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UCSF CTCRE Tobacco Documents Workshop 2015
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Putting the tobacco industry’s words to work for you 13 th Annual Tobacco Documents Workshop, May 8, 2015 Center for Tobacco Control Research & Education Naphtali Offen, UCSF
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Transcript of UCSF CTCRE Tobacco Documents Workshop 2015
Putting the tobacco industry’s words to work for you
13th Annual Tobacco Documents Workshop, May 8, 2015
Center for Tobacco Control Research & Education
Naphtali Offen, UCSF
Acknowledgments
LEGACY Jonathan LeffKaren WilliamsRichard BarnesRachel Taketa
Libby SmithPhil GardinerValerie YergerStan GlantzRuth Malone
Workshop goals
Introduction to documents
Tobacco-related cutting-edge issues:
Cigarette filters Menthol E-cigarettes FDA attempts to regulate tobacco End game strategies
Day’s agenda
Introduction Break Four presentations Lunch break / socializing After-lunch speaker Break Hands-on workshop in lab Wrap-up / networking here
Introduction to thetobacco documents
How we acquired them
What is in the collection
Why they are valuable
How we acquired them
State Attorneys-General sued major tobacco companies to recover Medicaid funds spent treating tobacco disease.
The industry produced truckloads of documents for trial.
Case was settled in 1998 with the Master Settlement Agreement (MSA).
Master Settlement Agreement original signatories
American Tobacco Brown & Williamson Lorillard Tobacco Philip Morris RJ Reynolds
Center for Indoor Air Research Council for Tobacco Research Tobacco Institute
Terms of MSA $206 billion payments to states over 25 years Industry-affiliated groups disbanded Ad restrictions Funding of Legacy
and…
Tobacco industry documents produced for trial must be made public!
Initial access to documents
Repositories in Minn.; Guildford, UK. Cumbersome process (time, expense)
Tobacco company internet sites Time limited (through 2010) Not user-friendly, different interfaces Searchable only via metadata Occasionally documents would vanish
Legacy Tobacco Documents Library (LDTL) at UCSF
Advantages: Housed at one site - UCSF Available in perpetuity User-friendly / intuitive Full-text searchable!
Limitations ofTobacco Documents
Don’t know what is missing Largely limited to discovery documents International documents spotty Newer documents more circumspect
What is in the collection
14.5 million+ documents
87 million+ pages
7500+ audio-visual items
45 separate collections
Document subjects
Marketing, advertising and public relations
Research and development
Customer research
Lobbying, legislative and legal efforts
Document formats
Letters, memos and faxes Marketing plansMeeting minutes and presentationsCourt transcriptsInvoices, statementsNewspaper articles/clippingsDiaries and notesJunk
Why they are valuable
Glimpse into workings of entire industry
Expose industry lies and tactics
Identify industry attempts at destabilizing tobacco control
Identify and expose industry front groups and allies
Why is this important?
[PM 1996] fir75c00
Exposing its bad behavior is feared by the industry.
Three simple rules
Say what the document is
Say what it means
Say what the implications are
[PM 1992] ngr62e00
Expose industry tactics
A Gay Cigarette?
[PM 1992] cmv24e00
“Own” what market?
[PM 1992] oui58e00
What’s the story?
What it is: PM wanted to “own” the gay market,
but…
What it means: PM didn’t want to be associated with it
What the implications are: PM may not be the corporate ally the gay
community thinks it is
Identify destabilizing attempts
[PM 1997] ayg53a00
What’s the story?What it is:
A plan to counter the effectiveness of tobacco control advocates
What it means:
Tobacco industry has ulterior motives when trying to form alliances with tobacco control organizations
What the implications are:
Tobacco control should avoid working with the industry
Identifying industry allies and front groups
“The whole question of getting third-party assistance … is to give us clout, to give us power, to give us credibility, to give us leverage, to give us access where we don’t ordinarily have access ourselves.”
PM 1984 fxz88e00
Exposing front groups
no-smoke.org
Lawsuits
Counter-advertising
Community engagement
Legislation
Policy debates
Additional document uses
Lawsuits
Department of Justice vs. Philip Morris et al.
“Defendants' internal documents and research…reveal their continued recognition that smoking causes serious adverse health effects and their fear of the impact of such knowledge on litigation.”
- Judge Gladys Kessler, Aug. 2006
Counter-advertising
American Legacy Foundation (truth® campaign)
[RJR 1995] mum76d00
Sub-Culture Urban Marketing
Targets: gay men in San Francisco’s Castro area and homeless men in the city’s Tenderloin neighborhood
In 1995 a major tobacco company planned to boost cigarette sales by targeting homeless people. They called their plan "Project SCUM: Sub Culture Urban Marketing."
Community engagementBrochures
Community engagementMedia advocacy
Community engagementTaking documents to community
[RJR 1988] tsn54d00
Legislation
FDA given limited authority over tobacco products (2009)
Controversial among advocates
Philip Morris promoted it
Documents reveal why (McDaniel, PA & Malone, RE, “Understanding Philip Morris's pursuit of US government regulation of tobacco”, Tob. Control, 2005)
PM’s Perspective
Regulation can give us an opportunity to move down the road toward corporate normalcy. … If we remain unregulated, our critics will be able to continue to define us as a member of a rogue industry and this will affect how we are viewed by legislators, regulators, opinion leaders, and, significantly, the general public.
