Recent eLetters
Displaying 1-10 letters out of 320 published
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Authors' Response
Submit responseThe volume of attention to our study in the U.S. and international press is not surprising, considering the widespread promotion of nicotine replacement products to all smokers in the population, and their growing inclusion in government subsidized health plans. Prior to addressing criticisms made by Stapleton and others, we note that their comments reflect at least one important area of agreement. The fact that no advantage for long term abstinence was found for users of nicotine replacement therapies (NRT) comes as no surprise even to critics of the study findings underscores general consensus that NRT treatment has not solved the problem of relapse to smoking.
The argument is that our study ignores initial quit rates and that improved initial quit rates would be expected to have a long-lasting effect on population smoking rates. The logic of this argument is that use of NRT will increase the number of smokers in the population who quit initially, and even given the same relapse rate as of non-users, NRT would result in a larger number of long term quitters than would be the case had none of the smokers used it initially. That hope or expectation was prominent around the time that the U.S. Food and Drug Administration permitted NRT to be sold without prescription. Unfortunately, however, the predicted increases in both rates of quitting and long-term quitters failed to materialize, (Pierce et al., 2012) even though annual sales of NRT in the U.S. increased dramatically.
The meta-analyses by Etter et. al., which Stapleton suggests provides better information than our recent study, is also based on clinical trials, and subject to limitations for assessing population effectiveness as discussed in our paper. Further, none of the prospective studies reviewed in Hughes et. al. found a population effect of over-the-counter NRT.
The argument has been made that a form of selection bias may have occurred in which persons more addicted may have been more likely to seek treatment and also have been more prone to relapse. The likelihood of such a bias affecting the results was diminished by the study's control for level of dependence. On the contrary, the counterargument could be made that persons who made the effort to try and use NRT were actually more highly motivated to quit and consequently should have been less likely to relapse, in further support of our study's findings. Indeed, because of the primary role of motivation in cessation, clinical trials for NRT tend to be highly selective for subjects who are strongly motivated to try and quit.
The possibility of recall bias (that people who quit a longer time ago would find it more difficult to recall whether or not they used NRT) was addressed in the study by a sensitivity analysis, the results of which showed consistency of findings based on prior six months, one year, and two years reported abstinence. The sample size was reasonable for this study; and, a point missed by Stapleton, was sufficient to detect a statistically significantly <higher> rate of relapse among formerly heavy smokers who used NRT without counseling.
Although a major objective of the study was not to assess adherence to NRT use or reasons for its inappropriate use, the fact that many NRT users did not continue to use it for the recommended eight weeks raises more of a question regarding its effectiveness outside of the controlled trial setting than doubt regarding the findings.
Braillon and Dubois suggested the results might have differed had we analyzed covariates using alternative forms. We analyzed the data using categorical as well as ordinal variables for dependence, including a three -category scale from the Fagerstrom Test of Nicotine Dependence, and four- category variables representing numbers of packs smoked per day, age as well as education, respectively. Analyzing these variables as categorical is common practice. We do not think that the continuous form is necessarily a better representation than the ordinal form for each of these variables since the theorized relationships with relapse are not necessarily linear and monotonic. The results of these analyses with respect to NRT were qualitatively the same as the original analyses showing no differences except that use of NRT for at least six weeks without counseling was associated with higher rates of relapse.
Finally, Beard et. al. reports regarding smokers who "had not smoked for the last 4 weeks" and no misrepresentation was intended.
We are gratified by the attention that our study has received because we think it is important to examine the evidence both for and against this approach to one of the most vexing public health scourges of our time - tobacco addiction.
Pierce JP, Cummins SE, White MM, Humphrey A, Messer K. Quitlines and Nicotine Replacement for Smoking Cessation: Do We Need to Change Policy? Annu Rev Public Health. 2012 Apr 4. [Epub ahead of print]
Etter JF, Stapleton JA. Nicotine replacement therapy for long- term smoking cessation: a meta-analysis. Tob Control 2006;15:280-5.
Hughes JR, Peters EN, Naud S. Effectiveness of over-the-counter nicotine replacement therapy: a qualitative review of nonrandomized trials. Nicotine Tob Res. 2011;13:512-22.
Beard, E., McNeill, A., Aveyard, P., Fidler, J., & West, R. Association between use of nicotine replacement therapy for harm reduction and smoking cessation: a prospective study of English smokers. Tobacco Control, 10.1136/tobaccocontrol-2011-050007 Online 1 December 2011.
