NOT PEER REVIEWED The main problem with the claim of equivalence between smoking and switching to iQOS is that some biomarkers of potential harm change over a much longer timeframe than the 90-day duration of the trials. Biomarkers of potential harm can reflect years of accumulated physical changes arising from smoking and only improve slowly after smoking cessation. The trial did, of course, pick up very substantial reductions in biomarkers of exposure, which would, over time, emerge as reductions in biomarkers of potential harm.
This would have been apparent and obvious to readers if the paper had also shown the results for the third arm of the trial, smoking abstinence. The biomarkers of potential harm for smoking abstinence and for switching to iQOS are quite similar in this trial. This is a curious omission. Furthermore, biomarkers of exposure turned quite similar for both switching to iQOS and smoking abstinence - both are greatly reduced, which is an encouraging finding about the iQOS product.
It is unlikely that anyone would argue against smoking abstinence on the basis of the biomarkers of potential harm in the original PMI study. However, the author has selectively used the iQOS data from these trials without the context of the smoking abstinence data to oppose the Modified Tobacco Product Application that PMI made to the U.S. FDA - the author's attempt to block this reduced-risk product from entering the US market. ...
NOT PEER REVIEWED The main problem with the claim of equivalence between smoking and switching to iQOS is that some biomarkers of potential harm change over a much longer timeframe than the 90-day duration of the trials. Biomarkers of potential harm can reflect years of accumulated physical changes arising from smoking and only improve slowly after smoking cessation. The trial did, of course, pick up very substantial reductions in biomarkers of exposure, which would, over time, emerge as reductions in biomarkers of potential harm.
This would have been apparent and obvious to readers if the paper had also shown the results for the third arm of the trial, smoking abstinence. The biomarkers of potential harm for smoking abstinence and for switching to iQOS are quite similar in this trial. This is a curious omission. Furthermore, biomarkers of exposure turned quite similar for both switching to iQOS and smoking abstinence - both are greatly reduced, which is an encouraging finding about the iQOS product.
It is unlikely that anyone would argue against smoking abstinence on the basis of the biomarkers of potential harm in the original PMI study. However, the author has selectively used the iQOS data from these trials without the context of the smoking abstinence data to oppose the Modified Tobacco Product Application that PMI made to the U.S. FDA - the author's attempt to block this reduced-risk product from entering the US market. https://tobacco.ucsf.edu/pmi’s-own-data-biomarkers-potential-harm-americans-show-iqos-not-detectably-different-conventional-cigs
The "serious criticism" that Mr. Bates refers to is from him (on another website).
In order for the FDA to issue an order allowing Philip Morris International to market IQOS in the United States as a reduced risk tobacco product, the law required that, among other things, FDA "determines that the applicant [PMI] has demonstrated that such product [IQOS], as it is actually used by consumers will significantly reduce harm and the risk of tobacco- related disease to individual tobacco users."
That is why PMI provided the information of biomarkers of potential harm to the FDA. and how they compare to values observed in smokers. My paper shows that, using PMI's own data, IQOS will not significantly reduce risk to consumers compared with cigarettes.
Bates ignores this reality and instead talks about biomarkers of exposure, which is a different question.
NOT PEER REVIEWED
This study has some important findings that could, if replicated, guide FDA decision making on applications from manufacturers to make modified risk tobacco product claims. However, while it does not detract from the study’s findings, the article does not accurately describe the standards FDA must apply when evaluating those applications. The abstract inaccurately suggests that tobacco products in the U.S. may make reduced-risk or reduced-exposure claims so long as they are not misleading, and does not mention that any explicit or implicit reduced-exposure or reduced-risk claims may not be legally made without first submitting an application to FDA and receiving a permissive order, which considers various other factors, as well.
The introduction of the paper does a bit better, accurately stating that the Tobacco Control Act requires prior review by FDA before making lower-exposure or lower-risk claims. But it then suggests that manufacturers can receive that permission if they either demonstrate that the product lowers harm or risk compared with other tobacco products or if they demonstrate that the product is free of or contains reduced levels of harmful chemicals and the related claims don’t mislead consumers to believe that the reduced-exposure means lower risk. While that description is accurate as far as it goes, it leaves off the enormously important requirement, in both cases, that a manufacturer’s application for permission to...