Policy debate:smoking in movies
[B&W 1983] mfs93f00
Tips
Decide what you want to focus on
Look for evidence in the documents
Find corroboration elsewhere, such as:
Research papersNews reportsOrganization recordsGovernment recordsInterviews
Conclusion
Study the industry as it has studied us.
Learn what they know and what they fear
Beat them with their own words.
Tobacco industry and smoker attitudes toward
cigarette butt waste
Elizabeth A. Smith, Ph.D.University of California, San Francisco
California Tobacco Related Disease Research Program Grant #17IT-0014National Cancer Institute Grant #120138
The cigarette butt problem Non-biodegradable cigarette butts
are the most littered item in beach and community clean-ups.
Butts contain toxins that leach into soil or water, endangering microorganisms and fish.
What about humans?
No evidence filters make cigarettes any safer.
Filters may be linked to shift from squamous cell cancer to adenocarcinoma.
Cigarette butts & industry
Tobacco industry research is usually ahead of tobacco control research.
Understanding the industry’s knowledge and concerns can help shape effective tobacco control initiatives.
Methods
“Snowball” search techniques
Terms include “butts,” “biodegradable,” and “filter”
690 relevant documents, most from mid-1990s, including strategy documents and focus group studies
Industry fears about litter
hvx21b00
myz37c00
vec52c00
Smoker beliefs about butts
Most know filters are not biodegradable
Most are oblivious to toxicity of butts
[hwx33d00 ]
[lof43d00]
“While virtually all respondents felt that litter . . . was the result of apathy, laziness, and insensitivity, most smokers admitted that they do litter with cigarette butts.” [mbj05c00]
Littering
Why do smokers litter?
“The process of flicking a cigarette to the ground and then stepping on it is
a natural extension of the defiant/ rebellious smoking ritual.”
a conscientious thing to do.” [mbj05c00]
Littering facilitates denial [mbj05c00]
“What else am I going to do with them?”
Smokers say they wish they didn’t:
“have to bury the butt in the bushes”
“have to throw them on the ground”
“have to throw the butt out the window”
Option 1: No more filters
myl38c00
Option 2: Biodegradable filters
Improve smoker and industry image [nuz30c00; ouu74a99]
Prepare for or pre-empt regulation requiring biodegradability [rvj95a99]
Avoid ‘green’ backlash [eij43d00]
But . . .
[vec52c00]
[dty03f00]
[myl38c00]
[myl38c00]
What’s their motivation?
“When all discarded filter tips look alike to the public the fact that some degrade more quickly than others may be of academic interest only, if the majority do not. For certain it is fanciful to expect gratuitous attribution of success from the public through elimination of only a small part of the problem.”
[tvj95a99]
. . . plus
Industry doesn’t know how to make a biodegradable filter
Biodegradability does nothing about toxicity of contents of butts
Option 3: Change behavior
Anti-litter campaigns
Pocket ashtray distribution
Permanent ashtray installation
Development of anti-litter campaign slogans
Smokers are sensitive and defensive
Cannot “single out” smokers as litterers
Cannot equate smoking with littering
Cannot imply that the smoker “had participated in littering behavior”.
Smokers’ favorite slogan
“A little thought, a lot less litter”
Anti-litter campaigns: images
mnt37d00
“Completely rejected”
[mnt37d00]
Pocket ashtrays
Pocket ashtrays
RJ Reynolds distributed millions (many branded)
No real evaluation data Some smokers like them; claim to use
them Some do not want to carry butts around:
“dirty,” “smelly,” “unsanitary”
Permanent ashtrays
Permanent ashtrays
Philip Morris installed in cities around the country [khp35c00]
No evaluation data
Advantages for industry: make it “more convenient” to smoke [vwo06c00]
signal permission to smoke [kll65a00]
institutionalize smoking areas [vhq83c00]
Make industry responsible for toxic butts
Industry fears being forced to take responsibility for butts.
Smoker psychology suggests changing behavior will be difficult.
Efforts have focused on “litter”, not “toxic” issue.
Eliminate filters California legislation
AB 48 (Mark Stone, D-Monterey Bay) Prohibits single-use filter made of any
material, including cellulose acetate, or other fibrous plastic material.
Start the conversation
Make that alliance!
E-Cigarettes: The Vapor This Time?
