Category Archives: White Paper

CASAA ecig survey results

by Carl V Phillips

At the end of 2015, CASAA conducted a survey of e-cigarette use, targeted at CASAA members who are adult U.S. residents. The survey was designed primarily to provide information relevant to evaluating FDA’s proposed “regulation” (i.e., ban) of e-cigarettes. We reported some of the results in our report to OIRA regarding the proposed regulation. What follows here is a bit more detail. Continue reading

Pamphlet: Tobacco harm reduction, e-cigarettes, and e-cigarette use: an overview

by Carl V Phillips

For a seminar at the U.S. Senate offices today (which also featured Gregory Conley and CASAA’s Igor Burstyn), I prepared a handout that I think is the best way to give an overview of what the title describes.

[Update: I neglected to mention that the event was hosted by the American Enterprise Institute (AEI), in the person of CASAA advisor Sally Satel. They and she did a great job of planning the event and getting a lot of people there to hear what we had to say. It was a great contribution to the cause.]

It is aimed at people who know a little bit about the topic, and thus have probably heard bits of the usual misinformation, but are fuzzy on even the basics. It glosses over the health science because Igor was covering that.

I figured I might as well share it more widely: Phillips – harm reduction and ecigs handout (pdf) [updated 19mar15 based on comments plus some additional tidying]. Comments welcome and feel free to share it. We will probably turn it into some sort of “permanent” CASAA document.

The only thing from my talk that is not in the document that is worth mentioning: When talking about the myth that flavors appeal only to kids, I pointed out that, as I understand, not too far from where we were sitting there is an Official Senate Candy Dish.

CASAA White Paper: Guide to Civil Disobedience

The following is the fourth in the series of CASAA White Papers.  As with the others, it is posted here to allow discussion.  Unlike the previous three, this is not considered a draft.  But discussion is welcome and revisions are possible if important potential improvements are identified.  For those who would like a downloadable formatted version, it is here.  Permission to copy, circulate, and post the downloadable file is granted, so long as nothing is changed.

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The CASAA Guide to Civil Disobedience in Defense of Smoke-free Tobacco/Nicotine Products
Continue reading

draft Regulatory Science White Paper #3: “Addictiveness” of nicotine and e-cigarettes

by Carl V Phillips

See yesterday’s post for more about the white paper series and our requests for comments.

This one calls for a bit of explanation.  This topic is difficult to nail down and say much that is concrete about (for reasons that are explained) and would not have been high on our list for the series.  However, when we met with OIRA they were particularly interested in this point, so we decided to do what we could.  Keep the two implications of that in mind if you would like to comment: 1) we know it is difficult to get this right, but decided to do it anyway, and 2) we are particularly interested in comments if you have any idea how anyone could do any better than this.

Consumer Advocates for Smoke-free Alternatives

DRAFT Regulatory Science #3:  “Addictiveness” of nicotine and e-cigarettes

draft – not yet peer reviewed

Soundbite version

While it is widely claimed that nicotine in general, and e-cigarettes in particular are addictive, there is actually no evidence that nicotine is, by itself, addictive (setting aside that there is no accepted definition of that word making the claim vague, and just following the common usage of the word).  It turns out that claims about the addictiveness of nicotine are based on studies of smoking.  When nicotine is isolated, there is widespread insistence that it is not addictive (the common insistence about NRT) and substantial evidence that even people who were completely captivated by smoking have a relatively easy time giving it up.  Whatever “addiction” to smoking means, it is clear that users of nicotine have a very different experiencee.

Background

It is widely claimed that nicotine consumption causes the effects on behavior and preferences that are sometimes labeled “addiction.”  However, such claims are based on the effects of cigarette smoking, the dominant modern method of nicotine consumption.  This means that the data is perfectly confounded: it is impossible to distinguish the effects of nicotine from other effects of smoking.  While there is little doubt that nicotine is the strongest attraction of smoking, further examination suggests that there is little reason to believe that nicotine delivered in other ways has the same captivating effects as smoking.  Indeed, there is no affirmative evidence to support such a hypothesis, and quite a bit of evidence that suggests it is not true.

