Identifying Global Tobacco Control Research Priorities: Improving Research to Practice W o r l d C o n f e r e n c e o n To b a c c o O r H e a l t h March 22, 2012 Singapore Cathy L. Backinger, PhD, MPH Deputy Director for Research Office of Science Center for Tobacco Products US Food and Drug AdministrationNo financial disclosuresThis project was begun when employed with the U.S. National Cancer Institute
Framework Convention on Tobacco Control 2005 – first global health treaty As of January 9, 2012 – 174 parties have ratified Successful implementation of FCTC provisions require ongoing research and surveillance FCTC addresses need for research, but did not include research priorities or topics
Objective Identify key priority research needs related to relevant provisions of FCTC by developing and disseminating scientific papers in order to improve global tobacco control Funding by the U.S. National Cancer Institute to the Society for Research on Nicotine and Tobacco (SRNT)
Process Assemble core team: – Lekan Ayo-Yusef, South Africa – Cathy Backinger, US – Ami Bahde, US – Scott Leischow, US – Bruce Wheeler, US
Process Identify internationally recognized scientific experts to serve as lead authors to develop papers in 7 areas: 1. Joaquin Barnoya, US – Article 8 – protection from exposure to tobacco smoke 2. Gary Giovino, US – Articles 20, 21 & 22 – surveillance/epidemiology, information exchange, infrastructure and capacity-building needs 3. Nigel Gray – Australia, Articles 9 & 10 – regulation of tobacco product contents and disclosures
Process4. David Hammond, Canada – Articles 11 & 12 – packaging and labeling; education, communication and public awareness5. Haydon McRobbie, UK, Article 14 - treatment6. Corne van Walbeek, South Africa, Articles 6 & 15 – price and tax measures, illicit trade7. Vish Viswaneth, US – Articles 13 & 16 – advertising, promotion and sponsorship; and sales to minors
Process Draft papers: – Review of relevant FCTC sections – Include brief history of regulation related to topic – Identify existing research – Identify critical gaps in research – Analysis of research expertise required to fill knowledge gaps
Process Papers to pay particular attention to: – Providing specific research questions – Addressing cross-cutting issues, e.g., children; other forms of tobacco; denormalization; industry influence; inequalities such as gender and cultural/regional issues; and low and middle income countries – Addressing infrastructure needs
Process Provide expert reviews: – Ron Borland, Australia – Mike Cummings, US – Tom Glynn, US – TH Lam, Hong Kong – Mitch Zeller, US Presented at SRNT-Europe for feedback and input Finalize papers for submission to NTR Present synthesis at WCTOH
FCTC research Needs – Demand reduction: Articles 6 -12&15 Lekan Ayo-Yusuf, DDS, MSc, MPH, PhD Department of Community Dentistry 22nd March 2012, WCToH, Singapore 1
Presentation overview Articles Lead authorArticle 6 (Taxation & pricing ) & 15 (illicit C. van Walbeek (South Africa)trade)Article 8 (Protection from Secondhand J. Barnoya (US/Guatemala)smoke)Article 9 & 10 (regulation of content & N. Grey (Australia)disclosure)Article 11 (Packaging & Labeling) & 12 D. Hammond (Canada)(public education & communication)What we know and priority research needs 2
Article 8: Protection from Second hand smoke 3
Article 8: What we know• 600,000 deaths as result of health consequences of SHS - cardiovascular disease, lung cancer, respiratory disease and developmental effects on children (Oberg et al., 2011; US Department of Health and Human Services, 2006).• Economic burden of SHS exposure –• In the US, in 2005, the annual costs of excess medical care, mortality and morbidity exceeded $10 billion and indirect costs have been estimated to be $5 billion (Behan et al., 2005).
Article 8: What we know.• A smoking ban is the only means of effectively eliminating indoor exposure to SHS and no engineering approach have been demonstrated or should be relied upon to control health risk from ETS exposure (American Society of Heating, 2008).• Separation of smokers from non-smokers, ventilation systems, air cleaning and filtration are all ineffective strategies to eliminate SHS exposure and its harmful effects (Barnoya and Navas-Acien, 2012).• The ventilation rate required to reduce SHS to acceptable levels of cancer risk would have to be increased 22,500 times compared to current ventilation standards (Repace, 2005; Repace and Johnson, 2006).
