SMOKE SIGNALS

PRESIDENT’S REPORT

by Neal L. Benowitz

President, SRNT

Nicotine remains a hot topic in the public policy and legal arenas in the Spring of 1997. Two big issues are alternative nicotine systems and lawsuits against the tobacco industry.

Alternative nicotine delivery systems was the topic of a recent international meeting in Toronto, organized by John Slade and Roberta Ferrence, both SRNT members. The broad question is whether making nicotine more accessible and less hazardous via non-tobacco delivery systems to be used by smokers who cannot quit smoking makes public health sense. Nicotine is currently available in a variety of medication forms and is being test-marketed by R.J. Reynolds as the Eclipse smoking device, an ostensibly less hazardous alternative to cigarette smoking. It seems clear that pure nicotine has substantially less medical toxicity than cigarette smoking, and that smokers are better off using nicotine instead of smoking, even if nicotine use persists indefinitely. The availability of nicotine delivery systems, however, might reduce the likelihood of quitting tobacco use altogether and could result in greater numbers of people who persist in smoking than would occur if smokers were strongly encouraged to quit as the only option.

There is also concern that nicotine delivery systems, particularly those that deliver nicotine to the brain rapidly (similar to cigarette smoking), might reinforce and maintain addiction as do cigarettes. Another concern about rapid nicotine delivery systems is the possibility of attracting nonsmokers to the use of nicotine. A careful study of benefits vs. risks of seeking alternative nicotine delivery systems available will require impact studies by experts in nicotine pharmacology, drug abuse, toxicology, economics, sociology, and public policy. This is clearly an area in which the members of SRNT can contribute greatly.

Another nicotine-related issue discussed at the meeting was regulation of the nicotine content of cigarettes. The pros and cons of policies that would promote the manufacturing and use of cigarettes with reduced nicotine content (presumably less addictive and more likely to promote quitting,) vs. nicotine-enriched cigarettes (which might result in less exposure to other combustion toxins) was debated. The World Health Organization has also been meeting to consider global strategies for cigarette regulation, which is essential, since the cigarette trade is a global issue. The findings of the Toronto conference are being analyzed by a committee that includes a representative from SRNT–Neil Grunberg, Chair of our Scientific Liaison and Public Policy Council. There will ultimately be a written document to which SRNT members will have access.

Tobacco litigation has been prominent in the news. As most of you know, 22 states Attorneys General are suing the tobacco companies for reimbursement of Medicaid health care costs attributable to cigarette smoking. The first of these cases, involving the State of Mississippi, is scheduled to go to trial in June, 1997. Nicotine plays a central role in these lawsuits because nicotine addiction underlies the widespread use of tobacco despite the known health hazards of smoking. Tobacco company documents, such as those described in JAMA last year and in a book recently published by Stan Glantz, show clearly that the tobacco industry has understood the role of nicotine in maintaining tobacco use for many years, while publicly denying that nicotine is addictive.

On March 20, 1997, a settlement between the states and the Liggett Tobacco Company was announced. This settlement included the following five features.

1. Liggett will acknowledge that smoking is addictive and will state so on the warning labels.

2. Liggett will acknowledge that cigarette smoking causes cancer.

3. Liggett acknowledged that some of its tobacco marketing has been directed toward minors and will not do so in the future.

4. Liggett will pay 25% of pretax profits to the states for the next 25 years.

5. Liggett released documents regarding industry-wide cooperation in dealing with tobacco issues and pledged to cooperate in suits against other companies.

The financial settlement with Liggett is inconsequential because Liggett has not been profitable recently, but acknowledging nicotine addiction and that tobacco causes disease and providing documents related to the industry's knowledge and strategies for dealing with the health hazards of tobacco use should be most helpful in impeaching the other tobacco companies in upcoming trials. As of April 16th, at the time of the writing of this column, there are rumors of a settlement between the state attorneys generals and the tobacco companies. Such a settlement would probably need to be mediated by congress, because it would release the tobacco industry from future liability claims.

