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Introduction This study explores how the emergence of FDA-funded Tobacco Regulatory Science (TRS) research complements and perhaps influenced the direction of tobacco research supported by NIH. Aims and Methods New NIH- and FDA-funded tobacco projects awarded in fiscal years (FY) 2011–2020 were identified using internal NIH databases of awarded grants. Project abstracts and research aims were coded by the authors to characterize research domains and tobacco products studied. Results Between FY 2011 and 2020, NIH funded 1032 and FDA funded 322 new tobacco projects. For the years and grant activity codes studied, the number of new NIH tobacco projects declined while FDA’s increased; combined the number of new projects held steady. Much of NIH research included smoking combustibles (43.7%). The most common products in FDA research were cigarettes (74.8%) and e-cigarettes/ENDS (48.1%). Most NIH (58.6%) and FDA (67.7%) projects included research on the determinants of tobacco use. Another area of apparent overlap was health effects (29.5% NIH and 30.1% FDA). Projects unique to NIH included treatment interventions (33.3%), disease pathology/progression (17.8%) and neurobiology (18.9%). A minority of both NIH and FDA projects included populations particularly vulnerable to tobacco product use. Conclusions In total, support for new tobacco research supported by NIH and FDA combined remained steady for the time period covered, though there was a concomitant decline in NIH tobacco projects with the increase in FDA-funded TRS projects for the activity codes studied. Despite the apparent overlap in some areas, both NIH and FDA support research that is unique to their respective missions. Implications NIH continues to support tobacco research that falls within and outside of FDA’s regulatory authorities. This research still is needed not only to bolster the evidence base for regulatory decisions at the national and state levels, but also to advance a comprehensive scientific agenda that can inform multiple levels of influence on tobacco control, use and addiction. It will be important to continue monitoring FDA-funded TRS and NIH-funded tobacco research portfolios to ensure that the level of support for and focus of the research is sufficient to address the burden of tobacco-related morbidity and mortality.

With the inundation of genetic information over the last decade, the behavioral and social sciences have the opportunity to not only advance their own areas of scientific inquiry but also to transform the study of gene–environment interplay. This is particularly true for developmental science, as its conceptual biopsychosocial principles are increasingly recognized as reflective of the functioning of genes and their complex partnership with environmental factors throughout development. This special issue on gene–environment interplay provides an overview and charts a course for the future and for the contribution that developmental scientists can make to advance the science.

Individual differences in dietary intake are thought to account for substantial variation in cancer incidence. However, there has been a consistent lack of effect for low-fat, high-fiber dietary interventions and risk of colorectal cancer. These inconsistencies may reflect the multistage process of cancer as well as the range and timing of dietary change. Another potential reason for the lack of effect is poor dietary adherence among participants in these trials. The authors examined the effect of strict adherence to a low-fat, high-fiber, high-fruit and -vegetable intervention over 4 years among participants (n = 1,905) in the US Polyp Prevention Trial (1991-1998) on colorectal adenoma recurrence. There was a wide range of individual variation in the level of compliance among intervention participants. The most adherent participants, defined as "super compliers" (n = 210), consistently reported that they met or exceeded each of the 3 dietary goals at all 4 annual visits. Multivariate logistic regression models were used to estimate the association between dietary adherence and adenoma recurrence. The authors observed a 35% reduced odds of adenoma recurrence among super compliers compared with controls (odds ratio = 0.65, 95% confidence interval: 0.47, 0.92). Findings suggest that high compliance with a low-fat, high-fiber diet is associated with reduced risk of adenoma recurrence.

