april 7, 2014 j. randy koch, ph.d. alison breland, ph.d. vcu center for the study of tobacco...
TRANSCRIPT
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Tobacco Control
April 7, 2014J. Randy Koch, Ph.D.Alison Breland, Ph.D.VCU Center for the Study of Tobacco Products
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Overview of Topics to Cover Today
Health effects of tobacco Tobacco dependence Epidemiology Types of tobacco products Cessation/Treatment Prevention strategies Virginia Youth Tobacco Projects Research
Coalition Family Smoking Prevention and Tobacco
Control Act
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Health Consequences
In the US: over 480,000 people die from tobacco related diseases each year Globally, nearly 6 million annually
What’s in tobacco that is so harmful? ̶� Nicotine̶� Carbon monoxide or CO (when burned)̶� Carcinogens (e.g., tobacco-specific nitrosamines, PAHs)
Morbidity and mortality caused by CO and carcinogens
Smoked tobacco use increases risk of: coronary heart disease by 2 to 4 times stroke by 2 times Lung cancer by 15-30 times chronic obstructive lung diseases (such as emphysema) by 10
times
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Tobacco Dependence/Withdrawal Effects of tobacco: mild euphoria, reduced
stress, increased energy, and appetite suppression
Dependence likely caused by nicotine Symptoms of withdrawal generally start
within 2 - 3 hours after the last tobacco use, and peaks about 2 - 3 days later Intense craving for tobacco Anxiety, restlessness, impatience Difficulty concentrating Drowsiness or trouble sleeping, as well as bad dreams
and nightmares Headaches Increased appetite and weight gain Irritability or depression
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Global Sources of Epidemiological Data
Lack of standardized data on a global level
Global Tobacco Surveillance System—1999+ Collaborative effort among WHO, United
States Centers for Disease Control and Prevention, and the Canadian Public Health Association
Surveys▪ Global Youth Tobacco Survey (GYTS)▪ Global School Personnel Survey (GSPS)▪ Global Health Professions Student Survey
(GHPSS)▪ Global Adult Tobacco Survey (GATS)
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GYTS: Current Cigarette Smokers
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Epidemiology: US rates
Currently, about 18% of US adults smoke cigarettes
Rates higher if you include any tobacco product
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Adult smoking prevalence by state
SOURCE: Behavioral Risk Factor Surveillance System, 2010; http://www.cdc.gov/VitalSigns/AdultSmoking/index.html#StateInfo
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Epidemiology: US rates (adults, cigarettes only)
Gender 20.5% of men 15.8% of women
Race 21.8% of American Indians/Alaska Natives 19.7% of whites (non-Hispanic) 18.1% of blacks (non-Hispanic) 12.5% of Hispanics
Socio-economic status 27.9% of adults who live below the poverty level 17.0% of adults who live at or above the poverty level
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Epidemiology: US rates (adults, cigarettes only)
Adults with mental illness 36% of adults with mental illness are
smokers
Adults with substance use disorders: ~80%
Adults with MH or SUD account for 40% of all cigarette smoked in the US
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Epidemiology: US rates for youth
Current use of cigarettes among youth: 3.5% of middle school students 14% of high school students
Rates higher if you include any tobacco product
Most adult smokers (80%) began smoking before age 18
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Past Month Tobacco Use among Youths Aged 12 to 17: 2002-2012
From: http://www.samhsa.gov/data/NSDUH/2012SummNatFindDetTables/NationalFindings/NSDUHresults2012.htm#fig4.1
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Types of Tobacco Products (US)
CigarettesCigarsPipesSmokeless tobacco (“dip”, “chew” or
“snus” note: many new varieties)Waterpipe (hookah)E-cigarettes (not actually tobacco,
although will likely be regulated as tobacco)
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Cigarettes
Modern cigarette developed in the early 1800s
At the start of the 20th century, less than 0.5% of the population smoked
Consumption peaked in the US in 1965: ~50% of men and 33% of women smoked
Smoking and Health: Report of the Advisory Committee to the Surgeon General (1964)
Start to see changes to cigarettes: “light” “filtered”; health claims
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FDA Regulation of tobacco products
Source: United States Department of Agriculture; Centers for Disease Control and Prevention; Alcohol and Tobacco Tax and Trade Bureau
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Cigarettes
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Cigarettes
Changes increased sales without harm reduction
“The weight of the evidence indicates that lower-tar and nicotine yield cigarettes have not reduced the risk of disease proportional to their FTC yields” (IOM, 2001).
