Karl Fagerström

Nicotine dependence versus smoking prevalence: comparisons among countries and categories of smokers.

OBJECTIVES: To collect available international data on nicotine dependence as defined by the Fagerström Test of Nicotine Dependence, and to compare levels of dependence among countries and categories of smokers. DATA SOURCES: Published and unpublished studies known to the authors and a search of EMBASE from 1985-1995. STUDY SELECTION: Studies included were those based on a nationally representative sample of a countrys population, or a sample of smokers seeking cessation assistance. DATA SYNTHESIS: Smokers who seek help in stopping smoking are much more dependent than the average smoker. Men consistently score higher on dependence than women. Ex-smokers appear to have lower dependence than current smokers. A country with low smoking prevalence, the United States, seems to have smokers with higher dependence scores than countries where smoking is more prevalent (such as Austria and Poland). CONCLUSIONS: Successful tobacco control may result in a higher dependence among the remaining smokers (due to selective quitting by low-dependent smokers). The remaining highly dependent smokers may need more intensive treatment.

European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health.

Rationale: This statement is an updated version of one released by the same authors in February 2003. The statement was produced to follow up the Royal College of Physicians (RCP) Tobacco Advisory Group report “Protecting smokers, saving lives: the case for a tobacco and nicotine regulatory authority”,1 which argued for an evidence based regulatory approach to smokeless tobacco and harm reduction and posed a series of questions that regulators must address in relation to smokeless tobacco. The purpose of this statement is to provide arguments of fact and principle to follow the RCP’s report and to outline the public health case for changing existing European Union (EU) regulation in this area. A review of regulation in relation to harm reduction and regulation of tobacco products other than cigarettes is required in Article 11 of EU directive 2001/37/EC,2 and this is a contribution towards forming a consensus in the European public health community about what policy the EU should adopt in the light of this review, or following ongoing legal action that may potentially strike out the existing regulation altogether. Public health case: We believe that the partial ban applied to some forms of smokeless tobacco in the EU should be replaced by regulation of the toxicity of all smokeless tobacco. We hold this view for public health reasons: smokeless tobacco is substantially less harmful than smoking and evidence from Sweden suggests it is used as a substitute for smoking and for smoking cessation. To the extent there is a “gateway” it appears not to lead to smoking, but away from it and is an important reason why Sweden has the lowest rates of tobacco related disease in Europe. We think it is wrong to deny other Europeans this option for risk reduction and that the current ban violates rights of smokers to control their own risks. For smokers that are addicted to nicotine and cannot or will not stop, it is important that they can take advantage of much less hazardous forms of nicotine and tobacco—the alternative being to “quit or die”… and many die. While nicotine replacement therapies (NRT) may have a role in harm reduction, tobacco based harm reduction options may reach more smokers and in a different, market based, way. Chewing tobacco is not banned or regulated in the EU but is often highly toxic, and our proposal could remove more products from the market than it permitted. Regulatory options: We believe that the EU policy on smokeless tobacco should adapt to new scientific knowledge and that the European Commission should bring forward proposals to amend or replace Article 8 of directive 2001/37/EC with a new regulatory framework. Canada has developed testing regimens for tobacco constituents and these could be readily adapted to the European situation. A review of EU policy in this area is required no later than December 2004, and we believe the Commission should expedite the part of its review that deals with harm reduction and regulation of tobacco products other than cigarettes so as to reconsider its policy on smokeless tobacco. We held this view before Swedish Match brought its legal proceedings to challenge EU legislation and we will continue to hold these views if its action fails.

