British American Tobacco and the "insidious impact of illicit trade" in cigarettes across Africa.

OBJECTIVES: To provide an overview of the complicity of British American Tobacco (BAT) in the illicit trade of cigarettes across the African continent in terms of rationale, supply routes and scale. METHODS: Analysis of internal BAT documents and industry publications. RESULTS: BAT has relied on illegal channels to supply markets across Africa since the 1980s. Available documents suggest smuggling has been an important component of BAT's market entry strategy in order to gain leverage in negotiating with governments for tax concessions, compete with other transnational tobacco companies, circumvent local import restrictions and unstable political and economic conditions and gain a market presence. BAT worked through distributors and local agents to exploit weak government capacity to gain substantial market share in major countries. CONCLUSIONS: Documents demonstrate that the complicity of BAT in cigarette smuggling extends to Africa, which includes many of the poorest countries in the world. This is in direct conflict with offers by the company to contribute to stronger international cooperation to tackle the illicit tobacco trade.

Eliminating child labour in Malawi: a British American Tobacco corporate responsibility project to sidestep tobacco labour exploitation.

OBJECTIVES: To examine British American Tobacco and other tobacco industry support of the Eliminating Child Labour in Tobacco Growing Foundation. DESIGN: Analyses of internal tobacco industry documents and ethnographic data. RESULTS: British American Tobacco co-founded the Eliminating Child Labour in Tobacco Growing Foundation (ECLT) in October 2000 and launched its pilot project in Malawi. ECLT's initial projects were budgeted at US2.3 million dollars over four years. Labour unions and leaf dealers, through ECLT funds, have undertook modest efforts such as building schools, planting trees, and constructing shallow wells to address the use of child labour in tobacco farming. In stark contrast, the tobacco companies receive nearly US40 million dollars over four years in economic benefit through the use of unpaid child labour in Malawi during the same time. BAT's efforts to combat child labour in Malawi through ECLT was developed to support the company's "corporate social responsibility agenda" rather than accepting responsibility for taking meaningful steps to eradicate child labour in the Malawi tobacco sector. CONCLUSION: In Malawi, transnational tobacco companies are using child labour projects to enhance corporate reputations and distract public attention from how they profit from low wages and cheap tobacco.

Serum nicotine and cotinine levels during nicotine-patch therapy.

We related serum nicotine and cotinine levels while subjects were smoking their usual numbers of cigarettes to levels while wearing a nicotine patch under carefully controlled, smoke-free conditions in a clinical research center. Twenty-four volunteers who needed intensive treatment for severe nicotine dependence were admitted to the clinical research center and were treated with a 22 mg transdermal nicotine patch each day and an intensive smoking-cessation program. Serum nicotine and cotinine levels, withdrawal symptoms, and hours and quality of sleep were noted. The steady-state serum nicotine and cotinine levels produced with the nicotine patch were lower than those observed when the subjects were smoking. Mean nicotine and cotinine levels were inversely related to mean withdrawal scores for the first 6 days. A fixed dose of transdermal nicotine will not be effective for all smokers. Individualization of therapy should be based on objective biologic measures such as serum cotinine and subjective assessment of withdrawal relief.

Nutritional status of a group of alcoholics before and after admission to an alcoholism treatment unit.

The nutritional status of the alcoholic has been presumed to be less than adequate because of the large quantity of alcohol ingested. Most reports have focused on the derelict alcoholic. In contrast, the patients in this investigation are more representative of the usual alcoholic population. The pretreatment dietary histories of 58 alcoholics were compared with their actual dietary intake while they were hospitalized for the treatment of alcoholism. Comparisons were also made between dietary intake by history and Recommended Dietary Allowances. The mean calorie, protein, fat, and carbohydrate intake of the patients was adequate and was well within the Recommended Dietary Allowances ranges. After the patients stopped drinking, they increased their intake of all major nutrients, especially carbohydrates. A subgroup of 11 patients whose recent dietary intake by history was corroborated by their urinary nitrogen excretion had no change in total caloric intake after they stopped drinking.

