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Tobacco Control 1995; 4 (suppl 2): S25-S43 S25 Tob Control: first published as 10.1136/tc.4.suppl2.S25a on 1 September 1995. Downloaded from

SESSION II EXAMINATION OF ALTERNATIVE TREATMENT GOALS

Introduction

Jack E Henningfield

I shall be your next presenter on our current Richard D Hurt is the director of the goal of cessation, but I should first Dependence Center and chair of the like to introduce my fellow presenters, Drs Division of Community Internal at Reuter and Hughes, and my panelists, Drs the Mayo Clinic in Rochester, Minnesota. Hurt, Rand, and Vocci. He has performed innovative research on Peter Reuter is a professor of the School of effective smoking interventions and has de Public Affairs at the University of , veloped a model for what comprehensive and head of the social specialisation in a hospital could be, programme there. Before coming to Maryland, ranging from inpatient to community inter Dr Reuter was the co-director of the vention approaches. Policy Research Center of the RAND Cor Cynthia S Rand is an associate professor of poration, and there he led the multidisciplinary Medicine in the School of Medicine, Division research programme that covered the entire of Pulmonary and Critical Care Medicine at range of issues from epidemiology the Johns Hopkins University. She has been to crop eradication. He is one of the harm heavily involved in smoking cessation research, reduction "warriors". He has been one of the including the lung health study, which gave people that have seen first hand why this is a her some special insights in what happens in controversial issue, and he will show that there large populations when you are trying to are some controversies that may apply to monitor them and when they have access to and others that may not as readily nicotine replacement over a long period of apply. time. John R Hughes is a professor of Psychiatry, Frank J Vocci is the deputy director of the Clinical Psychology, and Family Practice at the Uni Medication Development Division of the http://tobaccocontrol.bmj.com/ Branch, National versity of Vermont in Burlington. He is the National Institute on Drug Abuse. He was also Institute on Drug current president of the Society for Research at Food and Drug Administration when nico Abuse, on Nicotine and Tobacco and the chair of the tine polacrilex, or gum, was approved, and he Research Center, PO Box 5180, Baltimore, task force and nicotine now sees these issues both through the Maryland 21224, USA dependence treatment guidelines committee perspectives of other and from the J E Henningfield for the American Psychiatric Association. perspective of nicotine.

Introduction to tobacco as a

complementary strategy to smoking cessation on September 26, 2021 by guest. Protected copyright.

Jack E Henningfield

Reducing the prevalence of tobacco use even increasing over the past decade.1"3 Thus, through prevention and treatment efforts is in the absence of a dramatic lowering of universally supported by health professionals prevalence of tobacco use or of the conse because of the enormous potential for reducing quences of its use, more than one million the devastating effects of tobacco people will continue to die prematurely every use. In contrast, efforts to reduce the adverse two to three years for many years to come, and effects of tobacco in those who continue to many millions more will suffer unnecessarily smoke have generally been viewed as ineffec and be disabled by tobacco.4 tive and counterproductive. Recent data and The worldwide scenario is even bleaker. Clinical projections suggest that this latter assumption Annual morbidity is expected to increase from Pharmacology needs re-evaluation. Branch, National three million per year to 10 million per year Institute on Drug over the next two decades, with half a billion of Abuse, Addiction the world's current population dying of to Research Center, PO bacco related disease.4 Some of these deaths Box 5180, Baltimore, Background Maryland 21224, USA In the , the prevalence of ciga will be among non-smokers who cannot escape J E Henningfield rette smoking has been relatively stable at environmental smoke because of the high Correspondence to: Dr Jack about 26-27% for nearly five years, and prevalence of smoking. E Henningfield. smoking by youth has been stable or possibly These grim projections do not detract from S26 Henningfield Tob Control: first published as 10.1136/tc.4.suppl2.S25a on 1 September 1995. Downloaded from

