake every morning, to spread the word about the deadly rays they believe are being foisted on the world by the evil telecommunications industry. They follow in the hallowed footsteps of those in history who raised health alarms about railway travel, electric light, ordinary phones, radio, TV, electric blankets, computers, microwave ovens, wind turbines and solar roof cells etc. Some are also anti-vaccination (eg: this is one of their US queen bees).

The most amusing example was the terrifying prediction published in 2006, that by 2017, half of the entire world’s population would be struck down with “electrosensitivity” caused by exposure to electrical equipment and power lines.

They often are associated with formal sounding agencies or networks which are nothing but lobby groups of like-minded electrophobics.

The most common  “yes, but…” card dealt by these people to studies showing no rise in brain cancer is that “it is too soon to know .. the tidal wave of brain cancer is a few years off yet.” They often use the 30-40 latency period between onset of smoking and lung cancer as an analogy. But this is simply a case of these people trying to walk on both sides of the street. As we wrote in our response:

” Further, we are perplexed that on the one hand, Bandara [one of our critics] argues that this association needs to be studied for “several decades until common use would accumulate decades of exposure comparable to long latency periods of brain tumours”, while in Morgan’s paper (written by 3 out of 4 authors affiliated with the Environmental Health Trust with which she [Bandara] is also affiliated) excess relative risks between mobile phone use and brain cancer are argued as occurring following exposures of as little as between 5 and 10 years of mobile phone use. Morgan et al. even suggest that the INTERPHONE study may suggest a “promotion effect” with use as few as 1–4 years (see their Table 2).”

With any cancer, we see latency periods between exposure onset and peak new incidence of the cancer of concern. But in the years and decades before that maximum incidence rate is reached, we see evidence of a slowly rising incidence.

For example, smoking prevalence grew rapidly from the late nineteenth century, following dramatic price falls when cigarette manufacturing became mechanised. In 1971, Alton Oschner. a renowned US surgeon, reflected on his first encounters with a lung cancer case in 1919 and the slow-burn rise in the incidence of the disease in the decades that followed.

“Bronchogenic carcinoma, which was an extremely rare disease until the mid 1930’s, is increasing faster than any other cancer in civilized countries. In 1919, its incidence was so rare that when I was a junior medical student in Washington University, the two senior classes were asked to witness the autopsy of a man having died of carcinoma of the lung because Dr. George Dock, Professor of Medicine, thought we might never see another such case as long as we lived. Being young and impressionable, this impressed me very much. It was not until 1936, 17 years later, that I saw my next case of bronchogenic cancer, and in a period of six months

I saw nine cases. Having been impressed with the rarity of the condition in 1919, this seemed indeed an epidemic. Because all the patients were men, heavy smokers, and had begun smoking at the beginning of the first World War, and after determining that the consumption of cigarettes was relatively low in the United States until the first World War, when there was a tremendous increase, I had the temerity to predict that cigarette smoking was responsible for the increased incidence.”

With the brain cancer-mobile phone claim, we are not seeing even an upward trickle in incidence despite many millions of person-years exposure.

As it dawns on these cultists that the evidence from whole population cancer incidence studies is not allowing them to win this argument, some start trying to blame all sorts of problems on the exposure using the fallacy “after, therefore because of”.  Health problems that are increasing include autism and depression.  And so is mobile phone use. Ergo,  mobile phones are probably causing these problems, runs the next phase in their argument.

A recent determined emailer asked me, knowingly: “If someone repeated your study with respect to the incidence of depression since the introduction of mobile phones, instead of with respect to brain cancer, I wonder what they would find. The following graph suggests that depression is on the rise with ever higher rates at earlier ages in every new generation.”

When I was teaching in my university’s Master of Public Health program I used to set my more wide-eyed students a question to try and get them to understand the difference between association and causation: “95% of people involved in car crashes on the way to work are found to have eaten breakfast in the 90 minutes before. Eating breakfast causes car crashes. Discuss.”  Mobile phone phobics might learn something from thinking about that question. But I doubt it.

 

Declaration: mobile phone opponents often ask if I have any competing interests in this issue (ie support from the mobile phone industry). In 1997 (22 years) ago, I had a small grant ($23,895) from the  Australian Mobile Telephone Association (AMTA) to conduct a national survey of mobile phone use in emergency situations. None of that money benefited me or my co-author personally but paid for the conduct of the survey. We published this paper: Chapman S, Schofield WN. Lifesavers and samaritans: emergency use of cellular (mobile) phones in  Australia. Accident Anal Prev 1998;30:815-9.

Most research grant agencies and journals have policies that competing interests extinguish after (typically) 3-5 years from the end of the grant. I have never received any support for my work on mobile phones and cancer, and could not name a single employee of AMTA or any telecommunications company.

 

Any radio discussion of ecigarettes inevitably attracts evangelical callers wanting to tell their story of the miracle they have experienced:

• “As a fortunate survivor of extended tobacco addiction, 40 years of a pack a day, I have not smoked a single bit of tobacco since I started vaping 5 months ago. I was able to finally give up tobacco after failed attempts at cold turkey, patches, and gum as NRT”
• “I know about 200 people in our small town of 3000 that vape, and only about 3 of those still smoke some cigarettes, and those that do have cut consumption by about 90%.” [note here that a recent English analysis concluded “If use of e-cigarettes and licensed NRT while smoking acted to reduce cigarette consumption in England between 2006 and 2016, the effect was likely very small at a population level.”)

As I’ve previously summarised, there are many reasons why such testimonial statements are considered the weakest form of evidence in answering questions about whether ecigs are serious new entrants in the population-wide game of helping smokers to quit.

The obvious problems with individual testimonies are self-selection bias (people with a success story are far more likely to want to enthusiastically proselytise their story than the many who try and fail); lead time bias or “borrowing from the future” (some people who quit would have quit weeks or months later anyway, perhaps on their own or using another approach, thus artificially inflating the apparent importance of the method they used when they quit); and relapse.

Relapse is a major, much studied sequalae to quit attempts. Far more smokers relapse than quit permanently. Across all methods, relapse dominates, with the maximum rates occurring in the first month after an attempt (eg: see table below).

Source

This means that cross-sectional (“snap-shot”) surveys which report findings on what people’s smoking status is on the day they answered the survey questions have major limitations. Many people have inaccurate recall of their smoking and quit attempt histories and many people who report being ex-smokers on the day they answered the question would answer that they had returned to smoking if asked the same question a few weeks or months later.