Plasma lipids and apolipoprotein A-I and A-II levels in alcoholic patients.

This prospective study compared total plasma lipids, high-density lipoprotein cholesterol (HDL-C), and apolipoproteins A-I (apo A-I) and A-II (apo A-II) in 72 alcoholic patients and in 285 nonalcoholic controls. The HDL-C in the alcoholic group was not significantly different from that in the nonalcoholic controls. Alcoholic men had significantly higher levels of cholesterol and triglycerides and lower levels of apo A-I when compared with nonalcoholic controls. Alcoholic women had significantly higher levels of cholesterol and apo A-II when compared with nonalcoholic controls. Serial measurements in 25 alcoholic patients showed a significant decline in HDL-C, apo A-I, and apo A-II levels during the 4-wk hospital stay. HDL-C demonstrated its expected inverse relationship with plasma triglyceride level and its direct relationship with apo A-I, apo A-II, and the hepatic enzyme aspartate aminotransferase.

Nicotine patch therapy in adolescent smokers.

OBJECTIVE: To evaluate the safety, tolerance, and efficacy of 24-hour nicotine patch therapy in adolescent smokers who were trying to stop smoking. DESIGN: Nonrandomized, open-label, 6-month clinical trial. SETTING: Five public high schools in the Rochester, MN, area. SUBJECTS: Twenty-two adolescent smokers, aged 13 through 17 years, with current smoking rate of 20 or more cigarettes per day (cpd). INTERVENTION: Daily nicotine patch therapy for 8 weeks (22 mg/d for 6 weeks followed by 11 mg/d for 2 weeks). Weekly individual behavioral counseling and group support continued for 8 weeks with follow up visits at 3 and 6 months and a mailed survey at 1 year. MAIN OUTCOME MEASURES: Self-reported smoking abstinence verified by expired air carbon monoxide of 8 ppm or less, nicotine withdrawal symptoms, adverse experiences, and blood cotinine levels. RESULTS: Subjects had a mean +/- SD smoking rate of 23.3 +/- 5.0 (range, 20 to 35) cpd at study entry and 2.6 +/- 1.6 years of smoking; the mean age was 15.9 +/- 1.2 (range 13 through 17) years, and 68% were girls. Of the 22 participants, 19 (86%) completed patch therapy, 3 (14%) had biochemically validated smoking cessation at week 8, and 1 continued to be smoke free at 3 and 6 months after patch initiation. There was a significant decrease from baseline in the mean nicotine withdrawal scores for days 4 and 7 of week 1 and the mean for weeks 2 through 8. Skin reactions were the most common adverse event. As the worst skin reactions, 55% had erythema only, 5% had erythema and edema, and 9% had erythema and vesicles, whereas 32% had no skin reactions. Other reported adverse events were headaches (41%), nausea and vomiting (41%), tiredness (41%), dizziness (27%), and arm pain (23%). None of these were considered serious, life threatening, or led to the discontinuation of patch therapy. In adults with comparable smoking rates, we found that the adolescents had lower blood cotinine levels. Those smoking 20 to 25 cpd had cotinine levels of 146 +/- 84 (adolescents) vs 260 +/- 98 (adults) ng/ml, and those smoking 26 to 35 cpd had levels of 169 +/- 73 vs 276 +/- 110 ng/ml, respectively. CONCLUSION: Nicotine patch therapy seems safe in adolescent smokers. Placebo-controlled trials are needed to establish the efficacy of nicotine patch therapy in adolescents.

Diagnosis of alcoholism with a self-administered alcoholism screening test: results with 1,002 consecutive patients receiving general examinations.