NOT PEER REVIEWED
This study has some important findings that could, if replicated, guide FDA decision making on applications from manufacturers to make modified risk tobacco product claims. However, while it does not detract from the study’s findings, the article does not accurately describe the standards FDA must apply when evaluating those applications. The abstract inaccurately suggests that tobacco products in the U.S. may make reduced-risk or reduced-exposure claims so long as they are not misleading, and does not mention that any explicit or implicit reduced-exposure or reduced-risk claims may not be legally made without first submitting an application to FDA and receiving a permissive order, which considers various other factors, as well.
The introduction of the paper does a bit better, accurately stating that the Tobacco Control Act requires prior review by FDA before making lower-exposure or lower-risk claims. But it then suggests that manufacturers can receive that permission if they either demonstrate that the product lowers harm or risk compared with other tobacco products or if they demonstrate that the product is free of or contains reduced levels of harmful chemicals and the related claims don’t mislead consumers to believe that the reduced-exposure means lower risk. While that description is accurate as far as it goes, it leaves off the enormously important requirement, in both cases, that a manufacturer’s application for permission to make a modified-risk claim must also show that the proposed claim will benefit the health of the population as a whole (taking into consideration impacts of the product and its marketing with the modified-risk claim on implementation, cessation, relapse, etc.).
This study’s findings could have been presented even more powerfully if the article had also discussed their relevance to FDA’s consideration of how reduced-risk or reduced-exposure claims would impact the public health based on the claims likely influence on youth and adult consumer behaviors.
NOT PEER REVIEWED
More than 1,000 participants were exposed to IQOS in our clinical studies. The authors of the letter “Possible hepatotoxicity of IQOS" based their analysis on approximatively 10% of the data instead of examining the data as a whole. For example, for the five-day exposure studies in confinement, they stated that the percentage of participants with elevated bilirubin in IQOS arm was more than three times higher than that observed in the smoking abstinence (SA) arm in the European study (8.8% [7 participants] in IQOS arm, 2.6% [1 participant] in SA arm). However, they missed reporting that this percentage was lower in the IQOS arm than in the cigarette smoking (CC) arm in the Japanese study (10% [8 participants] in IQOS arm, 15% [6 participants] in CC arm). They also stated that the mean increase in alanine aminotransferase (ALT) was higher with IQOS than with CC or SA in the Japanese study but did not report that in the European study, the mean increase in ALT was lower in the IQOS arm than in the CC or SA arm.
Similarly, for the 90-day exposure studies in an ambulatory setting, they mentioned that the percentage of participants with increased ALT levels after 60 days of exposure was higher within the IQOS arm (6.3% [5 participants] in IQOS arm, 0% in CC arm, 2.6% [1 participant] in SA arm) in the U.S. study. However they omitted to mention that in the Japanese study, this percentage was lower in IQOS arm compared with CC or SA arms after 3...
NOT PEER REVIEWED
More than 1,000 participants were exposed to IQOS in our clinical studies. The authors of the letter “Possible hepatotoxicity of IQOS" based their analysis on approximatively 10% of the data instead of examining the data as a whole. For example, for the five-day exposure studies in confinement, they stated that the percentage of participants with elevated bilirubin in IQOS arm was more than three times higher than that observed in the smoking abstinence (SA) arm in the European study (8.8% [7 participants] in IQOS arm, 2.6% [1 participant] in SA arm). However, they missed reporting that this percentage was lower in the IQOS arm than in the cigarette smoking (CC) arm in the Japanese study (10% [8 participants] in IQOS arm, 15% [6 participants] in CC arm). They also stated that the mean increase in alanine aminotransferase (ALT) was higher with IQOS than with CC or SA in the Japanese study but did not report that in the European study, the mean increase in ALT was lower in the IQOS arm than in the CC or SA arm.
