On 2016 May 23, Clive Bates commented:

Robert Jackler assumes a priori that attracting adolescents to vaping through flavour descriptors is a bad thing. Saul Shiffman provides a compelling defence of their study showing that teenage interest in flavours was low and this should not concern us much. But this framing may be an over-simplification.

E-cigarette appeal may be good for health

What if the rise in e-cigarette use among adolescents is displacing tobacco smoking, and that this effect accounts for the rapid fall in teenage smoking measured in both the NYTS survey: Tobacco Use Among Middle and High School Students — United States, 2011–2014 and the University of Michigan Monitoring the Future survey, Media release: Teen cigarette smoking drops to historic low in 2015?

In that case, critics must contemplate the idea that e-cigarettes have a harm reduction function among adolescents and that their attractiveness to young people who would otherwise become smokers may be overall a public health benefit. Levy DT, 2017 shows that e-cigarettes create many beneficial pathways for the evolution of nicotine use and abstinence. It is far from clear that obstructing these pathways with policies or campaigning communications is positive for public health.

Scope for adverse unintended consequences

There is already evidence that measures designed to block youth access to e-cigarettes have adverse unintended consequences on youth smoking: see Friedman AS, 2015 and Pesko MF, 2016 on the impact of e-cigarette age restriction laws on cigarette smoking. It is not a great leap of logic to hypothesise that making e-cigarettes less attractive to adolescents would attenuate the decline in smoking that is, or should be, the primary concern in tobacco policy.

The appropriate focus is on adults

The right way to address this issue is not to try to micro-manage adolescent behaviours but to ensure that adults have attractive alternatives to smoking. Restrictions imposed with the misguided purpose of 'protecting' adolescents from very low-risk alternatives to cigarettes could have the effect of harming longstanding adult smokers - the real at-risk group. Several surveys (e.g. Farsalinos KE, 2014) have shown that non-tobacco flavours matter to adults who are using e-cigarettes as an alternative to smoking and are part of the long-term transition away from tobacco use.

Conclusion

Anyone proposing a ban on certain flavours or flavour descriptors needs to assess the risk of harmful unintended consequences - that more adolescents will take up smoking instead of vaping, and that adults smokers will find vaping a less attractive alternative to smoking and never switch, remain as dual users, or relapse back to smoking.

On 2016 Jan 10, Carl V Phillips commented:

I read with interest the exchange between Robert Jackler and Saul Shiffman about this paper and would like to comment on two bits of the exchange. In general, I believe that Shiffman’s responses were compelling, and that they effectively rebutted Jackler’s criticisms. In particular, I agree with his assessment that Jackler basically starts with a premise that the paper’s conclusions are wrong and then speculates about what made them wrong, rather than actually building a case that anything was wrong.

Jackler makes various accusations (some overt, some innuendo) about Shiffman et al. being inappropriately influenced by their sponsor. Shiffman responds by mischaracterizing these as ad hominem. Ad hominem attacks are common in this space, and anyone who departs from a strict tobacco control party line will almost inevitably be the target of them. But the term is also misused in this space, and this is an example. Claiming “Shiffman et al.’s research should be ignored because they consort with those I declare to be the enemy,” would be ad hominem, but there is only a hint of that in Jackler’s comments. Instead, he mostly claims that the research was faulty because of influences of the funder on the design of the particular research. This may be a cheap rhetorical tactic and unsubstantiated innuendo – as Shiffman argues – and it is certainly insulting to the integrity of the authors, but none of that makes it ad hominem.

Jackler introduces one valid scientific concern, and it should be extended to a most of the research in this space. He argues (my paraphrase) that the expressed lack of interest in the products, whatever flavor descriptor was offered, mostly reflects the general hostility toward tobacco products that is inculcated in this population of teenagers. Schiffman responds to the criticism as phrased, quite legitimately, by arguing this was exactly the authors’ point, that flavors are not overcoming the programmed resistance to using the products. But the comment and response skirt the real scientific concern here: All of the research in and around this point produces rough measures that only partially inform the question of interest, which is, “what product characteristics cause different choices in the real world?”

Teenagers’ responses to abstract survey questions, posed by people who presumably feel a lot like the authority figures who have been instilling the anti-tobacco message, probably do just trigger the inculcated response. This makes them a limited measure of whether a flavor option will change someone’s choice when he is presented with the opportunity to try a product. The present study is clearly more informative than anything cited in support claims that flavors have caused a torrent of underage use (let alone claims that attracting underage users is the purpose of interesting flavors, given that adults clearly prefer them; see, for example, my recent report of survey results at http://antithrlies.com/2016/01/04/casaa-ecig-survey-results/). But what was measured is only one contributor to the actions of interest.

The failure to recognize that what is measured is not the same as what is being asked extends throughout this field of inquiry. Jackler asserts that looking at flavor usage patterns would be a better measure, and Shiffman correctly points out that this would be an answer to an different question. It would tell us something that relates the question of interest, though it is even further removed than what the study measured. Yet it is quite common for opponents of product availability to claim that mere demonstrated preference for a particular product feature is evidence that the feature is causing use. Indeed, guessing at what Jackler alludes to as an “extensive body of research” about preferences for flavors of other tobacco products, this describes most of that research. Fuzzy and noisy observations that are probably associated with the question of interest can allow us to modestly update our beliefs. But commentators, including many research authors, make absolute claims, apparently oblivious to the necessary epistemic modesty.

