Transcript Presentation by Herb Severson

New Tobacco Products: Harm
Reduction or Harm Induction?
Herbert H. Severson
Senior Research Scientist
Oregon Research Institute
Eugene, Oregon
Harm Reduction Definition
Harm reduction refers to minimizing
harms and decreasing total morbidity
and mortality, without completely
eliminating tobacco and nicotine use
Institute of Medicine study, 2001
New Products
Lower tobacco-specific nitrosamines
 Spitless
 In neat packets
 Different flavors
 Snus products produced by American
Tobacco Companies

New Smokeless Products
Urgency for Research
Increased advertising directed at
smokers and influx of new products
 Controversy over the use of smokeless
tobacco as a harm reduction agent
 Little data to determine the impact of
these products and to support it’s use as
a harm reduction agent

State of affairs
Scientific consensus on lower risks to
individual users of ST
and at the same time
 Adamant dissension, sometimes bitter
& personal, on whether ST can help to
reduce population tobacco harm

What We Know - Point #1
Wide variability in tobacco-specific
nitrosamines (TSNAs) in noncombustible oral products
 Considerable levels of carcinogenic
tobacco-specific nitrosamines even in
newer oral tobacco products

Tobacco-Specific Nitrosamines
Across Products
Product
µg/g product (wet weight)
NNN NNK
NAT
NAB
Total
Copenhagen Snuff
2.20
0.75
1.80
0.12
4.80
General Snus
0.98
0.18
0.79
0.06
2.00
Camel Snus (frost)
0.83
0.16
0.14
0.01
1.12
Taboka
0.91
0.06
0.23
0.00
1.27
Revel
0.62
0.03
0.32
0.02
0.99
Ariva
0.02
0.04
0.12
0.01
0.19
nd
nd
nd
nd
nd
Commit
(lozenge, 2 mg nicotine)
What We Know - Point #2

Significant reductions in toxicant
uptake can occur when tobacco users
switch from products with higher
TSNAs to products with lower TSNAs
Urinary Total NNAL in Smokeless Tobacco Users
Who Switched to Snus or Nicotine Patch
Mean total NNAL (pmol/mg creatinine)
4.5
4
3.5
3.2
3
2.8
2.8
2.5
2
1.5
1.5
*
1.4
*
0.3
Snus (N=19)
49% reduction
1
0.5
0.5
0
0.5
* P< 0.01
Baseline
Week 2
Visit
Patch (verified, N=15)
Patch (N=22)
0.2 89-90% reduction
Week 4
What We Know - Point #3
Wide variability in levels of free
nicotine in oral tobacco products
 Considerable amounts of free nicotine
in some of the newer tobacco
products that may sustain addiction

What We Know: Wide Variability in
Nicotine Levels Across Products
Nicotine (mg/g dry weight)
Product
pH
Copenhagen Long Cut
7.53
26.7
7.14
Skoal Long Cut
7.51
25.6
6.03
Marlboro Snus Rich
6.80
25.2*
1.42*
Camel Snus Original
7.46
28.2
6.09
General Snus
7.95
16.7
7.69
Total
Free
* increased in the past year: 2008 values; total 17.8, free 1.08
I. Stepanov et al, Nicotine Tob. Res. 12: 1773 (2008)
What We Know
Products with lower TSNAs are not
benign
 Oral pathologies
 Pancreatic cancer
 Metabolic syndrome
 Fetal toxicity
 Cardiovascular disease?
Reasons for opposing use of ST for
reducing population tobacco harm
1. “Main concern with marketing ST as
cessation aid or substitute for cigarettes”
“(a) . . . limited studies to show that
the dual use of smokeless
tobacco and cigarettes is not as
harmful or more harmful than the
single use of these products.”
Sequential or Concurrent Dual Use?

