On Thursday 28 May, the second of two workshops on e-cigarette research priorities will be held with a focus on the outcomes arising from e-cigarette use, including e-cigarette attitudes and behaviours, and longer-term health outcomes. The meeting is organised by Cancer Research UK, British Heart Foundation, Department of Health, Economic and Social Research Council and Medical Research Council. It is predominantly a scientific gathering, but I will be going and several vapers have been invited to contribute views. It’s a very positive initiative in my view. I’d welcome your views:
In advance of the event, the organisers have asked participants to think about the following questions:
“For the topic of the e-cigarettes use, attitudes and behaviours the most important question for the progress of e-cigarette research is…”
“For e-cigarettes and long-term outcomes, the most important question for the progress of e-cigarette research is…”
As many of readers of this blog have informed opinions and valuable insights on these matters, I thought would ask for views on these questions or anything else relevant to the research priorities for e-cigarettes… please use the comments to put your point of view or email me.
I’ll probably change my mind after listening to the arguments and hearing what everyone else has to say, but for now my own priorities are as follows:
Guiding principles
I think it’s worth orientating the discussion with some guiding principles that help to determine what is in scope and what is a distraction…
- Guiding principle 1: the research funded by these bodies should inform some useful activity that improves health outcomes – i.e. it informs product or marketing regulation, fiscal strategy, practice in NHS, public health messages or public risk communication. It should not be based on curiosity the mistaken assumption that we need to know everything about these products. Everyone proposing an idea should be able to say: we would use this information to….
- Guiding principle 2: the research funded by the bodies should meet a public interest ‘additionality’ test – that is it should use public or charity money to do things that are not the responsibilities of companies or regulators and would not happen without their involvement. So the research agenda should be designed around the role that public bodies and charities play in society.
- Guiding principle 3: the research funded by the bodies should be predicated on careful framing of issues under investigation. For example, when considering ‘flavours’ and their alleged appeal to adolescents, research should start with an analysis of the pathway by which a flavour could alter behaviour to cause harm, but also the way that the same flavour could be beneficial (if it attracts someone – even a young person – from smoking to vaping). Investment in defining the frameworks in which research is designed and evaluated is a vital prior step to defining any research priorities. (Note: Mike Siegel makes an interesting point about how the US FDA research programme is stacked towards investigating potential negatives).
Research agendas
I prefer to think in terms of a research ‘agenda’ – a programme of investigation designed to round out understanding of a particular set of issues. Here are four research agendas that matter to me:
- Risk perception agenda: given what is known (and unknown), how should a member of the public think about the risks of vaping, both compared to smoking and in absolute terms? How do people actually think about the risks vaping? What can be done to bring reality and perception into closer alignment? I think it is particularly important for trusted sources of advice like CR-UK and BHF to be able to speak candidly about risks in a way that serves the public interest and their charitable objectives (i.e. is not highly hedged, risk averse waffle), but to be able to do this with evidence based confidence. I would favour Public Health England having an objective to align risk perception and actual risk – this research agenda would characterise the problem and point the way to solutions.
- Nicotine-using population behaviour agenda: what is the appropriate way to characterise vaping / tobacco / nicotine use and transitions between different types of use? I would like to see well designed surveys that capture smoking and vaping behaviour and its evolution at quite high resolution – not just as an extension of a smoking cessation survey (i.e. to include new vapers and ex-vapers and ex-smokers). This strand of research should be designed to capture supposed unintended consequences such as gateway effects, renormalisation of smoking or reduced quitting – and would require methodological work to achieve that. It should also be designed to capture the converse of these: more quitting, greater denormalisation of smoking, gateway exits etc. This is to provide the basis for confidence or otherwise in regulatory policy at population level.
- Adverse policy impacts agenda: what adverse or unintended consequences could poorly designed regulation, policy or communications have (generally manifest as more smoking than there otherwise would be)? With the introduction of the EU Tobacco Products Directive, the opening of discussions about taxing e-cigarettes, and local measures eg to ban vaping in public places (possible differences within the nations of the UK allowing for natural experiments) can we test that the policies work as intended or conversely that they create unintended consequences. This should be seen as an evaluation of regulatory impacts with a view to improving policy through research. What would be the suite of evaluations that would test the potentially problematic aspects of the EU TPD? We should have baselines in place before May 2016 when the measures start to bite.
- ‘Dual use’ agenda: what are the risks and benefits of smoking and vaping concurrently? Are there benefits in cutting down and by how much before it makes a material gain? Conversely what are the main risks – does it make people less likely to quit, or more likely? How should we characterise dual use: there is obviously a vast difference between someone who smokes once a month and vapes daily, and someone who vapes once a month and smokes the rest of the time, but both could be considered ‘dual users’.
The papers for the meeting include a useful background summary of US discussions coming from a 2013 seminar on e-cigarette research priorities hosted by National Institutes for Health. These are interesting with some valuable insights, but in my view focus too much on biomedical / toxicological issues – or as I see that: finding out a great deal about relatively trivial risks.
