Valerie B. Yerger

“It’s Like Tuskegee in Reverse”: A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research

Community-based participatory research (CBPR) addresses the social justice dimensions of health disparities by engaging marginalized communities, building capacity for action, and encouraging more egalitarian relationships between researchers and communities. CBPR may challenge institutionalized academic practices and the understandings that inform institutional review board deliberations and, indirectly, prioritize particular kinds of research. We present our attempt to study, as part of a CBPR partnership, cigarette sales practices in an inner-city community. We use critical and communitarian perspectives to examine the implications of the refusal of the university institutional review board (in this case, the University of California, San Francisco) to approve the study. CBPR requires expanding ethical discourse beyond the procedural, principle-based approaches common in biomedical research settings. The current ethics culture of academia may sometimes serve to protect institutional power at the expense of community empowerment.

African American leadership groups: smoking with the enemy

Background: Among all racial and ethnic groups in the USA, African Americans bear the greatest burden from tobacco related disease. The tobacco industry has been highly influential in the African American community for decades, providing funding and other resources to community leaders and emphasising publicly its support for civil rights causes and groups, while ignoring the negative health effects of its products on those it claims to support. However, the industry’s private business reasons for providing such support were unknown. Objective: To understand how and for what purposes the tobacco industry sought to establish and maintain relationships with African American leaders. Methods: Review and analysis of over 700 previously secret internal tobacco industry documents available on the internet. Results: The tobacco industry established relationships with virtually every African American leadership organisation and built longstanding social connections with the community, for three specific business reasons: to increase African American tobacco use, to use African Americans as a frontline force to defend industry policy positions, and to defuse tobacco control efforts. Conclusion: As the tobacco industry expands its global reach, public health advocates should anticipate similar industry efforts to exploit the vulnerabilities of marginalised groups. The apparent generosity, inclusion, and friendship proffered by the industry extract a price from groups in the health of their members. Helping groups anticipate such efforts, confront industry co-optation, and understand the hidden costs of accepting tobacco industry largesse should be part of worldwide tobacco control efforts.

Tobacco documents research methodology

Tobacco documents research has developed into a thriving academic enterprise since its inception in 1995. The technology supporting tobacco documents archiving, searching and retrieval has improved greatly since that time, and consequently tobacco documents researchers have considerably more access to resources than was the case when researchers had to travel to physical archives and/or electronically search poorly and incompletely indexed documents. The authors of the papers presented in this supplement all followed the same basic research methodology. Rather than leave the reader of the supplement to read the same discussion of methods in each individual paper, presented here is an overview of the methods all authors followed. In the individual articles that follow in this supplement, the authors present the additional methodological information specific to their topics. This brief discussion also highlights technological capabilities in the Legacy Tobacco Documents Library and updates methods for organising internal tobacco documents data and findings.

Melanin and nicotine : A review of the literature

The role of melanin in nicotine uptake and metabolism has received little attention. Because nicotine has been shown to accumulate in tissues containing melanin, exploring links between melanin and nicotine may provide additional clues to understanding smoking behavior and disease effects. To examine the scientific literature on the relationship between melanin and nicotine, we conducted a PubMed search. We also searched online archives of internal tobacco industry documents. We retrieved and reviewed 82 published research papers related to melanin and nicotine or melanin and metabolism of other drugs, and 150 relevant internal tobacco industry documents. The published literature suggests that nicotine may accumulate in human tissues containing melanin and this retention may increase melanin synthesis. Existing research on the relationship between melanin and nicotine lacks an adequate consideration of this relationships potential impact, if any, on nicotine metabolism, level of nicotine dependence, and ability to quit smoking. Differential accumulation of nicotine in melanin-containing tissues could have implications for individuals with high levels of melanin.

Menthol's potential effects on nicotine dependence: a tobacco industry perspective.

