Clearing the Smoke Assessing the Science Base for Tobacco Harm Reduction (2001) / Chapter Skim
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4 Products for Tobacco Exposure Reduction
4 Products for Tobacco Exposure Reduction
Pages 82-139
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From page 82... ...
Some modifications have had the potential for harm reduction. This section describes current tobacco products, including the curing and processing of tobacco, design features (both historical and contemporary)
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From page 83... ...
Smokeless tobacco includes tobacco that is sniffed, dipped, or chewed according to the type and constitution of the tobacco. Smokeless tobacco products are made from dark or burley-leaved tobacco.
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From page 84... ...
Bright tobacco has medium nicotine content. Air curing uses heat only to maintain temperature and humidity, not to speed the curing process.
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From page 85... ...
Almost all commercial tobacco products, however, use N tabacum species and a small amount of N
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From page 86... ...
and their relative contribution to overall toxicity compared to compounds such as TSNA, BaP, and carbon monoxide (CO) is not definitively known.
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From page 87... ...
The degree of ventilation allowed by the paper can be manipulated in the production process. More porous cigarette paper has been shown to reduce smoke yields of CO and tar as well as volatile nitrosamines, TSNAs, and BaP through dilution.
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From page 88... ...
The majority of cigarettes sold in the United States today have cellulose acetate filters. Most cellulose acetate filters reduce tar and nicotine yields by 40-50% compared to nonfiltered cigarettes (Davis and Neilson, 1999~.
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From page 89... ...
Machine-generated smoke yield tests, however, position cigarettes so that the ventilation holes are exposed. Jenkins and colleagues conducted a study in 1982 comparing smoke yields between open and blocked tip ventilation.
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From page 90... ...
Tar Yield VF-A 3.8+0.5 9.4+0.9 VF-C 2.9+0.6 7.6+0.9 VF-D 1.6+0.2 9.7+0.8 F-A 18.5+1.2 ND F-C 16.4+1.4 13.2+0.6 F-D 9.9+0.8 11.7+1.3 NF-A 22.5+1.0 21.3+1.5 NF-C 19.4+1.1 21.3+1.0 Nicotine Yield VF-A 0.40+0.05 0.72+0.05 VF-C 0.25+0.04 0.45+0.03 VF-D 0.19+0.05 0.62+0.07 F-A 1.09+0.07 ND F-C 0.94+0.02 0.71+0.06 F-D 0.61+0.02 0.68+0.10 NF-A 1.14+0.05 1.37+0.07 NF-C 1.13+0.13 1.6+0.23 Carbon Monoxide Yield VF-A 4.1+0.7 12.3+1.5 VF-C 2.1+0.2 8.7+1.2 VF-D 1.0+0.1 10.7+0.4 F-A 15.7+1.8 ND F-C 13.4+1.2 17.9+1.2 F-D 8.5+0.3 11.5+0.7 NF-A 11.3+1.0 12.8+2.7 NF-C 11.3+1.2 12.9+0.8 NOTE: F=filter; ND=not determined; NF=nonfilter; VF=ventilated filter; A,C,D=different brands. SOURCE: Modified from Jenkins et al., 1982 in NIH, 1996.
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From page 91... ...
Currently Available and Novel PREPs Modifications of Conventional Tobacco Products (See Table 4-2) A new curing process is being used for the production of tobacco with substantially reduced tobacco-specific nitrosamines (Star Scientific, 1999~.
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From page 92... ...
A package insert for Advance cigarettes lists these findings as reported independently by the FTC and the Massachusetts Department of Public Health. Smokeless Tobacco Products Currently, most smokeless tobacco users in the United States use moist snuff.
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Cigarette-like Products Aside from modifications of traditional tobacco products, there has been a recent introduction of cigarette-like products.
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From page 94... ...
Reynolds Tobacco Company, 2000~. The advertisements for Eclipse also address social acceptance because it produces no ash and substantially less visible environmental tobacco smoke (ETS)
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From page 95... ...