Other areas might include: a few ideas to stimulate thinking: vapers’ attitudes and beliefs; personal histories (in lieu of cohort studies); defining and refining insights into ‘nicotine addiction’; role of peer support and networks compared to official sources of advice; health economics and NHS cost/saving impact or social cost benefit analysis; smokers preferences in higher resolution (wish to quit, smoke, vape – and how strongly?); barriers to switching and reasons for relapsing; the optimum healthcare system interventions (SSS, GPs, campaigns); brief advice interventions at the point of sale (newsagents and vape stores, or online).
More randomised controlled trials (RCTs)?
Also, I would like to see a challenge to the uncritical but widely held assumption that RCTs are the way ‘gold standard’ method to establish ‘efficacy’ of e-cigarettes. I am a big fan of RCTs by the way, and not just for drugs, but for any type of intervention where you wish to test the impact of doing one thing differently – for example, using different methods to teach reading in primary schools or offering micro-finance to women in developing countries. But RCTs have limitations in understanding the real world impact, in the way that one might try to establish the impact of a drug on disease or smoking cessation rates. Some issues about RCTs in this field, because the real would behaviour:
- Not random: a major consideration about e-cigarettes will be who is willing to use them to try them – if vaping is a ‘treatment’ route that appeals to, say, 60% of smokers but using a nicotine receptor partial agonist medicine appeals to only 5% then a straight randomised comparison will be highly misleading. The influences on these preferences are also non-random – including doctors’ advice or peer group influence.
- Not controlled: in real life the use of e-cigarettes changes over time and will vary according to many uncontrollable influences – people graduate from cig-a-likes to 2nd or 3rd generation devices and may change the strengths and flavours they use over time. They may or may not learn more about vaping or access advice from mentors. There is also constant demotivating negative new flow from public health sources, or new policy developments that change the context in which e-cigarettes are used and understood. For example, over the time that good study would take the perceptions of e-cigarettes risks have changed markedly (for the worse).
- Not a trial: Vaping is not one thing, so the investigator needs to ask what is being tested – and in particular if the outcome the investigator is measuring is the one the subject is seeking. Even this is complicated as an individual’s the pattern of use often evolves over time, and the reasons and motivations to vape may change – it can be seen as a gradual substitution of one habit for another over a lengthy transitional time. People can start to use e-cigarettes for convenience (using nicotine in places where smoking is banned), but evolve their motivation to include health and wellbeing through cutting down or quitting.
In theory it would be possible to address some of these concerns in study design – but the more that is done, the closer the investigator inevitably comes to observing the real behaviour, in all its multi-factoral complexity.
I am happy to see good RCTs done on vaping, but they should be reported and interpreted carefully – with a clear articulation of what feature of vaping is the subject of the controlled trial (the one thing that is varied), and a careful articulation of the limitations of such studies and all the uncontrolled confounders. My view is that greater emphasis should be placed on observational studies – both cross-sectional like the Smoking Toolkit Survey and longitudinal.
Update 29 May 2015. Reflections on the e-cigarette research priorities event…
I was pretty pleased with the way the seminar went – there were strong evidence-based and convincing presentations from Robert West (PDF), Linda Bauld (PDF), Ann McNeill (PDF) and Lion Shabab, which told a very positive story about the impacts of e-cigarettes at individual and population level. There was also a quite positive and enquiring discussion, with some good exchanges over differences of opinion, that all led to reasonable sense of direction (see below). There were also presentations from Amanda Amos and Marisa de Andrade with Gerard Hastings on the subject of the tobacco industry and renormalisation of smoking by the rise of vaping. The seminar identified four high level themes for research (Drivers, Perceptions, Behaviours, Outcomes). Under each of these themes I’ve added below some of the things that came up under these headings in discussion, tempered of course by my own views.
1. Drivers
This is about analysing and understanding what external factors shape e-cigarette use and its interaction with tobacco use. Examples:
- Regulation. What will the effect of regulation be on use, and ultimately on outcomes? There was particular emphasis on evaluation of the incoming Tobacco Products Directive and having baseline data in place before the directive applies from 20 May 2016 – with tests to theories about its benefits and unintended harmful consequences to be tested.
- Price & economic drivers. How do users react to prices and price differentials – what are the relevant price elasticities and cross-elasticities?
- Marketing. Is marketing of e-cigarettes beneficial (e.g. driving switching from smoking to vaping and supporting an insurgent product attack a harmful incumbent) or harmful (e.g. by somehow persuading people to smoke)? Are the controls proposed by CAP effective, unduly restrictive or inadequate? What is the impact of the broader bans imposed by the TPD? What sort of marketing innovations will emerge as restrictions bite?
- Vaping bans. Will these drive people back to smoking? What is the optimum policy?
- Health care system behaviour. What is the ideal way for a health care system to maximise the opportunity and minimise any risks – i.e. what approach should Stop Smoking Services take to e-cigarettes?
- Particular populations. Are there interventions that could work for those in deep poverty, with mental health conditions, held in institutions like prison or psychiatric institutions, or using the NHS?
- Public messaging. What is the impact of risk communication of other messages about vaping, coming from public health bodies, the industry, commentators etc
- Industry. What is the industry (appropriately segmented) doing? Where are its interests antagonistic to public health and where are its interests aligned? What policies could improve alignment?
2. Perceptions
What are people’s beliefs about vaping and smoking? In essence, this theme would explore the psychological landscape that underpins nicotine use and behaviour change. Examples:
- Risk perceptions. What do users and non-users believe about risks – relative to smoking and relative to other risks in society?
