The Australian Senate Select Committee on Tobacco Harm Reduction’s calls for submissions and its two full public hearing days have concluded with transcripts published, and replies to questions on notice published. This Committee follows the 2018 report from the House of Representatives Standing Committee on Health, Aged Care and Sport on Report on the Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia. That report saw the pro-vaping committee chair Trent Zimmerman and Liberal member Tim Wilson embarrassingly forced to publish a minority report when they were rolled by a majority of the committee. Another minority report from the Liberal member Andrew Laming, a doctor, received a fraction more attention that the time it took to read it.
Australia’s vaping interests think Laming is the bee’s knees and gave him their prestigious award which undoubtedly went straight here.
The Senate Committee is due to publish its report later this month, with some predicting another minority report outcome. This will probably be pleasing to the Health Minister Greg Hunt, whose proposed scheme to ban personal importation of nicotine for vaping and to encourage the Therapeutic Goods Administration to introduce prescribed access to some e-cigarettes with nicotine, was supported by the submissions and evidence of nearly all Australian health and medical agencies which made submissions. This was the position I took in my submission, written with Prof Mike Daube (Curtin University) and Prof Matthew Peters (respiratory medicine, Concord Hospital).
Hey backward Aussies … listen up!
One of the interesting aspects of this enquiry has been the publication of many submissions from overseas. Some of these were apparently solicited by the Committee, but many appear to be unsolicited. It’s understandable that international commercial vaping interests would want to take every opportunity to try and cement some bricks in the wall of a future market, so submissions from tobacco companies like BAT, Philip Morris and Imperial Brands and their acolytes, plus Juul and vaping minnow companies were predictable. But I was surprised to see a good many submissions from individuals in British, US and New Zealand public health.
I’ve asked around my colleagues to see if they are in the habit of – off their own bat – sending submissions to UK, US or New Zealand parliamentary enquiries. None (myself included) can ever recall doing this unless requested to do so, and all agreed that it is an unusual and peculiar form of arrogance that disinhibits people from other countries to try and tell Australia’s politicians where the advice they are getting from their own experts is all wrong.
Australia has always been a global pioneer in tobacco control policy and campaigning. As you can read in our submission, we have comparable-to-better smoking prevalence than each of those three nations, achieved without being awash with e-cigarettes. The tobacco and vaping industries have a lot of skin the game of wrecking Australia’s global reputation as a vanguard nation in tobacco control, setting agendas for others. We were first nation to introduce plain packaging, and one of the first to put tobacco stock out-of-sight in shops. We banned tobacco advertising and stopped smoking in pubs and restaurants way before the UK (the USA will probably never fully ban tobacco advertising), introduced graphic health warnings earlier, and have the world’s highest priced tobacco.
So as a banana republic still on the nursery slopes of public health and tobacco control, we naturally appreciate advice from these other nations. Our approach to e-cigarette regulation is consistent with recommendations from the WHO and many other expert agencies and our record in other aspects of public health – such as COVID19 isn’t too bad either (new cases yesterday USA 202,780; UK 16,578; Australia 8)
Four English tobacco control experts Ann McNeill, Jamie Brown, Lion Shahab and Robert West read our evidence and wrote to the Committee. We were invited to reply. Here’s what we wrote.
Response to letters from Professors Brown, Shahab and West and Professor McNeill
Emeritus Professor Simon Chapman AO, Emeritus Professor Mike Daube AO, Professor Matthew Peters AM
We thank the Committee for the opportunity to respond to the letters from Professors Brown, Shahab and West, and McNeill.
Professors Brown, Shahab and West’s brief letter entitled “Impact of e-cigarettes on smoking in England” provides different conclusions from the data on the impact of e-cigarettes on smoking prevalence in England. They claim these as “the correct analyses”. We would however note that:
In their cited BMJ paper they wrote:
“With quit attempts at 32.5% of eight million smokers (2.6 million) in 2015, and prevalence of e-cigarette use in quit attempts at 36% in that year, this equates to 54288 additional short to medium term quitters in 2015 compared with no use of e-cigarettes in quit attempts. We would expect up to two thirds of these individuals to relapse at some point in the future, so we would estimate that e-cigarettes may have contributed about 18000 additional long term ex-smokers in 2015. This figure is similar to that estimated indirectly using the estimated effect size of e-cigarettes and the numbers using them. Although these numbers are relatively small, they are broadly similar to previous estimates, and are clinically significant because of the huge health gains from stopping smoking. A 40 year old smoker who quits permanently can expect to gain nine life years compared with a continuing smoker. This number of additional quitters is unlikely to produce a detectable effect on smoking prevalence in the short term, but might be picked up over a period of several years.” (our emphases)
In their later Addiction paper they wrote:
“that 845,152 smokers used e-cigarettes in quit attempts; this equates to 50700 … additional past-year smokers who report that they are no longer smoking as a consequence of e-cigarette use in a quit attempt in 2017. This is broadly similar to the estimate which we reported for 2015.”