The widespread failure to differentiate between consumption of cigarette smoke and of nicotine appears to be largely a historical accident, stemming from failure to adequately test the nicotine hypothesis before accepting it.  The conflation has recently been embraced by anti-tobacco extremists as a convenient tactic for attacking tobacco harm reduction in general and e-cigarettes in particular.  It is more difficult to explain why the conflation became so embraced by tobacco control activists during the period when the only nicotine products (pharmaceutical nicotine products, a.k.a., nicotine replacement therapy, NRT) were actively touted by them, but that was how the politics played out.  Pointing out that the evidence did not support the popular claim largely fell to researchers who were not part of the tobacco control industry (e.g., Frenk and Dar), though recently some who conflated smoking and nicotine in the past have corrected that error (e.g., Fagerstrom).

Note that the word “addictiveness” is used in the title here because it is a common touchstone for the general concept.  That word, along with its other grammatical forms, has no defensible or even widely-accepted scientific or medical definition, and indeed are used in ways that make it nearly impossible to define and that create confusion.  When the word is used, it refers to some haphazard combination of dependency (having negative withdrawal effects), behavior patterns, appreciation of the product, other impacts on preferences, and biomarkers.  Sometimes it those using the word mean nothing more than someone uses, or even merely likes, a vilified product.  Thus, when speaking for ourselves in this document we avoid forms of that word and substitute other words (we have chosen “captivate”) that refer to the feelings or behaviors that the word evoke.  Those words are also not scientifically defined, of course, but their vagueness is clear and thus they are unlikely to be misinterpreted as if they are precise scientific claims.  When a form of the word “addiction” are used, it refers to specific or general claims made by others.

Some commentators have tried to salvage the concept of nicotine being addictive by suggesting that variations in user reactions to products are simple different degrees of addiction, with the nicotine still being the cause of addiction.  While this scale might be a valid approach for a more concrete concept like dependence, it clearly defies the general interpretation of the word “addiction,” which implies some kind of consuming and overwhelming motivation.  A scale of addictiveness that goes down to zero is nothing more than a scale of preference — how much someone likes a particular experience.  To call something addictive (or even “a little bit addictive”) because someone tried it and liked it rather than hating it, and thus might be inclined to try it again sometimes, is clearly disingenuous and intended to mislead people with a normal interpretation of the word.  So while there is no metric available and thus obviously no bright line, it is clear that “addiction” implies some substantial captivation and thus “a little bit addictive” should mean not addictive.  This is a necessary clarification for attempting to address the question at hand, since without it everything that people fits the definition of addictive and the question becomes nonsense.

Empirical evidence

Establishing a negative epistemic claim — that there is not evidence that nicotine delivered other than via smoking has the same captivating properties as smoking — is necessarily difficult.  The best support for the lcaim is the observation that when a references is given for the claim that nicotine is addictive, it is invariably to a study of smoking.  There simply appears to be no evidence that extracted nicotine has the behavioral or preference effects that are often called addiction.

NRT products are generally claimed to be non-addictive or close to it, even by those who aggressively condemn smoking for being addictive (example).  In the few studies of use of these products among non-tobacco-users (as a treatment for diseases where nicotine is beneficial), there were no reports of subjects having a difficult time quitting.  While the designers and manufacturers of NRT products attribute the lack of addictiveness to specific design details, a plausible alternative explanation is that nicotine alone never has the same behavioral effects as smoking.  There is no recorded history of NRT products that were abandoned because they were judged to be addictive, as we would expect if the design details really mattered much.  For some NRT products (nicotine gum, in particular), use defies the ostensible intentions of the designers because they can be used ad lib to generate nicotine pharmacokinetics that are quite similar to smokeless tobacco or e-cigarettes, products that are often declared to be addictive.  Yet there is little concern expressed about the gum being addictive.  While the oral NRT products have unpleasant taste and feel which makes them unappealing, the user can deliver as much nicotine as they want, as with e-cigarettes.  So if these NRT are non-addictive, it is difficult to see how nicotine or e-cigarettes could be addictive.

