The Global Research Neglect of Unassisted Smoking Cessation: Causes and Consequences

The Global Research Neglect of Unassisted Smoking Cessation: Causes and Consequences

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The Global Research Neglect of
Unassisted Smoking Cessation:
Causes and Consequences
Simon Chapman and Ross MacKenzie review the evidence and argue that health promotion messages should emphasize that the most successful method used by most ex-smokers is unassisted cessation.



Simon Chapman, Ross MacKenzie School of Public Health, University of Sydney, Australia

Citation: Chapman S, MacKenzie R (2010) The Global Research Neglect of Unassisted Smoking Cessation: Causes and Consequences. PLoS Med 7(2): e1000216. doi:10.1371/journal.pmed.1000216



Published: February 9, 2010

Copyright: © 2010 Chapman, MacKenzie. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: National Health and Medical Research Council (Australia) Project Grant 2006–09 #401558. The funders had no role in the decision to submit this manuscript or in its preparation.

Competing interests: SC was a member of the Australian Smoking Cessation Consortium that received research funding from GlaxoSmithKline in 2001–2002.

Abbreviations: NRT, nicotine replacement therapy

[url=mailto:simon.chapman@sydney.edu.au]* E-mail: simon.chapman@sydney.edu.au[/url]

Provenance: Not commissioned; externally peer reviewed


Summary Points
  • Research shows that two-thirds to three-quarters of ex-smokers stop unaided. In contrast, the increasing medicalisation of smoking cessation implies that cessation need be pharmacologically or professionally mediated.
  • Most published papers of smoking cessation interventions are studies or reviews of assisted cessation; very few describe the cessation impact of policies or campaigns in which cessation is not assisted at the individual level.
  • Many assisted cessation studies, but few if any unassisted cessation studies, are funded by pharmaceutical companies manufacturing cessation products.
  • Health authorities should emphasise the positive message that the most successful method used by most ex-smokers is unassisted cessation.
Introduction Top As with problem drinking, gambling, and narcotics use [1][9] population studies show consistently that a large majority of smokers who permanently stop smoking do so without any form of assistance [10][15]. In 2003, some 20 years after the introduction of cessation pharmacotherapies, smokers trying to stop unaided in the past year were twice as numerous as those using pharmacotherapies and only 8.8% of US quit attempters used a behavioural treatment [16]. Moreover, despite the pharmaceutical industry's efforts to promote pharmacologically mediated cessation and numerous clinical trials demonstrating the efficacy of pharmacotherapy, the most common method used by most people who have successfully stopped smoking remains unassisted cessation (cold turkey or reducing before quitting [16],[17]). In 1986, the American Cancer Society reported that: “Over 90% of the estimated 37 million people who have stopped smoking in this country since the Surgeon General's first report linking smoking to cancer have done so unaided.” [18]. Today, unassisted cessation continues to lead the next most successful method (nicotine replacement therapy [NRT]) by a wide margin [15],[16].

Yet, paradoxically, the tobacco control community treats this information as if it was somehow irresponsible or subversive and ignores the potential policy implications of studying self-quitters. Unassisted cessation is seldom emphasised in advice to smokers [19]. We know of no campaigns that highlight the fact that most ex-smokers quit unaided even though hundreds of millions have done just that. Reviews typically give unassisted cessation cursory attention [20], framing it as a challenge to be eroded by persuading more smokers to use pharmacotherapies: “Unfortunately, most smokers …fail to use evidence-based treatments to support their quit attempts” [21]; “If there is a major failing in the UK approach, it is not that it has medicalised smoking, but that it has not done so enough.” [22]. Clinical guidelines also ignore unassisted cessation [8]. Finally, although the US National Center for Health Statistics routinely included a question on “cold turkey” cessation in its surveys between 1983 and 2000, this question disappeared in 2005 [23].

Because of these prevalent attitudes, smoking cessation is becoming increasingly pathologised, a development that risks distortion of public awareness of how most smokers quit to the obvious benefit of pharmaceutical companies. Furthermore, the cessation research literature is preoccupied with the difficulty of stopping. Notably, however, in the rare literature that has bothered to ask [24], many ex-smokers recall stopping as less traumatic than anticipated. For example, in a large British study of ex-smokers in the 1980s, before the advent of pharmacotherapy, 53% of the ex-smokers said that it was “not at all difficult” to stop, 27% said it was “fairly difficult”, and the remainder found it very difficult [25].

We recently hypothesized that research into smoking cessation follows what we call “the inverse impact law of smoking cessation.” This law posits that “the volume of research and effort devoted to professionally and pharmacologically mediated cessation is in inverse proportion to that examining how most ex-smokers actually quit. Research on cessation is dominated by ever-finely tuned accounts of how smokers can be encouraged to do anything but go it alone when trying to quit—exactly opposite of how a very large majority of ex-smokers succeeded.” [26]

In this Policy Forum, we test this law and, because a recent review of Cochrane selected randomized controlled trials of NRT [27],[28] found that while 51% of industry-funded trials reported significant cessation effects, only 22% of nonindustry trials did, we also test the hypotheses that research on pharmaceutically mediated cessation is frequently conducted by researchers supported by pharmaceutical companies and that support for research into unassisted cessation and nonpharmaceutical interventions is less common. Throughout this Policy Forum, by assisted cessation, we mean any pharmacotherapy or any individual or group behavioural or cognitive intervention. By unassisted cessation, we mean approaches that involve none of these interventions but instead include interventions such as changes in tobacco tax, smoking restrictions, or public awareness campaigns designed to stimulate cessation. We then consider why research into how most people stop smoking is being neglected and reflect on the potential negative consequences for public health of repeatedly megaphoning the message that “serious” cessation is assisted cessation, a message that implies that unassisted cessation is less worthy of research attention, publicity, and consideration by quitters. Finally, we suggest how the message that smokers are getting about cessation should be adjusted to help more people quit.