Any settlement with the tobacco industry must include strategies to reduce tobacco use. A financial settlement alone will not be very helpful in the promotion of health and would not prevent American children from becoming addicted to nicotine. Recently, David Burns and a number of tobacco and health researchers and policy experts (most are SRNT members) have proposed a series of elements to promote public health that should be part of any settlement. An opinion article describing these elements is currently in press in Tobacco Control. Briefly, these elements are as follows:

1. Accept responsibility that tobacco use is a major cause of death and disability and that nicotine is an addictive agent.

2. Ban tobacco advertising and promotion to avoid influences that encourage nonsmokers to begin smoking and current smokers to continue.

3. Accept FDA jurisdiction, allowing the FDA to regulate nicotine in tobacco and to coordinate efforts to find pharmacological alternatives to tobacco for nicotine-addicted smokers.

4. Reimburse states for health care costs.

5. Fund programs and research in tobacco control.

6. Accept legislation and regulations protecting the rights of nonsmokers and stopping opposition to clean air laws, and in particular, the OSHA-proposed regulations on smoking in the workplace.

7. Fund a national media anti-tobacco campaign.

8. Provide cessation assistance for addictive smokers.

SRNT members can help in the effort by lobbying their medical and other health-related organizations, as well as by communicating directly with politicians, with the message that there should be no settlement with the tobacco industry unless these elements to protect the public health are included.

SRNT members will hear much more about alternative nicotine delivery systems and about the state of tobacco litigation at our upcoming annual meeting. You will find the schedule for the meeting on our web page as well as on pages 6-7 of this issue. See you in Nashville in June.


INTERNATIONAL NEWS...

Current Trends in Nicotine Research in France

 

by Karen Slama

Chief, Tobacco Prevention Division

IUATLD

The French Response to Tobacco

One of France’s professional philosophers recently wrote that the problems of asbestos are at the very heart of the question of influence because the asbestos lobby was able to distort information and deceive politicians and citizens.1 This is in contrast with his thoughts about tobacco. He writes, concerning a suit brought by the family of a young woman who died of lung cancer: "Let us be clear, the plaintiffs consider that the young woman was not responsible. She could not read the inscriptions on each pack of cigarettes, did not understand the medical information broadcast everywhere, ignored substitution therapy. At the very heart of this suit is disregard for the individual and the individual’s freedom." This attitude shows one side of the dichotomy of the French response to tobacco. France is, after all, a country that passed anti-tobacco legislation that other countries can only dream about,* showing a very real awareness that environment shapes behavior and that protection of the population is within the mandate of the government. Opinion polls continually find that over 80% of the French public support the tobacco control laws and appreciate clean air policies. At the same time, both government bodies and health officials are loath to accept tobacco use as anything but individual choice. They are against marginalizing people who make, sell, use, or are in any other way associated with tobacco, which makes enforcement of the law practically inconceivable, and with little enforcement, adherence to the law has been sporadic.** The government itself has not assumed responsibility for enforcing the law, leaving this to the CNCT, the French Committee Against Tobacco, which is our only permanent watchdog of tobacco industry activity. So it appears that the money spent for advertising before the law is now being spent on illegal promotions.***

Nevertheless, anti-tobacco norms would grow if the laws of the land were enforced. The combination of regular tax or price increases, the prohibition of advertising, and general public discussion of tobacco is showing signs of bearing fruit. There has been, since 1991, a drop of 11% in total tobacco sales, and anti-tobacco activities are proliferating. There are several dark shadows over this sunny picture, however. The overall prevalence of smoking is still around a third of the population, as it has been since at least 1976, when the first surveys began looking at smoking behavior. Within that population, we have fewer men and more women than in the past, but no foreseeable drop in prevalence. We may see prevalence rates rise, for our influence on young people is practically nil compared to the influence of the tobacco promoters and adolescents smoking environment.