Objective To examine what the tobacco industry knows about the potential effects menthol may have on nicotine dependence. Methods A snowball strategy was used to systematically search the Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu/) between 22 February and 29 April, 2010. Of the approximately 11 million documents available in the Legacy Tobacco Documents Library, the iterative searches returned tens of thousands of results. We qualitatively analysed a final collection of 309 documents relevant the effects of menthol on nicotine dependence. Results The tobacco industry knows that menthol overrides the harsh taste of tobacco and alleviates nicotines irritating effects, synergistically interacts with nicotine, stimulates the trigeminal nerve to elicit a ‘liking’ response for a tobacco product, and makes low tar, low nicotine tobacco products more acceptable to smokers than non-mentholated low delivery products. Conclusion Menthol is not only used in cigarettes as a flavour additive; tobacco companies know that menthol also has sensory effects and interacts with nicotine to produce tobacco products that are easier to smoke, thereby making it easier to expose smokers, especially those who are new and uninitiated, to the addictive power of nicotine.

Menthol sensory qualities and smoking topography: a review of tobacco industry documents

Objective To determine what the tobacco industry knew about the potential effects of menthol on smoking topography—how a person smokes a cigarette. Methods A snowball strategy was used to systematically search the Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu) between 1 June 2010 and 9 August 2010. We qualitatively analysed a final collection of 252 documents related to menthol and smoking topography. Results The tobacco industry knew that menthol has cooling, anaesthetic and analgesic properties that moderate the harshness and irritation of tobacco. Owing to its physiological effects, menthol contributes to the sensory qualities of the smoke and affects smoking topography and cigarette preference. Conclusion Our review of industry studies suggests that the amount of menthol in a cigarette is associated with how the cigarette is smoked and how satisfying it is to the smoker. If menthol in cigarettes was banned, as the US Food and Drug Administration (FDA) is currently considering, new/experimental smokers might choose not to smoke rather than experience the harshness of tobacco smoke and the irritating qualities of nicotine. Similarly, established menthol smokers might choose to quit if faced with an unpleasant smoking alternative.

Taking it to the Streets: Responses of African American Young Adults to Internal Tobacco Industry Documents

Since the Master Settlement Agreement of 1998 between 46 states and the major tobacco companies forced the release of over 30 million pages of previously secret internal tobacco industry documents, researchers have been exploring how information in the documents can be useful for advancing public health efforts. Previous research shows that the tobacco industry has made massive efforts to target marginalized communities, not only through typical advertising channels but also through establishing financial and other ties with influential leadership groups. However, no previous studies have explored how members of targeted groups might respond at the grassroots level to actual internal tobacco industry documents about such targeting. This exploratory focus group study, which invited urban African American participants to comment on previously secret internal tobacco industry documents, suggests that such documents may be useful in efforts to socially denormalize tobacco use, promote critical reflection about community targeting, and mobilize individuals toward quitting.

Combining community participatory research with a randomized clinical trial: The protecting the hood against tobacco (PHAT) smoking cessation study

BACKGROUND This article describes the process and results of a smoking cessation intervention randomized clinical trial (RCT) that was conducted as a community-based participatory research project. This RCT tested whether outcomes are improved by adding social justice and tobacco industry targeting messages to a smoking cessation program conducted among African American adults within a low-income community in San Francisco, California. This study provides lessons for future similar research projects that focus on urban low-income populations. METHODS Participants were randomly allocated to receive a smoking-cessation program (control group [CG]) or CG care plus tobacco industry and media (IAM) messages. Primary interventions were behavioral. At intake, participants reporting severe withdrawal or smoking > or = 25 cigarettes daily were offered free nicotine replacement therapy. Baseline data were from an in-person interview. Outcome measures included self-reported smoking status; validation of quitting was by salivary cotinine assays. RESULTS Of 87 participants providing baseline data, 31% (27) did not join the RCT. Proportions quitting in the CG and IAM group were 11.5% and 13.6% at 6 months and 5.3% and 15.8% at 12 months, respectively. CONCLUSION African Americans in underserved inner-city neighborhoods can be recruited into RCTs with community participatory approaches. Differences between the CG and IAM in proportions who quit were 2.1% and 10.5% at 6 and 12 months, respectively. More than 3 years with adequate funding, high staffing ratios, and intense outreach and follow-up schedules are needed to achieve recruitment and study goals.

