IQOS Use, “Switching” and “Quitting”: The Evidence

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Key points

  • PMI’s figures for global IQOS use are based partly on commercial data which cannot be independently verified. It is also skewed by data from Japan where e-cigarettes are banned, and therefore there is less competition for IQOS.
  • Its ‘switching’ estimates are based on short term assessments and cannot be generalised as sustained behaviour change. Its research on IQOS prevalence and the nature of ‘switching’ has been challenged
  • PMI downplays dual use of IQOs with cigarettes. Academic studies from Japan and South Korea, and PMI’s own research, have found that most IQOS users continue to smoke cigarettes. There is evidence that even low frequency smoking is still harmful to health, a risk which is not accounted for by PMI.
  • It also downplays the potential for initiation by non-smokers, including among youth.

Background

In February 2020, PMI stated that 14 million people were using IQOS. According to PMI, 10 million IQOS users (71% of the total) had stopped smoking and “switched” to IQOS, and an estimated 4 million were “in various stages of conversion” (i.e. still smoking cigarettes).1 In September 2020, PMI CEO Andre Calantzopoulos, speaking at the Concordia Annual Summit, gave a figure of 11.2 million as having switched to IQOS.2

PMI states that its “aspiration” is for the number of smokers switching to IQOS to exceed 40 million by 2025.3

PMI states that its estimates are based on “PMI financials or estimates, IQOS user panels and PMI market research” (see image 1).4

For an overview see the main page: PMI’s IQOS: Use, “Switching” and “Quitting”

Estimates of IQOS Use

In early estimates of IQOS use presented by PMI, the methodology for calculating “conversion” rates was unclear. In 2016, industry journal Tobacco Reporter stated that at the Goldman Sachs Global Staples Forum in May 2016, then-PMI Chief Financial Officer Jacek Olczak said that in Japan, IQOS had “a full conversion rate of 60 percent from combustible cigarettes”, but no data source was cited.5

In the UK, PMI claimed that, after IQOS was launched in December 2016, 70% of IQOS consumers “are able to give up conventional cigarettes” which “compares with about 15-20 percent of people who use e-cigarettes”.6 It did not reveal the source of this data and it was unclear if it related only to users in the UK. At the time, UK and Ireland managing director for PMI’s UK arm, Philip Morris Limited, Peter Nixon said that it had hired “freelancers” who earned £50 every time they converted someone from cigarettes to IQOS6 (Reuters reported that these freelancers acted “like quitting coaches” but it is not known if Nixon used that phrase).6

In September 2017, The Washington Post reported PMI’s claim that 72% of IQOS users in Japan had completely switched from cigarettes to IQOS, with no details of data sources.7 Also in September, Branislav Bibiv (PMI Romania Managing Director) said that IQOS had achieved a 7 out of 10 conversion rate among adult smokers, again giving no sources for the figure.8

PMI’s use estimates were reported around the world from 2017. Although it was not always specified in media articles, the figures are assumed to represent total global users. However, the figures were initially almost totally made up of users in Japan and continued to be heavily skewed by data from this key market. In March 2017, PMI reported that 1.4 million people had converted to IQOS.9 By May 2017, the reported figure had risen to 1.8 million.10

Figures reported in the media cannot be relied upon to be accurate. For example in July 2017, the number of ‘converted’ IQOS users was reported in Saudi Arabia as 2 million11 and in India as 2.9 million.12

In its 2018 annual report, PMI stated that 6.6 million smokers had stopped smoking and switched to IQOS and that 3 million were in the process of “conversion”.13 In its 2019 report, it stated that 7.3 million had stopped smoking and switched, but no figure was given for those in “conversion”.14

PMI surveys

In 2019, a paper written by PMI employees was published in the journal JMR Research Protocols.15 It stated that, in March 2018, PMI launched the first in a series of annual surveys to estimate the prevalence and use patterns of IQOS and other nicotine products in Germany, Italy and part of the UK. It described these surveys as including a “representative sample of the general population [although the UK sample was only to be drawn from Greater London] and a sample of IQOS users”, the latter selected from PMI’s “user database”, which was not further described.15 The methods section referred to a “Smoking Questionnaire” to assess patterns of use, which included questions around the use of IQOS and HEETS sticks.15 PMI stated that “the results of the first year data analysis are expected to be available by June 2019”. As of October 2020, however, these results did not appear to be publicly available.