A recent study indicates that smokers who switch to Accord under experimental conditions are exposed to minimal CO and less nicotine compared to their usual brand (Buchhalter and Eissenberg, 2000~. PHARMACEUTICAL PRODUCTS Unlike tobacco products, medications developed to aid smoking cessation have undergone rigorous scientific and regulatory examination.
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From page 96... ...
Currently, these pharmaceuticals are not recommended solely for the purposes of reducing the number of cigarettes or as a step toward achieving abstinence, to treat withdrawal symptoms or craving in situations when smoking is not allowed, or for quitting tobacco products other than cigarettes. In addition, the safety and efficacy of these medications in pregnant smokers have not been determined, and the use of medications to aid smoking cessation in this population has been delegated to the discretion of the physician.
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From page 97... ...
In 1991 and 1992, the United States was introduced to nicotine patches distributed by four different pharmaceutical companies. The first patch introduced in the U.S.
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From page 98... ...
The route of administration will contribute to the side-effect profile and contraindications (see Table 4-3~. Contraindications include smokers in the immediate postmyocardial infarction period with serious arrhythmias TABLE 4-3 Side Effects and Contraindications of Nicotine Replacement Products Product Most Frequent Side Effects Contraindications Nicotine Gum Jaw ache, mouth soreness, TMD, Dentures dyspepsia, hiccups Nicotine Inhaler Local irritation of mouth Allergy to menthol and throat, coughing, rhinitis Nicotine Patch Local skin reaction, sleep Skin disorders disruption Nicotine Spray Nasal and airway irritation Reactive airway disease, sinusitis Bupropion Insomnia and dry mouth Seizures, concurrent use of MAO inhibitors, history of eating disorders NOTE: MAO=Monoamine Oxidose; TMD=temporomandibulor joint disfunction.
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From page 99... ...
also varies across products. The nicotine replacement product that has the shortest TmaX is nicotine nasal spray followed by nicotine inhaler, nicotine gum, and finally the nicotine patch (see Figure 4-1 and Table 4-5~.
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From page 100... ...
The fastest time for maximum nicotine concentration occurs with cigarettes, followed by nicotine nasal spray, smokeless tobacco, then other nicotine replacement agents. Smokeless tobacco appears to take longer or seems equal in time to reach maximum
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From page 101... ...
Of the few nicotine replacements studied, withdrawal symptoms and the rate of use beyond the recommended period for the nicotine patch appear to be minimal and the abuse potential appears to be low (see deWit and Zacny, 1995; Hughes, 1998~. In clinical trials, prolonged use of nicotine gum (e.g., 12 months)
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From page 102... ...
Sustained abstinence was the primary outcome examined, rather than point prevalence, although point prevalence rates TABLE 4-6 Costs for Tobacco Products and FDA-Approved Medicationsa Product Cost per Day Cigarettes (20 per day) Smokeless tobaccob Nicotine gum Nicotine inhaler Nicotine patch Nicotine spray Bupropion $1.70-$4.85 per pack $1.88-$2.00 $4.26-$6.87 (10 2-4 mg pieces)
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From page 103... ...
Other nicotine replacement products are likely to be developed in the future. It is likely that nicotine replacements with a faster speed of delivery that mimic the effects of cigarettes will be explored, with the hopes that such delivery devices would be safer than nicotine-containing tobacco products.
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From page 104... ...
The use of the nicotine patch would result in a steadystate trough level of nicotine to prevent withdrawal symptoms, whereas the ad libitum product could be used during periods when an urge to smoke is experienced. Treatment studies have been conducted that examine a combination of nicotine gum and patch (Kornitzer et al., 1995~; nicotine spray and patch (Blondal et al., 1999~; and nicotine inhaler and patch (Westman et al., 2000~.
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From page 105... ...
, the efficacy of this product has been attributed to an increase in dopamine levels. Dopamine levels are increased by nicotine and constituents in tobacco smoke, and this increase is thought to be responsible for some of the positive reinforcing effects of cigarette smoking.
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From page 106... ...