- Purpose and motivation. What are people trying to achieve (quitting, smoking differently, avoiding smoking bans, protecting their kids etc) and how committed are they to it?
- Value propositions. What do people like and dislike about smoking and about vaping – and how strong are their feelings? What would cause users to switch from one to the other, or to relapse? How important are flavours?
- Users views. What do users want, if anything – e.g. from health professionals, health organisations, government, regulators? What regulations are they worried about or pleased about and why?
3. Behaviours
There was high level of support for surveys that extend and deepen our insights into what is actually going on in smoking and vaping and at higher resolution. Examples:
- Patterns of use and trends. Systematic collection of data on e-cigarette use, tobacco use and other forms nicotine use – with careful distinction between intermittent, daily and ‘dual use’, with better subdivision of dual use. Are e-cigarettes assisting smoking cessation or diverting from it? This could build on the Smoking Tool Kit
- Type of use. What types of devices, flavours, strength? Where are people shopping? Are these changing advantageously or adversely over time? Are other uses emerging (e.g. vaping instead of eating a dessert or drinking?)
- Users. Who is using what – by age, social-class, gender etc? Are there social class gradients or changing patterns of use in people with mental health conditions?
- Identifying gateway effects (entries or exits). Some methodological work needed to design studies that could define and detect any changes in smoking caused by e-cigarettes – for better or for worse?
4. Outcomes
We can’t produce a 50 year cohort study to assess health impacts for at least 50 years, but regulatory, fiscal, communications and professional practice decisions need to be made now, what reasonable judgements can be made from what we do know or can learn in the short to medium term. Examples:
- Direct measurement of short to medium terms impacts on smokers who switch or cut down. What are measurable impacts on respiratory function, asthma, COPD and cardiovascular events? Are there changes to CVD risk factors (blood pressure, cholesterol etc)?
- Impact on wellbeing, self-esteem, anxiety etc. What happens to these important psycho-social indicators when people change from one type of nicotine use to another – and how does this compare to quitting completely?
- Proxies for overall health impact. We may not be able to go forward in time, but can we make useful disease risk and life expectancy judgements based on exposures to toxins? Are there pitfalls such as non-linear dose-risk relationships?
- At risk groups. What if any are the additional risks during pregnancy? Among young people? What should pregnant smokers be told about vaping?
- Cutting down. What is the health impact of cutting down or different types of dual use? How much is it necessary to cut down before there is a material gain in health prognosis?
To reiterate – these were the kind of ideas I picked up in the discussions – not the final note of the meeting. All of these need to be tested against the principles set out about and perhaps some drawn together across themes.
Let me know what you think!
Usage patterns and equipment usage conditions – this would enable a representative test model to be generated which could be used in all future studies. How do vapers vape? How often, how long a draw, how long between sessions? Which conditions are generally acceptable to vapers, which are not, and how do they interact (coil temperature, airflow, juice density and flow etc). These are things that vapers know through experience, and research scientists regularly disregard to their detriment.
From ASH’s discussion paper on harm reduction and electronic cigarettes
“The risk of over-regulation, as set out in the principles, is an area that has received less attention than the discussion of under-regulation.”
It is likely that,should a significant number of non-TI manufacturers decide that they can’t/won’t comply with any new regulations,any other research will be fairly meaningless.Whilst it will lie outside the expertise of current TC researchers,an examination of the factors that have led to the current ‘golden’ scenario of high quits/low relapse/no deaths would highlight how best to lock-in the current benefits.We’ve already done risks to death with no obvious downsides despite some rather desperate bias.
This whole area is one of heart-sinking desperation since none of it is needed at all. If a public health goal is to get people to stop smoking after the 20% Prevalence Rule operates, then the best way (actually, the only way)is to allow market forces to enable the process and if necessary help them along with tax breaks. In other words, if we already have ways that will enable more than half of current smokers to quit should they wish (as we do), then let them do so without hindrance; if we already have products that will enable more than half of current smokers to quit should they wish (as we do), then let them buy those products without hindrance. In other words:
1. Enable full, unhindered and unencumbered access to vaping products and Swedish Snus.
2. Promote them as a viable solution, don’t ban or cripple them.
3. Make them completely tax-free at point of sale: zero tax *of any kind*.
That’s how to reduce smoking. Any other way is just an excuse to protect the status quo.
It’s just done to protect government tobacco tax revenues and social cost savings (around £20 billion a year in the UK, clear, after all expenses are paid), pharmaceutical industry income from drug sales to treat sick smokers (at least 10% of their overall gross and more like 15%), and tobacco industry revenue (which is less in the UK than pharma makes from smoking-related disease – where tobacco makes £2bn, pharma makes £3bn plus).
Unfortunately we already have a crippling regulatory structure imposed and about to be implemented. Why help it? Why help the “vast, stinking cesspit of corporate corruption” that is the EU?
Another matter: CRUK have in the past been one of the most efficient protectors of cancer in the UK, presumably on behalf of their pharmaceutical industry sponsors and cooperating strongly with the stinking, corrupt EU cesspit. Why work with them?