Moreover, the common absolute claims (e.g., “this shows kids are not interested in flavors” or “this proves that flavors are attracting kids”) are absurd on their face. For any improvement in a product’s quality (such as the availability of a particular flavor), there are some combinations of individual preferences such that the improvement would tip someone’s preference about wanting to use the product. Since there are a lot of people, chances are some have that preference pattern for any substantial improvement (and this will include some “proper” and some “improper” users, if one is inclined to create such categories). The question cannot be, “are any kids motivated by the flavors?” (or by flavor descriptors, which is a somewhat different question), because the answer to that is surely yes. The question must be, “how many?” The Schiffman et al. results contradict the political claims that underage users are flocking to e-cigarettes in droves because they have heard about the particular flavors from the study, but absolute claims that have been made about the results are clearly false. Any author who seeks to make a scientific contribution in this area needs to explain, at least very roughly, how empirical results contribute to an economic model of preference and choice that can provide a quantitative estimate of the phenomenon of interest. (Anyone who wants to go further and claim that the phenomenon is substantially harmful, to whatever extent it occurs, must present separate analysis. This obviously does not follow from claims that the phenomenon is occurring, as many authors imply; it is entirely plausible that the material impact is nil or even beneficial.)

The absolutist rhetoric that dominates the policy fights in this area seeps into the science and poisons it, causing researchers to traffic in simplistic claims. Indeed, the rhetoric that causes the problems addressed above is exemplified in the second sentence of the abstract, in which the authors assert that e-cigarette use has no benefits apart from smoking cessation. This is obviously not true; if people are choosing an action, it is because it has benefits. But if the myth to the contrary is taken as a premise – effectively assuming that actions are caused by demonic possession rather than volition – it is very difficult to apply the economic reasoning sketched above. Researchers and commentators in this area give little indication they recognize that they are making claims about choices, which are volition that is a function of preferences, opportunity, and product characteristics. They need to assess how particular observations fit into a model of that process, rather than implicitly assuming that whatever happened to be measured is isomorphic to the outcome of that process.

On date unavailable, commented:

None

On 2016 Jan 08, Saul Shiffman commented:

CONTINUED FROM PRIOR POST

Jackler: Given the long history of tobacco industry manipulation of scientific research, the fact that the Shiffman et al. study was designed and sponsored by an e-cigarette brand gives reason for skepticism . . . The circumstances under which the paper arose, as illustrated by the timeline below, indicates that NJOY had a powerful motivation to commission a paper exculpating e-cigarette flavors from preferential youth appeal proximate to the time that Pinney Associates was engaged and the survey was conducted. [Followed by long discourse on conjectured commercial context . . .] . . . In summary, it appears that the Shiffman et al. paper was not hypothesis driven research, but rather a study commissioned by NJOY to create cover for their reversal on flavors driven by dropping market share.

Response: Dr. Jackler raises the point that our disclosed relationship with an entity with a commercial interest should increase skepticism among readers of the paper. The purpose of disclosure is transparency, and an invitation for readers who wish to be so to be skeptical. Skepticism is welcome. Certainty without data, not so much….. Dr. Jackler has no information whatsoever about the origin and motivation for the study. Absent any actual information, Dr. Jackler constructs a just-so story about how the research came about, in order to make an ad hominem argument. We again suggest that the appropriate approach is to focus on the science and data.

Jackler: With teens uninterested and adults minimally interested in flavors (other than tobacco and menthol), one wonders why do they bother to market them. If so unappealing to their customers, what accounts for the dramatic rise in NJOY sales after introduction of flavors such as butter crunch, peach tea, and wild berry?

Response: As cited in our paper, there is independent evidence that adult smokers who are not confirmed e-cigarette users tend to prefer tobacco flavors, as they are familiar. With more experience and transition away from smoking to exclusive e-cigarette use, preferences shift to non-tobacco flavors (Farsalinos et al., 2013). That is consistent with what our paper showed.

In conclusion, e-cigarettes are a novel and disruptive force in the tobacco environment. While many are concerned that they may ultimately be harmful, there is a strong and legitimate segment of the tobacco control community that sees e-cigarettes as a potential public health breakthrough. Both sides can agree that there are many questions yet to be definitively answered by data. It would be most constructive to spend less time on ad hominem attacks, and get on with the science.

References

Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Spyrou A, Voudris V. Impact of flavour variability on electronic cigarette use experience: An internet survey. International Journal of Environmental Research and Public Health 2013;10:7272-7282. http://www.ncbi.nlm.nih.gov/pubmed/24351746

Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3881166/pdf/ijerph-10-07272.pdf.

Federal Register. Proposed Rules: Federal Policy for the Protection of Human Subjects.

1. Available at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf.

Manning KC, Kelly KJ, Comello ML. Flavoured cigarettes, sensation seeking and adolescents’ perceptions of cigarette brands. Tobacco Control 2009;18:459-465. http://www.ncbi.nlm.nih.gov/pubmed/19700436

Shiffman S, Sembower MA, Pillitteri JL, Gerlach KK, Gitchell JG. The impact of flavor descriptors on nonsmoking teens’ and adult smokers’ interest in electronic cigarettes. Nicotine and Tobacco Research 2015;17:1255-1262. http://www.ncbi.nlm.nih.gov/pubmed/25566782

Singh T, Marynak K, Arrazola RA, Cox S, Rolle IV, King BA. Vital Signs: Exposure to Electronic Cigarette Advertising Among Middle School and High School Students – United States, 2014. MMWR January 5, 2016;64. Available at: http://www.cdc.gov/mmwr/pdf/wk/mm64e0105.pdf.

Truth Initiative. The Truth About: Electronic Nicotine Delivery Systems. 2015. Available at: http://truthinitiative.org/sites/default/files/ENDS Fact Sheet - 1 4 16[1].pdf.

