NOT PEER REVIEWED This study violates basic ethical principles of research conduct
because it exposes children to unreasonable and unnecessary risks,
intentionally encourages parents to put their children at risk, and fails
to incorporate alternative methods that would reduce these risks.
The Helsinki declaration states that:
"The benefits, risks, burdens and effectiveness of a new intervention
must be...
NOT PEER REVIEWED This study violates basic ethical principles of research conduct
because it exposes children to unreasonable and unnecessary risks,
intentionally encourages parents to put their children at risk, and fails
to incorporate alternative methods that would reduce these risks.
The Helsinki declaration states that:
"The benefits, risks, burdens and effectiveness of a new intervention
must be tested against those of the best current proven intervention,
except in the following circumstances:
1. The use of placebo, or no treatment, is acceptable in studies
where no current proven intervention exists; or
2. Where for compelling and scientifically sound methodological
reasons the use of placebo is necessary to determine the efficacy or
safety of an intervention and the patients who receive placebo or no
treatment will not be subject to any risk of serious or irreversible harm.
Extreme care must be taken to avoid abuse of this option."
In the present study, children in group 1 were provided with an
intervention to reduce their exposure to secondhand smoke: parents were
asked not to smoke in the presence of their children. Children in group 2
were not provided with any treatment. According to the Helsinki
declaration, this would have been acceptable only if: (1) there was no
treatment available; or (2) children receiving no treatment would not be
subject to any risk of serious harm. Neither of these conditions are met.
Furthermore, this study goes beyond simply providing no treatment to
the children in group 2. Instead of simply observing these children over
time, the study protocol called for "asking" the parents not to change
their smoking habits.
In other words, the investigators knowingly and intentionally placed
the children in group 2 at significant risk of health damage.
In the United States, the federal regulations on the protection of
human subjects (section 46.406a) would have allowed this research to be
conducted on minors only if: "The risk represents a minor increase over
minimal risk." This condition is clearly not met, as the risks of
pneumonia, bronchitis, respiratory illness, and cardiovascular damage are
a major increase over minimal risk.
Moreover, there was an alternative procedure available that would
have provided the same scientific knowledge without putting children at
substantially more than minimal risk. The investigators could have
encouraged all parents not to smoke around their children and then
followed all the children over time as a single group. Then, they could
have assessed changes in secondhand smoke exposure and related those
changes (or lack of changes) to the persistence or disappearance of sleep
bruxism.
There is no justification for the investigators asking parents to
continue to smoke in the presence of their children.
Rather than acknowledge that they made a mistake, the instead defend
the study. But in defending the study, they deliver a definitive knock-out
blow to their argument that the study was ethical. They point out that
after being randomized to group 2, a number of the families dropped out of
the study, refusing to participate because: "aware of the risks of SHS,
[they] decided to reduce it and therefore did not participate."
If the subjects themselves realized that they were being put at undue
risk by agreeing to participate in the study, then it is quite clear that
this research was unethical. In fact, after a number of families refused
to participate because of the risks to which they were being asked to be
exposed, the IRB should have been informed and the study should have been
halted.
The authors go on to justify their research by noting that "all of
the parents of group 2 remaining in the trial were those who reported not
being able to reduce children's exposure to SHS." This is an unacceptable
argument. A feeling that one is not able to take a particular action is no
justification for investigators putting the children of those subjects at
risk and failing to deliver any intervention to encourage those parents to
quit, reduce their smoking, or not smoke in the presence of their
children.
NOT PEER REVIEWED We wish to comment on the findings of Smerecnik et al.1 with respect
to significant advances in genetic testing , which are highly relevant to
their review. Unlike the early single genetic marker tests analysed by
Smerecnik et al.,1 where subjects are dichotomised to positive or negative
results, genetic susceptibility tests for lung cancer are now multivariate
risk tests.2 These new risk tests incorpora...