In another study, bupropion and bupropion plus nicotine patch were observed to be more effective than placebo or nicotine patch alone, although in this study the efficacy of the patch was unusually poor (Jorenby et al., 1999~. Based on the PHS metaanalyses of these two studies, the OR was 2.1 (95% CI=1.5, 3.0)
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From page 107... ...
Clinical trials have focused on the use of a combination of mecamylamine and the nicotine patch. The rationale behind this antagonistagonist combination is that both mecamylamine and nicotine from the patch would block the reinforcing effects of nicotine by occupying the nicotinic receptor sites.
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From page 108... ...
Although, earlier studies showed some promise for naltrexone as a smoking cessation aid, long-treatment outcome success has not been enhanced by naltrexone over placebo, even in combination with the nicotine patch (Won" et al., 1999~. Medications That Target Other Systems Clonidine is another antihypertensive that has been used to promote smoking cessation.
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From page 109... ...
Effects on withdrawal symptoms have also been equivocal, with some studies showing positive effects of this medication in reducing withdrawal symptoms (Gawin et al., 1989; Hilleman et al., 1992) and other studies showing no effect (Cincirpini et al., 1995; Robinson et al., 1992; Schneider et al., 1996; West et al., 1991~.
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From page 110... ...
With the introduction of OTC nicotine patch and nicotine gum, the estimated number of pharmacological quit attempts increased from two million to three million in 1993-1995 to six million in 1996 with numbers increasing in 1997 and remaining stable in 1998 (CDC, 2000~. Successful quitting has been estimated to increase by 6%-20% when OTC products are made available compared to when only prescription products are available (Lawrence et al., 1998; Shiffman et al., 1998~.
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From page 111... ...
This situational use of nicotine replacement may indirectly lead to reduced smoking, as well. Third, harm reduction may also include long-term maintenance on a medication as a relapse prevention aid and not merely a smoking cessation aid.
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From page 112... ...
may reduce work-related accidents, which have been observed to increase during periods of tobacco withdrawal (Waters et al., 1998~. Use of Pharmacological Agents for Tobacco Exposure Reduction The use of nicotine replacements for tobacco exposure reduction has been suggested to minimize compensatory smoking behavior when reducing the number of cigarettes smoked (Shiffman et al., 1998~.
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From page 113... ...
They concluded by saying that high-dose nicotine has the potential to substantially reduce smoking and thereby harm. Current studies, which have examined the use of nicotine replacements for the primary purpose of cigarette use reduction, have shown substantial decreases in the number of cigarettes smoked and levels of carbon monoxide (Fagerstrom et al., 1997; Rennard et al., 1990~.
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. Nicotine replacements have been shown to reduce craving as well as withdrawal symptoms (Hughes et al., 1989)
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From page 115... ...
Longterm use of nicotine replacements may also be effective in sustaining abstinence and is less toxic than a relapse to smoking. There is a great need for large and long-term clinical trials to determine whether different pharmacological agents, including products other than nicotine replacements, can lead to prolonged and significant reductions in smoking and less harm to individuals.
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From page 116... ...
OTHER POTENTIAL HARM REDUCTION METHODS: BEHAVIORAL STRATEGIES AND TOBACCO CONTROL POLICIES Altering tobacco products and using pharmacological agents to reduce smoking are not the only methods of harm reduction. Behavioral methods and tobacco control policies have also led to reduced smoking.
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From page 117... ...
In general the results showed a mean reduction of 56% in the nicotine content of cigarettes, 28% in the number of cigarettes, and 19% in the percentage of cigarette smoked in the controlled smoking conditions. Studies have also been conducted to determine long-term maintenance of reduced smoking and the rate of cessation attempts among these individuals.
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From page 118... ...
This behavioral method systematically reduces the level of nicotine exposure, disrupts habitual smoking patterns, and gives smokers the opportunity to develop new behaviors or skills in response to cues associated with smoking. Summary and Recommendations In summary, the results from these studies show that smokers can reduce their smoking rate using behavioral methods, that this rate can be sustained over time, and that reduced smoking does not necessarily compromise cessation efforts.
