Mark Parascandola

Clinical Trials Methods for Evaluation of Potential Reduced Exposure Products

Potential reduced exposure products (PREPs) to tobacco toxicants may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Such an assessment involves determining the effects of these products on biomarkers of exposure and effect, which serve as proxies for harm, and assessing the potential for consumer uptake and abuse of the product. This article identifies critical methodologic issues associated with PREP assessments, reviews the methods that have been used to assess PREPs, and describes the strengths and limitations of these methods. Additionally, recommendations are provided for clinical trial PREP assessment methods and future research directions in this area based on this review and on the deliberations from a National Cancer Institute sponsored Clinical Trials PREP Methods Workshop. (Cancer Epidemiol Biomarkers Prev 2009;18(12):3143–95)

Surveillance Methods for Identifying, Characterizing, and Monitoring Tobacco Products: Potential Reduced Exposure Products as an Example

Tobacco products are widely sold and marketed, yet integrated data systems for identifying, tracking, and characterizing products are lacking. Tobacco manufacturers recently have developed potential reduced exposure products (PREP) with implied or explicit health claims. Currently, a systematic approach for identifying, defining, and evaluating PREPs sold at the local, state, or national levels in the United States has not been developed. Identifying, characterizing, and monitoring new tobacco products could be greatly enhanced with a responsive surveillance system. This article critically reviews available surveillance data sources for identifying and tracking tobacco products, including PREPs, evaluating strengths and weaknesses of potential data sources in light of their reliability and validity. With the absence of regulations mandating disclosure of product-specific information, it is likely that public health officials will need to rely on a variety of imperfect data sources to help identify, characterize, and monitor tobacco products, including PREPs. (Cancer Epidemiol Biomarkers Prev 2009;18(12):3334–48)

Criteria for evaluating tobacco control research funding programs and their application to models that include financial support from the tobacco industry

Much has been discussed and written about the purposes, outcomes and ethics related to tobacco industry funding of research.1–9 The issue is controversial because of tobacco industry funding mechanisms that have been used by the tobacco industry to gain credibility and to advance the industry’s interests, which may come at the expense of public health;6 at the same time others have argued that, given the scarcity of funding from other sources, tobacco industry support may be defensible, at least under some circumstances.10 These concerns raise the question of whether there could be a model of tobacco company funding that would be acceptable to the tobacco control research community. This paper presents a set of criteria for evaluating funding models and applies them to four diverse models. While tobacco consumption and prevalence rates have declined in many developed countries over the past 40 years, the projections are that worldwide tobacco-related deaths will increase in the 21st century.11 Despite the disproportionate toll tobacco use takes, there remains only a modest investment in research to better understand tobacco products, tobacco product marketing, addiction, treatment and consumer behaviour. For example, in the USA, where tobacco causes almost 30% of all cancer deaths, only 2.3% of the National Cancer Institute’s 2003 budget was spent on tobacco-related research funding.12 This level of research investment is inadequate relative to the magnitude of the damage caused by tobacco use.13 14 At the same time, the tobacco industry has funded tobacco and health related research at universities. In the current context of limited funding, individuals and institutions may welcome additional sources of support. However the evidence is now clear that the tobacco industry participated in a long-standing conspiracy to defraud the public regarding the health risks of smoking. In 2006, the …

Providing a Science Base for the Evaluation of Tobacco Products.

OBJECTIVE Evidence-based tobacco regulation requires a comprehensive scientific framework to guide the evaluation of new tobacco products and health-related claims made by product manufacturers. METHODS The Tobacco Product Assessment Consortium (TobPRAC) employed an iterative process involving consortia investigators, consultants, a workshop of independent scientists and public health experts, and written reviews in order to develop a conceptual framework for evaluating tobacco products. RESULTS The consortium developed a four-phased framework for the scientific evaluation of tobacco products. The four phases addressed by the framework are: (1) pre-market evaluation, (2) pre-claims evaluation, (3) post-market activities, and (4) monitoring and re-evaluation. For each phase, the framework proposes the use of validated testing procedures that will evaluate potential harms at both the individual and population level. CONCLUSIONS While the validation of methods for evaluating tobacco products is an ongoing and necessary process, the proposed framework need not wait for fully validated methods to be used in guiding tobacco product regulation today.

The strategic dialogue on tobacco harm reduction: A vision and blueprint for action in the United States

The issues related to tobacco harm reduction continue to challenge the tobacco control research and policy communities. The potential for combusting tobacco products to reduce exposure and risk remains largely unknown, but this has not stopped manufacturers from offering such products making these claims. The role of oral tobacco products in a harm reduction regimen has also been a source of dialogue and debate. Within the last few years, major cigarette manufacturing companies have begun selling smokeless products for the first time, claiming to target current cigarette smokers. Other cigarette manufacturers are also offering smokeless products in markets around the world. The harm reduction debate has at times been divisive. There has been no unifying set of principles or goals articulated to guide tobacco control efforts. In particular, the research needs are extraordinarily high in order to drive evidence-based policy in this area and avoid the mistakes made with “light” cigarettes. This paper discusses recommendations from a strategic dialogue held with key, mostly US-based tobacco control researchers and policy makers to develop a strategic vision and blueprint for research, policy and communications to reduce the harm from tobacco for the US. Short-term and long-term objectives are described.