NOT PEER REVIEWED We wish to comment on the findings of Smerecnik et al.1 with respect
to significant advances in genetic testing , which are highly relevant to
their review. Unlike the early single genetic marker tests analysed by
Smerecnik et al.,1 where subjects are dichotomised to positive or negative
results, genetic susceptibility tests for lung cancer are now multivariate
risk tests.2 These new risk tests incorporate clinical and genetic data
to derive a composite gene-based risk score. In doing so they recognise
that (1) environmental factors, like how much you smoked, are important
and (2) genetic data alone is not sufficiently accurate to assess a
person's risk. These distinguishing features of the recently developed
lung cancer susceptibility tests are very important in assessing how
patients respond for two reasons. First, this approach acknowledges that
environment is important and that regardless of level of risk, all smokers
can significantly mitigate that risk by quitting smoking (a unique feature
of smoking-related lung diseases). This means there is no concern about
genetic determinism (or nihilism), risk reduction is always possible.
Second, in contrast to these early single marker tests, there are no
"positive" and "negative" tests, all smokers tested have some level of
risk and importantly, only lifelong non-smokers are "low risk" (more
accurately reflecting the real-world situation).
We have developed a gene-based lung cancer risk score based on a persons
smoking, age, COPD, family history and genetic markers, where these
previously validated variables are combined to derive a composite score.2
This score has been prospectively verified and assigns smokers to
elevated, high and very high risk according to their total risk profile.3
We have assessed the potential clinical utility of this lung cancer risk
score in a feasibility study where randomly selected smokers underwent
brief counselling and were offered smoking cessation treatment. We found
84% of the smokers offered the test took the test, of which 52% took NRT
and 28% had quit smoking 6 months after testing (2 fold and 5 fold greater
than controls respectively).4 We conclude that our lung cancer
susceptibility test improved the outcome of brief intervention, by
facilitating the use of smoking cessation products (NRT) and subsequent
quit rate. Such a finding concurs with the tension-trigger-treatment model
proposed by Robert West where our gene-based test increased motivational
tension, undermined optimistic bias and, for 30-50% of smokers, triggered
a favourable outcome (NRT uptake and/or quitting smoking).
References
1. Smerecnik C, Grispen JE, Quaak M. Effectiveness of testing for genetic
susceptibility to smoking-related diseases on smoking cessation outcomes:
a systematic review and meta-analysis. Tob Control 2012; 21: 347-354.
2. Young RP, Hopkins RJ, Whittington CF, et al. Individual and cumulative
effects of GWAS susceptibility loci in lung cancer: associations after sub
-phenotyping for COPD. Plos One 2011; 6: e16467.
3. Young RP, Hopkins RJ, Hay B, Gamble GD. GWAS and candidate SNPs for
COPD and lung cancer combine to identify lung cancer susceptibility:
validation in a prospective study. Am J Respir Crit Care Med 2010; 181:
A3738.
4. Hopkins RJ, Young RP, Hay B, et al. Lung cancer risk testing enhances
NRT uptake and quit rates in randomly recruited smokers offered a gene-
based risk test. Am J Respir Crit Med 2012; 185: A2590.
Conflict of Interest:
Dr Young has helped to develop a gene-based risk test for lung cancer susceptibility. Patents related to this test are held by Synergenz Bioscience Ltd who helped fund the research underlying the develeopment of this test.
NOT PEER REVIEWED Fotuhi et al concluded in their interesting study of patterns in
smokers' cognitive dissonance-reducing beliefs that rationalisations about
smoking change systematically with changes in smoking behaviour(1).
Moreover, they argue that: i) changes in attitude on quitting are higher
for 'functional' beliefs rather than 'risk-minimising' beliefs and ii) if
smokers relapse these functional beliefs return to p...
NOT PEER REVIEWED Fotuhi et al concluded in their interesting study of patterns in
smokers' cognitive dissonance-reducing beliefs that rationalisations about
smoking change systematically with changes in smoking behaviour(1).