The increasing availability of personal genomic tests has led to discussions about the validity and utility of such tests and the balance of benefits and harms. A multidisciplinary workshop was convened by the National Institutes of Health and the Centers for Disease Control and Prevention to review the scientific foundation for using personal genomics in risk assessment and disease prevention and to develop recommendations for targeted research. The clinical validity and utility of personal genomics is a moving target with rapidly developing discoveries but little translation research to close the gap between discoveries and health impact. Workshop participants made recommendations in five domains: (1) developing and applying scientific standards for assessing personal genomic tests; (2) developing and applying a multidisciplinary research agenda, including observational studies and clinical trials to fill knowledge gaps in clinical validity and utility; (3) enhancing credible knowledge synthesis and information dissemination to clinicians and consumers; (4) linking scientific findings to evidence-based recommendations for use of personal genomics; and (5) assessing how the concept of personal utility can affect health benefits, costs, and risks by developing appropriate metrics for evaluation. To fulfill the promise of personal genomics, a rigorous multidisciplinary research agenda is needed. Genet Med 2009:11(8):559-567.

Objective The purpose of this study is to describe the focus and comprehensiveness of domains measured in e-cigarette research. Methods A portfolio analysis of National Institutes of Health grants focusing on e-cigarette research and funded between the fiscal years 2007 and 2015 was conducted. Grant proposals were retrieved using a government database and coded using the Host–Agent–Vector-Environment (HAVE) model as a framework to characterise the measures proposed. Eighty-one projects met the criteria for inclusion in the analysis. Results The primary HAVE focus most commonly found was Host (73%), followed by Agent (21%), Vector (6%) and Environment (0%). Intrapersonal measures and use trajectories were the most common measures in studies that include Host measures (n=59 and n=51, respectively). Product composition was the most common area of measurement in Agent studies (n=24), whereas Marketing (n=21) was the most common (n=21) area of Vector measurement. When Environment measures were examined as secondary measures in studies, they primarily focused on measuring Peer, Occupation and Social Networks (n=18). Although all studies mentioned research on e-cigarettes, most (n=52; 64%) did not specify the type of e-cigarette device or liquid solution under study. Conclusions This analysis revealed a heavy focus on Host measures (73%) and a lack of focus on Environment measures. The predominant focus on Host measures may have the unintended effect of limiting the evidence base for tobacco control and regulatory science. Further, a lack of specificity about the e-cigarette product under study will make comparing results across studies and using the outcomes to inform tobacco policy difficult.

Electronic cigarettes (e-cigarettes) represent an emerging public health issue. These devices deliver nicotine along with other constituents, including flavorants, via an inhalable aerosol. Their uptake is rapidly increasing in both adults and youths, primarily among current smokers. Public debate is increasing on how these devices should be regulated and used, yet only limited peer-reviewed research exists. To develop a informed policy for e-cigarettes, their effects on human behavior, physiology, and health need to be understood.This paper describes proceedings from a National Institutes of Health-sponsored workshop, which was held in November 2013, to identify research needs related to the effects of e-cigarettes. Discussion topics included e-cigarette risks and abuse potential; the potential role for e-cigarettes in harm reduction and smoking cessation; unintended consequences of e-cigarette use, such as becoming a gateway to conventional cigarettes; and dual use of both e-cigarettes and conventional cigarettes.The research needs identified by the workshop participants included the following: standards to measure the contents and emissions of e-cigarettes; biomarkers of exposure; physiological effects of e-cigarettes on tissues and organ systems, including pulmonary and cardiovascular; information on e-cigarette users, how the devices are used, and identification of the best tools to assess these measures; factors that drive use and influence patterns of use; and appropriate methods for evaluating a potential role for e-cigarettes in smoking or nicotine cessation. To understand fully the challenges and the opportunities that e-cigarettes represent, expertise will be needed in basic, behavioral, translational, and clinical sciences.