A national survey in 1995 found 59% of 18 year olds were smokers.2 Our influence on doctors isn’t much better, as smoking rates among doctors match those in the general adult population (between 32% and 37%),3 and schools of public health (training for administrators) do not include information about tobacco or its public health consequences. Although we are unlikely to see the rates of tobacco-related mortality that have been seen in the UK or the US due to lower total consumption of tobacco, premature mortality from lung cancer among men is still climbing, and among women has begun to rise rapidly.****

Despite a long history of research on the health consequences of smoking generally funded by the formerly government-run tobacco company, SEITA, the main French research bodies have until recently shown little interest or concern about tobacco use research. The national research institutes, INSERM (medical research) and CNRS (scientific and humanities research) have no teams exclusively devoted to tobacco research, while teams do exist for alcohol, AIDS, or illegal drug use. Funding is still available for tobacco-related disease epidemiology; but very little research money is allocated to research on tobacco pharmacology or behavior. In 1995, INSERM included tobacco research among topics in the major research category of consumption behavior, which also includes nutrition, medication, alcohol, and drugs. Nevertheless, it is difficult to find funding for research in tobacco. Most people who could be doing research in either nicotine pharmacology, smoking behavior or tobacco policy evaluation do research in other fields. In terms of public moneys, government agencies provide modest funds to research groups and subsidize anti-tobacco campaigns. There is a strong pervading belief in these organizations, however, that smokers should not be made uncomfortable about their smoking. In addition, smoking is still quite common among researchers. This may explain why some themes are resisted, such as use of fear tactics in health campaigns, measuring how much people actually know and what they believe, and public information campaigns on the ill effects of environmental tobacco smoke. There is a tendency both in government campaigns and those of NGOs to focus on children, in the hope that we can thus pass to a generation of non-smokers, even though there has been no evidence that prevention campaigns are effective in the absence of programs for the entire population. Resources for adults tend to go to specialist cessation clinics. A number of these clinics set up randomized trials of different treatments, usually funded by pharmaceutical companies. Other research is currently being sponsored by the European Union. However, much more could be done, for France is a country with under-utilized potential for both research and social policy concerning tobacco use.

* The Evin Act prohibits all direct or indirect tobacco advertising, sponsorship, or promotion, and establishes clean air standards for enclosed spaces used by the public (e.g., transport, worksites, restaurants, etc.). The law includes provision for evaluation. The price of tobacco has been excluded from the consumer price index, and occasional prices rises occur, either through raised taxes or negotiated retail price rises.

** A small evaluation of the effects of the law showed adherence to the ban on advertising, but only in terms of direct advertising; and only sporadic adherence to the clean air provision of the law: less than 50% adherence on school grounds, 52% adherence in the workplace, less than 30% adherence in restaurants or bars. Clean air standards are being reinforced in public transport. The law allows retransmission of Formula 1 motor-racing (and other motor vehicle sports) from areas where tobacco advertising is allowed.

*** In 1996, the CNCT estimated tobacco company spending on promotions at 1 billion francs (US$2000 million), in the form of cigarette brand name association with other products and promotional give-aways.

**** The rates in 1991 were, for men aged 25-64, 56.8/1000,000, up 17% from 1981, and for women aged 25-64, 6.1/100,000, up 36%. Source: Haut Committee de la Santee Publique, La Santee. Rapport General, La Documentation Francaise, 1994.

Note: A very informative analysis of the differences between France and the United States public policy responses to tobacco can be found in Nathanson, C. Disease prevention as social change: toward a theory of public health. Population and Development Review, 1996; 22: 6609-637.

