Data sources and applied methods for paclitaxel safety signal discernment.

Background: Following the identification of a late mortality signal, the Food and Drug Administration (FDA) convened an advisory panel that concluded that additional clinical study data are needed to comprehensively evaluate the late mortality signal observed with the use of drug-coated balloons (DCB) and drug-eluting stent (DES). The objective of this review is to (1) identify and summarize the existing clinical and cohort studies assessing paclitaxel-coated DCBs and DESs, (2) describe and determine the quality of the available data sources for the evaluation of these devices, and (3) present methodologies that can be leveraged for proper signal discernment within available data sources. Methods: Studies and data sources were identified through comprehensive searches. original research studies, clinical trials, comparative studies, multicenter studies, and observational cohort studies written in the English language and published from January 2007 to November 2021, with a follow-up longer than 36 months, were included in the review. Data quality of available data sources identified was assessed in three groupings. Moreover, accepted data-driven methodologies that may help circumvent the limitations of the extracted studies and data sources were extracted and described. Results: There were 39 studies and data sources identified. This included 19 randomized clinical trials, nine single-arm studies, eight registries, three administrative claims, and electronic health records. Methodologies focusing on the use of existing premarket clinical data, the incorporation of all contributed patient time, the use of aggregated data, approaches for individual-level data, machine learning and artificial intelligence approaches, Bayesian approaches, and the combination of various datasets were summarized. Conclusion: Despite the multitude of available studies over the course of eleven years following the first clinical trial, the FDA-convened advisory panel found them insufficient for comprehensively assessing the late-mortality signal. High-quality data sources with the capabilities of employing advanced statistical methodologies are needed to detect potential safety signals in a timely manner and allow regulatory bodies to act quickly when a safety signal is detected.

Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment.

BACKGROUND: Real-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions. OBJECTIVES: To determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure. METHODS: We compared studies that used data from the VQI registry with estimated costs of independent industry studies (counterfactual studies) using an established model using design specifications determined by FDA reviewers. RESULTS: We analyzed the initial six studies evaluating vascular devices for regulatory decisions using data from the VQI registry that generated evidence for four device manufacturers. Return on investment for these studies was estimated to be 143% and cost saving as 59% based on an actual per patient (with 5-year follow-up) cost of US$11K using VQI data versus US$26K from the counterfactual when averaged across all studies. Significant enrollment time savings (45%-71%) were also realized compared with industry-based estimates. CONCLUSIONS: The use of RWD from the VQI registry in this study and the transcatheter valve treatment coordinated registry network in a prior study indicates that substantial value was added to device evaluation projects by the reuse of registry data, with additional potential savings if linked claims data can be used instead of costly long-term in-person follow-up.

Determining value of Coordinated Registry Networks (CRNs): a case of transcatheter valve therapies.

BACKGROUND: The Transcatheter Valve Therapy (TVT) Coordinated Registry Network (CRN) supported 23 regulatory decisions and ensured evidence-based evaluation of the application of TVT technology. However, there are cost concerns that require value assessment of the TVT CRN compared with traditional study designs. OBJECTIVES: We aimed to determine the value created by the TVT CRN based on (1) Return on investment (ROI), (2) Time saved (TS) in conducting necessary regulatory studies. METHODS: For both ROI and TS analyses, we compared studies that used the TVT CRN with those that would have been required if the registry did not exist (counterfactual studies). To estimate ROI, we accounted for the costs of investment and gain from investment. Both the counterfactual costs and length of studies were projected using design specifications determined by US Food and Drug Administration (FDA) reviewers. RESULTS: We identified 21 studies using the TVT CRN (supporting 23 FDA decisions) that generated evidence on TVT for three device manufacturers. ROI is estimated to be greater than 550%. TS by using the CRN ranged from months to years. CONCLUSIONS: The CRN method to evidence generation creates value for manufacturers and the broader device ecosystem, demonstrated with this example of the TVT CRN. The public health benefits of evidence created by this CRN outweighs the difference in data quality between traditional clinical studies and the CRN method.

