Moving the WHO FCTC Forward in its Second Decade: The Role of Evidence in Strengthening and Accelerating the Fight

Against the Global Tobacco Epidemic

Geoffrey T. Fong (gfong@uwaterloo.ca)University of Waterloo and

Ontario Institute for Cancer Research

Tobacco Control Unit, Institut Català d'Oncologia,

Barcelona, Spain—March 21, 2017

The Global Tobacco Epidemic 1.1 billion people smoke

(82% live in LMICs) 20th century: 100 million deaths 21st century: 1 billion deaths This year: 5.4 million users will die and

600,000 non-users will die of second-hand smoke

Tobacco (smoking) causes 1/6 of all NCDs worldwide and is the only risk factor that causes all 4 leading NCDs

WHO: tobacco is the leading preventable cause of death and disability in the world

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“Tobacco is the most effective agent of death ever developed and deployed on a worldwide scale.”

– John Seffrin, former CEO American Cancer Society

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Tobacco: $1 —> $6,280,23715.3% annual rate

Stock Market: $1 —> $38,25510.1% annual rate

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The only feasible way to combat such a massive threat is by implementing

population-level interventions

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Huge Potential of Population Interventions

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Estimated cumulative tobacco deaths1950-2050

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2025 205020001950

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World Bank. Curbing the epidemic: Governments and the economics of tobacco control. World Bank Publications, 1999. p80.

Intervention impact depends on two main factors:

1. Timing 2. Strength

Key to Combating the Tobacco Epidemic:

1. Identify strong, evidence-based measures that will reduce tobacco-caused death and harm

2. Implement them as quickly as possible

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Framework Convention on Tobacco Control (FCTC)

Legally binding international treaty: first under the WHO Came into force in Feb 2005; ratified by 180 countries Multisectoral: whole-of-government approach Includes broad range of tobacco control policies:

• Pictorial warnings• Comprehensive smoke-free laws• Higher taxes to reduce demand• Bans/restrictions on marketing• Support for cessation• Measures to reduce illicit trade• Tobacco product regulation

Tobacco industry must be prevented from influencing policies and measures

Greatest disease prevention initiative in history

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Framework Convention on Tobacco Control (FCTC)

180 Parties (179 countries + European Union)

7 Conferences of the Parties Guidelines have been developed

and adopted for many of the Articles

New protocol on illicit trade was adopted at COP5 (2012)

Implementation has been slow: (1) Lack of sufficient resources(2) Low political will(3) Tobacco industry influence and legal challenges

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Impact Assessment Report to COP7 Global evidence review of 17 FCTC articles (ITC Project)

Reports for the Expert Group on the use of FCTC in tobacco control legislation and in defense of industry challenges (McCabe Centre) and industry response to FCTC (Stella Bialous)

Country missions to 12 FCTC Parties

Agenda item n° 5.2 COP7 Document n° 6 y16

• Analysis of WHO data from126 countries

• Predictor: number of highest-level implementations of key demand-reduction FCTC policies between 2007 and 2014

• Outcome: WHO smoking prevalence trend estimates from 2005 to 2015 (first decade of the WHO FCTC)

• Results: Each additional highest-level implementation associated with 1.57 percentage point decrease in smoking rate (7.09% relative decrease)

Gravely et al.—Lancet Public Health(Released tonight)

Protect People From Tobacco Smoke (FCTC Article 8)

2012: 1.1 billion people in 43 countries (16% of the world's population) are covered by complete smoke-free legislation.

2014: 1.3 billion people in 49 countries (18% of the world’s population)

Warn About The Dangers of Tobacco (FCTC Article 11)

2012: 1.0 billion people in 30 countries (14% of the world's population) are exposed to strong graphic health warnings.

2014: 1.4 billion people in 42 countries (20% of the world’s population)

“Tobacco use is unlike other threats to global health. Infectious diseases do not employ multinational public relations firms. There are no front groups to promote the spread of cholera. Mosquitoes have no lobbyists.”

– WHO Zeltner Report (2000)

Why has FCTC implementation been so slow and in many cases, at levels below the standards set

by the FCTC Article Guidelines?

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Tobacco Industry: Distorting Science

Creation of front groups to cast doubt on the evidence of the harms of smoking and then of second-hand smoke

Payment to “neutral” scientists for results-directed research

Creation of entire research programs to “generate a body of scientific and technical knowledge [through research] undertaken by whitecoats.”

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“Doubt is our product.”

