Tobacco Control

April 7, 2014J. Randy Koch, Ph.D.Alison Breland, Ph.D.VCU Center for the Study of Tobacco Products

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

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

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

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)

GYTS: Current Cigarette Smokers

Epidemiology: US rates

Currently, about 18% of US adults smoke cigarettes

Rates higher if you include any tobacco product

Adult smoking prevalence by state

SOURCE: Behavioral Risk Factor Surveillance System, 2010; http://www.cdc.gov/VitalSigns/AdultSmoking/index.html#StateInfo

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

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

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

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

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)

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

FDA Regulation of tobacco products

Source: United States Department of Agriculture; Centers for Disease Control and Prevention; Alcohol and Tobacco Tax and Trade Bureau

Cigarettes

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”

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

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).

Types of Tobacco Products Pipes

Waterpipe, or hookah CO exposure is much higher than

cigarettes (Eissenberg et al., 2011)

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

dissolvable tobacco

snus

Ploom loose-leaf vaporizer

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

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

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

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?

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

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

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)

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

Questions?

Prevention

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

Risk and Protective Factors Domains

IndividualFamilyPeerSchoolCommunity

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

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

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

Types of Prevention Strategies

School-based programsFamily-based programsMedia campaignsReducing youth accessExcise Taxes

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

School-Based Prevention—What Works?

Skills Training Academic Competence Social Competence Social Resistance Skills

Norms EducationMedia LiteracyShould not be one-time efforts--

booster sessions

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

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

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

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

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

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

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

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)

Virginia “Y Campaign”

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)

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

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

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

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

Family Smoking Prevention and Tobacco Control Act

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 

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 

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)

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  

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 

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

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.

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

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

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

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?

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?

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

Thank you

And, thank you for not smoking!