The Future of Tobacco Harm Reduction

Jonathan Foulds PhD

Director, Tobacco Dependence ProgramUMDNJ-School of Public Health

jonathan.foulds@umdnj.edu

www.tobaccoprogram.orgPresented at: 92nd Tobacco Merchants Association

Annual Meeting, Williamsburg VA, May 7-8, 2007

Acknowledgements/conflicts• Current funding support mainly from New Jersey

Department of Health and Senior Services, but also Cancer Institute of New Jersey, Robert Wood Johnson Foundation, NIDA & others.

• Grants/honoraria received from pharma. companies producing tobacco treatment meds.

• Compensated for testimony in litigation for plaintiffs against tobacco companies.

• I have never received any funding from the tobacco industry

• I write a regular weblog for a health website at:www.healthline.com/blogs/smoking_cessation/

Thanks to numerous colleagues for sharing their slides

History of Tobacco Harm Reduction

1954: The “Frank Statement to Smokers”“We accept an interest in people's health as

a basic responsibility, paramount to every other consideration in our business

We believe the products we make are not injurious to health.

We always have and always will cooperate closely with those whose task it is to safeguard the public health.”

Statements by Industry Representatives

“Moreover nicotine is addictive. We are then in the business of selling nicotine, an addictive drug…. But cigarettes –…..despite the beneficient effect of nicotine, have certain unattractive side effects:

They cause, or predispose to, lung cancer…. certain cardiovascular diseases..may well be truly causative in emphysema..”

1963, Addison Yeaman, Executive Vice President of Brown and Williamson Tobacco Company

Statements by Industry Representatives

“if our product is harmful, we’ll stop making it.”

James Bowling, Vice President, Philip Morris, 1972. (Kwitny, 1972)

Statements by Industry Representatives

“if anyone ever identified any ingredient in tobacco smoke as being hazardous to human health or being something that shouldn’t be there, we could eliminate it. But no one ever has.”

James Bowling, Philip Morris Vice President, 1976 (Bowling and Taylor, 1976)

What The Tobacco Industry Knew About Smokers

“Given a cigarette that delivers less nicotine than he desires, the smoker will subconsciously adjust his puff volume and frequency, and smoking frequency, so as to obtain and maintain his per hour and per day requirement for nicotine.....“

C. Teague, RJ Reynolds (1972)

Vents provide ventilation reducing machine scores but smokers can easily cover them

“Lighter” cigs usually are more ventilated and more readily enable compensatory smoking

Statements by Industry Representatives

“ Marlboro Lights cigarettes were not smoked like regular Marlboros. There were differences in the size and frequency of the puffs, with larger volumes taken on Marlboro Lights by both regular Marlboro smokers and Marlboro Lights smokers.”

Goodman B. Marlboro-Marlboro Lights Study Delivery Data.

Philip Morris; 1975. Bates No. 1001900842

Hazard ratios for lung cancer in men, 1982-8, by smoking status and tar yield of brand smoked, relative to current smokers of brands with tar ratings 15-21 mg

Harris, J. E et al. BMJ 2004;328:72

Copyright ©2004 BMJ Publishing Group Ltd.

Sales, Revenues and SAM 1964-2002

Sales, revenues and market shares extracted from Maxwell Reports, SEC 10-k filings, SAM calculated using CDC’s SAMMEC method.

Total cigarettes sold 1964-2002Reynolds Am. (incB&W, AT): 11,500 billions

Philip Morris: 6,600 billions

Lorrilard: 1,800 billions

Liggett: 870 billions

Total: 20, 770 billion cigarettesRevenue: $600 billions

Estimated Premature Deaths Caused (by cigs sold 1964-2002)

Reynolds Am. (incB&W, AT): 7.1 million

Philip Morris: 4.6 million

Lorrilard: 1.2 million

Liggett: 900,000

Total: 13.4 million premature deaths caused

August 17th, 2006, Tobacco Industry Loses DOJ lawsuit.

U.S. District Judge Gladys Kessler says:- “They mounted a coordinated, well financed,

sophisticated public relations campaign to attack and distort the scientific evidence demonstrating the relationship between smoking and disease.”

- “The evidence …proves that defendents have engaged in a massive 50-year scheme to defraud the American public.”

Is History Repeating Itself?

Eclipse (RJ Reynolds)

Advance (B&W)

Examples of toxic constituents in tobacco smoke, from over 4,000 identified chemicals.