Article 8: Research priorities• More research needed on key diseases suggested to be associated with SHS and the impact of ban e.g Breast Ca and spread of tuberculosis infection esp in LMIC.• Improved exposure assessment with regards to 3rd hand smoke assessment and its health effects.• What is the best assessment approach to monitoring exposure outdoors and in multi-unit housing especially with a focus on low SES children and other vulnerable groups?• Airborne nicotine & PM2.5 or questionnaire on exposure & measure of social support are still useful in LMIC.
Articles 9 and 10 –Regulating content & Disclosure 7
Articles 9 and 10 - What we know• Tobacco avoidance is the only way to prevent harm!• Unlike smokeless products, combustible products can’t be regulated by simply approving ingredients because of the complexities of interaction between smoking behaviour and combustion products from burnt tobacco and any additives present.• Addictiveness = prolonged use = prolonged toxin exposure = Harm• 3 major regulatory possibilities to reduce harm: Regulate toxicant levels (setting upper limits) Regulate nicotine (part of reducing dependence potential) Regulate additives and engineering features such as ventilation• Most independent chemistry work has focused on manufactured cigarettes and not other forms like Bidi’s or waterpipe. 8
Articles 9 and 10 - What we know• Only a small number of countries have legislated to mandate various forms of disclosure from the tobacco industry to provide for the regulation of tobacco products.• Few have been able to use legislation to commence any kind of regulatory process (now possible with FDA).• The scientific basis for defining objective criteria for defining types of tobacco products that might be subject to different regulatory standards.• A set of carcinogens/toxins to regulate and/or monitor have been identified (TobReg 2009).• Enough to establish appropriate standardized testing regimes for the carcinogens/toxins that are to be regulated and/or monitored.
Articles 9 and 10: What we need to know/infrastructure.• What standardized procedures and biomarkers should be used to measure exposure as the basis for monitoring effect of toxicant reduction?• What other factors contribute to the risk of developing addiction including packaging, marketing, sensory perception, and environmental stimuli?• Modelling to determine an algorithm to estimate the percentage of the current market that would be prohibited if upper limits were implemented (how low can we go?)• What surveillance is required to ensure that no major unintended consequences and to allow early action if signs of such problems occur?
Articles 9 and 10: What we might need to know• Farm level: tobacco company guides of requirements for growing, curing and on-farm processing of tobacco.• Manufacturing: disclosure, by product of design features and all additives with information as to amount, recipes for blends of tobaccos and any standardization of ingredients.• Performance: levels of identified chemicals per brand/variant using standardized testing and reporting criteria.• Marketing & post-marketing: disclosure of marketing budgets & volume of sales by brand/variant on daily basis
Articles 9 and 10: Research priorities (for early stages)• What empirical model can be developed to evaluate the impacts of various levels of reduction in target carcinogens/toxins, both by consumer market and overall?• What M&E mechanism would be most appropriate to assess the impacts of regulations when they occur e.g. research to identify better ways of measuring toxin exposure?• If compensatory smoking was to be substantially reduced, would it be possible to reduce average intakes of nicotine to levels that would make quitting easier?• How can governments and regulators best communicate about their efforts to reduce tobacco-related harm in ways that do not lead to unrealistic expectation about reduced harm?
Articles 6 and 15: What we know• Studies have shown that an increase in cigarette prices is effective in reducing cigarette consumption especially in LMIC (Jha & Chaloupka, 1999; IARC,2011).• Higher taxes and prices increases the possibility of illicit trade in cigarettes.• Tobacco taxes are regressive but the increase in the excise tax reduces the regressivity of the tax (Jha & Chaloupka, 1999).• Banning duty-free sales might reduce consumption as it reduces ability to legally avoid taxes.• Real, inflation-adjusted cigarettes prices increased in nearly all HICs between 1990 and 2008, but they decreased in more than half of the LMICs during the same period (Van Walbeek et al, forthcoming).