the considerable nicotine replacement preparations studied tosuccess of public health efforts, nor date do not contain do the highly toxicthey substances suggest that we should diminish efforts provided by tobacco products, dothat not provide have proved effective at reducing thethe explosive bursts prevalence of highly concentrated of smoking in the United States nicotine doses to the arterialfrom blood stream that its all time high levels in the 1960s. cigarettesHowever, do, and appear to be substantially the evidence that progress has slowed less capable of causingin new addiction the problems USA and that tobacco addiction orand sustaining addiction its compared to tobaccoassociated diseases continue to increase products.10"12 worldwide Data reported in hearings before supports the need for a re-examination the US Food and Drug Administration of (FDA), strategies to reduce the and in Julydisease 1992 indicated that despite the fact causedthat by tobacco use. The present paper many people who were prescribed and nicotine those that follow will provide an transdermal overview systems continued to smoke, most of some of the issues and unanswered appeared to doquestions. so at reduced levels and the incidence of heart attacks among transdermal users was several orders of magnitude lower The means than expected inversus the general population. the ends The two primary means of reducing tobacco caused death and disease are prevention of use and treatment Assessment of harm reductionof dependent persons. These efforts produced Traditionally, smoking cessation efforts the are first documented down turn in tobacco-caused assessed by dichotomous measures: any evi mortality in the USA in 1990 and dence of smoking they results in categorisation are of important to sustain.5 However, the aspatient as a hastreatment failure. been Harm discussed elsewhere,6 reducing tobacco-causedreduction approaches require attention to a death and disease is the long range broader range of outcome goal; variables. For ex strategies such as cessation treatment ample, are at the individual a level, meansproxy or sur and not necessarily the only means. rogate measures Other such as amount of tobacco means might include sub stantially consumedexpanded and systemic levels of tobacco approaches to prevention and a broadening related toxins, as well as direct measures of of the range of options for nicotine dependent toxicity such as lung and cardiovascular func tobacco users. Reducing the risk of tion, can beharm assessed. At the population level,in people who continue to smoke is an assessing theapproach impact of harm reduction ap to be considered in this paper. proaches may require closer attention to out come measures such as per capita cigarette consumption, per smoker cigarette consump http://tobaccocontrol.bmj.com/ Individual versus population effects of tion, per tobacco user consumption of all forms harm reduction of tobacco, and the percentage of smokers who It is important to recognise that harm re are "drippers" (people who smoke less than duction at the individual level does not necess five per day). For example, for many arily go hand in hand with reduction at a years in the United States, drippers have population level. For example, individuals who comprised about 10-15 % of the tobacco using sustain their nicotine addiction by smoking population.10 One potentially beneficial out cigarettes might lessen their risk of tobacco come of a harm reduction strategy would be to caused death and disability by switching to a increase the proportion of tobacco users who product. Unfortunately, the smoke at such low levels. These are just a few expanded marketing and broad perception of of the measurement and study design issues on September 26, 2021 by guest. Protected copyright. relative safety of smokeless tobacco products that need to be addressed as harm reduction contributed to the explosive rise in smokeless strategies are considered. tobacco use among young people in the United States from the 1970s to 1980s, and this appeared to have had little or no effect on Complementary prevention approaches reducing cigarette smoking among the Expanded prevention approaches could also young.2,7,8 Thus, although some individuals contribute to reduced prevalence of addictive might have somewhat reduced their . It appears that earlier onset of toxin intake by switching from cigarettes to tobacco use is associated with more severe smokeless tobacco, the health of the nation subsequent dependence than delayed onset of suffered. Similarly, the promotion of the tobacco use.13 This observation is similar to theoretically less toxic filtered cigarette has that regarding other addictive drugs,1415 and been attributed to helping to sustain the high suggests the expansion of prevention ap prevalence of smoking-and thus morbidity proaches aimed specifically at delaying the age and mortality - at the population level.9 It is of onset of any use, as well as imposing barriers therefore questionable whether smokeless to to delay the transition from occasional use to bacco or new cigarette types could be con regular use. These goals are especially im sidered viable as harm reduction approaches. portant in light of the fact that approximately In contrast to the use of tobacco products in two thirds of ail adolescents in the USA harm reduction approaches, an expanded use continue to sample cigarettes and one third to of nicotine-delivering preparations might be one half of these children develop depen effective at reducing harm by individual tobac dence.2'31617 co users as well as in the population. The Another approach would be to prevent the Examination of alternative treatment goals S27 Tob Control: first published as 10.1136/tc.4.suppl2.S25a on 1 September 1995. Downloaded from