Conflict of Interest:
None declared
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Throwing the baby out with the bath water
Submit responseThrowing the baby out with the bath water
Alain Braillon(a) MD, PhD, Gerard Dubois(b) MD, MPH.
(a) 27 rue Voiture. 80000 Amiens. France (b) Public Health. Amiens University Hospital. France
In an observational study Alpert and colleagues concluded that persons who have quit smoking relapsed at equivalent rates, whether or not they used nicotine replacement therapy (NRT) to help them in their quit attempts and challenged the funding of cessation medication policy.(1)
They failed to discuss the severe methodological limitations of their study which conflicts the evidences from so many randomized controlled trials. These include, to cite a few : a) the recall biases which challenge covariates quality; b) a major bias of selection considering the high percentages of non screened and of lost of follow-up during the three successive rows (see methods); c) the use of cut-points to derive subgroups for covariates which is not appropriate as there is a continuous distribution of the values with no obvious modal values; d) the absence of the measure of the initial quit rates with nicotine replacement therapy (NRT) and others methods; e) the effect of the comprehensive tobacco control policy implemented since 2002, a major confounding variable. Massachusetts now ranks 9th among the 50 states: 16.1% of the adult population (aged 18+ years) are current cigarette smokers.(2)
Finally, as a population study, the Massachusetts program is more convincing. Since 2006, Massachusetts has offered free treatments to help poor residents (Medicaid) stop smoking. When the program started, about 38 percent of poor Massachusetts residents smoked. By 2008, the smoking rate for poor residents had dropped to about 28 percent. This is 30,000 people in two and a half years, or one in six smokers. No changes were observed in those not covered by the plan (3) Tobacco cessation benefit that includes coverage for medications and behavioral treatments can significantly reduce smoking prevalence.(4)
1 Alpert HR, Connolly GN, Biener L. A prospective cohort study challenging the effectiveness of population-based medical intervention for smoking cessation. Tob Control. 2012. Oneline 10 Jan 2012. doi:10.1136/tobaccocontrol-2011-050129.
2 Centers for disease control and prevention. Smoking & tobacco use. State highlights 2010. Available at http://www.cdc.gov/tobacco/data_statistics/state_data/state_highlights/2010/states/massachusetts/index.htm Accessed 19 Jan 2012
3 Goodnough A. Massachusetts Antismoking Plan Gets Attention. 2009 Dec 16. The New York Times Available at http://www.nytimes.com/2009/12/17/us/17smoke.html Accessed 19 Jan 2012
4 Land T, Warner D, Paskowsky M et al. Medicaid coverage for tobacco dependence treatments in Massachusetts and associated decreases in smoking prevalence. PLoS One 2010 18;5(3):e9770.
Conflict of Interest:
Dr Braillon, a senior tenured consultant, was sacked in 2010 from Prof Dubois' unit by the French Department of Health against the advice of the National Statutory Committee. Prof Dubois was sued for libel by the French Tobacconists Union (Abuse of libel laws and a sacking: The gagging of public health experts in France. Tobacco control blog 8 November 2010). Prof Dubois is honorary president of Alliance Contre le Tabac and chairs the Addiction Committee of the National Academy of Medicine. He has received consulting fees from Pfizer.
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Misreporting of results: Correction of Alpert et al 2012
Submit responseIn their paper claiming to find that NRT is not effective long-term, Alpert et al [1] misrepresented findings from a paper for which I was primary author [2], citing it as evidence that other representative population studies have not found any beneficial effect of the use of NRT on annual smoking cessation rates. They state 'Beard et al found increased short-term abstinence only (sic) among persons who had reported using NRT six months earlier'. This is misleading given that we only looked at short -term cessation. The referencing is also erroneous, with our paper appearing as a sub-paper of Chapman and MacKenzie's [3], labelled 15a and 15 respectively. Our paper has no affiliation with these authors and we do not argue for the abandonment of clinical treatments for smokers.