Since 1972 we have used the Self-Administered Alcoholism Screening Test (SAAST) in impatient alcoholics and their spouses and in patients from a general medical population. The SAAST, a 35-item test with a yes/no format, was administered to 1,002 consecutive Mayo Clinic patients who generally were not acutely ill and were requesting an annual examination or a general reexamination for chornic but stable problems. Of the 1,002 patients, 5.4% gave responses to the SAAST that would indicate the presence of possible or probable alcoholism. The medical record review on a random selection of patients revealed a false-negative rate of 6.7%. We believe that the SAAST is an effective tool for the detection of alcoholism and that it can be used in the general medical setting.

Treatment of nicotine dependence.

Nicotine dependence is characterized by periods of relapse and remission. Health care workers can have a pivotal role in the treatment of nicotine dependence. Smokers should be identified and categorized based on their readiness to change. Smokers who are preparing to stop smoking should be given multicomponent therapy in a step-care approach using behavioral treatment, addiction treatment, pharmacotherapy, and techniques of relapse prevention. Pharmacotherapies approved by the Food and Drug Administration for smoking interventions include sustained-release bupropion, nicotine gum, the nicotine inhaler, nicotine nasal spray, and nicotine patches.

Legionella bozemanii pneumonia in an immunocompromised patient.

Legionella bozemanii, a rare cause of pneumonia, has a predilection for patients with impaired cellular immunity and underlying disease. We report the 12th culture-proven case of this infection, acquired in the community by a patient undergoing chemotherapy for chronic lymphocytic leukemia. The diagnosis was established when studies of bronchoalveolar lavage fluid produced a positive reaction with species-specific fluorescent antibody and growth on selective culture media. Although erythromycin was administered within 48 hours after the initial examination, the clinical condition did not improve substantially until rifampin was added to the antimicrobial regimen.

Long-term follow-up of persons attending a community-based smoking-cessation program.

The long-term effectiveness of a smoking-cessation program based on education, behavior modification, and group support was evaluated. Because of the availability of long-term follow-up data, the natural history of cessation of smoking in persons who had attended a smoking-cessation program could be studied. At 1 year, the permanent rate of cessation of smoking was 22%, and permanent cessation continued to occur at least through 6 years of follow-up. Factors related to a higher rate of cessation of smoking were a white-collar occupation, having previously stopped smoking for more than 1 month or more than 1 year, being male, and wanting to stop smoking because of health concerns. In the absence of an almost complete return of questionnaires, sole reliance on mailed self-reports would have substantially overestimated the smoking-cessation rates. Although smoking-cessation programs alone involve relatively few smokers, analysis of the methods used in programs such as the one described continues to be important for the development of successful efforts to help people stop smoking.

Alcoholism in elderly persons: medical aspects and prognosis of 216 inpatients.

We describe 216 elderly patients (65 years of age or older) who were treated for alcoholism in an inpatient treatment program. Emphasis is placed on the demographics, medical characteristics, results of laboratory tests, outcome of treatment, and various comparisons of early- and late-onset alcoholism. The frequency of serious medical disorders among these patients was higher than would be expected for the overall population of a similar age. Elderly alcoholics have more abnormal results of commonly used laboratory tests than do younger alcoholics. Our data show that the elderly alcoholic can be successfully treated in a medically oriented inpatient treatment program. The concept of less-intensive treatment for the elderly alcoholic is generally not supported. More-intensive treatment may be necessary for some of these patients because of the high frequency of accompanying major medical and psychiatric problems. Early-onset alcoholism predominated, but we found no major differences between the two groups.

Alcoholism in elderly persons: a study of the psychiatric and psychosocial features of 216 inpatients.

The medical records of 216 elderly persons, admitted to the hospital for treatment of alcoholism, were reviewed. Concern of family and friends was the most common factor motivating patients for admission. Patients with late-onset alcoholism reported an association between a life event and problem drinking more frequently than did the early-onset alcoholics. The most common associated psychiatric disorders were tobacco dependence (67%), organic brain syndrome (25%), atypical or mixed organic brain syndrome (19%), and affective disorder (12%). Fourteen percent of patients also had a drug abuse or dependence problem, all using legally prescribed drugs. Psychiatric diagnoses and results of psychologic testing did not differ between early-onset and late-onset alcoholism groups. In a 60-patient cohort studied for correlation of outcome of treatment for alcoholism with major psychiatric diagnoses, no associations were found.