References:

1. Etchegoyen A. Des Libertees Influences. Paris: Seuil, 1997, pp.166-168.

2. Connaissances, comportements et attitudes des jeunes Francais face au tabagisme. IPSOS/CFES Survey, May 1995.

3. Tessier J-F, Rene L, Nejjari, C, Belougne D, Moulin J, Freour P. Attitudes and opinions of French general practitioners towards tobacco. Tobacco Control 1993: 2:226-30; Tredaniel J, Karsenty S, Chastang C, Slama K, Hirsch A. Les habitudes tabagiques des medecins generalistes francais. Rev Mal Resp. 1993: 10: 35-8.


What's New in . . .

Biobehavioral Research

by David Gilbert

Southern Illinois University

While recent studies have led to important advances in our understanding of individual differences in smoking motivation and psychological effects of smoking abstinence, several methodological problems make work in this area more challenging than might seem to be the case. Individual differences in nicotine response, personality, psychopathology, and associated tendencies to self-medicate mood states and traits have received growing attention as possible mediators of the approximately 50 percent heritability of smoking1,2. Self-medication and other psychological tool models assume some beneficial cognitive or affective benefit of nicotine that more strongly disposes negative-affect-prone and cognitively impaired individuals to smoke. Such putative benefits, however, have been questioned based on observations that effects of nicotine on affect and performance in nonsmokers have frequently not been found and because quitting smoking, while increasing negative affect during the first week of abstinence, has been associated with subsequent negative affect ratings that are below pre-quit levels3,4. Methodological confounds, including the repeated measures effect, selective attrition, and the genetic differences between smokers, nonsmokers, and exsmokers cloud our understanding of smoking motivation, effects of nicotine, and smoking abstinence. This review outlines several rarely considered methodological roadblocks that must be circumvented in order to better understand the psychological effects of nicotine.

The question of whether nicotine has cognition-enhancing and mood-improving effects independent of withdrawal alleviation has been addressed by several experimental approaches, including administering nicotine to nonsmokers and exsmokers. Hughes5 articulately noted, however, that both neversmoker control groups and exsmoker control groups assume equivalence of smoker with neversmokers and exsmokers— an invalid assumption based on evidence of substantial genetic and personality differences between smokers and these other two groups1,2. Prospective studies show that the personalities, educational/intellectual levels, and family/social environments of children who eventually become smokers differ significantly from those who do not1. Even the minimally deprived smoker controls who do not yet exhibit withdrawal symptoms do not provide an adequate control group since absence of withdrawal-induced negative affect does not imply that deprivation does not produce a disposition towards negative affect that is alleviated by nicotine1. So what is the solution?

Some3,4 have interpreted findings as indicating that sustained smoking abstinence results in more positive and less negative emotional states than those existing prior to quitting. Almost all long-term abstinence studies are methodologically flawed, however, in that they do not take into account selective attrition and the repeated measures effect6,7 when interpreting their data to indicate that individuals return to pre-quit baselines or below. Selective attrition is the process whereby those individuals most stressed by quitting are most likely to relapse to smoking and are therefore not included in the group means that suggest a return to baseline levels1. Individuals who remain abstinent are different from those who relapse. They have typically experienced less stressful situations and are more psychologically stable. Since relapsers are not included in pre- vs. post-abstinence group means, the means are biased. Therefore, it is reasonable for such select, benign-environment, minimal vulnerability, long-term successful quitters, to return to pre-quit baselines or below1. This select population is not representative of the full population, however, and their reported decreases in negative affect may be more a function of their benevolent environment and personality traits than of their having quit smoking.

A second reason for lower negative mood scores weeks or months after quitting smoking is the repeated measures effect. Self-reported negative mood states decrease across time even though environmental factors are held constant (the repeated measures effect)7,8. That is, group mean scores on measures of negative affect are significantly higher when assessed at time-1 than at time-2 without intervention. The repeated measures effect has been found to be especially strong in the case of individuals scoring high on trait measures of depressive disposition and neuroticism7,8. We now turn to a methodological approach that can control for both the repeated measures effect and selective attrition.

