David T. Levy, Ph.D. Lombardi Comprehensive Cancer Center Georgetown University - Columbia University ...
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My Background n PhD in Economics n Economics Research (Competition Policy) ¨ Empirical studies (usually large data sets) ¨ Mathematical modeling ¨ Some cost-effectiveness n Public Health ¨ Previously dabbled in alcohol and traffic safety policy ¨ Simulation modeling using a multidisciplinary approach, BA in pol. philosophy
Computational Models n Simulation models/computational models are used in other fields, but are increasingly common in public health, especially in the fields of tobacco control and obesity n Models are especially useful where there are dynamic systems with many stages (e.g., policy -> environment -> behaviors -> health outcomes) and where the effects unfold over time. n Models attempt to make the connections between stages across stages and over time explicit, focusing on the movement of whole system rather than an isolated part
Characteristics of Modeling n Generally combine data and parameters from different sources n Provides structure by developing a framework and making assumptions explicit n Incorporates the effects that are difficult to distinguish empirically in statistical studies ¨ Non-linear relationships* ¨ Interdependencies* ¨ Dynamic processes* ¨ Feedback loops
Types of Model n Macro-simulations: groups of individuals (e.g., current, former and never smokers) ¨ Uni-directional causality ¨ Systems dynamic (feedback loops) n Micro-simulations: individuals in proportion to their composition in the population ¨ Monte-Carlo ¨ Agent-based and network models; make explicit assumptions about behaviors
Tobacco Control and Smoking n Tobacco control policies provide an example of one the greatest public health success stories – important to study what type of policies work in tobacco control and lessons for other public health risks n Smoking is a behavioral risk factor with clearest link to cancer- can study the role of dose, duration, and age; and the interaction with other non-cancer chronic diseases
What is SimSmoke? • SimSmoke simulates the dynamics of smoking rates and smoking-attributed deaths in a State or Nation, and the effects of policies on those outcomes. • Compartmental (macro) model with smokers, ex- smokers and never smokers evolving through time by age and gender. • Focus on tobacco control policies ¨ Effects vary by: n depending on the way the policy is implemented, n by age and gender n the length of time that the policy is in effect ¨ Nonlinear and interactive effects of policies
SimSmoke: Basic Approach Smoking- Policy Cigarette Attributable Changes Use Deaths Taxes Norms, Former and Total Mortality and Clean air laws Attitudes, current smokers, by type: Media Camp. Opportu- nities relative risks Lung cancer Marketing Other cancers Bans Heart disease Warning labels Stroke Cessation Tx COPD Youth Access MCH Outcomes
Model Setup n Excel model: Easily modifiable and transferable. Based on previously developed C++ model. n Transparent and easily adaptable by user n Easily Downloaded
Basic Structure of Model n Population model begins with initial year population and moves through time with births and deaths (Markov model) n Smoking model distinguishes population in never smokers, smokers, and ex-smokers and moves through time with initiation, cessation and relapse (Markov model) n Smoking-attributable deaths depend on smoking rates and RRs n Policy modules- one for each policy with independent effects on smoking rates
Population Model: Evolution of Population • Start with the Population in the base year, first year of the model, based on data availability and policies • Evolves through time: Birth Death rates rates Births Population Deaths Don’t explicitly account for immigrants due to data difficulties, but make population corrections
Smoking Model: Evolution of Smokers Initiation Population Ever Smoker* Not quit Current Smoker** Not initiate Cessation (quit) Relapse Never Smoker Ex-Smoker * Usually as smoked 100 cigarettes lifetime ** usually as smoked some or all days