For example, this study proposed that by 2014, 6.1m Europeans had quit smoking by vaping. But such “big” numbers often do not withstand scrutiny. The 6.1 million number comes from a cross-sectional survey where ex-smokers reported they used to smoke, then used e-cigarettes and now don’t smoke. Were it only that simple. This critique makes the key point that the survey questions would have allowed those who quit for only a short period to say they had stopped, when relapse is a major phenomenon and demands a longer-term view.

The critics also asked:

“… how many of those who claim that they have stopped with the aid of e-cigarettes would have stopped anyway, and how many of those who used an e-cigarette but failed to stop would have stopped had they used another method?”

Randomised controlled trials?

Well conducted randomised controlled trials are considered high quality evidence, but have major problems that make them difficult to generalise to “real world” settings. If you volunteer to participate in a trial, you are likely to have a disposition to want to help science and so will probably be very positive and diligent about following the study protocol – unlike the way many in real world conditions forget to take their drugs or relapse. Trial participants are regularly contacted by study organisers trained in  cohort retention strategies. This regular contact can result in trialists wanting to please “the lovely research assistant who calls me up each week” and can artificially increase study group retention rates, again unlike real world use where no such influences occur.

And if you are heavily dependent on nicotine, enrolled in an RCT  and allocated to a study arm with placebo nicotine, guess what? Your withdrawal symptoms will quickly let you know that you are not getting any nicotine, so your belief that the nicotine replacement (NRT or ecigs) you hope you are using might do the trick will instantly be in tatters, with undermining consequences for your quit attempt.

For all these (and several other) reasons, the most important forms of evidence about how people quit smoking are longitudinal cohort studies which use high quality participant selection protocols to best ensure that those being interviewed are a representative sample of the smoking population. With smoking cessation, the endemic problem of high relapse back to smoking makes it vital that we take a helicopter view across time of how long transitions in and out of smoking last, long term and permanent quitting, being the ultimate outcome of interest. The large body of evidence we have about relapse heavily underlines that “persistent abstinence” is of far more importance than a former smoker’s smoking status on a particular day, which can change quickly.

In 2018, two particularly important papers were published by US researchers using the longitudinal PATH ( Population Assessment of Tobacco and Health) data set.

Let’s take a close look at what they found.

Coleman B et al, Tob Control 2018;0:1–10. doi:10.1136/tobaccocontrol-2017-054174

This important report on transitions in the vaping and smoking status of a nationally representative cohort of American  adults  aged 18+ who use electronic cigarettes (EC) provides rich data that greatly advances our understanding of the natural history of EC use.

If we examine the report’s data and consider the net impact of vaping on the critical goals of having vapers stopping smoking and vaping non-smokers not starting to smoke, the findings are very sobering and should give strong reason for pause among those advocating e-cigarettes as a game-changing way of stopping smoking.

The study reported on transitions between participants’ responses at Wave 1 and Wave 2, obtained 12 months later. At Wave 2, of the cohort of 2036 dual users (EC + smoking) only 104 (5.1%) had transitioned to exclusively using ECs and another 143 (7%) had quit both EC and smoking for a combined total of 247 (12.1%) who had persistently quit smoking. Of the 896 exclusive EC users at Wave 1, 277 (30.9%) had stopped vaping at Wave 2.

So together, 524 out of the 2932 EC users (17.9%) followed from Wave 1 might be considered to have had positive outcomes at Wave 2 (ie: quitting smoking and/or quitting EC).

The other side of the coin however, shows that of the 2036 dual users at Wave 1, 886 (43.5%) relapsed to using cigarettes exclusively. In addition, among the 896 exclusive ECusers from Wave 1, 109 (12.2%) had stopped vaping and were now smoking, with another 121 having resumed smoking as well as using EC (i.e. became dual users). Importantly, 502 of 896 (56%) exclusive e-cigarette users were those who had never been established smokers prior to using e-cigarettes. Alarmingly, of these 502 adults, 120 (23.9%) progressed from using only e-cigarettes to either dual use (54 or 10.8%) or smoking only (66 or 13.2%).

Taken together, 886 dual users in Wave 1 relapsed to become exclusive cigarette smokers in Wave 2, and 230 exclusive vapers in Wave 1 took up cigarette smoking in Wave 2 (dual use or exclusively cigarettes). Undoubtedly, these should be considered as negative outcomes.

The table below shows that for every person vaping at Wave 1 who benefited across 12 months by quitting smoking, there were 2.1 who either relapsed to or took up smoking. Most disturbingly, in this adult cohort nearly one in four of those who had never been established smokers took up smoking after first using EC. Concern about putative gateway effects of ECs to smoking have been dominated by concerns about youth. These data showing transitions from EC to smoking in nearly a quarter of exclusive adult EC users with no histories of established smoking should widen this debate to consider adult gateway effects too.

By far the largest proportion of those with negative outcomes are those dual users who relapsed to smoking (886 or 43.5% of dual users). As the authors noted in their discussion, many of these were infrequent EC users, possibly involved in transitory experimentation at Wave 1. If we add the 902 who were still dual using at Wave 2, then 1788 of 2036 dual users (87.8%) in this sample might be said to have been held in smoking (dual using or exclusive smoking) 12 months later compared to 12.1% dual users who may have benefited by using ECs.

Commercial interests in both the tobacco and EC industries would be more than delighted with these findings. However, from public health harm reduction perspective these results argue against EC being a revolutionary effective harm reduction strategy, and point to their far stronger potential to both recruit smokers and hold many smokers in smoking.

Benmarhnia T et al American Journal of Epidemiology 2018 DOI: 10.1093/aje/kwy129

In a second paper using the PATH data, the authors considered persistent abstinence (not using tobacco for more than 30 days). The red highlighted section of the table below shows that those smokers who used ecigs (called ENDS in the table) had the worst persistent abstinence all-tobacco quit rates of any group in the cohort (5.6% of those who were vaping at the Wave 1 survey  and 3.7% of those who too up vaping between Wave 1 and Wave 2). By far the most successful all-tobacco quit rate was for “no aid used” (ie cold turkey or unassisted cessation) with 12.5%.

When we multiply these quit rates by the numbers of smokers using each quit method, the yield of persistent quitters is even starker (see the second table below derived from the data in the table immediately below).

So in this major national cohort of US smokers, not only did EC use produce the lowest rate of persistent abstinence from tobacco use after one year compared to all other quit methods, but EC’s contribution to population-wide tobacco abstinence was utterly dwarfed by all other methods (10.9% v 89.1%). The much-denigrated and neglected unassisted cessation approach quietly ploughed on, continuing  its massive historical dominance of how most ex-smokers quit, contributing 1.5 times more quitters than all other methods combined.