A study of HLA antigens in alcoholism.

The concept that alcoholism may be inherited has been suggested on the basis of twin and adoption studies and the further evidence that alcoholism is commonly seen in several members of a family. Genetic marker studies that have been conducted among alcoholics have often yielded seemingly contradictory results. Thus far, genetic marker studies involving HLA antigens have not been used in the study of alcoholism. In the current study, we identified and performed HLA typing in 52 alcoholics to determine whether a significant difference existed between the frequency of HLA-A and HLA-B locus antigens in an alcoholic population and that in a control population consisting of 1,704 nonalcoholic blood donors. In this study, we could not demonstrate a difference in the occurrence of these antigens between the two populations.

Alcoholism in physicians.

The Self-Administered Alcoholism Screening Test was completed by physicians attending an annual continuing medical education meeting. Of the responding physicians, 12% were identified as abstainers, 81% were classified as not alcohol-dependent drinkers, 5% were classified as possibly alcoholic, and 2% were classified as probably alcoholic. These results were similar to those obtained in a nonphysician general medical patient population previously given the same questionnaire. The data show that the prevalence of alcoholism among a group of physicians is not substantially different from that in a general medical population.

Nicotine-replacement therapy with use of a transdermal nicotine patch--a randomized double-blind placebo-controlled trial.

The rate of smoking was significantly reduced in volunteer subjects by providing effective nicotine replacement, self-help material, and weekly visits with a nurse for 6 weeks. Nicotine-replacement therapy with a transdermal nicotine patch (Nicolan) almost doubled the 6-week smoking-cessation rate in comparison with that in a placebo group (77% versus 39%; P = 0.002) among subjects who were smoking at least 20 cigarettes per day at baseline. Although most subjects who used the active nicotine patches had skin reactions, the reactions were primarily mild. For use of both active and placebo patches, the level of patient compliance was high. Among subjects who continued to smoke, the use of cigarettes was decreased to less than 50% of the baseline smoking level in 7 of 7 with active nicotine patches and in 15 of 19 with placebo patches. Outcomes beyond 6 weeks showed a substantial relapse rate in both groups. Thus, when nicotine-replacement therapy is provided, a need exists for concurrent behavioral intervention and training for prevention of a relapse, neither of which was part of this protocol.

Inpatient treatment of severe nicotine dependence.

The most severely nicotine-dependent patients who have tried traditional treatment programs without success may require maximal intervention to achieve abstinence. In the Clinical Research Center at the Mayo Clinic, we assessed the feasibility of an inpatient treatment program for 24 such subjects, who were hospitalized (in groups of 6) for 2 consecutive weeks. A combination of behavioral, chemical-dependence, and transdermal nicotine-replacement therapy was provided in a smoke-free, protected milieu. Components of the program included group therapy, management of stress, exercise, daily lectures, and supervised activities. The mean age of the 18 women and 6 men was 51.3 years (range, 29 to 69 years). The mean duration of smoking was 33.7 years, and the number of cigarettes smoked per day at the time of admission averaged 33.2. The most frequent tobacco-related medical illnesses were chronic obstructive pulmonary disease, arteriosclerosis obliterans, and coronary artery disease. All subjects but two--each smoked part of a cigarette--remained abstinent from the use of cigarettes while in the Clinical Research Center, and all completed the 2-week inpatient program. The subjects underwent follow-up for 10 weeks after dismissal and were contacted periodically thereafter. At 1 year, 7 of the 24 subjects (29%) had maintained continuous abstinence from smoking, and their self-reported status at 1 year was verified biochemically.

Cost-effectiveness of treating nicotine dependence: the Mayo Clinic experience.