Similarly, for the 90-day exposure studies in an ambulatory setting, they mentioned that the percentage of participants with increased ALT levels after 60 days of exposure was higher within the IQOS arm (6.3% [5 participants] in IQOS arm, 0% in CC arm, 2.6% [1 participant] in SA arm) in the U.S. study. However they omitted to mention that in the Japanese study, this percentage was lower in IQOS arm compared with CC or SA arms after 30 days of exposure (1.3% [1 participant] in IQOS arm, 4.8% [2 participants] in CC arm, 7.5% [3 participants] in SA arm).
Taken together, the changes reported by the authors concern a small number of participants across all arms and most likely represent normal fluctuations of these parameters.
Finally, the grade 2 ALT increase in IQOS arm that was mentioned in the letter corresponds to a participant with an isolated increase at Day 30, which is explained by the use of concomitant medication. This information was also part of the publicly available information but was not taken into account by the authors.
In conclusion, the data submitted to the FDA as well as the data gathered in the context of our post-market safety surveillance system, based on pharmaceutical industry best practices, show unquestionably that there is no increased risk of developing hepatotoxicity after switching to IQOS.
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different...
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different the outcome if administered by an organization such as my own where the respondents would likely be more at ease. And while if started from scratch with recruitment it might also attract other-thinking smokers that could skew it the other way (but also then questioning this study's sample at the same time), it need not be necessary in regard to the study limitation present here today.
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED
Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, tak...
NOT PEER REVIEWED
Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, taken as a whole, their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control. Current policy, which had its beginnings some 20 years or more later, is painted as being an outgrowth of the low tar programme and as being similarly tainted with industry influence. It reflects no credit on the editorial processes and decision making of Tobacco Control that authors were permitted to get away with such unsupported conclusions in their published paper.
The idea that reduction in tar yield of cigarettes could be an effective way of reducing the health risks of smoking goes back to the 1960s at least. It was supported by many distinguished epidemiologists, including Doll, Peto, and Wynder. See for example this 1979 statement by Ernst Wynder: ““One of the things that has always appealed to me about science is that if I find something that makes biological sense, then I feel reassured. Thirty years ago, when we had a 40mg tar cigarette, if you smoked 30 cigarettes a day you were exposed to about 1200 mg tar a day. Today’s cigarettes have 20 mg tar, so you are exposed to 600 mg daily. If there’s one thing everybody can agree on, it is that all tobacco-related cancers are dose related.” (1)
What was lacking in this formulation was an understanding that the risk from products is not simply determined by their composition, but resides in the interaction between the user and the product – as Michael Russell pointed out, if tar yield was everything, the most dangerous product would be the large Cuban cigar (1).
Russell was an outspoken critic of the ISCSH’s record. In a 1980 comment on the committee’s second report (2) he noted “Most of all it [the report] is remarkable for the stunning naivety of its implicit model of smoking behaviour”. He pointed out that: “Lower risk cigarettes are equated with cigarettes with lower tar and nicotine yields. If people smoked cigarettes in the same way that smoking machines do, this would indeed be the case. But there is much evidence that they do not….The tendency for smokers to regulate their smoke intake has been ignored by the Hunter Committee”.
Russell was not a member of the ISCSH (indeed, the membership of the committee was heavily tilted towards epidemiology and toxicology, and included no behavioural science expertise). It is in Russell’s insights and policy prescriptions that we can see the real intellectual underpinnings of UK policy on harm reduction in recent years.
Russell had a number of key insights, the most fundamental of which is that people smoke for nicotine (3). This coupled with the observation that the harms of smoking come not from the drug people are seeking, but from contaminants of the delivery system used to obtain it, led to his dictum “People smoke for the nicotine, but die from the tar”. As early as the mid-1970s he began to advocate an approach to tobacco harm reduction that was based on an appreciation of nicotine’s role (4, 5). He was the first to expose the fallacy of low tar cigarettes (6) and the first to explore the potential of non-combustible nicotine products for harm reduction (7-9). His 1991 paper in the British Journal of Addiction (10) and editorial in The Lancet (11) set out a vision for a transformed nicotine market: “If a strategy were adopted to sanction and encourage the use of purified nicotine products as substitutes for smoking, and at the same time impose stringent regulations on permissible constituents of cigarette smoke …….. the virtual elimination of smoking could become a more realistic health promotion target” (11). This represents a paradigm shift from the failed approach adopted in the 1970s. How it, or something springing from it, became a part of UK tobacco control policy in recent years, is a story for others to tell. But it did not happen through tobacco industry influence.