ATHRA, a small Australian lobby group for e-cigarettes with a Twitter following today of all of 494 (including many vaping activists from overseas), often argues that smoking prevalence in Australia is lagging behind the US and the UK. Its website states “Australia’s National Health Survey confirms that smoking rates have plateaued in Australia. According to the national survey this month, 15.2% of Australians adults smoked in 2017-18 compared to 16% three years ago.”

“Current smoking” to the Australian Bureau of Statistics means daily smoking plus “other” which means “current smoker weekly (at least once a week, but not daily) and current smoker less than weekly.” We now have 13.8% of adults smoking daily, and a further 1.4% less than daily.

And very critically, unlike in the USA and the UK, Australian data on “smoking” explicitly include use of other combustible tobacco products (see questions establishing “smoking” below). This means that Australia’s 2017-2018 15.2% smoking prevalence includes exclusive cigarette smokers, all cigarette smokers who also smoke other combustible tobacco products and any smokers who exclusively smoke any of the non-cigarette combustible products (eg: cigars, cigarillos, pipes, waterpipes, bidis).

ATHRA repeatedly asserts that the US and the UK, both awash with ecigarettes, have both galloped ahead of Australia in reducing smoking. A tweet from November 9, 2018 (below) shows  a graph they like to use.

US smoking prevalence: 14%  … or as high as 17.3%?

ATHRA’s graph above shows the US National Health Interview Survey (NHIS) “18+ smoking rate” being 14% for 2017. NIHAS defines “Current cigarette smokers [as] respondents who reported having smoked ≥100 cigarettes during their lifetime and were smoking every day or some days at the time of interview.”

But in fact, 14%  is the US prevalence for only cigarette smoking, not all smoking— see https://www.cdc.gov/nchs/nhis/SHS/tables.htm If we add all the other smoked tobacco products in widespread use in the USA (cigars, cigarillo, pipes, water pipes, hookahs, bidis) the prevalence of smokers who use any combusted tobacco product rises to 16.7% with an upper confidence internal boundary of 17.3% (see the table here).  Quite a way above Australia’s 15.2% rate.

More recent US data for the first half of 2018 show “the percentage of adults aged 18 and over who were current cigarette smokers was 13.8% (95% confidence interval = 13.08%-14.53%) which was not significantly different from the 2017 estimate of 13.9%.” So far, ATHRA has not issued any public statements about the fall in cigarette smoking stagnating in the US despite some 3% of adults vaping, but these can’t be far off. Surely?

The year before (2016), also in the midst of untrammelled ecigarette promotions, the prevalence of current cigarette smoking among US adults was 15.5%, a  slight but statistically nonsignificant rise from the 2015  figure of 15.1%.

Also, the 2016 NHIS US cigarette smoking prevalence estimate (15.1%) was a massive 24.5% lower than seen in the cigarette smoking prevalence figure (21%) for those aged 18+ in the 2015 National Survey on Drug Use and Health (NSDUH). With such different estimates, plainly, the real proportion is debatable.

A commentary in Addiction published in March 2017 commenting on another US survey noted “While it is possible that some proportion of non‐cigarette combustible tobacco use is concurrent with cigarette smoking, it is likely that overall combustible tobacco use prevalence for adults 18+ in the United States is higher than 15.2%, and somewhere in line or just below the 2013–14 National Adult Tobacco Survey (NATS) estimate that 18.4% of US adults aged 18+ were current users of any combustible tobacco product (defined by NATS as use every day or some days, with different thresholds of life‐time use by combustible tobacco product)”

UK

The UK government’s official smoking survey asks “do you smoke cigarettes at all nowadays? Please exclude electronic cigarettes”. In 2017, 15.1% of UK adults aged 18+ answered yes, but this figure also does not include people who smoke only non-cigarette combustible tobacco products such as cigars and pipe tobacco. So yes. 15.1% may be a cigarette paper below Australia’s 15.2% rate but it’s hardly a “man the lifeboats, the boat is sinking” difference that ATHRA and its spokespeople try to paint.

Latest adult prevalence data summary

• Australia: 15.2% (includes cigarette smokers plus all exclusive users of other combustible tobacco products)
• UK: 15.1% (cigarettes only: other exclusive combustible tobacco product users to be added)
• USA: 13.8% (cigarettes only: other exclusive combustible tobacco product users to be added)

And mostly down to ecigarettes?

ATHRA  argue that the widespread use of ecigarettes is a major factor explaining the falls in smoking prevalence in the UK and the USA. The graph below from the Smoking in England project transposes the dramatically increased use of ecigarettes in quit attempts with the slow decline in adult smoking prevalence in England.

No one could look at this graph and point to any clear relationship between the two.

By contrast, the graph below shows the relationship between cigarette costliness and smoking prevalence in the UK. It is very clear that as the real price of tobacco rose (and hence costliness increased) that smoking prevalence fell, in an almost complete inverse relationship.

Source: Smoking prevalence and Tobacco affordability index

Huge prevention effect of Australian tobacco control

Colin Mendelsohn from ATHRA has been beating the same “the wheels have fallen off falling smoking prevalence” drum since 2017. I criticised his statements at length here in August 2017.

What’s missing in his almost total focus on what’s happening with smoking prevalence, is that while Australia’s current decline in smoking prevalence status compares favourably to the US and UK, our data on youth smoking prevention are quite stunning. Only 1.9% of 15-17 year old Australians smoked in 2017-2018, down from 2.7% in 2014-2015 and 3.8% in 2011-2012. This is a 50% fall in the 7 years 2011-2018, during which time Australia introduced plain packs and a series of annual 12.5% tax increases from 2013-2018.

The proportion of adult Australians who have never smoked was 52.6% in 2014-15 and rose to 55.7% in 2017-18. These figures are the tobacco industry’s on-going nightmare, presaging it as a sunset industry which will wither and starve from lack of “replacement” customers as its current users quit or die.

In my August 2017 critique I highlighted several reasons why Mendelsohn’s claim at the time that there had been an increase in the number of smokers in Australia needed careful circumspection. I wrote:

“Mendelsohn appears to have arrived at a figure of 21 000 extra smokers by multiplying the percentage of daily smokers listed for each year in Table 3 of the AIHW report, with an estimate of population numbers of Australians 18 years and over in June 2013 and 2016 released by the Australian Bureau of Statistics in June 2017. These population estimates were published some months after the AIHW would have undertaken the analysis of smoking prevalence for 2016 and some years after it released its estimate of prevalence in 2013.