Utility and cutoff value of hair nicotine as a biomarker of long-term tobacco smoke exposure, compared to salivary cotinine.

While hair samples are easier to collect and less expensive to store and transport than biological fluids, and hair nicotine characterizes tobacco exposure over a longer time period than blood or urine cotinine, information on its utility, compared with salivary cotinine, is still limited. We conducted a cross-sectional study with 289 participants (107 active smokers, 105 passive smokers with self-reported secondhand smoke (SHS) exposure, and 77 non-smokers with no SHS exposure) in Baltimore (Maryland, USA). A subset of the study participants (n = 52) were followed longitudinally over a two-month interval.  Median baseline hair nicotine concentrations for active, passive and non-smokers were 16.2, 0.36, and 0.23 ng/mg, respectively, while those for salivary cotinine were 181.0, 0.27, and 0.27 ng/mL, respectively. Hair nicotine concentrations for 10% of passive or non-smokers were higher than the 25th percentile value for active smokers while all corresponding salivary cotinine concentrations for them were lower than the value for active smokers. This study showed that hair nicotine concentration values could be used to distinguish active or heavy passive adult smokers from non-SHS exposed non-smokers. Our results indicate that hair nicotine is a useful biomarker for the assessment of long-term exposure to tobacco smoke.

Assessing secondhand smoke using biological markers.

Secondhand smoke exposure (SHSe) is a known cause of many adverse health effects in adults and children. Increasingly, SHSe assessment is an element of tobacco control research and implementation worldwide. In spite of decades of development of approaches to assess SHSe, there are still unresolved methodological issues; therefore, a multidisciplinary expert meeting was held to catalogue the approaches to assess SHSe and with the goal of providing a set of uniform methods for future use by investigators and thereby facilitate comparisons of findings across studies. The meeting, held at Johns Hopkins, in Baltimore, Maryland, USA, was supported by the Flight Attendant Medical Research Institute (FAMRI). A series of articles were developed to summarise what is known about self-reported, environmental and biological SHSe measurements. Non-smokers inhale toxicants in SHS, which are mainly products of combustion of organic materials and are not specific to tobacco smoke exposure. Biomarkers specific to SHSe are nicotine and its metabolites (e.g., cotinine), and metabolites of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK). Cotinine is the preferred blood, saliva and urine biomarker for SHSe. Cotinine and nicotine can also be measured in hair and toenails. NNAL (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol), a metabolite of NNK, can be determined in the urine of SHS-exposed non-smokers. The selection of a particular biomarker of SHSe and the analytic biological medium depends on the scientific or public health question of interest, study design and setting, subjects, and funding. This manuscript summarises the scientific evidence on the use of biomarkers to measure SHSe, analytical methods, biological matrices and their interpretation.

Assessing secondhand smoke exposure with reported measures.

Non-smokers are exposed to tobacco smoke from the burning cigarette and the exhaled smoke from smokers. In spite of decades of development of approaches to assess secondhand smoke exposure (SHSe), there are still unresolved methodological issues. This manuscript summarises the scientific evidence on the use of SHSe reported measures and their methods, objectives, strengths and limitations; and discusses best practices for assessing behaviour leading to SHSe for lifetime and immediate or current SHSe. Recommendations for advancing measurement science of SHSe are provided. Behavioural measures of SHSe commonly rely on self-reports from children and adults. Most commonly, the methodology includes self, proxy and interview-based reporting styles using retrospective recall or diary-style reporting formats. The reporting method used will vary based upon the subject of interest, assessment objectives and cultural context. Appropriately implemented, reported measures of SHSe provide an accurate, timely and cost-effective method for assessing exposure time, location and quantity in a wide variety of populations.

Environmental monitoring of secondhand smoke exposure.