Phillip S. Gardiner, Dr. P. H.Policy and Regulatory Sciences Program Officer, Tobacco Related
Disease Research Program (TRDRP) University of California Office of the President
University of California San Francisco (UCSF)Center for Tobacco Control Research & Education
Annual Tobacco Documents WorkshopSan Francisco, California
May 8, 2015
From Whence E-cigarettes
• 2003: Chinese pharmacist, Hon Lik, is credited with conceptualizing and producing the first modern Electronic Cigarette
E-Cigarettes
• Nicotine Addiction: The Next Generation– Aerosolizes Nicotine Laced Propylene Glycol,
Glycerin, and Flavorings– Long Term Health Impact Unknown– Cessation Aid or Promoter of Nicotine Addiction
and Continued Tobacco Use– Explosion in Popularity especially among youth;
Emergence of a New Vaping Subculture– Little Regulation
E-Cigarettes: A Moving Target
• 400+ makes and models– Closed systems; cig-a-likes– Open systems; tanks– Hookah Pens, Vape Pens
• 7700+ Flavorings– Menthol– All Banned FDA flavors
• Tax the Liquid; the Nicotine; the Device
Component Parts E-Cig-a-Likes
E-Cig Tank Systems; Mods
E-Pens; E-Hookah Pens
• Cherry, Chocolate,• Vanilla, Bubblegum
E-Cigars
• Swisher Sweets E-cigars (Swisher International)
The E-Cigarette Explosion
• Market Size Continues to Increase – retail sales are over $2B currently; – $10B by 2017.
• E-cigs could surpass consumption of conventional cigs within the next decade (by 2023). (Herzog, 2014)
E-Cigarette Advertising Triples, 2011 to 2012
• “Overall, e-cigarette advertising expenditures across media channels tripled from $6.4 million in 2011 to $18.3 million in 2012– 80 unique brands– blu eCigs dominated ad spending, comprising
76.7% of all e-cigarette advertising– Highest in Magazines and TV; Lowest in
Newspapers• (Kim et al., 2014)
E-Cigarette Advertising Doubles, 2012 to 2013
• E - cigarette manufacturers have significantly increased marketing spending, more than doubling expenditures between 2012 and 2013.
In total, six e cigarette companies spent $59.3 million in 2013 to market e-
cigarettes(Durbin et al., 2014)
Kids Exposed to E-Cig Ads
• Between 2011 and 2013 exposure to e-cigarette TV ads increased by:– 256% among adolescents ages 12 to 17 – 321% among young adults, ages 18 to 24.
• Approximately 76% of the ads seen by each of the two age groups occurred while watching cable networks
– (Duke et al., 2014)
Youth E-Cig Use Continues to Rise
• Youth Smoking Rates Fall; E-Cigarette Use Rises– Tobacco Use 22.9% in 2013 - -24.3% in 2011.
– E-Cigarettes Use Tripled to 4.5% in 2013 from 1.5% in 2011.
– 13% of High School Students
• (CDC, 2014; CDC 2015)
Youth Using E-Cigarettes More than Regular Cigarettes
• 8th Grade: 9% e-cigarette; 4% regular cigarettes
• 10th Grade: 16% e-cigarette; 7% regular cigrettes
• 12th-Grade: 17% e-cigarette; 14% regular cigarettes (MTF, 2014)
Enter the tobacco industry• Lorillard (LO)
– Acquired the Blu E-Cigs in April 2012 for $135M.
• Reynolds American (RAI)
– Vuse: Microprocessor Controlled
• Altria Group (MO)
– MarkTen; Rolled out 2014
• NJOY (privately held)
– Ex Surgeon General Carmona; other personnel includes Several Ex-Altria Execs.
• Logic (privately held)
tobacco industry Taking Over the E-Cigarette Industry
• Convenience Store Sales Volume
– Reynolds Vuse 30.1%
– Lorillard blu 21.6%
– Logic* Logic 14.5%
– Altria Mark Ten 10.9%
– NJOY* NJOY 4.4% – (Herzog, March, 2015) * Privately held
Vape Shops on the Rise
• The "Starbucks of e-vapor“ – It is estimated that there are somewhere between
5,000-10,000 vape shops in the U.S.– Tank systems; Refills; Mix-your-Own– Vapers can hang out, work, socialize and vape– Purchase products; sample new ones– Eating and Drinking
– (Herzog, 2014)
New Bluetooth E-Cigarette Lets You Vape AND Receive Calls, Listen to Music
E-Cigarette Liquid: The “Juice”
E-Cigarette Liquid: The “Juice”
• E-Cigarette Liquid contains:– Nicotine, extracted from tobacco leaves
• Large variation in content between and within brands (Cheah et al 2012; Trtchounian et al 2011; Goniewicz et al 2013)
• Lethal if ingested; 60 mg Adult; 6 mg Children• Detrimental to fetuses (Martz, 2009)
• Tobacco specific nitrosamines (TSNAs) (Laugesen, 2008; Westenberger, 2009; Goniewicz et al 2013)
• 1.2mg of nicotine in each cigarette, or 24mg of nicotine per pack (1.2mg x 20 cigarettes)= ~ 1 e-cigarette
Nicotine Is Not Benign
• Nicotine can be acutely toxic; Poisonous and addictive
• Nicotine activates multiple biological pathways through which smoking increases risk for disease.
• Nicotine exposure during fetal development has a lasting adverse consequences on brain development and contributes to multiple problematic birth outcomes including low birth weight and still birth
– RSG, 2014
E-Cigarette Liquid: The “Juice”
• E-Cigarette Liquid contains:– Propylene Glycol - the vapor; the fog
• FDA approved food additive (humectant, solvent for colors and flavors), cosmetics, and medicines.