Public Health bodies shouldn’t be meddling with ecigs, but I suppose we’re stuck with them. Given that, a worthwhile research project might be to find out why the perception of ecigs has nosedived in recent years.
Chris asks why work with them? I have a great deal of sympathy for the sentiment behind that question but, like it or not, there are questions to which regulators want answers. If science doesn’t plug the gaps then propaganda will, and by being involved we at least stand a chance of having some influence over the process. We’ve all seen the results which ensue when agenda driven scientists set out to find ‘evidence’ to suit their policy preferences.
It would be correct to observe how Vaping plays out with the least interference from yourselves. You don’t have to do anything except wait and observe. No social engineering required. WE are the experiment. While this new and wondrous smoking turnaround is happening, leave us alone. There is a huge pool of already experienced vapers to “study”. And we are still learning. WE are happy to share our experiences – free! I’m sure, medically, many could prove the benefits of vaping with properly backed data from our doctors and dentists about “before” and “after”. The data is all there already! It simply has to be collected.
But, hey, the workshop-supporting “charities” (not really charities) need to spend our tax money somehow and tobacco control is the best way to get funding. So why spend our money on new “science” – when there are millions? of us worldwide who have medical records already?
Well, that’s what I think.
It is interesting to note that none(or very few) of the tens of thousands of studies done on cessation over the last 30 years have actually produced any help for smokers.I would guess that the only things that have really worked in practice are education and taxation – and these have only helped maintain(but not increase) the number of ex-smokers.
Similarly,we already have hundreds of ecig studies but don’t seem even to have reached Square One in most regulators/legislators/TC advocates minds regarding understanding or evidence.A cynic would conclude that we have too many TC academics to employ and that actually solving problems and finding useful things out will reduce the scope for further research.
I agree with just about every comment above – leave the e-cig revolution and associated good results alone and let it develop in the way it is currently going, without interference from those who know NOTHING of how they actually work. They have no understanding that this WORKS (as their own figures show) and the reason that it works and works well is because it is the consumers that drive the innovation and make it better and better. Things that don’t work well FOR THE CONSUMER are dropped from the market place within weeks of appearance and are replaced by the things that WORK.
Those who wish to interfere with this in any way shape or form, MUST then become accountable for the results of that interference. We as vapers who have successfully switched away from lit tobacco are the only ones who should have ANY SAY WHATSOEVER in how this market should be regulated.
That is all.
Before these people act to address a problem they need to know what the problem is. I would suggest they do an in-depth analysis of the number of deaths caused by vaping over the last 5/6 years and also the number of hospitalisations. Once they have this risk assessment they can perhaps realise what we vapers already know and act accordingly. As for long-term studies the above should be repeated every 5 years and any new risks found dealt with appropriately.
One research priority I would like to see is around making tobacco harm reduction even more effective. There are still a lot of dual users, even with 2nd & 3rd gen vapers. How can we make the value proposition so compelling that cigarettes are just the poorer option in every way? Does higher wattage vaping help? Do we need to have faster nicotine delivery? More clouds? Do we need to add other non nicotine psychoactive alkaloids to better reproduce the cigarette experience? Can the use of other THR methods such as nasal & oral snuff separately or concurrently help? More social support for vaping? Something else I haven’t thought of? And out of these, which are more effective than others? Are there some characteristics that predispose some people to quit more easily with vaping than others?
E-cigarette usage surveys (for adults and for teens) should inquire about “daily use” and “frequent daily use” of e-cigs (in addition to inquiring about “ever use” and/or “past 30 day use”), as including those questions would expose that virtually all “daily vapers” and all “frequent daily vapers” are either current smokers or former smokers who switched to vaping.
Most other e-cigarette research should be conducted on people who actually use e-cigarettes (especially “daily vapers” and “longtime daily vapers”).
Much of the e-cig research conducted so far has absurdly studied the impact of e-cigs on people who never or rarely use the products, on animals that aren’t like humans, or on cell tissues.
What I’m missing most in these surveys, especially concerning the supposedly “gated” children:
– What nicotine level?
I would bet that a lot of those experimenting nonsmoking teens, that the CDC scaremongers about is using these colourful, cheap disposable “vape sticks” that often come without nicotine.
About dual-use: it’s now the principal route to smoking cessation in the UK:
http://www.ecigarette-politics.com/dual-use.html
Interesting blog from Dr Siegel
http://tobaccoanalysis.blogspot.co.uk/2015/05/center-for-tobacco-products-research.html
I think TC research mindset is typified by Professor Britton who
a) claims ecigs could save 5m smokers lives in the UK then
b) says-in his PHE study-that ecig manufacturers should fund research themselves due to scarce research funding then
c)funds research counting the number of smoking events in popular movies
It’s like cutting smoking in half is all well and good but it shouldn’t be allowed to interfere with Tobacco Control plans and research
One thing that i think could be a study easy to make : take smokers with COPD switching to vape : the health results before and after.
We all here a lot of people saying their health is better after switching, but we don’t have a real proof of that.
(sorry for my bad english)
Hi Verinique
This study goes a long way towards what you are looking for (Riccardo Polosa 2015)
http://www.biomedcentral.com/content/pdf/s12916-015-0298-3.pdf
But I think more studies on relief of chronic disease symptoms in smokers would be well worthwhile.
thanks ! didn’t see that one
Here’s a cross-sectional which addresses COPD improvements.
