Our new meta-analysis of the entire relevant literature shows that e-cigarettes, as used, are associated with less not more quit

Here is the press release UCSF sent out about it:

E-Cigarettes, As Used, Aren’t Helping Smokers Quit, Study Shows  

New Analysis by UCSF Found “Vapers” Are 28 Percent Less Likely to Stop Smoking 


Electronic cigarettes are widely promoted and used to help smokers quit traditional cigarettes, but a new analysis from UC San Francisco found that adult smokers who use e-cigarettes are actually 28 percent less likely to stop smoking cigarettes.
The study -- a systematic review and meta-analysis of published data -- is the largest to quantify whether e-cigarettes assist smokers in quitting cigarettes.
The findings will be published online January 14, 2016 in The Lancet Respiratory Medicine.
“As currently being used, e-cigarettes are associated with significantly less quitting among smokers,” concluded first author Sara Kalkhoran, MD who was a clinical fellow at the UCSF School of Medicine when the research was conducted. She is now at Massachusetts General Hospital and Harvard Medical School.
“E-cigarettes should not be recommended as effective smoking cessation aids until there is evidence that, as promoted and used, they assist smoking cessation,” Kalkhoran wrote.
Electronic cigarettes, known by a variety of names including vapor pens, are battery-powered devices that heat nicotine and flavorings to deliver an aerosol inhaled by the user. While they are promoted as a way to quit traditional cigarettes, they also are promoted as a way to get nicotine in environments where traditional cigarettes are prohibited, even though more than 430 cities and several states ban their use in smoke free sites where conventional cigarettes are also prohibited.
In 2015, the U.S. Preventive Services Task Force concluded that there was insufficient evidence to recommend the devices to help adults quit smoking. No e-cigarette company has submitted an application to the U.S. Food and Drug Administration to approve e-cigarettes for smoking cession, and the FDA has not taken any action against companies that claim e-cigarettes are effective for quitting smoking.
In their analysis, the UCSF team reviewed 38 studies assessing the association between e-cigarette use and cigarette cessation among adult smokers. They then combined the results of the 20 studies that had control groups of smokers not using e-cigarettes in a meta-analysis that concluded that the odds of quitting smoking were 28 percent lower in smokers who used e-cigarettes compared to those who did not.  
There were no language restrictions imposed on the studies, which included both real-world observational as well as clinical studies. The studies included smokers who both were and were not interested in quitting, and included people as young as 15 years old.   
The studies included in the analysis controlled for many variables, including demographics, past attempts to quit, and level of nicotine dependence. 
“The irony is that quitting smoking is one of the main reasons both adults and kids use e-cigarettes, but the overall effect is less, not more, quitting,” said co-author Stanton A. Glantz, PhD, UCSF professor of medicine and director of the UCSF Center for Tobacco Control Research and Education. “While there is no question that a puff on an e-cigarette is less dangerous than a puff on a conventional cigarette, the most dangerous thing about e-cigarettes is that they keep people smoking conventional cigarettes.”
“The fact that they are freely available consumer products could be important,” Glantz added.
E-cigarette regulation has the potential to influence marketing and reasons for use, the authors wrote:
“The inclusion of e-cigarettes in smoke-free laws and voluntary smoke-free policies could help decrease use of e-cigarettes as a cigarette substitute, and, perhaps, increase their effectiveness for smoking cessation. The way e-cigarettes are available on the market – for use by anyone and for any purpose – creates a disconnect between the provision of e-cigarettes for cessation as part of a monitored clinical trial and the availability of e-cigarettes for use by the general population.” 
Kalkhoran’s research was supported by the National Institutes of Health National Research Service Award T32HP19025. Glantz’s work in the project was supported by grant 1P50CA180890 from the National Cancer Institute and the FDA Center for Tobacco Products. 