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Overt and covert political influence (donations, CSR) Misinformation and disinformation campaigns to spread and

perpetuate myths:• Graphic warnings will make people defensive; they will be

MORE likely to smoke• People, especially smokers, won’t support smoke-free laws• Tobacco growing/manufacturing/sales are central to the

country’s economy• Tobacco control laws will have negative economic impact

– “Smoke-free laws will hurt restaurants and bars.”– “Higher taxes/graphic warnings/plain packaging will

increase smuggling.”

Tobacco Industry Interference

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The fight against the industry is fought on the battlefield of evidence

Supportive arguments: What evidence do we have that tobacco control policies really do work?

Counterarguments: What evidence do we have that addresses the industry’s claims that policies won’t work and that they will lead to negative impact?

“The FCTC is an evidence-based treaty that reaffirms the right of all people to the highest standard of health.”

– FCTC Foreword

“Evidence” mentioned 5 times

“Scientific” mentioned 13 times

“Effective(ness)” mentioned 28 times

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What type of evidence is needed to strengthen and accelerate

FCTC implementation?

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The Path from Laws to Impact

Law is passed

Law is implemented,

communicated, enforced

Regulations are created

How EFFECTIVE is the law?

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Example: Smoke-free law in India

National tobacco control law (Oct 2008)—COTPA: Strong smoke-free law on paper.

The ITC Project in India (TCP India Project): Wave 1: Aug 2010–Sep 2011, 2-3 years > smoke-free law

ITC Survey: what is the actual impact of the law?1. Very high levels of smoking found in restaurants and bars2. Very low awareness of the law:

Smokers in Maharashtra: only 35% were awareSmokers in Madhya Pradesh: only 18% were aware

A very strong law on paper does not guarantee that it will have impact. Legislative analysis = potential impact, not actual impact.

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There is an essential need for research that evaluates the impact of the FCTC

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Challenges to Evaluating Policies

Not possible to conduct experiments (randomized controlled trials (RCTs)) on policies

But it is possible to evaluate the impact of policies using natural experiments (“quasi-experiments”)

1. Multiple country comparisons: international studies

2. Common methods and measures across countries

3. Cohort studies: focus on impact on individuals

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The International Tobacco Control Policy Evaluation Project (the ITC Project)

Canada United States Australia United Kingdom

Ireland Thailand Malaysia South Korea

China New ZealandMexicoUruguay

France NetherlandsGermany Bangladesh

IndiaBhutanBrazil Mauritius

Zambia Kenya Abu Dhabi

Greece

Hungary

Poland

Romania

Spain

Key Features of the ITC Project

Focus on science: – First-ever international cohort study of tobacco use– Focus on policy evaluation– Rigorous research design– Cross-country comparisons; health inequalities

Focus on dissemination: – National Reports, Policy Reports, etc., to communicate ITC findings to policymakers & other health stakeholders– Evidence to argue against myths of the tobacco industry

Focus on collaboration, building research capacity:– Over 100 research collaborators– Building research capacity for tobacco control research (especially within LMICs)

Content of the ITC Surveys

Unique ITCContent:150+ Qs

focusing on policy impact

Surveillancecontent

Surveillancecontent

Mixed Surveillanceand policy content

Throughout the policy sections there are measures relevant to monitoring

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ITC Surveys are being conducted in: Over 50% of the world’s population Over 60% of the world’s smokers Over 70% of the world’s tobacco users

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Warning labels– UK (2003): Text – India (2009): Graphic– UK (2009): Graphic– Thailand (2005, 2006, 2010): Graphic– Australia (2006): Graphic– Canada (2010): Graphic, Round 2– China (2008): Text; (2015): Larger font text– Mexico (2008): Graphic– Uruguay (2006,09): Graphic– Brazil (2008/09): Graphic, Round 3– Malaysia (2008): Graphic

– Mauritius (2009): Graphic– New Zealand (2008): Graphic

ITC Evaluation of FCTC Policies (Partial List)

Product policies– UK (EU): 10-1-10 regulation– US/Canada: Reduced ignition propensity– All countries: product; product x behavior Light/mild bans

– UK (2003) – Australia (2005) – Canada (2006) – Brazil + others (2009+)

Smoke-free– Ireland (2004) – Mexico (2008+)– Scotland (2005) – Brazil (2008+)– England (2007) – Bangladesh (2009+)– Uruguay (2006) – Bhutan (2009+)– France (2007/08) – India (partial)– Germany (2008+) – Mauritius (2009)– China (2008/09 + Olympics)– Netherlands (Part 2–2008/09)