Tar, Nicotine, CO CarbonylsFormaldehyde, Acetaldehyde, Acetone, Acrolein, Propionaldehyde, Crotonaldehyde, Methyl-Ethyl-Ketone, Butyraldehyde

PhenolicsHydroquinone, Resorcinol, Catechol, Phenol, Cresol (m+p and o) Benzo[a]pyrene Aromatic Amines3- and 4-aminobiphenyl, 1- and 2- aminonapthlene, o-toluidine, o-anisidineOxides of Nitrogen NO, Nox Hydrogen CyanideHCNAmmoniaNH3 VolatilesBenzene, Toluene, 1,3-butadiene, Isoprene, AcrylonitrileSemi-VolatilesPyridine, Quinoline, Styrene Trace Metals Nickel (Ni)

Cadmium (Cd) Lead (Pb) Chromium (Cr) Arsenic (As) Selenium (Se) MercuryMercury (Hg) Tobacco Specific NitrosaminesN-Nitrosonornicotine (NNN)

N-Nitrosoanabasine (NAB) Nitrosoanatabine (NAT)4-(N-nitrosomethylamino)-1-(3-pyridyl)-1-butanone (NNK)

Volatile NitrosaminesN,N-Nitrosodimethylamine (NDMA)N-Nitrosopyrrolidine (NPYR), N,N-Nitrosodiethylamine (NDEA)N,N-Nitrosoethylmethylamine (NEMA), N,N-Nitrosodipropylamine (NDPA)N,N-Nitrosodibuthylamine (NDBA), N-Nitrosopiperidine (NPIP)

Polycyclic Aromatic HydrocarbonsNaphthalene, 1-Methylnaphthalene, 2-methylnaphthalene, Acenaphthylene

Acenaphthene, Fluorene, Phenanthrene, Anthracene, FluoranthenePyrene, Benzo(a)anthracene, Chrysene, Benzo(b)fluorantheneBenzo(k)fluoranthene, Benzo(j)fluoranthene, Benzo(g,h,l)peryleneBenzo(e)pyrene, Benzo(a)pyrene, PeryleneIndeno(1,2,3,-cd)pyrene, Dibenzo(a,h)anthraceneDibenz(a,j)acridine, Dibenz(a,h)acridine, Dibenz(a,e)pyreneDibenz(a,h)pyrene, Dibenz(a,i)pyrene, Dibenz(a,l)pyrene7H-Dibenzo(c,g)carbazole,

Heterocyclic Aromatic Amines2-Amino-3-methylimidaszo(4,5-f)quinoline (IQ)2-Amino-3,4-dimethylimidazo(4,5-f)quinoline (MeIQ)2-Amino-3-methyl-9H-pyrido(2,3-b)indole (MeAaC)2-Amino-9H-pyrido(2,3-b)indole (AaC)1-Methyl-9H-pyridol(3,4-b)indole (Harman)9H-Pyrido(3,4-b)indole (Norharman)

Completely eliminate 2 of the toxic constituents [Lead and B(a)P]. How much less harmful is

that cigarette? Can anyone guess? Tar, Nicotine, CO CarbonylsFormaldehyde, Acetaldehyde, Acetone, Acrolein, Propionaldehyde,

Crotonaldehyde, Methyl-Ethyl-Ketone, ButyraldehydePhenolicsHydroquinone, Resorcinol, Catechol, Phenol, Cresol (m+p and o) Benzo[a]pyrene Aromatic Amines3- and 4-aminobiphenyl, 1- and 2- aminonapthlene, o-toluidine, o-anisidineOxides of Nitrogen NO, Nox Hydrogen CyanideHCNAmmoniaNH3 VolatilesBenzene, Toluene, 1,3-butadiene, Isoprene, AcrylonitrileSemi-VolatilesPyridine, Quinoline, Styrene Trace Metals Nickel (Ni)

Cadmium (Cd) Chromium (Cr) Arsenic (As) Selenium (Se) MercuryMercury (Hg) Tobacco Specific NitrosaminesN-Nitrosonornicotine (NNN)

N-Nitrosoanabasine (NAB) Nitrosoanatabine (NAT)4-(N-nitrosomethylamino)-1-(3-pyridyl)-1-butanone (NNK)