The estimate ignores the complexity of how survey results are weighted by population composition. It also ignores the fact that the prevalence figure is only an estimate, with margins of error. The AIHW’s table of relative standard errors and margins of error indicates that the prevalence of daily smoking among people aged 18 years and over in 2016 was somewhere between 12.2% and 13.4%. This means that the number of smokers in 2016 could have been anywhere between 2 293 000 and 2 512 000. A similar range applies to the figure for 2013. The calculation of an extra 21 000 smokers between 2013-2016 is therefore essentially meaningless.

Moreover, the Australian Bureau of Statistics population figures show that between 2013 and 2016, Australia’s population aged 18 years and over grew by 864 340 people as a result of births, deaths and immigration. Many immigrants in this number would be from nations where smoking rates are high, particularly among men.

The elephant in the room? Massive growth in never smokers from smoking prevention.

Media attention has focused on smokers. But applying the same calculation Dr Mendelsohn has done for current smokers to people in the rest of the population, one would conclude that there are more than 870 000 extra non-smokers in Australia in 2016 than there were in 2013 — more than 80 times the number of extra current smokers (and more than 40 times the number of extra daily smokers) that he is so concerned about.”

ATHRA has egg on its face with its apparently naïve understanding of what smoking prevalence data for the three countries actually mean.

Professor Robert West (a leading figure in tobacco cessation research, editor-in-chief of Addiction  and director of the large Smoking in England national study told the BBC in February 2016:

“[This widespread use of e-cigarettes] raises an interesting question for us:  If they were this game changer, if they were going to be – have this massive effect on everyone switching to e-cigarettes and stopping smoking we might have expected to see a bigger effect than we have seen so far which has actually been relatively small” [my emphasis]

and

“We know that most people who use e-cigarettes are continuing to smoke and when you ask them they’ll tell you that they’re mostly doing that to try to cut down the amount they smoke.  But we also know that if you look at how much they’re smoking it’s not really that much different from what they would have been doing if they weren’t using an e-cigarette.  So I think as far as using an e-cigarette to reduce your harm while continuing to smoke is concerned there really isn’t good evidence that it has any benefit.” [my emphasis]

Esther Han at the Sydney Morning Herald reported earlier this year here about funding received by ATHRA from two companies involved in the vaping industry and here about their receipt of $8000 from an organisation that received funding tobacco companies.

Fortunately, governments in Australia have heeded the evidence reviews from the CSIRO, the Therapeutic Goods Administration and the NHMRC, and the advice from the overwhelming proportion of public health and medical organisations (table below) to take a precautionary approach about many of the over-hyped claims being made for ecigarettes and the vast areas of research where the evidence remains non-existent or very limited.

 

With multi-party support, Australia remains in the very front line of global tobacco control with commitments like plain packaging, high taxation, retail display bans and smoke free policies. Australia’s smoking prevalence would look a lot better if governments had not fallen asleep at the wheel in one critical areas- failing to run evidence-based national media campaigns since 2012.

ATHRA’s public statements need to be scrutinized very, very carefully.

Tailpiece

After it was recently announced that Philip Morris/Altria is planning to invest in cannabis, ATHRA’s Colin Mendelsohn tweeted on Dec 8 that it was “surely a good thing if they make money” from this move. With 20.8% of US high school kids now currently vaping (at least once in the past 30 days)  compared to 3% of US adults, and the immense appeal of Juul involving its discreet properties (easily secreted, minimal clouding, memory stick lookalike), it is reasonable to ask what could possibly go wrong with PMI’s planned entry into the cannabis market. Vaping equipment is already being used to vape cannabis and other  drugs. Philip Morris of course would be horrified if children were to vape dope before sitting down in the classroom. It would just never happen, right?

[Updated 5 Apr, 2026]

I wrote my first book in 1983. It was a small manual of tactics for counteracting the tobacco industry’s promotional strategies, described by a tobacco industry snoop at the conference where I sold it to delegates as  “a rather paranoid and disturbing `contribution’ by an Australian called Simon Chapman”. I got a small grant from an international consumer organisation to print it and I took 300 copies to the 5^th World Conference on Smoking and Health in Canada where I sold copies for $5, recouping my excess baggage charge and adding a few first gold bricks to an authorship royalties’ pathway I planned to pave during the rest of my career. On the final night I spread all the bank notes over my hotel bed and dived into it, Scrooge McDuck style. I was on my way!

I followed this by convincing a small media studies publisher in London to publish a book from my PhD thesis in 1986. Great Expectorations: advertising and the tobacco industry. I never recall getting any royalties, but it got reviewed in the Times and the Guardian, with the Times even running an editorial. I got a lot of mail from readers. Long out of print, a US bookseller today hopes to extract $US169.73 for it from some discerning reader.

I then wrote a global atlas of tobacco control in the third world, as we called it then. The American Cancer Society paid for the printing and gave one to every delegate at the 7th world conference on tobacco control in Perth. This became the inspiration for subsequent international atlases of tobacco control published by the US Centers for Disease Control and later by Judith Mackay. I got no royalties for this one either and my hopes to put a deposit on an Aston Martin were looking ever fragile.

In 1994, I knew I was about to hit the big time when  British Medical Journal books published the first of two textbooks I wrote on the theory and practice of public health advocacy. This one, and the next (published by Wiley in 2007) saw annual royalty payments go into my bank. I never added them all up, but estimate that over the 24 years since I might have earned $12,000. Today my bank charges for the foreign deposits are usually as much as the annual royalties.

Two other books (one on gun control for Pluto Press and another on voluntary euthanasia) produced utterly desultory royalties, despite being on hot-button news issues. Like every author I’ve talked to, I spent many a weekend visiting bookshops sometimes looking in vain for these on the new releases display shelves.

These experiences left me convinced that writing non-fiction books was highly unlikely to earn me a living or even significant icing for my salary cake. But there are reputational benefits and indirect outcomes like conference invitations, consultancies and training opportunities that flow from publishing a book.

But well before thoughts of the untold riches heading their way, funnily enough every author hopes that their writing will be read. We polish, buff and manicure our babies through many revisions, all the time imagining the readers’ pleasure with the text. So when for my next six books I was given an opportunity to trade chimerical riches for gushing geysers of readers, I didn’t hesitate.