Advertising/Promotion– UK (2003): Comprehensive

– Canada (2003): Last part of Comp.– Thailand (2006): POS bans– Mexico (2008): Comprehensive

– Canada (2008+): Re-emergence of“descriptive” ads & possible new

ban– China (2011): Comprehensive– Many other countries: Partial

Taxation– All countries

Illicit trade – China (2008): prevalence

– Additional in Canada/U.S.: close to reserves – Bhutan (2009+): total ban on sales in country

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Tobacco Epidemic Evidence Systems

Tobacco-RelatedMorbidity and

Mortality FCTCRatification

FCTC PolicyImplementation

Policy MonitoringSystems

FCTC Reports,GTCR, CIvil Society

What policies have been implemented?

Legislation, reports from stakeholders

Legislative analysis of strength/weakness

FCTC PolicyImpact

Impact EvaluationSystems

ITC Project

What is the impact of the policies?

Individuals from the population

Measures of tobacco use, SHS exposure,

policy-relevant measures of impact,

mediators of behavior

SurveillanceSystems

GATS, STEPS,country systems

TobaccoPrevalence

What is tobacco prevalence?

Individuals from the population

Measures of tobacco use, SHS exposure

Systems

CentralQuestion

EvidenceSource

Measures& analysis

Shifting of focus for the FCTC in its Second Decade

Treaty Building

• Increasing ratifications

• Developing strong guidelines

Treaty Implementation

• Creating mechanisms to support implementation

• Strengthening and accelerating implementation

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Focus on Science: ITC Research on Tobacco Control Policies

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Creating Guidelines and Standards for Research

IARC Cancer Prevention Handbook (2008):

Methods for Evaluating Tobacco Control Policies

• Best practices in the evaluation of tobacco control policies

• Preparation of Handbook led by ITC Project investigators

• Conceptual Model of the ITC Project used to frame the evaluation methods of the Handbook

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ITC Economics Supplements

March 2014 July 2015

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Focus on Science: ITC Research on Health Warnings

Importance of Health WarningsCost-effective strategy for:

Educating the public Motivating smokers to quit Preventing non-smokers from starting to smoke Combating industry use of packaging as marketing and

promotional toolFCTC Article 11 Guidelines call for warnings that:

Appear on the top of front and back of the packageAre as large as possible (>50% of the front and

back)Include full colour pictures

FCTC Article 11 Guidelines also encourage Parties to implement plain packaging

Effectiveness of large pictorial warnings Conclusive evidence that large pictorial warnings are more

effective than text warnings. Pictorial warnings are more likely to: – Be noticed by smokers – Increase awareness of health risks – Promote quitting – Prevent smoking initiation among non-smokers

THAILAND 2014 (85% front & back)

INDIA 2016 (85% front & back)

AUSTRALIA 2012 (75% front & 90% back on

plain packaging)

NEPAL 2016(90% front & back)

Australia: March 2006 (30% front, 90% back)

3 million smokers in Australia:After the introduction of pictorial

warnings: • 870,000 more smokers noticed the warnings• 330,000 more smokers reported not smoking a cigarette because of the warnings

Noticing pre = 43%Noticing post = 72%

Increase of 29%

Not smoking cig pre = 10%Not smoking cig post = 21%

Increase of 11%

March 2006Pictorial

warnings on 30% of front and

90% on back

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In 2008, China & Malaysia had the same poor text-only warnings…

2009China stayed text-only

2009Malaysia went to graphic

Tobacco Control (2015); 24: iv6-iv13.

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ITC Evaluation: China’s Jan 2009 Text-Only Revision

About 300 million smokers in China:

• 8.4 million more smokers noticed the warnings• 15.9 million more smokers reported forgoing a cigarette because of the warnings

Noticing pre = 41.8%Noticing post = 44.6%

Increase of 2.8%

Forgoing cig pre = 16.8%Forgoing cig post = 22.1%

Increase of 5.3%

Malaysia: June 2009 (40% front, 60% back)

June 2009From text on

side to pictorial warnings:

40% of front, 60% on back

3.6 million smokers in MalaysiaAfter the introduction of pictorial

warnings: • 569,000 more smokers noticed the warnings• 1,202,400 more smokers reported not smoking a cigarette because of the warnings

Noticing pre = 51.4%Noticing post = 67.2%

Increase of 15.8%

Not smoking cig pre = 21.2%Not smoking cig post = 54.6%

Increase of 33.4%

If China implemented Malaysia’s graphic warnings...