Volatile NitrosaminesN,N-Nitrosodimethylamine (NDMA)N-Nitrosopyrrolidine (NPYR), N,N-Nitrosodiethylamine (NDEA)N,N-Nitrosoethylmethylamine (NEMA), N,N-Nitrosodipropylamine (NDPA)N,N-Nitrosodibuthylamine (NDBA), N-Nitrosopiperidine (NPIP)

Polycyclic Aromatic HydrocarbonsNaphthalene, 1-Methylnaphthalene, 2-methylnaphthalene, Acenaphthylene

Acenaphthene, Fluorene, Phenanthrene, Anthracene, FluoranthenePyrene, Benzo(a)anthracene, Chrysene, Benzo(b)fluorantheneBenzo(k)fluoranthene, Benzo(j)fluoranthene, Benzo(g,h,l)peryleneBenzo(e)pyrene, PeryleneIndeno(1,2,3,-cd)pyrene, Dibenzo(a,h)anthraceneDibenz(a,j)acridine, Dibenz(a,h)acridine, Dibenz(a,e)pyreneDibenz(a,h)pyrene, Dibenz(a,i)pyrene, Dibenz(a,l)pyrene7H-Dibenzo(c,g)carbazole,

Heterocyclic Aromatic Amines2-Amino-3-methylimidaszo(4,5-f)quinoline (IQ)2-Amino-3,4-dimethylimidazo(4,5-f)quinoline (MeIQ)2-Amino-3-methyl-9H-pyrido(2,3-b)indole (MeAaC)2-Amino-9H-pyrido(2,3-b)indole (AaC)1-Methyl-9H-pyridol(3,4-b)indole (Harman)9H-Pyrido(3,4-b)indole (Norharman)

Tobacco Harm Reduction

An intervention (policy, advice, treatment etc) designed to reduce the harm to health from tobacco,

without requiring complete abstinence from all tobacco

constituents (including nicotine) within 6 months

Types of Tobacco Harm Reduction1. Smokers reduce their cigarette consumption (not clearly effective).2. Smokers switch to long term nicotine replacement therapy (may be effective).3. Smokers use NRT during temporary abstinence to reduce nicotine withdrawal symptoms (may be effective for withdrawal, but unclear effects on smoking).4. Smokers switch to potentially less harmful type of smoking product.5. Smokers switch to potentially less harmful type of smokeless tobacco.

What about this product? Cigarette? Drug?

Source - http://www.nicstic.com/engl/index.php.

Same question - Cigarette? Drug?

Electronic Cigarette: • “Electronic Cigarette consists of a stainless steel

shell, lithium ion battery, micro-electronic circuit, atomizing chamber, and indicator light at the head of the Electronic Cigarette.”

• “It can make smokers enjoy the same pleasure as that of traditional cigar when inhaling the nicotine smog droplet, imitating the whole process of smoking.”

• “To quit the tobacco and nicotine smoking, Electronic Cigarette can be used with the four basic tastes such as the high, medium, low and zero nicotine thickness cartridges to meet the requirements of different smokers.”

Source: http://www.quism.net/elecig.html.

battery electronic circuit

atomizing chamber

cartridge inhaler

What is “markedly less harmful” ?

Nothing that involves the inhalation of combustion products.

Combustion creates an unavoidably toxic cocktail.

i.e. Omni, Eclipse, Advance etc would not be “markedly less harmful”.

What is “markedly less harmful” ?

Nicotine delivery products that do not require inhalation of combustion products or deliver concentrations of toxic chemicals likely to cause disease.

e.g. nicotine replacement therapies, and potentially low-nitrosamine smokeless tobacco products (e.g. snus, Ariva, Interval)

Smoking-Caused Mortality

1. Cancer (mainly of the lung) 39%.2. Cardiovascular (mainly MIs) 34%.3. Respiratory (mainly COPD) 20%4. Others (ETS, Perinatal etc) 7%

Source: Fellows & Trosclair, MMWR, 2002

Annual Smoking-Caused Morbidity

1. Respiratory: (59%)2. Cardiovascular: (27%).3. Cancer: (13%).

For each person killed by smoking each year there are over 20 alive and suffering a serious smoking-caused disease – mainly chronic respiratory diseases.

