28 June 2021

Steve Roulet discusses post-market evidence related to alternative nicotine-containing products. 

"Thus, Philip Morris develops and markets heated tobacco products and electronic cigarettes in order to enable smokers to find an acceptable smoke-free alternative, and thus reduce the damage to their health and reduce the damage linked to smoking at the population level."

Steve Roulet, Global Head of Behavioral Research Insights

Below is the transcript of the video:

Good morning, good afternoon to everyone listening to this recorded session. I'm very pleased to be a speaker for the Bulgarian Pharmaceutical Days. I am Steve Roulet, and I'm the Global Head of Behavioral Research Insights at Philip Morris. Today, I'm going to talk about post-market evidence related to alternative nicotine-containing products. I have been working with Philip Morris for about 20 years, and I've been involved in all pre- and post-marketing studies with the aim to assess the perception and the behavior of adult tobacco and nicotine-containing product user and adult non-tobacco and nicotine-containing product user, related to IQOS, which is Philip Morris's heated tobacco product.

During today's presentation, I will cover quite a lot of ground, starting with the overall harm reduction concept. Then I will move to Philip Morris’ overall scientific assessment program for Philip Morris’ smoke-free products with a particular focus on post-market studies that we have implemented in Japan, Italy, and Germany, but also showing you results form a recent study conducted in the beginning of last year in Bulgaria. Before closing my presentation, I will present you key results from independent studies showing that the prevalence of use of heated tobacco products among former and never tobacco and nicotine-containing product user, including youth, is low in countries where IQOS has been already commercialized.

Let me start with a short introduction. As shown on this slide, and despite existing tobacco control measures, from 1990 to 2017, smoking remains one of the most important risk factors for smoking-related diseases, such as cardiovascular disease, in Bulgaria. This also shows that there is a need for additional ways to reduce the harm of smoking, which should complement the current tobacco control efforts. One of them is the harm reduction concept, which has been successfully applied in many other areas, such as vaccination, for instance.

There are certain known facts about smoking. First, smoking is addictive and causes a number of serious diseases. Second, according to the World Health Organization, it is estimated that more than 1 billion people worldwide will continue to smoke in the foreseeable future. As illustrated by the tobacco harm reduction equation shown here, the contribution of a product to reducing tobacco-related harm at the population level depends not only on the degree of harm reduction of the product, but also on its adoption by smokers who would otherwise continue to smoke. Those smokers should give up smoking completely and should use those non-combustion alternatives exclusively. At the same time, it is equally important that the product is not attractive to nonsmokers and ex-smokers.

In order to get smokers to replace their cigarette with non-combustion alternatives, a range of products with reduced risk is needed to meet the diversity of smokers' preference in terms of taste, use ritual, and pharmacokinetics of nicotine. The non-combustion alternative therefore plays an important complementary role in prevention and cessation policy against tobacco-related damage. Thus, Philip Morris develops and markets heated tobacco products and electronic cigarettes in order to enable smokers to find an acceptable smoke-free alternative, and thus reduce the damage to their health and reduce the damage linked to smoking at the population level. Our ambition is to convert as many adult smokers who would otherwise continue to smoke as possible to smoke-free products.

This slide illustrates the relationship between combustion, as shown by the horizontal axis, and the risk of a product containing nicotine, as shown by the vertical axis. This slide also shows the growing number of alternatives that adult smokers can use to switch from cigarettes to smoke-free product alternatives, such as snus, electronic cigarettes, and heated tobacco products.

In terms of continuum of risk, this figure illustrates the fact that overall tobacco or nicotine-containing products belong to two different groups. On one hand, on the right, in the red zone, the product involving the combustion of tobacco, which are the most harmful. And on the other hand, on the left, in the green zone, products without combustion, i.e., smoke-free products with reduced risk.

As you can see, there is a huge gap that separates the two areas on the continuum of risk, which coincide with the distinction between products with or without combustion. The relative position of the different products on the continuum of risk depend on their characteristics, for example, their level of emission of toxic substances. Electronic cigarettes and heated tobacco products are non-combustion alternative and are therefore positioned to the left, and therefore, at the bottom of the continuum of risk. Further down the continuum of risk, you will find snus while nicotine replacement therapy products are positioned very low on the continuum of risk.