“Higher proportions of former smokers compared to current smokers reported that their condition improved after switching to EC use; the highest proportion reporting improvement were participants with COPD”
http://www.mdpi.com/1660-4601/11/4/4356/htm
A longitudinal study showing improved lung function in healthy vapers and dual-users.
https://www.srnt.org/conferences/SRNT_2015_Abstracts_WEB.pdf
PA13-3
CHANGES IN LUNG FUNCTION OVER TIME AFTER INITIATION OF
E-CIGARETTE USE
Shavonne M. Washington-Krauth, MA*, Tammy L. Burns, PharmD, Ryan W.
Walters, MS, Amy J. Arouni, MD, Creighton University
Background: Electronic cigarettes (e-cigarettes) are relatively new in the global
tobacco market with the first e-cigarette introduced in 2003. A paucity of literature
exists regarding the short- and long-term health effects of e-cigarettes. The current
study uses data from new e-cigarette users to model how lung function changes
over time.
Methods: This observational study enrolled 46 participants within the 7 days
following their first purchase of an e-cigarette. Visits occurred at baseline, 1, 3,
and 6 months after purchase. Lung function was a primary outcome measured
by handheld spirometry using percent of predicted Forced Expiratory Volume in
1 second (FEV1) and percent of predicted Forced Vital Capacity (FVC). Because
no smoking restrictions were placed participants, we adjusted for participants’ selfreported
average cigarettes smoked per day at each visit. Linear mixed-effects
models were employed for each outcome separately—polynomial effects were
evaluated and person-mean centering was used to partition the between- and
within-participant effects of the time-varying cigarettes smoked predictor.
Results: Non-daily smoking was reported by 10 participants at month 3. No
participant ceased using both smoking and e-cigarettes. Linear fixed effects were
indicated for both outcomes; no individual differences in this effect were observed.
Lung function improved over time with average increases of 1.67 percent and
1.06 percent per month for FEV1 and FVC, respectively (both p less than 0.05).
The average number of cigarettes smoked was not significantly related to FEV1;
however, a one-cigarette increase compared to a participant’s usual level of
smoking at a given visit decreased FVC by an average of 0.15percent at that visit
(p less than 0.05).
Conclusion: Lung function, assessed by spirometry, improved significantly from
baseline despite the majority of users continuing to smoke cigarettes. E-cigarettes
may result in an improvement in lung function with long-term use and reduction
of cigarette intake. The safety of long-term use of e-cigarettes has yet to be
established.
thanks :)
It’s going to take a great deal of persuading to convince me the risk benefit demands intervention.
What I do think needs looking at is the benefit side of the equation, as mentioned above.
I am sure there are a great number of nicotine research areas that could benefit from funding
And will be of use to wider population than just smokers or vapers.
Just one very specific piece of information we do need.
We need a verifiable LD50 for nicotine, the current guesses are being abused, because they are Chinese whispers, not science.
Mark, I agree with you that we need a new scientific study on nicotine toxicity, as it seems that many policy decisions (and media statements) regarding e-liquids are being made on the basis of the outdated (and not scientifically proven) estimate that 60mg would be fatal to a human.
In regard to perception of risks arising from e-cigs, I think there also needs to be some work done on the actual incidence of nicotine poisoning (as opposed to calls to poison centres) due to either ingestion of or contact with e-liquids since they were introduced. I don’t think that this would require a high level of manpower or funding, but it could show that public worries about such poisoning are either well founded or (much more likely, I believe) unwarranted. I don’t know if it is also the case in the UK, but in the USA it appears that people are contacting the poison centres with queries that indicate that they are unsure how poisonous e-liquids are; so I think the public need better information on what level of ingestion or skin contact might be harmful.
Measurable health impacts on those who have switched from smoking to vaping?
Could be done for age groups, or based on number of cigartettes smoked per day, or for smokers with a particular chronic health problems, over speficic time periods etc. Not rocket science to set the parameters, I would have thought.
Someone mentioned it before: in 30 years of TC research not one single study resulted in helping to improve the situation of smokers. It was all aimed to protect non-smokers from passive smoke. A bit odd since it is the smokers not the non-smokers who die like flies. As smokers we have been left in the cold for decades, so I join the majority of the comments, continue to do so please, pretty please with sugar on top, now we’ve have learned to take care of ourselves. The bulk of e-cig research fits in the TC agenda in order to be able to ban, cripple or to tax the hell out of it, not to help vapers or even less to help smokers…
BTW, how many vaper representatives are invited to that workshop in order to be part of the discussions and decisions, the answer to that question will need no further comment.
@Anonymous
May 28, 2015 at 2:28 pm:
“BTW, how many vaper representatives are invited to that workshop in order to be part of the discussions and decisions, the answer to that question will need no further comment.”
The first principle of public health policy implementation is to remove the primary stakeholders from the debate (the consumers). This includes their representatives, advocates and community organisations.
RCTs (like almost any study) have limitations. But for the success in the THR debate they are crucial because they will be considered the ‘gold standard’, like it or not.