• Short term exposure causes eye, throat, and airway irritation (Wieslander et al 2001; Vardavas et al 2012,)
• Long term exposure can result in children developing asthma. (Choi et al 2010)
• Chemical composition changes when heated (Henderson et al, 1981)
E-Cigarette Liquid: The “Juice”
• E-Cigarette Liquid contains:– Glycerin: A humectant used instead of or in
combination with propylene glycol in EC fluids for aerosol production.
– FDA Approved for ingestion.– Slightly hazardous in case of skin and eye contact,
ingestion, and inhalation; prolonged exposure may cause organ damage.
– Metals• Tin particles found in E-liquid (Williams et al., 2013)
E-Cigarette Liquid: The “Juice”
• E-Cigarette Liquid contains:– Flavorants. Key one Menthol; Candy flavoring
• Anesthetic effects,; promotes deeper inhalation; greater cell permeability
• Allows the poison to go down easier!
– Not GRAS! Ingestion vs. Inhalation– 7000+ flavors; appeals to kids (bubblegum, strawberry,
gummy bears, etc.)– Exotic for adults (Sex on the Beach, Aces and 8’s)
• Mix your Own (ala roll your own)
The Aerosol: Its Not Just Water Vapor
• E-Cigarette Aerosol Contains:– Propylene glycol, glycerol, flavorings, and
nicotine, which are found in the e-liquid, are also found in the e-vapor
– May contain Propylene oxide – Volatile Organic Compounds: Benzene
and Toluene
The Aerosol: Its Not Just Water Vapor
• E-Cigarette Aerosol Contains:– Carbonyl Compounds: Formaldehyde,
acetaldehyde, and acrolein– Metals: tin, silver, iron, nickel aluminum, sodium,
chromium, copper, magnesium, manganese, lead, potassium and silicate nanoparticles
– Tobacco specific nitrosamines (TSNAs) carcinogenic compounds found in tobacco and tobacco smoke.
• (Schripp et al, 2012: Westenberger 2009; Goniewicz et al, 2013; Williams et al, 2013; Henderson, 1981)
E-Cigarette Emit Metals used in Their Manufacturing
• Zinc and Nickel concentrations were found to be higher in e-cigarette emissions compared to conventional Cigarette emissions, originating from the cartridges holding the e-liquids.
• “Considering the potential adverse health effects associated with the inhalation of these metals (particularly Ni and Zn, and the emission observed both in our analysis as well as the study by Williams et al.13), attention should be directed toward eliminating the use of these metals in the cartridges during the manufacturing process of e-cigarettes.”– (Saffari et al., 2014)
E-Cigarettes: The Second Generation
• 1st Generation:– Cig-a-likes; Most Toxins Emitted in the Aerosol
Lower than Regular Cigarettes (Goniewicz et al., 2013)
– Aerosolizing Temperature 40 – 65c • 2nd Generation
– Tank Systems; refillables– Some Toxins Emitted Approaching Levels found in
Regular Cigarettes– Aerosolizing Temperatures >65c
As Battery Voltage Increase, Toxins Increase
• On Average, Toxins were 13 – 807 Fold Lower than Tobacco Cigarettes
• However, when voltage was increased from 3.2 to 4.8V:– 4 to over 200 times increase in formaldehyde,
acetaldehyde, and acetone levels– The levels of formaldehyde were in the range of
levels reported in tobacco smoke
(Kosmider et al., 2014)
Combustion; Heating; Aerosolizing
• Cigarettes burn tobacco at ~ 900˚ Celsius
• Heated Tobacco Products
• E-Cigarettes aerosolize nicotine laced propylene glycol at 40 – 65˚ Celsius *
• * 1st Generation
E-Cigarettes are Sooo Last YearHeat not Burn
Marlboro HeatstickHeat not Burn
Heat not Burn
• 8 major studies conducted by PMI in 2012• Findings:
– Heat not burn had significantly lower emissions of key toxins compared to regular cigarettes
• Philip Morris’ Marlboro HeatStick; Test Marketing Nagoya Japan and Milan Italy, November2014
• Reynolds ‘ Revo; Test Marketing Wisconsin, 2015
Secondhand Exposure to Vapors From Electronic Cigarettes (Czogala et al, 2013)
• The average concentration of nicotine resulting from smoking tobacco cigarettes was 10 times higher than from e-cigarettes (31.60±6.91 vs. 3.32±2.49 µg/m
• 7xs more Particulate matter• Still, in a room of 5 to or more e-cigarette
users, nicotine and particulate matter levels are above healthy levels
Secondhand Vaping and Nicotine
• Similar nicotinergic impact as tobacco cigarettes
• e-Cigarettes and tobacco cigarettes generated similar (p > 0.001) effects on serum cotinine levels
– (Flouris et al., 2013)
Secondhand Vaping and Nicotine
• The levels of airborne nicotine and cotinine concentrations in the homes with e-cigarette users were significantly higher than control homes. “Our results show that non-smokers passively exposed to e-cigarettes absorb nicotine.” – (Fernandez et al., 2014)
• Propylene glycol
• glycerin
• Flavorings (many)
• Nicotine
• NNN
• NNK
• NAB
• NAT
• Ethylbenzene
• Benzene
• P,m, xylene
• Toluene
• Acetaldehyde
• Formaldehyde
• Naphthalene
• Styrene
• Benzo(b)fluoranthene
• Benzo(ghi)perylene
• Acetone
• Acrolein
• Silver
• Nickel
• Tin
• Sodium
• Strontium
• Barium
• Aluminum
• Chromium
• Boron
• Copper
• Selenium
• Arsenic
E-Cig Aerosol Composition
• Cadmium
• Silicon
• Lithium
• Lead
• Magnesium
• Manganese
• Potassium
• Titanium
• Zinc
• Zirconium
• Calcium
• Iron
• Sulfur
• Vanadium
• Cobalt
• Rhubidium
Compounds in yellow are from FDA 2012, Harmful and Potentially Harmful
Substances – Established List
• Chlorobenzene
• Crotonaldehyde
• Propionaldehyde
• Benzaldehyde
• Valeric acid
• Hexanal
• Fluorine
• Anthracene
• Pyrene
• Acenaphthylene
• Acenapthene
• Fluoranthene
• Benz(a)anthracene
• Chrysene
• Retene
• Benzo(a)pyrene
• Indeno(1,2,3-cd)pyrene
Second Hand Vaping: The Take Home Message
“Overall, the e-cigarette is a new source of VOCs and ultrafine/fine particles in the indoor environment. Therefore, the question of “passive vaping” can be answered in the affirmative. However, with regard to a health-related evaluation of e-cigarette consumption, the impact of vapor inhalation into the human lung should be of primary concern” (Schripp, et al., 2012).