Articles 6 and 15• Industry attempts to influence tax levels & excise tax structures in their favour.• The tobacco industry uses profits from its more expensive brands to offset potential losses on its cheaper brands – ‘Under-shifting’ (Tavakoly, Taylor, Reed, & Gilmore, 2011).• Price discounting is has been used to gain market share in newly opened markets (Vateesatokit et al, 2000).• Evidence of Industry change to ‘over-shifting’ following the recent tax increases in Ukraine (Ross et al., 2011)
Articles 6 and 15 – research priorities• Monitoring tobacco consumption, prices and taxes.• Assessing the effectiveness of the tax structure in generating revenue and reducing tobacco use.• Strengthening the tax administration system in order to reduce tax evasion and tax avoidance.• Improving our understanding of the political economy of tobacco tax policy.• Employing a multidisciplinary approach to assessing the magnitude of illicit tobacco trade
Article 11: What we know• Health warnings on tobacco packages are a source of health information (Hammond et al.,2006).• Health warnings must be large and prominent.• Large and prominent warnings are more noticeable, perceived as more effective and allows for more content including additional text, larger images, and cessation information such as telephone quitline numbers (Hammond, 2011).• Evidence suggests that health warnings can promote cessation behaviour and help to reduce smoking uptake.
Article 11: what we know contd...• Findings from studies have shown that graphic warnings are more effective than text warnings (BRC Marketing and Social Research, 2004; Corporate Research Associates, 2005; Hammond 2011).• Evidence suggests that health warnings can reduce the general appeal of packages (Germain et al., 2010).• Messages on specific toxic constituents with explanation of their health effects are rated most effective (Health Canada, 2007).• Banning a small number of descriptors ‘light’ is insufficient to reduce false beliefs (Borland et al., 2008; Hammond et al., 2009).• Removing colour & imagery reduces false beliefs & makes HW more effective through increased noticeability, recall (Munafo et al., 2011)
Article 12: What we know (mass media campaigns)• Anti-tobacco mass media campaigns have the potential to influence individual behaviours, social norms and tobacco control policies, each of which can affect population-wide tobacco use (Hopkins et al., 2001; Hornik, 2002).• Reach & intensity: An average of at least 1,200 gross rating points (GRPs) per quarter for a total of 4,800 GRPs per year are needed to produce a detectable reduction in adult smoking prevalence (Wakefield et al., under review).• Durability: The beneficial effects of tobacco control advertising does not last beyond two months after broadcasting ends (Borland & Balmford, 2003; Wakefield et al.,2011, Wakefield et al., 2008).
Article 12 (Mass media campaigns)• Changing media environment posses challenge to achieving adequate exposure to planned messages as people have greater control.• Televised messages receive higher advertising response ratings than radio messages, are more likely to be recalled than messages on other channels (e.g. radio and outdoor) and more likely to be associated with reduced smoking initiation (US Department of Health and Human Services, In Press).• Studies have shown that tobacco ads which elicit strong negative motions (e.g. fear, guilt, disgust, anger) can increase attention, generate greater recall and appeal, and affect adolescents smoking related beliefs and intentions to smoke (National Cancer Institute, 2008; US Department of Health and Human Services, In Press).
Research priorities (Article 11)• Exploration of the interaction between health warnings and pack branding.• Research to identify the most cost-effective mix and best practices for sustaining health communication over time.• Research examining how pack shape and size interacts with the effectiveness and legibility of health warnings especially with cigarette packs with irregular shapes.• Research on health warnings for other tobacco products, including SLT.• Effectiveness of graphic fear-arousing depiction of health effects relative to other ‘themes’ or executional styles including testimonials or narratives.
Research priorities (Article 12)• Studies pertaining to media campaign investment strategy e.g. What level of media campaign investment (GRPs) and over what duration is needed to reliably detect sustained effects on changing tobacco use behaviour?• Studies to better understand how media messages are processed by their audiences e.g. Which advertising response measures, or efficient combinations of them (recall, perceived argument strength, perceived effectiveness, emotional response), best predict tobacco use behaviour change?• Studies of different anti-tobacco message sources and target audiences e.g. What are the effects of mass media campaigns aimed at prompting adults to quit on youth smoking uptake?• Studies of types of message for different media channels e.g. (can radio ad elicit as high a negative emotion as TV ad?