Past modifications did not alter exposure: changing puff topography, covering vent holes
New FDA regulation has eliminated the use of “light,” “low” and “mild”
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Types of Tobacco Products
http://www.smokefree.gov/tob-cigarillo.aspx
Cigars 5.4% of US adults use (>1 in past 30
days) 12.6% of high school
students 2.8% of middle
school students
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FIGURE 2. Consumption of cigarettes and other combustible tobacco products — United States, 2001–2011
Alternate Text: The figure above shows consumption of cigarettes and other combustible tobacco products in the United States during 2001-2011. Annual cigarette consumption declined each year during 2000-2011, including a 2.6% decrease from 2010 to 2011, but total consumption of combustible tobacco decreased only 0.8% from 2010 to 2011, in part, because of the effect of continued increases in the consumption of noncigarette combustible tobacco products. From 2000 to 2011, the percentage of total combustible tobacco consumption composed of loose tobacco and cigars increased from 3.4% (15.2 billion cigarette equivalents out of 450.7 billion) to 10.4% (33.8 billion of 326.6 billion).
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Types of Tobacco Products Pipes
Waterpipe, or hookah CO exposure is much higher than
cigarettes (Eissenberg et al., 2011)
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Types of Tobacco Products
Smokeless tobacco “Dip”, “Chew” (e.g., Skoal,
Wintergreen) Snus (Swedish) Marlboro snus, Camel snus Camel orbs, sticks, dissolvable strips Verve disc
Health effects? In Sweden, low rates of lung cancer, but effects in US not known
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dissolvable tobacco
snus
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Ploom loose-leaf vaporizer
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LED
Rechargeable Battery2v – 6v
Smart ChipAir Flow Sensor
AtomizerHeater
Cartridge w/ Nicotine Solution/E-juice/ E-liquid
E-Juice/E-LiquidNicotine SolutionPropylene Glycol and/orVegetable GlycerinDistilled WaterFlavorings (Baking)
Electronic Cigarettes
Use MethodsPre-FilledDrippingFill your ownMake your own
Vaper Slide courtesy of Andrea Vansickel
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Different ECIGS with varying power supplies. A is a V4L model (3.7 v) powered by a USB port. B is a V4L model (3.7 v) powered by internal rechargeable battery. C is a Silver Bullet powered by a 3.7 v replaceable/rechargeable battery. D is a ProVari powered by a 3.7 v replaceable/rechargeable battery and the user controls power settings ranging from 3.3 to 6.0 volts.
A B C D
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Types of Tobacco Products
Health effects of e-cigarettes unknown
2-6% of US adults have ever usedYouth: 3% to nearly 7% between
2011 - 2012$18 million grant to VCU awarded
September 2013 (5 years)
Images courtesy of Bob Balster and Andrea Vansickel
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Summary
Overall, tobacco use has been going down in the US (by small amounts in recent years)
Use of other products may be increasing
Hard to determine long-term impact of new products
Major concern—Will people switch to new “safer” products rather than quit?
Will youth start using new products?
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Smoking cessation
~70% of smokers say they want to quit
45% make quit attemptsRelapse rates are highTobacco produces dependence: very
difficult to quitTobacco is as addictive as heroin or
cocaine
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Smoking cessation
Medications to quit can increase likelihood of success Nicotine replacement therapy (nicotine
patch, gum, inhaler, lozenge, nasal spray)
Non-nicotine medications: ▪ buproprion (Zyban/Wellbutrin)▪ varenicline (Chantix)
1-800 QUIT-NOW (counseling)Websites
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Estimated abstinence rates—Behavioral therapies
Treatment Abstinence rate (%)
No counseling/behavioral therapy 11.2
Relaxation/breathing 10.8
Cigarette fading 11.8
Social support 14.4-16.2
Practical counseling 16.2
Source: Treating Tobacco Use and Dependence: 2008 Update (Clinical Practice Guideline, Fiore et al., 2008)
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Estimated abstinence rates—Medications
Treatment Abstinence rate (%)
Placebo 13.8
Chantix 33.2
High dose nicotine patch (more than 25 mg)
26.5
Wellbutrin (Zyban, bupropion) 24.2
Nicotine patch 6-14 weeks 23.4
Nicotine gum 19.0
Long term patch + ad lib gum or spray
36.5
Patch + Wellbutrin 28.9
Patch + antidepressants (Paxil, Effexor)
24.3
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Questions?