The “PMI Science” website presents some findings relating to the use of IQOS based on surveys conducted in Japan between 2016 and 2018. According to PMI’s website, a poster showing these findings was presented at the 2019 Global Forum on Nicotine.16 This poster appears to relate to a survey mentioned by PMI in the 2019 JMIR article.15 Although survey findings were presented by the PMI authors at two academic conferences (August 2017 and July 2018), as of October 2020 they do not appear to have been published elsewhere, or peer reviewed.1718 A further poster was presented at an event at CORESTA  (a tobacco industry association) in October 2018.19

Academic research on “switching” and quitting

Academic research published in 2020 by McKelvey et al. reviewed PMI’s IQOS evidence, which underpinned its pre-market tobacco product application (PMTA) and modified risk tobacco product application (MRTPA) to the FDA. The researchers identified a number of design flaws in PMI’s studies, notably around the concept of “switching completely”.20 While some terms, including ‘reduced’ and ‘eliminated’ were tested with participants, the term ‘completely switch’ was not validated to ensure it was understood. Respondents who reported to having ‘completely switched’ to IQOS, therefore, may have meant a variety of things, from exclusive use of IQOS to maintaining a low level of cigarette use. The authors noted that in PMI’s analysis there “was no category for ‘switching completely’ from cigarettes to IQOS. The ‘exclusive’ IQOS category included individuals at 95%–100% IQOS use, not necessarily completely switched”.20 See below for more details of these studies and their weaknesses.

Other research by Luk et al., published in September 2020, took a longer view than PMI and analysed data from a six month cessation trial in Hong Kong.21 While HTPs were not officially marketed in Hong Kong, they were easily obtainable online, and this study indicated rapid uptake with 10% of smokers starting to use IQOS in the trial period.  The researchers found that while HTP use alone was not associated with abstinence from cigarettes after six months, individuals also using cessation services were more likely to have quit.21

Dual and poly use

PMI consistently underplays the significance of dual and poly use of IQOS with cigarettes or other tobacco products.

PMI data

In 2017, PMI published its findings from the ‘real world’ (observational) studies it conducted in five countries between 2013 and 2015, which it had submitted as evidence to the FDA.2223 These studies in Germany, Italy, Japan, South Korea and Switzerland found that after 4 weeks, only 4.3% to 15.7% of participants (depending on country) “exclusively” used IQOS. Dual use rates (according to PMI’s own definition) ranged from 27% to 39% during the study period. These figures were initially high and then decreased over time as users reverted to conventional cigarettes, or “to a lesser extent” switched to HTPs.23

PMI conducted a similar study in 8 US cities that was published in 2019 in an online journal F1000 Research (not peer reviewed) which it also submitted to the FDA.24 Only 7.5% of US participants used IQOS exclusively during the study period; 63% continued to predominantly smoke cigarettes and 22% were defined as dual users.24 The FDA created its own chart based on PMI’s studies and definitions. This showed that across all five countries, significantly more people also used cigarettes (dual use) or reverted to cigarettes than exclusively, or even predominantly, used IQOS (Image 1).22

A screenshot of a chart.