In 2009 I approached Sydney University Press with a book idea on the prostate cancer testing debate. My editor there, Agata Mrva-Montoya, set out several options: a commercial option with a paperback book where I would get the standard 10% royalty, a paid ebook option (with 25% royalty), or a hybrid open access option where there would be a paperback and ebook option available for sale and a  totally free (for readers) pdf download. SUP has some 50 titles in its catalogue available as open access.

I elected for the pay-for-print/free download option for this and all subsequent books I’ve done with SUP. They republished the gun control book which had seen around 1000 sold in paperback with Pluto. Links to all these books are here.

The table shows the total and average per day accesses since each book was published. (table updated 22 Dec, 2025)

Book, open access publication date (*= Sydney University Press)	Total accesses (& per day)
* Let sleeping dogs lie: what men should know before getting tested for prostate cancer. Oct 29, 2010	86,567(15)
*Over our dead bodies: Port Arthur and Australia’s fight for gun control. Jan 15, 2013	49,798 (10)
*Removing the emperor’s clothes: Australia and plain  packaging. Nov 27, 2014	62,092(15)
*Smoke signals: selected writing. 28 Jul, 2017	9,855 (3)
*Wind turbine syndrome: a communicated disease. Dec 1, 2017	35,177 (12)
*Quit smoking weapons of mass distraction. Jul 25, 2022	9,449 (7)
Better to be looked over, than overlooked: 50 years in public health research and advocacy. Jan 14, 2026	1,195 (15)
The last right: Australians take sides on the right to die. May 1, 2014	6,454 (1)

These 261,387 accesses are very pleasing. I’m confident that a small fraction of that number would have been purchased if I’d gone for the pay-for-print option. My combined royalties to date for the print editions I’ve received for all of these books have been around $1000.

When I’ve recommended giving one’s books away online to authors who have gone down the sales-only route, I sometimes encounter a disdainful superiority in the remark “a curious mouse click on a pdf download button is not the same as someone actually reading a book”.

It’s certainly true that many people who open an online book don’t read it, or don’t read it fully.  But of course, the very same can be said about purchased books. How many books do we all have on our shelves that we bought with the intention reading them cover-to-cover but never got around to it?

I had a job throughout the years I wrote these books, so (thankfully) did not need to rely on income from publishing. Those who rely on writing for their living clearly cannot consider this route to readership.

For authors who do not need to rely on royalties, publishing open access is a good way to increase readership.

I’d seen the Rolling Stones at Wembley Empire Pool in north London in 1973 on the Goats Head Soup tour, still with Mick Taylor and Bill Wyman. I remember scorching versions of Starfucker, Happy and Rip this joint. I saw them again on the Voodoo Lounge tour at the Sydney Cricket Ground, supported by the Cruel Sea, with 78,000 others including my 13 year old son, Joe. Our tickets were numbered something like Stand 7 Row 1, seats 4 and 5. I just knew we would be in the first row right in front of the stage, not in the front row of a nosebleed stand where, without any binoculars, we could watch ants with guitars performing way off in the distance. I spent much of the evening trying to convince Joe that what we were experiencing was just amazing.

By the time they next came to Sydney in 2003, on the Licks tour, I’d surpressed the memory of that anti-climax but was crushed after trying and failing to get tickets to their sold out gigs at the Olympic stadium. But then they announced a single gig at the decaying art deco Enmore Theatre in the next suburb to ours. With maximum capacity of 1600, this called for the abandonment of all restraint on how unbelievable getting a ticket would be.

Sydney’s Enmore Theatre

Tickets would go on sale on a Monday morning at 9am, by phone or on-line. All the publicity insisted that all tickets would be sold to the first 1600 who got through. I got to my office at 8am and experimented with which desk arrangements of phone and mouse would give me as a right hander the best hope of frantic, rapid phone redial and repeat resets of the web booking page. I’d mouse with my right hand and press the redial button with my left. At 8.55am I got going, over and over for a full hour like a bar-pressing rat in a lab experiment. Not once did I get through.

As all optimism drained away, I gave it a few final attempts, running a “this time, surely” prayer in my head. Nothing. I then walked down two floors to the room that housed my research grant team. “Well, meet the guy who just wasted an hour of time he should have spent working away on a paper, trying in vain to get tickets to the Rolling Stones gig at the Enmore” I told them sheepishly.

Katie Bryan-Jones was a Californian Fulbright scholar who was spending a year with us. She was about six foot two, in her early twenties and bursting with good health and vitality. She looked at me and said deadpan “Do you like the Rolling Stones?”  I began to explain that everyone my age had grown up with their music as a soundtrack to their lives.

She interrupted me. “Hey, I‘ve got two tickets to that gig. Would you like one?” She explained that she’d heard that if you joined the Rolling Stones’ Australian fan club, and paid $100, you got well over that in merch like T-shirts, caps, badges and CDs but importantly, priority access to tickets. So she’d joined and got the tickets to the Enmore.

I nearly wet myself with excitement. These were the hottest tickets I could ever remember going on sale. An almost intimate gig with the world’s most famous ever rock band  to tell people about for the rest of your life. Would I like a ticket?  Is water wet? Is the Pope a catholic? But haven’t you bought the other ticket for your boyfriend or something? “Well, sort of .. but really, you’re very welcome to have it” she assured me. I handed her the money on the spot.

On the night of the gig a few weeks later, we met in a Turkish pide shop a block away from the Enmore. My shout and order anything you want, the magnanimous ticket holder told her. I’d brought a very good wine along.

An hour later, we walked down toward the theatre, stopping to buy and load up a disposable camera at a pharmacy. This I secreted down my underpants, expecting a no cameras inspection at the door.

As we neared the main entrance, Katie handed me the tickets. I looked at them and froze. There were no seat numbers on them. Had she been conned and been sent fake tickets?  It seemed possible.

Security goons swarmed everywhere. One came up to us and reached for our tickets. It was the “colourful Sydney identity” strongman Tom Domican. I was reminded of the Rolling Stones hiring the Hells Angels as security at the ill-fated Altamont concert  in 1969. He pointed us to an internal doorway which led us to the mosh pit. So not only had we real tickets, but we had the best tickets you could get. We were about 10 metres from the stage in a sea of aging forever youngs.

I saw a few famous names and faces near us in the crowd, Glenn A Baker and Adam Spencer were two.  How amazing that these celebrities had been able to get tickets in the huge competition to get the few that were on offer! What were the odds of that?

Jet were the support act. I remember nothing about them other than wanting them to get off after each song. Twenty interminable minutes later, it started. They opened with Midnight Ramber, Tumbling Dice and Live with me. Ronnie Wood and Keef both looked cadaverous. Both  ignored the smoking ban and played sweeping, chiming chops and riffs deep in my DNA. They throttled their guitar necks and looked utterly dissolute. Mick ran about all night, pouting and jaggering and enjoying it enormously. Charlie was in his own world, impassive and rock solid.