The paper is available on Lancet’s website here
By the way, Clive Bates published a preemptive attack on this paper (before reading it) on his blog.  People who carefully read our paper, particularly the sensitivity analysis (Table 2), will see that we anticipated and dealt with his predictable criticisms.


Specific responses to the "expert" criticism

Several people have emailed asking for our reaction to the “Expert reaction to meta-analysis looking at e-cigarette use and smoking cessation” released on the website ScienceMediaCenter.org the minute that the embargo on our Lancet Respiratory Medicine paper lifted. 
The most remarkable thing about these criticisms is their generality rather than engaging the specific substance of the paper. 
Careful readers will find that the paper considers all these issues (and more), including extensive discussion of the limitations of the available data. 
Despite these limitations, it is possible to draw important conclusions based on the available studies.
In particular, we conducted a formal sensitivity analysis of the factors (and other factors) that the experts raise, which appears in Table 2 of the paper. 
None of the factors that the "experts" raise affected the overall conclusion of the analysis that smokers who use e-cigarettes are less, not more, likely to stop smoking.
Here are our responses to the experts’ comments:

Prof. Robert West, Professor of Health Psychology, UCL, said:
“If use of e-cigarettes caused fewer smokers to quit, the quit rate in England would have decreased as use of e-cigarettes has increased. Data from The Smoking Toolkit Study – a large ongoing population survey of smoking in England – shows, if anything, the opposite (www.smokinginengland.info).
 “Publication of this study represents a major failure of the peer review system in this journal.”

Cigarette use rates have been declining since the 1970s in the UK, prior to the introduction of e-cigarettes.  Simply comparing rates of cigarette and e-cigarette use does not allow for evaluation of the association between e-cigarette use and quitting.  

Prof. Linda Bauld, Professor of Health Policy, University of Stirling; Deputy Director, UK Centre for Tobacco and Alcohol Studies; Chair in Behavioural Research for Cancer Prevention, Cancer Research UK, said:
“E-cigarettes have been called a ‘distruptive technology’ not just because of the controversy they have created but also because they pose significant challenges for research. The current paper represents the latest attempt to bring together the existing literature on e-cigarettes for smoking cessation. While its breath is to be commended, its conclusions (that e-cigarettes don’t work for smoking cessation) are at best tentative and at worst incorrect. The main reason for this is that attempting to directly compare the results of a body of literature that uses such a wide range of study designs and includes such variable (and often poorly defined) populations and outcomes is difficult, if not impossible. Some of the observational studies included in the review, in particular, suffer from a range of limitations that don’t allow us to reliably assess whether e-cigarettes help smokers quit.
The goal for this systematic review and meta-analysis was to be comprehensive in terms of the included literature.  We recognize there is variation in study design; these differences are summarized in Table 1, evaluated in the sensitivity analysis (Table 2), and discussed in detail in the appendix.  In the current regulatory environment, e-cigarettes are not prescription medicines that are only available for use in supervised smoking cessation attempts.  In addition, e-cigarette use outside a quit attempt can still affect quitting behavior.  The relationship between e-cigarette use and smoking cessation is important in all these situations.  Most important, as the sensitivity analysis showed, these differences do not materially affect the conclusion in the paper.
“For example, these studies: don’t properly assess whether participants have used e-cigarettes enough to make a difference for smoking cessation (such as including measures of ‘ever’ rather than ‘regular’ use);  may be biased in how participants in the studies were selected (i.e. not representative of e-cigarette users in the population): and, perhaps most importantly, have confounding factors including that smokers in the studies are these who have tried to quit many times in the past and may therefore be more likely to try the remaining new product  (e-cigarettes), or that they gave up using these devices early in the conduct of the study but were still included in the final results with the assumption that e-cigarettes didn’t ‘work’ for them whereas there could be multiple reasons why they stopped using the devices.
Table 1 and the detailed descriptions of the studies in the appendix describe what potential confounders were considered in the different studies.  Our sensitivity analysis showed that whether e-cigarette use was defined as current use or ever use did not significantly affect the results.
“Some of the more recent studies included in the review do point to the types of measures that should be used to assess e-cigarettes for smoking cessation. These categorise the type of device (as e-cigarettes are many products not one product), look carefully at when and for how long e-cigarettes were used, and ask whether participants were using them to stop smoking or for other reasons. These more carefully conducted studies shed light on how e-cigarettes could help smokers stop – for example if they contain sufficient nicotine, are used often and for long enough, and are more advanced (‘tank’) devices than earlier ‘ciga-like’ e-cigarettes. However, the current review does not separate out these studies or draw these distinctions but treats the body of evidence as a consistent and comparable set of studies when in fact it is not.