transition to high levels of addiction in those larly, the protracted use of replacement medi young people who have begun to smoke cations to produce what might be termed regularly. This would require the development "partial tobacco abstinence" or "major smok of treatment interventions targeted towards ing reduction" has not been studied as an the needs of young tobacco users. 18The fact endpoint in its own right, even though sub that nearly 40 % of adolescent smokers report stantial smoking reduction has often been some level of interest in youth-targeted smok reported as a byproduct of cessation efforts (for ing cessation programmes supports the de example, see 24). Finally, the protracted use of velopment of such programmes.19 to sustain remission and prevent Tobacco product and regulatory changes relapse is widely practised in other areas of might also contribute to prevention efforts. medicine but has not been systematically For example, more accurate labelling of the studied as a potential approach to treating delivery of nicotine and tar on cigarettes might tobacco dependence. Perhaps it should be. enable consumers to control and reduce their intake of such chemicals more effectively.20In addition, if the nicotine content of cigarettes Concluding comments was reduced to levels that were not sufficient to As harm reduction approaches to tobacco use cause or sustain addiction, then, even among are considered in the papers by Reuter and young people who take up cigarette smoking, Hughes in this supplement and in the ac later efforts to quit smoking upon reaching companying discussion, it should be apparent adulthood would not be complicated by the that such approaches can differ widely in form presence of nicotine addiction.21 These and and effect for individuals and populations. other new prevention approaches might be Rather than simply accepting or dismissing considered along with new treatment ap harm reduction approaches, the risks and proaches, since a fundamental public health benefits of each approach should be compared aim is to coordinate prevention and treatment and contrasted. Similarly, when looking at strategies to maximise the impact of each. other addictive drugs for insights into the potential risks and benefits of such approaches with respect to tobacco addiction,25 it is Complementary treatment approaches: important to consider the differences in the harm reduction pharmacology and toxicology of the substances Effective cessation interventions, such as nic that may also limit the applicability of any otine replacement, may be considered major conclusions reached (see discussion of such medical treatment advances because they in issues by Goldstein26). crease the likelihood of successful long term Finally, it is apparent that important un http://tobaccocontrol.bmj.com/ cigarette abstinence by three- to fourfold over answered questions about the viability and the ~ 7 % rates of success achieved by people impact of various harm reduction approaches who quit on their own. On the other hand, limit the accuracy of predictions.27 Therefore, most people given any form of smoking this paper and those that follow should be cessation treatment relapse to heavy addictive considered as early steps in a process that may cigarette smoking; their needs do not appear lead to new approaches to lessening the death to be adequately addressed by current and disability toll of tobacco. Ideally, such approaches, and treatment may be terminated approaches should strengthen the impact of if they resume smoking. One solution is to the existing prevention and treatment ap "recycle" such patients into new treatment proaches that have proven effective. programmes.22 Other issues are also relevant to these discus on September 26, 2021 by guest. Protected copyright. A complementary approach to the foregoing sions. For example, how would making a is to expand the range of treatment options and nicotine replacement treatment available over goals. An example of this is the potential for the-counter affect its value in cessation and different indications for medications for treat harm reduction interventions ? What would be ing nicotine dependence which have been the advantages and disadvantages of non proposed to the FDA.23 Those proposed nicotine-delivering medications for harm re indications are: duction compared to nicotine-delivering medi (1) Relieve withdrawal cations? How would treatment goals such as (2) Decrease use/achieve abstinence " partial tobacco abstinence " affect the broader (3) Prevent relapse goal of reduced population prevalence of (4) Reverse toxic effects tobacco use? Should products developed and marketed by tobacco companies, which differ These indications are similar to those proposed substantially from conventional tobacco pro for treatments targeted at other disorders of ducts (for example, RJ Reynolds's psychoactive substance use, such as , and Eclipse products) be exempted from the , and dependence. The first three sort of regulatory oversight given to foods and indications appear to be viable targets for drugs ? existing treatments; however, important ques These and many other issues will be discus tions need to be resolved by data collection. sed in the following papers and accompanying For example, would enabling people to achieve discussion. Few, if any of the issues are likely intermittent tobacco abstinence to meet oc to be resolved at this time. However, it would cupational demands by treating withdrawal appear that the time has come to re-evaluate symptoms increase or decrease the likelihood our goals and strategies if we are to produce that they will ultimately stop smoking? Simi further reductions in smoking-caused disease S28 Henningfield Tob Control: first published as 10.1136/tc.4.suppl2.S25a on 1 September 1995. Downloaded from

