In case you missed it, or if you want to watch it again, we have recorded the discussion session of our June 2021 Open Science Expert Talk focused on the challenge of measuring the use of nicotine-containing products. You can watch the video below to dig into the details and examples our speakers provided during the discussion, or read through the highlights on this page to get an overview of some of the main points.
There are a lot of studies out there. In fact, in the last five 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.
-Gizelle Baker, VP Global Scientific Engagement
Gizelle Baker: Hello, I'm Gizelle Baker. I'm an epidemiologist and biostatistician by training, with a degree from the Medical University of South Carolina. Today, I'm the Vice President of Global Scientific Engagement, where I lead a team of scientists that travel around the world and share the science behind our smoke-free products and on tobacco harm reduction more generally.
Pierpaolo Magnani: Good morning, good afternoon, good evening, everybody. I'm Pierpaolo Magnani. I'm from Italy. I have a degree in studies in economics from the University of Roma La Sapienza, and currently at PMI I'm Global Head of Behavioral and Regulatory Insights. I have a small team of scientists and consumer researchers, and what we do, we develop and we conduct most of the pre- and post-market studies that we use to measure the potential, the likely effect of smoke-free products, smoke-free alternatives in modern users and non-users populations.
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 five 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 compatible 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.