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From page 119... ...
Increased taxes on smokeless tobacco also result in a reduction in the amount used as well as the frequency of use (Chaloupka et al., 1996~. Workplace smoking restrictions have also significantly reduced the consumption of cigarettes (IOM, 2000~.
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From page 120... ...
Other tobacco control policies include tobacco advertisement bans and limiting access of adolescents to tobacco products. While a limited set of tobacco advertising restrictions have no effect on tobacco consumption, comprehensive tobacco advertising bans have reduced tobacco consumption by more than 6% and counter advertising by 2% (Saffer and Chaloupka, 1999~.
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From page 121... ...
. Other approaches include reducing tobacco consumption, by use of either pharmacotherapies, behavioral strategies, or polices that restrict access to tobacco products.
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From page 122... ...
Finally, a number of regulatory issues will have to be addressed. REGULATION OF EXPOSURE REDUCTION PRODUCTS Drugs The regulatory system in the United States for therapeutic drugs, administered by the Food and Drug Administration, is the most stringent regulatory system in our society for new products.
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From page 123... ...
. Nicotine-containing drugs are currently approved by the FDA only to reduce withdrawal symptoms as an aid in smoking cessation.
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From page 124... ...
In 1996, the FDA claimed regulatory authority over cigarettes and smokeless tobacco products on the grounds that a cigarette is a medical device intended to deliver the drug nicotine. This resulted in extensive litigation between the FDA and the tobacco industry, the details of which are included in the next section.
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From page 125... ...
The Food, Drug and Cosmetic Act (FDCA) , however, is silent with respect to tobacco products and thus stands as a potential
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From page 126... ...
Following this investigation, the FDA asserted its jurisdiction and proposed regulation of certain tobacco products in the Federal Register in August 1995. The authority for such regulation was based on new evidence showing that cigarettes and smokeless tobacco products are nicotinecontaining (i.e., drug-containing)
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From page 127... ...
, which upheld the FDA's regulatory authority over tobacco products and supported the FDA definition of tobacco products as combination drug and drug delivery devices. The court, however, ruled that the FDA had no statutory authority to regulate tobacco advertising or promotion.
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From page 128... ...
For example, an exposurereducing claim for a smokeless tobacco product, to the effect that it (like nicotine patches) promotes cessation of smoking, could be judged by the FDA as a drug claim requiring approval under a new drug application.
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From page 129... ...
The contrast between the regulatory systems for drugs or devices and for tobacco has been discussed by a number of authors (Henningfield, and Slade, 1998; O'Reilly, 1989; Page, 1998; Slade and Henningfield, 1998; Warner et al., 1997) , who point out the paradox of a stringent regulatory system for exposure reduction products developed by the pharmaceutical industry and a weak regulatory system for exposure reduction products developed by tobacco manufacturers.
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From page 130... ...
1988. Nicotine absorption and cardiovascular effects with smokeless tobacco use: comparison with cigarettes and nicotine gum.
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From page 131... ...
1999. Mentholated cigarette smoking and lung-cancer risk.
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From page 132... ...
1993. Effectiveness of nicotine patch and nicotine gum as individual versus combined treatments for tobacco withdrawal symptoms.
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From page 133... ...
1992. Effect of transdermal nicotine patches on cigarette smoking: a double blind crossover study.
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From page 134... ...
1998. Dependence on and abuse of nicotine replacement medications: an update.
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From page 135... ...
1998. Does over-the-counter nicotine replacement therapy improve smokers' life expectancy?
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From page 136... ...
1998. Federal regulation of tobacco products and products that treat tobacco dependence: are the playing fields level?
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1994. Mecamylamine combined with nicotine skin patch facilitates smoking cessation beyond nicotine patch treatment alone.
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From page 138... ...
1976. Plasma nicotine levels after cigarette smoking and chewing nicotine gum.
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From page 139... ...
1995. Analysis regarding the Food and Drug Administration's jurisdiction over nicotine-containing cigarettes and smokeless tobacco products.
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