Recent eLetters
Displaying 1-10 letters out of 325 published
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Corrections to citations and interpretation of Hughes, et al
Submit responseI would like to make one correction and some comments on this article's interpretations of our prior review article on hardening (Drug Alcohol Dependence 117:111-17, 2011).
The Cohen et al article cites the prior review as treating "tobacco control policies solely as a driver of quit attempts, with no impact on the ability to maintain abstinence after a quit attempt (p 266)." The article actually stated "tobacco control activities appear to more strongly influence a quit attempt whereas treatment. . . appears to more strongly influence the ability to abstain.(p 112) "
The article also proposes that rather than conduct more research on hardening as the prior review proposed, that we should more fully fund tobacco control interventions(p 265). Since when do research and tobacco control funds compete? Should we stop all lung cancer research as well?
The article also states knowing if hardening occurs "will not have bona fide implications" for tobacco control. The prior review outlined that if hardening was occuring due to the inability to stop due to increased nicotine dependence, this would suggest that a larger and larger group of smokers would be unlikely to quit without treatment. This assertion is based on the evidence that dependent drug users often need more than simple motivation to quit.
The article also states that "insistence that individual smokers are becoming more resistant to quitting and that populations are hardening (note my review never "insisted" this) is reminiscent of victim blaming. (p 266). If anything hardening recognizes that some smokers are unable to quit, not due to lack of motivation, but because they have a significant disorder (nicotine dependence) that can improve with treatment. This is more emphathic than it is victimizing. In fact, "denormalization" (i.e. stigmatization)is much more victim blaming than noting some smokers have a disorder. Would we say promoting antidepressants for those who cannot overcome depression by themselves is "victim blaming" whereas seeing depression as abnormal (i.e. denormalizing) is not?
Finally, many articles on hardening begin by pointing out that we have not really increased quit attempts or cessation success recently in the US (see article by Zhu). In response, many tobacco control advocates say essentially "it's not that the tobacco control actions don't work, it's because they have not been fully implemented." That is a reasonable hypothesis, but it is just a hypothesis. Although some correlational data support it (e.g. see success in CA), the more valid direct experimental tests via the many community trials do not consistently support the hypothesis (e.g. see Cochrane review of community trials).
Conflict of Interest:
I have received grants and consulting fees from several for-profit and non-profit companies that market medication and psychosocial treatments for smoking cessation or engage in tobacco control activities
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Limited Sampling and lack of social group can effect the comparison of cigarette- and hookah-related videos on YouTube
Submit responseNOT PEER REVIEWED We want to share our thoughts regarding the conclusions of this comparison. We strongly believe that this research must be evaluated with a larger sample. The criteria for inclusion or exclusion need to be revised, for two reasons:
1. If we search for videos on Youtube using the words "cigarette" or "hookah", there are more than 86,500 and 39,850 videos respectively (search dated, March 15th, 2012). We assume that the criteria the authors used for choosing the 66 and 61 videos for cigarette and hookah respectively are insufficient.
The authors have considered the remarks of the Youtube users on these videos. However, the conclusions that can be drawn are limited due to the small sample size.
A social group needs to be defined when working with a search engine like Youtube, where the respondents are normally not available. In this research the social group has not been defined since there are no interview data.
We strongly believe that online survey based research with search engines like Youtube has an advantage of being low coast and less time consuming but yet there is a need of respondents belonging to a specific social group.
We suggest this research could be improved by targeting a specific social group on Youtube and using an online questionnaire based survey of the respondents who comment on Youtube videos to have a comparison of what they comment and what they think based on their knowledge and exposure as members of a specific social group.
Conflict of Interest:
None declared
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Free NRT by mail an intent-to-treat defeat
Submit responseZawertailo, Selby and colleagues conclusion that free replacement nicotine (NRT) by mail is effective is deeply disturbing.[1] While the study's free abstract portrays free NRT by mail as a resounding success (21.4% smoking cessation at 6 months versus 11.6% for no-intervention), it neglects mention that under intent-to-treat analysis that there was zero benefit over no-intervention (an average of 8.7 percent 30-day point prevalence at 6 months for both mailed NRT and control).
All evidence presented in the 2008 Guideline Update relied exclusively upon intent-to-treat data. Here, the rates shared in the abstract ignore 2,746 six-month follow-ups where participants were successfully reached by phone. Why? Because they either hung-up or refused interview. It's a number greater than the 2,601 actually interviewed. Do happy, thankful and successful quitters normally hang-up after previously agreeing to follow-up?
A number of recent population studies have found NRT totally ineffective (Ferguson 2005, Doran 2006, Hartman NCI 2006, Pierce 2012, Alpert 2012 and Coleman 2012). The prospect of a billion smoking related deaths before century's end, now is not the time for creative quitting definitions which ignore disappointed or disgruntled participants.
John R. Polito, JD
[1] Zawertailo L, Dragonetti R, Bondy SJ, Victor JC and Selby P, Reach and effectiveness of mailed nicotine replacement therapy for smokers: 6-month outcomes in a naturalistic exploratory study. Tob Control. doi:10.1136/tobaccocontrol-2011-050303
Conflict of Interest:
Pro bono director of a cold turkey quitting forum.
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Response to Thomson et al.