The studies of more intensive users of e-cigarettes and users of higher generation devices were specifically discussed in the Discussion as populations who might have increased rates of smoking cessation.  It is important to emphasize that these people represent a small fraction of all e-cigarette users. 

“The review also omits an important part of the picture when assessing any benefits of e-cigarettes in helping smokers quit – and that is the sheer reach of these devices. They are now the most popular aid to stopping smoking in the UK, for example, used by over 2.6 million people. Even low quit rates (which, it has to be said, are also found for licensed smoking cessation aids like Nicotine Replacement Therapy) for groups in studies could translate to many smokers quitting when applied at the population level.

The fact that e-cigarettes are popular as quit aids does not make them effective.  The overall conclusion from all the available data suggests that e-cigarette use is depressing quitting.

“Other systematic reviews of the literature on e-cigarettes for smoking cessation are underway as this is such a rapidly moving area of research. These should not repeat the mistake of this current review which is to not take account of the huge variability in the characteristics of e-cigarette users, the devices themselves, and patterns of use. Alternative, more carefully conducted, reviews are needed if  we are to provide health professionals and, most importantly, smokers with high quality information about the circumstances in which e-cigarettes may help people to move away from the more deadly alternative – combustible tobacco.”

We look forward to reading these studies when they are published.  We hope that such studies are not simply limited to e-cigarettes used under “ideal” conditions, but rather are studied as actually promoted and used in the real world.

Rosanna O’ Connor, Director of Tobacco, Alcohol & Drugs, Public Health England, said:
“There are over a million ex-smokers using an e-cigarette in Britain and we need to provide those who continue to smoke with accurate, balanced information on different quitting methods.
“Evidence from practice in England shows that two out of three smokers who combined e-cigarettes with additional expert support from a local stop smoking service quit successfully and while dual use is a complex issue, many vapers report using an e-cigarette to cut down and ultimately quit. Smokers who have struggled to quit in the past could try vaping, and we encourage vapers to take that next step and stop smoking completely.”

Our paper is based on all the available data as of the time we wrote the paper. 

Peter Hajek, Director of the Tobacco Dependence Research Unit, Queen Mary University of London (QMUL), said:
“This review is grossly misleading in my opinion. There are several problems with the way studies were selected and used, but the main flaw is simple, though not easy to spot. The studies that are presented as showing that vaping does not help people quit only recruited people who were currently smoking and asked them if they used e-cigarettes in the past.  This means that people who used e-cigarettes and stopped smoking were excluded.  The same approach would show that proven stop-smoking medications do not help or even undermine quitting.

The studies included are divided into study type and time of e-cigarette assessment in longitudinal studies.  The sensitivity analysis showed no significant difference in the results based on whether e-cigarette use was assessed at baseline or at follow-up. 

“Here is an analogy: Imagine you recruit people who absolutely cannot play piano. There will be some among them who had one piano lesson in the past. People who acquired any skills at all are not in the sample, only those that were hopeless at it are included. You compare musical ability in those who did and those who did not take a lesson, find a difference, and report that taking piano lessons harms your musical ability. The reason for your finding is that all those whose skills improved due to the lessons are not in the sample, but it would not necessarily be obvious to readers.