The complex composition of secondhand smoke (SHS) provides a range of constituents that can be measured in environmental samples (air, dust and on surfaces) and therefore used to assess non-smokers' exposure to tobacco smoke. Monitoring SHS exposure (SHSe) in indoor environments provides useful information on the extent and consequences of SHSe, implementing and evaluating tobacco control programmes and behavioural interventions, and estimating overall burden of disease caused by SHSe. The most widely used markers have been vapour-phase nicotine and respirable particulate matter (PM). Numerous other environmental analytes of SHS have been measured in the air including carbon monoxide, 3-ethenylpyridine, polycyclic aromatic hydrocarbons, tobacco-specific nitrosamines, nitrogen oxides, aldehydes and volatile organic compounds, as well as nicotine in dust and on surfaces. The measurement of nicotine in the air has the advantage of reflecting the presence of tobacco smoke. While PM measurements are not as specific, they can be taken continuously, allowing for assessment of exposure and its variation over time. In general, when nicotine and PM are measured in the same setting using a common sampling period, an increase in nicotine concentration of 1 µg/m(3) corresponds to an average increase of 10 µg/m3 of PM. This topic assessment presents a comprehensive summary of SHSe monitoring approaches using environmental markers and discusses the strengths and weaknesses of these methods and approaches.

Secondhand tobacco smoke: an occupational hazard for smoking and non-smoking bar and nightclub employees.

BACKGROUND: In the absence of comprehensive smoking bans in public places, bars and nightclubs have the highest concentrations of secondhand tobacco smoke, posing a serious health risk for workers in these venues. OBJECTIVE: To assess exposure of bar and nightclub employees to secondhand smoke, including non-smoking and smoking employees. METHODS: Between 2007 and 2009, the authors recruited approximately 10 venues per city and up to five employees per venue in 24 cities in the Americas, Eastern Europe, Asia and Africa. Air nicotine concentrations were measured for 7 days in 238 venues. To evaluate personal exposure to secondhand smoke, hair nicotine concentrations were also measured for 625 non-smoking and 311 smoking employees (N=936). RESULTS: Median (IQR) air nicotine concentrations were 3.5 (1.5-8.5) µg/m(3) and 0.2 (0.1-0.7) µg/m(3) in smoking and smoke-free venues, respectively. Median (IQR) hair nicotine concentrations were 6.0 (1.6-16.0) ng/mg and 1.7 (0.5-5.5) ng/mg in smoking and non-smoking employees, respectively. After adjustment for age, sex, education, living with a smoker, hair treatment and region, a twofold increase in air nicotine concentrations was associated with a 30% (95% CI 23% to 38%) increase in hair nicotine concentrations in non-smoking employees and with a 10% (2% to 19%) increase in smoking employees. CONCLUSIONS: Occupational exposure to secondhand smoke, assessed by air nicotine, resulted in elevated concentrations of hair nicotine among non-smoking and smoking bar and nightclub employees. The high levels of airborne nicotine found in bars and nightclubs and the contribution of this exposure to employee hair nicotine concentrations support the need for legislation measures that ensure complete protection from secondhand smoke in these venues.

Impact of tobacco control interventions on smoking initiation, cessation, and prevalence: a systematic review.

BACKGROUND: Policymakers need estimates of the impact of tobacco control (TC) policies to set priorities and targets for reducing tobacco use. We systematically reviewed the independent effects of TC policies on smoking behavior. METHODS: We searched MEDLINE (through January 2012) and EMBASE and other databases through February 2009, looking for studies published after 1989 in any language that assessed the effects of each TC intervention on smoking prevalence, initiation, cessation, or price participation elasticity. Paired reviewers extracted data from studies that isolated the impact of a single TC intervention. FINDINGS: We included 84 studies. The strength of evidence quantifying the independent effect on smoking prevalence was high for increasing tobacco prices and moderate for smoking bans in public places and antitobacco mass media campaigns. Limited direct evidence was available to quantify the effects of health warning labels and bans on advertising and sponsorship. Studies were too heterogeneous to pool effect estimates. INTERPRETATIONS: We found evidence of an independent effect for several TC policies on smoking prevalence. However, we could not derive precise estimates of the effects across different settings because of variability in the characteristics of the intervention, level of policy enforcement, and underlying tobacco control environment.