Conclusions• Given that much of the evidence-base underlying these articles (with perhaps the exception of Article 6), derives from high-income and to a lesser extent middle-income countries, there is need for evidence on the extent to which consumer needs differ in much different social and political contexts, including different social norms and pattern of tobacco use that exist in several low-income countries.• A prerequisite for advancing these research needs would be related to stronger emphasis on capacity building for research and the demand for research by policy makers in these LMICs.• The growing innovation in product designs calls for vigilance in making sure that research is also innovative and includes other forms of tobacco use other than manufactured cigarettes as we know it today.• The building of research infrastructure that would be required to advance FCTC in LMIC would without doubt require international collaboration. 24
Research priorities for effective FCTC implementation Ron Borland PhD The Cancer Council Victoria The Cancer Council Victoria
Articles covered• Article 6 Price and tax measures and Article 15 Illicit trade• Article 13 Marketing restrictions and Article 16 Sales to minors• Article 14 Cessation• Articles 20-22 Monitoring, information sharing and infrastrructure The Cancer Council Victoria
Common themes• Needs for research and capacity differ for High income, Middle income and Low income countries• Also vary by degree of progress in implementation of FCTC provisions The Cancer Council Victoria
Price, Tax and Illicit trade priorities• Monitoring of tobacco consumption, prices and taxes.• Assessing the effectiveness of the existing tax structure in generating revenue and reducing tobacco use.• Strengthening the tax administration in order to reduce tax evasion and tax avoidance.• Improve our understanding of the political economy of tobacco tax policy• Employing a multidisciplinary approach to assessing the magnitude of illicit tobacco trade The Cancer Council Victoria
Improved monitoring• Price and tax income • Lack of consistency in collection of basic data • Need for Agency other than COP to take role• Consumption • Gross taxed sales problematic if illicit trade high • Self-report surveys often underestimate use • this may change over time The Cancer Council Victoria
Tax increases• Understanding determinants of pursuing tax increases• Value of earmarked taxes• Effects of size and frequency of tax rises• Effects of tax structure on avoidance and equity ‒Uniform seen as ideal• Responses to tax rises among poor who don’t quit• Sensitivity of ANDs to price differences The Cancer Council Victoria
Strengthening the taxadministration in order to reduce tax evasion and tax avoidance. The Cancer Council Victoria
Industry responses• Impacts of price-related marketing• Value of minimum price legislation• How the industry influences tax policy• Role of market structure • Under or over shifting of price in response to tax The Cancer Council Victoria
Illicit trade• Employing a multidisciplinary approach to assessing the magnitude of illicit tobacco trade ‾ Improving estimates of its size• Utility of containment strategies ‾ High tech stamping ‾ Licensing and tracking systems The Cancer Council Victoria
Research Priorities for Article 14 –Demand reduction measuresconcerning tobacco dependence andcessation• Use of cessation in proportion to need – Not very relevant to low income countries The Cancer Council Victoria
Priorities for Cessation research• Monitoring tools – Standardised measure of cessation outcomes• Other priorities – promote cessation of tobacco use – assist healthcare workers provide better help to smokers (e.g. through implementation of TDT guidelines, and training) – enhance population based TDT interventions – assist people cease the use of other tobacco products. The Cancer Council Victoria
Monitoring• This is a common need that spans all countries and calls for international collaboration with harmonisation of research methodology and outcome measures. The Cancer Council Victoria
Improved promotion of cessation• Investigate the effect of mass media campaigns to promote cessation in an equitable way – In MIC: just implement• Monitor tobacco use among HPs in LMIC• Investigate more effective ways to integrate the provision of brief advice to quit smoking into routine clinical practice of HPs – Implement in MIC• Investigate how advice to stop and referral to cessation services can be implemented into non- healthcare settings and determine the impact of such advice The Cancer Council Victoria
Improved services and aids• Improving quitlines and use of internet – Implement in MIC• Investigate role of cheap meds – Efficacy in general use – Cost-effectiveness in MIC The Cancer Council Victoria
Research Priorities for FCTC Articles 13 & 16:Tobacco Advertising, Promotion, andSponsorship and Sale to and by Minors• Largely legislative agenda• Many issues no-longer relevant for leading nations• No specific recommendations for issues of minors The Cancer Council Victoria
Promotion and marketing bans• Reasons for variations in bans across countries• Case studies of implementation successes and failures• Monitoring exposures – Especially in new media• Promotion of ANDS to FMC The Cancer Council Victoria
Articles 20-22 Monitoring,Evaluation and Cooperation• Article 20: Research, surveillance and exchange of information• Article 21: Reporting and exchange of information• Article 22: Cooperation in the scientific, technical, and legal fields and provision of related expertise The Cancer Council Victoria