E-Cigarettes Source of Thirdhand Smoke Exposure
• Conclusions: This study indicates that there is a risk of thirdhand exposure to nicotine from e-cigarettes. Thirdhand exposure levels differ depending on the surface and e-cigarette brand.
• Future research should explore the potential risks of thirdhand exposure to carcinogens formed from nicotine released from e-cigarettes (Goniewicz and Lee, 2014)
Health Effects of E-Cigarettes
• Long Term Health Effects are unknown• Short-term Health Effects include:
– Decreased Fractional exhaled Nitric Oxide (FeNO) [a measure of lung function retardation]
– Increased respiratory resistance– Decreases in the eye’s tear film stability– Acute nicotine poisoning
– (Vardavas, 2012; Norback and Lindfren, 2001)
Health Effects of E-Cigarette
• Constricts peripheral airways, possibly as a result of the irritant effects of propylene glycol, which could be of particular concern in people with chronic lung disease such as asthma, emphysema, or chronic bronchitis.
– (Vardavas, 2012)
Health Effects of E-Cigarette
• Adversely effects epithelial functions of young people.
• Even nicotine-free e-liquid promotes pro-inflammatory response and HRV infection.
• Both e-liquid without nicotine and with nicotine inhibits lung innate immunity (e.g., SPLUNC1) that is involved in lung defense against HRV infection.
• “These findings strongly suggest the deleterious health effects of e-cigarettes in the airways of young people.” (Wu, et al., 2014)
Calls to California Poison Control Centers Concerning E-Cigs
2010 4
2011 12
2012 19
2013 thru Feb 2014 155(F. Lee Cantrell California Poison Control System, 2014)
From Whence E-cigarettes
• 2003: Chinese pharmacist, Hon Lik, is credited with conceptualizing and producing the first modern Electronic Cigarette
Non-Combustible Cigarettes - Vaping 1980
• Title: Non-Combustible Cigarettes - "Vaping"– Author: Felton, DG– Corporate Author:– Date: 19800313– Bates:109876582-109876588– Collection: British American Tobacco– Bookmark:
http://legacy.library.ucsf.edu/tid/lsl80a99
Non-combustible Cigarette: Alternative Method of Nicotine Delivery
• Presentation by Dr . Norman L . Jacobson of San Antonio to a meeting of the American College of Chest Physicians at Houston on 4-8th November, 1979
Origins of the Terms Vaping and Vapers
• This presentation describes a practical and apparently satisfying method of administering nicotine by nicotine vapour inhalation via a non-combustible cigarette, hereafter referred to as an NCC
• To simplify description, we will hereafter refer to nicotine vapour inhalation through an NCC as vaping and people who inhale nicotine vapour as vapers .
The Aerosol This Time? Precaution Advised
• E-Cigarette Vapor– Concentrations of pollutants and carcinogens less
than in cigarettes– Great variation within and between products; no
product standards– Renormalization; youth uptake on the rise– Intermediate and long term health effects
unknown– Maybe safer, but this doesn’t mean safe
Thank You!