References
1. Gori GB, Bock FG. Banbury Report 3: A Safe Cigarette? Cold Spring Harbor Laboratory; 1980.
2. Jarvis MJ, Russell MAH. Comment on the Hunter Committee's second report. British Medical Journal. 1980;5; 280(6219):994-5.
3. Russell MA. Cigarette smoking: natural history of a dependence disorder. Br-J-Med-Psychol. 1971;44(1):1-16.
4. Russell MA. Realistic goals for smoking and health. A case for safer smoking. Lancet. 1974;16; 1(851):254-8.
5. Russell MA. Low-tar medium-nicotine cigarettes: a new approach to safer smoking. Br-Med-J. 1976;12; 1(6023):1430-3.
6. Russell MAH, Jarvis M, Iyer R, Feyerabend C. Relation of nicotine yield of cigarettes to blood nicotine concentrations in smokers. British Medical Journal. 1980;280(6219):972-6.
7. Russell MAH, Jarvis MJ, Feyerabend C. A new age for snuff? Lancet. 1980;1; 1(8166):474-5.
8. Russell MAH, Jarvis MJ, Devitt G, Feyerabend C. Nicotine intake by snuff users. Br Med J. 1981;26; 283(6295):814-7.
9. Russell MAH, Jarvis MJ, West RJ, Feyerabend C. Buccal absorption of nicotine from smokeless tobacco sachets. Lancet. 1985;2(8468):1370.
10. Russell MAH. The future of nicotine replacement. Br-J-Addict. 1991;86(5):653-8.
11. Russell MAH. Nicotine use after the year 2000. The Lancet. 1991;337:1191-2.
NOT PEER REVIEWED Martin Jarvis is right to describe the Hunter Committee era as “a sorry tale” that by and large is well told by Elias and Ling, but his assertion that “taken as a whole their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control” is way over the top, as is his criticism of “the editorial processes and decision-making of Tobacco Control”.
In a paper that runs to a little over five pages of text, there are very brief references to current policies on the first page, then further brief references towards the end, suggesting that there are lessons to be drawn from the earlier episodes.
The paper might indeed have expanded further on the industry-friendly record of the Hunter Committee, noting that after his term as Chairman of the Committee ended, Lord Hunter became a consultant for Imperial Tobacco, while a civil servant who worked on smoking and serviced the Hunter Committee went on to work for Gallahers. It might also have included more emphasis on the way tobacco substitutes dominated public discourse on tobacco policy issues during the 1970s (1), although in fairness to the authors they appear to have been misled by the re-writing of history evident in some of the material they cite, particularly from industry actors.
But this would simply have added more weight to the conclusion that during the 1970s discussion, debate and massive promotion of tobacco substitutes by t...
NOT PEER REVIEWED Martin Jarvis is right to describe the Hunter Committee era as “a sorry tale” that by and large is well told by Elias and Ling, but his assertion that “taken as a whole their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control” is way over the top, as is his criticism of “the editorial processes and decision-making of Tobacco Control”.
In a paper that runs to a little over five pages of text, there are very brief references to current policies on the first page, then further brief references towards the end, suggesting that there are lessons to be drawn from the earlier episodes.
The paper might indeed have expanded further on the industry-friendly record of the Hunter Committee, noting that after his term as Chairman of the Committee ended, Lord Hunter became a consultant for Imperial Tobacco, while a civil servant who worked on smoking and serviced the Hunter Committee went on to work for Gallahers. It might also have included more emphasis on the way tobacco substitutes dominated public discourse on tobacco policy issues during the 1970s (1), although in fairness to the authors they appear to have been misled by the re-writing of history evident in some of the material they cite, particularly from industry actors.