Epidemiology of tobacco use and dependence in adults in a poor peri-urban community in Lima, Peru.

BACKGROUND: Tobacco smoking is an important public health concern worldwide leading to both chronic disease and early death. In Latin America, smoking prevalence is estimated at approximately 30% and prior studies suggest that the prevalence in Peru is 22% to 38%. We sought to determine the prevalence of daily smoking in a poor peri-urban community in Lima, Peru. METHODS: We conducted a cross-sectional survey in a random sample of adults ≥40 years of age living in Pampas de San Juan de Miraflores, Lima, Peru. We asked participants to respond to a survey that included questions on sociodemographics, tobacco use and dependence. RESULTS: We enrolled 316 participants. Average monthly household income was ≤ 400 USD and nearly all homes had running water, sewage, and electricity. Most individuals had not completed high school. Smoking prevalence was 16% overall, yet daily smoking prevalence was 1.9%. Former daily smokers comprised 3.8% of current nonsmokers and 9.1% current occasional smokers. Average scores for the Fagerstrom Test for Nicotine Dependence for daily smokers and occasional smokers were 1.5 and 0, respectively. CONCLUSIONS: Daily use of tobacco is uncommon among adults in peri-urban communities of Lima, Peru, unlike their counterparts in Lima and other Latin American capital cities. Tobacco dependence is also low. Hence, efforts aimed at primary prevention are of utmost importance in these communities. This study provides an accurate baseline using an internationally recognized assessment tool (Global Adult Tobacco Survey), allowing for accurate assessment of tobacco control interventions over time.

Racial differences in hair nicotine concentrations among smokers.

INTRODUCTION: In the United States, race/ethnicity is a strong determinant of tobacco use patterns, biomarkers of tobacco smoke components and metabolites, and likelihood of successful cessation. Although Black smokers tend to smoke fewer cigarettes than White smokers, they have higher cotinine levels and disease risk and lower cessation success. We examined racial differences in hair nicotine concentrations among daily tobacco smokers (n = 103) in Baltimore, Maryland. METHODS: Participants completed a survey, and hair samples were collected and analyzed for nicotine concentration using gas chromatography coupled with mass spectrometry. RESULTS: After adjustment, hair nicotine concentrations among Black smokers were more than 5 times higher than among White smokers (95% CI 3.0, 10.5). Smokers reporting hair treatments other than coloring (bleaching, permanent, or straightening) in the past 12 months had 66% lower (95% CI 32%, 83%) hair nicotine concentrations. Smokers reporting smoking their first cigarette within 30 min of waking had twice the hair nicotine concentrations of those whose time to first cigarette was greater than 30 min after waking (95% CI 1.1, 4.2). For every additional cigarette smoked per day up to 20, mean hair nicotine concentration among all smokers increased by 4% (95% CI -1%, 9%). CONCLUSIONS: This study demonstrates that Black smokers have substantially higher hair nicotine levels than White smokers, after controlling for cigarettes smoked per day and other exposure sources. Time to first cigarette, cigarettes smoked per day, and use of hair treatments other than coloring were also associated with hair nicotine concentrations among smokers.

Tobacco sales and promotion in bars, cafes and nightclubs from large cities around the world.