About three quarters of the way through, two ordinary looking guys in jeans and tees with guitars sauntered on stage. I missed what Mick said but then it rapidly dawned: it was Angus and Malcom Young from AC/DC. The four guitar gods dueled through the BB King standard Rock me baby, and Angus and Keef duck-walked across stage, Chuck Berry style. We all died and went to heaven.

I’ve seen hundreds of musical acts over my life (Bands seen), many unforgettable. But this had just everything. It was the benchmark. The best. Pure bliss.

Throughout the night, Mick constantly pulled on a water bottle and at one stage threw an open one into the air near us. Water that had been in the bottle, perhaps in direct contact with his lips splashed over us. This molecular intimacy made us both decide that, for those moments, homeopathy might well have something to it after all.

Me, I’ve not washed my face in the 20 years since.

Sydney Morning Herald review

The full concert

10 favourite Rolling Stones tracks  I’m movin’ on (live)  She said yeah  That’s how strong my love is Get off my cloud Monkey man Can you hear me knockin’ Fool to cry Backstreet girl  Too much blood   Rocks off  (and my band doing it in 2012  at Balmain’s Cat & Fiddle pub with Adam Spencer guesting on guitar)

I’m often asked “so now that we have plain tobacco packs, with their huge graphic health warnings, what’s next in the marshaling yard to try and drive home the realities of the risks of smoking?”

Canada pioneered graphic health warnings on packs in 2000, and by 2016, over 100 nations required the “see and can’t forget” pictorial warnings. Canada is now actively considering health warnings on all cigarettes (see picture).

One of the most potent of all the graphic health warnings that have run in Australia since 2006 is the one about smoking causing gangrene.

Gangrene (rotting flesh) can occur with peripheral vascular disease. It occurs mostly in the extremities of the body, particularly in the in the feet and toes when insufficient blood supply reaches these areas due to narrowing of the blood vessels. Smoking is a major risk factor for PVD because it is a vasoconstrictor and raises blood pressure.

The first public campaign to highlight gangrene was run in New South Wales in a 1983 campaign for the NSW health department developed by John Bevins.  A TV ad on amputation after gangrene was screened in the years after the gangrene pack warning appeared.

I helped find the lower photograph below of the gangrenous foot that was used in Australia’s first generation of graphic health warnings that appeared from 2006. I obtained it from a surgeon at Sydney’s Westmead Hospital where I worked at the time. He gave me these two photographs of gangrenous limbs of smoking patients. I sent them to the Health Department in Canberra who tested them in focus groups. The first one showing the exposed bone was apparently rejected as being just too confronting.

The huge reaction the gangrene warning and the public discussion the graphic warnings caused got me thinking about how they might be made even more powerful.

In 1981, I saw John Waters’ cult film, Polyester staring the drag queen Divine and Tab Hunter. Waters incorporated “Odorama” scratch and sniff cards into the film. Wikipedia notes that “Special cards with spots numbered 1 through 10 were distributed to audience members before the show (see picture below). When a number flashed on the screen, viewers were to scratch and sniff the appropriate spot. Smells included the scent of flowers, pizza, glue, gas, grass, and faeces. For the first DVD release of the film the smell of glue was changed due to, as Waters states, “political correctness”. The gimmick was advertised with the tag “It’ll blow your nose!”

Gangrene has a very potent foul smell that can be highly distressing to patients and those who care for them before amputation.  When I started being asked the “what’s next?” question, I wondered about the potential of extending tobacco health warnings into the olfactory zone.

I called up a Professor of Chemistry at my university and asked him whether he knew of any chemical attempts to develop the smell of rotting flesh. I explained my interest. Absolutely deadpan and as quick as a flash, he told me that there were two candidate organic compounds cadaverine and putrescine. Putrescine is manufactured industrially. He called me back an hour later, having looked up the costs of bulk supplies of putrescine. I recall it was not off the planet and in any case, would be paid for by tobacco companies if the idea ever progressed.

Australia’s tobacco packaging legislation could easily be amended to allow for the mandatory incorporation of a putrescine scratch and sniff tab on packs carrying the gangrene warning.

In 2015, two psychologists conducted experiments where they exposed subjects to three odours: a neutral smell, ammonia and putrescine. They recorded how long it took subjects to walk 80 metres away from the campus exposure locations after smelling these odours. Those randomly allocated to the putrescine smell walked away faster from the exposure sites, causing the authors to speculate that “the results are the first to indicate that humans can process putrescine as a warning signal that mobilizes protective responses to deal with relevant threats.”

“Heath warnings don’t work”

There is a conventional folk wisdom popular among continuing smokers that tobacco pack warnings have no impact: they keep smoking regardless and just switch off. The companion argument here is that smokers are fully informed about the risks of smoking and so banging the same drum about health risks is a useless strategy.

There are several big problems with these arguments. First, if health warnings were so ineffective, someone needs to explain why  the tobacco industry has fought them tooth and nail all around the world for decades, particularly when they moved from anodyne to explicit, specific and graphic warnings. As recently as December 2016, British American Tobacco’s lawyers were attempting to stymie increased graphic health warnings in Hong Kong and Philip Morris did all it could to prevent Uruguay from implementing graphic health warnings. Companies don’t usually bother attacking policies that are ineffective and have no impact n their bottom line.

Second, it has been repeatedly shown that the overwhelming reason given by ex-smokers in explanation about why they were determined to quit, is health concerns. There is daylight between those concerns and other reasons that are nominated, as shown in the table below. Just where is it that smokers pick up these concerns from? Where would they ever find out or reflect on what atheroma or a brain bleed from stroke looks like if they never saw an image of it? How would they know about a person with emphysema’s constant struggle to breathe if they had not seen vision of it in a health warning ad? People with end-stage emphysema don’t tend to walk around in public very much, because they can’t.

And third, there is a very substantial body of research that examines questions about the impact of pack warnings on smokers’ understanding of risk, intention to quit and quitting behaviour, concluding that warnings can be powerful ingredients in motivating quitting.

Big Tobacco will hate this proposal. And that’s all we should really need to know in deciding that it’s an excellent idea.

 

 

This week, the journal Addiction published a letter signed by 6 high profile researchers, each with histories of working with tobacco companies on putatively reduced harm products. Their brief letter sought to “discuss” the ethical issues, as they saw them, that justified their remunerated research engagement. But it contained little more than several glib assertions.