Furthermore, observational surveys on e-cigarettes will also have severe limitions (http://www.ncbi.nlm.nih.gov/pubmed/18201639, http://www.ncbi.nlm.nih.gov/pubmed/25542911) and their results are wildly and widely misinterpeted against EC’s efficacy (see, tobaccoanalysis.blogspot.com/2014/05/glantz-review-article-is-little-more.html, http://circ.ahajournals.org/content/131/6/e341.extract).
RCTs can be a great counterbalance.
Most importantly of all, in the two published RCTs, EC proved efficacious in the face of enormous challenges. These challenges have been glossed over even by THR proponents, interpreting efficacy to be limited.
Here are some of the underappreciated but serious challenges against switching which subjects faced in the existing RCTs.
Caponnetto et al reported the following challenges:
– battery life allowed 50-70 puffs only – barely half of what an average smoker puffs daily. Can this be considered a substitute for smoking?
– 39% lost to follow-up conservatively deemed smokers
– “many respondents complained of…poor taste” – no flavour selection.
– Intervention was cessation aid style 12 week temporary EC use – NOT long-term THR.
– “malfunctions were common.”
– “the model under investigation is not very efficient at delivering nicotine.”
– inclusion criteria: unwilling to quit.
Bullen limitations included:
– participants given instructed to use them “until 12 weeks after their chosen quit day.” This is not THR, but withdrawal treatment.
– “the cartridges contained less nicotine than labeled, and delivery was inefficient.. users consumed on average just over one cartridge per day, delivering around only 20% of the nicotine obtained from cigarette smoking.”
– product reviews report battery life doesn’t get through the day (https://www.e-cigarette-forum.com/forum/threads/recommendation-elusions-may-break-the-bank-though.167561/#post-2815659).
I think it’s obvious that well-done RCTs must be done to correct this.
Even well done, RCTs can cook vaping’s goose.
It’s in the very nature of RCTs that the parameters must be rather restrictive to get reproduceable result. Unfortunately with vaping those restrictions are just what renders vaping almost as ineffective as NRTs, which are already inside the straight jacket of medicinal regulation. [Crippling Control]
Another rather common mistake by scientists: Select an arbitrary model of ecig (and liquid) for some tests and then assume that the results can be easily extrapolated to ALL ecigs. Don’t Dismiss Differences!”
They are not marginal as with different bands of tobacco. They are HUGE.
And finally: Why should ecigs have to compete with NRTs at all?
Yes, some people consider them as NRT 2.0 and use them accordingly. But that’s NOT what they primarily are. They are just nicotine containing consumer products competing with tobacco cigarettes. Nobody considers and evaluates cola or tea exclusively as Caffeine Replacement Products. [Vaping vs NRT]
You actually don’t need any study to know whether they work or not. As it’s a consumer product all you need are the existing numbers from the free market: The number of consumers grows => vaping works! Even inspite of all that scaremongering propaganda. If it didn’t work, more people would return to smoking.
‘You actually don’t need any study to know whether they work or not. As it’s a consumer product all you need are the existing numbers from the free market: The number of consumers grows => vaping works! Even inspite of all that scaremongering propaganda. If it didn’t work, more people would return to smoking.’
This is so obvious. But needs to be said.
Thank you for responding.
It isn’t likely RCTs would “cook vaping’s goose,” as you say. Existing RCTs have done much to persuade many of EC’s efficacy (especially as reflected in Cochrane).
Nor do the restrictive nature of clinical trials render vaping similar to NRT. Four intervention cohorts show vaping is many times more efficacious than NRT (remember the two RCTs had presented special challenges, as listed above):
http://www.ncbi.nlm.nih.gov/pubmed/25380748
http://www.ncbi.nlm.nih.gov/pubmed/21989407
http://www.mdpi.com/1660-4601/11/11/11220
http://digitalunc.coalliance.org/islandora/search/mods_name_personal_namePart_ms%3A%22Squires,%5C%20Rhonda%5C%20D.%22
Besides for regulatory restriction, a major limitation of NRT is the role non-pharmacological stimuli play in maintaining nicotine addiction, see:
http://www.ncbi.nlm.nih.gov/pubmed/1859927/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2838240/
http://link.springer.com/article/10.1007/s002130051162
This too suggests that vaping should do much better that NRT even in a clinical setting.
The existing RCTs and observational results make robust RCTs imperative. The evidence (above) tells us that vaping can do so much better in well-done RCTs than it has previously.
What I’ld really wish is some real scientist consider my ideas about Diminishing Dependency and do some studies along these lines.
As I noticed myself and have read many similar “anecdotes”, I can go much longer without vaping than I could when smoking. That part has already been confirmed with the study Dependence levels in users of electronic cigarettes, nicotine gums and tobacco cigarettes”
Now wouldn’t it be a great advancement in the understanding of tobacco addiction to find out, what exactly ecigs are missing for the minority of vapers who would really love to switch completely, but still can’t let go of the occasional smoke? And I’m not talking about vapers who dual use because they still like smoking. Yes, they exist, too. It’s their choice.