TRDRPResearch for a Healthier California
Grant FundingCutting Edge ResearchScientific Conferences
Dissemination of Research Findings
THE “ENDGAME”: LET’S START WITH MENTHOL
Valerie B. Yerger, NDTobacco Documents Workshop
Center for Tobacco Control Research & EducationMay 8, 2015
WHY WE SHOULD START WITH MENTHOL: “THE TOP 10”
#10
Menthol makes smoking easier
Publicly Say, “Menthol is Just a Flavor”
• “The is no evidence that menthol has any effect on the smoker other than the effect…on the taste and flavor of the cigarette.” (RJ Reynolds, 1982)
• “Menthol is a flavor…PM USA only adds menthol to the flavor recipes of cigarettes.” (Jane Y. Lewis, Senior Vice President, Altria Client Services, PM USA; TPSAC Meeting, July 15, 2010)
tid/xro95d00
But Confidentially Say, “Menthol Makes Smoking Easier”
The whole smoking experience [with menthol]…thus becomes much more pleasant. Negatives are minimized (tobacco taste and harshness); positive attributes are superimposed (coolness and menthol taste). (British American Tobacco Company, 1982)
Adding menthol to cigarettes masks the harshness of tobacco and provides an “extra something,” which make cigarettes more desirable to some smokers. (Roper Organization, 1979)
tid/tss75e00
tid/raf36a99
Cooling Effects of Menthol
• “Menthol has properties of a drug,” including cooling effects (Roper Organization, 1979)
• Menthol’s cooling effect alleviates nicotine’s irritating effect (RJ Reynolds, 1983)
• Even at low or subliminal levels, menthol reduces “nasal sting, tongue bite, and harshness” (RJ Reynolds, 1986)
tid/tss75e00
tid/kcl3900
tid/eax18c00
#9
Menthol keeps smokers smoking
Menthol Inhibits Smoking Cessation
• Perceived health benefits or belief that menthol will reduce negative health effects of smoking
• When a smoker has a cold or sore throat, menthol makes it easier to keep smoking in spite of discomfort
• Due to the odor of its smoke, menthol cigarettes are perceived to be more socially acceptable to others than non-mentholated cigarettes
[tid/boo21a00]
[tid/fcb49d00]
[tid/dfl76b00]
#8
Menthol is more than a flavoring; it’s important to the
industry
Menthol Modulates Nicotine’s Effects (Philip Morris, 1991)
Menthol Stimulates the Trigeminal Nerve
Of interest to the tobacco industry because nicotine also stimulates this nerve
Essential to eliciting a liking response for a tobacco product
Menthol found to be a “partial replacement” for nicotine
[tid/use78e00]
[tid/asz71f00]
[tid/feu54d00]
#7
Menthol extends beyond cigarettes to
other tobacco products
These are NOT Cigarettes
Menthol e-Cigarettes
#6
Menthol is present even in nonmenthol tobacco products
All Tobacco Products Contain MentholMenthol content of US tobacco products
Product Menthol (mg)
Regular (non-menthol) cigarettes 0.003Menthol cigarettes (weak effect) 0.1-0.2Menthol cigarettes (strong effect) 0.25-0.45Pipe tobacco 0.3Chewing tobacco 0.05-0.1
Hopp, 1993
“Menthol at very low levels is sometimes used in nonmenthol brands.”
William R. True, Senior Vice President of R&D,
Lorillard, FDA TPSAC Meeting, July 2010
#5
Menthol disproportionately affects some groups
Smoking Prevalence by RaceMenthol vs. Non-Menthol Use in Adults
White African American Hawaiian Hispanic Asian0%
5%
10%
15%
20%
25%
24%
84%
53%
38%24%
76%
16%
47%
62%
76%
Non-MentholMenthol
Smoking Incidence from NHIS 2009; menthol preference from NSDUH 2009
Menthol Cigarette Use Among Youth (%)
Hersey J, et al. (2006) Are menthol a starter product for youth? Nicotine and Tobacco Research. 8(3):403-413.
#4
Menthol is a social justice issue
Menthol = Health Disparities
• African Americans bear a disproportionate burden of tobacco-related diseases and death
• 83% African American smokers consume menthol brands
• Inner city neighborhoods targeted with menthol marketing
Lung, Bronchus Cancer Death Rates (per 100,000) United States, 2011
(Nat’l Program Cancer Registries)
White
Africa
n American
Hispanic
Asian/P
acific I
slander
American In
dian/Alask
a Native
01020304050607080
MaleFemale
#3
Because WE CAN keep menthol out of our
communities
Family Smoking Prevention and Tobacco Control Act, 2009
Gives the Food and Drug Administration (FDA) the authority to regulate tobacco products
Family Smoking Prevention and Tobacco Control Act, 2009
Allows FDA to require new restrictions and changes to tobacco products to protect the public health
Family Smoking Prevention and Tobacco Control Act, 2009
Prohibits the manufacture of all cigarettes with candy, fruit, or clove flavorings (menthol excluded)
Tobacco Products Scientific Advisory Committee (TPSAC)
• Established by the “Tobacco Control Act” to advise the FDA
• Mandated to produce report about impact of the use of menthol in cigarettes on the public health, including “such use among African Americans, Hispanics and other racial and ethnic minorities”
Findings from TPSAC Report:July 21, 2011
• Menthol linked to youth initiation and increased nicotine addiction
• Menthol linked to higher rates of smoking and decreased success in quitting
• “Removal of menthol cigarettes from the marketplace would benefit public health in the United States”
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/
UCM247689.pdf
FDA Releases Independent Review: July 23, 2013
• Likely associated with increased smoking initiation and progression to regular cigarette smoking
• Greater addiction and less successful cessation, especially among African Americans
• Likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes
• Validates TPSAC report released two years earlier
FDA. Preliminary scientific evaluation of the possible public health effects of menthol versus nonmenthol cigarettes. Silver Springs, MD. July 23, 2013.