Testing the Inverse Impact Law of Smoking Cessation Top On May 12, 2009, we searched Medline for “smoking cessation,” limiting results to English language original articles, meta-analyses, and reviews published in 2007 and 2008. Of the 885 papers returned, we excluded those that dealt specifically with the effects of cessation on behavioural, cognitive or affective variables, study recruitment research, health economics, and those papers that had a different primary focus, such as smoking-related diseases.

Of the 662 papers that met our inclusion criteria, 511 were studies of cessation interventions. The other 118 were mainly studies of the prevalence of smoking cessation in whole or special populations. Of the intervention papers, 467 (91.4%) reported the effects of assisted cessation and 44 (8.6%) described the impact of unassisted cessation (Figure 1). Some of those quitting as a consequence of unassisted cessation policies or programs would have used assisted methods, but these papers reported only on smoking status, not on how those who quit did so. Of the studies describing assisted interventions, 247 (52.9%) involved pharmacotherapy and 220 (47.1%) nondrug interventions. Of the papers describing cessation trends, correlates, and predictors in populations, only 13 (11%) contained any data on unassisted cessation.

Figure 1. Focus of original research and reviews of 662 smoking cessation papers indexed by Medline, 2007–2008 (percent of all papers).

*, Pharmacotherapy: NRT only 57; bupropion only 19; varenicline only 26; combination/head-to-head trials 56; other pharmacotherapy 20; pharmacotherapy versus nonpharmacotherapy 7; pharmacotherapy with counselling 49; meta-analyses/systematic reviews 8; reduced nicotine cigarettes 2; smokeless tobacco 3. **, Nonpharmacotherapy: community cessation centres, groups, counselling 28; primary health care 29; hospital-based or referrals 39; workplace programs 6; schools/youth 16; quitlines 26; phone or posted initiated by professionals 16; Web-based 32; combination quitline/Web/calls 9; pamphlets/books 2; spirometry as motivator 2; acupuncture/acupressure 3; exercise 6; meta-analyses/systematic reviews 6. ***, Trends, correlates and predictors. Whole or special populations 82; youth 16; primary health care 6; hospital patients 12; workplaces 2. #, Three articles were unobtainable.

doi:10.1371/journal.pmed.1000216.g001

We then randomly chose 30 papers that considered assisted cessation interventions, 30 that considered unassisted cessation interventions, and 30 that discussed the prevalence of smoking cessation to test the hypothesis these groups of papers would not differ in terms of whether authors and/or studies had received support from a pharmaceutical company manufacturing smoking cessation products. For papers that contained no declarations of competing interests and/or pharmaceutical industry funding, we emailed the corresponding authors to request this information. Where no replies were received, we examined these authors' previous publications on cessation from the past 5 years for such declarations.

Of the 84 papers for which competing interest information was available, 12/25 (48%) of pharmacotherapy intervention studies, 3/29 (10.3%) of nonpharmacotherapy intervention studies, and 0/30 of unassisted cessation studies had at least one author declaring support from a company manufacturing cessation products and/or research funding from such a company (p<0.001). Five of the six authors who did not respond to requests for information on competing interests were previously involved in studies on pharmacological interventions for cessation.


Why Does the Research Concentrate on Assisted Cessation? Top With approximately two-thirds [16] to three-quarters [15] of ex-smokers stopping unaided, our finding that 91.3% of recent intervention studies focused on assisted cessation provides support for the inverse impact law of smoking cessation [26], although further studies are needed to confirm that the bias towards studies on assisted cessation interventions that we discovered is a long-standing one and not peculiar to the years we studied. We believe there are three main synergistic drivers of the research concentration on assisted cessation and its corollary, the neglect of research on the natural history of unassisted smoking cessation. These are: the dominance of interventionism in health science research; the increasing medicalisation and commodification of cessation; and the persistent, erroneous appeal of the “hardening” hypothesis.

The Dominance of Interventionism Most tobacco control research is undertaken by individuals trained in positivist scientific traditions. Hierarchies of evidence give experimental evidence more importance than observational evidence [29],[30]; meta-analyses of randomized controlled trials are given the most weight. Cessation studies that focus on discrete proximal variables such as specific cessation interventions provide “harder” causal evidence than those that focus on distal, complex, and interactive influences that coalesce across a smoker's lifetime to end in cessation. Specific cessation interventions are also more easily studied than the dynamics and determinants of cessation in populations [31]. Experimental research focused on proximal relationships between specific interventions and cessation poses fewer confounding problems and sits more easily within the professional norms of scientific grant assessment environments, which are populated largely by scientists working within the positivist tradition.

The dominance of the experimental research paradigm is amplified by pharmaceutical industry support for drug trials. More than half the papers we found on assisted cessation were pharmaceutical studies and, unsurprisingly, these were much more likely than papers on nonpharmacological interventions to have industry-supported authors. Companies have an obvious interest in research about the use and efficacy of their products and less interest in supporting research into forms of cessation that compete with pharmacotherapy for the cessation market.

The availability of pharmaceutical industry research funding—often provided without the lengthy processes of open tender or independent peer review—can be highly attractive to researchers. Furthermore, it is often observed that “research follows the money,” with scientists being drawn to well-funded research areas [32]. The large pool of research funding for pharmacotherapeutic cessation may cause researchers to gravitate toward such studies while those interested in the natural history of smoking cessation have to secure funding through highly competitive public grant schemes.

This greater availability of funding for certain sorts of research produces a distorted research emphasis on pharmacotherapy that, when combined with the industry's formidable public relations abilities and direct-to-consumer advertising, concentrates both scientific and public discourse on cessation around assisted pharmacotherapy. In 2006, the global NRT market was estimated at $1.7 billion [33]. The pharmaceutical industry places more messages about quitting in front of smokers than any other source: in the USA, there are 10.37 pharmaceutical cessation advertisements per month but only 3.25 government and NGO cessation messages [34].