E-cigarettes have offered the first widely-studied large-scale experience of nicotine use without the other exposures from smoking or smokeless tobacco use.  (There has long been fairly widespread long-term consumption of NRT products, using them similarly to other tobacco products and not as temporary cessation aids.  But because this is not acknowledged by manufacturers and advocates of the products, there has been a glaring failure to study this population.)  Evidence from the e-cigarette experience strongly suggests that nicotine delivered via e-cigarettes this form is not so captivating as smoking, even among those who found that e-cigarette use was the only way they could manage to quit smoking.

Among the thousands of individual testimonials about successful smoking cessation using e-cigarettes, there are many reports of users easily or accidentally quitting the e-cigarettes after establishing their switch to them, or dropping the nicotine concentration they are using down to zero.  Many other users report that they feel less captivated by their e-cigarette use compared to smoking.  Many significantly reduce their nicotine content but do not eliminate it, which might suggest a dependency but not necessarily the other characteristics that are usually implied by “addiction.”  Those who keep vaping zero-nicotine may be captivated by the physical act of smoking/vaping, but clearly were not captivated by the nicotine itself.

Several surveys of e-cigarette users further support these observations, including those by CASAA (results not yet published), Farsilinos et al.Dawkins et al., and Heavner et al.  Quitting e-cigarettes and reducing and eliminating the nicotine occur even though experienced users have access to inexpensive products and realize that e-cigarettes are very low risk and thus they have little incentive to quit (let alone to use zero-nicotine e-cigarettes).  This suggests that not only are many former smokers not captivated by the nicotine, but become relatively indifferent about it in the absence of smoking.

None of this data allows an estimate of the prevalence of these tendencies.  This is obviously true of testimonials, but also all surveys to date have used convenience samples — mostly of experienced e-cigarette enthusiasts — with unknown sampling properties.  Still, it does demonstrate that for some established tobacco users, e-cigarette use is less captivating than smoking.  There is no evidence that suggests anyone has the opposite reaction.

There have been no reports claiming someone who was not previously a smoker becoming addicted to nicotine via e-cigarettes.  The newness of the products means that perhaps there will be such cases though none have yet been reported.  However, given that there are a substantial number of well-resourced anti-tobacco activists who insist that addiction to nicotine occurs almost instantaneously and are intent on showing that e-cigarettes are evil, their failure to find and report even a single such case suggests that it is not happening.  We can be sure that if even a single personal testimonial supported the claim, the story headlined “I thought e-cigarettes were harmless, but then I got addicted” would be irresistible to the media.  The story’s absence strongly supports the epistemic negative that no such testimonial exists.

The evidence about smokeless tobacco is more difficult to interpret.  While there can be no quantitative metric for a concept that is not defined in the first place, attempts to compare the “addictiveness” of smokeless tobacco to smoking have suggested that they are similar.  This occurs even in the USA, where the population was largely tricked into believing that the risks from smokeless tobacco were similar to those from smoking, and thus believed they had a compelling reason to quit.  Most research on this topic is suspect because it comes from sources with an enormous conflict of interest — they oppose the use of smokeless tobacco and thus are motivated to overstate its harms — but cannot be dismissed entirely.  Better evidence comparing the captivation effects of smokeless tobacco compared to smoking or e-cigarettes could distinguish among the hypotheses presented below

Use of traditional cigars (or “large cigars” as referred to in marketing and regulation) does not generally produce the same behaviors and feelings as cigarette smoking.  Most cigar users use them only occasionally.  A similar pattern is observed for hookah smokers (at least in Western cultures), where it is an occasional indulgence and not a captivating habit.  However, research on these products is limited, so it is difficult to draw any firm conclusions.