We note that in the Addiction paper, the authors did not discount that figure by two thirds relapsing in the future, as they did in their BMJ paper. Applying that discount to the 845,152 smokers who used e-cigs in a quit attempt (50,700 who were not smoking in 2017 x 0.33) we get 16,731 (3.1%) who by the authors’ 2015 assumptions, would have quit in the long term. Expressed differently, 96.9% of smokers using e-cigs in quit attempts in England in a year are estimated to not quit in the long term. This is a proportion very close to the quit rate (4%) for quit attempters allocated to no quitting support arms in the recent Cochrane trials update.
So 16,731 of 7 million English smokers were additional long term quitters in one year because of e-cigarettes: 1 in 418 of all English smokers. We heartily concur with Professors Brown, Shahab and West that “This number of additional quitters is unlikely to produce a detectable effect on smoking prevalence in the short term”. 16,000 -18,000 is not well expressed as “tens of thousands a year”, so we remain curious about why they believe our interpretation of their data is incorrect.
Brown et al’s BMJ paper states that there were 8 million smokers in England in 2015 and their Addiction paper says this had fallen to 7 million in 2017 (a fall of approximately 12.5% or 6.25% per annum). If we assume there were 3 full years encompassed in the 2015-2017 period, there were 3 years of ~17,000 estimated additional long term quitters between 2015-17, then some 51,000 (5.1%) of the extra 1 million who were not smoking in 2017 might be attributable to e-cigarette use. The other 949,000 fewer smokers would be attributable to deaths of smokers, cessation by smokers other than via e-cigarettes and increasing numbers of never smokers thanks to prevention policies and programs.
With England seeing major declines in the use of varenicline, bupropion and NRT use while vaping soared, it is likely that some of those 51 000 would have been smokers who might otherwise have quit using those methods.
This positive figure—however large it actually is when the additional cessation forgone from other evidence-based medications no longer being used is netted out—needs to be contextualised against concerns that e-cigarettes may be holding many smokers in smoking who might otherwise have quit. There is considerable international evidence that this is occurring.
Recent US longitudinal data from the PATH study found:
“Cigarette use was persistent, with 89.7% (95% CI 89.1% to 90.3%) of exclusive cigarette users and 86.1% (95% CI 84.4% to 87.9%) of dual users remaining cigarette users (either exclusive or dual) after any one year.”
“Among all W1 (Wave 1 or baseline) daily smokers, there were no differences in discontinued smoking between daily smokers who vaped (concurrent users) and exclusive daily smokers”
A just-published paper from the ITC-4CV four country (Australia, USA, UK, Canada) cohort survey found that after 18 months:
“smokers with established concurrent use [smoking and vaping] were not more likely to discontinue smoking compared to those not vaping … it is clear that the rates of transitioning away from smoking remain unacceptably low, and perhaps current vaping tools at best bring the likelihood of quitting up to comparable levels of less dependent smokers. The findings of our international study are consistent with the findings of the US PATH transition studies, and other observational studies, in that most smokers remain in a persistent state of cigarette use across time, particularly the daily smokers.”
A preliminary report of a Swiss study (“E-cigarette Use for Smoking Reduction and Cessation in a Four-year Follow-up Study Among Young Swiss Men: Some may Benefit, but they are Few.”) is available as a not-yet peer reviewed preprint here
This study included over 5,000 young Swiss men. It found that, at the general population level, EC use had no beneficial effects on reducing or ceasing smoking. Non-smokers (never- and ex-) and smokers at baseline were more likely to be smokers 4 years later if they subsequently had initiated use of ECs. The authors conclude that “Some smokers may have benefitted from using ECs, but they were few. At the general population level, ECs are not predominantly used in a way, which might optimise reducing or ceasing smoking. Therefore, the public health effect on the general population of using ECs may be questionable, as may policy measures to facilitate EC use.”
We note in Brown et al’s Addiction paper the fall in the proportion of smokers making quit attempts, from almost 40% in 2013 to about 34% in 2017.
The definitions of quit attempts differ somewhat between the surveys used in different countries and it is acknowledged that quit rates will fall after periods when large numbers of smokers have already successfully quit (for instance immediately following large tax increases).
Nevertheless, we note finally that—in contrast to the 29% of smokers in England who made a quit attempt in 2019—the proportion of current smokers who report having attempted to quit in the previous 12 months in Australia—a country with much lower rates of use of e-cigarettes—was about 50% in 2007 and 2013 and is still 51% in 2019.
If the proportion of smokers trying to quit in England was 50% rather than 30%, an additional 1.4m additional smokers would be making quit attempts each year, with an additional 56,000 likely to succeed even assuming no additional cessation support. The challenge for tobacco control in both our countries is to simultaneously increase both the numerator of quit successes and the denominator of quit attempts.
All major companies in the global tobacco industry are now promoting putative harm reduced products, while continuing to aggressively promote cigarettes. It is clearly in the industry’s interests to sell as much of both types of product as possible. If e-cigarettes put quitting in a prolonged holding pattern for many smokers and relapse to smoking is widespread, vaping may be holding many in smoking who might otherwise have quit.
Response to Professor McNeill’s letter is entitled “Additional Comment to the Australian Select Committee on Tobacco Harm Reduction”
We would note the comments below.