The Medicalisation and Commodification of Cessation Tobacco use, like other substance use, has become increasingly pathologised as a treatable condition as knowledge about the neurobiology, genetics, and pharmacology of addiction develops. Meanwhile, the massive decline in smoking that occurred before the advent of cessation treatment is often forgotten. Warner [35] documented this decline, which started following news coverage of the 1964 report of the US Surgeon General. He noted that “per capita consumption likely would have exceeded its actual 1975 value by 20 to 30 per cent” without this decline. Other than the first small pack warnings that appeared from 1966 in the USA, this effect occurred without any elements of today's comprehensive approaches to tobacco control.

In 1975, Renaud wrote of the fundamental tendency of capitalism to “transform health needs into commodities … When the state intervenes to cope with some health-related problems, it is bound to act so as to further commodify health needs.” [36]. The burgeoning commodification of cessation by manufacturers of both effective and ineffective [37] drugs seems to have induced a kind of professional amnesia in tobacco control circles about the millions who quit in the decades before the dominance of the contemporary smoking cessation discourse by pharmacotherapy. As Granfield and Cloud remarked about the substance abuse field's aversion to studying unassisted recovery by narcotics addicts, the dominance of assisted cessation in the tobacco control field “has a common tendency to exclude the experiences of people who do not fit into prevailing models of substance problems and treatment” [2].

The Persistent, Seductive, and Erroneous Appeal of the “Hardening” Hypothesis This hypothesis predicts that where “smoking prevalence is lowest or the most progress in reducing smoking prevalence has been made, the remaining smokers are more likely to be ‘hard-core’, or refractory to a policy and/or treatment interventions, because the people who have quit were less dependent on nicotine, and/or more motivated to quit.” [38]. The intuitive attractions of this hypothesis generated an entire US National Cancer Institute monograph [39]. Hardening adherents argue that ex-smokers are dominated by those who were not heavily addicted and so who were better able to quit unaided and that a greater proportion of today's smokers, said to be more addicted, cannot succeed alone and need help. This hypothesis has been heavily criticised [40]. Most recently, data on smoking in 50 US states for 2006–2007 indicate that the mean number of cigarettes smoked daily, the percentage of cigarette smokers who smoke within 30 minutes of waking, and the percentage who smoke daily are all significantly lower in US states with low smoking prevalence, compelling evidence against the hardening hypothesis [38].


Does Research into Assisted Cessation Apply to the Real World? Top Accumulated evidence from clinical trials shows unequivocally that those who use NRT in trials have 50%–70% greater success than those using placebo [28]. But clinical trial conditions typically overstate real world effectiveness because of factors such as trial participants getting free drugs and “Hawthorne” effects caused by the research attention paid to participants [41] and the participants' desire to please the researchers with whom they interact. Moreover, Mooney et al. [42] found that only 23% of NRT placebo-controlled trials assessed blindness integrity and 71% of these trials found that the participants could detect if they had been assigned to the active agent, a rate significantly above chance.

The results from a smaller, but growing, literature examining “real world” use provides a more sobering assessment of the potential of this intervention to significantly improve population rates of cessation. Walsh's review concluded that it is “not yet established that NRT alone is superior to self-quitting in an unsupported OTC [over the counter] environment” [41] and noted major limitations in Hughes' earlier, more optimistic meta-analysis [43].

For the clinical trial efficacy of NRT to be replicated in the real world, smokers may need to have some form of support during their cessation efforts but few smokers are interested in engaging with smoking cessation support services. In Australia, for example, in spite of the national quitline number appearing on every cigarette pack and in every government quit message, only 3.6% of smokers called the quitline in a year [44]. In 2000–2004, in the UK area with the highest reported cessation support participation rate, only 6% of smokers used the available support services [45]. Prospects for engaging larger proportions of smokers in more intensive interventions seem poor.

Overall, population level analyses of the impact of the proliferation, deregulation, and widespread promotion of NRT and other pharmacotherapies have failed to show any significant, sustained impact on smoking prevalence, despite the conclusions of clinical trials. Cummings and Hyland's 2005 review concluded that: “Time series analyses of national cigarette consumption and NRT sales from 1976 to 1998 suggest that sales of NRT were associated with a modest decrease in cigarette consumption immediately following the introduction of the prescription nicotine patch in 1992. However, no statistically significant effect was observed after 1996, when the patch and gum became available OTC. … annual quit rates as well as age-specific quit ratios remained stable” [46]. Similar conclusions were reached for Massachusetts [47] and California [48]. Most recently, Wakefield et al. assessed the impact of televised antismoking advertising, cigarette price, sales of NRT and bupropion (a smoking cessation drug), and NRT advertising by examining monthly Australian smoking prevalence from 1995 to 2006. They found that, unlike antismoking advertising and price, neither NRT or bupropion sales nor NRT advertising had any detectable impact on smoking prevalence [49]. Although this lack of effect may have been due to power limitations (some 40% of smokers make an attempt to quit each year, a fraction of these use pharmaceutical aids, and an even smaller fraction quit, which means that extremely large population samples are needed to detect any effect of these interventions), it hardly inspires confidence that assisted cessation makes a major contribution to reducing smoking in populations.

The public is often advised that assistance at least doubles cessation rates. But while the clinical trial literature consistently shows higher quit rates from assisted than unassisted cessation, population studies show the opposite. For example, a 1990 US study found 47.5% of those who tried to quit unaided over 10 years were successful, compared with 23.6% using cessation programs [10]. Schachter noted that treatment-aided cessation rates may be lower than unassisted quit rates because of selection bias: those seeking treatment are likely to have made unsuccessful quit attempts and may be more failure-prone [50]. In 2008, Shiffman et al. reiterated this point: “Further, smokers self-select for treatment, based on their perceived need and expectations of difficulty quitting …so treatment-seeking itself can index risk for failure, undermining the validity of comparisons of outcome between treatment-seekers and non-seekers.” [16],[51].