Even though we cannot randomly assign individuals to become smokers or nonsmokers, it is possible to randomly assign willing smokers to quit smoking for some period of time or to a control group of delayed quitters, and then to assess whether quitters return to pre-quit cognitive and affective levels and the relative affective states of quitters and controls. Such a delayed-quit control group controls for the effects of the repeated measurements effect and provides a control group, as opposed to a simple (unstable or otherwise) baseline. Experimental studies have shown that within the delayed-quit control design the researcher can also limit differential attrition by using financial contingencies that maximize study completion7,8. A lack of randomly assigned no-quit control groups is a major methodological flaw that prevents differentiation of effects of time and repeated measures. Most studies assessing the time course effects of quitting smoking1 do not provide such controls. The few studies including such controls indicate the clear need for such controls and the danger of failing to do so.

The importance of controlling for the repeated measures effect and of using a randomly assigned no-quit control in assessing individual differences in affective responses to quitting smoking is demonstrated in two NIDA-funded studies7,8. Using randomly assigned delayed-quit groups and multiple pre-quit baseline mood measures (POMS and Beck Depression Inventory [BDI]), it was observed7,8 that pre-quit negative moods decreased consistently over the first eight to fifteen assessments. The decrease in symptoms of depression was especially large in smokers scoring above the median on a measure of trait depression. In the depression-prone group, the drop in BDI depression from first pre-quit baseline measure to the mean of the eighth through tenth pre-quit measures was from approximately 8 to 4, while the low depression group decreased from 2 to 1. Upon quitting, the group scoring above the median on trait depression (MMPI D score) exhibited large increases in BDI state depression. After 30 days of abstinence, the post-quit BDI state depression scores did not show even a significant tendency to return to the level immediately prior to quitting, though the 30 day abstinence BDI scores were lower than the very first pre-quit baseline assessment. Thus, interpretation of whether an individual returned to baseline depended on which baseline was used. The delayed-quit control group added convergent validation for the thesis that the quitters never returned to baseline values. The delayed-quit controls also exhibited significantly lower BDI and POMS scores during the month after their series of baseline measures.

These decreases in self-reported negative affect occurred without any smoking or other intervention. Thus, we must be cautious in inferring change when experimental designs are flawed. It is clear that the question of whether smokers actually return to pre-quit baseline levels of affect and cognitive performance has not been adequately assessed in the vast majority of studies.

References:

1. Gilbert, D. G. (1995). Smoking: Individual differences, psychopathology, and emotion. Washington, DC: Taylor & Francis.

2. Heath, A. C., Madden, P. A. F., Slutske, W. S. & Martin, N. G. (1995). Personality and the inheritance of smoking behavior: A genetic perspective. Behavior Genetics, 25 (2), 103-117.

3. Cohen, S. & Lichtenstein, E. (1990). Perceived stress, quitting smoking, and smoking relapse. Health Psychology, 9, 466-478.

4. Parrott, A. C. (1995). Smoking cessation leads to reduced stress; but why? International J Addictions, 30, 1509-1516.

5. Hughes, J. H. (1991). Distinguishing withdrawal relief and direct effects of smoking. Psychopharmacology, 104, 409-410.

6. Choquette, K. A. & Hesselbrock, M. N. (1987). Effects of retesting with the Beck and Zung depression scales in alcoholics. Alcohol and Alcoholism, 22, 277-283.

7. Gilbert, D. G. (1996, November). Nicotine-induced performance differences between smokers and nonsmokers. Paper presented at the International Symposium on Nicotine and Human Performance. Washington, DC, November 22, 1996.

8. Gilbert, D. G., Plath, L., Rabinovich, N., McClernon, F. J., Meliska, C. J. & Jensen, R. A. (1997). Effects of smoking abstinence on mood and craving in men: Influence of negative affect-related personality traits, habitual nicotine intake, and repeated measurements. Manuscript submitted for publication.