Australia’s Therapeutic Goods Administration (TGA) last week rejected an application to liberalise the scheduling of nicotine (see from page 71).
This prompted the predictable round of protests from proponents of e-cigarettes who have long touted them as the next public health wonder of the world, even as important as antibiotics.
But unlike antibiotics, which are heavily regulated, require a prescription, and must demonstrate both safety and efficacy to regulatory bodies, e-cigarettes and the liquids used in them are virtually unregulated.
Tobacco harm reduction has had a history of monumental failures. It started with the global multi-million dollar promotion of filters. One of these was the infamous asbestos-filtered “micronite filters” in Kent cigarettes. More recently, we saw the now outlawed consumer deceptions of the light and mild cigarette fiasco. And on the way we even had “reduced carcinogen” brands.
These were designed to keep people smoking and slow the mass exodus that began in the early 1960s. Millions did just that. Only quitting and the decreasing incidence of smoking (ie. never starting) have dramatically decreased the tobacco disease epidemic.
It would be wonderful if e-cigarettes were finally a harm reduction holy grail. But there are many reasons to remain cautious.
Here I look at 12 mantras about e-cigarettes that seem to have failed to impress the TGA.
1. Vaping is ‘95% less harmful than smoking’
A hand-picked group of 12 produced this magic number when asked to rank the health risks of 12 nicotine delivery products, including cigarettes. Several of the group had no research record or expertise in tobacco control; some had histories of financial connections with manufacturers of e-cigarettes and tobacco companies. There were no toxicologists, cancer or cardiovascular specialists among the authors.
The “95%” number was uncritically repeated in a Public Health England report, which even described e-cigarettes as “around 95% safer [not less dangerous] than smoking” (my emphasis). Incredulous toxicologists have since pointed out “there is no evidence for the 95% estimate”.
This specific point estimate (synonymous with “5% as bad for you as smoking”) has rapidly evolved into “fact” (in the political sense of that term). It is repeated in a large fraction of popular press reports and widely used in arguments, snipes, and broadsides from vaping advocates. It seems to have emerged from nowhere when the Public Health England report asserted the figure. That traced to what was actually a huge misinterpretation of what was only a made-up number, from one junk-science journal article.
Phillips may be unique in believing the number is closer to 1%. His supporters in the tobacco and vaping industries are probably very happy with the PR potential of that estimate.
2. Vaping is orders of magnitude less harmful than smoking
Because vapers don’t inhale smoke, with its toxic cocktail of carcinogens, irritants and carbon monoxide, this is almost certainly going to be the consensus when sufficient longitudinal data emerge, particularly when it comes to cancer. However, the already mentioned “group of 12” has claimed that “The paucity of evidence for serious harm to users of e-cigarettes over the years since they were first marketed in 2006, with millions purchased, in itself is evidence” of vaping being all but benign.
Even perceptive vapers have seen through this nonsense. It took several decades for the full effects of smoking tobacco to emerge. Worrying evidence about cardio-respiratory effects is alreadymounting. These highly respected researchers estimated the long-term effects of vaping may equate to 50% of the risk of cardio-respiratory harm that tobacco causes, what they call a “substantial” exposure.
Tobacco-caused cancers may well reduce in people who only vape. But cancer deaths represent only 37% of all tobacco deaths: cardio-respiratory deaths make up most of the rest.
3. Nicotine in vaping is benign
While some make facile comparisons of the risks of nicotine with drinking coffee, the International Agency for Research on Cancer recently noted “evidence has indicated the potential for nicotine to cause DNA damage” and “inhibit apoptosis, and stimulate cell proliferation and angiogenesis …”, declaring that evaluation of electronic cigarettes and nicotine is a “high priority”.
The recent US Surgeon General Report highlighted the adverse effects of nicotine on brain development in young people and in pregnancy. A recent study has further revealed previously unrecognised negative effects of nicotine, and vaping, on the heart.