A final example of how promoters of assisted cessation can maintain their position in the face of apparently contradictory results comes from a recent US study of unplanned cessation [52], which corroborated previous findings [53],[54] by reporting that unplanned cessation attempts were twice as successful as planned attempts and, significantly, that most unplanned quit attempters did not use any assistance. The authors noted that: “Given the evidence that use of medication can double success rates, it is surprising that even without this assistance unplanned quitters were more likely to be successful. It seems important to find ways to combine the favorable prognosis of unplanned quit attempts with the benefit of medication, for example, by ensuring easy, rapid access to medication.” They then suggested the removal of barriers to NRT sale such as prescription-only or pharmacy-only status, failing to note that these barriers had already been removed in the USA. The “surprise” expressed by the authors of this paper (all of whom had declared support from the pharmaceutical industry) seems revelatory of the myopic hold that assisted smoking cessation can have on the population-wide picture of how people quit.


The Consequences of the Research Neglect of Unassisted Cessation Top There has been a long history of criticism of the medicalisation of everyday life [55] to service social control [56] and medical and pharmaceutical industry profits [57]. As Caron et al. note: “the classic drawback of medicalization is its reductionism, which places excessive emphasis on the biological and individual determinants of disease at the expense of a more holistic perspective that emphasizes the social, cultural, and environmental contributions to disease and illness.” [58]. The neurobiology of nicotine dependency is well-established [59], and understanding of its genetics [60] is accelerating. But plainly, with the existence of many millions of unassisted ex-smokers and given the ways that international variations in their distribution reflect social, cultural, and public-health policy variables, smoking cessation in populations is explained by far more than neurobiology and pharmacology.

The persistent messaging that nicotine addiction is refractory and stopping unaided will be futile deflects attention away from what is by far the most common story of cessation: people doing it without professional or therapeutic help. When citizens have common, self-limiting ailments and traits and behaviours are regularly redefined as needing treatment, avoidable iatrogenic consequences and burgeoning health care expenditure can follow. But the steady erosion of human agency as populations lose confidence in their own ability to change unhealthy practices is perhaps of greater concern. Several negative consequences arise from smokers being increasingly imbued with the message that serious efforts at cessation require treatment.

It is understandable that smokers might feel it would be foolish to attempt to stop unaided when unassisted cessation is dismissed in pharmaceutical industry–supported demonstrably misleading propaganda [61] by statements such as: “It is hopelessly outdated to suggest: ‘willpower alone is enough to quit’. … Quitting ‘cold turkey’ does not generally translate into sustained abstinence from tobacco, and results in unnecessarily low rates of success for most smokers.” [62]; and: “[the] narrow ‘de-medicalized’ view of nicotine addiction …[has] conceivably perpetuated the epidemic [and] contributed to innumerable deaths” [62]. Because most assisted cessation attempts end in relapse, such “failure” risks are interpreted by smokers as “I tried and failed using a method that my doctor said had the best success rate. Trying to quit unaided – which I never hear recommended – would be therefore sheer folly.” Such reasoning might well disempower smokers and inhibit quit attempts through anticipatory, self-defeating fatalism [63].


Why Study Unassisted Cessation? Top In any endeavour, whether it be health-related such as weight loss, physical activity or ending narcotics use, or wider achievements such as business success or artistic virtuosity, it would seem reasonable to consider that studying those who had succeeded or excelled might reveal factors that might be valuable to others. Studying the habits, attitudes, routines, and environments of people who succeed where many others fail is commonplace in other fields so why not study unassisted smoking cessation?

The relatively few studies reporting on people who have quit unaided provide important information about factors associated with motivating quit attempts and with successful unaided cessation. Some of these factors are amenable to change via legislation or mass-reach public-awareness campaigns. Smoke-free homes [15] and workplaces [64], family and social support [65], bold pack warnings [66], price, and hard-hitting, well-funded campaigns [49] have all been associated with increased cessation activity and success, and relapse has been associated with exposure to social smoking cues [67].

Warner and Mackay argue that: “We can have our cake and eat it too” [68], stating that further resources and emphasis should be given to treating tobacco dependence as well as to public-health, population-focused approaches to promoting cessation. Certainly, smoking cessation treatment is one of the most cost-effective interventions in modern medicine [69], and wealthy nations can afford both approaches. However, today's largest tobacco markets are nations with massive populations on low incomes for whom pharmacotherapy is prohibitively expensive. In Indonesia for example, 3 months of NRT costs as much as 7 year's supply of cigarettes, placing NRT totally out of the reach of all but the wealthy [70]. NRT would thus seem to be largely irrelevant to population-wide cessation goals in many low- and middle-income nations.

Such nations emphatically cannot afford “both” and are often still struggling to fund basic primary health care, public-health, and sanitation infrastructures. Population-oriented, mass-reach tobacco control policy and programs are the exceptions in such nations. In our view, it would be a disaster for tobacco control progress if such nations were to be influenced to proliferate labour-intensive UK-style [71] models of assisted cessation before they implemented comprehensive and sustained population-focused cessation policies and programs. In most nations, tobacco control is in its nascent phase. Siphoning resources and scarce personnel into smoking cessation strategies that reach relatively few and help even fewer would be grossly inequitable.


