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Goal
Given a hypothetical potential reduced risk product, do methods exist to predict its net benefit/harm at the population level, and what are they. What product characteristics are of concern?
Purpose Of Committee
The purpose of the Population Effects and Behavior Assessment (PEBA) Committee is to provide the Core Committee (CC) with an assessment of the potential consequences on the population of making reduced risk claims about tobacco products, and to provide the CC with an assessment of different methods for surveillance of population level use patterns and disease outcomes. Specific consequences to be addressed include altered initiation/recruitment of non-smokers (especially adolescents) and changes in patterns of cessation and relapse. The PEBA Committee will review the current relevant literature, and suggest ways of assessing potential reduced-risk products (and their marketing) for their potential population impact. Critical research needs will be identified.
Work Product
The results of this investigation will be presented in summary format to the Core Committee at their October 19-20, 2005 meeting, as a summary chapter in the RRRvw Core Committee report by April 2006, and as a formal report by late 2006.
Areas of Inquiry
Emphasis will be placed on anticipating the impact the introduction of products with reduced risk claims will have on the intensity and prevalence of tobacco use at the population level, and the means of monitoring these effects. There will also be some consideration of methods for monitoring health outcomes in users.
Specific questions to be addressed include:
- What has been the past experience with anticipated reduced risk actions, such as reduced yield cigarettes or smokeless tobacco, and what do they lead us to expect, and beware of? What product characteristics are of concern?
- How does socio-economic status affect potential reduced risk product use? What effect does mental illness have on use and possible abuse of potential reduced risk products?
- What predictors of quitting and relapse exist, how strong are they and how might these interact with the existence of potential reduced risk tobacco products?
- Who starts smoking, when and why? What influences the subsequent trajectory of use, and the levels of addiction reached? To what degree is habit maintenance reinforced by the nicotine content and delivery itself and/or by factors other than nicotine?
- What do/will individuals think of reduced risk products, how will they be perceived and how will this affect their use? Suggest methods to evaluate the population's interpretation of product claims, and their impact.
In summary, what could be the adverse consequences of introducing a potential reduced risk tobacco product? Do we anticipate an increase in tobacco use, either of the reduced risk product or via a gateway effect? If it is reasonable to anticipate increased nicotine usage, what aspects should be of greatest concern (e.g. teenage use, binge or social use, others?) and therefore most carefully monitored? Do we anticipate other adverse effects, such as a decrease in quitting, or increased time spent using prior to quitting or increased relapse? Which of these, and how much, would be of concern?
Surveillance
What surveillance methods should be used, and how will the rate of adoption, rate of use, intensity of use and effect on addiction and health be monitored? How should population effects be quantified? It is anticipated that surveillance will include requirements for biochemical verification of actual exposure; specific recommendations fall within the scope of the EA committee.
The committee will provide the core committee with:
- A discussion of surveillance/survey methods that could be used pre-market, in test markets, and post-marketing to evaluate the impact of a tobacco product with a reduced risk claim on population behavior.
- Recommendations on the best combination of study results, to increase confidence in the evidence and the reliability of the conclusions, and recommendations on the best individual methods and combination of methods to provide reliable and timely data
- A hierarchy of assessment criteria and methods, based on data quality, statistical strength, timescale, and the ability to be cross correlated with other studies,
- A brief discussion of the quantitative aspects of study design and interpretation, and the implications for risk characterization.
Recommendations and Research Needs
Recommend future directions and requirements for surveillance, the reporting of data, and appropriate responses to adverse trends.
What critical data are currently unavailable related to assessing undesired population effects of potential reduced-risk tobacco products? What kinds of studies are likely to provide these data? Are there limitations that must be overcome before such studies could be undertaken, and what steps could be taken to address these limitations?
Are current methods adequate to assess short-term and long-term population and behavior impacts of a potential reduced-risk tobacco product? If not, what types of research could aid in the development of appropriate methods? Are there emerging methods that could improve analysis in this area?
Key Personnel:
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Keith Lenghaus |
lenghausk@LSRO.ORG |
301-634-7154 |
LSRO staff |
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