But this would simply have added more weight to the conclusion that during the 1970s discussion, debate and massive promotion of tobacco substitutes by tobacco companies succeeded in hijacking the tobacco public policy and media agenda, and diverted the government of the day from evidence-based approaches recommended by health authorities to reduce smoking. Elias and Ling have good reason to suggest that there are similarities between then and now.
In passing, Jarvis’s summary that the novel products of the day failed “because consumers rejected them” omits much. One important reason for the failure of tobacco substitutes was that industry rhetoric and hype to the contrary, there was ultimately justifiable concern, with concomitant media coverage, that “all the generally available brands contained 75 per cent tobacco, and were no more than additions to the low and low-to-middle tar range” (1). Indeed, it would have been quite possible for smokers switching to part-substitute brands to find themselves moving to higher tar products.
But before this message hit, there had been a mountain of industry-generated publicity promoting the notion that “safer” and (as inevitably reported) “safe” new brands were on the way. This approach was supported with public relations ploys such as an Imperial Tobacco press conference about part-substitute cigarettes the day after the launch of the 1977 Royal College of Physicians’ “Smoking Or Health” report. Not surprisingly, the tobacco trade press was quick to congratulate the company concerned on its success in diluting the impact of the College report.
1. Daube M. The politics of smoking: thoughts on the Labour record. Community Medicine. 1979; 1, 306-314
NOT PEER REVIEWED
We thank Dr. Jarvis for his appreciation of our historical scholarship but disagree that our conclusion, “the promotion of tobacco harm reduction may serve the interests of tobacco companies more effectively than the public,” is an attack.
Our paper is about how policy affects ideas and vice versa. The ideas guiding the product modification program led to bad outcomes. That these ideas have been reanimated merits critical assessment. Voluntary agreements led to industry influence over the ISCSH’s recommendations, which in turn undermined public health. We point out that some of the same premises that led the ISCSH astray are popular again. Jarvis claims that current UK harm reduction policy has nothing to do with the product modification program, and everything to do with the influence of the late Michael Russell. Russell’s impressive scholarship – and oft-quoted statement, “people smoke for the nicotine, but die from the tar” – is indeed hugely influential among proponents of tobacco harm reduction. Jarvis posits that Russell’s work serves as a “paradigm shift” on which the UK’s current embrace of long-term nicotine maintenance and tobacco harm reduction actually rests, and which severs any link between the failures of product modification and widespread fears of a redux today.
Yet Russell’s work represents more a variation in theme than it does revolution in content. Russell’s policy recommendations operate from the same premises a...
NOT PEER REVIEWED
We thank Dr. Jarvis for his appreciation of our historical scholarship but disagree that our conclusion, “the promotion of tobacco harm reduction may serve the interests of tobacco companies more effectively than the public,” is an attack.
Our paper is about how policy affects ideas and vice versa. The ideas guiding the product modification program led to bad outcomes. That these ideas have been reanimated merits critical assessment. Voluntary agreements led to industry influence over the ISCSH’s recommendations, which in turn undermined public health. We point out that some of the same premises that led the ISCSH astray are popular again. Jarvis claims that current UK harm reduction policy has nothing to do with the product modification program, and everything to do with the influence of the late Michael Russell. Russell’s impressive scholarship – and oft-quoted statement, “people smoke for the nicotine, but die from the tar” – is indeed hugely influential among proponents of tobacco harm reduction. Jarvis posits that Russell’s work serves as a “paradigm shift” on which the UK’s current embrace of long-term nicotine maintenance and tobacco harm reduction actually rests, and which severs any link between the failures of product modification and widespread fears of a redux today.
