New Tobacco Products: Harm Reduction or Harm Induction? Herbert H. Severson Senior Research Scientist Oregon Research Institute Eugene, Oregon
Jan 14, 2016
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 nitrosaminesSpitlessIn neat packetsDifferent flavorsSnus 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 timeAdamant 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 non-combustible 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
Commit (lozenge, 2 mg nicotine)
nd nd nd nd nd
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
1.4
3.2
1.5
0.5
0.2
2.82.8
0.50.3
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
Baseline Week 2 Week 4
Visit
Mea
n t
ota
l NN
AL
(p
mo
l/m
g c
rea
tin
ine)
* P< 0.01
*
*Patch (verified, N=15)
Patch (N=22)89-90% reduction
Snus (N=19)49% reduction
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
Product pHNicotine (mg/g dry weight)
Total Free
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
* increased in the past year: 2008 values; total 17.8, free 1.08I. Stepanov et al, Nicotine Tob. Res. 12: 1773 (2008)
What We Know
Products with lower TSNAs are not benignOral pathologies Pancreatic cancerMetabolic syndromeFetal toxicityCardiovascular disease?
Reasons for opposing use of ST for reducing population tobacco harm
“(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.”
1. “Main concern with marketing ST as cessation aid or substitute for cigarettes”
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.
“(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.”
2. “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 lower standard for toxinstoxins 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”
“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 addictionST may facilitate use of cigarettesQuitting 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 StudyHatsukami and Severson
Randomized clinical trial comparing the efficacy of oral tobacco and pharmaceutical nicotine lozenges in smoking cessation
Acceptability of ST products for cessationAssess 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
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