Monitoring and evaluation• Validity of self-report – Especially where socially unacceptable• Validity of production and trade data• Better measures of industry activity• Finding better and less costly sampling strategies• Calibrating to understand differences in estimated between sources• Internet surveillance• Surveillance in special populations• Understanding alternative crops The Cancer Council Victoria
Cooperation• Gaps and successes in collaboration and cooperation• Understanding the opposing networks• Identify barriers to more effective cooperation• What infrastructure do we need? The Cancer Council Victoria
Synthesis• Good surveillance is critical – Prevalence surveys – Not just of outcomes, but of mechanisms • Including of the vector• Strong evaluation capacity – Must be able to evaluate policies, not just local and individual interventions• Knowledge must be fed back to inform action The Cancer Council Victoria
Comments and Challenges Scott Leischow, PhD The University of Arizona Tucson, Arizona
New research and synthesis of existing research• Expand economic analyses of policy impact, including causal modeling• Analysis and modeling of factors impacting illicit trade, particularly in LMIC and when considering taxation• Consumer perception research on warning label content (inc. plain packaging, imagery) and packaging? Impact on social norms and behavior?• Communicating risk (eg on additives), and blending media approaches• Behavioral economic research…why do people make decisions not may hurt them?
New research and synthesis of existing research• What channels of communication are best for specific populations, products, message types?• What types of mass media work in which groups and situations, and how to effectively use social media? How to blend mass media approaches in targeted populations (eg via Facebook)?• Assessing the impact and use of existing and emerging technologies (eg text messaging), esp in LMIC• Dissemination and knowledge transfer/translation research with emphasis on
New research and synthesis of existing research• Research on optimizing tobacco treatment with different populations, brief support in LMIC• What policy changes can increase desire to quit (eg excise taxes), and what is the impact on specific populations (eg low income) ?• Improved monitoring of effective treatments across LMIC and HIC, inc cost effectiveness• How are social norms changed among healthcare workers to quit tobacco, and to treat different types of tobacco users
New research and synthesis of existing research• Analysis of unique tobacco constituents (eg acetaldehyde), and differences by country, region, etc, and what is the impact of nicotine delivery and/or disease risk?• Analysis of effective ways to reduce or eliminate harmful constituents• How to effectively reduce compensatory smoking• Abuse liability/consumer appeal, eg nicotine content/reducing addictive potential of cigarettes• Research on the tobacco industry itself, eg on pricing, government and other corporate influence
New and expanded surveillance• Creation of a tobacco surveillance clearinghouse for broad collections of data (products and their constituents & performance, marketing, sales, tobacco use, biospecimen, clinical, health outcomes, documents, etc).• Creation of databases of raw data, not just publications, to allow for independent analyses of relationships.• Expand existing surveillance systems (eg ITC) to collect needed data (eg women use, providers, indigenous, low income, new/expanding products like waterpipe, 3rd hand smoke & its effects), including marketing data that many scientists do not now use (eg GIS mapping of sales data)
New and expanded surveillance• Development of an rapid and extensive early warning system for tracking, reporting, analysis, interpretation and communication related to tobacco product tactics, use patterns, health outcomes similar to that used for communicable disease• Creation of an international tracking system to assess cross border trade, differences in product and marketing• Minimum dataset for each country, eg pre/post policy change• Tracking cross-border advertising• Reasons (other than secular trends) for different estimates across surveys• Tracking and analysis of illicit trade, inc health effects
Consensus efforts• Development of and agreement on scientific mechanisms for triangulating disparate data (eg epi, clinical, animal, etc) to develop best estimates on causality – both for individuals and populations• Agreement on validity and reliability of other measures, inc. industry activities• Agreement on prioritizing biomarker indicators for exposure and health outcomes that can be the focus of regulatory efforts• Agreement on use and expansion of existing tobacco surveillance structures and functions to develop a recommendation on what data are needed to understand the impact of intersecting influences/factors
Consensus efforts• Determination of which data are unique to each country, and must be collected, and which can be generalized• Develop and agree on methodologies to test consumer perceptions• How to prioritize research that has the best potential to achieve the greatest public health gains, taking into consideration factors that could lead to unintended consequences• How do we determine when we know enough (eg about removal of certain constituents, reduction of nicotine, etc) that action is warranted and can be defended? And what are the criterion for determining that the weight of evidence supports action, and what types of research are needed (experimental, quasi-exper, surveillance, etc)?