While 181 nations have ratified the WHO’s Framework Convention on Tobacco Control, with its Article 5.3 setting out guidelines for limiting tobacco industry interference with tobacco control (“There is a fundamental and irreconcilable conflict between the tobacco industry’s interests and public health policy interests”), a small number of researchers apparently believe they  can rise above such concerns.

Their letter comes at a time when nearly all tobacco companies are adding so-called reduced risk products to their product portfolios. Some, like Philip Morris are engaging in “we’re changing” charm offensives claiming they are trying “to stop selling cigarettes as soon as possible”.

Ever since the bad news began rolling in from the early 1950s about the inconvenient problem of the very nasty harms smoking causes (latest estimates are that two in three long term smokers will die of a smoking caused disease, translating to some 7 million deaths a year), the industry has pursued a public agenda of announcing successive generations of allegedly reduced harm products. Unfortunately, every one of these  crashed as false hopes. All were primarily designed to keep nicotine addicts loyal to the companies’ evolving products and to dissuade people from quitting, as hundreds of millions around the world began doing in increasing numbers from the early 1960s, the great majority without any assistance and often without much difficulty.

No need to quit, when you can keep smoking a “reduced risk” cigarette?

No industry likes seeing its longest and most loyal customers dying early. They’d far prefer that they lived to consume and be contributing cash cows for as many years as possible. There is also no industry more loathed and mistrusted than the tobacco industry. Against this, the harm reduction agenda represents a trifecta of hope for Big Tobacco: it’s a kind of perpetual holy grail, never reached but always sought, with the promise of seeing smokers living and consuming longer. It’s also a way of enticing new generations of users into the market who each time swallow the hype about radically reduced risk products. And it carries hope of eroding the industry’s on-going corporate pariah status, with its attendant risks of attracting sub-optimal staff indifferent to working in a killer industry. It’s a virtue signalling cornucopia that keeps on giving.

Enter e-cigarettes

E-cigarettes and heat-not-burn products (ENDS or Electronic Nicotine Delivery Systems) are the latest harm reduction debutantes. The size of the popularity wave they are riding in several nations puts these products in the league of two previous, disgraced heavyweight champions of harm reduction: filter tips and so-call light and mild, cigarettes. Filters are almost universally still used today in cigarettes, but with 7 million deaths a year still occurring, it’s a bit like saying that arsenic is less harmful than cyanide, thanks to filters. Because of compensatory smoking, lights and milds were declared misleading and deceptive descriptors by the Australian Competition and Consumer Commission in 2005 and outlawed. Tobacco companies in the USA are currently running court-ordered corrective advertising, including messages about the lights and milds scam.

The rise of ENDS has been accompanied by a chorus of Big Tobacco CEOs proclaiming that they mark the beginning of the end of smoking. “Look what we are doing.” they gush “We are transforming ourselves into companies that are saving lives! We are investing billions into research, development, production and marketing of these new products.”

With their new health promotion vocation, they have tried to cosy up to governments, the WHO and sadly, to researchers like those who signed the letter in Addiction.

The Jekyll and Hyde defence

The authors of the letter in Addiction state that they “limit our work with the industry to projects involving reduced-risk products.” This argument is a kind of Jekyll and Hyde defence. It invites readers to consider that tobacco companies produce both morally defensible and indefensible products, and that it is ethically unproblematic for a scientist to have supportive dealings with those representing the Dr Jekyll persona, but self-evidently unethical to do anything to support murderous Hyde characters.

The unavoidable, blindingly obvious problem here of course, is that Jekyll and Hyde are the same person. Prisons are full of people who at their trials presented outstanding employment records, character references, and receipts for generous charity donations, but who had feet of clay and committed heinous deeds. In the corridors of tobacco companies there are divisions of both Jekylls and Hydes. The two camps may have little to with each other (BAT’s “science” twitter feed @BAT_Sci daily parades the work of its busy harm reduction product staff, but I’ve never seen mention of what its legions of cigarette division chemist staff are up to).

But on the floors that house those in the executive who pull the strings for the entire companies, they know exactly how the company bread is buttered and what the future vision looks like. And for all the sloganeering about the end of smoking, that future has, as it has always been, cigarettes right at the very front of the business model.

PMI’s global market is dominated by cigarettes.

BAT’s 2018 half yearly report could not have been more emphatic on this from its opening paragraph “Our strategy is to continue to grow our combustible business while investing in the exciting potentially reduced risk categories of THP, vapour and oral. As the Group expands its portfolio in these categories, we will continue to drive sustainable growth.” (my emphases)

A senior Philip Morris International spokesman, Corey Henry, told  the New York Times in August 2018 “As we transform our business toward a smoke-free future, we remain focused on maintaining our leadership of the combustible tobacco category outside China and the U.S.”

Philip Morris USA’s website candidly speaks of “making cigarettes our core product”.

Reduced risk products instead of or as well as cigarettes? 

The Addiction letter authors wrote “If the tobacco industry seeks to make money by making reduced risk products instead of  [my emphasis] more risky products, we fail to see this as a menace to public health.”

Yes, I’m afraid they do fail to see. Put simply, there is no evidence – apart from an incontinent river of public declarations – that any tobacco company is taking its foot off the twin business-as-usual accelerators of massively funded marketing of combustible tobacco products (chiefly cigarettes), and continuing  efforts to discredit and thwart policies known to have an impact on preventing uptake and promoting cessation.

In recent years companies like BAT and Philip Morris have been relentless in seeking to dilute, delay and defeat any policy posing any threat to their tobacco sales. This is not the behaviour of an industry earnestly trying to get all its smokers to quit. Witness their massive efforts to stop Australia’s historic plain packaging legislation. Witness their years’ long efforts to stop Uruguay’s graphic health warnings.  As recently as December 2016, BAT’s lawyers wrote this appalling letter to the Hong Kong administration trying to stop graphic health warnings going ahead. This was from a company which, published in its 2016 financial results statement a call to “champion informed consumer choice”.

Attacking tobacco tax

British American Tobacco’s twitter feeds relentlessly highlight seizures of illicit tobacco. The sub-text for these is that tobacco tax is so high that it is fueling demand for cheaper, illicit tobacco which evades tax. Joining the dots, the proposal here is that governments should stop raising tobacco tax (and perhaps even reduce it) to perversely “help” smokers buy the company’s brands.

In nauseatingly unctuous displays of civic-mindedness, the companies publicly wring their socially responsible hands about smokers having to interact with criminal tax evaders, unknowingly channeling their tobacco purchasing money into terrorism, and depriving national treasuries of much-needed revenue.