The methods and interpretations in our paper follow standard statistical methods for analyzing and interpreting data.

“E-cigarettes are a major development in public health. It is unfortunate that their potentially huge positive impact is being hindered by excessive regulations triggered by misleading suggestions.”

As our paper concludes, the evidence to date indicates that smokers who use e-cigarettes are less, not more, likely to stop smoking. 

Prof. Ann McNeill, Professor of Tobacco Addiction, National Addiction Centre, Institute of Psychiatry Psychology & Neuroscience, King’s College London (IoPPN), said:
“This review is not scientific. The information included about two studies that I co-authored is either inaccurate or misleading. In addition, the authors have not included all previous studies they could have done in their meta-analysis. I believe the findings should therefore be dismissed. I am concerned at the huge damage this publication may have – many more smokers may continue smoking and die if they take from this piece of work that all evidence suggests e-cigarettes do not help you quit smoking; that is not the case.
The problems with the authors’ interpretation of the two papers mentioned above are as follows: The first study (Adkson et al) is not longitudinal as has been reported here – e-cigarette use was measured at follow up, the same time as quit status was ascertained. The second study (Hitchman et al) included smokers who were using e-cigarettes at baseline and therefore included smokers who may have tried to use e-cigarettes to quit and failed, and excluded smokers who successfully used e-cigarettes to quit. The authors of this meta-analysis had been previously informed by the authors of the Adkison paper that they were misreporting the findings.”

In the Adkison study, the measurement of cigarette use was longitudinal (from one wave to another), while the assessment of e-cigarette use was at follow-up.  For the longitudinal studies, the paper was clear about the time of e-cigarette assessment, i.e. whether it was at baseline or follow-up (Table 1 and the discussion of individual studies in the appendix).  The results in the Hitchman study, like any such study, are based on the behavior reported during the time of the study.    In any event, the sensitivity analysis did not show an effect of the timing of e-cigarette measurement on results.  

Some more technical points on using meta-analysis

Pooling studies that are not identical
Ideally in a meta-analysis all the studies would be done identically with the same outcome and independent variables in the same populations.  This ideal is never met in practice, so there is always some level of heterogeneity.  The accepted way of handling this is to do a random effects meta-analysisWikipedia has a nice description of how this works:  “This approach When there is heterogeneity that cannot readily be explained, one analytical approach is to incorporate it into a random effects model. A random effects meta-analysis model involves an assumption that the effects being estimated in the different studies are not identical, but follow some distribution. The model represents the lack of knowledge about why real, or apparent, treatment effects differ by treating the differences as if they were random.” 
One important point that the Wikipedia entry does not mention is a random effects meta-analysis produces wider confidence intervals than a so-called fixed effects meta-analysis (which you can use when there is study homogeneity).  The reason for this is the fact that you are accounting for between-study differences in a random effects meta-analysis, which adds another component to uncertainty in the estimates. 
What this means in practical terms is that it is harder to reach statistical significance.