1. Alpert, H. R., Connolly, G. N., & Biener, L. A. (2012). prospective study challenging the effectiveness of population-based medical intervention for smoking cessation. Tobacco Control, 10.1136/tobaccocontrol-2011-050129 Online 12 January 2012
2. Beard, E., McNeill, A., Aveyard, P., Fidler, J., & West, R. (in press). Association between use of nicotine replacement therapy for harm reduction and smoking cessation: a prospective study of English smokers. Tobacco Control, 10.1136/tobaccocontrol-2011-050007 Online 1 December 2011
3. Chapman, S, & MacKenzie, R. (2010). The global research neglect of unassisted smoking cessation: causes and consequences. PLoS Med,7(2), e1000216.
Conflict of Interest:
Emma Beard has received conference funding from Pfizer
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Online trade of Snus as well as Gutkha (Indian variety of smokeless tobacco-ST) should be banned. WHO FCTC must have a special focus on this deadly threat of oral cancer to millions.
Submit responseProfessor Chitta Choudhury Director, International Centre for Tropical Oral Health, UK
Nitte University Dept of Oral Biology Genomic Studies | Cen Oral Dis Prev Control, Mangalore, India.
NOT PEER REVIEWED I refer to the report "How online sales and promotion of snus contravenes current European Union legislation, published recently in Tob Control 21 January 2012. Like Snus, the online trade of Gutkha (Indian variety of Smokeless tobacco- ST) is gaining popularity as well as in several outlets in the UK. If you visit some of the shops in East and north-west London or in Birmingham, Manchester, Leeds, and Leister (where SE Asian immigrants are living) you can easily find many shops displaying various brands of Gutkha sachets. As a member of the National Institute of Clinical Excellence, (NICE, UK) stakeholders on Smokeless Tobacco control for SE Asian Migrants , I joined in a meeting and raised the question of why we can't stop such trade,likewise Snus. But the fact is that there is no strong legislative support to ban this trade. There is no doubt that online trade of ST products (not only Snus, also Guthka) is on rise. Anyway, the results of a database search regarding online sales and promotion of Snus revealed that online vendors are targeting non- Swedish EU citizens. Such online trade may also cross more distant borders, reaching Asia, Africa and Gulf countries. Of course, such business is against the EU regulation. The Snus is banned in the UK and EU countries, but not the Gutkha. We don't know why Gutkha is not banned in EU. In this context, I refer one of our discussions published in Tob Control 9 Nov 2010, suggesting that Snus and quid (eg. Gutkha) consumption is a risk factor not only for the occurrence of Oral Cancer, but also for development of Metabolic Syndrome http://tobaccocontrol.bmj.com/content/19/4/297/reply#tobaccocontrol_el_3489 In my opinion, we require a clear-cut and focused directive of the WHO Framework Convention on Tobacco Control that specifically addresses Snus and Gutkha. If we can not control online trade of Snus, it will be a bad situation, because the web-based trade crosses the border very quickly, not only in EU but also other parts of the world. The disturbing fact is that Sweden is a signatory of the FCTC yet the Swedish Government is getting revenue from this online Snus trade.
Professor Chitta CHOUDHURY | Nitte University & Int'l Centre of Tropical Oral Health, UK Director, Centre for Oral Disease Prevention & Control, NICE Stakeholder on ST control for SE Asian Migrants in the UK.
cr_choudhury@yahoo.co.uk
Conflict of Interest:
None declared
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Perverse conclusion from results
Submit responseThe results of the recent study by Alpert et al. were interpreted incorrectly with respect to the efficacy of nicotine replacement therapy (NRT).(1) The study only considered relative relapse rates among people who had already stopped smoking according to whether they had used NRT or not. This is clearly an inadequate design to address the issue of efficacy because it ignores the initial quit rates in the two groups. Only if the results had indicated significantly higher relapse among those using NRT might they have offered evidence against long-term NRT efficacy, depending, of course, on the initial difference in quit rates (not measured) and the difference in relapse rates. However, this was not the case. There was no evidence of differential relapse. Therefore, the conclusion that these data provide evidence against the effectiveness of NRT is wrong.
Had the authors considered more thoroughly the literature they would surely have been enlightened by the meta-analysis review of relapse and long-term NRT effectiveness published in Tobacco Control.(2) It would have helped them understand the issues and to draw an appropriate conclusion, rather than a perverse one. That review included 4792 randomized subjects (not self-selected as in the new study) followed up for several years and found the same result as Alpert: the relapse rate did not differ between those using NRT and others. Consequently, because the initial NRT quit rate was higher, efficacy remained after a mean follow-up time of 4.3 years (Odds ratio =1.99, 95% C.I. = 1.50 to 2.64). In contrast to the new study, all the subjects in that review received some form of professional support, although often minimal. Therefore, the same finding with respect to relapse in the new population-based study tends, if anything, to broaden rather than diminish the evidence for long-term NRT effectiveness.