What Message Should Smokers Get about Cessation? Top The persistence of unassisted cessation as the most common way that most smokers have succeeded in quitting is an unequivocally positive message that, far from being suppressed or ignored, should be openly embraced by primary health care workers and public-health authorities as the front-line, primary “how” message in all clinical encounters and public communication about cessation. Put another way, a failure to emphasise that most smokers have always stopped unaided would be like claiming that most domestic cooks attend cooking classes. Along with motivational “why” messages designed to stimulate cessation attempts, smokers should be repeatedly told that cold turkey and reducing-then-quitting are the methods most commonly used by successful ex-smokers, that more smokers find it unexpectedly easy or moderately difficult than find it very difficult to quit [25], that many successful ex-smokers do not plan their quitting in advance [52][54], and that “failures” are a normal part of the natural history of cessation—rehearsals for eventual success. Lessons learned from researching policy tractable, social support, and personal behavioural (“quit tips”) variables associated with successful cessation should be fed into policy and program planning. Talk of unassisted cessation being “the enemy” of evidence-based cessation should be roundly criticised as both incorrect and unhelpful. Unfortunately, the ability of manufacturers to promote their products through advertising is likely to “drown out” the perspective we urge. We suggest, therefore, that public sector communicators should be encouraged to redress the overwhelming dominance of assisted cessation in public awareness, so that some balance can be restored in smokers' minds regarding the contribution that assisted and unassisted smoking cessation approaches can make to helping them quit smoking.

What Message Should Smokers Get about Cessation?
  • There is good news about cessation: in a growing number of countries, there are more ex-smokers than smokers.
  • Up to three-quarters of ex-smokers have quit without assistance (“cold turkey” or cut down then quit), and unaided cessation is by far the most common method used by most successful ex-smokers.
  • A serious attempt at stopping need not involve using NRT or other drugs or getting professional support.
  • Early “failure” is a normal part of trying to stop. Many initial efforts are not serious attempts.
  • NRT, other prescribed pharmaceuticals, and professional counselling or support also help many smokers, but are certainly not necessary for quitting.
Author Contributions Top ICMJE criteria for authorship read and met: SC RM. Designed the experiments/the study: SC. Analyzed the data: SC. Collected data/did experiments for the study: SC. Wrote the first draft of the paper: SC. Contributed to the writing of the paper: SC RM.


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JohnPolito
Joined: 11 Nov 2008, 19:22

10 Feb 2010, 16:37 #2

Smoking Racket

by Simon Chapman - Feb 10, 2010  ABC.net.au
In 2006, the global nicotine replacement therapy (NRT) market was estimated at $1.7 billion. The pharmaceutical industry places more messages about quitting in front of smokers than any other source: in the USA, smokers see 10.37 pharmaceutical cessation advertisements per month compared with 3.25 from health agency messages. The constant megaphoning of the idea that quitting requires drugs is causing a rather spurious tail to wag a large banished dog carrying an important message.

Twenty years after the launch of NRT, studies repeatedly show two thirds to three quarters of permanent ex-smokers stop unaided and about half find it easier than anticipated - a phenomenon that also occurs with problem drinking, gambling and narcotics use. But when was the last time you heard that good news? Instead, the increasing medicalisation of cessation emphasizes the opposite and that serious attempts at quitting should be pharmacologically mediated.

The good news on cessation is treated almost like a state secret. There are no campaigns highlighting that most ex-smokers quit unaided despite globally hundreds of millions having done so. Among my colleagues, unassisted cessation is rarely researched, instead framed in studies often funded by the pharmaceutical industry as a challenge to be eroded by persuading more to use drugs. Yet if a smoker asked "how do most smokers quit?", failure to emphasise that most have always stopped unaided would be like explaining that most cyclists have professional tuition rather than being self-taught or that most domestic cooks attend cooking classes.

Quitting has become increasingly pathologised, risking distortion of public awareness of its natural history, to the obvious benefit of the drug industry. Research on cessation is dominated by ever-finely tuned accounts of how smokers can be encouraged to do anything but go it alone when trying to quit - exactly opposite of how a very large majority of ex-smokers succeeded.

A large body of evidence from clinical trials shows unequivocally that those who use NRT in trials have 50%-70% greater success than those using placebo. But clinical trial conditions overstate real world efficacy because of factors such as trialists getting free drugs, effects caused by the research attention paid to them and subjects' desire to please the researchers with whom they interact. A 2005 review concluded "sales of NRT were associated with a modest decrease in cigarette consumption immediately following the introduction of the prescription nicotine patch in 1992. However, no statistically significant effect was observed after 1996, when the patch and gum became available OTC." Moreover, one review found only 23% of NRT placebo-controlled trials assessed blindness integrity and 71% of these trials found that subjects could detect if they had been assigned to the active agent.

Another review of all NRT randomized controlled trials found 51% of industry-funded trials reported statistically significant cessation effects, against 22% of non-industry trials.

Many assume that we are now down to a "hard core" of smokers. Ex-smokers are assumed to be dominated by those who were not heavily addicted and so who were better able to quit unaided and that a greater proportion of today's smokers need help. But recent data comparing smoking in 50 US states provides compelling evidence against this idea: the average cigarettes smoked daily and the percentage who smoke daily are all much lower in US states with low smoking prevalence, exactly the opposite of what would follow.

When citizens have common, self-limiting ailments, traits and behaviours like smoking regularly redefined as needing treatment, avoidable iatrogenic consequences and burgeoning health care expenditure can follow. But the steady erosion of human agency as populations lose confidence in changing unhealthy practices is of greater concern. There are serious negative consequences arising from smokers being increasingly imbued with messages that serious efforts at cessation require treatment.

When unassisted cessation and willpower are dismissed in pharmaceutical industry supported propaganda, smokers might understandably feel that it would be foolish of them to attempt to stop unaided. Because most assisted cessation attempts end in relapse, such "failure" risks being interpreted by smokers as "I tried and failed using a method that my doctor said had the best success rate. Trying to quit unaided - which I never hear recommended - would be therefore sheer folly." Such reasoning is likely to disempower smokers, inhibiting quit attempts through anticipatory, self-defeating fatalism.