DISCLOSURES The study in the original paper was sponsored by NJOY, Inc., a developer and marketer of electronic nicotine delivery systems. The authors have worked in tobacco control and tobacco research for as long as 40 years. In the past three years, PinneyAssociates has provided services for a range of companies, including GlaxoSmithKline Consumer Healthcare on their stop-smoking medications (Nicorette and NicoDerm CQ in the U.S.), for NJOY, Inc., and since February 2015, for Reynolds American, Inc. (RAI) on tobacco harm minimization. Our work for RAI focuses on products, regulations, and policies related to smoking cessation and harm minimization; we do not work on combustible conventional cigarettes. Some of us (JGG, SS) also are members in a limited liability corporation that owns intellectual property for an as-yet not-commercialized nicotine gum, an option for which has been acquired by Niconovum, a subsidiary of RAI.

On 2016 Jan 08, Saul Shiffman commented:

CONTINUED FROM PRIOR POST

Jackler: With such a low response rate, responders may have had a special motivation to participate. This raises the likelihood of selection bias, differences between responders and non-responders, a factor which undermines the value of surveys with a small percentage of responders.

Response: With regard to the response rate, the issue of selection bias must certainly be considered. It is important to note that in such online surveys with research panels, email invitations are blasted out, and it is not even known how many recipients got the email or saw it. Furthermore, the study closed when the target sample size was reached and it is likely additional invitees tried to enroll, but were too late. Online surveys routinely send large numbers of invitations in order to complete data collection quickly. We capped the total numbers of respondents (432 for adults and 216 for teens) in order to ensure that the combinations of product and flavors were balanced for appropriate comparisons to be made in the analyses. Most important, nothing in the invitation hinted at the subject of the survey, so it is not at all clear what bias might be introduced by the respondents' choice to complete this survey versus some other surveys they may have been invited to complete. Dr. Jackler seems to believe that a sample with a higher response rate would yield a different conclusion; we would welcome seeing such data, and hope Dr. Jackler will produce it.

Jackler: Two sorts of teens are likely to reply to such a survey: those contemplating e-cigarette use who may be attracted to the products being surveyed and those who are vehement in their intention to neither smoke nor vape and are motivated to send a rejectionist message.

Response: Dr. Jackler’s comments suggest he did not understand our research method adequately. The core of his concern about some distortion introduced in the sample would only be plausible under the circumstance where potential participants were informed (or somehow were able to deduce) the nature and focus of the survey. This information was not provided during recruitment, and even during screening, participants were asked about bottled water and ice cream in addition to tobacco product use, to mask the survey's focus. In other words, respondents could not have elected to enroll or not enroll in this survey on the basis of its content, because they did not know the content.

Jackler: A sizable fraction of teens are opposed to smoking, some with notable vehemence instilled by parents and schools. It would be expected that a fraction of teen responders felt a special impetus to do so as a means of communicating their opposition to tobacco products. The motivation of teen responders to oppose smoking is the most probable reason for the low interest in e-cigarettes which the authors erroneously interpreted as a lack of interest in flavored e-cigarettes.

Response: Dr. Jackler's point is that some teens are simply opposed to smoking of any kind, including e-cigarettes, and thus are not influenced by offering of different flavors. We agree – that's exactly the point: offering flavors seems unlikely to attract the teens not already smoking or predisposed to smoke!

Jackler: That the paper reaches the conclusion: “Nonsmoking teens’ interest in e-cigarettes was very low” is yet another reason to question the survey’s validity. This observation is at variance with 2014 CDC data showing a rapid rise in e-cigarette use among high school students coupled with a reduction in combustible cigarette use.

Response: Dr. Jackler earlier criticized our study for focusing on non-smoking teens, as opposed to all teens or smoking teens. Here, he ignores this fundamental design feature. There is no contradiction between our finding and the uptake of e-cigarettes by teens, because data repeatedly show that e-cigarettes are being taken up predominantly by SMOKING teens. The use of e-cigarettes by non-smoking teens (especially any kind of substantial use) is exceedingly low (Truth Initiative, 2015), consistent with our findings. Dr. Jackler points out that smoking prevalence is dropping even as e-cigarette use increases. One explanation is that e-cigarettes are drawing teens away from smoking to e-cigarette use, which is not inconsistent with our data.

Jackler: One interpretation of these data is that, relatively speaking, non-smoking teens prefer a variety of sweet and fruity flavors while adult smokers prefer tobacco flavor.

Response: Dr. Jackler’s alternative interpretation of our results, that the teen nonsmokers actually “prefer” a range of flavors, would seem to be utterly contradicted by the data, which (a) show very low absolute appeal of e-cigarettes among nonsmoking teens, and (b) show no statistical variation in teen interest by flavor.

Jackler: The Shiffman et al. survey offers no benefit to the minors surveyed and entails significant risks. Exposing teens to a harmful product they may not have considered using, such as use of e-cigarettes and flavored e-cigarettes, could increase the likelihood that they will try the product and develop nicotine addiction. This represents a clear risk to the future health of the minor. The existence of risk, coupled with the lack of benefit to the individual child, necessitates both institutional review and parental informed consent.