In their Viewpoint “Genomic priorities and public health” (Special Section on Genomic Medicine, 24 Oct., p. [599][1]), K. R. Merikangas and N. Risch propose that diseases appearing to be “highly amenable to environmental modification” should take low priority in genomic research. Their

Although it is recognized that many common complex diseases are a result of multiple genetic and environmental risk factors, studies of gene-environment interaction remain a challenge and have had limited success to date. Given the current state-of-the-science, NIH sought input on ways to accelerate investigations of gene-environment interplay in health and disease by inviting experts from a variety of disciplines to give advice about the future direction of gene-environment interaction studies. Participants of the NIH Gene-Environment Interplay Workshop agreed that there is a need for continued emphasis on studies of the interplay between genetic and environmental factors in disease and that studies need to be designed around a multifaceted approach to reflect differences in diseases, exposure attributes, and pertinent stages of human development. The participants indicated that both targeted and agnostic approaches have strengths and weaknesses for evaluating main effects of genetic and environmental factors and their interactions. The unique perspectives represented at the workshop allowed the exploration of diverse study designs and analytical strategies, and conveyed the need for an interdisciplinary approach including data sharing, and data harmonization to fully explore gene-environment interactions. Further, participants also emphasized the continued need for high-quality measures of environmental exposures and new genomic technologies in ongoing and new studies.

We examined patients' ratings of communication with health care providers by sociodemographic characteristics, health care access, and health status. Data were from a national, population-based survey, the 2003 Health Information National Trends Survey (HINTS). The survey was administered to 6,369 adults from a representative sample of U.S. households. Linear regression analysis was conducted using SUDAAN. None of the sociodemographic variables were significantly associated with patients' ratings of providers' communication behavior in the linear model. Ratings of health care providers' communication behavior, however, were significantly higher among respondents with health insurance (p = 0.007) and those with a usual source of health care from whom they consistently sought care (p < 0.001). Ratings of provider communication were significantly lower among respondents who perceived their general health to be fair or poor (p < 0.001) and among those respondents with greater depressive symptoms (p < 0.001). Differences in patient ratings of health care providers' communication by health care access and health status suggest the potential for disparities in health outcomes.

Background: Pro- and anti-inflammatory cytokine genes may be important in the maintenance and progression of colorectal cancer. It is possible that single-nucleotide polymorphisms in inflammatory genes may play a role in chronic colonic inflammation and development of colorectal adenomas. Furthermore, common variants in cytokine genes may modify the anti-inflammatory effect of nonsteroidal anti-inflammatory drugs (NSAIDs) in the prevention of colorectal cancer. Methods: We examined the association between cytokine gene polymorphisms and risk of recurrent adenomas among 1,723 participants in the Polyp Prevention Trial. We used logistic regression to calculate odds ratios (OR) for the association between genotype, NSAID use, and risk of adenoma recurrence. Results: Cytokine gene polymorphisms were not statistically significantly associated with risk of adenoma recurrence in our study. We observed statistically significant interactions between NSAID use, IL-10 −1082 G>A genotype, and risk of adenoma recurrence (P = 0.01) and multiple adenoma recurrence (P = 0.01). Carriers of the IL-10 −1082 G>A variant allele who were non-NSAID users had a statistically significant decreased risk of multiple adenoma recurrence (OR, 0.43; 95% confidence interval, 0.24-0.77) as well as a nonsignificant 30% decreased risk of any adenoma recurrence. In contrast, NSAID users who were carriers of the IL-10 −1082 G>A variant allele were at an increased risk of any adenoma recurrence (OR, 1.55; 95% confidence interval, 1.00-2.43). Conclusion: These findings suggest that individuals who are carriers of the IL-10 −1082 G>A variant allele may not benefit from the chemoprotective effect of NSAIDs on adenoma polyp recurrence. (Cancer Epidemiol Biomarkers Prev 2006;15(3):494–501)

OBJECTIVES: To examine the association of health care access/use, trust of physician advice, and depressive symptoms with the ability to sustain smoking cessation. METHODS: Data from a nationally representative sample were used to compare current smokers (n = 1246), sustained quitters (n = 1502), and never smokers (n = 3277). RESULTS: Sustained quitters reported fewer depressive symptoms (OR = 0.92) and were more likely to have health insurance (OR = 1.75) and a usual source of care (OR= 1.40) that they had seen within the last year (OR = 2.16) and that they were more likely to trust (OR = 1.40). CONCLUSIONS: Identification of these factors may inform providers' efforts to target and assist in smoking cessation.