PRESIDENT’S REPORT

The Eclipse meeting presented a forum for tobacco researchers to see R.J. Reynolds data on Eclipse, a novel "smokeless" cigarette. These data included chemistry, toxicology, and human studies. Most participants agreed that Eclipse is likely to be less harmful than smoking regular cigarettes with respect to cancer and lung disease, although there may be no impact on risk of heart disease. There was much debate as to whether Eclipse will be regulated, and whether aggressive marketing would result in smokers switching from regular cigarettes to Eclipses rather than quitting, or whether Eclipse would be used by children as a starter product. In any case, as John Slade noted, Eclipse represents a paradigm shift, and brings us closer to realizing the option of nicotine maintenance therapy.

The CEASE trial was a pan-European trial of transdermal nicotine therapy for smoking cessation, comparing standard (15mg) and high (25mg) doses and standard (8 weeks) versus prolonged (22 weeks) duration therapy. This study adds to our knowledge of the clinical pharmacology of nicotine replacement by confirming a benefit (although modest) of higher doses of nicotine and showing for the first time in a prospective way that prolonging transdermal nicotine therapy does not improve outcome.

The AHCPR conference provides an opportunity for researchers as well as clinicians and health care administrators to review systematically the AHCPR guidelines, which were recently published in JAMA by Michael Fiore and committee. These guidelines represent an important step in developing standards for health care providers in the delivery of smoking cessation therapy, including the use of nicotine replacement products. The AHCPR guidelines provide a much needed guideline for clinical practice. The next step in the evolution of smoking cessation therapy will be individualizing therapy, based on level of dependence and personal characteristics of the smoker. Our current state of knowledge about individualization is inadequate at this time, but hopefully some answers will be forthcoming in the next few years.

The summer transdermal nicotine systems marketed by McNeil and Smith Kline Beacham have been released over the counter, and nicotine nasal spray has become available by prescription. This substantially expands our options for nicotine replacement therapy but also raises the challenges of how best to incorporate over-the-counter nicotine medications into smoking cessation therapy within the medical care system.

Finally, President Clinton’s approval of the FDA’s proposals to curb adolescent smoking is great news. The new policies will restrict access of adolescents to cigarettes by removing most vending machines, banning sampling, and requiring proof of age. The proposed regulations will also substantially change advertising of cigarettes forcing them to be located away from schools, and making any advertisements to which adolescents have access be done in black and white text only.

These seemingly disparate events fit together nicely as part of the evolution of an integrated strategy to reduce the prevalence of cigarette smoking. Initiation in kids should be curbed by the new FDA regulations. Smoking cessation treatment is becoming institutionalized, and more effective treatments are being made available. We are steadily learning more about how best to use nicotine replacement products, and their availability to smokers has been tremendously enhanced. For those addicted smokers who cannot quit, a nicotine maintenance/harm reduction strategy seems to be well on its way. Quite a summer for nicotine, and members of SRNT have played a big part in all of these developments.

We will hear all about these developments and many more at the next annual meeting. Please mark your calendar and be sure to be in Nashville June 13-15, 1997.

The Czech Republic (formerly part of Czechoslovakia) has 10,000,000 inhabitants. Smoking prevalence in the adult population is 37%, with prevalence in men being higher than that in women (46% versus 31%).

Anti-smoking activities have been slow to develop. Results of large studies became available towards the end of 1960's, and the first significant step in combating smoking was the setting up of the Committee on Smoking and Health at the Pneumological and Phtiseological Society in 1972. This committee disseminated information on smoking and health to members of the society. It also initiated and compiled a proclamation in 1978, signed by six medical associations in the country expressing their position on tobacco smoking and its impact on health. The Committee was also involved in epidemiological research on smoking prevalence among adults and youth, spreading information to the public and collaborating with the Health Education Institute in producing leaflets and booklets. The first nationwide campaign on smoking was called the "Chance for Three Million" and took place in 1988. After this campaign a substantial decrease in smoking prevalence was observed.

The first law concerning smoking was the Law on Protection against Alcoholism and other Toxicomanias in 1989. It banned smoking on public transport, in school and health premises, and in indoor sports establishments and workplaces where there was risk of fire. Sale of tobacco products to children under 16 years was banned. ‘Smoking’ advertising (not ‘tobacco’ advertising) was banned in information media. The law on Consumer Protection, passed in 1991, banned all tobacco advertising. The most recent law concerning smoking, The Law on Advertising Regulation, however, passed in 1995, allows all tobacco advertising in all media except TV. The paragraph in the 1989 law banning smoking advertising was cancelled as well.

After the ‘Velvet Revolution’ in 1989, which separated Slovakia and the Czech Republic, an explosion of tobacco advertising came to the Czech Republic particularly from the West. One of the largest foreign investments was by Philip Morris in the town of Kutna Hora, buying 71% of the state tobacco monopoly. R J Reynolds is currently creating a new manufacturing plant in the town of Benesov.