Response: We certainly agree that the survey did not benefit respondents, and was not presented (or intended) as a benefit to them. We do not agree that it posed any risk. The survey had no promotional value or content, and did not in any way encourage use of e-cigarettes. No graphics or branding were presented, and no claims were made. It simply presented text on a hypothetical e-cigarette flavor and asked for a rating of interest. Further, it should be noted that awareness of e-cigarettes is nearly universal among teens (Singh et al., 2016), so it was highly unlikely that the survey even introduced anyone to the concept of e-cigarettes. We note that surveys, including those fielded and sponsored by the government, routinely ask participants about smoking and their interest in smoking without any implication they have put participants at risk. Current Federal rules exempt survey research from IRB review in which respondents are anonymous, as well as research that asks about matters that do not put the respondents at legal risk or risk of embarrassment. Our study met both criteria. Of interest, 16 federal agencies have proposed IRB rules that go out of their way to further emphasize that simple surveys such as this are exempt from review (Federal Register, 2015).

CONTINUED IN NEXT POST

On 2016 Jan 08, Saul Shiffman commented:

Response to Dr. Jackler’s critique of Flavor Descriptors Paper published in Nicotine and Tobacco Research (Shiffman et al., 2015)

PLEASE NOTE: We have divided our response into several consecutive posts, to deal with the length limitations imposed by PubMed, while quoting Dr. Jackler's original comments, to allow readers to better follow the conversation.

We appreciate the continuing interest in our work and relish critical commentary and suggestions. Such a dialogue will serve to advance science and thus foster the development and implementation of public health-advancing policies.

In the post below, we have replied to the criticisms of our study raised by Dr. Jackler (most of which are redundant with those raised by Drs. Popova and Glantz, see our earlier post). We note that many of Dr. Jackler's remarks are ad hominem. We believe the science should be judged on its merits, so will not comment on Dr. Jackler's imaginings about our motives, just as we will discipline ourselves to be silent about his.

Three comments about general process and principles are worth making before we address specific issues:

1) All the issues raised by Dr. Jackler were also raised by Dr. Stanton Glantz in a peer review for the journal Nicotine and Tobacco Research, and subsequently posted by Dr. Glantz on the web. (The review was conducted single-blind, but Dr. Glantz' s posted comments are all but identical to the review, which makes clear he was the reviewer.) In accord with good peer review practice, the journal editor asked us to respond, and two editors and another (anonymous) peer reviewer were satisfied that we had responded adequately to the critiques, and that they did not fundamentally undermine the scientific quality of the work. Perhaps we are seeing the beginning of an era where peer reviewers do not accept editorial and consensus judgments, but simply repeat their critique on the web. 2) Some of the comments on methodology made by Dr. Jackler suggest methods he wishes we had used, populations he wishes we had studied, and studies he wishes we had done. We do not claim that our one study answers all questions, and cannot know whether different methods might have yielded different results – and neither can Dr. Jackler . The currency of science is empirical data, not hypothetical speculation. The real test is replication and extension. If critics believe different methods or populations would yield different results, they owe it to the science to do the work to show that. It has been 12 months since our study was published – time enough for Dr. Jackler to have collected the data he believes would be more informative. Criticism is easy; data counts.

3) Much of Dr. Jackler's critique amounts to his certainty that our study must be wrong, and therefore flawed, because it contradicts what he is certain he "knows" must be true, even though the data are not there. If the results contradict his intuition or certainty, then the methods must be flawed, and the researchers biased, and unethical, to boot. Returning to point #2, intuition and subjective certainty are nice; data are better. If there are conclusions Dr. Jackler wishes to assert, let him present definitive data.

Below, we take up each of Dr. Jackler's comments, quoting from his posting:

Jackler: In comparing the relative appeal of flavored e-cigarettes to non-smoking teens versus smoking adults, the obvious hypothesis would be that flavors would be of greater attraction to the young.

Response: It is uncertain what critique of our method, analysis, or interpretation can be derived from a statement of “the obvious hypothesis,” other than “I disagree with the results, because they violate my intuition.” Intuition is good. Data are better. The "obvious hypothesis" is sometimes wrong. We note also that a previous study, often cited in support of teen interest in flavors in cigarettes (and cited in our paper; Manning et al., 2009), shows interest in flavors is seen ONLY in teens who score high on sensation-seeking, which predisposes teens to cigarette smoking. Thus, observations or intuitions about the appeal to smokers cannot be generalized to all teens, and our data on nonsmoking teens is not incompatible with existing data on smoking teens.

Jackler: In a broader context, a finding that adolescents have no preference for sweet and fruity flavors would mean that e-cigarettes somehow are a special exception to well established consumption trends throughout the food and beverage industry.

Response: Dr. Jackler's statement ignores what we demonstrated empirically in the study – that the favors tested DID appeal to teens in foods and beverages (ice cream and bottled water), using the very methods he criticizes, even while having no effect on their interest in e-cigarettes. Again, data must trump intuition and conjecture.

Jackler: The logical way to determine the differences in e-cigarette flavor preferences between adults and teens would be to compare the actual frequency of flavor use by teen and adult e-cigarette users. Rather than use a direct method, Shiffman et al. compared a small cohort of teen non-smokers with adult smokers . . . There is reason to question the validity of comparing non-smoking teens with adult smokers as they are notably unequal groups. Nationally only approximately 15% of teens smoke whereas the entire adult survey group smoked. In this survey teen smokers were systematically excluded.

Response: Certainly the suggestion of comparing actual use patterns of adults and teens would be useful, but it would answer a different question than the one we set out to answer. As we clearly stated in our paper, we focused our research on the reported interest of the flavor descriptors on the two populations we regarded as being of most interest: current nonsmoking teens (who some assert are being lured in to use of nicotine by the appealing flavor descriptors, which would be a public health concern) compared to current adult smokers (whom one would want to find e-cigarette flavors appealing, to facilitate transition away from combustion cigarettes, a transition that we and many others regard as a public health good). Dr. Jackler is right that it would be interesting to know the flavor preferences of teen smokers, and we hope he or others will do that research. However, it is not clear that attracting a teen smoker away from using deadly combustible cigarettes to using e-cigarettes is the biggest public health worry – the big concern has been whether e-cigarettes would attract teens who are NOT smoking, hence our focus on this group.