Structural and Functional Factors• Optimize communication and collaboration between government agencies, and between government agencies and the public health community (including SRNT), to assure a consistent approach to the science- to-policy needs – How do we speed the flow of knowledge from discovery to development to delivery?• Creation, maintenance, and optimization of science networks (national and international) to foster a ‘shared situational awareness’ on the state of the science, and rapid sharing of new data in a transparent fashion to reduce ‘silos’ – Identify examples of relevant networks that are effective(eg Tobacco Laboratory Network), and develop comparable ones for other areas where needed.
Development Analysis & Interpretation Decision making Synthesis Delivery TRAINING Dissemination and Implementation of Policy into Practice Surveillance & Epi Behavior Change and Health Research Outcomes: •Individual Evaluation •Group •Population DiscoveryLeischow, and see also NCI Monograph 17 Outcomes
Questions• Given the heterogeneity of the research environment and differing research needs, is it possible to develop research priorities? How might that be done? How do we learn from other domains, eg communicable disease, etc.• Similarly, a dramatic increase in unique questions and research needs is underway, driven in large measure by the need to make policy decisions. With the lag between research data and policy need, is it possible to develop research priorities?• How can time critical research questions be addressed? What will that require? And who will fund it?• How can research capacity be increased, particularly in LMIC? And how can priorities be determined since we cannot do it all?
Questions• How do we expand training to increase the next generation of independent translational and transdisciplinary scientists?• How do we go about using our knowledge (eg from behavioral science) to elevate research as a priority for funding? How do we change the ‘it’s not our problem’ mentality?• What is the role of organizations like WHO, civil society, professional organizations (eg SRNT), government agencies and the corporate community regarding knowledge synthesis & dissemination, bringing together key players, linking science to policy, etc.?And…How do we best ‘plan’ for unintended consequences?
Science and Research to Inform Regulation of Tobacco ProductsWorld Conference on Tobacco Or Health Singapore March 22, 2012 Cathy L Backinger, PhD, MPH Deputy Director for ResearchOffice of Science, Center for Tobacco Products 1
CTPs Authority Under the Tobacco Control Act• Gives CTP, FDA authority to regulate tobacco products -- products made or derived from tobacco intended for human consumption (but not those marketed for tobacco cessation or other therapeutic uses)• Recognized FDA as the “primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products”• Gave FDA direct authority over cigarettes, roll-your-own and smokeless tobacco products• FDA can assert jurisdiction over other tobacco products through rulemaking (cigars, pipe tobacco, hookah, e- cigarettes, etc) – FDA has announced we intend to do that 2
CTP Must Use a Public Health/Population Health Regulatory Standard• Tobacco products cannot be regulated using FDA‟s traditional „safety and efficacy‟ standard• The Tobacco Control Act mandates its regulation using a population health standard including impact on both users and non-users of tobacco products 3
FDAs Authority Under the Tobacco Control Act is Broad• Premarket applications for new and modified risk tobacco products• Require post-market surveillance for modified risk tobacco products• Establish tobacco product standards to protect the public health• Require reporting of ingredients• Health warnings on marketed products & ads• Advertising and promotion restrictions• Registration and listing• Authority to conduct research to support tobacco 4 product regulation
Tobacco Control Act - LimitationsCTP does not have the authority to:• Set nicotine levels to zero• Require prescriptions for tobacco products• Set price of tobacco products• Regulate medications/products marketed to treat tobacco dependence• Regulate clean indoor air policies• Regulate tobacco growing 5
FDA Tobacco Control Goals1. Prevent youth tobacco use2. Encourage those who use tobacco to quit3. Promote public understanding of contents and consequences of use of tobacco products4. Develop science base and continue meaningful product regulation to reduce the toll of tobacco-related disease, disability, and death 6
CTP Research Priorities• Diversity of Tobacco Products• Reducing Addiction• Reducing Toxicity and Carcinogenicity• Adverse Health Consequences• Communications• Marketing of Tobacco Products• Economics and Policies 7