Yet Russell’s work represents more a variation in theme than it does revolution in content. Russell’s policy recommendations operate from the same premises as the ISCSH. While Russell criticized the ISCSH for its discount of compensation, (which he believed medium- high- nicotine cigarettes could help remedy) the same foundations appear in his recommendations: reduced toxicity is reduced risk, (1) collaboration with the tobacco industry doesn’t influence outcomes, (2) nicotine addiction is inevitable, (3) and products must be popular to curtail use. (4)
We caution that enthusiasm for the tantalizing fantasy of reduced risk products and tobacco industry resources may lead us to readopt the premises promoted by the tobacco industry for decades.
In their response, Drs. Britton and O’Connor implore public health to promote evidence-based tobacco harm reduction. We could not agree more.
1. The Lancet. Nicotine Use After the Year 2000. Lancet. 1991; 337: 1191-2.
2. Russell M. Conversation with Michael AH Russell. Addiction (Abingdon, England). 2004; 99: 9-19.
3. Jarvis M and Russell M. Comment on the Hunter Committee's second report. British medical journal. 1980; 280: 994.
4. Russell M. The future of nicotine replacement. British Journal of Addiction. 1991; 86: 653-8.
NOT PEER REVIEWED
Euromonitor International is a privately held, independent provider of strategic market research with no agenda other than to present the most realistic illicit trade data impartially and within its wider industry context. Subscribers to Euromonitor’s Passport Tobacco database are varied and include tobacco control/ public health groups, academia, retailers, manufacturers of raw materials as well as tobacco brand owners and banks/ consultancies, amongst others.
These same stakeholders are approached by Euromonitor for comment on industry trends, including those of illicit sales. Euromonitor’s stated sources for illicit cigarettes sales thus include trade press, customs offices, interviews with manufacturers and retailers, government and academic organisations. This is reconciled against local knowledge of the market and illicit trade’s wider context – eg national economic performance, trends in taxation, unit prices and duty paid sales, porosity of borders, law enforcement efforts, and so on. There is no reliance on any one source.
By its very nature, illicit trade in tobacco products is a contentious area and one that is difficult to quantify – there are often wide discrepancies between various sources on illicit trade, reflecting vested interests in either deflating or inflating figures. In these circumstances, Euromonitor strives to present the most widely accepted and realistic estimate of the illicit market, based on a holistic...
NOT PEER REVIEWED
Euromonitor International is a privately held, independent provider of strategic market research with no agenda other than to present the most realistic illicit trade data impartially and within its wider industry context. Subscribers to Euromonitor’s Passport Tobacco database are varied and include tobacco control/ public health groups, academia, retailers, manufacturers of raw materials as well as tobacco brand owners and banks/ consultancies, amongst others.
These same stakeholders are approached by Euromonitor for comment on industry trends, including those of illicit sales. Euromonitor’s stated sources for illicit cigarettes sales thus include trade press, customs offices, interviews with manufacturers and retailers, government and academic organisations. This is reconciled against local knowledge of the market and illicit trade’s wider context – eg national economic performance, trends in taxation, unit prices and duty paid sales, porosity of borders, law enforcement efforts, and so on. There is no reliance on any one source.
By its very nature, illicit trade in tobacco products is a contentious area and one that is difficult to quantify – there are often wide discrepancies between various sources on illicit trade, reflecting vested interests in either deflating or inflating figures. In these circumstances, Euromonitor strives to present the most widely accepted and realistic estimate of the illicit market, based on a holistic view of the wider national context and the factors that contribute towards it (as described above) – no single source or figure is taken as definitive and all figures undergo this wider review. Furthermore, this wider context is discussed at length in the attendant analysis in each country report where the trends behind the figures are laid out.
Given Euromonitor’s exhaustive geographic coverage of this dataset – at 100 markets researched in-field for illicit trade, there is no other source like it – as well as our annual revisiting of this dataset, it is inevitable that some changes between editions will be necessary. Euromonitor is transparent about its reasons for change and welcomes any discussion on what can be a opaque area - we are always happy to engage with all concerned stakeholders and review their own sources, on a country-by-country basis, should they exist.