Nicotine replacement: a new approach to reducing tobacco-related harm

Primary prevention is usually regarded as the most desirable goal in efforts to control tobacco-related diseases. However, this has not been very effective so far; moreover, it would take 30-40 yrs for primary prevention to translate into major health benefits. Modification of tobacco products and/or reduction of tobacco use may also have some impact on tobacco-related diseases. A tobacco dose-dependent risk has been observed in these diseases, including cancer, cardiovascular diseases, chronic nonspecific respiratory disorders, and problems during pregnancy. Reduced smoking (smoking fewer cigarettes, leading to a reduced intake of toxic substances) may be indicated in individuals who: 1) are failing in cessation attempts; 2) want to quit but are unable to do so; and 3) do not want to quit but want to reduce smoking. Studies have shown that nicotine replacement medications may be an untapped source in efforts to reduce smoking. Based on Austrian data, it is estimated that, approximately 10 yrs after implementation, a 1% reduction in smoking could save 14 male lung cancer deaths each year, and a 50% reduction would save 700 male lives. Inclusion of females and other tobacco-related diseases suggest that thousands of lives could be saved if smoking could be reduced by 50%. In the European Union, such a reduction in smoking could save > or = 100,000 lives annually. Even a 1% reduction would save 1,000 lives. In conclusion, reduced smoking should be explored as a valid method of reducing tobacco-related harm in those unwilling or unable to quit smoking.

Toward a comprehensive long term nicotine policy

Global tobacco deaths are high and rising. Tobacco use is primarily driven by nicotine addiction. Overall tobacco control policy is relatively well agreed upon but a long term nicotine policy has been less well considered and requires further debate. Reaching consensus is important because a nicotine policy is integral to the target of reducing tobacco caused disease, and the contentious issues need to be resolved before the necessary political changes can be sought. A long term and comprehensive nicotine policy is proposed here. It envisages both reducing the attractiveness and addictiveness of existing tobacco based nicotine delivery systems as well as providing alternative sources of acceptable clean nicotine as competition for tobacco. Clean nicotine is defined as nicotine free enough of tobacco toxicants to pass regulatory approval. A three phase policy is proposed. The initial phase requires regulatory capture of cigarette and smoke constituents liberalising the market for clean nicotine; regulating all nicotine sources from the same agency; and research into nicotine absorption and the role of tobacco additives in this process. The second phase anticipates clean nicotine overtaking tobacco as the primary source of the drug (facilitated by use of regulatory and taxation measures); simplification of tobacco products by limitation of additives which make tobacco attractive and easier to smoke (but tobacco would still be able to provide a satisfying dose of nicotine). The third phase includes a progressive reduction in the nicotine content of cigarettes, with clean nicotine freely available to take the place of tobacco as society’s main nicotine source.

The anti-smoking climate in EU countries and Poland.

BACKGROUND In the fall of 1998, 9095 smokers above 18 years, were interviewed about their smoking behaviour and knowledge and attitudes relating to the smoking. The survey (S) was conducted for the Cancer Commission of the EU and sponsored by SmithKline Beecham. An anti-smoking thermometer that is intended to assess the anti-smoking climate (ASC) in each EU country plus Poland was created. In doing so country owners of the S were asked to choose and rank the five questions in the S they thought best reflected the ASC. The five questions chosen were--smoking is a major cause of death and disease, want to stop smoking, governments should do more, ever made a serious quit attempt and smoke free areas should be provided. METHOD The smokers comprised a representative sample of smoking cigarette per day, vis-a-vis age, sex and rural or urban area. Face to face interviews were conducted using a semi-structured questionnaire. RESULTS Poland had the most developed ASC, 368 points, followed closely by Sweden 358. In the bottom were Germany 266 and Austria 258. Large differences were noted on willingness to quit; from the 85% in Sweden to Italy 37%. CONCLUSION The ASC varies considerably within EU and measures to reduce the death and disease from smoking should be tailored to the situation in each country.

Introducing oral tobacco for tobacco harm reduction: what are the main obstacles?

