OPEN SCIENCE, JUNE 2021

      The challenge of measuring the use of nicotine-containing products

      In this Open Science event, we examined how to scientifically quantify product use and address the relative risks associated with multiple product use. We discussed our commitment to a smoke-free future, understanding the choices smokers make during this transition, and whether they are switching completely to scientifically substantiated alternatives or making other choices.

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      More tobacco- and nicotine-containing products means more choices

      Most importantly, anyone who does not smoke should not start. For those people who do smoke, the best thing they can do to for their health is to quit smoking. For those who don’t quit, the health impacts of cigarette smoke can be greatly reduced if they switch completely to an alternative that is scientifically substantiated to be less harmful than cigarettes.

      But what choices do smokers actually make regarding cigarettes? Tobacco harm reduction would be much simpler if everyone who smoked cigarettes would quit, but that isn’t the case. People make many other choices. They may switch to a heated tobacco product or an e-cigarette, they may use multiple products, and those multiple products may or may not include cigarettes. And how often a person uses their nicotine-containing product also varies, as well as which products they use over time can change.

       

      Complexities of nicotine product use patterns

      How a smoker uses the products available to them does matter. Perhaps someone who smokes regularly decides to replace some of those cigarettes with another product. That’s a step in the right direction, but not the same as quitting or switching completely. However, if they already smoke and add a new tobacco- or nicotine-containing product on top of that, one has to assume it can only add to their risk profile.

      So scientifically, how do we quantify use? Does smoking a cigarette once per month make the person a smoker? Shouldn’t the definition be the same for smoke-free products so we can properly compare them? Also important: how can we talk about multiple product use in a way that addresses the products’ relative risks?

      Event details

      Tobacco- and nicotine-containing product use patterns

      In this 4th Open Science Event, we have taken a closer look at all these issues and more, first in a round table discussion with three of our leading scientific experts and then in our live Q&A. 

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      Open Science Speakers

      Measuring the use of nicotine-containing products: addressing the challenges

      In our fourth Open Science session, we explain that there are meaningful differences in the methodologies used by the studies on smoke-free products that focus on the use of nicotine-containing products. These methodological differences are driven by multiple factors such as the consistency of questions used, the sample size, the sample source, or the nature of the studies themselves (cross-sectional or longitudinal). The simple fact that there are many variables in the studies, the study methods, the analysis, and the interpretation makes measuring the use of nicotine-containing products a challenge.

      Understanding users’ behavior with nicotine-containing products is essential alongside knowing if the product is used by the right audience (i.e., adult smokers who would otherwise continue to smoke) while it is not picked up by unintended audience (i.e., youth, former smokers, and never smokers).

      What products are being used? Are adult smokers switching to these products and stopping their cigarette consumption? Or are they continuing to smoke cigarettes while at the same time adding other tobacco products on top of that? To provide meaningful answers to these questions and ultimately develop a clear picture, we recognize the importance of developing study methodologies that are accurate and reliable.

      Explore more about this engaging topic by watching the video.

      Highlights from June 2021 Open Science

      Gizelle: Let me be clear on this. The best thing that any smoker can do is to quit tobacco and nicotine altogether, but we all know a large portion of them won't, and for these people, the smokers who would otherwise continue to smoke cigarettes, replacing their cigarettes with a less harmful alternative can be a way to reduce the smoking-related impacts on their health, only if they completely stop smoking cigarettes. This is because, although these products are not risk free, and they contain nicotine, which is addictive, they expose users to fewer and lower levels of toxicants than cigarettes do.

      But it's going to be important that we understand their use behaviors in order to understand the potential for these products to have a positive impact on their health. This is why we need to know: what products are people actually using? Are smokers switching to these products actually stopping their cigarette consumption? Or are they continuing to smoke cigarettes while at the same time adding additional tobacco products on top of that? We also need to know how they're using the products, both the frequency of use and intensity of use.

      Gizelle: There are a lot of studies out there. In fact, in the last 5 years, there have been more than 6,000 publications on smoke-free products. Within these publications, there's a lot of variability in the studies, the study methods, and the analysis and interpretation. This is why dialogs like we're having today are so important.

      If we look at our clinical studies, we have seen that the level of exposure to toxicants, and therefore the impact on exposure, is almost exclusively driven by the amount of cigarettes that a person is smoking. Simply put, the fewer cigarettes that a smoker smokes, the lower their exposure to the toxicants.

      The fact is that many of these new products generate toxicants at levels that are orders of magnitude below cigarettes, primarily because of their absence of combustion. However, it's really important that people understand that reducing cigarettes is not the same as completely stopping cigarettes or completely switching to a less harmful alternative.

      The most important thing for a smoker is to stop smoking cigarettes altogether. At the same time, we have to understand that with every new product that enters the market, there will be some level of curiosity, and therefore some level of dual use is likely, and maybe even expected. Behavioral change is complex and for the most part, these changes don't just happen overnight. So we have to ask ourselves, how can we best minimize the amount of dual use or the length of dual use and maximize the quitting or full switching?

      Pierpaolo: We can observe meaningful differences depending on the methodologies used. The study methodology that we use obviously depends mostly on the study objective. For example, in our cross-sectional surveys in the general population that are measuring prevalence, we classify a respondent as a user or smoker if they answer that they are currently using tobacco products either daily or occasionally.

      To the extent possible, we are trying to make sure that those definitions that we used in our cross-sectional surveys are consistently applied across studies and that the criteria are uniform across the different product categories.

      And while the approach of using comparable criteria and questions for all products of interest is logical, this is not always the case. This is because products like e-cigarettes or heated tobacco products are new, and then the research often develop new questions to measure the use prevalence of such products, which makes comparisons with smoking cigarettes very difficult. For example, some surveys would use the 100-cigarette threshold for cigarettes, while for the e-cigarettes, the same surveys will only use the one-time use.

      If you smoke a few cigarettes in your life, you are counted as a never smoker. But if you puffed on e-cigarettes once or twice, you might be counted as an e-cigarette user. I think there are three important points that I would like to stress at this point in time. I think first it's important that we are able to differentiate between experimentation, trial, and established use.

      Second, I think understanding the frequency of use is also important. If someone uses an e-cigarette daily, but smoked one cigarette once in the past 30 days, are they really a dual user of e-cigarettes and cigarettes?

      And finally, we need to understand smoking intensity. The health impact is likely to be different for somebody who is smoking one cigarette a day and also uses an e-cigarette, but for someone else who is smoking 15 cigarettes a day and also uses an e-cigarette.

      Gizelle: It's the research question that will actually define the study design, the study population, the data that you collect in the study, and the way that you analyze the results. You will collect data from all studies, but if the design is wrong, the results may not be suitable for the question that you're asking, and you won't be able to get answers in a meaningful way.

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      Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.