We know from epidemiology that continued smoking results in increased risk of developing a smoking-related disease. Epidemiology has also demonstrated that if a smoker quits, the risk of developing a smoking-related disease decreases.
These two epidemiological observations form the basis of our assessment framework for smoke-free products. Through the design of all of our studies, our goal is to build scientific evidence that will demonstrate the likely risk profile of smokers who switch to smoke-free products. The goal is to determine if the risk profile of switching to a smoke-free product is similar to continued smoking, or to smoking cessation, or somewhere in between.
The chart is for illustration purposes only. The red line illustrates the increase in the risk of developing a smoking-related disease by continued smoking, while the green line represents the decrease in the risk of smoking-related disease after quitting.
Since smoking cessation is the “Gold Standard” for assessing the reduction in risk for smokers, our goal is to develop products that have a risk profile as close as possible to the risk profile demonstrated by smoking cessation.
“ [Cessation is the] “gold standard” [for the assessment of an RRP, providing] an aspirational goal for risk and exposure.”
― Institute of Medicine, 2012
What clinical trials support our assessment?