20

Research Needs: Public Health Implications of E-Cigarettes

The committee was tasked to provide a list of research needs to inform Food and Drug Administration (FDA) and e-cigarette regulation that will be prioritized with respect to

• Research to gather information of most importance for the regulation of electronic cigarettes to protect the population health
• Research that should be a priority for federal funding

The committee identified many gaps in the literature during its review and identified dozens of important specific research needs for understanding the harm reduction potential and public health implications of e-cigarettes, as other research groups have documented (Walton et al., 2015). As described in Chapters 6 and 15, the committee identified two overarching research needs: addressing gaps in substantive knowledge and improving research methods and quality. Specific items for consideration identified by the committee are noted for each of these and appear in approximately the order in which the underlying research need emerged within Section III.

ADDRESSING GAPS IN SUBSTANTIVE KNOWLEDGE

Recommendation 20-1: The committee recommends that the Food and Drug Administration and other federal research sponsors and/or device manufacturers prioritize e-cigarette research

that addresses key gaps regarding harm reduction and the public health implications of e-cigarettes. This might include rapid response funding opportunities. Specific items for consideration follow.

• Potential of e-cigarettes to influence the ever use of combustible tobacco cigarettes:
  • Research that addresses potential dose–response associations between e-cigarette use and combustible tobacco cigarette smoking in adolescents and young adults, including detailed assessment of the use frequency and intensity, and dependence symptoms, for both products.
  • Studies that follow an entire population of youth beginning at an age in which risk of use of any product is negligible (e.g., 10 years old) and investigate time-varying associations between e-cigarette use and later combustible tobacco cigarette use at multiple developmental stages throughout the entire period of risk (e.g., up until age 29), while using multiple methods to establish temporal precedence of e-cigarette use relative to smoking.
  • Whether use of e-cigarettes with specified product characteristics is associated with different risk of ever smoking and progression to inform product standard.
• Potential of e-cigarettes to promote smoking cessation and/or harm reduction:
  • Carefully designed studies, especially adequately powered randomized controlled trials, of the effectiveness of e-cigarettes as cessation aids, using standards that have been used to evaluate smoking cessation pharmacotherapies:
    • Trials that compare e-cigarettes to FDA-approved smoking cessation pharmacotherapies and other evidence-based cessation treatments are most informative.
    • Trials could also compare the effectiveness of e-cigarettes as used in combination with existing FDA-approved cessation aids.
    • Trials should be conducted not only in general populations of smokers, but also among subgroups of smokers with higher smoking rates, among smokers less likely to use or respond to existing cessation treatments, and among individuals for whom tobacco smoking is especially harmful.
    • Trials should assess adverse events in a detailed and standardized manner to permit assessment of the harms of these devices compared with other smoking cessation aids.

IMPROVING RESEARCH METHODS AND QUALITY

Recommendation 20-2: The committee recommends that the Food and Drug Administration and other federal research sponsors and/or device manufacturers prioritize research on the public health implications of e-cigarettes that improves the quality of e-cigarette research. This includes protocol and methods validation and development and use of appropriate study designs, including the use of appropriate control groups.

• Prospective observational studies to assess the association of e-cigarettes with smoking cessation that include careful, detailed assessment of factors that existing research suggests may be important to moderate the effect of e-cigarettes on cessation, including frequency and duration of use as well as nicotine dependence, reason for use, and intention to quit.

• Studies that build on existing nationally representative population surveys of adults to monitor patterns of e-cigarette use in detail on an ongoing basis to include characterization of patterns of e-cigarette use such as the frequency and duration of use, type of device used, and reason for use.

REFERENCE

Walton, K. M., D. B. Abrams, W. C. Bailey, D. Clark, G. N. Connolly, M. V. Djordjevic, T. E. Eissenberg, M. C. Fiore, M. L. Goniewicz, L. Haverkos, S. S. Hecht, J. E. Henningfield, J. R. Hughes, C. A. Oncken, L. Postow, J. E. Rose, K. L. Wanke, L. Yang, and D. K. Hatsukami. 2015. NIH electronic cigarette workshop: Developing a research agenda. Nicotine & Tobacco Research 17(2):259–269.