in the United Health Cervice,States Centers and tofor reverseDisease Control, the Office on Smoking and Health, 1988. (DHHS Publication No escalating growth (CDC) 88-8406.) of tobacco-caused disease occurring in 11 mostHenningfield other JE,nations Stapleton of the JM, world. Benowitz NL, London ED. Higher levels of nicotine in arterial than in venous blood after cigarette smoking. Drug Alcohol Depend 1993; The views expressed 33: 23-9. in this paper are those of the author and do not reflect 12an Henningfield official JE, Keenan RM. Nicotine delivery positionkinetics of the US federal government or its agencies. and abuse liability. J Consult Clin Psychol 1993; 61: 743-50. 13 Breslau N, Fenn N, Peterson EL. Early initiation and nicotine dependence in a cohort of young adults. Drug 1 US Centers for Alcohol Depend Disease1993; 33: 129-37. Control and Prevention. Cigarette smoking among 14 Robins LN, Murphy GE.adults Drug use in a normal population - United States, 1993. MMWR 1994; 43: 925-30. of young negro men. Am J Public Health 1967; 57: 2 Lynch BS, Bonnie 1580-96. RJ, eds. Growing up tobacco free: Preventing nicotine 15 Kandel DB. Issues of sequencing of addictionadolescent drug use in children. Committee on preventing nicotine and other problem behaviors. Drugs addictionSociety 1989; 3: in children and youths, Institute of 55-76. Medicine. Washington, DC: National Academy Press, 16 Giovino GA, Henningfield 1994. JE, Tomar SL, Escobedo LG, 3 US Department Slade J. Epidemiology of of tobacco Health use and dependence. and Human Services. Preventing tobacco use among Epidemiol Rev 1995; 17: 48-65.young people: a report of the Surgeon General. Atlanta, 17 Kessler D. Nicotine addiction Georgia: in young people. N Engl J Public Health Service, Cen ters for Disease Med 1995; 333: 186-9. Control and Prevention, Office on Smoking and 18 Henningfield Health, JE. Nicotine addiction. In: Substance 1994. abuse. (US Government Printing Office No S/N Ross roundtable 017-001-00491-0.) on critical issues in family medicine. 4 Peto R, Lopez Columbus, OH : Ross ProductsAD, Division, 1994: 171-86.Boreham J, Thun M, Heath C. Mortality from 19 George H. smokingGallup International Institute. Teen-age attiin developed countries 1950-2000. Oxford: Oxford tudes and behaviorUniversity concerning tobacco. Princeton, NJ: Press, 1994. 5 US Centers for George H Gallup InternationalDisease Institute, 1992. Control and Prevention. Cigarette smoking-attributable 20 Henningfield JE, Kozlowski LT, Benowitz mortality NL. A proposal and years of potential life lost-United States, to develop meaningful labeling for cigarettes.1990. JAMA MMWR 1993; 42: 645-9. 6 Schuh LM, Henningfield 1994; 272: 312-4. JE. Nicotine replacement treat ment and public 21 Benowitz NL, Henningfieldhealth JE. Establishing a nicotineinterventions: toward a marriage of two approaches. threshold for addiction. N EnglIn: J Med 1994; 331:Slama 123^. K, ed. Tobacco and health : proceedings of 22 Hughes JR.the An algorithm for smokingninth cessation. Arch Earn world conference on tobacco and health (in press). Med 1994; 3: 280-5. 7 US Department 23 Woody GE, McNicholas of LF, Vocci Health F, Henningfield JE, and Human Services. The health consequences of and staff of pilotusing drug evaluation unit of Foodsmokeless and Drug tobacco. A report to the advisory committee Administration. Draft report to the USto Food and Drugthe Surgeon General. Bethesda, Maryland: . November Health 12, 1992. Service, National Institutes of Health, 1986. 24 Transdermal (NIH Nicotine Study Group. TransdermalPublication nicotine No 86-2874.) 8 Connolly GN, for smoking cessation.Winn Six-month results from twoDM, Hecht SS, Henningfield JE, Walker B, Hoffmann multicenter controlled clinical trials. JAMA 1991;D. 266: The reemergence of smokeless tobacco. N Engl 3133-8. J Med 1986; 314: 1020-7. 9 Slade J, Connolly 25 Reuter P, MacCoun RJ. Lessons from theGN, absence of harm Davis RM, Douglas CE, Henning field JE, Hughes reduction in American JR, drug policy. Tobaccoet Control al. Report of the tobacco policy research study 1995; 4 (suppl 2): groupS28-32. on tobacco products. 1992; 26 Goldstein A. 1Addiction: (suppl):from biology to drug policy. New S4-9. 10 US Department York: WH Freeman andof Company, Health1994. and Human Services. The health consequences of 27 Hughes smoking:JR. Applying harm reduction to smoking. nicotineTobacco addiction : A report of the Surgeon General, Control 1995; 4 (suppl 2): S33-8. 1988. Rockville, Maryland: Public http://tobaccocontrol.bmj.com/