Sequential “dual” use (moving completely off
cigarettes to ST) will very likely show some
reduction in smoking-caused diseases—as a
function of duration of smoking & daily dose of
smoking

As with dual use of NRT and cigarettes in
smokers who do not want to quit smoking*,
because nicotine intake is somewhat
regulated, total intake of smoke toxins is
unlikely to rise with dual use and will likely
decrease
* Fagerstrom, KO, Tejding R, Westin A, Lunell E. Aiding reduction of smoking with
nicotine replacement medications: hope for the recalcitrant smoker? Tob Control.
1997 Winter;6(4):311-6.
2. “Main concerns with marketing ST as
cessation aid or substitute for cigarettes”
“(b) Aggressive marketing of smokeless
tobacco as less risky than cigarettes may
not necessarily lead to reduced total
tobacco use but increased use, especially
newly initiated use.”
“Main concerns with marketing ST as
cessation aid or substitute for cigarettes”
“(c) Oral smokeless tobacco products are
not harmless . . . .”
[There is a need for a regulatory
authority to set a] “lower standard for
toxins and require disclosure over
these products” [to be able to] “assess
true harm from oral tobacco use.”
New FDA Regulations may develop these
standards
“Main concerns with marketing ST as
cessation aid or substitute for cigarettes”
“. . . (d) smokeless tobacco use may
be a gateway to using cigarettes.
Whereas few smokers switch to
smokeless tobacco, a greater
number of smokeless tobacco users
switch to cigarettes, a more deadly
product
“No Consensus on Gateway”

In support for gateway
Tomar SL. Is use of smokeless tobacco a risk factor for
cigarette smoking? The U.S. experience. Nicotine and
Tobacco Research, 2003;5(4):561-70.
Severson, H.H., Forester, K.A., & Biglan, A. (2007). Use of
smokeless tobacco is a risk factor for cigarette smoking.
Nicotine & Tobacco Research 9(12); 1331-1337.


In opposition to gateway


O’Connor RJ, Flaherty BP, Edwards BQ, et al. Regular
smokeless tobacco use is not a reliable predictor of smoking
onset when psychosocial predictors are included in the model.
Nicotine and Tobacco Research, 2003; 5(4), 535-44.
Ramstrom LM, Foulds J Role of snus in initiation and
cessation of tobacco smoking in Sweden. Tob Control. 2006
Jun;15(3):210-4.
Arguments For ST Use for Cigarette
Harm Reduction
Fewer negative health consequences
associated with smokeless tobacco use
compared to cigarettes
 Swedish snus experience

Arguments Against ST Use for
Cigarette Harm Reduction
ST use is harmful and less harmful
products are available
 ST use leads to nicotine addiction
 ST may facilitate use of cigarettes
 Quitting ST is difficult

NIH State-of-the-Science Conference on Tobacco
Use: Prevention, Cessation, and Control
Data about the effectiveness of ST in
facilitating smoking cessation and
associated harm reduction are very limited.
High-quality comparisons of ST to proven
pharmacologic and behavioral cessation
interventions are needed
http://consensus.nih.gov/
What We Need to Learn







Level of toxicants in these newer products
Addictive potential of these products
Consumer perception of these products
Use of these products by consumers
Health impact of these newer products
Effectiveness of products as a smoking
cessation aid
What impact these products have on a
population level (e.g., rate of initiation,
maintenance, or precipitation of relapse)
Harm Reduction Study
Hatsukami and Severson
Randomized clinical trial comparing the
efficacy of oral tobacco and
pharmaceutical nicotine lozenges in
smoking cessation
 Acceptability of ST products for
cessation
 Assess the toxicity of tobacco exposure
for participants in the RCT


Funded by the National Cancer Institute
Product Preference of Six Oral
Tobacco Products

Provide data on preference of ST products



Subjective rating of product
Withdrawal symptoms during ST use
Optional: Can choose to quit smoking using ST
choice
ST Products Used in Study 1

Compared:





Camel Snus – Mellow & Frost
Marlboro Snus – Peppermint & Rich
General Snus (Swedish)
Stonewall – Java, Wintergreen, & Natural
Ariva – Java & Wintergreen
ST Product Preference Study Design
Subject Orientation
Baseline Week 0
1 Week Data Collection
Sample Weeks 1 – 2
Three Oral Tobacco Products per Week
Cessation Weeks 3 – 4
Smoking Cessation Using Product of Choice
Week 5
Oral Tobacco Cessation
Week 9
Follow-Up Phone Call
Conclusion
Whether smokeless tobacco is a viable
treatment method for smoking cessation
is unknown
 Developing more rapid and acceptable
methods of nicotine delivery may be
better alternative to using smokeless
tobacco