Smoking-Attributable Deaths % smokers and ex- Death Deaths Total Deaths smokers rates by Attributable to smoking Smoking Relative status risks Smoking attributable deaths = (Smoker death rate –never smoker death rate) * # Smokers + Σ years quit (Ex -smoker death rate –never smoker death rate) * # Ex-smokers Summed over ages and by gender
Relationship between policies and smoking rates based on: n Evidence from tobacco and other risky behavior literature, n Theories (Economics, Sociology, Psychology, Epidemiology, etc), and n Advice by a multidisciplinary expert panel
Policy Effect Sizes n In percentage terms relative to smoking rate (1+PR), PR = percent reduction Based on studies n Initial impact on cessation through prevalence (1+PR). Maintained through initiation rates (1+PR) and increased through cessation rates (1-PR) Less known about these effects n Effects may differ by age or gender n Effects depend on the way in which policy is implemented: level, coverage, degree of enforcement, publicity, etc.- newly incorporated enforcement and information issues
We use MPOWER Policies n Taxes –as a percent of retail prices, effects depend on size of tax increase and initial price. through elasticities (uses constant elasticities, vary by age, but not gender), no effect yet on smuggling. Goal= specific ad valorem and excise tax at 70% of price n Smoke-Free Air Laws depend on: ¨ Where applied: n Worksites (3 levels) n Restaurants and bars n Other public places ¨ Enforcement now has a stronger role
Policies based on FCTC/MPOWER n Tobacco control/media campaigns n Marketing/Advertising Bans n Health Warnings n Cessation Treatment: Availability of pharmacotherapy, cessation treatment (financial access, quitlines and web-based treatment n Youth access (minimum purchase age): enforcement and vending and self-service bans
Past vs. Future n Tracking Period- starts from year where requisite data available, e.g., 1993 for most US models, and continues to the current recent year. The tracking period is used to: ¨ Calibrate the model- adjust the parameters ¨ Validate the model- test how well it predicts ¨ Examine the role of past policies n Future Projection- examine the effect of policies from current year forward, e.g., the effect of a ciga- rette tax increase or the ability to reach the Healthy People 2020 smoking prevalence goal of 12%
Models developed for: 33 Countries: Albania*, Argentina*, Bangladesh, Brazil,* Canada, China, Czech Rep,* Egypt, Finland,* France,* Germany,* Great Britain,* India, Indonesia, Ireland,* Italy,* Japan,* Korea*, Malaysia, Mexico, Netherlands*, Pakistan, Poland, Philippines, Taiwan*, Russia, Spain, Sweden, Thailand,* Turkey, Ukraine, US,* Vietnam* 6 States: Arizona*, California*, Kentucky*, Massachusetts, Minnesota,* NY * Paper published
Policymakers have used models for: • ADVOCACY: Justification by forecasting future tobacco use and health outcomes and showing the effect of past policies • PLANNING: • Estimate the likely impact of alternative interventions in specific situations and on specific populations • Assess and rank strategies for reaching goals prior to commitment of resources • Develop more systematic surveillance and evaluation networks • HEURISTIC: Understanding the complex network of policies surrounding tobacco use and health outcomes at research and policy-making levels.
Counterfactuals: If no policies n To consider the effect of all policies implemented since 1993 (baseline year), we first set policies through 2010 to their 1993 levels to obtain the counterfactual smoking rates (the absence of post-1993 policies). n The difference between the smoking prevalence with polices at 1993 levels and the smoking rate with actual policies implemented yields the net effect of policies implemented since 1989. n For the role of single policies, we compared the scenario with only that policy implemented to the counterfactual policy scenario. n The impact of policies on deaths was estimated by subtracting the number of SADs with policies implemented from their number with policies kept at 1993 levels.
