A New Option For Smokers
Cigarette smoking is one of the leading preventable causes of death and illness in the world. The best way for people to eliminate the adverse health consequences of smoking is to never start, and, for smokers, to stop. However, many smokers will not quit, even those who want to do so, and thus continue to consume a dangerous product. An option for these smokers is the development of novel products that are scientifically substantiated to be less harmful and are acceptable alternatives to cigarettes.
The 2014 U.S. Surgeon General’s Report, “The Health Consequences of Smoking—50 Years of Progress,” says that successes in tobacco control have cut smoking rates more than half since the 1964 Surgeon General’s Report; from 42% in 1965 to 18% in 2012. But the report also points out that more than 42 million Americans still smoke and that “the burden of death and disease from tobacco in the U.S. is overwhelmingly caused by cigarettes and other combusted tobacco products; rapid elimination of their use will dramatically reduce this burden.”
The picture is consistent around the world; there will be more than one billion smokers around the globe in the foreseeable future, and millions of them are in the United States. From a public health perspective, however, the only policy approach to tobacco use traditionally offered to American smokers has been cessation.
So the question is…
Can reduced-risk tobacco products be relied upon as a strategy to help those who would otherwise continue smoking?
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) — which passed with overwhelming bipartisan support from the U.S. Congress in 2009 — gives the Food and Drug Administration (FDA) a powerful tool to improve public health by ensuring that tobacco products marketed with claims of reduced harm or risk of tobacco-related disease actually do reduce harm or risk of disease. FDA has issued guidance with a 360-day timeframe for review of applications for Modified Risk Tobacco Products (MRTP) under section 911 of the Federal Food, Drug, and Cosmetic Act (FDCA), as modified by the Tobacco Control Act.
Philip Morris International (PMI) submitted an application to FDA in December 2016 for authorization to market its novel Tobacco Heating System (THS), one of its candidate reduced risk products, in the U.S. as a Modified Risk Tobacco Product.
It is one thing to make a tobacco product that is less hazardous; it is quite another to do so while making the product acceptable and appealing so that adult smokers will want to switch to it from cigarettes. Less harm without appeal will generate little in the way of public health benefits. These are big challenges, but ones, which, if met, can produce significant benefits for public health.
This concept can be explained best by the following harm reduction equation:
Modified risk tobacco products must also be marketed in a manner that conveys their benefits to adult smokers without encouraging never smokers, former smokers and especially minors to begin using them.
Philip Morris International’s Assessment Approach
Philip Morris International’s comprehensive assessment program is designed to address these challenges and follows relevant scientific precedents and the FDA’s Draft Guidance for Modified Risk Tobacco Product Applications. Clinical and scientific assessment methods are similar to those used by the pharmaceutical industry, including product design controls, a range of toxicological tests, clinical studies, premarket consumer perception, and behavior studies and postmarket assessments.
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.
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