Moreover, they argue that: i) changes in attitude on quitting are higher
for 'functional' beliefs rather than 'risk-minimising' beliefs and ii) if
smokers relapse these functional beliefs return to pre-quit levels, iii)
that changes in beliefs follow the changes in behaviour (quitting),
suggesting that iv) these changes are rationalisations invoked in the
service of motivation to reduce cognitive dissonance and that v) smokers
are able to reduce dissonance by modifying their beliefs in ways that help
to rationalise their continued smoking.
We wish to suggest an alternative understanding. The functional belief
items include questions such as "smoking calms you down when you are
stressed or upset" and "smoking helps you concentrate better". We propose
that these items are not examples of dissonance-reducing attitudes but are
representations of smokers' genuine experiences of nicotine withdrawal 'in
between' cigarettes or on quitting, i.e. 'stress' and 'poor
concentration'(2). In this way they are more a proxy for the physiological
states induced by nicotine deprivation rather than attitudes and beliefs
per se. Therefore 'risk-minimising beliefs' such as 'the medical evidence
that smoking is harmful is exaggerated' and 'you've got to die of
something, so why not enjoy yourself and smoke' may more truly represent
cognitive dissonance, as they do not overlap with experiences indicating
withdrawal symptoms.
A misinterpretation of these withdrawal symptoms by smokers and a
commonly held belief that smoking reduces stress will undoubtedly result
in the kind of results that the authors report - but should these results
really be interpretated as supporting their hypothesis? Once smokers stop
smoking, withdrawal symptoms subside over ensuing weeks (3), with
'functional' justifications for smoking naturally receding. They would
return when the smoker then recommences to a physiological state of
dependency and nicotine deprivation.
The theory of reasoned action holds that attitude changes precede
behavioural change (4). The authors conclude that their study shows
conversely, for smokers that their changes in attitudes are likely to be a
result of their changes in smoking behaviour. This interpretation does not
prove causation if these 'cognitive-dissonance' measures are more an
indication of the presence of physiological symptoms rather than attitudes
and beliefs per se.
We do agree, however, with Fotuhi et al's proposal that public health
measures should target smokers' beliefs that smoking reduces stress. This
would promote greater understanding about the withdrawal process and link
it to why pharmacotherapy can be a useful adjunct to quitting and thereby
increase their sense of response and self-efficacy (5).
We have been working in Australia with Indigenous smokers who have a
high prevalence of smoking. One of the teaching tools we have developed is
a simple visual model to explain to the lay public in the context of a
group or personal intervention why smoking increases stress levels, how
withdrawal symptoms make smokers more stressed and how nicotine
replacement therapy can be efficacious (6).
Resistance to anti-tobacco messages, and cognitive dissonance will
most likely continue to plague smokers who do not feel able to quit.
Although for Indigenous smokers, knowledge acquisition alone may not be
enough to support successful cessation (7), we believe smokers'
justifications for smoking may also represent the truth for them of their
experiences of withdrawal, and a lack of understanding about nicotine
deprivation.
References
1. Fotuhi O, Fong GT, Zanna MP, Borland R, Yong H-H, Cummings KM.
Patterns of cognitive dissonance-reducing beliefs among smokers: a
longitudinal analysis from the International Tobacco Control (ITC) Four
Country Survey. Tobacco Control. January 3, 2012. doi:
10.1136/tobaccocontrol-2011-050139
2. Parrott AC, Garnham NJ, Wesnes K, Pincock C. Cigarette Smoking and
Abstinence: Comparative Effects Upon Cognitive Task Performance and Mood
State over 24 Hours. Human Psychopharmacology: Clinical and Experimental.
1996;11(5):391-400.
3. Hughes JR. Tobacco withdrawal in self-quitters. J Consult Clin Psychol.
1992;60(5):689-97.
4. Fishbein M, Ajzen, I. Belief, attitude, attention and behaviour: An
introduction to theory and research. Reading, MA: Addison-Wesley; 1975.