Advocacy: Impact of Past Policies in Minnesota 30.0% Smoking prevalence > 25% less as a result of policies by 2010 and grows over time! 25.0% 20.0% 15.0% 10.0% Policies actually implemented Policies at 1993 level 5.0% Price only 0.0% 1993 1997 2001 2004 2007 2011 2021 2031 2041
Advocacy: Minnesota Deaths Averted Due to Policies MALE AND 1993-‐20 1993-‐204 FEMALE SADs 1993 2003 2011 2021 2031 2041 11 1 Policies actually implemented 5,575 5,640 5,932 6,261 5,918 4,920 108,253 285,365 Policies at 1993 level 5,575 5,759 6,515 7,586 7,697 6,844 111,150 333,053 LIVES SAVED All policies 119 583 1,325 1,779 1,924 2,897 47,687 Price only 52 268 623 858 967 1,329 22,829 Smoke free air only 41 234 552 765 834 1,098 20,228 Mass media only 61 275 583 761 824 1,396 20,833 Youth access only 41 209 485 688 811 1,027 18,321 Cessation treatment only 44 235 548 747 819 1,152 19,901
Advocacy: Other successes due to tobacco policies Percent reduction in smoking prevalence (18 and above): n > 30% reduction ¨ Brazil (almost 50% reduction due to policies) ¨ California n At least 25% Reduction ¨ United Kingdom ¨ Minnesota ¨ Thailand n 20% Reduction ¨ Arizona ¨ Korea ¨ Ireland ¨ NYS ¨ Netherlands
Planning: Male Smoking Prevalence: SimSmoke Predictions vs. Surveys, Minnesota 28.0% 26.0% 24.0% 22.0% 20.0% 18.0% 16.0% 14.0% 12.0% 10.0% 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 SimSmoke CPS-TUS MATS
Ireland Male Smoking Prevalence,1998-2010 data, data, data
Planning: Ranking the effect of future policies Ireland SimSmoke male prevalence Policies/Year 2010 2011 2020 2030 2040 Status Quo Policies 26.1% 25.9% 24.1% 21.8% 20.0% Independent Policy Effects Tax 70% of Retail Price 26.1% 25.1% 23.1% 20.6% 18.7% Complete Smoke Free & Enforcement 26.1% 25.9% 24.1% 21.7% 20.0% Comprehensive Ad Ban & Enforcement 26.1% 25.8% 24.0% 21.6% 19.9% High Intensity Tobacco Control Campaign 26.1% 24.3% 22.4% 20.0% 18.2% Strong Health Warnings 26.1% 25.6% 23.8% 21.4% 19.7% Strong Youth Access Enforcement 26.0% 25.8% 23.5% 20.8% 18.8% CessaRon Treatment Policies 26.1% 25.4% 23.1% 20.6% 18.8% Combined Policy Effects All of the above 26.0% 22.4% 19.3% 16.4% 14.4% % Change in Smoking Prevalence from Status Quo Independent Policy Effects Tax 70% of Retail Price -‐3.3% -‐4.3% -‐5.5% -‐6.6% Complete Smoke Free & Enforcement -‐0.2% -‐0.3% -‐0.3% -‐0.3% Comprehensive Ad Ban & Enforcement -‐0.5% -‐0.6% -‐0.7% -‐0.7% High Intensity Tobacco Control Campaign -‐6.3% -‐7.3% -‐8.2% -‐8.9% Strong Health Warnings -‐1.2% -‐1.5% -‐1.6% -‐1.6% Strong Youth Access Enforcement -‐0.4% -‐2.5% -‐4.2% -‐6.0% CessaRon Treatment Policies -‐2.2% -‐4.3% -‐5.5% -‐5.9% Combined Policy Effects All of the above -‐13.5% -‐19.9% -‐24.6% -‐28.1%
Planning: Health Effects Delayed SimSmoke Projections Smoking-Attributable Deaths Status Quo vs. All FCTC Policies for Finland More immediate impact on heart disease and maternal and child health
Planning: There may be limits to current policies: We may need more than traditional policies to reduce smoking by more than 50% n Those with the weakest current policies (e.g., Russia and China) show the potential for largest reductions in smoking prevalence, with forecasts of about a 50% reduction in smoking prevalence in going from very limited policies to fully FCTC-consistent policies n How can we surpass a 50% reduction? ¨ Improved cessation treatments, e.g. better and more tailored interventions with follow-up and integrated services ¨ May need to alter the tobacco products available, e.g., reduce nicotine and other addictive constituents or disallow current cigarettes in favor of safer forms of tobacco
FDA Public health standard “Public health standard” calls for the review of the scientific evidence regarding 1. Risks and benefits of the tobacco product standard to the population as a whole, including both users and non-users of tobacco products; 2. Whether there is an increased or decreased likelihood that existing users of tobacco products will stop using such products; and 3. Whether there is an increased or decreased likelihood that those who do not currently use tobacco products, most notably youth, will start to use tobacco products Example: Mandatory “product standards” that would limit the allowable levels of ingredients in tobacco products (menthol, nicotine, etc) 30
Planning: Modeling the effects of a ban on menthol cigare=es Scenarios inves@gated: Possible effects of a ban: n Menthol smokers switch to 1. 10% of the former menthol non-‐menthol brand. smokers quit and 10% of those who would have n Menthol smokers quit at iniRated as menthol differenRal rate than if smokers never smoke; non-‐menthol smoker. 2. 20% quit and 20% do not n Some individuals who iniRate, and; would have iniRated smoking with menthol 3. 30% quit and 30% do not cigareXes never start. iniRate