Jackler: Shiffman et al. compared a small cohort of teen non-smokers with adult smokers via a marketing survey conducted for the sponsoring e-cigarette brand (NJOY) . . . The Shiffman et al. study consisted of an online survey inquiring about interest in products of the NJOY e-cigarette brand.

Response: Unfortunately, Dr. Jackler is simply wrong; we did not attach a brand name to any of the three types of products (e-cigarettes, ice cream, and bottled water) tested nor was the sponsor of the study mentioned to respondents. In addition, Dr. Jackler characterizes our study as a "marketing survey." It was no such thing. It was conducted for research and publication. This is yet another ad hominem argument to impute motives to us, without evidence, and, more importantly, without relevance.

CONTINUED IN NEXT POST

On 2015 Nov 01, Robert Jackler commented:

Commentary on Shiffman et. al. study which surprisingly found no preference for flavored electronic cigarette products among teens.

The paper ‘Impact of flavor descriptors on non-smoking teens and adult smokers’ interest in electronic cigarettes” by Shiffman and coworkers suffers from flaws in experimental design and data interpretation which call into question their conclusions that flavored e-cigarettes are not of differential appeal to teens.1 As discussed in detail below, their survey methodology has a high likelihood of selection bias, the study groups are too dissimilar to enable the comparisons made, informed consent for minors was not obtained despite evident risks, and commercial interest appears to have influenced the study’s outcome. In comparing the relative appeal of flavored e-cigarettes to non-smoking teens versus smoking adults, the obvious hypothesis would be that flavors would be of greater attraction to the young. The factual basis for this conjecture is the extensive body of research which found that flavored tobacco products have differential appeal to youth. This led the US Congress to ban flavored cigarettes in 2009. In a broader context, a finding that adolescents have no preference for sweet and fruity flavors would mean that e-cigarettes somehow are a special exception to well established consumption trends throughout the food and beverage industry.

Concerns over survey validity:

The logical way to determine the differences in e-cigarette flavor preferences between adults and teens would be to compare the actual frequency of flavor use by teen and adult e-cigarette users. Rather than use a direct method, Shiffman et. al. compared a small cohort of teen non-smokers with adult smokers via a marketing survey conducted for the sponsoring e-cigarette brand (NJOY). There is reason to question the validity of comparing non-smoking teens with adult smokers as they are notably unequal groups. Nationally only approximately 15% of teens smoke whereas the entire adult survey group smoked. In this survey teen smokers were systematically excluded.<br> The Shiffman et. al. study consisted of an online survey inquiring about interest in products of the NJOY e-cigarette brand. These included then current flavors (tobacco and menthol) and a list of contemplated flavors. A survey of flavor preferences for bottled water and ice cream was used as a comparison. Invitations were sent to 20,235 adults and 14,151 teens with a mere 432 adults and 216 teens enrolled. This is an under 2% response rate. With such a low response rate, responders may have had a special motivation to participate. This raises the likelihood of selection bias, differences between responders and non-responders, a factor which undermines the value of surveys with a small percentage of responders.2 A sizable fraction of teens are opposed to smoking, some with notable vehemence instilled by parents and schools. It would be expected that a fraction of teen responders felt a special impetus to do so as a means of communicating their opposition to tobacco products. Two sorts of teens are likely to reply to such a survey: those contemplating e-cigarette use who may be attracted to the products being surveyed and those who are vehement in their intention to neither smoke nor vape and are motivated to send a rejectionist message. The motivation of teen responders to oppose smoking is the most probable reason for the low interest in e-cigarettes which the authors erroneously interpreted as a lack of interest in flavored e-cigarettes. That the paper reaches the conclusion: “Nonsmoking teens’ interest in e-cigarettes was very low” is yet another reason to question the survey’s validity. This observation is at variance with 2014 CDC data showing a rapid rise in e-cigarette use among high school students coupled with a reduction in combustible cigarette use. Not surprisingly, their survey showed non-smoking teens queried on common consumer products (ice cream and flavored water) indicated widespread interest in flavors. In the adult cohort, flavor preferences for e-cigarettes, other than tobacco and menthol, roughly paralleled that of ice cream and water. (Shiffman et al. Figure 3b) That teens expressed a liking for flavored ice cream, but not e-cigarettes, may well be accounted for by responses of teens who had no interest in e-cigarette products. (Shiffman et. al. Figure 3a) It was not that these non-smoking teens did not like the e-cigarette flavors, but rather they categorically were uninterested in NJOY’s products in all flavor variations. In their flavor analysis, the paper’s data reveals a marked preference among adult smokers for tobacco flavor and menthol flavors with all other flavors (except vanilla) appearing at a fraction of their appeal. (Shiffman et al. Figure 1) Among teen non-smokers, by contrast, interest was essentially equal across flavors with no preference for tobacco or menthol flavors. One interpretation of these data is that, relatively speaking, non-smoking teens prefer a variety of sweet and fruity flavors while adult smokers prefer tobacco flavor. This interpretation of their data is the opposite the authors’ conclusions.