In 1993, a World Health Organization mission headed by Neil Collishaw visited Prague to assess all governmental and non-governmental antismoking activities in the country. At that time, the National Centre for Health Promotion (the successor of the former Health Education Institute) was the main coordinator of tobacco control activities including the production of leaflets and booklets. The WHO mission recommended that the Czech republic set up an Action Unit on Smoking Prevention, which resided at the Ministry of Health for a year when a new minister took over and dissolved it. It then set itself up again in the National Institute for Health Promotion; but on 1st January 1996, this national Institute was disbanded, and all smoking control activities are now the responsibility of the National Institute of Public Health, where the Action Unit on Smoking Prevention was reestablished. There are currently plans for legislation to ensure regular national smoking prevalence surveys and to improve information dissemination.

The Czech Committee of the European Medical Association is concerned with physician education in smoking cessation methods and nicotine replacement therapy (NRT) and in smoking control. Courses on smoking cessation methods and NRT are organized in cooperation with the Postgraduate Medical School, and more than 300 physicians and nurses have been trained in helping smokers to stop. Some of them are running smoking cessation clinics (about 30 in the country). This organization also coordinates mutual support and collaboration among all seven Czech medical faculties. Each faculty has a tobacco education coordinator nominated by the Dean. Smoking control and cessation methods, as well information on the health impact of smoking, are incorporated into the medical curriculum. With the help of medical students, smoking prevalence among health professionals has been assessed since 1994. One third of physicians (38% males and 26% females) and 49% of nurses smoke. In the Institute of Preventive Medicine of Masaryk University in Brno, two studies are being carried out at present: a controlled three-year prospective evaluation of an antismoking intervention on sixth-grade school children in about 100 schools around the country, and a study of the impact of smoking on human sperm vitality.

The smoking control and research community is very small in the Czech Republic; we all know each other and collaborate. The first publication for doctors was issued in 1980, and a detailed report summarizing all available studies was published in 1993. To provide support for health professionals involved in tobacco control, a textbook for physicians and medical students on smoking cessation methods is being prepared with about 30 authors. To stimulate doctors to be active and to provide them with information, we asked leading persons in different medical branches to describe briefly the impact of smoking from their point of view. The book is expected to be published at the end of 1996.

Editor's note: Summer vacations have taken their toll on the "What's new in..." feature; instead of our usual triptych, only biobehavioral research (formerly clinical research) is represented. All three columns will return in the Fall issue.

Although the effect of smoking on blood pressure and heart rate has been studied for years, many questions remain unanswered. For example, the acute effect of smoking has been demonstrated repeatedly in the laboratory, but generalization of this effect to the natural environment is inconsistent. In particular, it is unclear whether smokers have higher or lower blood pressure than nonsmokers and whether blood pressure decreases or not when smokers quit. Epidemiological and laboratory studies of smoking effects will be reviewed here and the hypothesized physiological mechanisms described, along with suggestions for future research.

The findings from these studies of the effect of smoking and smoking cessation on blood pressure and heart rate suggest several directions for future research. First, the timing of measurements in laboratory studies and in epidemiologic investigations of smokers must be carefully considered. In particular, laboratory studies of smokers frequently employ a two-hour abstinence period, but it has been demonstrated that blood pressure and heart rate are still significantly elevated at this point. Moreover, these cardiovascular measures show a downward trend during the first few hours of abstinence, which could interfere with interpretation of levels during a laboratory study that employed repeated measurements over time. An abstinence period of at least 8 hours is suggested before taking laboratory measurements. For epidemiologic investigations of blood pressure and heart rate levels in smokers, at the very least, time from last cigarette should be standardized.

Second, there is disagreement over whether heart rate and blood pressure changes are sustained indefinitely after cessation. Future research should be directed toward exploring the time course of changes in individuals who quit smoking and toward identifying characteristics (e.g., age, weight, baseline blood pressure level, nicotine dependence) that differentiate smokers who show substantial permanent decreases in blood pressure after cessation from those who show minimal or transient changes.

Third, to our knowledge, the studies of the effect of smoking cessation on cardiovascular levels have only employed normotensives (or people whose hypertensive status is undocumented). Given the roles that smoking and hypertension play as risk factors for cardiovascular diseases, whether hypertensive quitters show effects that differ from normotensive quitters is certainly of interest.

Research cited above from the Center for Health Sciences was supported by NHLBI grant HL39225 and funds provided by the Cigarette and Tobacco Surtax Fund of the State of California through the Tobacco-Related Disease Research Program of the University of California grants 1RT547 and 3RT376.