With the number of smokers worldwide currently on the rise, the regular failure of smokers to give up their tobacco addiction, the direct role of smoke (and, to a much lesser extent, nicotine) in most tobacco-related diseases, and the availability of less toxic (but still addictive) oral tobacco products, the use of oral tobacco in lieu of smoking for tobacco harm reduction (HR) merits assessment.Instead of focusing on the activity itself, HR focuses on the risks related to the activity. Currently, tobacco HR is controversial, generally not discussed, and consequently, poorly evaluated.In this paper, we try to pinpoint some of the main reasons for this lack of interest or reluctance to carry out or fund this type of research. In this paper we deal with the following issues: the status of nicotine in society, the reluctance of the mainstream anti-tobacco lobby toward the HR approach, the absence of smokers from the debate, the lack of information disseminated to the general population and politicians, the need to protect young people, the role of physicians, the future of HR research, and the role of tobacco companies.

E-25. Effective treatments for smoking: Established and experimental approaches

Treatment for tobacco smoking can be either behavioural or pharmacological. Among the behavioural methods cognitive behaviour therapy is probably the most effective procedure but also expensive and seldom available. Fortunately simpler counselling methods that can easily be applied by untrained physicians and nurses are also effective. The US practice guideline for treatment of tobacco dependence [l] has found the following approaches to be effective; simple brief advice, a dose response effect of time spent counselling with an effect from even t3 minutes time, a dose response effect of number of sessions and total time spent counselling up to 300 minutes. Content and procedures with good efficacy is general problem solving, rapid smoking (inhaling from a cigarettes approximately every 7th second until nausea or vomiting occurs) and availability of social support. Today there are programs on the internet that are believed to be effective, particularly those which are interactive. Among the pharmacological treatments nicotine replacement (NR), most commonly in the forms of gum and patch, has been on the market for 2.5 years. Its safety is excellent with hardly any contraindications for smokers. An exempt is with pregnancy. Pregnant smokers should take extra care to not use nicotine in any form but they should be recommended NR, e.g. a patch worn for 16 hours if they can not stop smoking otherwise. Nicotine per se has been implied in some in vitro studies to be a cancer promotor but that has never been proven in human in vivo studies. The absorption of nicotine is much slower from the NR products than from the cigarette that on top of higher venous nicotine concentrations also causes high arterial boli coinciding with each inhalation. The different administration forms are all equally effective with close to a doubling of success rates 1 year after quitting. Underdosing is common and therefore encouraging the patient to consume appropriate doses is important. Overdosing is virtually unheard of. One way to avoid underdosing is to use a patch and combine it with one of the more acute administration forms, e.g. gum, lozenge, oral inhaler [2]. In Sweden, where smoke free tobacco use is more common than smoking among men as many men have used smoke free tobacco to give up smoking as have used NR. Some US experience also shows that smokefree tobacco can be preferred and helpful in aiding stopping smoking [3]. A more recent pharmacological treatment is Bupropion (B) which is a reuptake inhibitor of dopamine and noradrenaline and a nicotine receptor antagonist [4]. The effects of Bupropion are also well known since before it was tested as a treatment for tobacco dependence it had been used as an antidepressant for many years. The efficacy of B is similar to that of NR. Patients considered for B have to be more carefully monitored in order to screen for some contraindications, most important susceptibility to seizures. B has been found to be effective among earlier failures on NR and even B itself. Some clinicians also combine NR and B in more dependent smokers [5]. Among the experimental treatments there are several “vaccines” in development that will create antibodies against nicotine and thus reduce the rewarding effects of nicotine in the brain. It is thought that the vaccines possibly can be used for, a. achieving abstinence, b. avoiding relapse and c. primary prevention. No efficacy trials have been reported yet [6]. The most advanced vaccines are in phase II currently. There are also new non-nicotinic substances under clinical development for treatment of tobacco dependence. The two most well known are a THC receptor antagonist (Rimonabont) and a partial nicotine agonist that both are in phase II-III development. Also new NR products with faster uptake and higher dose delivered are being developed. New uses of particularly the NR products are also to be expected like for example a. long term relapse prevention, b. temporary abstinence, and c. gradual reduction of smoking to quit. Never before has the physician had better tools available to help deal with the dependence that causes premature death in half of its life long users.