Inappropriate Claim of Exemption from IRB for Survey of Minors

The Shiffman et. al. survey offers no benefit to the minors surveyed and entails significant risks. Exposing teens to a harmful product they may not have considered using, such as use of e-cigarettes and flavored e-cigarettes, could increase the likelihood that they will try the product and develop nicotine addiction. This represents a clear risk to the future health of the minor. The existence of risk, coupled with the lack of benefit to the individual child, necessitates both institutional review and parental informed consent.3

The paper concludes that adult interest in flavors as modest, with the exception of classic tobacco flavor, which they observed can “ease the transition for smokers from a familiar product to a less-familiar one.” With teens uninterested and adults minimally interested in flavors (other than tobacco and menthol), one wonders why do they bother to market them. If so unappealing to their customers, what accounts for the dramatic rise in NJOY sales after introduction of flavors such as butter crunch, peach tea, and wild berry?

References:

1. Shiffman S, Sembower M, Pillitteri J, Gerlach K, Gitchell J. Impact of electronic cigarette flavor descriptors on non-smoking teens’ and adult smokers’ interest in electronic cigarettes. Nicotine Tob Res. 2015 Jan 7. pii: ntu333.

2. Groves RM, Peytcheva E. The Impact of Nonresponse Rates on Nonresponse Bias: A Meta-Analysis The Public Opinion Quarterly Vol. 72, No. 2 (Summer, 2008), pp. 167-189

3. Heath and Human Services. Institutional Review Board Exemptions: Special Classes of Subjects: Children and Minors: (http://www.hhs.gov/ohrp/archive/irb/irb_chapter6.htm)

4. Pinney Associates: About our Company. (http://www.pinneyassociates.com/overview.xml)

5. NJOY to Discontinue Flavors, Takes Additional Steps to Prevent Underage Electronic Cigarette Use. Reuters. Dec 10, 2009

6. Giovenco DP, Hammond D. Corey CG, et. al. E-Cigarette Market Trends in Traditional U.S. Retail Channels, 2012–2013. Nicotine & Tobacco Research, 2015, 1–5

7. Wells Fargo Securities. Equity Research: Vapor - NJOY’s New Product Line Positions it Ahead of the Pack. Wells Fargo Securities; 2014.

8. Richtel M. E-Cigarette Makers Are in an Arms Race for Exotic Vapor Flavor. New York Times, July 15, 2014.

9. NJOY tops US retail Vaping sales. Convenience Store news Nov 11, 2014. http://www.csnews.com/product-categories/tobacco/iri-njoy-tops-us-retail-vaping-sales

Interest Disclosure: Dr. Jackler served as a consultant to the State of California Attorney General’s office on the 2014 motion to enforce the 2010 Soterra (NJOY) consent judgment.

On 2015 Nov 01, Robert Jackler commented:

Commentary on Shiffman et. al. study which surprisingly found no preference for flavored electronic cigarette products among teens.

The paper ‘Impact of flavor descriptors on non-smoking teens and adult smokers’ interest in electronic cigarettes” by Shiffman and coworkers suffers from flaws in experimental design and data interpretation which call into question their conclusions that flavored e-cigarettes are not of differential appeal to teens.1 As discussed in detail below, their survey methodology has a high likelihood of selection bias, the study groups are too dissimilar to enable the comparisons made, informed consent for minors was not obtained despite evident risks, and commercial interest appears to have influenced the study’s outcome. In comparing the relative appeal of flavored e-cigarettes to non-smoking teens versus smoking adults, the obvious hypothesis would be that flavors would be of greater attraction to the young. The factual basis for this conjecture is the extensive body of research which found that flavored tobacco products have differential appeal to youth. This led the US Congress to ban flavored cigarettes in 2009. In a broader context, a finding that adolescents have no preference for sweet and fruity flavors would mean that e-cigarettes somehow are a special exception to well established consumption trends throughout the food and beverage industry.

Concerns over survey validity:

The logical way to determine the differences in e-cigarette flavor preferences between adults and teens would be to compare the actual frequency of flavor use by teen and adult e-cigarette users. Rather than use a direct method, Shiffman et. al. compared a small cohort of teen non-smokers with adult smokers via a marketing survey conducted for the sponsoring e-cigarette brand (NJOY). There is reason to question the validity of comparing non-smoking teens with adult smokers as they are notably unequal groups. Nationally only approximately 15% of teens smoke whereas the entire adult survey group smoked. In this survey teen smokers were systematically excluded.<br> The Shiffman et. al. study consisted of an online survey inquiring about interest in products of the NJOY e-cigarette brand. These included then current flavors (tobacco and menthol) and a list of contemplated flavors. A survey of flavor preferences for bottled water and ice cream was used as a comparison. Invitations were sent to 20,235 adults and 14,151 teens with a mere 432 adults and 216 teens enrolled. This is an under 2% response rate. With such a low response rate, responders may have had a special motivation to participate. This raises the likelihood of selection bias, differences between responders and non-responders, a factor which undermines the value of surveys with a small percentage of responders.2 A sizable fraction of teens are opposed to smoking, some with notable vehemence instilled by parents and schools. It would be expected that a fraction of teen responders felt a special impetus to do so as a means of communicating their opposition to tobacco products. Two sorts of teens are likely to reply to such a survey: those contemplating e-cigarette use who may be attracted to the products being surveyed and those who are vehement in their intention to neither smoke nor vape and are motivated to send a rejectionist message. The motivation of teen responders to oppose smoking is the most probable reason for the low interest in e-cigarettes which the authors erroneously interpreted as a lack of interest in flavored e-cigarettes. That the paper reaches the conclusion: “Nonsmoking teens’ interest in e-cigarettes was very low” is yet another reason to question the survey’s validity. This observation is at variance with 2014 CDC data showing a rapid rise in e-cigarette use among high school students coupled with a reduction in combustible cigarette use. Not surprisingly, their survey showed non-smoking teens queried on common consumer products (ice cream and flavored water) indicated widespread interest in flavors. In the adult cohort, flavor preferences for e-cigarettes, other than tobacco and menthol, roughly paralleled that of ice cream and water. (Shiffman et al. Figure 3b) That teens expressed a liking for flavored ice cream, but not e-cigarettes, may well be accounted for by responses of teens who had no interest in e-cigarette products. (Shiffman et. al. Figure 3a) It was not that these non-smoking teens did not like the e-cigarette flavors, but rather they categorically were uninterested in NJOY’s products in all flavor variations. In their flavor analysis, the paper’s data reveals a marked preference among adult smokers for tobacco flavor and menthol flavors with all other flavors (except vanilla) appearing at a fraction of their appeal. (Shiffman et al. Figure 1) Among teen non-smokers, by contrast, interest was essentially equal across flavors with no preference for tobacco or menthol flavors. One interpretation of these data is that, relatively speaking, non-smoking teens prefer a variety of sweet and fruity flavors while adult smokers prefer tobacco flavor. This interpretation of their data is the opposite the authors’ conclusions.