Pharmacotherapy is also irrelevant in today's largest tobacco markets, which are nations with massive populations on low incomes, making the drugs prohibitively expensive. In Indonesia, three months NRT costs as much 7 year's supply of cigarettes. It would be a disaster for tobacco control progress if such nations were to be influenced to proliferate labor-intensive and expensive approaches based on assisted cessation before they implemented comprehensive and sustained population-focused cessation policies and programs like tax rises, advertising bans and graphic pack warnings.

The persistence of unassisted cessation as the most common way that most smokers have always succeeded in quitting is an unequivocally positive message which should be openly embraced by health authorities as the front-line, primary "how" message in all clinical encounters and public communication about cessation. Along with motivational "why" messages designed to stimulate cessation attempts, smokers should be repeatedly told that cold turkey and reducing then quitting are the methods most commonly used by successful ex-smokers; that more smokers find it unexpectedly easy or moderately difficult than find it very difficult to quit; and that "failures" are a normal part of the natural history of cessation - rehearsals for eventual success.
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JohnPolito
Joined: 11 Nov 2008, 19:22

09 Aug 2011, 01:00 #3

Tar wars over smoking cessation
Author: Simon Chapman professor of public health, University of Sydney

Journal:  Tobacco Control, BMJ 2011;342:d5008 doi: 10.1136/bmj.d5008

The pharmaceutical industry has a clear commercial interest in eroding public and professional confidence in unassisted smoking cessation, yet easily implemented ideas, such as graphic health warnings, are more effective than nicotine replacement therapy, says Simon Chapman Simon Chapman professor of public health, University of Sydney

Tobacco control is the poster child for those now rallying behind international action to control non-communicable disease. In nations that have implemented comprehensive policies and programmes to reduce tobacco use, there have been often continuing and large scale falls in smoking prevalence over the past 20 to 40 years, in the number of cigarettes smoked per day, and—the ultimate test of effectiveness—in the incidence of index diseases like lung cancer.1

The World Health Organization’s Framework Convention on Tobacco Control, with 174 nations having now ratified its legally binding provisions, has inspired thinking about the applicability of the tobacco control model to chronic disease at large.2 This momentum should be profiled and boosted by the September United Nations High-level Meeting on Non-communicable Diseases.

Although preventing uptake among young people has long been a mantra for governments of all political stripes, far more lives will be saved over the next decades by promoting cessation in current smokers.3 There is now extensive consensus on what the so called best buys in tobacco control are when reducing consumption across whole populations is the goal.

All parties—including the perennially protesting tobacco industry ("Of all the concerns . . . taxation alarms us the most"4)—agree that tobacco tax increases are the ace in the pack. Promoting quit attempts in large numbers of smokers is the most important strategy for improving cessation rates throughout a population.5

Australia has seen daily smoking prevalence fall to 15.1%, with tax and well funded mass media awareness campaigns being mainly responsible.6 Youth smoking prevalence is also the lowest on record, because youths are influenced by adult targeted campaigns7 and the growing denormalisation of smoking.

One of the best kept secrets in tobacco control is that the great majority of ex-smokers quit without any formal assistance.8 Between two thirds and three quarters of long term ex-smokers stop without using nicotine replacement therapy or other drugs or attending any sort of smoking cessation service.9 10 Only 1-7% of smokers will even call a quitline.11

Before the advent of nicotine replacement therapy, some 37 million American smokers stopped smoking.12 Other than the early non-specific pack warnings, there were few to none of the policies that we see today driving this exodus. Millions quit because they were exposed to years of news reports of the growing bad news on smoking and health.13

There is a conventional wisdom that those who have quit smoking are those who were least addicted: they were low hanging fruit who could be stimulated by anti-smoking policies to quit by themselves. But those who still smoke, the argument proceeds, are mostly those who are impervious to population health measures like tobacco excise increases, the growing denormalisation of smoking, and the messages in mass reach advertising campaigns.14

Against this view is evidence from 50 US states for 2006-7 that indicates that the mean number of cigarettes smoked daily, the percentage of cigarette smokers who smoke within 30 minutes of waking, and the percentage who smoke daily are all significantly lower in US states with low smoking prevalence, compelling evidence against the “hardening” hypothesis that would predict just the opposite.15

There is a longstanding debate between those in tobacco control with clinical perspectives who are preoccupied with smoking cessation rates16 and those whose focus is on maximising cessation numbers throughout populations.17 This debate seems likely to intensify in low income nations where the global tobacco epidemic is now well established, where the bulk of global tobacco caused deaths are already occurring, but where tobacco control tends to be rudimentary.

Those wanting the best possible population-wide impact to flow from the current UN momentum on non-communicable disease control will need to be vigilant against the lobbying activities of the pharmaceutical industry smoking cessation juggernaut, with its mission to medicalise smoking cessation and discredit unassisted cessation as a recipe for failure.

The industry, with its formidable promotional and public relations budgets, and an army of research consultants whose findings tend to show better outcomes than researchers not funded by industry,18 has a clear commercial interest in eroding public and professional confidence in unassisted cessation.

This is despite the enduring superiority of unassisted cessation across decades in delivering far more ex-smokers than all other approaches to cessation combined.9 19 Smokers are now recommended to use NRT (nicotine replacement therapy) before they quit ("pre-quit"), while attempting to quit, in combination, and long after stopping to prevent relapse.

A large body of clinical trial evidence provides the bedrock for this advice. But there are major differences between clinical trials and real world use in smoking cessation.20 21 Unlike real world users, those taking part in trials get free pharmaceuticals; have frequent contact with trial researchers, creating Hawthorne effects; and are paid travel and expenses.

Trial participants are unrepresentative of the general population22 and cessation trials exclude those with mental health problems,23 who are heavily over-represented among smokers. NRT trials have poor blindness integrity, with over half of studies in one review showing trial participants were significantly more likely than chance to accurately guess that they had been allocated to the placebo arm, meaning that their faith in the treatment they were receiving was likely to be poor.