The FDA is able to REDUCE MENTHOL USE But…it is taking a long, long time
150
• From 2010-2050, “9 million people will initiate smoking because of the availability of menthol cigarettes”
• Had menthol prohibition gone into effect in 2011, over 320,000 deaths would be prevented by 2050
• Approximately one-third of those lives saved would be African American
We CANNOT Wait on FDA to ACT
Tobacco Products Scientific Advisory Committee. Menthol cigarettes and public health: Review of the scientific evidence and recommendations, July 21, 2011
“We must find ways to protect our young people before it is too late and addiction becomes part of their lives…we must do more as a city…we cannot wait for action from the State or Federal Level.”
Mayor Rahm EmanuelJuly 25, 2013
Chicago Mayor Makes Urgent Request to Health Board and Dept of Public Health
Chicago’s Buffer Zone Ordinance
• Creates a 500 ft. buffer zone around Chicago schools
• Prohibits the sales of ALL flavored tobacco products, including menthol cigarettes, Black & Milds, Swisher Sweets, blunt wrappers
– Introduced on Nov 25, 2013– Adopted Dec 11, 2013– Effective July 16, 2014
Chicago Flavored Tobacco Toolkit
• Ordinance, regulations• Resolutions• Mayoral reports on
menthol• City council agendas• Public testimonies and
policy briefs• FDA comments
• Archived webinar menthol presentations
• Photos• Press releases; public
responses• Public education
campaign ads• Copies of tweets
https://drive.google.com/folderview?id=0Bxndf1MBoZU1aHRsRFpfUZI0RGM&usp=sharing
#2
Menthol brings EVERYONE to the table
www.SavingBlackLives.org
MAJOR BLACK ORGANIZATION TAKES STAND AGAINST TOBACCO
Delta Sigma Theta Sorority, Inc. Urges FDA to Ban Menthol
• April 20, 2013: Berkeley Bay Area Alumnae Chapter introduced resolution, “Prohibiting the use of menthol as a characterizing flavor in cigarettes”
• July 15, 2013: Menthol resolution approved at its 51st national convention in Washington, D.C.
• March 5, 2014: The 16th National President of Delta Sigma Theta Sorority, Inc. Thelma T. Daley appears at Press Conference calling for a ban on menthol
• “The elimination of menthol in the cigarette seems to be…something that could be changed.”
• “…Delta Sigma Theta Sorority…will do more to…move this barrier out of the way so that little black girls and little black boys may grow up to be healthier.”
Dr. Thelma T. Daley, 16th National President of Delta Sigma Theta, March 5, 2014
#1
How can we achieve health equity if tobacco products
with menthol are available?
Credit: United Way of the Columbia-Willamette
So, Why Start with Menthol?
• Menthol makes tobacco products easier to take up, easier to smoke, more addictive, and more difficult to quit
• Youth and minority groups are more likely to use menthol cigarettes than general population
• Tobacco industry specifically targets menthol brands to inner city, at-risk youth and marginalized communities
• Engages communities most burdened by tobacco
What can the documents tell us about the tobacco endgame?
Ruth E. Malone, RN, PhDDepartment of Social & Behavioral Sciences
University of California, San Francisco
Research colleagues• Elizabeth Smith, PhD• Patricia McDaniel, PhD• Valerie Yerger, ND• Naphtali Offen, BS• Dorie Apollonio, PhD• Vera Harrell, BA• Anne Lown, PhD• Brie Cadman, MS• Quinn Grundy, RN, PhD(c)• Susan Forsyth, RN, PhD (c)• Hannah Patzke, RN, BSN• Norlissa Cooper, RN, MS
Funders
• California Tobacco-Related Disease Research Program (TRDRP)
• National Cancer Institute• National Institute on Drug Abuse• Nursing Alumni/Mary Harms Endowed Chair
Outline
• Endgame thinking in tobacco control• Endgame in industry documents• Types of endgame strategies• Legal, policy and strategic considerations• An endgame for the US
Australian Council on Smoking & Health Parody of 1953 NYC meeting b/t tobacco companies and PR firm Hill & Knowlton. Source: tobaccotactics.org
Source: Newsbiscuit
2010 Editorial
What an endgame is not• More of the same: Educational programs
telling kids they shouldn’t smoke
What an endgame is not
What an endgame is not
• More of the same: Telling smokers it is bad for them and they should quit
So…what is an ‘endgame’?• Initiatives designed to change/eliminate
permanently the structural, political and social dynamics that sustain the tobacco epidemic, in order to end it within a specific time.--Adapted from: Malone, R. E., McDaniel, P. A., Smith, E. A. (2014). Tobacco Control Endgames: Global Initiatives and Implications for the UK. Cancer Research UK
As usual, industry ahead of us…
PM 2045996032/6062
Corporate image: Public
PM 2031599541/9584
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Endgame in PM documents
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182PM 2048302297/2344
• Causes death to smokers, and nonsmokers. Also causes annoyance.
Candid observations
183
Our objective should be to address social acceptability issue. It will get worse if we don’t try to do something.
We must give people the impression that we are more responsible than they think.
Social acceptability
184
Industry trade-offs
Sooner or later we will lose advertising. Trade this now in exchange for immunity on product liability, or trade tombstone advertising for this.