Inappropriate Claim of Exemption from IRB for Survey of Minors

The Shiffman et. al. survey offers no benefit to the minors surveyed and entails significant risks. Exposing teens to a harmful product they may not have considered using, such as use of e-cigarettes and flavored e-cigarettes, could increase the likelihood that they will try the product and develop nicotine addiction. This represents a clear risk to the future health of the minor. The existence of risk, coupled with the lack of benefit to the individual child, necessitates both institutional review and parental informed consent.3

The paper concludes that adult interest in flavors as modest, with the exception of classic tobacco flavor, which they observed can “ease the transition for smokers from a familiar product to a less-familiar one.” With teens uninterested and adults minimally interested in flavors (other than tobacco and menthol), one wonders why do they bother to market them. If so unappealing to their customers, what accounts for the dramatic rise in NJOY sales after introduction of flavors such as butter crunch, peach tea, and wild berry?

References:

1. Shiffman S, Sembower M, Pillitteri J, Gerlach K, Gitchell J. Impact of electronic cigarette flavor descriptors on non-smoking teens’ and adult smokers’ interest in electronic cigarettes. Nicotine Tob Res. 2015 Jan 7. pii: ntu333.

2. Groves RM, Peytcheva E. The Impact of Nonresponse Rates on Nonresponse Bias: A Meta-Analysis The Public Opinion Quarterly Vol. 72, No. 2 (Summer, 2008), pp. 167-189

3. Heath and Human Services. Institutional Review Board Exemptions: Special Classes of Subjects: Children and Minors: (http://www.hhs.gov/ohrp/archive/irb/irb_chapter6.htm)

4. Pinney Associates: About our Company. (http://www.pinneyassociates.com/overview.xml)

5. NJOY to Discontinue Flavors, Takes Additional Steps to Prevent Underage Electronic Cigarette Use. Reuters. Dec 10, 2009

6. Giovenco DP, Hammond D. Corey CG, et. al. E-Cigarette Market Trends in Traditional U.S. Retail Channels, 2012–2013. Nicotine & Tobacco Research, 2015, 1–5

7. Wells Fargo Securities. Equity Research: Vapor - NJOY’s New Product Line Positions it Ahead of the Pack. Wells Fargo Securities; 2014.

8. Richtel M. E-Cigarette Makers Are in an Arms Race for Exotic Vapor Flavor. New York Times, July 15, 2014.

9. NJOY tops US retail Vaping sales. Convenience Store news Nov 11, 2014. http://www.csnews.com/product-categories/tobacco/iri-njoy-tops-us-retail-vaping-sales

Interest Disclosure: Dr. Jackler served as a consultant to the State of California Attorney General’s office on the 2014 motion to enforce the 2010 Soterra (NJOY) consent judgment.

On 2016 Jan 10, Carl V Phillips commented:

I read with interest the exchange between Robert Jackler and Saul Shiffman about this paper and would like to comment on two bits of the exchange. In general, I believe that Shiffman’s responses were compelling, and that they effectively rebutted Jackler’s criticisms. In particular, I agree with his assessment that Jackler basically starts with a premise that the paper’s conclusions are wrong and then speculates about what made them wrong, rather than actually building a case that anything was wrong.

Jackler makes various accusations (some overt, some innuendo) about Shiffman et al. being inappropriately influenced by their sponsor. Shiffman responds by mischaracterizing these as ad hominem. Ad hominem attacks are common in this space, and anyone who departs from a strict tobacco control party line will almost inevitably be the target of them. But the term is also misused in this space, and this is an example. Claiming “Shiffman et al.’s research should be ignored because they consort with those I declare to be the enemy,” would be ad hominem, but there is only a hint of that in Jackler’s comments. Instead, he mostly claims that the research was faulty because of influences of the funder on the design of the particular research. This may be a cheap rhetorical tactic and unsubstantiated innuendo – as Shiffman argues – and it is certainly insulting to the integrity of the authors, but none of that makes it ad hominem.

Jackler introduces one valid scientific concern, and it should be extended to a most of the research in this space. He argues (my paraphrase) that the expressed lack of interest in the products, whatever flavor descriptor was offered, mostly reflects the general hostility toward tobacco products that is inculcated in this population of teenagers. Schiffman responds to the criticism as phrased, quite legitimately, by arguing this was exactly the authors’ point, that flavors are not overcoming the programmed resistance to using the products. But the comment and response skirt the real scientific concern here: All of the research in and around this point produces rough measures that only partially inform the question of interest, which is, “what product characteristics cause different choices in the real world?”