This may translate into poorer quitting outcomes, thus exaggerating differences between active and placebo NRT outcomes.24 Finally, far more trial participants complete the recommended drug course than in real world settings.21 25 All this combines to produce trial quit rates that are higher than those in real world settings. A recent Glasgow study found just 2.8% of smokers using medication who received up to 12 weeks of individual counselling with pharmacists had quit at one year.26

However, debates about real world effectiveness of cessation pharmacotherapy are somewhat ethereal to the circumstances of the vast majority of smokers in low income nations. In late 2009 in a Phnom Penh, Cambodia, pharmacy a pack of 105 pieces of 2 mg NRT gum was selling at $58.10 (£35.44; €40.62). Product information for 2 mg Nicorette gum advises a maximum of 24 pieces per day (www.nicorette.com/quit-smokingproducts/ ... e-gum.aspx).

Even if that were halved, a 30 day supply would cost a Cambodian smoker $199.20, when average monthly income is $170.27 The cost of NRT and varenicline in low income nations in the Middle East and North Africa shows a similar picture.28  At these prices, NRT remains beyond the reach of anyone but wealthy élites in the world’s poorest nations.

Such costs mean that NRT is irrelevant to any serious talk about strategy that could make a national impact in low income nations. But the massive populations of low and middle income countries like China, India, Indonesia, Mexico, Bangladesh, and Nigeria collectively contain millions of affluent smokers who represent a goldmine to the pharmaceutical industry.

It can be expected that the industry will maximise every opportunity to surf the new UN inspired wave of interest and seek to continue to dominate public dialogue on cessation with pharmaceutical solutions. The WHO Framework Convention on Tobacco Control endorses assisted cessation but its provision is poor throughout much of the world.29

In the West, despite at least two decades of industry promotions, despite armies of drug retailers, and despite increasing success in the lobbying of governments to subsidise cessation pharmacotherapy, most ex-smokers continue to quit unaided.

Every major tobacco control conference in the past 30 years has given major emphasis to ways of encouraging doctors and primary healthcare workers to routinely counsel and assist smokers to quit.

Yet recently, only 6.4% of 29,492 smokers in a UK health region were prescribed cessation medication in a two year study period.30 Reviewing the potential population impacts of various smoking cessation approaches, a 2000 US National Institutes of Health monograph concluded of physician interventions, "it is not clear that additional resources would add to the number of individuals encountering these interventions . . . the promise of these interventions as established in clinical trials is not fulfilled in their real-world applications."31

Against this background, there ought to be a serious pause before governments in low and middle income countries embrace frontline, labour intensive, or pharmaceutical based cessation strategies, which will soak up large resources, have low consumer acceptability, particularly to the poor, and therefore make little contribution to population-wide cessation.

If smoking is to reduce in the world's poorest nations, strategies commensurate with the size of the challenge need to be adopted. Easily implemented strategies that reach every smoker, like tax, graphic pack warnings, smokefree public places, and mass reach public awareness campaigns, need to be front and centre here, with assisted cessation placed in perspective.

Great encouragement can be taken from the current support by Bloomberg Philanthropy to assist in the development of mass reach awareness campaigns now running in India, China, Vietnam, Russia, Mexico, and Bangladesh, and major
investment is occurring in capacity building to ensure that such campaigns are sustained (www.worldlungfoundation.org/). 

Thailand32 and Uruguay are arguably world leaders in comprehensive tobacco control and their and other nations' successes deserve to be megaphoned at the UN summit.

[url=mailto:simon.chapman@sydney.edu.au]simon.chapman@sydney.edu.au[/url]








Competing interests: Simon Chapman is a director of Action on Smoking and Health, Australia and editor emeritus of Tobacco Control.  Provenance and peer review: commissioned; not externally peer reviewed.