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Prevention
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Risk and Protective Factors Effective prevention programs are based
on reducing risk factors and/or enhancing protective factors
Related to age, gender, race, and environment A need for preventive interventions tailored to
specific populations and settings
Most risk and protective factors related to a broad array of youth problems, but some are unique
Additive effect—goal is to affect the balance of risk and protective factors
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Risk and Protective Factors Domains
IndividualFamilyPeerSchoolCommunity
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Risk and Protective Factors Individual Risk
Factors Psychiatric
disorders Novelty/sensation
seeking Positive attitudes
towards substance use
High antisocial behavior
Individual Protective Factors Ambitious life goals High religiosity
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Risk and Protective Factors Family Risk Factors
Family conflict Family history of
antisocial behavior Family attitudes
favorable to substance use
Family Protective Factors Parental
nonsmoking Parental advice not
to smoke Parental monitoring Strong family bonds
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Risk and Protective Factors Peer Risk Factors
Peer tobacco use
Community risk factors Exposure to tobacco
advertising Perceived
availability of tobacco
School Risk Factors Low school
connectedness Low academic
achievement School misbehavior
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Types of Prevention Strategies
School-based programsFamily-based programsMedia campaignsReducing youth accessExcise Taxes
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School-Based Prevention Programs
Schools are most common setting for tobacco use prevention programs Provide relatively easy access to youth Can address other concerns of interest
to schools Can be integrated into school curriculum
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School-Based Prevention—What Works?
Skills Training Academic Competence Social Competence Social Resistance Skills
Norms EducationMedia LiteracyShould not be one-time efforts--
booster sessions
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Life Skills Training
Gilbert Botvin and colleagues, Cornell University
Target Population: Grades 6, 7 and 8 or Grades 7, 8 and 9
Three year program (15, 10 and 5 session) Focus on:
Drug resistance skills and information Self-management skills General social skills
Interactive program using facilitated discussion, role playing, and small group activities
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Adjusted Substance Use Means at One-Year Follow-up
LST Control Group
Mean SE Mean SE X2 df P
Smoking 1.79 .08 2.13 .09 6.4 1 .006
Drinking 1.82 .08 2.11 .08 5.8 1 .008
Marijuana 1.69 .10 1.87 .11 1.3 1 .126
N= 802Griffin et al., 2003
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Family-Based Prevention Programs
Parents are a major influence on youth behavior, especially on children
Most common approaches focus on enhancing parenting skills Age appropriate expectations Consistent and appropriate discipline Monitoring of child activities/friends
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Family-Based Prevention—What Works?
Strengthen family bonding and positive relationships
Improve parenting skillsHelping families to develop and
enforce rules about substance useProviding information about drugs
and their effects on development
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Strengthening Families Program Richard Spoth and colleagues, Iowa State
University Target Population: Youth 10 to 14 years old (also
available for younger children) Seven sessions Parents and youth meet separately for first hour
and then together for second hour Parent sessions
Skill-building focused on establishing rules, limits, and consequences while expressing love; communication with youth; handling stress; using community resources
Uses videos demonstrating parenting skills, with role playing, discussion and skill building activities
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SFP (cont’d)
Youth sessions Youth skill-building focuses on following rules, peer
pressure resistance, handling stress, and problem-solving Group discussions, group skill practice, and social
bonding activities
Family sessions Games and projects to increase family bonding, build
positive communication skills, plan family activities, and facilitate learning to solve problems together
Booster program 3 to 12 months after completing initial program—Four sessions
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Spoth et al., 2004
OutcomeInitiation Proportion
Estimated time in months from pretest
SFP Control Difference
Lifetime alcohol use .40 38.2 25.3 12.9
Lifetime alcohol use without parental permission .40
46.8 34.4 12.4*
Lifetime drunkenness .35 58.6 45.3 13.3*
Lifetime cigarette use .30 54.9 30.8 24.1*
Lifetime marijuana use .10 63.7 48.6 15.1
Intervention–Control Differences in Time to Initiation Rates: 6 Year Follow-up
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Mass Media Interventions Systematic review by Brinn et al., 2010
(Cochrane Collaboration) There is some evidence that mass media can
prevent the uptake of smoking in young people, however the evidence is not strong and contains a number of methodological flaws.