Planning Modeling a Menthol Ban Using SimSmoke 32
Heuristic: Youth Access Policy n Past literature suggests youth access policies lead to increased retail compliance. n Effects on actual smoking rates are unclear. Two potential reasons ¨ Role of non-retail sources of cigarettes (parents older friends theft) ¨ Level and extent of policies
Heuristic: Policy Components Affecting Retail Compliance Compliance Publicity Penalties Checks Per Year Multiplicative relationship Retail Compliance S-shaped curve, subject to substitution into other sources Reduction in Smoking Rates Reduced Smoking A Advertising Expenditures per Capita
Heuristic: The Decision to Quit Success Self Quit Fail Success Rx Pharm. Attempts Fail to Quit Success NRT OTC Fail Current Behavioral Success Smoker Treatment Fail Behavioral Success No quit & Rx Fail attempt Pharm Continues Behavioral Success Smoking & NRT OTC Fail Framework used to show effects for specific policies
Heuristic: Cessation Treatment Policies n AVAILABILITY: Ability to obtain NRT, Buproprion and Varenecline by Rx or over-the counter n FINANCIAL ACCESS: payment or mandatory coverage for cessation treatments ¨ Prescription or OTC pharmacotherapies alone ¨ Behavioral treatment alone ¨ Pharmacotherapies and behavioral n QUITLINES: delivered by government and coordinated through health care system n BRIEF INTERVENTIONS: delivered by health care providers n Web-based treatment: supervised and used by health care agencies of provider n Follow-up of Care: health care providers, quitlines, web Each of the above affects quit attempts and treatment use with potential interactions (synergies among policies)
Heuristic: Smokeless as Harm Reduction } Harm reduction: As a substitute for cigarettes (provides the nicotine fix), it has been suggested that use of at least some smokeless can reduce overall harm, because of lower health risk, similar to methadone for heroine addicts. Smokeless risks less than cigarettes (which are not inhaled into lung), but depends on contents, also no second hand smoke. } Potentially harm increasing, if: } If smokeless leads to increased youth initiation and acts as a gateway to cigarettes } Encourages dual use with cigarettes instead of cessation from cigarettes
Heuristic: Health effects and polytobacco use: simple example with only cigarettes and smokeless Initiation Initiation cigarette smokeless use use Sole Dual Sole cigarette cigarette & smokeless use smokeless us (habit) habit (habit) Cigarette Smokeless Dual use only only attributable attributable attributable death death death Need to know relative risks for those who continue to use and for former users
Tobacco Use in Sweden, Males, 2004-2020 18.0% 16.0% 14.0% 12.0% 10.0% 8.0% 6.0% Declines in cigarette use accompanied by constant rates of 4.0% sole and dual use of snus, suggesting that users are shifting 2.0% from single to dual use 0.0% 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Male Cigarette Use (alone) Male Snus Use (alone) Male Combined Snus and Cigarette Use 39
Heuristic: Future challenges for Sim- Smoke and tobacco control modeling n Constantly changing market with new products and dual uses for cigarettes, smokeless, cigars, and pipes; transitions in the use of the different products is unlikely to be stable n Relative health risks are often unknown, especially for new products and for dual use n Difficult to anticipate industry reactions to policies both in consumer markets and in the political arena n Need to consider the heterogeneity of individuals; tobacco users are increasingly low SES and with mental health issues
Heuristic: Tobacco control is complex: Modeling provides a framework Industry behavior Tobacco Control Policy Tobacco, retail Taxes, laws, regulations Environment Attitudes, norms, Physiology opportunities (economic, Genetics, diet, other other) Risky behaviors: Using cigarettes, cigars, and smokeless and other Health Outcomes non-combustibles Death, disease, dollars Limited evidence for many of these linkages, models provide guidance on areas for future research
Need for Collaborative Modeling Since different models will highlight different aspects of the problem, information from the different models will need to be combined in a systematic manner An example is NCI’s CISNET program: n The models consider common research questions using a natural history of disease framework n The models use a common data sources to help identify reasons for any differences results n The results are compared to provide a reasonable range of outcomes for decision-makers n Models are well documented using publicly available model profiler Georgetown University is home for smoking/lung group (Levy) and coordinating center for the breast cancer group (Mandelblatt)
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