Teenagers’ responses to abstract survey questions, posed by people who presumably feel a lot like the authority figures who have been instilling the anti-tobacco message, probably do just trigger the inculcated response. This makes them a limited measure of whether a flavor option will change someone’s choice when he is presented with the opportunity to try a product. The present study is clearly more informative than anything cited in support claims that flavors have caused a torrent of underage use (let alone claims that attracting underage users is the purpose of interesting flavors, given that adults clearly prefer them; see, for example, my recent report of survey results at http://antithrlies.com/2016/01/04/casaa-ecig-survey-results/). But what was measured is only one contributor to the actions of interest.

The failure to recognize that what is measured is not the same as what is being asked extends throughout this field of inquiry. Jackler asserts that looking at flavor usage patterns would be a better measure, and Shiffman correctly points out that this would be an answer to an different question. It would tell us something that relates the question of interest, though it is even further removed than what the study measured. Yet it is quite common for opponents of product availability to claim that mere demonstrated preference for a particular product feature is evidence that the feature is causing use. Indeed, guessing at what Jackler alludes to as an “extensive body of research” about preferences for flavors of other tobacco products, this describes most of that research. Fuzzy and noisy observations that are probably associated with the question of interest can allow us to modestly update our beliefs. But commentators, including many research authors, make absolute claims, apparently oblivious to the necessary epistemic modesty.

Moreover, the common absolute claims (e.g., “this shows kids are not interested in flavors” or “this proves that flavors are attracting kids”) are absurd on their face. For any improvement in a product’s quality (such as the availability of a particular flavor), there are some combinations of individual preferences such that the improvement would tip someone’s preference about wanting to use the product. Since there are a lot of people, chances are some have that preference pattern for any substantial improvement (and this will include some “proper” and some “improper” users, if one is inclined to create such categories). The question cannot be, “are any kids motivated by the flavors?” (or by flavor descriptors, which is a somewhat different question), because the answer to that is surely yes. The question must be, “how many?” The Schiffman et al. results contradict the political claims that underage users are flocking to e-cigarettes in droves because they have heard about the particular flavors from the study, but absolute claims that have been made about the results are clearly false. Any author who seeks to make a scientific contribution in this area needs to explain, at least very roughly, how empirical results contribute to an economic model of preference and choice that can provide a quantitative estimate of the phenomenon of interest. (Anyone who wants to go further and claim that the phenomenon is substantially harmful, to whatever extent it occurs, must present separate analysis. This obviously does not follow from claims that the phenomenon is occurring, as many authors imply; it is entirely plausible that the material impact is nil or even beneficial.)

The absolutist rhetoric that dominates the policy fights in this area seeps into the science and poisons it, causing researchers to traffic in simplistic claims. Indeed, the rhetoric that causes the problems addressed above is exemplified in the second sentence of the abstract, in which the authors assert that e-cigarette use has no benefits apart from smoking cessation. This is obviously not true; if people are choosing an action, it is because it has benefits. But if the myth to the contrary is taken as a premise – effectively assuming that actions are caused by demonic possession rather than volition – it is very difficult to apply the economic reasoning sketched above. Researchers and commentators in this area give little indication they recognize that they are making claims about choices, which are volition that is a function of preferences, opportunity, and product characteristics. They need to assess how particular observations fit into a model of that process, rather than implicitly assuming that whatever happened to be measured is isomorphic to the outcome of that process.

On 2016 May 23, Clive Bates commented:

Robert Jackler assumes a priori that attracting adolescents to vaping through flavour descriptors is a bad thing. Saul Shiffman provides a compelling defence of their study showing that teenage interest in flavours was low and this should not concern us much. But this framing may be an over-simplification.

E-cigarette appeal may be good for health

What if the rise in e-cigarette use among adolescents is displacing tobacco smoking, and that this effect accounts for the rapid fall in teenage smoking measured in both the NYTS survey: Tobacco Use Among Middle and High School Students — United States, 2011–2014 and the University of Michigan Monitoring the Future survey, Media release: Teen cigarette smoking drops to historic low in 2015?

In that case, critics must contemplate the idea that e-cigarettes have a harm reduction function among adolescents and that their attractiveness to young people who would otherwise become smokers may be overall a public health benefit. Levy DT, 2017 shows that e-cigarettes create many beneficial pathways for the evolution of nicotine use and abstinence. It is far from clear that obstructing these pathways with policies or campaigning communications is positive for public health.

Scope for adverse unintended consequences

There is already evidence that measures designed to block youth access to e-cigarettes have adverse unintended consequences on youth smoking: see Friedman AS, 2015 and Pesko MF, 2016 on the impact of e-cigarette age restriction laws on cigarette smoking. It is not a great leap of logic to hypothesise that making e-cigarettes less attractive to adolescents would attenuate the decline in smoking that is, or should be, the primary concern in tobacco policy.

The appropriate focus is on adults

The right way to address this issue is not to try to micro-manage adolescent behaviours but to ensure that adults have attractive alternatives to smoking. Restrictions imposed with the misguided purpose of 'protecting' adolescents from very low-risk alternatives to cigarettes could have the effect of harming longstanding adult smokers - the real at-risk group. Several surveys (e.g. Farsalinos KE, 2014) have shown that non-tobacco flavours matter to adults who are using e-cigarettes as an alternative to smoking and are part of the long-term transition away from tobacco use.

Conclusion

Anyone proposing a ban on certain flavours or flavour descriptors needs to assess the risk of harmful unintended consequences - that more adolescents will take up smoking instead of vaping, and that adults smokers will find vaping a less attractive alternative to smoking and never switch, remain as dual users, or relapse back to smoking.