Image 1: FDA chart showing dual use, based on PMI’s data (Source: FDA)22

McKelvey et al. found that PMI’s consumer perception and behaviour studies were fundamentally flawed in multiple ways: findings were extrapolated from a diary task to the whole sample, when only half of the participants had completed it; studies did not count use of other tobacco products, only cigarettes and IQOS; studies were limited to a 4-6 week period, when HeatSticks were provided for free (giving a price advantage and potential bias, meaning that the results were not representative of smokers or HTP users); and they did not allow sufficient time to identify how many IQOS users might “switch back” to cigarettes.20 The authors concluded that statements made by PMI based on this research were not supported by its own evidence:

“PMI concluded that IQOS ‘has the potential to completely ’switch’ a sizeable proportion of participants’,[15] despite the fact that in these PMI studies, an unknown percentage (but no more than 3%–15%) of adult cigarette smokers with access to IQOS free of charge switched completely.”20 

In addition, they stated that PMI had mis-represented its own finding around participants’ quit intentions and downplayed the likelihood of dual or poly use.20

Despite its weaknesses, the FDA concluded that PMI’s studies were “supportive that marketing IQOS with a reduced exposure claim could appeal to current smokers who are most likely to benefit from their use, and this supports a likely benefit to population health”.22

In its MRTP application to the FDA, along with evidence from its observational studies, PMI submitted evidence from its pre- and post-consumer surveys in Japan.22 According to the FDA, PMI’s 2016 pre-market study indicated a “high prevalence of dual use with cigarettes” (84.9% ) and “For most heat‐not‐burn product users, heat‐not‐burn products comprised less than 30% of their average total daily tobacco consumption”.22 While its post-market panel study six months later reported lower dual use, the FDA noted significant limitations, including that participants were all registered IQOS users, and therefore were not a representative sample even within Japan.22

The PMI poster based on its Japan surveys, presented at the 2019 Global Forum on Nicotine (GFN), refers to “dual use” and “poly-use” of “tobacco- or nicotine-containing products” (referred to here as TNPs).16 It states that “around 70% of IQOS users were using the product either exclusively or in combination with other smoke-free products with the majority of IQOS users using IQOS exclusively”[original text in bold].16 There is no definition of these other products: PMI does not refer to the use of other nicotine products, like e-cigarettes or snus, in its public statements about IQOS and “switching” from cigarettes, even though it has these in its portfolio of next generation products. This presentation also de-emphasises the nearly 30% of users who were still smoking cigarettes or other combustible tobacco products. PMI’s data indicates that the number of those using IQOS and combustible tobacco products fell slightly in 2018, but that it remained nearly a third of IQOS users. These figures also showed that exclusive use of IQOS decreased, while dual use with other “smoke-free TNPs” increased.16 There appears to be no further analysis of poly use.

Apart from this not being a representative sample of the global population, e-cigarettes are banned in Japan, meaning that IQOS has little market competition from other products. As the FDA noted: “Consumers may be more likely to try using IQOS if non‐cigarette tobacco products such as nicotine‐containing e‐cigarettes are not readily available”.22

An earlier PMI presentation in 2017 also showed significant dual and poly use of cigarettes and other nicotine products, including Japan Tobacco’s HTP Ploom, which gave a more detailed breakdown of dual use.25

Researchers have also criticised PMI’s IQOS impact modelling as flawed. Max et al. stated that its “International Population Impact Model” (PHIM) “excludes morbidity, underestimates mortality, excludes tobacco products other than cigarettes, does not include FDA-recommended impacts on non-users and underestimates the impact on other population groups”.26

Market research

Euromonitor International (which receives project funding from FSFW and PMI) published a report in May 2020, which included some general findings on nicotine use from surveys it conducted in 2019 and 2020.27 In part, this survey was designed to “understand the extent and nature of dual and multiple formats”.27 The report noted that the HTP market is still relatively small, and that dual and poly use is most common among smokers who also use e-cigarettes and/or other products (which were not specified in this report). It also stated that in the case of HTPs, only 15% of users reported that they were planning to quit completely in the next year, and that this was “the smallest proportion of consumers of any category”.27 Euromonitor suggests this is due to the “immaturity” of the HTP category compared to other tobacco and nicotine product categories, such as e-cigarettes.27

For information on the global HTP market see Heated Tobacco Products

PMI-funded research by FSFW

FSFW published a detailed report on global nicotine trends in 2018 (updated in 2019), primarily based on Euromonitor data, as part of its work towards a “Tobacco Transformation Index”.28 These reports were focussed on the nicotine market and did not include any information on ‘dual’ or ‘poly’ use of nicotine products, except one reference in relation to dual use of cigarettes and roll-your-own tobacco.2930

Academic research on dual use at country-level

There is emerging independent evidence that people continue to smoke cigarettes and use other conventional tobacco products while using IQOS and other HTPs. Some of this evidence shows that this is also the case among young adults and youth, and that some non-smokers may be attracted to HTPs.

