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Pessimus sabbati: the tobacco and vaping industries’ worst week

Proponents of e-cigarettes in Australia will be quick to tell you that the sale of these products is legal in most comparable overseas jurisdictions, and that they are helping cigarette smokers to quit.

Australian authorities have been more cautious, but there is an ongoing federal parliamentary inquiry to investigate the health impacts of e-cigarettes and personal vaporisers, their marketing, possible use as smoking cessation aid, and the “appropriate regulatory framework” for these products.

Our skepticism may well prove to be a strength. The post below, from Emeritus Professor of public health and long-time tobacco control campaigner, Simon Chapman, describes the tobacco companies’ “week from hell” in the US, as an influential report found scant evidence to support the benefits of vaping, and raised substantial concerns that it is a gateway to smoking.

Adding insult to injury, tobacco company Philip Morris suffered a setback in its marketing plans, after failing to convince an FDA panel that its “modified risk tobacco product” was less harmful than cigarettes.

No doubt the evidence will continue to unfold as Australia considers its options.


Simon Chapman AO writes:

Many will remember when in late 1992, on the 40th anniversary of her accession to the throne, Queen Elizabeth II described the year as her annus horribilis after a string of very public domestic scandals and separations. Last week, it was the turn of the vaping and tobacco industries to experience days they are unlikely to forget. It is likely to go down as their pessimus sabbati (worst week).

Days of reckoning

On January 23, 2018 the most prestigious scientific bodies in US (and arguably global) science, the National Academies of Sciences, Engineering and Medicine (NASEM) published a 613 page, 16 chapter door-stopper of a report on the Public Health Consequences of E-Cigarettes.

Two days later, the US Food and Drug Administration’s scientific advisory panel, assessing submissions made by Philip Morris about its “heat not burn” putative “harm reduction” product IQOS (I Quit Ordinary Smoking), rejected arguments made by the company that IQOS was less harmful than smoking cigarettes. The vote was a decisive and humiliating 8-0, with one abstention.

A major setback

Their decision is a major setback to Philip Morris and other tobacco companies that are stampeding to develop, and to gain approval for, allegedly reduced risk products. They had hoped that in the US (one of the few advanced economies where tobacco advertising is still allowed) they could promote these products as “safer”. The US has a large, well-resourced and thorough drug regulatory system. Many other nations, including Australia, will certainly pay close attention to the panel’s judgement.

IQOS has been test marketed in Japan, a nation known for its early and often fickle adoption of new technologies, including in tobacco products. But Japan has a notorious reputation in global tobacco control, with long standing direct government interest in the tobacco trade, an immensely powerful tobacco industry, very low tobacco tax and bizarre regulations like banning smoking outdoors on footpaths but not indoors in bars and restaurants. Few if any other nations would look to Japan for leadership in sensible tobacco control.

The evidence and the lack of evidence

The NASEM report was built around a precise system of evidence assessment that ranged across six levels ranging from “no available evidence”, through “insufficient”, “limited”, “moderate”, “substantial” and up to “conclusive”.  NASEM reached 47 conclusions, listed here.

The key claims made by e-cigarette advocates are that these products are far safer than cigarettes; that they are very good at helping smokers quit; and that there is little evidence that kids who have never smoked and who experiment with vaping have a much greater likelihood of going on to smoke than kids who do not try vaping.

The NASEM report reviews the evidence on each of these key areas in far greater detail and transparency than any previous reviews. Among its key conclusions are:

Health effects

  • There is conclusive evidence that in addition to nicotine, most e-cigarette products contain and emit numerous potentially toxic substances.
  • There is conclusive evidence that other than nicotine, the number, quantity, and characteristics of potentially toxic substances emitted from e-cigarettes is highly variable and depends on product characteristics (including device and e-liquid characteristics) and how the device is operated.
  • There is substantial evidence that except for nicotine, under typical conditions of use, exposure to potentially toxic substances from e-cigarettes is significantly lower compared with combustible tobacco cigarettes
  • There is substantial evidence that e-cigarette aerosols can induce acute endothelial cell dysfunction, although the long-term consequences and outcomes on these parameters with long-term exposure to e-cigarette aerosol are uncertain.
  • There is substantial evidence that components of e-cigarette aerosols can promote formation of reactive oxygen species/oxidative stress. Although this supports the biological plausibility of tissue injury and disease from long-term exposure to e-cigarette aerosols, generation of reactive oxygen species and oxidative stress induction is generally lower from e-cigarettes than from combustible tobacco cigarette smoke.
  • There is substantial evidence that some chemicals present in e-cigarette aerosols (e.g., formaldehyde, acrolein) are capable of causing DNA damage and mutagenesis. This supports the biological plausibility that long-term exposure to e-cigarette aerosols could increase risk of cancer and adverse reproductive outcomes. Whether or not the levels of exposure are high enough to contribute to human carcinogenesis remains to be determined.
  • There is moderate evidence for increased cough and wheeze in adolescents who use e-cigarettes and an association with e-cigarette use and an increase in asthma exacerbations.