5. Witte K, Meyer G., Martell, D. Effective health risk messages: a step-
by-step guide. Thousand Oaks, CA: Sage Publications; 2001.
6. Baker F, Gould, GS. Blow Away The Smokes DVD: Quit Cafe Scene starts
13.00min. 2011 [4 July 2012]; Available from:
http://www.blowawaythesmokes.com.au
7. Gould G, Munn, J, Watters, T, McEwen, A, Clough, A. Knowledge and views
about maternal tobacco smoking and barriers for cessation in Aboriginal
and Torres Strait Islanders: a systematic review and meta-ethnography. Nic
Tob Res. 2012;under review
The author seeks to analyze the interference of the International
Tobacco Growers Association (ITGA) in the decisions of the 4th Conference
of the Parties (COP 4) on the Framework Convention on Tobacco Control
(FCTC) regarding Guidelines recommending the prohibition of additives in
cigarettes and includes Brazil as one of the countries influenced by this
organization.
As members of the Brazilian del...
The author seeks to analyze the interference of the International
Tobacco Growers Association (ITGA) in the decisions of the 4th Conference
of the Parties (COP 4) on the Framework Convention on Tobacco Control
(FCTC) regarding Guidelines recommending the prohibition of additives in
cigarettes and includes Brazil as one of the countries influenced by this
organization.
As members of the Brazilian delegation to COP4, we are deeply concerned
with the conclusions drawn by the author, that were based mainly on the
size and composition of the delegation as an indicator of the possible
interference of ITGA.
We are aware that the Association of Brazilian Tobacco Growers (AFUBRA), a
member of ITGA, pressed government officials and legislators to work
against the approval of the Guidelines and related recommendations. Their
arguments were recently published in the Journal in the News Analysis
session(a).
However this misinformation was challenged publicly ( b) and their
pressure has not influenced Brazil's government position as can be
demonstrated in the records of COP4 plenary discussions and confirmed by a
recent regulation that positioned Brazil as the first country in the world
to adopt a total ban on cigarette additives.
In Brazil, a National Inter Ministerial Commission for the Implementation
of the WHO FCTC (CONICQ), created by Presidential Decree, has proven to be
very successful in the implementation of an inter sectorial agenda for
tobacco control, aligning all sectors of the government with the FCTC
objectives and neutralizing the tobacco industry interference on tobacco
control policies. Currently, eighteen different sectors of the government
are part of CONICQ and most of its representatives attended COP4 due to
the priority assigned to the theme and the opportunity the proximity of
Uruguay has provided for Brazil's delegates' participation.
As a major tobacco producer, apart from implementing the core FCTC
provisions, Brazil has the additional duty to safeguard 180,000 tobacco
growers and their families from sanitary, social and economic
vulnerabilities related to this activity in view of FCTC Articles 17 and
18. For this reason the Ministry of Agrarian Development and the Ministry
of Agriculture are part of CONICQ and Brazil has joined the article 17 and
18 FCTC Working Group as a key facilitator Party.
However, the author highlighted the number of representatives of the
Brazilian delegation as suspiciously higher than usual and drew
attention to the fact that it had six representatives from the Ministry of
Agriculture, a sector of the government claimed by the author to be an
ally of the tobacco industry. Apart from not being true (the delegation
had only one representative from this Ministry of Agriculture, the
other five being representatives from the Ministry of Agrarian Development, which
is responsible for the National Program for Diversification in Tobacco
Cultivated Areas), this statement raises an unfair suspicion of conflict
of interests and violation of Article 5.3 by the country, a theme that has
been treated with utmost importance by CONICQ, which has recently published
ethical guidelines for its membership.