All this neatly avoids the public understanding that tobacco companies have used tax rises as air cover to add to their own margins by raising the prices they charge retailers who in turn pass on these increases to smokers. For example, In Australia from August 2011 to February 2013, while excise duty rose 24¢ for a pack of 25, the tobacco companies’ portion of the cigarette price (which excludes excise and GST), jumped $1.75 to $7.10. While excise had risen 2.8% over the period, the average net price had risen 27%. Philip Morris’ budget brand Choice 25s rose $1.80 in this period, with only 41¢ of this being from excise and GST. (see p77 here)

These public displays also keep attention away from the large body of evidence across many years that shows the tobacco industry has long supplied tobacco products to agents in knowledge that these products would enter the illicit, tax avoiding market.

The Philip Morris fully-funded “Foundation for a Smokefree World” has recently awarded New Zealander Marewa Glover $1m to advance harm reduction globally among indigenous peoples. Glover has been a frequent written and vocal critic of tobacco tax, claiming it is ineffective in reducing demand.  This contrasts to the overwhelming consensus of evidence about the role of tax in reducing demand. Price elasticity is why all tobacco companies (just like those in every industry) engage in price discounting: smokers smoke more when prices fall, and less when they rise.

In 2011, BATA’s Australian CEO David Crow told a Senate committee “We understand that the price going up when the excise goes up reduces consumption. We saw that last year very effectively with the increase in excise. There was a 25 per cent increase in the excise and we saw the volumes go down by about 10.2 per cent; there was about a 10.2 per cent reduction in the industry last year in Australia.”

All but one of the authors of the Addiction letter are from the USA. Professor Robert West, editor of Addiction, has recently drawn attention to the propensity of American researchers for US parochialism. Looking outside of the US border, we see rampant cigarette promotion still happening wherever possible, particularly in low income nations.  A moment’s searching finds examples like the Philip Morris’ controlled Indonesian Sampoerna company, with around a third of the country’s cigarette sales, promoting “stronger” cigarettes on the crest of a 15% industry-wide increase in smoking in the world’s fourth most populous nation. Or evidence of ubiquitous selling of single cigarettes across Africa and promotions near schools.

What could it do?

If Big Tobacco was sincere in its claims it wants to stop selling cigarettes there is much it could do. It could immediately stop all advertising and promotion of tobacco products around the world. It could voluntarily introduce the world’s best practices in graphic health warnings on packs (every company makes decisions every year about how its packaging will look). It could stop supplying illicit trade with tobacco products (currently estimated at one third of all illicit trade), knowing the importance of this in supplying very low income smokers with cigarettes that allows them to keep smoking and hopefully graduate to company brands.

Of course, it will do none of this, continuing instead to endlessly witter its sanctimonious claims about getting out of cigarettes but doing nothing to demonstrate that it is.  What it is doing, is to hide behind the weasel words that it will get out of selling cigarettes “as soon as possible”. That’s about as meaningful as saying “when hell freezes over”.

In this, it contrasts with sections of the motor vehicle industry and some governments over the transformation of motor vehicles from being powered by fossil fuels and moving to electric power, in concert with goals to move power generation to renewables. Volvo has announced that 50% of its vehicles will be electrically powered by 2025. By 2017, 10 nations had set dates for the end of fossil fuel car sales. More will follow. No tobacco company has set any target dates.

Over decades, we have seen Big Tobacco’s response to any proposal that threatens their bottom line. Any government announcing that it would no longer allow combusted tobacco to be sold would see every stop being pulled out by the industry to prevent this. But meanwhile the industry, hand-on-heart, assures us all that it really, really wants smoking to end.

And do they really reduce harm?

And then, at the end of the day, all this requires that we all acquiesce and accept that so-called reduced risk products will, in fact, be found to actually reduce risk after years of use.  The diseases caused by smoking are chronic diseases (pulmonary, cardiovascular, cancer). For each of these, many years pass between the uptake of smoking across a population and evidence of rising disease incidence.

The seminal January 2018 report of the US National Academies of Science, Engineering and Medicine repeatedly concluded that the quality of evidence now available that e-cigarettes actually reduce health risks was either non-existent, low or limited (see health effects conclusions here) because of the insufficient time that large numbers of people have been vaping.

There are many reasons to expect that e-cigarettes may indeed cause less disease than cigarettes. But we know from recent data from longitudinal samples that by far the largest proportion of e-cigarette users continue to smoke (“dual users”); that the reduction in the number of cigarettes that they smoke each day is trivial (see Table 3 here); that reducing (rather than quitting) smoking confers little risk reduction; and that for every one e-cigarette user who has a positive outcome by quitting smoking, more than two continue smoking and vaping, or relapse totally to smoking.

Source: Coleman et al (2018)

Moreover, if we add the dual users who relapsed, the once exclusive e-cigarette users who took up smoking, and the dual users who just kept on smoking and vaping, this important study shows that 12 months on, for every e-cigarette user who benefited by quit smoking and/or e-cigs, 4.6 e-cig users relapsed to smoking, took up smoking or were held in dual use.  Little wonder that tobacco companies are wildly enthusiastic about these products.

The 6 authors of the letter state that they are comfortable in working for the industry because “the FDA  considers the tobacco industry  legitimate, why should we not do so?”  The FDA is not directly funded by the tobacco industry, but is regulating it, so there is a world of difference here. This assertion merely acknowledges that tobacco industry manufactures products that are legal to sell if meeting standards being developed by the FDA.

There is much research undertaken on illicit drugs, but it is not funded by the criminals in charge of the trade. Few sensible people would argue that such research is not very important, but no one would seriously suggest that it would be ethical to accept funding by drug dealers.

Most understand that companies have a corporate interest in funding researchers whose outputs will be useful to them, and not create conflicts with their commercial ambitions. There is a very extensive research literature (eg here) that shows a consistent association between industry funding and research findings that are positive for the funding companies.

This is the reason that all serious journals require full disclosure of funding, and why some journals will not accept papers authored by tobacco industry researchers and why the Cochrane Collaboration insists that a majority of its review authors have no competing interests and refuses to consider reviews funded by commercial interests. For these reasons, mechanisms like mandated hypothecated taxes on the industry to fund external research have been proposed  as a way of better ensuring the independence and transparency of such research.

The concerns I have described should suggest that the opprobrium some of the authors have experienced should come as no surprise to them. I would welcome any of them responding to the issues I have raised by using the comments function on this page.