Scientific analysis

There are several plausible explanations for the observations.  All of these hypothesized explanations suggest that nicotine per se is not particularly captivating.  No single explanation is going to be universal, given population heterogeneity:  Some former smokers who switch to e-cigarettes are inclined to then quit e-cigarettes or nicotine, while other become dedicated vapers.  Some smokers find nicotine alone to be an appealing substitute, while others find that smokeless tobacco is a good substitute but nicotine alone is not (and, of course, many find neither to be satisfying).

The only plausible hypothesis that is both consistent with the data and maintains the centrality of nicotine is that differences in the pharmacokinetics explain the different reactions.  Cigarettes deliver a much faster Tmax (time until the peak level is reached) for nicotine than any other tobacco product and unless the user of a smoke-free product uses a lot for an extended period, cigarettes also produce a higher Cmax (how high that peak is).  That this would result in greater captivation is consistent with what we know from research on other drugs as well as human experience.  Under this hypothesis we would expect that smokeless tobacco, e-cigarettes, and NRT would have similar levels of “addictiveness,” and those would be less than those of all variations on smoking.  This does not tend to conform to the current interpretations of the evidence (though, as noted, that evidence is sketchy).

Tobacco includes other psychoactive chemicals that might act independently or synergistically with nicotine to make it more captivating than nicotine alone.  There are people who find that nicotine alone is not a particularly pleasant drug, but that whole tobacco is.  The systematic affirmative evidence that these constituents are the important difference is limited to rat studies (example) which have little relevance to human preferences and behavior, but do suggest biological plausibility.  It theoretically also may also be that the smoke itself has constituents that make it more captivating.

Inhalation versus other delivery methods is another frequently proposed contrast, since delivery is more rapid and might reach different receptors.  However this hypothesis is quite inconsistent with the data (e-cigarettes use is unlike smoking; smokeless tobacco use may be somewhere in between; NRT inhalers are claimed to not be addictive).

Alternatively, the contrast may be caused by nothing more than established habits.  Those who quit the nicotine-only products — either e-cigarettes or NRT — had been using them for far shorter periods than the average smoker or smokeless tobacco user who tries to quit.  A lack of established routine or change of routine makes behavior change easier.  This hypothesis is compatible with nicotine being the major contributor to the appeal of the products, but suggests that the captivation has other causes.  A related hypothesis can be found in discussions about how to market alternatives to cigarettes, with an emphasis on consumer “moments.”  If the marketers are right, and much of the appeal of smoking is that it creates focused carved-out short periods, then the context of nicotine delivery, and not just the chemical, is critical.

Whatever the explanation, it is clear that the claim that nicotine is highly addictive is naive and unsubstantiated.  Overwhelming evidence suggests that e-cigarettes do not have the same captivating properties as smoking, and a similar claim is made about NRT.  There is no apparent basis for claiming that nicotine alone, absent a history of smoking, produces “addiction.”

Our position

The concept of addictiveness is a worthwhile area of study and concern, but in the politics of tobacco products, it is used merely as rhetoric.  Many of the same people who tout NRT condemn e-cigarettes because of the supposed addictiveness of the nicotine they deliver, even though there is very little difference in nicotine delivery between the two categories.  If asked what they even mean by the word, almost no one condemning e-cigarettes because the are addictive could provide a remotely coherent answer (and even the few reasonably cogent answers are still scientifically imprecise and either do not apply or do not reflect the dire implications usually assigned to the word).  These observations alone are sufficient to show that the supposed worry is disingenuous.  The lack of evidence that nicotine alone is particularly captivating, and the affirmative evidence that suggests it is not, means that there is no scientific basis for such worry.  Unless some other evidence emerges, or products are developed that have different capitvation properties, the trope that nicotine is addictive should be seen as mere political rhetoric or blind repetition by those who do not know it is political rhetoric and believe there is such evidence.