4. Vaping has caused 6.1 million European smokers to quit
This factoid was megaphoned from a paper authored by a researcher with a history of funding from e-cigarette manufacturers. It was a secondary analysis of a cross-sectional survey since pilloried in the journal Addiction, where it was published. As any epidemiology student knows, causality can never be claimed from cross sectional studies. Among other criticisms, the critics 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.
They also noted the questions asked would have allowed those who quit for only a short period to say they had “stopped”.
Longitudinal studies with a minimum of 12 months follow-up of randomly selected cohorts have shown sobering results, a long way from the hype of vaping having the equivalent efficacy of antibiotics. One such follow-up reported:
Daily use of e-cigarettes while smoking appears to be associated with subsequent increases in rates of attempting to stop smoking and reducing smoking, but not with smoking cessation.
A companion paper reported daily use of tank-system (refillable) e-cigarettes were the only type of e-cigarette to show a significant improvement in smoking cessation. The very latest data from England show about half of daily e-cigarette users are also smoking (slide 9) and the rate at which English smokers have tried to stop is the lowest in 2016 (30.9%) than it has been since 2007 (42.5%) when the study began (slide 22).
This raises important questions about whether e-cigarettes may be keeping many smokers smoking, while helping others to quit.
5. Just cutting back smoking (rather than quitting) significantly reduces risk
It’s obvious, surely, if you don’t quit but only cut down the amount you smoke, the reduced smoking is going to reduce the harm you are doing? Obvious that is, until you actually look at very large studies that have looked at the death rates down the track in those who reduce but don’t quit.
First, twoexamples followed 479,156 men for 11 years and found no association between smoking reduction and all cancer risk but a significant decrease in risk of lung cancer, with the size of risk reduction “disproportionately smaller than expected”. Second, a study of 51,210 people followed from the 1970s until 2003 found no evidence smokers who cut down their daily cigarette consumption by more than 50% reduced their risk of premature death significantly.
Vaping advocate and Addiction editor Professor Robert West puts it succinctly:
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.
And as we saw earlier, a large proportion of people who vape, continue to smoke.
6. Vape is just like water vapour and (often) nicotine
But let’s not forget some 8,000 beguiling often kiddie-friendly flavours in e-juice that help the nicotine go down (with apologies to Mary Poppins) have mostly been approved as food additives but have never been approved for inhalation. Here’s what the US flavouring industry said:
The manufacturers and marketers of ENDS [electronic nicotine delivery systems], and all other flavored tobacco products, and flavor manufacturers and marketers, should not represent or suggest that the flavor ingredients used in these products are safe because they have … status for use in food because such statements are false and misleading.
… breathing spray mists of these materials should be avoided. In general, Dow does not support or recommend the use of Dow’s glycols in applications where breathing or human eye contact with the spray mists of these materials is likely …
Vapers average about 200 inhalations a day, with this study finding a range of 6 to 611 puffs. That’s an average 73,050 deep lung bastings a year, and right up to 223,168. Like cigarette smoke, vape mist contains fine, ultra-fine and nanoparticles, including metals and silicate. It is anything but just like inhaling steam in a shower.
Put simply, we have no data on what happens to people’s long-term respiratory or cardiovascular health when they pull these nanoparticles deep into their lungs daily, over many years, at the above rates.
7. Nicotine-free cigarettes contain no nicotine
E-cigarette advocates were excited about a recent study reporting many US teens did not vape for nicotine, but for the flavours. In NSW, it is illegal to sell vape liquid containing nicotine. But a NSW Health random check found many samples contained it. Other examples in the US, and elsewhere, of alleged “non-nicotine” refills turning out to contain nicotine exist, hence the headline “‘Nicotine-Free’ E-Cigs Still Deliver the Juice”.
The US Food and Drug Administration (FDA) summed up:
Testing also suggested that quality control processes used to manufacture these products are inconsistent or non-existent.
