We use Population Health Impact Modelling to assess effects on tobacco prevalence and mortality of introducing a Reduced Risk Tobacco Product (RRP). Simulated samples start in 1990 with a US-representative smoking prevalence. Individual tobacco histories are updated annually until 2010 using estimated probabilities of switching between never/current/former smoking where the RRP is not introduced, with current users subdivided into cigarette/RRP/dual users where it is. RRP-related mortality reductions from lung cancer, IHD, stroke and COPD are derived from the histories and the assumed relative risks of the RRP. A basic analysis assumes a hypothetical RRP reduces effective dose 80% in users and 40% in dual users, with an uptake rate generating ∼10% RRP and ∼6% dual users among current users after 10 years. Sensitivity study changes in tobacco prevalence and mortality from varying effective doses, current smoking risks, quitting half-lives and rates of initiation, switching, re-initiation and cessation. They also study extreme situations (e.g. everyone using RRP), and investigate assumptions which might eliminate the RRP-related mortality reduction. The mortality reduction is proportional to the dose reduction, increasing rapidly with time of follow-up. Plausible increases in re-initiation or dual users' consumption, or decreased quitting by smokers would not eliminate the drop.

Based on the Food and Drug Administration's Modified Risk Tobacco Product (MRTP) Application draft guideline, Philip Morris International (PMI) has developed a Population Health Impact Model to estimate the reduction in the number of deaths over a period following the introduction of an MRTP. Such a model is necessary to assess the effect that its introduction would have on population health, given the lack of epidemiological data available prior to marketing authorization on any risks from MRTPs. The model is based on publicly available data on smoking prevalence and on the relationships between smoking-related disease-specific mortality and various aspects of the smoking of conventional cigarettes (CCs), together with an estimate of exposure from the MRTP relative to that from CCs, and allows the exploration of possible scenarios regarding the effect of MRTP introduction on the prevalence of CC and MRTP use, individually and in combination. By comparing mortality attributable in a scenario where the MRTP is introduced with one where it is not, the model can estimate the mortality attributable to CCs and the MRTP, as well as the reduction in the deaths attributable to the introduction of the MRTP.

BackgroundRecent reviews claiming smokeless tobacco increases pancreatic cancer risk appear not to have considered all available epidemiological evidence; nor were meta-analyses included. We present a systematic review of studies from North America and Europe, since data are lacking from other continents. Risk is also difficult to quantify elsewhere due to the various products, compositions and usage practices involved.MethodsEpidemiological studies were identified that related pancreatic cancer to use of snuff, chewing tobacco or unspecified smokeless tobacco. Study details and effect estimates (relative risks or odds ratios) were extracted, and combined by meta-analyses.ResultsNine North American and two Scandinavian studies were identified. Reporting was limited in four studies, so only seven were included in meta-analyses, some providing results for never smokers, some for the overall population of smokers and non-smokers, and some for both.Giving preference to study-specific estimates for the overall population, if available, and for never smokers otherwise, the random-effects estimate for ever smokeless tobacco use was 1.03 (95% confidence interval 0.71–1.49) based on heterogeneous estimates from seven studies. The estimate varied little by continent, study type, or type of smokeless tobacco.Giving preference to estimates for never smokers, if available, and overall population estimates otherwise, the estimate was 1.14 (0.67–1.93), again based on heterogeneous estimates. Estimates varied (p = 0.014) between cohort studies (1.75, 1.20–2.54) and case-control studies (0.84, 0.36–1.97). The value for cohort studies derived mainly from one study, which reported an increase for never smokers (2.0, 1.2–3.3), but not overall (0.9, 0.7–1.2). This study also contributed to increases seen for snuff use and for European studies, significant only in fixed-effect analyses.The studies have various weaknesses, including few exposed cases, reliance in cohort studies on exposure recorded at baseline, poor control groups in some case-control studies, and lack of a dose-response. Publication bias, with some negative studies not being presented, is also possible.ConclusionAt most, the data suggest a possible effect of smokeless tobacco on pancreatic cancer risk. More evidence is needed. If any risk exists, it is highly likely to be less than that from smoking.

Quantitative risk assessment of novel Modified Risk Tobacco Products (MRTP) must rest on indirect measurements that are indicative of disease development prior to epidemiological data becoming available. For this purpose, a Population Health Impact Model (PHIM) has been developed to estimate the reduction in the number of deaths from smoking-related diseases following the introduction of an MRTP. One key parameter of the model, the F-factor, describes the effective dose upon switching from cigarette smoking to using an MRTP. Biomarker data, collected in clinical studies, can be analyzed to estimate the effects of switching to an MRTP as compared to quitting smoking. Based on transparent assumptions, a link function is formulated that translates these effects into the F-factor. The concepts of 'lack of sufficiency' and 'necessity' are introduced, allowing for a parametrization of a family of link functions. These can be uniformly sampled, thus providing different 'scenarios' on how biomarker-based evidence can be translated into the F-factor to inform the PHIM.