Effective media campaigns:▪ Based on good market research▪ Identify and tailor message to specific groups (market
segmentation)▪ Last longer and more intensive▪ Use multiple media (TV, radio, newspapers)
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Virginia “Y Campaign”
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Reducing Youth Access
Primarily focus preventing illegal sales to minors Retailer education Active enforcement
Systematic review by Stead, 2008 (Cochrane Collaboration) Active enforcement more effective in reducing
sales to minors Little evidence of impact on perceived
availability of tobacco products or on prevalence of youth smoking (only three controlled trials)
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Reducing Youth Access—Synar Amendment
Enacted in 1992Required States to enact laws
prohibiting the sale or distribution of tobacco products to those under 18 years old Required unannounced inspections of
retail outlets and reporting of results “False buys” Established targets for “violation rates” Failure to meet targets could result in
loss of funds—up to 40% of SAPT Block Grant
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State Tobacco Excise Taxes
Create a financial disincentive to use tobacco
Based on known relationship between price and sales Elasticity of demand (Ed ) is percentage
change in sales as a result of percentage change in price
Ed = -1.5 (10% increase in prices results in 15% reduction in sales
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Excise Taxes (cont’d)
Relationship between price and sales (demand) complicated by role of addiction
Adults Ed = -.40 to -.70 (IARC, 2011)Less research on youth
Illegal product for youthGenerally believed that youth are
more price sensitive Less disposable income Less addicted
Youth Ed = -.9 to -1.5
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Excise Taxes (cont’d)
“Policies that affect the price of tobacco products are the single most effective means of decreasing tobacco use, especially among youth and young adults.” (CDC, 1998)
Tobacco companies often respond by decreasing wholesale price
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Family Smoking Prevention and Tobacco Control Act
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FSPTCA: Key Requirements
Restricts cigarettes and smokeless tobacco retail sales to youth Require proof of age to purchase
tobacco products Require face-to-face sales, with some
exemptions for vending machines and self-service displays in adult-only facilities
Ban the sale of packages of fewer than 20 cigarettes
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FSPTCA: Key Requirements
Restricts tobacco product advertising and marketing to youth Limit color and design of packaging and
advertisements, including audio-visual advertisements (pending litigation)
Ban tobacco product sponsorship of sporting or entertainment events under the brand name of cigarettes or smokeless tobacco
Ban free samples of cigarettes and brand-name non-tobacco promotional items
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FSPTCA: Key Requirements Prohibits “reduced
harm” claims including “light,” “low,” or “mild,” without an FDA order to allow marketing
Requires bigger, more prominent warning labels for cigarettes and smokeless tobacco products (pending litigation)
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FSPTCA: Key Requirements
Tobacco industry must disclose research on the health, toxicological, behavioral, or physiologic effects of tobacco use
Tobacco industry must disclose information on ingredients and constituents in tobacco products; and must notify FDA of any changes
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Limits on FDA Authority
FDA cannot: Ban certain specified classes of tobacco
products Require the reduction of nicotine yields
to zero Require prescriptions to purchase
tobacco products Ban face-to-face tobacco sales in any
particular category of retail outlet
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Population Assessment of Tobacco and Health (PATH): Study Goals
Examine what makes people susceptible to tobacco-product use
Evaluate initiation and use patterns, including use of (new products, multiple products, and switching of tobacco products)
Study patterns of tobacco-product use, cessation and relapse
Track potential behavioral and health impacts
Assess differences in tobacco-related attitudes, behaviors, and health outcomes among racial/ethnic, gender, and age subgroups
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PATH Survey Method
Number of Participants: about 59,000
Representative sample from across the United States
Age: 12 years and older who may or may not use tobacco products.
Participants will be interviewed once a year for at least three years.
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Tobacco Centers of Regulatory Science
Research centers funded by the FDA to “provide the scientific evidence needed to better inform FDA’s regulatory authorities”
The FDA has funded 14 centers, including VCU
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Center for the Study ofTobacco Products at VCU
$18.3 millionSeptember 2013-2018Thomas Eissenberg & Robert Balster,
Co-DirectorsMulti-University
Virginia Commonwealth University
American University of Beirut
Penn State University
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CSTP Goal
Develop and test a model for evaluating modified risk tobacco products (MRTPs) that may come to be regulated by the FDA Using e-cigarettes as the exemplar, but
which can be applied to many other forms of MRTPs
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Harm Reduction vs. Abstinence
Are modified risk tobacco products (MRTPs) truly safer? Toxicant exposure Abuse liability Short- and long-term health effects Effects of unorthodox use
Do MRTPs help people to quit or are they merely substitutes for times when they cannot smoke?
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CSTP Major Studies Engineering
Does product construction and engineering affect output?
Human Lab Studies Smoking topography, physiological effects, nicotine and
toxicant exposures, dependence potential Naturalistic Randomized Controlled Trial
How are products used under naturalistic conditions? What happens to other forms of tobacco use? What adverse effects are produced?
Attitudes and Beliefs How are products perceived using such sources as
internet, chat rooms, questionnaires, etc? Are products used in unintended ways and impact on
output/effects?
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Other CSTP Components
Training and Education Train next generation of tobacco
regulatory scientists (pre- and post-doctoral)
Seminars Course on tobacco regulatory science
Pilot Research Program Extend research to other MRTPs