Smoking Cessation Guidelines From The Agency for Health Care Policy and Research: A Role for Specialists

As with previous AHCPR guidelines, a major charge to the panel was that its recommendations be derived from empirical evidence. To this end, the guideline staff reviewed some 3,000 English-language articles published between 1975 and 1994. From this sample, more than 300 articles were selected for review based on (1) publication in a peer-reviewed journal, (2) being a tobacco-use cessation intervention delivered in a randomized, controlled trial, and (3) providing follow-up information for at least 5 months after the quit date. The one exception to the above insistence on randomized, controlled trials was that the panel also considered the results of previously published meta-analyses based on randomized clinical trials. Independent raters coded each article selected for review to capture key methodological and outcome information (typically, smoking cessation rates). The database served as the basis for a number of meta-analyses that led to the specific recommendations for each of the target audiences. Six major findings emerged from the work of the Guideline Panel. These are:

A novel feature of the Smoking Cessation Clinical Practice Guideline was the inclusion of explicit recommendations for health care delivery administrators, insurers, and purchasers. This acknowledged both the increasing role of managed care organizations in determining health care resource allocation, as well as the historical frustration smoking cessation specialists and primary care clinicians have experienced when third-party payers refused to reimburse for effective smoking cessation services. The Guideline Panel recommended that this group make institutional changes in both ambulatory and inpatient settings to facilitate identification of, and intervention with, all tobacco users; that effective smoking cessation treatments (both pharmacotherapy and counseling) be paid services for all health insurance subscribers; and that clinicians delivering effective smoking cessation interventions be reimbursed appropriately.

SRNT members who are interested in obtaining a copy of the Clinical Practice Guideline, the Quick Reference Guide for Smoking Cessation Specialists, or other related documents may obtain them from AHCPR’s Web site (http://www.ahcpr.gov/guide/) or may call the AHCPR Publications Clearinghouse toll-free at 800-358-9295.

The American Psychiatric Association, the first organization to recognize nicotine dependence formally, has outlined an aggressive national antismoking policy and has vigorously promoted smoke-free psychiatric units. The APA has now produced a Practice Guideline for the Treatment of Patients with Nicotine Dependence. The guideline complements the AHCPR guideline by focusing on three specific groups of smokers: 1) smokers who have failed initial treatments for smoking cessation and need more intensive treatment, 2) smokers being seen by a psychiatrists for a psychiatric disorder other than nicotine dependence and 3) psychiatric patients who smoke and are temporarily confined to a smoke-free inpatient or residential setting. Recommendations are concrete and detailed and carry ratings from I to III based the adequacy of the data. Evidence from studies other than randomized trials and clinical expertise were often used to make recommendations; thus, the guideline tends to recommend treatment more often and to be more specific about recommendations than other guidelines.

The guideline recommends 10 therapies (rated I or II; see Table); classifies 11 others as promising and possibly worthy of recommendation based on individual circumstances (III); and lists 21 others as not recommended. SRNT members will probably be most interested in the sections on promising therapies as some of these therapies are likely to be the treatments of the future.

In terms of smokers who have failed initial therapy (usually nicotine gum or patch and/or group behavior therapy), the guideline recommends assessing the adequacy of prior treatments, screening for psychiatric disorders, especially alcohol/drug disorders, and trying to determine if the relapse was due to withdrawal and/or psychosocial reasons. It recommends combined nicotine patch and nicotine gum [II], clonidine [II], and nicotine nasal spray [II] as pharmacotherapies as well as intensive, individual behavior therapy [III] for this group of smokers.

In terms of smokers being seen by psychiatrists, the guideline recommends placing smoking cessation on all treatment plans [I], motivate patients to attempt to stop during non-crisis periods [I] and provide initial therapy [I]. It also recommends psychiatrists follow those who stop closely to detect any remission in psychiatric disorders or changes in blood levels of medications [II].

For patients on smoke-free wards, the guideline recommends clear instructions about the nosmoking policy, advice to stop smoking, and education about withdrawal [III]. It also recommends behavioral strategies [III] and nicotine gum or patch [II] to decrease withdrawal.

The approximately 40-page guideline will be published as a supplement to the October issue of the American Journal of Psychiatry and can be obtained from the American Psychiatric Association Press by calling (800) 368-5777.

A major study released by the World Health Organization and the World Bank as we go to press forecasts that the largest health problems in 25 years will be chronic conditions caused by tobacco use, not infectious disease. By the year 2020, tobacco-related diseases will cause one in every ten deaths¾a total of 8.4 million¾worldwide. Mental illness, led by Major Depressive Disorder (a condition strongly associated with smoking), will be the second-worst scourge by 2020, trailing only heart disease. The authors conclude that governments are spending too little on these chronic diseases in comparison with infectious diseases, and that spending should be refocused to prepare for the onslaught of chronic conditions, which are often expensive to treat and require long-term care. A look at the list below might easily persuade an unbiased nicotine researcher that in a climate of limited resources, funding targeted for research on tobacco and nicotine would address not only the needs of the world of the year 2020 but the challenges of the 1990’s, and that learning more about nicotine and its blandishments now might reduce the need to treat chronic tobacco-related problems in the coming decades.