CONTEXT: Little is known about tobacco promotion activities in low and middle-income countries. Information on tobacco sales, advertisement and promotion in bars, cafes and nightclubs is needed to develop interventions to reduce smoking initiation and relapse, particularly among youths and young adults. OBJECTIVE: To evaluate cigarette sales and tobacco advertisement and promotion in bars, cafes and nightclubs using a volunteer survey approach in large cities throughout the world. METHODS: Between 2007 and 2009, we administered an interview-based survey to 231 bar/cafe/nightclub owners/managers in 24 large cities in Africa, the Americas, Asia and eastern Europe. RESULTS: Cigarette sales and tobacco advertisement and promotions were found in bars/cafes/nightclubs in most cities. Examples of promotions included cigarette giveaways and event sponsorship. Establishments that allowed smoking were more likely to sell cigarettes compared to smoke-free establishments (OR 8.67, 95% CI 3.25 to 23.1). Larger establishments (maximum occupancy ≥ 100 vs <100 customers) were more likely to have tobacco advertising (OR 4.35, 95% CI 2.04 to 9.24) and to receive promotional items from tobacco companies (OR 3.18, 95% CI 1.41 to 7.17). CONCLUSIONS: Cigarette sales and tobacco promotions were common in bars, cafes and nightclubs in the majority of cities. Socialising and hospitality venues must be covered by legislation banning tobacco sales and promotions to limit exposure among populations at high risk of tobacco initiation and relapse from quitting.

Workplace smoking restrictions in China: results from a six county survey.

OBJECTIVE: To determine the coverage of smoking restriction policies in indoor workplaces in China and to assess the relationships between these restrictive policies and secondhand smoke (SHS) exposure and smoking behaviours. METHODS: A cross-sectional household survey was conducted in six counties in Sichuan, Jiangxi and Henan provinces in 2004. Using a standardised questionnaire, information on demographic characteristics, knowledge, attitudes and behaviours related to smoking and SHS exposure was collected through face-to-face interviews by trained local investigators among 12 036 respondents. Of respondents, 2698 individuals worked mainly indoors and were included in data analysis. RESULTS: Only 28.5% of respondents reported that indoor workplaces had a smoke-free policy. Even when respondents reported smoke-free policies, 41.1% smokers reported that they were non-compliant with policies and smoked at work. In addition, 32.0% of non-smokers reported being exposed to SHS at work despite smoke-free policies. Non-smokers who reported no smoking restriction policies were 3.7 times more likely to be exposed to SHS than those working in smoke-free workplaces (adjusted OR 3.7, 95% CI 1.3 to 10.1). On average, respondents complying with smoke-free policies smoked 3.8 fewer cigarettes than those reporting no policies in their workplaces at a marginally non-significant level (p=0.06) (adjusted mean difference -3.8, 95% CI -8.0 to 0.5). CONCLUSIONS: In China, few workplaces have implemented policies to restrict smoking, and, even in workplaces that have policies, workers report exposure to SHS while at their places of employment. Many workers report a lack of compliance with smoke-free policies. China needs better implementation of SHS policies to promote compliance. Working to improve implementation of smoke-free policies would promote cessation since Chinese smokers who were compliant with these efforts reported smoking fewer cigarettes per day.

Promoting smoke-free environments in Latin America: a comparison of methods to assess secondhand smoke exposure.

Secondhand smoke (SHS) contains toxicants and carcinogens that are known to cause premature death and disease. Objectively measuring SHS exposure can support and evaluate smoke-free legislation. In Latin America, the most commonly used methods to measure SHS exposure are airborne nicotine and respirable suspended particles (PM2.5). Here we present results from studies conducted in public places and homes across Latin American countries. Airborne nicotine was detected in most locations between 2002-2006, before the implementation of 100% smoke-free legislation in Uruguay, Panama, Guatemala and other large cities within Latin America. Between 2006 and 2008, PM2.5 levels were found to be five times higher in places where smoking was present at the time of sampling compared to those without smoking. Measuring SHS exposure across Latin America has increased our understanding of the magnitude of exposure in this region and results have been used to effectively promote smoke-free legislation.

[Monitoring strategy for control of tobacco in Mexico: advertising, promotion and sponsorship, packaging and labeling]. / Estrategia de vigilancia para el control del tabaco en México: publicidad, promoción y patrocinio, empaque y etiquetado.