1 Thun MJ, Jemal A. How much of the decrease in cancer death rates in the United States is attributable to reductions in tobacco smoking? Tob Control 2006;15:345-7.
2 Blouin C, Dube L. Global health diplomacy for obesity prevention: lessons from tobacco control. J Public Health Policy 2010;31:244-55.
3 Peto R. Global tobacco mortality: monitoring the growing epidemic. Proceedings of Tenth World Conference on Tobacco or Health; 1997 24–28 August; Beijing.
4 Philip Morris. The perspective of PM International on smoking and health issues. 1985. http://legacy.library.ucsf.edu/tid/nky74e00/pdf.
5 Hyland A, Borland R, Li Q, Yong HH, McNeill A, Fong GT, et al. Individual-level predictors of cessation behaviours among participants in the International Tobacco Control (ITC) Four Country Survey. Tob Control 2006;15:iii83-94.
6 Wakefield MA, Durkin S, Spittal MJ, Siahpush M, Scollo M, Simpson JA, et al. Impact of tobacco control policies and mass media campaigns on monthly adult smoking prevalence. Am J Public Health 2008;98:1443-50.
7 White VM, Warne CD, Spittal MJ, Durkin S, Purcell K, Wakefield MA. What impact have tobacco control policies, cigarette price and tobacco control programme funding had on Australian adolescents’ smoking? Findings over a 15-year period. Addiction 2011;106:1493-502.
8 Chapman S, MacKenzie R. The global research neglect of unassisted smoking cessation: causes and consequences. PLoS Med 2010;7:e1000216.
9 Shiffman S, Brockwell SE, Pillitteri JL, Gitchell JG. Use of smoking-cessation treatments in the United States. Am J Prev Med 2008;34:102-11.
10 Lee CW, Kahende J. Factors associated with successful smoking cessation in the United States, 2000. Am J Public Health 2007;97:1503-9.
11 Tzelepis F, Paul CL, Walsh RA, Wiggers J, Knight J, Lecathelinais C, et al. Telephone recruitment into a randomized controlled trial of quitline support. Am J Prev Med 2009;37:324-9.
12 American Cancer Society. Cancer facts and figures 2010. American Cancer Society, 1986. www.cancer.org/downloads/STT/CAFF2003PWSecured.pdf.
13 Warner KE. The effects of the anti-smoking campaign on cigarette consumption. Am J Public Health 1977;67:645-50.
14 Warner KE, Burns DM. Hardening and the hard-core smoker: concepts, evidence, and implications. Nicotine Tob Res 2003;5:37-48.
15 Giovino GA, Chaloupka FJ, Hartman AM, Gerlach Joyce K, Chriqui J, Orleans CT, et al. Cigarette smoking prevalence and policies in the 50 States: an era of change—the Robert Wood Johnson Foundation ImpacTeen Tobacco Chart Book. University at Buffalo, State University of New York, 2009. www.impacteen.org/statetobaccodata/char ... 060409.pdf.
16 West R, McNeill A, Britton J, Bauld L, Raw M, Hajek P, et al. Should smokers be offered assistance with stopping? Addiction 2010;105:1867-9.
17 Chapman S. The inverse impact law of smoking cessation. Lancet 2009;373:701-3.
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19 Fiore MC, Novotny TE, Pierce JP, Giovino GA, Hatziandreu EJ, Newcomb PA, et al.  Methods used to quit smoking in the United States. Do cessation programs help? JAMA 1990;263:2760-5.
20 Walsh RA. Over-the-counter nicotine replacement therapy: a methodological review of the evidence supporting its effectiveness. Drug Alcohol Rev 2008;27:529-47.
21 Walsh RA. Australia’s experience with varenicline: usage, costs and adverse reactions. Addiction 2011;106:451-2.
22 Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?” Lancet 2005;365:82-93.
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25 Zwar NA, Nasser A, Comino EJ, Richmond RL. Short-term effectiveness of bupropion for assisting smoking cessation in general practice. Med J Aust 2002;177:277-8.
26 Bauld L, Boyd KA, Briggs AH, Chesterman J, Ferguson J, Judge K, et al. One-year outcomes and a cost-effectiveness analysis for smokers accessing group-based and pharmacy-led cessation services. Nicotine Tob Res 2011;13:135-45.
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Cite this as: BMJ 2011;342:d5008
Last edited by JohnPolito on 09 Aug 2011, 01:04, edited 1 time in total.
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JohnPolito
Joined: 11 Nov 2008, 19:22

12 Aug 2011, 13:42 #4

The British Medical Journal has added my below online response to the discussion of Professor Chapman's above Tar Wars article.  It's my hope that some un-conflicted researcher will someday soon become curious as to the common thread among all successful non-medication ex-smokers.  Sadly, the quitting product industry's economic influence over researchers is so tremendous that finding a truly independent researcher is one of life's greatest challenges.  Regards,  John

    Smoking cessation trials should end use of placebo controls
  • John R. Polito, Nicotine Cessation Educator -  Director, WhyQuit.com
Bravo to Professor Chapman for the courage to write "Tar Wars Over Smoking Cessation." As director of the leading cold turkey stop smoking website, I've resided on the front lines of this war since June 2000. It was then that an 18 member panel, 11 of which openly declared pharmaceutical industry financial ties,[1] authored official U.S. cessation policy, the Clinical Practice Guideline. The panel declared, "There are numerous effective medications for tobacco dependence and clinicians should encourage their use by all patients attempting to quit smoking ..."[1]

The Guideline effectively destroyed all support for all non- medication quitting programs, including cold turkey. But as Professor Chapman correctly notes, quitters generally do not use quitting programs. His concern is the greater harm, the industry's assault and erosion of confidence in the unassisted quitter's own natural nicotine dependency recovery instincts.

Nicotine dependency is a brain wanting disorder in which dopamine pathway function is taken hostage by nicotine. Receptor stimulation, saturation, up-regulation, nicotine's two hour elimination half-life and durable nicotine replenishment memories combine to leave the new addict totally convinced that that next nicotine fix is as important to survival as nutrition or hydration.[2]

Imagine being hungry and craving food 10, 15 or 20 times a day. Welcome to the world of nicotine normal. Quitting product marketing preys and feeds upon this neuro-chemical lie, a lie which threatens to plant a half billion current smokers in early graves. It falsely suggests that quitting without medication is difficult to near impossible. As Professor Chapman notes, "the great majority of ex-smokers quit without any formal assistance."

What are the common threads among successful unassisted quitters? Are there key lessons that if shared via cigarette packs could double or even triple success rates? Thanks to industry influence, governments around the globe are not asking such questions or studying successful unassisted quitting. Instead, they discourage it.

Try and locate any long-term real-world quitting method survey in which unassisted quitters failed to prevail over medication quitters. Look closely at UK NHS data. You'll discover that cold turkey remains king outside clinical trials. Placebo is not a real quitting method and as Professor Chapman notes, placebo trials had rather serious blinding concerns. Imagine trying to hide withdrawal's onset from experienced quitters who'd become experts at recognizing it.

If I had one wish it would be an end to the practice of using placebo controls, the worst cessation intervention known. Instead, I'd pit new products against "real" cold turkey quitters, armed with a few key relapse prevention lessons. But such studies will not happen, as cold turkey clinical victories could cost the industry billions.

[1] Fiore MC et al, Clinical Practice Guideline - Treating Tobacco Use and Dependence, USDHHS, June 2000; Appendix C - Financial Disclosures, Page 173; Medication Recommendation #7, Page 18.

[2] Polito, JR, Addiction to Smoking Nicotine a Mental Illness and Disease, WhyQuit News, WhyQuit.com, April 12, 2010.

Competing interests: Pro bono director of a non-medication quit smoking forum.




BMJ Link -   http://www.bmj.com/content/343/bmj.d500 ... _el_268410 
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