Abstract
Smoking cigarettes kills more than 400,000 people annually in the United States and 5 million worldwide. According to the World Bank, without effective intervention, this number will increase to 10 million worldwide deaths per year by the early part of this century. An effective program to reduce the suffering and death of 10 million people every year does not yet exist. The product of concern continues to be offered for sale and promoted through the use of effective marketing messages that attract ~1.5 million new daily smokers in the U.S. every year, mostly individuals under 18 years of age. This despite active efforts by the public health community to encourage cessation and discourage initiation. The product also contains an addictive substance, nicotine, which hampers efforts of smokers to quit, even though quitting is an effective method to reduce individual health risk. Although medical, scientific and public health organizations have concluded that the best means to protect individual and public health from tobacco harms are to achieve abstinence, prevent initiation and relapse and eliminate environmental tobacco smoke exposure, consideration is also being given to the concept that reducing adverse impacts on the health of tobacco-users who will not or can not abstain from the use of tobacco products (i.e., "risk reduction") may also be a valuable component of a comprehensive tobacco control program. This presentation will review several critical questions associated with the evaluation of a product's potential risk-reduction characteristics, such as: What are the appropriate benchmarks/standards against which exposure reductions and risk reductions will be compared? Are there validated and reliable markers of exposure to cigarette smoke/tobacco products that could be used to assess the validity of exposure-reduction claims? Are there validated and reliable biological markers or surrogate endpoints for the early detection of tobacco-related toxicity/disease that could be used to assess the validity of reduced-risk claims?