As noted above, the relative risk of the product is only one of the two factors contributing to the reduction of the risk associated with smoking, the other being the degree of adoption and use of the product by smokers, while, and equally important, these products should not be attractive to nonsmokers and ex-smokers. It is therefore important to maximize the adoption of these products by smokers while minimizing the adoption of these products by nonsmokers and ex-smokers. We also believe that it's important that each product is scientifically substantiated.

Now, I would like to focus my presentation on one heated tobacco product marketed under the brand name IQOS since 2014, in Japan. As mentioned earlier, with the increasing availability of tobacco and nicotine-containing products that heat tobacco instead of burning it and have the potential to present less risk of harm compared to cigarettes, it is important to assess the impact of their emergence, not only at an individual level, but also at the population level.

Since 2016, Philip Morris has conducted several repeated cross-sectional surveys in Japan, Italy, and Germany, to monitor the use prevalence of its heated tobacco product after its commercialization. As shown on the righthand side on this slide, in the top blue box, post-market studies and surveillance are a key component of Philip Morris's overall scientific program for Philip Morris's smoke-free products.

Leveraging a simplified transition model from Abrams et al., I would like to focus today on three important pathways that should be considered to minimize tobacco harm on the population level.

  • • First, the product that presents less risk of harm compared to cigarettes generates switching among the intended audience. In the context of today's presentation, this means that ensuring that current adult smokers are switching to IQOS.
  • • It is equally important to minimize the unintended consequences, meaning that it's important that the product that presents less risk of harm compared to cigarettes generates low initiation among never users. In the context of today's presentation, this means ensuring that never tobacco and nicotine-containing product users do not initiate with IQOS.
  • • Lastly, the product that presents less risk of harm compared to cigarettes generates low relapse or low reinitiation among former smokers. In the context of today's presentation, this means ensuring that former tobacco and nicotine-containing product users do not relapse or do not reinitiate tobacco and nicotine-containing products with IQOS.

As mentioned earlier, PMI has been conducting repeated cross-sectional surveys within large national representative samples of randomly selected participants coupled with web-based surveys in large IQOS users sample. The representative sample among the adult population is of key importance to measure precisely the prevalence of tobacco and nicotine-containing product use, including IQOS, at population level. The sample of IQOS users provides robust indicator of tobacco and nicotine-containing product initiation, relapse, and reinitiation with IQOS. Once IQOS has reached a certain uptake, we will be able to draw more precise estimates about initiation, relapse, and reinitiation from the general population sample. I would also like to draw your attention to the fact that Philip Morris protocol and supporting documents of these cross-sectional studies have been published in peer-reviewed journals.

In terms of study design, the general adult population survey is a door-to-door survey carried out among the representative sample of the national general adult population. The sample is large and therefore provides a reliable estimate. The IQOS users survey is an online survey carried out among a random sample of IQOS users who registered their device after purchase to the PMI IQOS Owner Database. This sample is also large, and here again, provides a reliable estimate.

In today's presentation, I will show you results for the year 2019 as well as trend data for the three countries. Let me now turn to the study results, starting with the sample characteristics. This slide shows the sample characteristics in terms of sex and mean age for Japan, Italy, and Germany. You can also see the large sample size for both populations in each country.

This slide shows the total prevalence of tobacco and nicotine-containing product use in Japan, Italy, and Germany among the general adult population. The study data shows that the prevalence of tobacco and nicotine-containing products has remained overall stable in Japan, and that the total prevalence of tobacco and nicotine-containing product use is higher in Germany and Italy, compared to Japan.

On this slide, you can see how Philip Morris data compares with external independent sources. In short, PMI cross-sectional study data are in line with external independent study data in the three countries. In Japan, the National Health and Nutrition Survey conducted by the Japanese Ministry of Health in 2019 shows a prevalence of tobacco or nicotine-containing products similar to PMI estimates. Unlike Japan, where the study population and the study year are similar between the Japanese Ministry of Health's survey, and PMI cross-sectional study, the difference in Italy and Germany might be attributable to:

  • • First, the difference in terms of age group, as the data from the World Health Organization is from 15 years old and above, while our survey is from 18 years old and above, which is the legal age for smoking.
  • • Second, the difference in terms of study use.