9.5% x 300M = 28.5 million more smokers would have noticed the warnings often

8.4% x 300M = 25.2 million more smokers would have read the warnings closely

4.4% x 300M = 13.2 million more smokers would have reported that the warnings made them think about the health risks of smoking

7.7% x 300M = 23.1 million more smokers would have reported that the warnings made them think about quitting

17.6% x 300M = 52.8 million more smokers would have reported that the warnings had stopped them from smoking a cigarette at least once

China’s warning labels changed in April 2012

January 2009Text warnings on

30% of front (Chinese) & 30% of back (English)

April 2012: Revised Font size doubled, but still

30% on front and backEnglish warning replaced

with Chinese

Decrease in warning label impact after doubling font size of text warnings in China

Jan 2009Text

warnings on 30% of front

(Chinese) and back

(English)

Thinking of harms pre = 13%Thinking of harms post = 12%

Decrease of 1%

Likelihood quitting pre = 9%Likelihood quitting post = 8%

Decrease of 1%

Evaluation of the 2012 change in Chinese warnings:It was a failure

Out of the 300 million smokers in China: •3 million FEWER smokers reported thinking about harms of smoking because of warnings•3 million FEWER smokers reported that warnings made them a lot more likely to quit

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Examples of ITC Project FindingsSmoke-Free Laws

Smoking in Restaurants

Decrease in restaurant smoking in China is much smaller than in other ITC countries that have implemented completely comprehensive smoke-free laws

Smoking Prevalence observed in restaurants in 7 ITC China cities from Wave 2 to 5 (2007 to 2015) compared to other countries before and after comprehensive smoke-free laws: Ireland (2004), Scotland (2006), France

(2008), Germany (2007-08), Netherlands (2008), Mexico City (2008), Other Mexican Cities (2008), and Mauritius (2009)

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Korea

Note: the percentage shown for Republic of Korea in 2016 is based on a preliminary, unweighted, and unadjusted dataset

But Beijing’s comprehensive smoke-free law shows that comprehensive smoke-free

laws can work in China (data from Xiao et al., 2016)

Strong Article 8 implementation leads to dramatic decreases in tobacco smoke in public areas

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Beijing

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Support for smoking bans in barsPre-post in 6 ITC countries + China

Smokers’ support for comprehensive smoke-free laws in China is already MUCH higher than it was in any other ITC country before those countries implemented smoke-free laws that were successful.

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Examples of ITC Project FindingsPlain/Standardized Packaging

Plain (Standardized) Packaging Tobacco packaging is a central component of marketing Plain/standardized packaging eliminates both the

graphic elements of branding and the structural elements (size and shape of the package).

– All packages look the same– All packages have the same shape

Recommended in Article 11 and 13 Guidelines

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Industry challenges Australia’s plain packaging

1. Constitutional challenge: High Court finds for Australia 6-12. Bilateral Investment Treaty: Philip Morris Asia (based in

Hong Kong) brings a challenge via the BIT between Hong Kong and Australia. Australia wins its jurisdictional challenge.

3. World Trade Organization: Challenge from Honduras, Dominican Republic, Cuba, and Indonesia. Over 40 countries exercised their third-party rights in this dispute: by far the largest number ever for a WTO dispute

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ITC Evidence on Australia Plain Packaging

Yong et al. (2016): plain packaging significantly increased health warning effectiveness

Swift et al. (2014): Smokers’ support for plain packaging rose significantly after implementation

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Examples of ITC Project FindingsHealth Warnings:

Defending Uruguay’s Large Pictorial Warnings Against Challenge From

Philip Morris International

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Uruguay

Uruguay increases warning size from 50% (recommended minimum under the FCTC Article 11 Guidelines) to 80%.

Philip Morris International claims these large warnings are an infringement of the bilateral investment treaty between Switzerland and Uruguay.

PMI seeking $25 million in damage to their “brand”, which they describe as their most valuable asset

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ITC Articles in Tobacco Control on the Impact of Australia’s Plain Packaging Law

Borland et al: Health warnings are more effective > plain packaging

Swift et al: Smoker support for plain packs goes up > implementation

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PMI Uses Trade Treaty to Challenge UruguayPhilip Morris International challenges 80% Uruguay’s warnings claiming that warnings larger than 50% (Article 11 Guidelines) would not be more effective.