Link between facultative melanin and tobacco use among African Americans.

Nicotines affinity for melanin-containing tissues may result from its precursor function in melanin synthesis or the irreversible binding of melanin and nicotine. The objective of this study was to investigate a hypothesized association of tobacco use, dependence, and nicotine exposure with melanin pigmentation among African American smokers. A criterion-based sample was employed to collect data from a study of 147 adult African American current smokers. Carbon monoxide, saliva cotinine samples, and skin reflectance measures were obtained from each participant. Questionnaire data on demographic, sociological and behavioral questions related to smoking and skin color were gathered. The three dependent measures were the average number of cigarettes per day (CPD), Fagerström Test of Nicotine Dependence (FTND) score, and cotinine concentration. Analysis of variance, Pearson Correlations, and Multiple Linear Regression were conducted to analyze findings. The mean constitutive melanin reading was 56.3 and 66.5 for facultative melanin. Respondents on average smoked 19 CPD, had a mean FTND of 5.6, and a cotinine concentration of 435 ng/ml. Facultative melanin level was correlated with CPD and cotinine concentration in the bivariate analysis. The multiple linear regression results revealed that facultative melanin was significantly and positively related to CPD, the FTND, and cotinine. The results of this analysis support the hypothesis of a positive association between melanin levels and tobacco use, dependence, and exposure among African American smokers. This analysis may have important implications for research and interventions on tobacco dependence and disease outcomes. Further research on melanin and nicotine among African Americans as well as other population groups is warranted.

The Association of Menthol Cigarette Use With Quit Attempts, Successful Cessation, and Intention to Quit Across Racial/Ethnic Groups in the United States

Introduction Few studies have examined the relationship between menthol use and smoking cessation across various racial/ethnic groups; the findings were mixed. This study explored the association of menthol cigarette use with quit attempts, smoking cessation, and intention-to-quit among US adults and by race/ethnicity. Methods Using the 2006/2007 and 2010/2011 Tobacco Use Supplements to the Current Population Survey data, this study analyzed 54 448 recent active smokers, defined as current smokers or former smokers who quit less than 12 months ago. Three behaviors were examined: any quit attempts in the past 12 months, successful cessation for ≥3 months, and intention-to-quit smoking in the next 6 months. For each cessation behavior, multiple logistic regression models were estimated separately for the full-sample and stratified racial/ethnic subsamples. Results While 72.3% of African American recent active smokers typically smoked menthol cigarettes, this proportion was 21.7%, 21.5%, and 28.0% for whites, Asians, and Hispanics, respectively. African American menthol smokers had higher odds of quit attempts compared to non-African American, non-menthol smokers (full-sample analysis), as well as African American non-menthol smokers (subsample analysis). Menthol use was not significantly associated with quit attempts in other racial/ethnic subsamples. There was no significant difference in either successful cessation or intention-to-quit between menthol and non-menthol smokers. Conclusions African American menthol smokers were more likely to attempt to quit smoking than non-menthol smokers but these quit attempts did not translate into successful cessation. This study revealed no association of menthol use with quit attempts, successful cessation, and intention-to-quit among other racial/ethnic groups. Implications The findings suggested that African American menthol smokers were more motivated to quit smoking; yet, the results also indicated no significant differences in successful cessation between African American menthol and non-menthol smokers. Interventions targeting menthol smokers within the African American community may help bridge this gap. While more local sales restrictions are beginning to occur (eg, Tobacco 21 efforts), additional policies restricting price discounting as well as the regulation of access to and the time, place, and/or manner of menthol tobacco advertising could also improve cessation rates. Further evaluation is needed to determine the viability of these policies.