NOT PEER REVIEWED The main problem with the claim of equivalence between smoking and switching to iQOS is that some biomarkers of potential harm change over a much longer timeframe than the 90-day duration of the trials. Biomarkers of potential harm can reflect years of accumulated physical changes arising from smoking and only improve slowly after smoking cessation. The trial did, of course, pick up very substantial reductions in biomarkers of exposure, which would, over time, emerge as reductions in biomarkers of potential harm.
Show MoreThis would have been apparent and obvious to readers if the paper had also shown the results for the third arm of the trial, smoking abstinence. The biomarkers of potential harm for smoking abstinence and for switching to iQOS are quite similar in this trial. This is a curious omission. Furthermore, biomarkers of exposure turned quite similar for both switching to iQOS and smoking abstinence - both are greatly reduced, which is an encouraging finding about the iQOS product.
It is unlikely that anyone would argue against smoking abstinence on the basis of the biomarkers of potential harm in the original PMI study. However, the author has selectively used the iQOS data from these trials without the context of the smoking abstinence data to oppose the Modified Tobacco Product Application that PMI made to the U.S. FDA - the author's attempt to block this reduced-risk product from entering the US market.
...
NOT PEER REVIEWED
The "serious criticism" that Mr. Bates refers to is from him (on another website).
In order for the FDA to issue an order allowing Philip Morris International to market IQOS in the United States as a reduced risk tobacco product, the law required that, among other things, FDA "determines that the applicant [PMI] has demonstrated that such product [IQOS], as it is actually used by consumers will significantly reduce harm and the risk of tobacco- related disease to individual tobacco users."
That is why PMI provided the information of biomarkers of potential harm to the FDA. and how they compare to values observed in smokers. My paper shows that, using PMI's own data, IQOS will not significantly reduce risk to consumers compared with cigarettes.
Bates ignores this reality and instead talks about biomarkers of exposure, which is a different question.
NOT PEER REVIEWED
This study has some important findings that could, if replicated, guide FDA decision making on applications from manufacturers to make modified risk tobacco product claims. However, while it does not detract from the study’s findings, the article does not accurately describe the standards FDA must apply when evaluating those applications. The abstract inaccurately suggests that tobacco products in the U.S. may make reduced-risk or reduced-exposure claims so long as they are not misleading, and does not mention that any explicit or implicit reduced-exposure or reduced-risk claims may not be legally made without first submitting an application to FDA and receiving a permissive order, which considers various other factors, as well.
The introduction of the paper does a bit better, accurately stating that the Tobacco Control Act requires prior review by FDA before making lower-exposure or lower-risk claims. But it then suggests that manufacturers can receive that permission if they either demonstrate that the product lowers harm or risk compared with other tobacco products or if they demonstrate that the product is free of or contains reduced levels of harmful chemicals and the related claims don’t mislead consumers to believe that the reduced-exposure means lower risk. While that description is accurate as far as it goes, it leaves off the enormously important requirement, in both cases, that a manufacturer’s application for permission to...
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Show MoreMore than 1,000 participants were exposed to IQOS in our clinical studies. The authors of the letter “Possible hepatotoxicity of IQOS" based their analysis on approximatively 10% of the data instead of examining the data as a whole. For example, for the five-day exposure studies in confinement, they stated that the percentage of participants with elevated bilirubin in IQOS arm was more than three times higher than that observed in the smoking abstinence (SA) arm in the European study (8.8% [7 participants] in IQOS arm, 2.6% [1 participant] in SA arm). However, they missed reporting that this percentage was lower in the IQOS arm than in the cigarette smoking (CC) arm in the Japanese study (10% [8 participants] in IQOS arm, 15% [6 participants] in CC arm). They also stated that the mean increase in alanine aminotransferase (ALT) was higher with IQOS than with CC or SA in the Japanese study but did not report that in the European study, the mean increase in ALT was lower in the IQOS arm than in the CC or SA arm.
Similarly, for the 90-day exposure studies in an ambulatory setting, they mentioned that the percentage of participants with increased ALT levels after 60 days of exposure was higher within the IQOS arm (6.3% [5 participants] in IQOS arm, 0% in CC arm, 2.6% [1 participant] in SA arm) in the U.S. study. However they omitted to mention that in the Japanese study, this percentage was lower in IQOS arm compared with CC or SA arms after 3...