(1) Alpert HR, Connolly GN, Biener L. A prospective study challenging the effectiveness of population-based medical intervention for smoking cessation. Tob Control 2012 10.1136/tobaccocontrol-2011-050129 Online 12 January
(2) Etter JF, Stapleton JA. Nicotine replacement therapy for long- term smoking cessation: a meta-analysis. Tob Control 2006;15(4):280-5.
Conflict of Interest:
John Stapleton has conducted trials of nicotine replacement and other treatments for tobacco dependence supported by the Medical Research Council, the Department of Health and Cancer Research UK. He was formally an adviser on issues of study design and methodology to several manufacturers of smoking cessation medications, including NRT, bupropion and varenicline.
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Placebo was never a real-world quitting method
Submit responseMany of Alpert, Connolly and Biener's population level NRT post- cessation findings are disturbing and worthy of further and deeper review. What's most baffling is that any government would invest so much confidence and so many lives in a product without demanding a shred of population level evidence as to its worth.
According to this paper, the odds of relapse for a heavily dependent NRT quitter who had quit less than six months were 3.53 times that of a heavily dependent quitter who quit without NRT or professional help. If true, that puts a rather hefty dent in NRT's most favored failure explanation, its selection bias theory.
This finding makes troubling the fact that varenicline (Chantix/Champix) failed to prevail in long-term point prevalence quitting over nicotine patch in the only head-to-head clinical trials to date (Aubin 2008 and Tsukahara 2010).
Alpert and colleagues do not attempt to explain the conflict between clinical trial and population level NRT findings. But I submit that this outcome was suggested by the first NRT clinical trial ever, the 1971 nicotine gum study by Ohlin and Westling.
Ohlin and Westling found that counseling and support ("ten visits and more persuasion") was superior to nicotine gum alone, but that nicotine gum could defeat placebo gum users. Even then, Ohlin and Westling documented obvious nicotine gum blinding concerns.
Try to name any other placebo-controlled study area where the condition sought to be treated (withdrawal) does not exist until researchers command its onset. Name any other study area where the placebo group is actually punished within 24 hours by a rising tide of anxieties.
Have three decades of referring to nicotine as "medicine" and its use "therapy" undermined natural learning and the quitter's ability to self- discover the most critical recovery lesson of all, that lapse almost always equals relapse, that one puff is too many and thousands never enough?
Nearly all population level quitting method surveys to date have found NRT less effective long-term than quitting without it. If true, are taxpayers today paying to reduce the quitter's odds of success? Are we responsible for undercutting their chances and costing many their lives?
John R. Polito Nicotine Cessation Educator
Conflict of Interest:
Pro bono director of a cold turkey stop smoking website.
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Is it Population control or tobacco
Submit responseAttending the RCP annual conference in 1999 in London, I remember a delegate suggesting during a discussion on tobacco control that providing cheap tobacco could be one way for China to control its population. Though the suggestion was generally felt to be in poor taste, I am shell shocked to read the conclusions of this article !
Conflict of Interest:
None declared
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Butt Perceptions & Butt Solutions....
Submit responseOne would imagine that public concern about butt litter would largely rise with the amount of butt litter that occurs. One would also reasonably imagine that news articles dealing with the "problem" of butt litter would similarly rise. If we take those two assumptions as being a given for the moment, and then look at the statistics uncovered by this research, we see something very interesting.
Using Google's time search feature we are able to search for news stories/articles in discrete time units. During the period of 10 inclusive years 1982 to 1991, there were 7 stories: i.e. less than one story per year. But during the inclusive 8 year period of 2002 to 2009, there were 242 stories, roughly 30 per year. That's over a 3,000% increase in public perception of and attention to the problem, which would indicate that there may have been as much as a 3,000% actual increase in the amount of butt litter between these two comparative periods.
Some of that may have been generated by increased paranoia about smoke and dislike/hatred of smoking and smokers, but it's likely that a great deal of it represents an actual and very serious increase in the problem.