Source: Hyland et al, MMWR 2003

Feeling exiled? Never miss a moment.

www.myexalt.com

TSNA Levels in Oral Snuff (ug/g)

128

64

41

17 7.52.8

0

20

40

60

80

100

120

140

Silver CreekSkoalCopenhagenKodiakTimberWolfEttan

TSNAug/g

Silver Creek Skoal Copenhagen Kodiak Timber EttanWolf

Source: American Health Foundation, 2001

TSNA Levels and Aging

41.1

2.8

60.6

4.2

75.9

2.6

94.3

2.70

102030405060708090

100

0 2 4 6

Copenhagen (UST)Ettan (Swedish Match)

TSNALevels

Source: American Health Foundation 2001(in months)

Minimize Risk

• Don’t sell cigarettes or any other smoked products – they maximize risk.

• Don’t sell defective products in which the concentration of carcinogens increases significantly as the product sits on the shelf.

• Produce and aggressively market high quality, minimal risk, consumer acceptable smokeless products.

Minimize Risk

• Minimal risk = below Gothiatek standard for all toxins, esp. TSNAs, B(a)P .

• Consumer acceptable = adequate nicotine delivery to give a boost in blood nicotine concentration of 10 ng/ml within 10-15 minutes.

• Marketing strategy should NOT be to keep people smoking where its allowed.

What is Swedish snus?Moist fine-ground oral tobacco predominantly from air-cured dark tobaccos selected for low carcinogencity

Manufactured by a pasteurizing-like heating process (without any fermentation as used in most manufacturing procedures for American snuff)

∎ TSNA content: < 5 mg/kgB(a)P content: < 10 µg/kg

•Low TSNA content and low mutagenic activity compared with smokers (similar to non users)High pH (7.8-8.5) – facilitates nicotine absorption

Gothiatek standard: voluntary toxicity standard used for snus by Swedish

Match Tobacco CompanyToxin Limit (wet weight, 50% H2O)Nitrate 3.5 mg/kgT.S.N.A 5 mg.kgNDMA 5 micrograms/kgBaP 10 micrograms/kgCadmium 0.5 mg/kgLead 1.0 mg/kgArsenic 0.25 mg/kgNickel 2.25 mg/kgChromium 1.5 mg/kg

0

5

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0 5 10 15 20 25 30 35 40 45 50 55 60

Minutes

Plas

ma

nico

tine

Con

cent

ratio

n (n

g/m

L)

Cigarette 2 g. Swedish snus 2 mg. gum 21 mg. patch

Health Effects of Snus

• Causes Nicotine Dependence (similar to cigarettes)

• Causes oral lesions but NOT oral, gastric or head/neck cancer.

• May increase cardiovascular risks, but less than cigarettes (5 studies find no increase, one finds increased M.I. risk).

• May increase pancreatic cancer risk but less than smoking

• Almost certainly harmful to unborn fetus (though less so than cigarettes).

• No effects on respiratory disease/lung cancer.

Sales of Snus and Cigarettes in Sweden 1916 - 2002 (Source: Swedish Match 2001)

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%%

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1976 1980 1985 1988 1996 2000 20020

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Daily snus use, womenDaily snus use, men

Daily smoking, womenDaily smoking, men

1976-1988 NTS-surveys, 1996-2002 ITS/FSI-surveysRamstrцm 2003

Prevalence of daily moking and daily snus useMen and women (age 18-70) in Sweden 1976-2002

Observations (bars) and least square regression lines

Successful quitters (men)

71,3% ofex-smokershad not usedsnus to quit

28.7% hadused snusto quit

2/3 of thembecame chronic users(16%)

Quit snus

also

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0.9

1

1987 1988 1989 1990 1991 1992 1993 1994 1995

Year

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ativ

e ris

k st

anda

rdiz

ed to

198

7 =

1 1

Men age 30-64 Women age 30-64

Trends in Per Capita Consumption of Various Tobacco Products – United

States, 1880-2000

Source: Tobacco Situation and Outlook Report, U.S. Department of Agriculture, U.S. CensusNote: Among persons >18 years old.

Beginning in 1982, fine-cut chewing tobacco was reclassified as snuff.

0

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Cigarettes Cigars Pipe/Roll your own Chewing Snuff

Conclusion

The tobacco industry should immediately be focusing on producing and selling low-toxicity smoke-free products, with a rapid exit strategy from all combustion products (cigarettes, cigars etc).

If you don’t do this rapidly I believe you will start to lose more product liability law-suits based on needlessly persisting in selling a defective product, and you will be regulated out of existence by gradually tighter product regulation focusing on nicotine.