The error that has confused the issue of so called “nicotine dependency” i.e. Smoking tobacco, is that it’s the nicotine that keeps people smoking. Burning tobacco releases other chemicals on which the dependency hinges. Nicotine was made the whipping post to thrash smokers against by the Tobacco Control Industries, who have parroted the same old dogma for years – and still do. When I changed to vaping in 2011, I realised that we had been told lies by our scientific betters. I never go crazy to get my fix as I used to when I was smoking. To switch successfully, I believe, people need to avoid commercial cigarettes like the plague, roll their own and use natural tobacco without additives. And then, when switching, dual use until they are vaping more and smoking less. The addictive chemicals gradually leave the system, and the craving for smoking subsides. Switching is a gradual process. It is not simply giving a smoker a ciggalike of dubious quality and expecting them to stop smoking. Some of the studies I have read, would make anyone with the tiniest piece of knowledge of smoking or vaping, fall off their chairs laughing. That’s “science” for you!
Dear Clive,
Excellent as usual, My comment would be that I would like to see some sort of research on “message impact” on uptake, use and unintended negative consequences.
In effect, what would happen if Public Health made massive campaigns with a distinct and modified message directed at smokers: Quit, switch, cut down, just try and get off the fags ASAP, otherwise they’ll kill you.
Sweden has 1 million snus users and 1 million smokers of a population total of 10 million. Advertising has been banned since the 80’s, Prices are very high, Public Health refuses to endorse snus even for inveterate smokers after other interventions have failed, and yet through word of mouth and informal channels hundreds of thousands of Swedes are successful ex-smokers through use of snus.
Negative public health messages on snus has not managed to sway word of mouth.
The UK has had widespread advertising of vaping products in a relatively unregulated marketplace with no snus. Almost all messages from Public Health on vaping has been totally negative. Still vaping has been adopted by more than a million and a half UK residents in less than 10 years.
What would the effect be if we had (responsible) marketing AND positive messages from Pubic Health?
I saw one recently like this, but I suspect many of these tests that report bad battery life and dual usage are on cigalikes.
We need to draw a clear line between ourselves and cigalikes. I think it’s part of a false narrative that Public Health is trying to sell to the public, with Nicotine Control being Batman and Big Tobacco playing, appropriately enough, the Joker. Now we’re the meddling kids.
So play up the fact that vapers swear by, and prefer, the generation 2 and 3 devices, made by ex smokers to tempt smokers. Our mission is to obsolete tobacco, and give every smoker an honest choice.
Big T”s mission is to sell cigarettes, crush the competition, and turn smokers off or keep them dual using with their cigalikes. I think cigalikes were actually invented to discredit vaping, and I would not touch them with a ten foot pole.
Also, I found a study on WebMD dated 3/12/2014 titled Nicotine Patches Don’t Help Pregnant Women Quit Study. I immediately asked 4 Pharma shills
By your own logic, why is Pharma addicting unborn children to nicotine?
Norbert, D Schwartz was the only one who answered me. He said stupidity and greed….then argued with me anyway. He taunted me that Big T. had bought some patent on a cigalike. Whoops!
I answered back the vaping industry ARE the consumers, and even billion dollar businesses need consumers. Whoops!
But honestly – not like it would have worked – WERE they trying to addict unborn children to nicotine? And could a smoker learn his/her mother used a patch during the pregnancy, so they could sue Pharma for addicting them to nicotine?
It’s pretty easy to come up with just enough facts to mess with someone’s mind.
Like I have always said, they’ll finally give us what we want if we hold out. Not for our health. For our money.
So if Big Tobacco pulls their death sticks off the market, maybe that would be a worthy gesture to win us over. Because we don’t need them anymore. They have to make us want them. But as far as me personally, they’re boycotted for life.
The power of the purse. And for the politicians – get some numbers on the vape shops. Businesses, employees, revenues generated for localities. Politicians notice that stuff, and you have to register to vote or they don’t care whatsoever what you think.
Re: "I think cigalikes were actually invented to discredit vaping [ . . . ]" – Angel Tibbs
So far as I know, a guy named, Hon Lik, who, himself, had been a smoker — and whose father was a heavy smoker that died of lung cancer — was the guy who invented the "cigalike." (Not to mention . . . without which, ANY and ALL electronic cigarettes, currently on the market, today, would not exist.) (Extra side note: There was, however, another electronic-steam producing-cigarette, dating back to 1963, that apparently just never caught on.)
Cigalikes have worked, just fine, for me. (Specifically, Smokeless Image – Volt. The refillable cartridge/"cartomizer" type — not the disposables.)
I smoked two packs a day, for 32 years. Though it wasn’t easy, I was able to switch over to the supposedly useless cigalike, ***completely — and instantly.*** That is to say, I was able to quit smoking, on the spot, with them.
I know that the 2nd and 3rd generation e-cigs are more proficient at delivering nicotine . . . But! *For myself,* nicotine is only half of the story. There is also this little thing about having this little fucking thing in your hand, etc. (I.e. the habitual motions, and the like, of having a *cigarette sized* object in my hand. And nearly all of the time, too.)
I smoked tobacco ***cigarettes*** for 32 years. NOT a big pipe-like thing. (When I was much younger, I did, however, occasionally smoke marijuana with a pipe. But that is not the thing I want to simulate, here . . .)
Granted the over-the-counter, liquor store/gas station disposables are NOT the greatest. But, just one of those pieces of shit was enough to convince me that I might be able to quit smoking with the help of an electronic cigarette. Thankfully, with the help of a variety of internet resources, I was able to find a worthy brand of cigalike that could — and DID — do the trick.