So what changed in our society between those two periods that caused this problem to undergo such an incredible escalation? It could be that there are now far more smokers per given area than there were in the 1980s... but tobacco control statistics don't seem to bear that out: generally they claim a decrease in smokers while habitable/used land areas in cities/towns/beaches/parks etc have generally increased along with general population growth during those years. It could be that smokers are now less conscious of butt littering as a problem, but given the increase in media attention to the issue this is also unlikely to be a cause.
The one outstandingly obvious and overwhelming cause of this problem would seem to be the antismoking movement's insistence upon throwing smokers out into the streets to smoke rather than allow for provision of comfortably separated and ventilated indoor options and venues for smokers and their friends.
If cigarette butt pollution is indeed the true concern here, then such indoor options should clearly be explored. If however, as indicated in the abstract, the focus on cigarette butt litter is simply because such a focus is seen as a way to "justify environmental regulation and policies that raise the price of tobacco and further denormalise its use." -- a pure social engineering mechanism -- then such solutions will of course be ignored.
Which path do you think tobacco control will take?
Michael J. McFadden,
Author of "Dissecting Antismokers' Brains"
Conflict of Interest:
Author of "Dissecting Antismokers' Brains" Active member of (and sometimes officer in) a number of citizens' Free Choice groups. No compensation involved.
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Reply to Glantz and Polansky
Submit responseNOT PEER REVIEWED Glantz & Polansky respectfully suggest that I should (1) "Base my criticisms on actual data and analysis, rather than raising hypothetical problems and presenting them as if they had been demonstrated to be real" and (2) "Criticise the proposal based on the actual behavior of the motion picture industry, not on whether or not youth see some R-rated films."
Suggestion 1 seems to be proposing that no one should ask questions about others' research but instead, keep silent until they complete their own studies. I will reflect on that advice next time I receive reviewers' comments on my research. However, in 17 years of editing, I don't believe I ever saw an author respond to a reviewer's criticisms by saying these would be ignored until the reviewer submitted their own research.
In fact, Matthew Farrelly who co-authored our PLoS Med paper[1] has done such research[2] - cited in our paper -- which demonstrated that smoking is inextricably intertwined with a range of other youth-enticing variables in movies [2]. As we wrote, smoking characters never just smoke, and movies showing smoking have a lot more in them that might appeal to youth at risk of smoking than just smoking. This is a core issue that has been ignored in all studies to date, other than Farrelly et al's.
Glantz and Polansky's main finding is that "movies with smoking make 87% of what comparably rated smoke-free films make". Consider why this might be the case. It is implausible that this could be explained by market forces whereby word would quickly spread around a nation "do not go to see movie X .. it contains smoking!" Rather, it is far more likely that movies where smoking occurs are from less popular genres: another illustration of how preoccupation with judging a movie by whether or not it contains smoking can obscure consideration of the totality of a movie's appeal, both in box-office potential and to youth at risk of smoking.
As to their second suggestion, it is indisputable that large proportions of young people often see adult-rated material. There are many studies showing this in the violence and sexual content areas, as well as in the tobacco field. My point is simply this: if the R-rating solution is designed to prevent youth seeing smoking, it may prevent them seeing it in cinemas, but it will not prevent them seeing the newly rated R movies elsewhere with consummate ease, increasingly so as download and i-View markets rapidly expand. This being the case, it surely cannot be long until proponents of R-rating realize that they will need to call for total movie censorship of smoking. If they are comfortable with that, is it time to be open about it?
References
1. Chapman S, Farrelly M. Four arguments against the adult-rating of movies with smoking scenes. PLoS Med 2011; e1001078. doi:10.1371/journal.pmed.1001078 Published Aug 23 2011
2. Farrelly M, Kamyab K, Nonnemaker J, E. C (2011) Movie smoking and youth initiation: parsing smoking imagery and other adult content. Social Science Research Network. Social Science Research Network. Available: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1799561.
Conflict of Interest:
None declared
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health warnings unlikely to be effective
Submit responseBut the evidence is that no media campaign based on health warnings is likely to be effective.
So comparing different varieties of campaigns unlikely to be effective doesn't seem very productive.
Comparing varieties of campaigns using themes known to be effective, might be worthwhile.
Ref:
Evaluation of Antismoking Advertising Campaigns Lisa K. Goldman, MPP; Stanton A. Glantz, PhD. JAMA. 1998;279(10):772-777. doi: 10.1001/jama.279.10.772
Conflict of Interest:
None declared
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