The assessment of cumulative exposure based on collecting information on the history of active cigarette smoking has been and is being undertaken in a variety of ways. While a very detailed assessment may be required for studies with a focus on particular aspects of smoking behavior and history, comparability of measurements and results across studies remains a primary concern. Addressing the problem of heterogeneity of exposure assessment across studies can be achieved by a core set of questions that cover the major dimensions of cigarette smoking, and yet comply with current criteria used for defining smoking history and status. In studies where no very high level of exposure assessment is required or where smoking is not the major subject of investigation, a practical standardized core set of questions appears to be of considerable value, in particularwith regard to making results more comparable across studies.

Philip Morris International (PMI) has developed the Population Health Impact Model (PHIM) to quantify, in the absence of epidemiological data, the effects of marketing a candidate modified risk tobacco product (cMRTP) on the public health of a whole population. Various simulations were performed to understand the harm reduction impact on the U.S. population over a 20-year period under various scenarios. The overall reduction in smoking attributable deaths (SAD) over the 20-year period was estimated as 934,947 if smoking completely went away and between 516,944 and 780,433 if cMRTP use completely replaces smoking. The reduction in SADs was estimated as 172,458 for the World Health Organization (WHO) 2025 Target and between 70,274 and 90,155 for the gradual cMRTP uptake. Combining the scenarios (WHO 2025 Target and cMRTP uptake), the reductions were between 256,453 and 268,796, depending on the cMRTP relative exposure. These results show how a cMRTP can reduce overall population harm additionally to existing tobacco control efforts.

Philip Morris International (PMI) has developed the Population Health Impact Model (PHIM) to quantify, in the absence of epidemiological data, the effects of marketing a candidate modified risk tobacco product (cMRTP) on the public health of a whole population. Various simulations were performed to understand the harm reduction impact on the U.S. population over a 20-year period under various scenarios. The overall reduction in smoking attributable deaths (SAD) over the 20-year period was estimated as 934,947 if smoking completely went away and between 516,944 and 780,433 if cMRTP use completely replaces smoking. The reduction in SADs was estimated as 172,458 for the World Health Organization (WHO) 2025 Target and between 70,274 and 90,155 for the gradual cMRTP uptake. Combining the scenarios (WHO 2025 Target and cMRTP uptake), the reductions were between 256,453 and 268,796, depending on the cMRTP effective dose. These results show how a cMRTP can reduce overall population harm additionally to existing tobacco control efforts.

SUMMARYThe smoking questionnaire (SQ), a multidimensional questionnaire covering the major dimensions of cigarette smoking, was developed to address the heterogeneity in the assessment of smoking exposure. It consists of eight questions and can be completed within a few minutes. Test-retest reliability of the SQ and concurrent validity with the Behavior Risk Factor Surveillance System (BRFSS) 2011 questionnaire were examined in a clinical study conducted in adult US current menthol cigarette smokers. The SQ and the BRFSS were self-administrated twice before and after randomization with a 6-day interval. The inter-temporal analyses included current smokers aged 22 to 66 years who completed the SQ at both timepoints. The percent agreement of items and 95% confidence intervals were calculated for the comparisons between the two timepoints and between the SQ and the BRFSS questionnaire. To evaluate the feasibility of the SQ and to capture subjects' opinions about the SQ, a meta-questionnaire was administrated. High test-retest reliability levels (percent agreement of > 70 to 100% between the two timepoints) were found for SQ smoking behavior items, in particular for items related to current smoking status, 100-cigarettes lifetime, regular smoking, age of initiation and preferred brand. Moderate (55% agreement) to high test-retest reliability (84% agreement) was found for daily consumption of manufactured cigarettes. The comparison between the SQ and the BRFSS 2011 showed a high concurrent validity (98 to 100% agreement). The SQ was completed on average in 3 to 4 min and was assessed as easy to use. The findings demonstrate that the SQ is reliable in smokers and a practical tool to assess smoking exposure in clinical studies. [Beitr. Tabakforsch. Int. 27 (2017) RESUMELe questionnaire sur le tabagisme (SQ), questionnaire multi-dimensionnel couvrant les principales dimensions du tabagisme, a été développé afin de remédier à l'hétéro-généité dans l'évaluation de l'exposition au tabagisme. Il se compose de huit questions et peut être complété en quelques minutes. La fiabilité test-retest du SQ ainsi que la validité concomitante avec le questionnaire du Système de surveillance des facteurs de risque comportementaux (BRFSS) de 2011 ont été examinées dans une étude clinique menée chez des adultes américains, fumeurs de cigarettes au menthol. Le SQ et le BRFSS ont été autoadministrés deux fois, avant et après randomisation, avec un intervalle de 6 jours. Les analyses inter-temporelles comprenaient des fumeurs actuels âgés de 22 à 66 ans qui ont rempli le SQ aux deux points de mesure. La concordance en pourcentage des items et les intervalles de confiance à 95% ont été calculés pour les comparaisons entre les deux points de mesure, ainsi qu'entre le SQ et le BRFSS. Afin d'évaluer la faisabilité du SQ et pour saisir les opinions des sujets sur le SQ, un méta-questionnaire a été administré. Des niveaux élevés de fiabilité test-retest (concordance en pourcentage > 70-100% entre les deux points de mesure) ont été trouvés pour ...