Improved health in switchers

  • There is limited evidence for improvement in lung function and respiratory symptoms among adult smokers with asthma who switch to e-cigarettes completely or in part (dual use).
  • There is limited evidence for reduction of chronic obstructive pulmonary disease (COPD) exacerbations among adult smokers with COPD who switch to e-cigarettes completely or in part (dual use).

Smoking cessation

  • There is moderate evidence from randomized controlled trials that e-cigarettes with nicotine are more effective than e-cigarettes without nicotine for smoking cessation.
  • While the overall evidence from observational trials is mixed, there is moderate evidence from observational studies that more frequent use of e-cigarettes is associated with increased likelihood of cessation.
  • Overall, there is limited evidence that e-cigarettes may be effective aids to promote smoking cessation.

Gateway effects

  • There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults.

Too good to ignore

In a slap in the face to the much-megaphoned factoid that e-cigarettes are “95% safer” than smoking, the NASEM report fails to even reference the much criticised report of the 12 individuals who produced that figure. Last year a senior official of Public Health England, Professor John Newton, told an Australian parliamentary enquiry of this 2014 report “We say what really matters is that evidence underlying this figure came from the Nutt report.”

While PHE had endorsed the “95% safer” figure to the delight of vaping advocates, significantly, the NASEM report does not provide any estimate of comparative safety, because of the widespread lack of evidence about the actual risks of vaping, so thoroughly reviewed in their report.

An Australian federal parliamentary committee has been working on a report on e-cigarettes for much of 2017. Much of the content of the NASEM report contradicts screeds of information given by vaping advocates to the committee. It will be interesting to see how the committee incorporates this new tsunami of unparalleled evidence from the NASEM report into its findings.

Comments 13

  1. Geoff says:

    Big difference here is vaping is illegal in Australia (much to the detriment of smokers) and in the US/EU/UK and many more countries its not. All this will be used for in Australia is to stop smokers getting access to tobacco harm reduction (which seems to be almost celebrated in this article) which is far from being a good thing.

    Harm reduction for heroine uses is ‘right on’ in Australia. Harm reduction for smokers (which a much much larger death toll) is not.

    Where is the logic?

  2. Margaret says:

    if you watch the youtube video of NASEM at 33.08 the summary says this

    “Summary
    While e-cigarettes are not without health risks, they are likely to be far less harmful than combustible tobacco cigarettes

    E-cigarettes contain fewer numbers and lower levels of toxic substances than conventional cigarettes”

    http://nationalacademies.org/hmd/Reports/2018/public-health-consequences-of-e-cigarettes.aspx

    a no brainer for me
    i have been vaping for 6 years and will continue as i believe the UK Royal College of Physicians and UK Public Health England when they say ecigs are 95% safer than combustible smokes.

    • Simon Chapman says:

      Margaret, the whole drift of the NASEM report is that the use of ecigs is far too immature for there to be any credible, definitive pronouncements made about relative dangers of ecig use compared to cigarette smoking. The “95%” figure was produced by a specially selected group of 12 people. The provenance of that figure and the process that lead to it has been utterly shredded in this paper in the Annual Review of Public Health, http://www.annualreviews.org/doi/abs/10.1146/annurev-publhealth-040617-013757 I agree that ecigarettes are likely to be “far less” risky than cigarettes, but cigarettes are SO deadly (2 in 3 long term users dying from smoking caused diseases) that even something half as deadly would probably still cruise into any top 10 of public health problems. We just don’t go around “recommending” such risks. We put strict controls around drugs that have high risks of causing problems but which may save lives, control serious pain etc. We don’t sell them alongside confectionary. String regulation has always been my position. Have you noticed the obvious effort by some vaping “leaders” to framing smoking as something you should not quit, but something you should just switch (to vaping). All remaining smokers apparenlty just can’t or won’t quit. That is of course utter nonsense.

  3. Annette says:

    It’s interesting that those opposed to eliquid containing nicotine in Australia have not, to my knowledge responded to the 400 page report on ecigarettes bought out by the Royal College of Physicians. Because they have come to a different conclusion than the reports here. This is the same Royal College of Physicians that went public with the news that smoking caused lung cancer in the 1960s.
    It is also interesting to note that many American states issued bonds which would be paid back with the money from the tobacco master settlement in the US. The payment on these bonds are now due only smoking rates are now the lowest they ever have been and some US states may face bankruptcy.

    • Paula says:

      Yes I too, would like to hear a response to the 400 page report on e-cigarettes brought out by the Royal College of Physicians. I’m wondering why no one seems to acknowledge it?

  4. Joe says:

    This is the best spin I have seen since Warnie retired. The report states “Across a range of studies and outcomes, e-cigarettes appear to pose less risk to an individual than combustible tobacco cigarettes”. That a product posing less risk is harder to access than one posing greater risk makes no sense. And why those who claim to advocate for harm reduction celebrate this is difficult to understand. Australia will catch up with the rest of the world in due course.