OBJECTIVE: To estimate the cost-effectiveness of treating nicotine dependence, expressed as cost per net year of life gained by smoking cessation. DESIGN: A cost-effectiveness analysis was conducted of a cohort of consecutive adult patients treated for nicotine dependence from April 1988 through December 1992 at the Mayo Clinic Nicotine Dependence Center (NDC). MATERIAL AND METHODS: The study cohort consisted of 5,544 patients (50.8% female; mean age, 47.8 years) with a mean baseline smoking rate of 25.4 cigarettes per day. After an initial consultation, a nonphysician counselor developed an individual nicotine dependence treatment plan, which could include follow-up counseling, nicotine replacement therapy (patches or gum), group therapy, or an inpatient program. A relapse-prevention program included telephone calls and a series of letters to the patient. We computed the years of life gained for each person specific to age, gender, smoking rate at entry, and 6-month smoking status by using published mortality rates for current and former cigarette smokers. The 6-month smoking status was assumed to be applicable at 1 year. For subsequent determinations, we modeled by computer simulation the year-by-year (to age 100) smoking status by using published relapse and late cessation rates. Coupled with treatment costs, this information allowed the expression of cost per net year of life gained by stopping smoking. Net years of life gained, discounted 0, 3, and 5%, were computed with use of cessation and relapse rates expected for patients not seen in the NDC. Treatment costs were based on 1993 rates for the intervention services but did not include any tobacco product cost savings associated with smoking cessation. RESULTS: The 1-year smoking-cessation rate was 22.2%. With all NDC patients included, the estimated net years of life gained, with use of a 5% rate of discount for benefits, was 0.058, and the corresponding cost was $6,828 per net year of life gained. CONCLUSION: In comparison with the cost-effectiveness of other medical services, the cost of $6,828 per net year of life gained by treatment of nicotine dependence is relatively inexpensive. Such cost-outcome data are important as economic considerations are applied for optimal allocation of limited health-care resources. Nonphysician health-care professionals can assume a key role in the provision of cost-effective nicotine dependence intervention.

Nicotine nasal spray for smoking cessation: pattern of use, side effects, relief of withdrawal symptoms, and cotinine levels.

OBJECTIVE: To determine the extent of side effects during the initial use of nicotine nasal spray for smoking cessation. DESIGN: We performed a one-sample, noncomparative, open-label evaluation of the pattern of use, side effects, relief of withdrawal symptoms, and cotinine levels with nicotine nasal spray. MATERIAL AND METHODS: Adult smokers were recruited to use the nicotine nasal spray for smoking cessation at a dosage of 1 to 2 mg/h. Subjects completed daily diaries, which included an assessment of nicotine withdrawal symptoms, previously reported irritant effects of the nicotine nasal spray, and symptoms of nicotine toxicity. A plasma cotinine level was measured at baseline and at day 7 for calculation of percentage replacement. RESULTS: The mean age of the 50 study subjects was 43.7 years, 46% were women, and the mean baseline smoking rate was 28.5 cigarettes per day. We found an increase in five symptoms (runny nose, nasal irritation, throat irritation, watering eyes, and sneezing) that had been essentially absent before initiation of use of the nicotine nasal spray. All but throat irritation decreased significantly during days 0 through 7 of the study. The mean daily frequency of nicotine nasal spray use for the first week was 15.0 doses. Use of the nasal spray decreased significantly (P<0.001) during the initial 8 weeks of treatment. The mean percentage cotinine replacement for those subjects who were abstinent at day 7 was 38.6%. CONCLUSION: Although nicotine nasal spray causes substantial irritant side effects during the first few days of use, these adverse effects decrease significantly within the first week. Despite these side effects, subjects continued to use the nicotine nasal spray and experienced a high rate of initial abstinence from smoking.

Residential (inpatient) treatment compared with outpatient treatment for nicotine dependence.