The author also stated that the majority of tobacco producers grow other agricultural products. This is not the reality in Brazil where
most tobacco growers do not rely on other agricultural products for income
generation. They are fully dependent on the tobacco supply chain
articulated by major transnational tobacco companies that attract them
through the deceptive calls that growing tobacco generates wealth and
prosperity. What they actually find is an endless cycle of debt, economic
dependency and health risks inherent to this activity. In this context
they do need support to shift to other livelihoods. Thereby, FCTC articles
17 and 18 deserves special attention from FCTC Member States as they
represent not only an important tool for rescuing tobacco growers from
this risky economic dependence but a way to reduce the power of
tobacco companies to interfere with the FCTC implementation.
Finally, it's worth noting that even considering its status as a major
tobacco producer and exporter, Brazil is a country that has proven to be
capable to reduce smoking prevalence by 50% in the last 20 years by
implementing sound tobacco control measures.
We would appreciate if this letter is published in order to correct erroneous and unacceptable
conclusions mentioned in the article that reflect on the credibility of Brazil's
delegation.
On behalf of the Brazilian delegation that attended COP4
Dr Tania Maria Cavalcante
Coordinator of the Executive Secretariat of the National Commission for
the Implementation of the FCTC (CONICQ)/ National Cancer Institute/
Ministry of Health/Brazil
Mrs Adriana Gregolin
Coordinator, National Program for Diversification in Tobacco Cultivated
Areas /Family Farming Secretariat / Ministry of Agricultural
Development/Brazil
Prof Dr Vera Luiza da Costa e Silva
Coordinator, Center for Studies on Tobacco
Control Policies, National Public Health School, Oswaldo Cruz Foundation,
Ministry of Health/Brazil
(a) News analysis - Brazil: industry fury at new proposals September
2011 Volume 20 Issue 5. Available at
http://tobaccocontrol.bmj.com/content/20/5/323.full
(b) Aditivos em cigarros / Instituto Nacional de Cancer Jose Alencar
Gomes da Silva, Comissao Nacional para a Implementacao da Convencao-Quadro
para o Controle do Tabaco e de seus Protocolos. -- Rio de Janeiro : Inca,
2011. Available at
http://bvsms.saude.gov.br/bvs/publicacoes/aditivos_cigarros_notas_tecnicas.pdf
I 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 "...
I 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
NOT 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, 201...
NOT 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.
Zawertailo, 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 poi...
Zawertailo, 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.
NOT 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 mark...
NOT 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.
NOT 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]
NOT 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 Educator
References:
[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.
The 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
adva...
The 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.
NOT PEER REVIEWED This study violates basic ethical principles of research conduct because it exposes children to unreasonable and unnecessary risks, intentionally encourages parents to put their children at risk, and fails to incorporate alternative methods that would reduce these risks.
The Helsinki declaration states that:
"The benefits, risks, burdens and effectiveness of a new intervention must be...
NOT PEER REVIEWED We wish to comment on the findings of Smerecnik et al.1 with respect to significant advances in genetic testing , which are highly relevant to their review. Unlike the early single genetic marker tests analysed by Smerecnik et al.,1 where subjects are dichotomised to positive or negative results, genetic susceptibility tests for lung cancer are now multivariate risk tests.2 These new risk tests incorpora...
NOT PEER REVIEWED Fotuhi et al concluded in their interesting study of patterns in smokers' cognitive dissonance-reducing beliefs that rationalisations about smoking change systematically with changes in smoking behaviour(1). Moreover, they argue that: i) changes in attitude on quitting are higher for 'functional' beliefs rather than 'risk-minimising' beliefs and ii) if smokers relapse these functional beliefs return to p...
The author seeks to analyze the interference of the International Tobacco Growers Association (ITGA) in the decisions of the 4th Conference of the Parties (COP 4) on the Framework Convention on Tobacco Control (FCTC) regarding Guidelines recommending the prohibition of additives in cigarettes and includes Brazil as one of the countries influenced by this organization. As members of the Brazilian del...
I 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 "...
NOT 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, 201...
Zawertailo, 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 poi...
NOT 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...
The 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 adva...
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