Another thing is, in quitting smoking, I wasn’t particularly interested in starting a new hobby — I was interested in . . . quitting smoking. 2nd and 3rd generation devices seem to require far more time and effort than I was willing, or wanting to spend, on such an endeavor as quitting smoking. It was hard enough as it was.
Bottom line is: Everyone has their own tastes, preferences, needs, etc. (And if cigalikes are part of some conspiracy, then we are, all, in on it.)
I thought it wouldn’t hurt to include this link, here:
http://nicotinepolicy.net/all-authors/118-guest/4255-gfn-welcome-han-li
The man, Han Li — (Apparently, I misspelled his name . . . And, so too, have many others! o.O ) — spoke, just yesterday, at the The Global Forum on Nicotine (in Warsaw, I think).
Amazing Clive! You agree with Stan Glantz on at least one crucial thing:
“I agree with West that, for mass-marketed products like e-cigarettes, the kind of real-world study he did is more meaningful than randomized clinical trials.” S.G. here
http://tobacco.ucsf.edu/e-cigs-can-increase-odds-smokers-using-them-quit-while-still-having-overall-negative-effect-populati
Yes, ha ha – if only it was funny. I don’t agree with Glantz’s absurd representation in his post, and neither does Robert West – even if we both agree that surveys can be more useful and certainly a useful complement to RCTs.
Regards
Clive
Clive, with regard to the two previous postings above:
Veronique
May 28, 2015 at 8:25 am • Reply
One thing that i think could be a study easy to make : take smokers with COPD switching to vape : the health results before and after.
We all here a lot of people saying their health is better after switching, but we don’t have a real proof of that.
(sorry for my bad english)
o Clive Bates
May 28, 2015 at 9:37 am • Reply
Hi Verinique
This study goes a long way towards what you are looking for (Riccardo Polosa 2015)
http://www.biomedcentral.com/content/pdf/s12916-015-0298-3.pdf
But I think more studies on relief of chronic disease symptoms in smokers would be well worthwhile.
What does your cited study offer Veronique, specifically regarding her enquiry with COPD? The Polosa study you cite actually states, with regard to COPD:
“Asthma and chronic obstructive pulmonary disease (COPD) are progressive diseases characterized by persistent inflammatory and remodeling responses of the airways causing respiratory symptoms and progressive decline in lung function [17,18]. Although it is well established that the inflammatory response to cigarette smoke plays a key role in COPD pathogenesis . . .”
“To date, no formal efficacy and safety assessment of EC use in COPD patients has been conducted. There is only evidence from a case series of three inveterate smokers with COPD, who eventually quit tobacco smoking on their own by switching to an EC [21].” (My Emphasis)
So, this study does NOT appear go a long way towards what Veronique is looking for, as you suggested. What we do have are several recent studies:
Sussan et al: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0116861
Shivalingappa et al :http://www.fasebj.org/content/29/1_Supplement/LB631.short Schweitzer et al: http://ajplung.physiology.org/content/ajplung/early/2015/05/11/ajplung.00411.2014.full.pdf
presenting preliminary links between ENDS Aerosol and the pathogenesis of COPD. Other recent papers, presented at the very recent American Respiratory Society Conference in Colorado, demonstrate links between ENDS aerosol and airway inflammation, reduced cough reflex and reduced immune response, here: http://www.atsjournals.org/doi/abs/10.1164/ajrccm conference.2015.191.1_MeetingAbstracts.A2716
and then several others listed and described here: http://www.dddmag.com/news/2015/05/e-cigarettes-arent-benign-suggest-recent-studies
Thus, your conclusion that further studies are required is appropriate.
Dear “Anonymous”
Perhaps you thought the full quote was too long?
I’d recommend reading the views of Dr Farsalinos on lung cell and mouse studies….
A new study in mice provides no information for smokers but verifies e-cigarettes are less harmful
Cell studies on e-cigarettes: don’t waste your time reading (at least most of) them
A new study verifies that e-cigarettes are less toxic on lung cells compared to tobacco cigarettes
I don’t want cynical propaganda on this site without a degree of accountability – so if you want to post this sort of thing, please identify yourself in future.
Because you’re quoting me, i’ll answer too, i am absolutely satisfied with Clive answer, and it’s just because i’m totally sure (and i’m the real proof, living it myself) that vaping gives benefits to smokers health, and i surely don’t want mouse (i’m totally against animals testing) or cells studies … i think we have enough smokers in the world to make real data studies searching what vape can make on breath, biological results, etc. More and more will got, more and more the proof will be done. (and still sorry for my english ! :))
Regarding TPD restrictions, an RCT comparing efficacy of cigalikes vs more advanced equipment(subox?)in helping smokers stop smoking would be very beneficial.
The other one that’s always thrown at us is to address the actual addictiveness of nick-o-teen as its a constant negative in public psyche and really needs truth
Personally I would just like work done on a way of mantaining ‘reliable standards’ as to the purity of the e-liquid, I would much prefer to pay a bit more and know that has been made under the same sort of quality controls as most cosmetics and ‘non prescription generic’ pharma