We used a random effects meta-analysis. 
All the studies included in our meta-analysis shared two important elements
They all used smoking cessation (more precisely no longer smoking) as the outcome and they all compared people using e-cigarettes with people not using e-cigarettes.
There were many other details that varied – whether the study was longitudinal or cross-sectional, a clinical trial or observational study, whether the subjects were actively trying to quit smoking, where the people lived, when e-cigarette use was assessed, what covariates were controlled for, etc.  We considered that in two ways. 
First, as described above, we used a random effects meta-analysis in the paper.
Second, we did a sensitivity analysis to test whether any of these (and other) factors and quite convincing found that none of them made any significant difference in the overall conclusion that e-cigarettes were associated with less quitting.  Indeed, in the original submission I think we looked at seven factors and added two more (totaling 9) in response to the reviewers’ comments.  This sensitivity analysis is one of the most important contributions the paper makes because it shows that the theoretical problems that the critics raise are not, in fact, making much difference in the results.
All the studies did not have the purpose of studying e-cigarettes for cessation
As noted above, all the studies measured the same outcome: no longer smoking.  The important point made in the paper is that we study e-cigarettes as they are used in the real world.  This is a broader question than whether e-cigarettes used as part of a smoking cessation program help is what effect they are having on cessation overall.    It is possible that they could be helping some people quit and serious harming others.  The fact that we found overall less quitting among people in studies of people who were trying to quit shows that, at the very least, the latter group dominates the former.  Moreover, the sensitivity analysis showed that whether the people were trying to quit did not affect the overall conclusion.
We included observational studies not just RCTs
It is important to keep in mind that e-cigarettes are not prescription drugs used under close medical supervision, but mass consumer products (a point we make in the paper).  Understanding the impacts of e-cigarettes requires studying them in the real world, not just the highly artificial environment of a randomized clinical trial.  In addition, lots of research on health effects and even effects of therapy is done in observational studies.
For these reasons, I actually think that the observational studies are more relevant than the RCTs.  But we included both in our paper.  Again, the sensitivity analysis showed that the study type didn’t significantly affect the results.
Other reasons that we can have confidence in our results
Despite the differences between the individual studies, the results were broadly consistent  (Figures 2 and 3).  From this perspective the heterogeneity strengthens the overall conclusion.
Another very well done (probably the best done) large longitudinal study (over 5000 men followed for a year with excellent control for confounders) was published after we completed our paper.  It showed depressed quitting smoking among e-cigarette users that was consistent with our meta-analysis.  The paper is here.
Finally, there is no such thing as a perfect study
In our paper (near the end of the Discussion) we describe what a perfect study of e-cigarettes and quitting would look like and make the point that doing such a study is impossible.  The fact that no study can do everything every critic can think of makes it possible to criticize any study.  This nit picking is a well-established industry strategy for discounting studies they don’t like.
What we do, and, indeed, what meta-analysis done properly is for, is to look beyond the individual studies for overall patterns in the data.

Re: Specific responses to the "expert" criticism

I was struck by the curious unanimity of the "experts" at Science Media Center. 5 different "experts", all 5 are agreed, all 5 are deeply critical. Not one thinks otherwise. Not one.

The Science Media Center doesn't say how these 5 were chosen. Does not present this as "our experts say" or "experts who are critical say" or "there are experts who say". Does not even mention that there are experts in the world with other views. On the contrary, implies there are none: presents these 5 as the expert opinion, this is what experts say, period.
While this is of course misleading, it's also revealing: it goes to the credibility of the Science Media Center. A look at that:
Jon Krueger

Clinical trials vs observational data

I note that the 2 clinical trials included in your analysis show increased quite rates with e-cigs.
Could you explain why you believe the observational data is more reliable than the clinical trial data?

Clinical trials vs. observational data

First, we did not treat either kind of data as "more relaible."  All studies were included in the main meta-analysis.  In addition, the sensitivity analysis (Figure 2) showed that the results from the clinical trials were not significantly different from the observational studies.
The advantage of clinical trials is that they are conducted in highly controlled environments so are easier to interpret. 
The advantage of observational studies is that they reflect actual use patterns in the real world. 
It is well established that medicines do not work as well in the real world because they are often not used or monitored properly or because they are used by people beyond the kind of people who are in the clinical trials.
It is also important to keep in mind that e-cigarettes are not prescription medicines that are used under close medical supervision, but mass marketed consumer products.  For that reason, I think that the observational studies are more relevant to assessing e-cigs.  Having said that, as noted above, we treated both kinds of data equally in the analysis.

