Methods to assess potential reduced exposure products.

University of Minnesota Cancer Center, Minneapolis, MN 55414, USA.
Nicotine & Tobacco Research (Impact Factor: 2.81). 01/2006; 7(6):827-44. DOI: 10.1080/14622200500266015
Source: PubMed

ABSTRACT The availability of tobacco products purported to reduce toxin exposure or potentially reduce health risks necessitates the development of methods and identification of biomarkers that can be used to assess these products. These assessments occur on multiple levels and stages, from identifying constituents in the tobacco products and smoke, to human exposure and health effects trials, to postmarketing surveillance. A conference of multidisciplinary experts was convened to present and discuss methods and biomarkers to assess these products and to consider the infrastructure necessary to facilitate the evaluation process. Although no currently available set of measures was thought to be sufficient for determining the relative health risk of potential reduced exposure products, this paper provides a blueprint for future research toward this end.

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: A randomized, controlled, open-label, parallel-group, single-center study to determine biomarkers of exposure to 12 selected harmful and potentially harmful constituents (HPHC) in cigarette smoke, excretion of mutagenic material in urine, and serum Clara cell 16-kDa protein (CC16) in 102 male and female Japanese subjects who smoked Marlboro Ultra Lights Menthol cigarettes (M4J(M); 4mg tar and 0.3mg nicotine) at baseline. Subjects were randomized to continue smoking M4J(M), or switch to smoking either the Electrically Heated Cigarette Smoking System menthol cigarette (EHCSS-K6(M); 5mg tar and 0.3mg nicotine) or the Lark One menthol cigarette (Lark1(M); 1mg tar and 0.1mg nicotine), or to no-smoking. The mean decreases from baseline to Day 5/6 were statistically significant (p⩽0.05) for exposure to 10 of 12 cigarette smoke HPHC including the primary endpoint (carbon monoxide) and urinary excretion of mutagenic material in the EHCSS-K6(M) group (-12.3% to -83.4%). Smaller, but statistically significant reductions (p⩽0.05) occurred in the Lark1(M) group (-3.3% to -35.2%), with the exception of urinary mutagens. The largest mean reductions (all p⩽0.05) in exposure to cigarette smoke HPHC and excretion of mutagenic material occurred in the no-smoking group (-1.4% to -93.6%). Serum CC16, an indicator of lung epithelial injury, was not significantly different between groups.
    Regulatory Toxicology and Pharmacology 08/2012; 64(2). · 2.13 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: INTRODUCTION: Framework Convention on Tobacco Control (FCTC) Articles 20, 21, and 22 call for strong monitoring and reporting of tobacco use and factors influencing use and disease (Articles 20 and 21) and for collaboration among the Parties and relevant organizations to share resources, knowledge, and expertise on all relevant tobacco control strategies (Article 22). METHODS: This paper provides background information and discusses research strategies that would strengthen these efforts and better inform the Parties. By necessity, Articles 20 and 21 are discussed separately from Article 22, although 1 example that relates to both 20/21 and 22 is discussed at the end. RESULTS: Twelve important research opportunities on surveillance and evaluation are recognized, along with 4 on collaboration. The authors believe that the 6 most important areas for research would study (a) possible underreporting of tobacco use among certain demographic groups in some countries, (b) measures of industry activities, (c) optimal sampling strategies, (d) sentinel surveillance, (e) networks of tobacco companies and their partners as they promote tobacco use and interfere with implementation of the FCTC, and (f) network/relationship factors that impact diffusion of knowledge and decision making on the implementation of the FCTC. In addition, we call for a review process of existing surveillance and evaluation strategies to coordinate activities to make optimal use of existing resources. This activity would involve networking as prescribed in Article 22. CONCLUSIONS: Studies and activities such as these would facilitate control of the tobacco epidemic.
    Nicotine & Tobacco Research 01/2013; · 2.48 Impact Factor

Full-text (2 Sources)

Available from
May 16, 2014