Scientific Assessment Approach
The Goal: A Risk Profile Approaching Cessation
Philip Morris International’s goal is to demonstrate that switching fully to its candidate reduced-risk products has a risk reduction profile approaching that of cessation, referred to by the U.S. Institute of Medicine (IOM) as the “gold standard” for assessing risk reduction.
Philip Morris International’s Assessment of Modified Risk Tobacco Products
The first step in assessing the aerosol generated by a candidate reduced-risk product is to confirm a reduction in the levels of harmful and potentially harmful constituents (HPHCs) compared to cigarette smoke. HPHCs are considered to be the primary cause of smoking-related diseases.
The next step is to confirm that the reduction in HPHCs results in reduced toxicity. Philip Morris International (PMI) takes toxicological assessment one step further by using a new area of science known as systems toxicology, which allows the use of non-clinical data to quantify the reduced impact of its products on the mechanisms leading to disease and thereby model their risk reduction potential compared with cigarettes.
Clinical studies are a cornerstone of the assessment program. They assess whether a reduction in the formation of HPHCs measured in the laboratory leads to a reduction in HPHC exposure under real use conditions when an adult smoker switches to the product. They also demonstrate whether switching from cigarettes to a candidate reduced-risk product has a beneficial effect on a smoker’s health profile. Clinical studies help determine the extent to which adult smokers would find the product an acceptable alternative to cigarettes.
Premarket perception and behavior research is conducted to determine consumer understanding of the product’s attributes and communications (including risk perception) and the extent to which marketing of the candidate reduced-risk product will encourage adult smokers to switch as well as the likely impact on nonsmokers and former smokers initiating tobacco use. This research is critical to help make a premarket determination of the overall public health impact of the product. This novel area of research undertaken by PMI is designed to meet the burden established by the Tobacco Control Act’s provisions on Modified Risk Tobacco Products.
PMI’s assessment of candidate reduced-risk products continues after its products are placed on the market. Postmarket studies are important to verify how consumers use the product, assess the longer term risk, and analyze the product’s impact on health of the population as a whole.
Developing The Product
Assessment of a candidate reduced-risk product’s risk reduction potential relies on the quality of the initial product design and on strict manufacturing controls to ensure that the product delivers consistent aerosol without combustion. In this initial phase of designing a product, PMI verifies that the product design does not pose any additional risks to those already known for combustible cigarettes. Only then can further research begin.
The next step is to verify a candidate reduced-risk product’s potential to reduce risk by measuring reductions in the levels of toxic compounds as well as the reduction in toxicity when compared to smoke from conventional cigarettes. If they are reduced significantly, clinical studies can begin.
Once laboratory research is completed, PMI conducts clinical studies with adult smokers to understand whether switching to a candidate reduced-risk product reduces user’s exposure to toxic compounds. Clinical studies also help determine whether such reduction leads to a reduction in the risk of developing a smoking related disease. The effects measured in smokers who switch to a candidate reduced-risk product are compared with those in smokers who continue to smoke cigarettes, and smokers who quit for the duration of the study.
Consumer Perception And Behavior Assessment
PMI conducts several types of perception and behavior studies before a product is introduced on the market to understand its potential to benefit public health. These studies measure both the extent to which a candidate reduced risk product will encourage adult smokers to switch and, at the same time, the likely impact on initiation of tobacco use among nonsmokers and former smokers. In essence, the PBA provides data on how U.S. consumers — both smokers and nonsmokers — will likely react and behave once the product is on the market.
Postmarket Studies And Surveillance
PMI’s research continues once a candidate reduced-risk product is on the market in order to assess the product’s effect on public health. It consists of safety surveillance, cross-sectional surveys to monitor prevalence, and cohort studies to monitor the ongoing health effects of switching to a candidate reduced-risk product.
Learn more about PMI’s scientific assessment program:
Smith, M. R., B. Clark, F. Luedicke, J.-P. Schaller, P. Vanscheeuwijck, J. Hoeng and M. C. Peitsch (2016). Evaluation of the Tobacco Heating System 2.2. Part 1: Description of the system and the scientific assessment program. Regul Toxicol Pharm, in press. (PMID: 27450400) doi:10.1016/j.yrtph.2016.07.006
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