Strategies: Dump tobacco
Today all the facts seem to indicate that tobacco is a could be dying industry.
I think we all believe that our future lies outside tobacco, and principally in the food business. I certainly believe this.
PM 2023027920/7949
Strategies: Dump tobacco
If at the end of two years it looks like it is not working we should implement Option A and get rid of the tobacco business.
PM 2023027920/7949
Strategies: Skim off tobacco
We should consider the “unthinkable” – look at the skim off idea.
PM 2023028192/8203
Approaches to endgame
• Regulate product• Regulate users• Regulate market
Regulate product
• Regulate nicotine levels in manufactured tobacco products
• Eliminate deceptive filters, reduce pH, reduce known carcinogens
• Eliminate menthol
Regulate Users
• Smoker’s license• Prescription to purchase
Regulate Markets• Regulated market model• Cap profits• Provide market incentives to industry to
reduce consumption• Permit sales of combustible tobacco products
only in restricted outlets• Restrict sales to those born before certain
year: “Tobacco free generation” proposal• Abolish sales of cigarettes
Areas of Modest Agreement• The industrially produced cigarette is the single
most deadly product ever made.• The tobacco epidemic is a product of the 20th
century• Use of tobacco and nicotine products by
children is not a good thing.• Clean indoor air is a good thing.• No other product shown to kill half its normal
users is widely available on market today.
Historical Precedents for Action
Driving questionHow is it that the single most deadly
product ever made continues to be sold on every street corner?
A possible endgame for the US
• Federal level—FDA: Reduce nicotine in combustible tobacco; eliminate flavors
• FDA: Regulate ecig marketing• All levels: Effective, ongoing
countermarketing, incl Tobacco Industry Denormalization
• Ecigs, NRT available for ‘can’t/won’t quit’
A possible endgame for the US
• Local level: Outlet restrictions; plan to phase out sales of conventional cigarettes; incentives for retailers to stop selling
• State level: Reduce #, density retail outlets via increasing cost of licensing, incentives to stop selling, move toward sales only in state outlets; raise age of purchase yearly
• Eliminate POS marketing for both cigs & ecigs• Smokefree laws include ecigs
A Modest Proposal
• Consider leveraging e-cigarette ‘moment’ to achieve phaseout of combustible tobacco products sales
• Could unite ‘vapers’, harm reduction advocates and public health
• Incentives for industry to re-tool
Policy questions
• Question is no longer whether, but when and in what sequence
• Which endgame approaches are most feasible, most expeditious, most simple?
• What models for regulating other deadly products can be drawn upon?
• How can we craft a new narrative that makes an endgame for tobacco the only possibility?
California• Second-lowest smoking prevalence in US• 20-year TC program, dedicated funds from
tobacco tax initiative• Mass media and community coalitions• 3 themes: 1) tobacco industry lies; 2) nicotine
is addictive; 3) secondhand smoke kills
California• Top priority: Limit tobacco-promoting
influences by curtailing marketing; deglamorising; exposing industry practices; holding industry accountable for impact of its products. Trial and error philosophy
• Strong smokefree policies, including some outdoor and MUH
• Has never had major focus on cessation; primary aim is social denormalisation
California
• Next 10 years: Focus on retail setting• Already has statewide licensing• Increase costs/renewal frequency• Limit number or density• Eliminate coupons/ retail incentives• Eliminate display• Tobacco waste stream initiatives
POS as critical to Endgame • Local & state levels: Reduce number and density of retail outletsDevelop long term plan to phase out sales of
conventional cigarettesProvide incentives for retailers to stop sellingRaise age of purchase yearlyEliminate POS marketing for both cigs & ecigs• All levels: Denormalization Malone, R. E. (2013). Tobacco endgames: What they are and are not, issues for tobacco control strategic planning,
and a possible US scenario. Tobacco Control,22, i42-i44.
Legal considerationsTobacco Control Legal Consortium Analysis, 2014
• Regulation of retail sales state/local function• No legal barriers to state or local govts
restricting or prohibiting sales of a tobacco product
• FDA bill expressly preserves local/state power to adopt any “measure relating to or prohibiting the sale” of tobacco products
Emerging phenomenon: Some retailers ending tobacco sales
--Denormalization
“This is how I explained it to my staff here, was that at one time, we didn’t realize that we shouldn’t be selling cigarettes, but now it’s more than obvious.”
Owner, pharmacy 4
Retail initiatives: San Francisco
• 2008: Ban on sales in pharmacies• 2014: Cap of 45 tobacco permits in each of
SF’s 11 districts• No new permits to restaurants or bars• Attrition model: gradually reduce # of
outlets
New York
Elements of a new narrative
• Industrially produced epidemic• Fundamentally defective product• We have lost too many loved ones• Less deadly alternatives exist • Compare w other dangerous products
phased out or strictly regulated• Not a “normal business” anymore
Public would never stand for this
But…PM Public Opinion Data United States, 2004
Wish there was some way to eliminate cigarettes 68%
Right and responsible thing to do… go out of business 59%
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“You can’t…”
• Have nonsmoking sections in restaurants• Ban smoking on airplanes• Have smokefree workplaces• Have smokefree bars (and pubs!)
Imagining things otherwise