The next slide will show the prevalence of IQOS use in those three countries. However, given the low prevalence of IQOS use among the general adult population, in particular, in Italy and Germany, during today's presentation I will only show you the prevalence of IQOS among those who are using tobacco and nicotine-containing product, in short, TNP users, and not among the total general adult population.

As you can see on this slide, IQOS uptake among tobacco and nicotine-containing product users is higher in Japan than in Italy or Germany. In Japan, for instance, in 2017, one out of ten TNP users were using IQOS, while in 2019, close to one out of five TNP users were using IQOS. This data also shows that IQOS is able to satisfy one very important aspect of the harm reduction equation, which is to switch adult smokers from cigarettes to products that present less risk of harm compared to cigarettes, in this case, IQOS. This slide also shows that factors such as regulatory framework and consumer acceptance may explain differences in IQOS uptake across these countries.

Now, I would like to elevate the discussion and show you the overall prevalence of use of IQOS on a global level. At the end of March 2021, PMI estimates that there were a total of 19.1 million legal age IQOS users worldwide, and that the trend of IQOS users is growing. PMI further estimates that 73 percent of this total, meaning 14 million adult smokers, have stopped smoking and switched to IQOS. This data shows that IQOS is able to satisfy, a second very important aspect of the harm reduction equation, which is about switching completely adult smokers from cigarettes.

Now it is important to assess whether our internal data is supported by independent study data. If we look at Japan, the National Health and Nutrition Survey conducted by the Japanese Ministry of Health in 2019, shows that 75 percent of males and 81 percent of females use heated tobacco products exclusively, which is in line with our estimates.

Now, I would like to show you study data about initiation, relapse, and reinitiation, as those elements are also pivotal from a harm reduction perspective in order to ensure that the impact of IQOS and any other smoke-free alternative is minimal among never and ex-smokers. This slide shows the rate of initiation of tobacco and nicotine-containing products in the past 12 months prior to this survey in adult never tobacco and nicotine-containing product users in Japan, Italy, and Germany.

Our cross-sectional study data shows that on a population level, there is very low to non-existent tobacco and nicotine product initiation with IQOS. PMI cross-sectional data from the IQOS users sample is aligned with data found in the general population survey. As shown on this slide, more than 99 percent of current IQOS users in Japan, Italy, and Germany, have a history of regular tobacco and nicotine-containing product use before switching to IQOS.

Among current IQOS users who had a history of regular tobacco and nicotine-containing product use, PMI cross-sectional data from the IQOS users sample show that about 98 percent of current IQOS users were smoking cigarettes when they started to use IQOS. In other words, they switched from cigarettes to IQOS. At the same time, only 1 to 2 percent of current IQOS users relapsed or reinitiated tobacco use with IQOS.

We believe that accurate, truthful, and non-misleading information to adult smokers are a key element to facilitate the switching from cigarettes to IQOS or smoke-free products. In fact, our data showed that reduced formation and/or reduced harm messages facilitate the transition, adoption, and the exclusive use of smoke-free products among adult smokers who would otherwise continue to smoke. As shown on this slide, data from our studies conducted in Japan and Germany show that there are differences in the perceived health risks of using IQOS compared to the health risks of smoking cigarettes.

Additionally, it is important to note that IQOS users do not perceive IQOS use as safe or risk-free, but rather as presenting a lower health risk than smoking cigarettes. This risk perception, measured in Japan and Germany, corresponds to the relative risk to health of the product which are reasonably likely, as mentioned by the FDA in the United States, based on the scientific analysis of the dossier submitted by Philip Morris for IQOS.

PMI’s cross-sectional studies have several strengths. These studies are conducted on an annual basis, and the data collection uses the same sampling framework and methods. The study applied widely accepted definitions of tobacco and nicotine-containing product use in accordance with the World Health Organization guidelines. Both sample sizes are large and provide a high level of precision of the main outcomes.