Some of the press coverage

http://www.medicalnewstoday.com/articles/305070.php and this http://medicalxpress.com/news/2016-01-e-cigarettes-smokers.html
http://www.thesun.co.uk/sol/homepage/news/6862506/Study-claims-that-electronic-cigarettes-make-it-harder-to-quit-fags.html : S.K. followed by Quote by Hajek – “grossly misleading”
http://equilibrioinformativo.com/2016/01/e-cigarettes-dont-help-smokers-quit/ : “a major blow to leading health officials in England, who have repeatedly insisted that e-cigarettes are a key tool to reduce smoking rates.”
http://abruzzo.tv/news/2016/01/15/e-cigarettes-dont-help-smokers-quit/ : Cleveland quote links to gateway data in last paragraph . . .
http://www.prnewswire.com/news-releases/validity-of-uc-san-franciscos-meta-analysis-on-e-cigs-and-cessation-brought-into-question-by-researchers-300204918.html  . . . biased report with little balance . . . Cancer Research UK, PHE, SFATA etc all pile in . . .
http://www.theguardian.com/society/2016/jan/15/e-cigarettes-lower-the-odds-of-quitting-successfully-contested-study-claims http://www.techtimes.com/articles/124597/20160115/e-cigarettes-do-not-help-smokers-quit-tobacco-how-to-effectively-quit-smoking.htm
http://www.ash.org.uk/media-room/news/ash-daily-news/:ash-daily-news-for-15-january-2016#article_11789 http://www.nwitimes.com/niche/get-healthy/e-cigarettes-don-t-help-smokers-quit-tobacco-study/article_4d57f48d-2b7a-58b7-8b91-e42fb4ff0fca.html

Discussion of the paper on KQED Forum

KQED Forum, a live public affairs talk show, spent 30 minutes on the paper with Dr. Glantz and American Vaping Association head Greg Connoly.  Worth a listen at

Why not NCBI publisher?

Why was this paper not published through the NCBI? Given the analysis was funded by the US governent, it would be the most logical place to submit it for publication.

This paper will be published in Pub Med Central (NCBI)

In accordance with the federal rules for such things the paper will appear on Pub Med Central 1 year after it is published in Lancet Respiratory Medicine
I, and lots of other academics, think papers should appear there immediately, but that is not the way the rules work.
The paper is available for free right now on the Lancet website (link in original blog post) if you register.

A Complaint Letter to the BBC Over Their "analyses" . . .

This was never responded to:
From: Bareham David (LCHS)Sent: 11 February 2016 16:00To: 'feedback@bbc.co.uk'Subject: Formal Complaint Regarding "More or Less" Radio 4 Broadcast Regarding Electronic Cigarettes: "On the mixing of apples with oranges".Importance: High
Please may I make a formal complaint regarding the poor quality research and lack of scientific critical appraisal of this “More or Less” Radio 4 Broadcast regarding Electronic Cigarettes:
The presenter, along with a “Reviewer”, Wesley Stephenson, provided a “critique” of a recent research paper: “E-cigarettes and smoking cessation in real-world and clinical settings: a systematic review and meta-analysis”. There are several issues with their “critique” that reveal poor quality research, and an absence of scientific curiosity and questioning regarding the views of the “experts” used to challenge the validity of the study in question.
1)     In the Introductory Section, the Presenter notes the recent licensing of an “electronic cigarette” by the MHRA, suggesting/insinuating that this is evidence that contradicts the findings of Kalkhoran/Glantz paper. However, if the researchers involved had reviewed this issue, they would discover that even “vapers” themselves do not consider this to be an electronic cigarette: it does not heat a liquid; it does not emit “vaper”/aerosol, as per this link http://vaperanks.com/first-e-cigarette-to-be-awarded-medicine-license-in-the-uk-is-not-really-an-e-cigarette/ . This is confirmed in the email, as attached, from Action on Smoking and Health. This was initial evidence that the “researchers” undertaking this program have not produced a well-researched, scientific broadcast of quality, but one of misinformation and sound-biting.