Japan

The largest HTP market by far, with 2.7% of the total population (around 4.4 million people) estimated to be using the devices on at least a monthly basis in 2018.31 Analysis of the ITC Japan Survey, a nationally representative web survey, found that most Japanese HTP users (68%, two thirds of whom used IQOS) also smoked cigarettes.31 Further analysis, based on the same survey data, found that over 30% of current smokers used IQOS and that “the use of HTPs had rapidly extended to current smokers, regardless of their intention to quit”.32 As Stoklosa and colleagues pointed out in their response to PMI’s claims published in the BMJ in September 2020, this analysis showed that “HTP use is more prevalent among the smokers who did not intend to quit their combustible cigarette use than among those who wish to quit”.33 The researchers defined HTP users as those who used any HTP at least once a month, contrasting with PMI’s definition of 5% use over the previous 7 days. “Exclusive users” of HTPs or combustible cigarettes were defined as participants who only used either one of the two products and dual users as participants who used both products at least monthly, which also contrasts with PMI’s more broad definitions.32 The researchers’ findings on dual use, including by young people, confirmed earlier analysis conducted on the 2017 ITC survey in Japan.34

South Korea

In the second biggest market for HTPs after Japan, researchers have also found high dual and poly use among adults and youth. A study conducted 3 months after the introduction of IQOS in 2017 based on a small sample of young adults found that all IQOS users also smoked cigarettes and e-cigarettes.35 Analysis of a survey of South Korean youth conducted in 2018 found “high poly tobacco use and the lack of an association between HTP use and cigarette quit attempts”; over three quarters of those who had used HTPs continued to smoke conventional cigarettes.36 Analysis of the 2018 Korea Community Health Survey found that dual use figures were even higher for over 18s, with over 96% being dual users of HTPs and cigarettes.37 The researchers also found that dual users “were not associated with an intention to quit cigarette smoking within a month”.37

US

Research in one of the newer markets for HTPs, but expected to grow quickly since the FDA’s MRTP decision, has suggested that introduction of IQOS will result in adolescent and young adult non-users initiating tobacco use with IQOS and could also increase poly-use of IQOS along with other tobacco products.38 Before the FDA decision, researchers also noted that the conditions of the MRTP state that it “should not increase initiation among non-users of tobacco products, and hence should not appeal to former users and never users” and “should not have a significant impact on the decision of a smoker who would otherwise quit smoking”.39 The FDA’s decision requires PMI to monitor unintended consequences on youth.22 With PMI’s history of youth targeted marketing,40 there is a crucial need for independent monitoring to avoid conflicts of interest.

The US Centers for Disease Control and Prevention (CDC)’s website states that “Heated tobacco products have not been scientifically shown to help smokers quit.”41

UK

IQOS has been on sale in the UK since 2016. An evidence review by Public Health England (PHE), which mainly covered e-cigarettes, stated that in 2017 awareness and use of HTPs was still “very rare”.42 Research published in a 2018 paper (co-authored by one of the contributors to the PHE report) found  that less than 2% of the UK’s total population used HTPs.43

PHE recommended that monitoring should include “transitions between smoking, EC [e-cigarette] use and heated tobacco product use.”42

IQOS as a Cessation Tool

There is very little evidence, as of October 2020, that IQOS is effective as a quit tool at the individual level or population level. While IQOS has been associated with a reduction in cigarette consumption in Japan, it has not been shown to reduce the overall prevalence of smoking, or the reduction of harm.

For more information on PMI’s attempts to move into the cessation space see the overview page: PMI’s IQOS: Use, “Switching” and “Quitting”

Relevant Links

TobaccoTactics Resources

TCRG Research

 

References

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