Gravely et al., 2016 (Tob Control)

Size increasedfrom 50% to 80%

Size increasedfrom 50% to 80%

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Arbitration panel rules against PMI on all counts PMI required to pay all court costs + $7M to

Uruguay for its legal costs

Broad Conclusions from the ITC Project The FCTC policies are effective if implementation and

enforcement are strong Policies in LMICs are effective IF governments are

supportive AND if the proper structures (e.g., enforcement) are in place AND if tobacco industry is not so strong

– Impact of tax/price & health warnings may be greater in LMICs

Policies in HICs/LMICs are NOT effective IF governments are not supportive, i.e., where tobacco industry is strong

– Netherlands, China, India

Evidence across different domains that policies lead to reductions in tobacco use (warnings, smoke-free laws)

– US FDA’s analysis: Canadian pictorial warnings decreased prevalence by only 0.088%. ITC reanalysis: estimated decrease = 2.87–4.68%. Implies that pictorial warnings could reduce smokers by 5.3–8.6M.

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Dissemination of ITC Project Findings:Knowledge Transfer and Utilization Products for researchers, policymakers, and advocates

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22 ITC National Reports Across 16 Countries– France: Wave 1 National Report (Feb 2009)—English and French– France: Wave 2 National Report (Oct 2011)—English and French– Germany: Waves 1–2 National Report (Jan 2010)– Bangladesh: Wave 1 National Report (Apr 2010)—English and Bengali– Mauritius: Wave 1 National Report (May 2010)– Mauritius: Wave 2 National Report (May 2011)– Mauritius: Wave 3 National Report (May 2012)– Netherlands: Waves 1–3 National Report (June 2010)– Bhutan: Wave 1 ITC Bhutan Report (May 2011)– Malaysia: Waves 1–4 National Report (March 2012)– Uruguay: Waves 1–3 National Report (August 2012)—English and Spanish– Republic of Korea: Waves 1–3 National Report (Nov 2012)—English, Korean– China: Waves 1–3 ITC China Report (Dec 2012)—English and Chinese– India: Wave 1 (Sep 2013)– Canada: Waves 1–8 (Nov 2013)– United States: Waves 1–8 (Feb 2014)– Brazil: Waves 1–2 (May 2014)– Zambia: Wave 1 (May 2014)– Uruguay: Waves 1–4 National Report (Aug 2014)– Netherlands: Waves 1–8 National Report (Sep 2015)– Zambia: Waves 1–2 (Dec 2015)– Kenya: Wave 1 (Dec 2015)Additional National Reports in preparation: Brazil, France

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ITC National Reports: France

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ITC National Reports: Bangladesh (April 2010)

Preface from the Prime Minister,Sheikh Hasina

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ITC National Reports: China (Dec 2012)

China Report released in Beijing in Dec 2012 at the Chinese Communist Party School and at the

China NCD Forum

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Current and New Directions for the ITC Project

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Product Regulation Research:New and Emerging Nicotine Delivery Products

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New & Emerging Tobacco/Nicotine Products

What is the role of policies?

Trends in E-cigarette use

Trends in Using E-cigarettes at Last Quit Attempt

New major grant from US National Cancer Institute:• 5 interlinked projects

• Extension and expansion of ITC cohorts in Canada, US, UK, Australia with addition of measures of e-cig use.

• Impact of e-cigs on smoking, quitting, dual use, etc.

Yong et al (NTR 2017): impact of regulatory environment on the effectiveness of e-cigarettes for cessation• ≥ 30 day abstinence: E-cigarettes only vs. No meds/no ecigs

• More restrictive countries (Canada, Australia) vs. Less restrictive countries (USA, United Kingdom)

• Less restrictive countries: E-cigs significantly higher than No Aids

• More restrictive countries: E-cigs significantly lower than No Aids

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Conclusions

There is a shift in focus to supporting stronger and more rapid implementation of the FCTC

Some countries have implemented the FCTC at high levels; but many others have not

There is now strong and building evidence that the FCTC has accelerated implementation of strong tobacco control measures and that this decreases tobacco use

But progress is slow and measures are being weakened by industry influence

Evidence on impact of FCTC policies is critically important to support stronger and more rapid implementation of the FCTC.

Ontario Institute for Cancer ResearchSenior Investigator Award

Canadian Institutes of Health ResearchFoundation Grant

US National Cancer InstituteResearch Grants

Support for the ITC Project

Geoffrey T. Fong: gfong@uwaterloo.cawww.itcproject.org

University of WaterlooOffice of Research