  1. The subsequent section predominantly utilises multiple verbal quotes from “experts” critiquing the paper. These included opinions from: Professor Linda Bauld, who stated that it is “too early” to undertake a review such as this i.e. a meta-analysis, and that “if you put garbage in you will get garbage out”; Professor Ann McNeill, who argued that the paper is “not scientific”; Professor Peter Hajek (a co-author of the Cochrane Review on Electronic Cigarettes that is cited by Wesley Stephenson in the broadcast), who states that the Kalkhoran/Glantz paper is “grossly misleading”; and Professor Robert West.

Professor West’s comments are particularly interesting to focus on initially. He stated that the paper being reviewed inappropriately combined the results of studies of users of electronic cigarettes who were trying to quit tobacco with other, different studies, where the users were not trying to quit. They are fundamentally “heterogeneous”, although he does not use the term, and he states, simply, that paper under review is “mixing apples with oranges”. In effect, this is the major “confounding variable” and “fundamental flaw” that he focuses on, and it makes the study results invalid.
This is NOT, however, what Professor West stated regarding the aforementioned Cochrane Review (as per the above link): which does exactly the same thing. Specifically, the two Randomised Controlled Trials that the Cochrane Review put through the mathematical analysis of meta-analysis were (and I quote from the Review directly):
“The ASCEND trial (Bullen 2013) randomized 657 smokers (middle- aged, highly dependent, with one-third being of New Zealand Maori origin) who wanted to quit . . .”. (my emphasis) and
“the three-arm ECLAT trial (Caponnetto 2013a), 300 smokers (again middle-aged and highly dependent) who were not intending to quit smoking . . .” (my emphasis).
When these clearly heterogeneous studies were “mathematically mixed” by McRobbie et al in the Cochrane Review, Professor West publically, but incongruously, stated:
“This study tells us that even the older style electronic cigarettes improve smokers’ chances of stopping by about 50 per cent.” (http://www.dailymail.co.uk/health/article-2877321/E-cigarettes-help-people-quit-smoking-Review-finds-no-adverse-effects-short-medium-term-use.html ).
There is no criticism regarding erroneous methodology, fundamental flaws and confounding variables. It is apparently “OK”, according to Professor West, to “lump” heterogeneous data together: if you get a result you that agree with and approve of.
Moreover, there is no mention from Professor West, nor mention from the Presenter of the broadcast, nor Wesley Stephenson, that the Cochrane Review actually states, with regard to the quality of the evidence analysed in it, that:
“ . . . the small number of trials, low event rates and wide confidence intervals around the estimates mean that our confidence in the result is rated 'low' by GRADE standards.”
Why did Wesley Stephenson not include this key methodological issue in his “broadcast/critique”, but simply just cite The Cochrane Review, without reviewing it for issues that, ironically, correspond to exactly those he and Professor West have with the Glantz/Kalkoran? Mr. Stephenson has applied a “Blind Faith” approach to, not only the quality of the Cochrane Review, but to the opinion of “expert” Professor West, who via his incongruous and contradictory viewpoints, puts a self-inflicted hole below the waterline in his “expert” status. Mr. Stephenson erroneously used the Cochrane Review and West’s opinion to challenge the validity of the more recent meta-analysis.
Moreover, if Mr. Stephenson had properly researched this issue, he would have discovered that the “objections” regarding the paper were not just partly tackled in the body research, as he points out, but were specifically responded to, “expert by expert”, in the time period immediately after publication: http://tobacco.ucsf.edu/our-new-meta-analysis-entire-relevant-literature-shows-e-cigarettes-used-are-associated-less-not-more-quit . This omission in reporting is concerning, and represents poor quality research, or, worse case, bias.
Alternatively, as the Cochrane Review successfully passed through Peer Review, maybe it is in fact appropriate to try to combine this type of heterogeneous data, but try to allow and control for it? Presumably, that is what the authors of both the Cochrane AND Glantz/Kalhkoran Reviews believe they did. Either way, Professor West’s comments are clearly contradictory and sophistic in nature: and Mr. Stephenson falls for them, hook, line and sinker. It could bring the Editor at The Lancet some comfort in the recognition that the Cochrane Collaboration apparently also believe it is appropriate to positively Peer Review and publish papers, that attempt to “mix apples with oranges”. 
Furthermore, if Mr. Stephenson had undertaken more substantive research around the statements made by Professor West and others, he might well have spotted that the publication of the comments were made via the Science Media Centre : at exactly the same time that the paper was published in The Respiratory Lancet. The Science Media Centre has an “interesting” history, as is made explicitly clear here from “Powerbase”. The objectivity of this Centre has been clearly called into question, including, ironically, “issues” that it has previously had with the BBC. A key criticism, however, gleaned from this review reads:
“The Science Media Centre (SMC) is... not as independent as it appears. It was set up to provide accurate, independent scientific information for the media but its views are largely in line with government scientific policy.” Dr David Miller, Stirling Media Research Institute.
Subsequently, if the comments of the aforementioned “experts” are again reviewed, in the light of this discussion, important questions include:

