Recommendations for the Appropriate Structure, Communication, and Investigation of Tobacco Harm Reduction Claims. An Official American Thoracic Society Policy Statement

Abstract

The tobacco harm reduction literature is replete with vague language, far-reaching claims, and unwarranted certainty. The American Thoracic Society has increasingly recognized the need for a framework for reliably making such claims. Evidence-based standards improving the scientific value and transparency of harm reduction claims are expected to improve their trustworthiness, clarity, and consistency. Methods: Experts from relevant American Thoracic Society committees identified key topic areas for discussion. Literature search strategy included English language articles across Medline, Google Scholar, and the Cochrane Collaborative databases, with expanded search terms including tobacco, addiction, smoking, cigarettes, nicotine, and harm reduction. Workgroup members synthesized their evidentiary summaries into a list of candidate topics suitable for inclusion in the final report. Breakout groups developed detailed content maps of each topic area, including points to be considered for suggested recommendations. Successive draft recommendations were modified using an iterative consensus process until unanimous approval was achieved. Patient representatives ensured the document's relevance to the lay public. Results: Fifteen recommendations were identified, organized into four framework elements dealing with: estimating harm reduction among individuals, making claims on the basis of population impact, appropriately careful use of language, and ethical considerations in harm reduction. Discussion: This statement clarifies important principles guiding valid direct and inferential harm reduction claims. Ideals for effective communication with the lay public and attention to unique ethical concerns are also delineated. The authors call for formal systems of grading harm reduction evidence and regulatory assurances of longitudinal surveillance systems to document the impact of harm reduction policies.

What are the respiratory effects of e-cigarettes?

“…Given uncertainties in health effects and harm reduction potential, different regulatory approaches have been adopted in different countries, with the UK at one extreme promoting the use of e-cigarettes for harm reduction,183 and the US, the European Union, and other countries on a spectrum from harm reduction to a principle of precaution. The position of respiratory and other academic and public health societies has generally emphasized a precautionary approach, with the notable exception of the UK’s Royal College of Physicians 184185186187188189. For example, a recent European Respiratory Society panel concluded that as the chronic effects of e-cigarette use are unknown, no evidence shows that they are safer than other tobacco products and that, on the basis of current knowledge, negative health effects cannot be excluded.…”

NewsCAP: New guidelines favor varenicline for smoking cessation.

“…Finally, clinical trial SAE rates are not synonymous with product safety. Electronic cigarettes appear to carry their own unique risk profile, with wide variability in effects across product categories, aerosol constituents, ages of initiation, and consumer use patterns (91). The panel was aware of large epidemiologic studies of the respiratory and cardiovascular impact of electronic cigarette use and highlighted that the overall health consequences of electronic cigarette use have become increasingly suspect (92-94); conversely, initial safety concerns over varenicline have diminished under scrutiny (95,96).…”

“…The primary impediment to confidently answering the question is the lack of randomized trials directly comparing varenicline with electronic cigarettes. Assuming a specific antecedent exposure causing electronic cigarette-or vaping-associated lung injury can be identified, it may become ethically feasible to conduct trials blinding participants to both the intervention and the comparator (91). In all cases of clinical trials involving electronic cigarettes, we recommend using objective measures of compensatory behaviors and long-term control over dependence, not simply counts of cigarettes consumed (120).…”

The long-term supply of tobacco and nicotine: some goals, principles and policy implications

“…We recognise that some non-prescription nicotine products are effective cessation tools, and may be required in an interim period. We also recognise that there is an extensive discussion on harm reduction strategies for tobacco and nicotine 26–28. We suggest that regulation should support people addicted to nicotine to transition to a state where they are no longer dependent on any nicotine products.…”