OBJECTIVE: To describe strategies used in the publicity, marketing, and sale, of tobacco products in 12 cities in Mexico. MATERIAL AND METHODS: Tobacco products points of sale (POS) were identified within a 500 m radius of Global Youth Tobacco Survey (2005-2006) schools. We used observational surveys and an online Geographic Information System (GIS). RESULTS: In the 257 schools visited, we found, on average, 8.3 stores and 5 street vendors around each of them. Forty-four percent of the stores had interior tobacco publicity, 8.3% had tobacco products at children's eye level, 6.5% had some promotion, 33.6% had a no selling to minors sign, and 44.4% of stores and 58.8% of street vendors sold single cigarettes. CONCLUSIONS: Tobacco products are largely publicized and marketed around schools. There is no compliance of tobacco control legislation in regards to selling to minors and single cigarettes. It is necessary to implement a surveillance system to monitor strategies for tobacco control and the tobacco industry.

Estimating the risks and benefits of nicotine replacement therapy for smoking cessation in the United States.

OBJECTIVES: To compare potential population-wide benefits and risks, we examined the potential impact of increased nicotine replacement therapy (NRT) use for smoking cessation on future US mortality. METHODS: We developed a simulation model incorporating a Monte Carlo uncertainty analysis, with data from the 2005 National Health Interview Survey and Cancer Prevention Study II. We estimated the number of avoided premature deaths from smoking attributable to increased NRT use, before and after incorporating assumptions about NRT harm. RESULTS: We estimate that a gradual increase in the proportion of NRT-aided quit attempts to 100% by 2025 would lead to 40,000 (95% credible interval=31,000, 50,000) premature deaths avoided over a 20-year period. Most avoided deaths would be attributable to lung cancer and cardiovascular disease. After we incorporated assumptions about potential risk from long-term NRT, the estimate of avoided premature deaths from all causes declined to 32 000. CONCLUSIONS: Even after we assumed some harm from long-term NRT use, the benefits from increased cessation success far outweigh the risks. However, the projected reduction in premature mortality still reflects a small portion of the tobacco-related deaths expected over a 20-year period.

Promoting smoke-free environments in Latin America: a comparison of methods to assess secondhand smoke exposure / Promoción de ambientes libres de humo en América Latina: una comparación de métodos para evaluar la exposición a humo de tabaco

Secondhand smoke (SHS) contains toxicants and carcinogens that are known to cause premature death and disease. Objectively measuring SHS exposure can support and evaluate smoke-free legislations. In Latin America, the most commonly used methods to measure SHS exposure are airborne nicotine and respirable suspended particles (PM2.5). Here we present results from studies conducted in public places and homes across Latin American countries. Airborne nicotine was detected in most locations between 2002-2006, before the implementation of 100 percent smoke-free legislation in Uruguay, Panama, Guatemala and other large cities within Latin America. Between 2006 and 2008, PM2.5 levels were found to be five times higher in places where smoking was present at the time of sampling compared to those without smoking. Measuring SHS exposure across Latin America has increased our understanding of the magnitude of exposure in this region and results have been used to effectively promote smoke-free legislation.

El humo de tabaco (HT) contiene tóxicos y carcinógenos que causan muerte prematura y enfermedades. La medición objetiva de la exposición en el ambiente a HT puede apoyar y evaluar las legislaciones que prohiben fumar. Aquí presentamos resultados de estudios realizados en lugares públicos y hogares latinoamericanos usando los métodos más comunes para esta exposición: nicotina y partículas respirables (PM2.5). Se detectó nicotina en el aire de la mayoría de los lugares muestreados entre 2002-2006, antes de la ejecución de la legislación 100 por ciento libre de humo en Uruguay, Panamá, y Guatemala. Entre 2006-2008, los niveles de PM2.5 resultaron ser cinco veces mayores en lugares donde personas fumaban comparado con lugares sin fumadores. Medir la exposición al HT en América Latina ha aumentado nuestra comprensión de la magnitud de la exposición en esta región y ha servido para promover eficazmente legislación libre de humo de tabaco.

