David T. Levy, Ph.D. Lombardi Comprehensive Cancer Center Georgetown University - Columbia University ...

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David T. Levy, Ph.D. Lombardi Comprehensive Cancer Center Georgetown University - Columbia University ...
David	
  T.	
  Levy,	
  Ph.D.	
  
                                                                                                         Lombardi	
  Comprehensive	
  Cancer	
  
                                                                                                         Center	
  	
  
                                                                                                         Georgetown	
  University	
  


David T. Levy, Ph.D. Lombardi Comprehensive Cancer Center Georgetown University - Columbia University ...
  
David T. Levy, Ph.D. Lombardi Comprehensive Cancer Center Georgetown University - Columbia University ...
  
David T. Levy, Ph.D. Lombardi Comprehensive Cancer Center Georgetown University - Columbia University ...
  
David T. Levy, Ph.D. Lombardi Comprehensive Cancer Center Georgetown University - Columbia University ...
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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