    • Simon Chapman says:

      Joe,do you seriously think that the lessons learned from history of the way that tobacco became available as freely as it was for decades is a template that we should follow for ecigs? The health risks of smoking only came apparent 30-40 years after the mass uptake of smoking following mechanisation & low prices, mass advertsing, zero restrictions on use etc. Ecigs have been in widespread use in few nations for less than 10 years & the NASEM report documents a large amount of emerging data on why we should be very concerned about what may be coming down the track. I have spent 40 years working with many others to turn around the “free=for-all” status that tobacco enjoyed and smoking rates have never been lower than they are now. Vaping advocates oppose each and every one of the restrictions that now apply to smoking (ad bans, high taxes, indoor bans, unforgettable health warnings, retail display bans). Yes we celebate waht we have achived. Lung cancer & heart disease have been falling for decades. We certainly don’t want to repeat the mistakes of the past.

      • Paula says:

        Simon, are you saying that we have to wait 30 to 40 years before you’ll accept that e-cigs are safer than smoking? Precaution is one thing, but complete closed mindedness is another.

        If you want long term and absolute proof, then explain to me how is it that other nicotine replacement measures such as patches, gums, inhalers etc. have been so easily and quickly approved without the long term evidence that you require for e-cigs?

        It seems to me that the real reason people are against e-cigarettes is because it seems to LOOK like smoking, because of the vapour produced.

        Secondly, the only acceptable approach to quitting smoking here in Australia seems to be complete abstinence, to the point of coercion. Have you not learned that prohibition never works?

  5. Simon Chapman says:

    NRT went through TGA regulation which involves submitting safety and efficacy data about standardised products, just like ecigs & amp; IQoS are trying to do right now in the USA.

    For years NRT was prescription only and only after widespread use, lots of assessment about whether (for example) it caused coronary events ((it was was observed that many taking NRT had heart attacks but of course many who smoke have those too, so worth asking whether the observed incidence was any different to the expected (predicted) incidence etc)).

    NRT was then deregulated. That’s what happens to all therapeutic goods (I know, I know ecigs, you’ll say, are not therapeutic goods — fine, then let’s hear no more about how well they perform in cessation). Ecig advocates think ecigs are “too important” to have to go through all that. Cancer quack cure sellers make the same arguments of course.

    Please tell us how smokers are coerced (forced) to stop.

    Prohibition (which I don’t advocate — I advocate regulation) actually can have substantial public health benefits, by-the-way. Don’t take my word for it, Take Prof Wayne Hall’s, whose views on ecigs would probably have your support, https://www.ncbi.nlm.nih.gov/pubmed/20331549. The 1930s alcohol prohibition did not stop all drinking, but but it reduced it substantially.

    I quite agree that the “look” of vaping is a problem. There has never been an epidemic of kids trying or habituating to NRT gum or patches. People don’t say they have a “patch lifestyle” as I’ve heard vapers talk about, patches & amp; gums don’t come in ~8000 flavours and beguiling “look at mine” gear; you can’t have gum or patch contests like you can with vape clouding. See what I’m saying?

  6. Simon Chapman says:

    Meant to write not “It the was deregulated.” but “It was then deregulated”

  7. Paula says:

    The following product is readily available in Australia but I still don’t understand how this product is acceptable whereas e-cigarettes are considered the devil? Both involve inhalation, so you might understand my confusion here. What long term (30+ years) evidence have you got that this product is safe whereas nicotine in vaping devices isn’t?
    https://www.nicorette.com.au/products/nicotine-inhalator
    I just want to understand what the actual issue is, because logically, I can’t find it in any anti vaping arguments so far. Can anyone clarify the issues for me in a non technical and non political way?

  8. Paula says:

    Thank you, Simon. Yes, I do see you’re points, and understand what you’re saying. It’s true that there is a small portion of vapers out there that are all about the “clouds” of smoke they can produce and the “tricks” they can do. There is a kind of underground alternative lifestyle thing happening, but that is because of the prohibitive laws surrounding vaping. I’m sure this must be obvious?

    Most people who vape in Australia, I believe, are just normal every day people of every age and socioeconomic type, who want to stop smoking but have found that nothing else works for them. They find vaping and it works. This is not a rare thing. If you look at the data, literally MILLIONS of people around the world have been able to stop smoking by switching to vaping. The evidence is there. Those are the facts.

    I still don’t understand why the facts don’t matter when it comes to policy. I don’t understand how evidence can be spun according to personal ideology when we are supposed to be dealing with science in the service of humanity.

    I just don’t understand.

  9. Simon Chapman says:

    Hi Paula,

    Memorable figures like “millions” quitting are thrown around by people hyping e-cigs. But it’s important to look atthose numbers carefully. Basic questions that you have to ask are: how was the data obtained? How long had people quit for? Did the estimates consider relapse back to smoking (which is extremely common)? How many of an alleged number who quit in a period using ecigs would have quit anyway had ecigs not been available? Thie paper http://onlinelibrary.wiley.com/doi/10.1111/add.13343/full is the best example I know of researchers trying to consider those issues and come up with an estimated number who quit in a year using ecigs, taking into account those who would have quit anyway and relapse. For England, where there are 8.46m smokers, they estimate that the net quitting effect attributable to ecigs was just 16,000 in a year. So if we back-of-an-evelope multiply that by say 10 years, we get 160,000 across that period. That’s a VERY long way short of the stuff we read about England from vape hypers.

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