A critique of the Australian National Health and Medical Research Council CEO statement on electronic cigarettes.

This paper critically analyses a statement by Australia's National Health and Medical Research Council (NHMRC) on e-cigarettes in May 2022 that will be used to guide national policy. We reviewed the evidence and the conclusions drawn in the NHMRC Statement. In our view, the Statement is not a balanced reflection of the benefits and risks of vaping because it exaggerates the risks of vaping and fails to compare them to the far greater risks of smoking; it uncritically accepts evidence of harms from e-cigarettes while adopting a highly sceptical attitude towards evidence of their benefits; it incorrectly claims that the association between adolescent vaping and subsequent smoking is causal; and it understates the evidence of the benefits of e-cigarettes in assisting smokers to quit. The Statement dismisses the evidence that vaping is probably already having a positive net public health effect and misapplies the precautionary principle. Several sources of evidence supporting our assessment were published after the NHMRC Statement's publication and are also referenced. The NHMRC Statement on e-cigarettes does not present a balanced assessment of the available scientific literature and fails to meet the standard expected of a leading national scientific body.

Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial.

Importance: Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy. Objective: To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation. Design, Setting, and Participants: This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome. Interventions: Treatments were provided in accordance with the manufacturers' recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support. Main Outcomes and Measures: The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025. Results: Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, -1.62% [1-sided 97.5% CI, -5.02% to ∞]; P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002). Conclusions and Relevance: Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. Trial Registration: anzctr.org.au Identifier: ACTRN12616001654448.

Does the gateway theory justify a ban on nicotine vaping in Australia?

Australia bans the sale, possession and use of liquid nicotine for vaping. One of the major arguments used to justify Australia's policy is that the availability of nicotine vaping products will lead a substantial number of young people who would otherwise not have smoked cigarettes to take up regular smoking (the gateway theory). In this article, we provide a critical analysis of the use of the gateway theory to justify Australian policy. We argue first that the evidence that vaping serves as a gateway to smoking is unconvincing. Smoking more often precedes vaping than vice versa, regular vaping by never-smokers is rare and the association is more plausibly explained by a common liability model. Second, we argue that even if the evidence were stronger it would not justify a ban on the sale of nicotine to adult smokers because there are other ways of preventing adolescent vaping that do not require a ban. We describe an alternative regulatory model for Australia that would address legitimate concerns about preventing adolescent uptake while allowing adult smokers to access these products for cessation or as an alternative to smoking cigarettes.

The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial.

BACKGROUND AND AIMS: Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline. DESIGN: Two-arm, parallel group, randomized, non-inferiority trial, with allocation concealment and blinded outcome assessment. SETTING: Australian population-based study. PARTICIPANTS: Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services. INTERVENTION AND COMPARATOR: Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12-minute sessions). MEASUREMENTS: Assessments will be undertaken by telephone at baseline, 4 and 7 months post-randomization. Participants will also be contacted twice (2 and 4 weeks post-randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview. COMMENTS: If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world-wide.

Electronic cigarettes in physician practice.

There is growing evidence for the effectiveness of e-cigarettes as a quitting aid and, although not completely harmless, the scientific consensus is that they are substantially less harmful than smoking tobacco. More research is needed, but there is now sufficient empirical evidence and real-world experience over more than a decade to consider their use as a legitimate tobacco harm reduction tool for smokers who are unable or unwilling to quit with conventional strategies. Smokers should be advised that the highest success rates occur with daily use with nicotine e-liquid and newer e-cigarette models. After quitting smoking, it is preferable to aim ultimately to cease vaping if possible, but long-term use of e-cigarettes is safer than relapsing to smoking.

Smoking cessation in people with alcohol and other drug problems.

BACKGROUND: People who consume alcohol and other drugs are at particularly high risk of harm from smoking, yet tobacco use is commonly neglected in this patient group. OBJECTIVE: The objectives of this article are to increase awareness of the high risk of tobacco-related harm in people who consume alcohol and other drugs, identify the barriers to quitting and provide practical guidelines to assist quitting. DISCUSSION: People who are dependent on alcohol and other drugs are far more likely to die from a smoking-related illness than from their other drugs. Most are motivated to quit smoking; however, their quit rates are lower than in the general population. Substance users who also smoke can usually be treated with similar behavioural and pharmacological treatments as others who smoke, but generally require more intensive and longer treatment. Quitting smoking at the same time as undergoing other drug treatment does not undermine drug treatment outcomes and may improve them. Smoking cessation should be integrated into the routine care of patients who consume alcohol and other drugs.