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different...
Show MoreNOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
1. Britton, J. and Bogdanovica, I. Electronic cigarettes. A report commissioned by Public Health England. Public Health England, 2014. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
Show More2. Bauld, L., Angus, K., and de Andrade, M. E-cigarette uptake and marketing. A report commissioned by Public Health England. Public Health England, 2014. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
3. McNeill, A., Brose, L., Calder, R., Hitchman, S.C., McRobbie, H., and Hajek, P. E-cigarettes: an evidence update. A report commissioned by Public Health England. Public Health England, 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
4. Tobacco Adviso...
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Show MoreElias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, tak...
NOT PEER REVIEWED Martin Jarvis is right to describe the Hunter Committee era as “a sorry tale” that by and large is well told by Elias and Ling, but his assertion that “taken as a whole their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control” is way over the top, as is his criticism of “the editorial processes and decision-making of Tobacco Control”.
In a paper that runs to a little over five pages of text, there are very brief references to current policies on the first page, then further brief references towards the end, suggesting that there are lessons to be drawn from the earlier episodes.
The paper might indeed have expanded further on the industry-friendly record of the Hunter Committee, noting that after his term as Chairman of the Committee ended, Lord Hunter became a consultant for Imperial Tobacco, while a civil servant who worked on smoking and serviced the Hunter Committee went on to work for Gallahers. It might also have included more emphasis on the way tobacco substitutes dominated public discourse on tobacco policy issues during the 1970s (1), although in fairness to the authors they appear to have been misled by the re-writing of history evident in some of the material they cite, particularly from industry actors.
But this would simply have added more weight to the conclusion that during the 1970s discussion, debate and massive promotion of tobacco substitutes by t...
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We thank Dr. Jarvis for his appreciation of our historical scholarship but disagree that our conclusion, “the promotion of tobacco harm reduction may serve the interests of tobacco companies more effectively than the public,” is an attack.
Our paper is about how policy affects ideas and vice versa. The ideas guiding the product modification program led to bad outcomes. That these ideas have been reanimated merits critical assessment. Voluntary agreements led to industry influence over the ISCSH’s recommendations, which in turn undermined public health. We point out that some of the same premises that led the ISCSH astray are popular again. Jarvis claims that current UK harm reduction policy has nothing to do with the product modification program, and everything to do with the influence of the late Michael Russell. Russell’s impressive scholarship – and oft-quoted statement, “people smoke for the nicotine, but die from the tar” – is indeed hugely influential among proponents of tobacco harm reduction. Jarvis posits that Russell’s work serves as a “paradigm shift” on which the UK’s current embrace of long-term nicotine maintenance and tobacco harm reduction actually rests, and which severs any link between the failures of product modification and widespread fears of a redux today.
Yet Russell’s work represents more a variation in theme than it does revolution in content. Russell’s policy recommendations operate from the same premises a...
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Euromonitor International is a privately held, independent provider of strategic market research with no agenda other than to present the most realistic illicit trade data impartially and within its wider industry context. Subscribers to Euromonitor’s Passport Tobacco database are varied and include tobacco control/ public health groups, academia, retailers, manufacturers of raw materials as well as tobacco brand owners and banks/ consultancies, amongst others.
These same stakeholders are approached by Euromonitor for comment on industry trends, including those of illicit sales. Euromonitor’s stated sources for illicit cigarettes sales thus include trade press, customs offices, interviews with manufacturers and retailers, government and academic organisations. This is reconciled against local knowledge of the market and illicit trade’s wider context – eg national economic performance, trends in taxation, unit prices and duty paid sales, porosity of borders, law enforcement efforts, and so on. There is no reliance on any one source.
By its very nature, illicit trade in tobacco products is a contentious area and one that is difficult to quantify – there are often wide discrepancies between various sources on illicit trade, reflecting vested interests in either deflating or inflating figures. In these circumstances, Euromonitor strives to present the most widely accepted and realistic estimate of the illicit market, based on a holistic...
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