Point 1: Here, we would refer the Committee and Professor McNeill to our response above to Professors Brown, Shahab and West.
Point 2: Referring to our submission on page 10, where we write “Relapse to smoking is very prevalent. (A UK 15 month follow‐up of vapers found that overall 39.6% had relapsed to smoking, with those using tank systems faring worst (45.6%).)”, Professor McNeill claims that this is misleading in a number of ways.
“Rather than go into the details, I copy here the conclusions of the study (Brose et al, 2019), but would be happy to provide further information if required: “In a group of ex‐smokers who had stopped smoking for at least 2 months, relapse to smoking during a 15‐month follow‐up period was likely to be more common among those who at baseline vaped infrequently or used less advanced devices”.
As an author on the Brose paper, Professor McNeill knows that daily vapers had almost exactly the same risk of relapse as those who had never vaped. (34.5% vs 35.9%). The clear messages from that paper are that vaping does not prevent relapse and that even daily vaping is barely different from not vaping in preventing relapse.
Professor McNeill is also an author on a recent analysis of 4 Country ITC study data which concluded not only that “Among all W1 (Baseline) daily smokers, there were no differences in discontinued smoking between daily smokers who vaped (concurrent users) and exclusive daily smokers” but that “Most ex-smokers remained abstinent from smoking, and there was no difference in relapse back to smoking between those who vaped and those who did not.”
Point 3: Prof McNeill attempts to defend her position on EC safety that is unchanged since 2014 in the face of the substantial new evidence, particularly on respiratory and cardiovascular risk. She asks the Committee to believe that using separate and undefined methodology she as an individual, her academic collaborators and associated organisations have arrived at precisely the same 95% less harmful figure as the group assembled by Nutt in 2013 – a group that noted with a now notoriously sweeping caveat that there was no clear basis for selection of its members and that had very little in the way of data to rely on (“A limitation of this study is the lack of hard evidence for the harms of most products on most of the criteria”).
This 2020 paper from the American Journal of Public Health is highly critical of the continued use of this “95%” figure, or indeed of any ballpark figure stated without the provision of even rudimentary calculations about the long term consequences of using an extremely wide category of ENDS products.
“Trust us. We have considered it.”
Professor McNeill draws the Committee’s attention to a statement authored by herself and Professor Hajek explaining the 95% in more detail which was published as an addendum to the 2015 PHE report.
We agree that the Committee should give this statement its close attention because it actually provides nothing remotely approaching any worked calculations for detailed analysis of any risk comparing cigarettes and e-cigarettes. Like the Nutt report, and Professor McNeill’s reference to reports planned for publication in 2021 and 2022, it basically says “Trust us. We have considered it.”
In their explanatory memorandum, McNeill and Hajek state, firstly:
“Our review aimed to assess whether studies that have recently been widely reported as raising new alarming concerns on the risks of e-cigarettes changed the conclusions of the previous independent review (Britton and Bogdanovica, 2014) and other reassuring reviews.”
The review by Britton and Bogdanovica states:
“Despite some manufacturers’ claims that electronic cigarettes are harmless there is also evidence that electronic cigarettes contain toxic substances, including small amounts of formaldehyde and acetaldehyde, which are carcinogenic to humans, and that in some cases vapour contains traces of carcinogenic nitrosamines, and some toxic metals such as cadmium, nickel and lead. Although levels of these substances are much lower than those in conventional cigarettes, regular exposure over many years is likely to present some degree of health hazard, though the magnitude of this effect is difficult to estimate.”
Nowhere in this review is any estimate made of relative safety and 95% as an estimate is not anywhere mentioned, let alone calculations provides for any comparison with cigarettes.
Underpinning the unreliability of any academic estimate of relative harm is this statement also made in the Britton and Bogdanovica review:
“The world literature on harm reduction practice is extremely limited. Such data as is available on the content and emission characteristics of products currently on the UK market has been produced almost entirely by independent researchers, not by suppliers. Absorption characteristics are virtually unknown. However, this is data that can and should be required of manufacturers or suppliers, and will be as a result of medicines or TPD regulation, but for up to three years will not be required. While a clearly important area of research, it seems inappropriate to use scarce public research funding to provide this data. This responsibility should be placed, as soon as possible, on suppliers.”
McNeill and Hajek in their 2015 report state:
“We concluded that these new studies do not in fact demonstrate substantial new risks and that the previous estimate by an international expert panel (Nutt et al, 2014) endorsed in an expert review (West et al, 2014) that e-cigarette use is around 95% safer than smoking, remains valid as the current best estimate based on the peer-reviewed literature.”
The West et al report was a submission to a UK All-party Parliamentary group. This report does make that statement that ECs are much less harmful but provides no evidence and defines no process for which a harm determination could be made. Specifically, within the West report, the only estimate of 95% safer is referenced to the Nutt report. It does not endorse that figure – it only states that this is an estimate. Indeed, it states that “the precise harm from long-term use is not known” A careful examination of the documentary trail for evidence supporting the 95% (or any) figure calls into considerable question the argument put by Professor McNeill to the Committee.