Our cross-sectional studies have some limitations. The studies relied on self-reported measures, for instance, participant's history of TNP use and therefore may have been impacted from reporting or recall bias. The survey among the IQOS owner population were based on IQOS users who registered their devices in the PMI’s IQOS owner database, which might not be fully representative of all IQOS users.

Though I'm sure you were very interested in the data collected in various countries, you are probably wondering if we have similar information for Bulgaria. In the beginning of 2020, we have commissioned a National Patient Organization to conduct a cross-sectional study with the aim to measure prevalence of tobacco or nicotine-containing product use in Bulgaria, including heated tobacco products and electronic cigarettes, as well as product history and perception of harm of tobacco and nicotine-containing products.

The National Patient Organization in Bulgaria assigned a survey to Kantar agency in Bulgaria. The survey has been designed in cooperation with the pre-established consultative working group of representatives and experts from the Medical University of Sofia, the Medical University of Plovdiv, the Medical University of Varna, the Ministry of Economy, and the Institute of Tobacco and Tobacco Products. The survey was partially funded by Philip Morris Bulgaria.

Let me start by briefly describing you some important aspects about the survey. This was a nationally representative survey for the adult population age 19 to 64 years old living in Bulgaria. To ensure a nationally representative sample, a two-stage cluster sampling with random selection of respondent in the household was applied. The survey was conducted face-to-face using a tablet to facilitate and ensure quality during the data collection phase.

The main sample was made of more than 2,000 respondents, ensuring robust and reliable estimates. The study was also augmented by two boosted samples among 300 users of heated tobacco products and users of e-cigarettes to provide more granular data on those important aspects. As you can see, field work was conducted between February and March last year, and the results were published on August 4. The link to access the publication can be found at the bottom of the slide. Let me now turn to some of the key results.

As shown on this slide, the overall prevalence of tobacco or nicotine-containing products in Bulgaria among the adults aged 19-64-years-old population is high, with 59 percent who claim to have used tobacco or nicotine-containing product in the past year. Based on the WHO information, the prevalence of tobacco or nicotine-containing product in Bulgaria remains one of the higher within the European Union. Of importance, the majority of tobacco and nicotine-containing product users in Bulgaria are using tobacco or nicotine-containing products on a daily basis, 46 percent, while the prevalence of occasional use reaches 13 percent.

Now, let's have a look at the prevalence of the type of tobacco products among those using tobacco or nicotine-containing products in Bulgaria. This slide shows the share of tobacco or nicotine-contain products among daily users of tobacco or nicotine-containing products, which represents 46 percent of the adult population in Bulgaria. The data indicates that close to 90 percent of all daily users of tobacco or nicotine-containing products are using manufactured cigarettes only, about 9 percent are using heated tobacco products, and 1 percent electronic cigarettes. The data also indicates that the prevalence of dual use among daily users of tobacco and nicotine-containing products is low at 1 percent.

Coming back to one very important aspect of the harm reduction equation, which is about switching adult smokers from cigarettes to products that present less risk of harm compared to cigarettes, such as heated tobacco products. This data shows that such alternative are able to satisfy that aspect. Though not shown on the graph, the survey also showed that more than 70 percent of heated tobacco products and electronic cigarette users are using their respective product as their main product. In line with what PMI has found in other countries, the vast majority of heated tobacco product users and e-cigarette users in Bulgaria had a history of tobacco and nicotine-containing products before switching to their respective products, showing that the risk of initiating tobacco and nicotine-containing product use with these products is low, which is a key aspect for harm reduction at the population level.

Now, let's have a look at the perception of risk of the various tobacco and nicotine-containing products. This slide shows the perception of harm on the various tobacco and nicotine-containing products in Bulgaria. The horizontal axis shows the different categories of products, while the vertical axis shows the risk from least harmful, with a score of 1, to most harmful, with a score of 10. All the scores on the graph are average scores.