Submit responseNOT PEER REVIEWED I note this article in Tobacco Control quotes my two recent articles on the Bhutanese endgame. However, the Tobacco Control article to a certain degree does not catch the spirit of what is going on in Bhutan and what I concluded in my publications. Importation of small amounts of tobacco for personal consumption is legal. Sales are not--they are banned nationwide. Nevertheless, there is a major tobacco black market and smuggling that bypasses the provision of importation for personal use because the actual demand is much higher than the restricted supply coming in over the border. In other words, the issue of violating prohibition or even quasi-prohibition looms large. There is no discussion in this article of how to specifically solve this major problem particularly in the context of previous failed prohibition or neo-prohibition projects like American alcohol prohibition.Conflict of Interest:
None declared
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What are U.S. health officials smoking?
Submit responseNOT PEER REVIEWED Zhu and colleagues' population level findings contribute to a growing body of external real-world evidence supporting the conclusion that the quitting product marketing industry's "double your chances" mantra is false and deceptive, and that smoker reliance upon it is likely responsible for a host of negative consequences, including failure to quit and premature demise.[1]
Their review of twenty years of National Health Interview Survey data documents how, despite arrival of a host of new quitting products since 1991, the average annual cessation rate has seen little change. The rate has hovered around 4.4%, with the past decade showing a slight decline over the prior decade, dropping to 4.2% from 4.7%.[2]
The authors give more than 200 randomized quitting product trials a pass in labeling them "rigorous," while noting that clinical and real-world populations and environments differ. While true and less controversial, I submit that we cannot blind quitters with lengthy quitting histories as to the presence or absence of full-blown withdrawal. Placebo assignment awareness among expert quitters occurs within 72 hours of full nicotine cessation. I contend that placebo-controlled efficacy findings reflect expectations not worth, at levels roughly corresponding to study participant quitting experience.[3]
It is no secret that approved quitting products have failed to prevail over non-medication, non-NRT, unassisted and cold turkey quitters in nearly all population level assessments since 2000.[4] The burning question is why public health officials have not suspended current cessation policy, which in the U.S. continues to make approved quitting product use recommendations mandatory.
In June 2000, U.S. health officials intentionally turned their backs on the smoker's natural quitting instincts, in officially ending all support of cold turkey quitting. Since then, the U.S. Guideline has stated that, unless medically contraindicated, all quitters should be told to purchase and use approved quitting products.[5]
Interestingly, a number of the twenty-year time-line ticks inversely correspond to the intensity of quitting product marketing. For example, 1999 to 2001 saw a full percentage point drop. The June 2000 Guideline with its mandatory use recommendation received wide dissemination, with 44,000 copies of the 179 page document distributed by 2002.
Today, official U.S. Cessation policy is to undermine confidence in natural cessation at every opportunity. According to current policy, smokers should never attempt to abruptly end nicotine stimulation of brain dopamine pathways, but to continue stimulation via replacement nicotine, bupropion or varenicline.
Imagine being a cold turkey quitter, visiting the government's www.SmokeFree.gov quit smoking site, and being bombarded 173 times with the message to use "medication" or "medicine." Imagine downloading a copy of "Clearing the Air," the government's leading quitting booklet, and on page 10 under the "Cold Turkey" section being falsely told that "fewer than five percent of smokers can quit this way," that "most smokers have more success with one of the assisted quitting methods discussed below."[6]
Cold turkey remains the most popular and productive quitting method of all, generating more long-term successful ex-smokers than all other methods combined. I commend the authors for raising the unintended consequence of over-emphasis upon approved products. Imagine the confidence injury to natural cessation inflicted by three decades of cold turkey bashing. Imagine the hopelessness of repeatedly attempting cessation by use of the best science has to offer, and each time falling flat on your face.[7]
The authors suggest that the obvious solution isn't so much in working to improve interventions but finding ways to induce more attempts. While important, if placebo-controlled trials were fatally flawed, what do we really know about quitting? What would be the outcome of trials pitting those wanting to quit cold turkey against those wanting to use approved products?
And how difficult or expensive would it be to conduct prospective studies which follow and monitor cessation attempts, methods and outcomes among smoking patients of family practice physicians? How hard would it be to test five to ten minute patient counseling scripts within the treatment setting?
There has been almost no study of the common threads among successful cold turkey quitters. Could something as simple as a public health campaign which teaches that lapse almost always equals relapse, arm quitters with the most critical survival lesson of all, that one equals all, that one puff would be too many, while thousands never enough? I submit that it could.[8]
John R. Polito
Nicotine Cessation EducatorReferences:
[1] Polito JR, Are those who quit smoking paying with their lives because of NRT's failure? BMJ 2012; 344:e886.
[2] Zhu SH, Lee M, Zhuang YL, Gamst A, Wolfson T, Interventions to increase smoking cessation at the population level: how much progress has been made in the last two decades? Tob Control. 2012 Mar;21(2):110-8.
[3] Polito JR, Smoking cessation trials, CMAJ. 2008 Nov 4;179(10):1037-8; author reply 138. Free Full Text
[4] Polito JR, Are those who quit smoking paying with their lives because of NRT's failure? BMJ. 2012 Feb 7;344:e886. doi: 10.1136/bmj.e886.
[5] Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville (MD): U.S. Department of Health and Human Services, Public Health Service, 2008. Full Text PDF
[6] NIH-Publication No. 11-1647, Clearing the Air, Printed Oct. 2008, Reprinted August 2011. Full Text PDF
[7] Polito JR, Dying truths about quitting methods, WhyQuit.com, Nov. 14, 2011. Full Text
[8] Polito JR, How to quit smoking, WhyQuit.com, December 18, 2010. Full Text
Conflict of Interest:
Pro bono director of an online cold turkey nicotine cessation forum.
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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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