Lessons from the absence of harm reduction in American drug policy

Peter Reuter*, Robert J MacCoun

Even among its supporters, the American drug lying logic of American drug control. Finally on September 26, 2021 by guest. Protected copyright. control strategy provides few grounds for we tentatively suggest its relevance to smoking enthusiasm. Despite many indications that the policy. prevalence of drug use has declined over the past decade, in many ways the severity of the School of Public drug problem has remained fairly constant.1 Drug policy and drug related harms Affairs and Moreover, our current mix of is The American "drug problem" is in fact Department of Criminology, expensive, intrusive, and may actually con constituted by quite a variegated list of harms.6 University of tribute to drug related harm.2 Thus there is The table provides a partial listing intended to Maryland, Van considerable interest-as documented by a illustrate the diversity. Munching Hall, College Park, steady stream of popular books, television Some harmful effects are undoubtedly a Maryland 20742, USA programmes, and analytic and newspaper es direct function of drug use itself, and par P Reuter says - in looking at a much wider array of drug ticularly of dependence. But much of the harm is attributable to the criminal distribution of Graduate School of control strategies, including approaches that , go well beyond simply tinkering at the edges of drugs. Certainly the violence in drug selling7 University of existing programmes. and the development of a large criminal California, 2607 In this essay we shall provide a brief economy8 are functions of the conditions that Hearst Avenue, Berkeley, California overview of one such alternative approach, the we have created around drug selling, rather 94720-7320, USA harm reduction paradigm.3"5 We shall discuss than any psychopharmacological characteris R J MacCoun its influence in Western Europe and the tics of the drugs per se. It is not implausible Correspondence to: barriers to its diffusion into American policy that a prohibition on might lead to P Reuter PhD towards illicit drugs, and we shall offer a markets with potential for violence; such an *Dr Reuter delivered this framework highlighting ways in which harm inference is even more plausible witff respect paper at the conference. reduction might be integrated into the under to cigarettes. Prohibition-related ill-effects are