In short, cigarette smokers understand that all tobacco and nicotine-containing products are harmful. At the same time, they perceive that heated tobacco products are less harmful than smoking cigarettes, which is in line with the risk profile of the product category. Before closing my presentation, I would like to cover some key aspects that I believe are of key importance for today's presentation. As mentioned earlier, post-market studies are a key component of PMI’s overall scientific assessment program for PMI's smoke-free products. At the same time, we believe external scientific review of our data, as well as independent studies, are equally important.

At PMI, we support the implementation of well-designed and well-conducted studies as shown today in the context of Bulgaria. After reviewing the results from PMI’s consumer perception studies performed in the U.S., the published literature, and the results from countries outside of the U.S. where IQOS has been marketed, the FDA concluded that the results do not raise concerns that the MRTP would generate a high level of interest among former smokers, generate a high level of interest among never smokers, or generate a high level of interest among young adult never smokers. In short, the findings of PMI's application for the U.S. are consistent with the potential benefits to population health.

In the next few slides, I will show you data that continues to support U.S. Food and Drug Administration’s conclusions. In particular, I will show you independent study data on youth. Before doing that, I would like to mention that Philip Morris is particularly concerned with the use of non-combustion products by young people. We are aware that this can be a problem, which is why we have put in place a large number of measures to prevent youth from having access to Philip Morris smoke-free products. Let's now look at some of the data.

In Japan, based on the representative longitudinal survey conducted online, Matsuyama and Tabuchi showed that the prevalence of heated tobacco product use in the past 30 days was low, and estimated to be 1 percent in never smokers and to be 2.9 percent among former smokers in 2019. The 2019 study data showed similar results as those found by Tabuchi et al. in previous years, as shown in this table. In Germany, the analysis by Orth and Merkel shows that the prevalence of ever use of heat-not-burn products among youth and young adults is low, and that there was almost non-existing heat-not-burn use in the past 30 days among 12 to 17 years old. In Switzerland, the analysis by Delgrande et al. also shows that the prevalence of use of heat-not-burn products was low, with a prevalence of use in the past 30 days of 1.1 percent among young people age 15 years old. In Japan, the analysis by Kuwabara et al. also showed that the prevalence of use of heat-not-burn products was low, with a prevalence of use in the past 30 days of 0.5 percent among young people, age 12 to 15 years old, and 0.9 percent among you people age 15 to 18 years old.

To date, data on gateway associated with the use of heat-not-burn products, is very limited. One of the only analyses of gateway associated with the use of heat-not-burn products is the analysis of Wozacki et al., which is also based on the population survey, age 12 to 18 years old, that is still appearing on this slide. Their conclusion was that heat-not-burn products do not cause a gateway effect in the younger generation in Japan. In short, based on the external data from Japan, Germany, and Switzerland, it appears that the prevalence of use of heat-not-burn product among never, ex-smokers, and youth is low.

The last slide of my presentation today before the conclusion is the analysis from Cummings et al., which shows that the accelerated decline in cigarette sales in Japan since 2016 corresponds to the introduction and growth in the sales of heated tobacco products. This analysis reaches the same conclusion from another analysis of sales data in Japan, conducted by Stoklosa et al., which found that cigarette sales have likely been reduced through the rollout of IQOS, while combined product volume remains unchanged. Those analyses are highly pertinent as they show that there is a replacement of the consumption of cigarettes by the consumption of heated tobacco products, rather than an incremental use of heated tobacco products.

I would like now to conclude my presentation. Though it appears quite challenging to have only one slide as conclusion, let me still try to highlight some of the fundamental aspects that I've shown you today. The U.S. Food and Drug Administration concluded that the findings of PMI applications for IQOS are “consistent with a potential benefit to population health”. PMI’s post-market cross-sectional studies and independent external studies continue to show that current IQOS use is in line with the principle of tobacco harm reduction. There is IQOS uptake among current adult smokers. There is low tobacco initiation with IQOS among never smokers, including youth, and low tobacco relapse and reinitiation with IQOS among former smokers.

We believe that it is important to provide access to smoke-free products so that adult smokers can switch from cigarettes to those reduced-risk alternatives. Lastly, PMI will continue to conduct post-market studies as part of PMI’s overall scientific assessment program for PMI’s smoke-free products. I would like to thank each of you for listening to me today.

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