8. Second-hand vape is harmless, so it should not be restricted
I’d rather sit next to a vaper than a smoker. But those vape clouds we see and then don’t see don’t just vanish. They can be measured. This study of a vapers’ meeting where 59-86 people were vaping found counts of PM2.5 airborne particles (fine particulate matter, 2.5 micrometers or less in diameter) 125-330 times higher than in the same room when empty. This is higher than particle concentrations recorded in bars where cigarette or waterpipe smoking are allowed. That will likely explain the other real-world experiences reported by vapers like this.
If vaping were allowed in bars, restaurants and planes, we all would face behaviour like this scene. Try imagining workable regulatory wording that would allow “discreet” vaping by a few, but prohibited exuberant “clouding” by a group of vapers drinking in a bar.
If vaping emissions were really benign, indoor vaping advocates should take courage and call for it to be allowed in classrooms, crèches, hospitals and neonatal wards. The fact they don’t rather suggests they know well such a position would be irresponsible.
9. There’s no good evidence for e-cigarettes being a gateway to smoking in young people
In England, this appears to be the case. But in the USA, there’s a rapidly growing body of evidence suggesting a possible effect. Centers for Disease Control data from 2015 demonstrate a concerning sudden cessation and plateau in the previous decline of US high school students smoking tobacco, while e-cigarette use is skyrocketing.
Smoking was plummeting in young people in the USA and UK long before e-cigarettes appeared. Today, more young people in the US are using nicotine than ever, which may signal health and brain developmental problems down the track.
10. E-cigarette explosions are overrated
E-cigarette advocates point out other lithium battery-powered items like mobile phones and laptops have exploded, so we should all calm down about dramatic explosions.
When mobile phones explode, we see global recalls as happened with the Samsung Galaxy Note 7. The lack of regulatory standards for e-cigarettes and their components stands in stark contrast to these other products. I’m very pleased e-cigarettes are banned on airlines, but wonder about what would happen if one exploded in stowed luggage.
11. Big Tobacco really wants its smoking customers to switch to e-cigarettes
If this was true, how do we then explain the companies continue to do all they can to wreck effective tobacco control policies like plain packaging, graphic health warnings and significant tobacco tax hikes?
In Hong Kong in December 2016 British American Tobacco was still lobbying against graphic health warnings. And Philip Morris was threatening Uruguay over its advanced tobacco control policies, until it lost its case at the World Bank’s International Centre for Settlement of Investment Disputes in 2016.
Surely, if they were sincere here, they should be pleased governments are trying to get smokers to quit? Philip Morris has been running targeted advertising campaigns with major youth appeal. And new evidence collated from its own documents demonstrates its interest in e-cigarettes, as long ago as 1990, was only ever for them to be used as a complement to cigarettes.
Big Tobacco has heavily invested in e-cigarettes, with all major tobacco companies now having them in their portfolios. The big picture here is that Big Tobacco wants people to smoke and vape, not vape instead of smoking.
12. Leading public health agencies encourage ‘light touch’ regulation
This is mostly the case in England, but very much not the case in many other nations. Advocates constantly point to two e-cigarette “friendly” reports from the UK Royal College of Physicians and Public Health England, which had several common authors.
But 18 nations ban e-cigarettes outright, with more having various degrees of restrictions. Among leading agencies with strong concerns about e-cigarettes are the US Surgeon General, the World Health Organization, the FDA, 31 mostly major health agencies that petitioned the FDA to regulate e-cigarettes, Australia’s National Health and Medical Research Council and now the TGA.
E-cigarettes have been generating a huge wave of research interest over the past few years. The next decade promises to throw the light of much needed evidence on many of the issues above. In the meantime, the Australian TGA’s caution should be respected.
Before retiring from employment with the University of Sydney the author contributed to an options paper on the regulation of Electronic Nicotine Delivery Systems commissioned by the Department of Health, Canberra. He wrote a first draft of a section on their use in smoking cessation.
Authors: Simon Chapman, Emeritus Professor in Public Health, University of Sydney