  • If it is “too early” to undertake such a study i.e. a meta-analysis, and utilise data of low quality as both Linda Bauld and even the Cochrane Review acknowledge, why are Linda Bauld et al so comfortable in citing The Cochrane Review/Meta-Analysis elsewhere? Could it again be that she, and significant co-authors, are simply satisfied with the conclusion, and therefore do not challenge the methodology in the same, robust and passionate fashion? Wesley Stephenson does not comment on this, because he has not fully researched the issue: his approach is one of blind faith.



  • Wesley Stephenson, who merely cites the Cochrane Review and does not critique it, in doing so fails to note that Professor Hajek incongruously claims that the Glantz/Kalkhoran paper is “grossly misleading”, for using similar methodology that he did.


  • Wesley Stephenson has clear issues with the Peer Review process for this paper. He claims that, apparently, one of the Peer Reviewers believed that the study should never have been published. It is imperative to note therefore, considering the co-authors already discussed, that the Public Health England Reviews of both 2014 and 2015 were published: with no Peer Review process e.g. no review by the U.K. Faculty of Public Health. This is revealed here, very recently, in a highly critical appraisal of the PHE Report, by two English Professors of Toxicology. This leaves the validity of their review in extreme jeopardy, as presumably Mr. Stephenson would agree?

One final comment. The write-up on the BBC Radio 4 Webpage regarding this programme is tainted by inappropriate, loaded language. It states:
“Do e-cigarettes make quitting smoking more difficult?
Research last month claimed to show that e-cigarettes harm your chances of quitting smoking. The paper got coverage world-wide but it also came in for unusually fierce criticism from academics who spend their lives trying to help people quit. It's been described as 'grossly misleading' and 'not scientific'. We look at what is wrong with the paper and ask if it should have been published in the first place.” (my emphasis).
Arguably, this infers that the authors of the paper being reviewed are NOT involved in trying to help people quit tobacco, which is misleading and erroneous. Professor Glantz, for example, has a forty year history of successfully challenging the Tobacco Industry, including legally ground breaking work with the resultant +/- $250 Billion Tobacco Master Settlement Agreement, plus input on multiple papers related to tobacco and cessation. The written language utilised is worryingly loaded against the authors. The true nature of why the criticism was so “unusually fierce” was never properly researched and reviewed by Mr Stephenson. This was, therefore, not at all a properly researched, balanced, scientific review of the Glantz/Kalhkoran paper.
            I look forward to hearing the BBC’s responses to these representations shortly.
Yours sincerely,
David Bareham
David W Bareham BSc Hons (Physiotherapy) MSc (Pain Management).
Specialist Respiratory Physiotherapist
Lincolnshire Community Health Services NHS Trust
Locality Office
Louth County Hospital
LN11 0EU
Tel:  01205 315247 Option 5
Mobile: 07826 533 652
Fax: 01507 354957 
non secure email David.Bareham@lincs-chs.nhs.uk
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