Estrategia de vigilancia para el control del tabaco en México: publicidad, promoción y patrocinio, empaque y etiquetado / Monitoring estrategy for control of tobacco in Mexico: advertising, promotion and sponsorship, packaging and labeling

Objetivo. Describir las estrategias de publicidad, mercadeo, y venta productos del tabaco en 12 ciudades de México. Material y métodos. Los puntos de venta de tabaco, a 500mts alrededor de escuelas participantes de la Encuesta de Tabaquismo en Jóvenes (2005-2006), fueron identificados usando formatos observacionales y un Sistema de Información Geográfica en línea. Resultados. En promedio se encontraron 8 establecimientos y 5 puestos de calle alrededor de las 257 escuelas visitadas. 44.4 por ciento de los establecimientos tenía publicidad en interior, 8.3 por ciento poseían productos a la altura de los ojos de los niños y 6.5 por ciento tenía alguna promoción. El 33.6 por ciento tenía letrero de prohibición de venta a menores, en tanto que 44.4 por ciento de los establecimientos y 58.8 por ciento puestos de calle vendían cigarros sueltos. Conclusiones. Los productos de tabaco son ampliamente publicitados y comercializados alrededor de las escuelas. Existe un alto incumplimiento de las leyes referentes a la venta a menores y por menores. Es urgente implementar un sistema que permita una vigilancia continua de las estrategias de la industria y para el control del tabaco.

Objective. To describe strategies used in the publicity, marketing, and sale, of tobacco products in 12 cities in Mexico. Material and Methods. Tobacco products points of sale (POS) were identified within a 500 m radius of Global Youth Tobacco Survey (2005-2006) schools. We used observational surveys and an online Geographic Information System (GIS). Results. In the 257 schools visited, we found, on average, 8.3 stores and 5 street vendors around each of them. Forty-four percent of the stores had interior tobacco publicity, 8.3 percent had tobacco products at children's eye level, 6.5 percent had some promotion, 33.6 percent had a no selling to minors sign, and 44.4 percent of stores and 58.8 percent of street vendors sold single cigarettes. Conclusions. Tobacco products are largely publicized and marketed around schools. There is no compliance of tobacco control legislations in regards to selling to minors and single cigarettes. It is necessary to implement a surveillance system to monitor strategies for tobacco control and the tobacco industry.

Determinants of hair nicotine concentrations in nonsmoking women and children: a multicountry study of secondhand smoke exposure in homes.

The main purpose of this study was to identify and evaluate determinants of hair nicotine concentrations in nonsmoking women and children exposed to secondhand tobacco smoke at home. Hair samples were collected from nonsmoking women (n = 852) and from children (n = 1,017) <11 years of age living in households (n = 1,095) with smokers from 31 countries from July 2005 to October 2006. Participants' ages, activity patterns and socioeconomic characteristics including education and employment status, and hair treatment information were collected. Multilevel linear regression modeling was used to identify the main determinants of hair nicotine concentration measured by gas chromatography coupled with mass spectrometry. Increased indoor air nicotine concentration at home were associated with increased hair nicotine concentrations in nonsmoking women and children. This association was not changed after controlling for other explanatory variables. After controlling for age, length of exposure, and socioeconomic characteristics, hair nicotine concentrations in nonsmoking children and women were estimated to be increased by 3% and 1%, respectively, for a 1 microg/m(3) increase in air nicotine concentration. The association between children's exposure to secondhand tobacco smoke at home and hair nicotine concentration was stronger among younger children and children with longer exposure at home.

Lung cancer in never smokers: a call to action.

The causative association between tobacco use and lung cancer is a well-established fact. However, lung cancer also occurs, at surprisingly high rates, in lifelong never smokers. In fact, lung cancer in never smokers is among the leading causes of cancer-related mortality. This CCR Focus summarizes recent data, identifies knowledge deficits, and suggests future research directions with regard to this critically important subset of lung cancer patients.