Tobacco use transitions in the United States: The National Longitudinal Study of Adolescent Health

OBJECTIVES The purpose of this study is to evaluate and describe transitions in cigarette and smokeless tobacco (ST) use, including dual use, prospectively from adolescence into young adulthood. METHODS The current study utilizes four waves of the National Longitudinal Study of Adolescent Health (Add Health) to examine patterns of cigarette and ST use (within 30 days of survey) over time among a cohort in the United States beginning in 7th-12th grade (1995) into young adulthood (2008-2009). Transition probabilities were estimated using Markov modeling. RESULTS Among the cohort (N=20,774), 48.7% reported using cigarettes, 12.8% reported using ST, and 7.2% reported dual use (cigarettes and ST in the same wave) in at least one wave. In general, the risk for transitioning between cigarettes and ST was higher for males and those who were older. Dual users exhibited a high probability (81%) of continuing dual use over time. CONCLUSIONS Findings suggest that adolescents who use multiple tobacco products are likely to continue such use as they move into young adulthood. When addressing tobacco use among adolescents and young adults, multiple forms of tobacco use should be considered.

Monitoring Tobacco-Specific N-Nitrosamines and Nicotine in Novel Smokeless Tobacco Products: Findings From Round II of the New Product Watch

INTRODUCTION Analysis of novel smokeless tobacco products purchased in Round I of the New Product Watch (NPW)-a national tobacco monitoring network-demonstrated that some tobacco constituents vary not only across various brands but also regionally and over time within the same product. In this study, we analyzed snus and dissolvable tobacco products that were purchased in Round II of the NPW. METHODS We analyzed tobacco-specific N-nitrosamines (TSNA) and nicotine in snus and dissolvable tobacco products that were purchased in various regions of the country during the spring and summer of 2011. The results were compared against the Round I data, across different U.S. regions, and among products. RESULTS A total of 216 samples were received from different states representing 6 regions of the country. Compared with the previous analyses, TSNA levels increased significantly in Marlboro and Camel Snus and some dissolvable Camel products. The levels of unprotonated nicotine in Marlboro Snus and Camel Snus in this study were not different from Round I but varied significantly by regions; the differences between the highest and the lowest average regional levels were ~3.2-fold in Marlboro Snus ~1.7-fold in Camel Snus. CONCLUSIONS Our results indicate that some novel smokeless tobacco products contain TSNA at the levels found in the conventional moist snuff. Observation of regional variations in unprotonated nicotine content in both Round I and Round II of NPW suggest that manufacturers may tailor the levels of this constituent consistently to different regions.

Tobacco use among Southwestern Alaska native people

INTRODUCTION We examined the characteristics, attitudes, beliefs, and exposure to tobacco products in a cohort of rural dwelling Alaska Native (AN) people. METHODS We conducted a study of 400 of AN adult tobacco users and nonusers living in Southwestern Alaska. Questionnaires covered variables such as demographics, tobacco-use history, current tobacco use and dependence scales, general health status, attitudes and beliefs about tobacco, and quitting history. RESULTS The study population smoked 7.8 cigarettes per day compared with 16.8 on average for the U.S. population: a significant proportion of the population engaged in dual use of cigarettes and smokeless tobacco products. Over one third (40.9%), first tried tobacco at age 11 or younger. The mean measures of tobacco addiction (e.g., Fagerstrom Test for Nicotine Dependence, Severson Scale of Smokeless Tobacco Dependence) scores were lower compared with other U.S. populations. CONCLUSIONS Very high tobacco-use prevalence, dual product use, and early tobacco use are observed in Southwestern AN people. Unexpectedly these did not appear to be correlated with heavier individual tobacco use or higher levels of addiction in this population.

Characteristics of current and recent former smokers associated with the use of new potential reduced-exposure tobacco products

OBJECTIVES To identify sociodemographic characteristics associated with having tried a potentialy reduced-exposure tobacco product (PREP) and to compare the smoking and quitting behaviors and attitudes of smokers who have tried a PREP product with non-PREP users. METHODS Analysis is based on a sample of 43,419 current and recent former smokers from the 2003 Tobacco Use Supplement to the Current Population Survey. RESULTS Overall, PREP use is low (2.5%). Current daily and someday only smokers have higher rates of use (2.9% and 2.4%, respectively) compared with former smokers (1.5%). PREP use is higher in southern states and among younger smokers, non-Hispanic Whites, and those with some college education. Smokers who have tried a PREP product are more likely to smoke light or ultra-light cigarettes, report more symptoms of nicotine dependence, smoke more cigarettes per day, report a higher number of quit attempts, and seek quitting assistance from pharmacotherapy and behavioral therapies compared with non-PREP users. DISCUSSION These findings support the concern that current smokers who are highly dependent yet motivated to quit smoking may seek PREPs as an alternative strategy to smoking cessation.

Food and Drug Administration Evaluation and Cigarette Smoking Risk Perceptions

OBJECTIVES To examine the relationship between a belief about Food and Drug Administration (FDA) safety evaluation of cigarettes and smoking risk perceptions. METHODS A nationally representative, random-digit-dialed telephone survey of 1046 adult current cigarette smokers. RESULTS Smokers reporting that the FDA does not evaluate cigarettes for safety (46.1%), exhibited greater comprehension of the health risks of smoking and were more likely (48.5%) than other participants (33.6%) to report quit intentions. Risk perceptions partially mediated the relationship between FDA evaluation belief and quit intentions. CONCLUSIONS These findings highlight the need for proactive, effective communication to the public about the aims of new tobacco product regulations.