OBJECTIVE: To compare smoking abstinence outcomes between smokers treated in a residential (inpatient) program and those treated in an outpatient program to determine if residential treatment was superior to outpatient treatment in smokers with moderate to severe nicotine dependence. PATIENTS AND METHODS: Patients treated in the residential nicotine dependence program at the Mayo Clinic, Rochester, Minn., between May 1, 1992, and January 31, 1996, were selected for this study. Each patient in the residential treatment group (n=146) was matched to 2 patients who received an outpatient nicotine dependence consultation by a trained counselor (n=292). Each patient was matched on age, sex, year seen, number of cigarettes smoked per day, longest previous abstinence, education, and marital status. Abstinence at 6 and 12 months was determined by self-report. For the purposes of analysis, each patient with missing outcome data was considered to be smoking. RESULTS: The 6-month abstinence rates for the residential group compared with the outpatient group were 45% and 26%, respectively (P<.001), and the 12-month abstinence rates were 45% and 23%, respectively (P<.001). After adjusting for matching variables that were not exactly matched (age, baseline number of cigarettes smoked per day, and longest previous abstinence) and the baseline variables, including education, age when started smoking, and degree of nicotine dependence, there was a significant effect of residential treatment on 6- and 12-month abstinence rates (P<.001). Odds ratio of 6-month abstinence in the residential group was 2.74 (95% confidence interval, 1.60-4.71; P<.001) and at 12 months was 3.03 (95% confidence interval, 1.74-5.27; P<.001). CONCLUSION: Residential treatment for tobacco dependence is superior to outpatient treatment in some smokers who are moderately to severely nicotine dependent.

A dose-ranging pharmacokinetic study of nicotine tartrate following single-dose delayed-release oral and intravenous administration.

BACKGROUND: Ulcerative colitis is predominantly a disease of non-smokers, and transdermal nicotine is therapeutic but often results in side-effects. Administration of nicotine tartrate as a liquid enema decreases systemic nicotine absorption and may be effective for treatment of active distal ulcerative colitis. Ileocolonic delivery of nicotine tartrate via a delayed release oral capsule would be the preferred route to deliver nicotine to the colon. AIM: To determine the bioavailability and pharmacokinetic parameters of delayed-release oral nicotine tartrate capsules (Eudragit S100 coated) at doses of 3 mg and 6 mg nicotine. METHODS: Twenty healthy human subjects received delayed-release oral nicotine tartrate at one of two doses (each group n = 10): 3 mg and 6 mg nicotine. All subjects also received intravenous nicotine tartrate (at a dose of 15 micrograms nicotine base/kg) during a separate study period. Serum nicotine concentrations were determined by gas chromatography-mass spectrometry. In addition, concentrations of serum cotinine (major nicotine metabolite) were determined by high-performance liquid chromatography in all samples for two subjects (both given 6 mg nicotine). Adverse reactions were determined by questionnaire. RESULTS: The mean bioavailabilities of nicotine after ileocolonic nicotine tartrate administration via delayed-release oral capsules at doses 3 mg and 6 mg nicotine were 41% and 42%, respectively. The ratios (after adjusting for nicotine dose) of cotinine area under the curve (AUC) for delayed-release oral nicotine to cotinine AUC for intravenous nicotine were 1.5 and 1.6 for the two subjects undergoing cotinine pharmacokinetics, demonstrating significant first-pass metabolism. Serum nicotine concentrations did not predict adverse reactions. CONCLUSIONS: Nicotine tartrate delivered to the ileocolon as a delayed-release oral capsule at doses of 3 mg and 6 mg nicotine considerably reduced systemic nicotine bioavailability. This reduction in bioavailability appears to be a result of first-pass hepatic metabolism rather than poor mucosal absorption of nicotine. The therapeutic potential of an ileocolonic delivery formulation of nicotine tartrate, which can potentially limit toxicity by local delivery of high doses of nicotine, should be investigated in patients with ulcerative colitis.