It can be argued that even cigarettes do not meet a reasonable definition for “addiction,” a word that evokes the much more intense and all-consuming reactions that some people have to the use of drugs like cocaine, amphetamines, or strong narcotics.  Still it does appear that some tobacco products are more captivating than others and that cigarettes are the “most addictive” among them (granting that since “addictive” is ill-defined, the phrases “most addictive” is perhaps unforgivably ill-defined).

This creates some considerations that matter little to the tobacco control extremists, but which are important to those interested in health and consumer welfare.  Improving the quality of a THR product will make it a satisfying substitute for more would-be smokers and will increase the welfare of those using it.  To anti-tobacco extremists, this very appeal is a downside and they tend to call it “abuse potential,” but to those whose motives are not dominated by a quasi-religious objection to tobacco use, making people happier, ceteris paribus, is considered a plus, not a minus.  However, to the extent that those same quality features make it unpleasant to quit (as opposed to pleasant to use — a subtle but important distinction), should someone decide that is what they would prefer, there is a downside to quality.  The perfect low-risk product would be highly appealing and a very satisfying substitute for smoking, but the only barrier to quitting would be that it is appealing and thus there are benefits that the user does not want to give up.

The current holy grail of e-cigarette developers seems to be to make them as much like cigarettes as possible.  This has obvious benefits for harm reduction, but has the downside that it might be making them more captivating (a downside for consumers, that is — for the producers this may be considered an additional benefit).  If there were some legitimate research into the concept of “addictiveness” that did not merely conflate it with attractiveness, it might be possible to figure out how to create more of the latter and less of the former, which would be beneficial for consumers.  Unfortunately, this is a line of research that is unlikely to be pursued by the tobacco control special interests or the industry, and they control almost all of the available research funding.

draft Regulatory Science White Paper #2: The “gateway effect”

by Carl V Phillips

You will recall that a month ago, we posted our first draft white paper, on e-cigarette use by children.  We received, in various forms, the very useful suggest that our original title for the series (position papers or position statements) was misleading and did not do them justice.  Thus, we have renamed the series “Regulatory Science” and just call them white papers.

The term “regulatory science” is a thing right now, and is the language being used by the FDA and others.  It is not clear exactly what it means (and, indeed, it is my personal feeling that almost anytime someone precedes “science” with an adjective like that — pretty much any adjective that does not demarcate a specific area of science like “biological” — the adjective might as well be “junk”). We have chosen to interpret the term as something like: “scientific analysis that is specifically geared toward translating the scientific knowledge base into decision-relevant information”.   That is basically what I taught as a professor, and that turns out to be almost completely absent (perhaps completely now that I am retired from academia ;-) from public health sciences programs.

Anyway, the first white paper has now been reviewed — by you and recruited peer reviewers — and will be finalized and posted soon.  The second and third are done.  The second follows this paragraph.  As before, we are interested in any comments from anyone — peer review type comments especially, but we will certainly consider anything else that might strike you also.  CASAA members are invited to weigh in on the “our position” bit, since you are part of “our” (want to comment on that and are not a member? join – it’s free!).

Consumer Advocates for Smoke-free Alternatives Association

DRAFT Regulatory Science Series #2:  The “gateway effect”

draft – not yet peer reviewed

 Soundbite version

Those who oppose the promotion of tobacco harm reduction frequently claim that low-risk tobacco products will cause people to start smoking, the so-called “gateway effect.”  This claim has been heavily employed in anti-e-cigarette disinformation campaigns.  However, there is absolutely no evidence that such causation occurs.  Data that is cited in support of gateway claims about smokeless tobacco merely demonstrates the obvious point: people who use one tobacco product are more likely to use other tobacco products than those who avoid tobacco entirely.  Moreover, a moment’s thought reveals that such an effect is unlikely:  Why would someone who chose abstinence over smoking, upon discovering that they prefer a third alternative to either of those, be caused to make a change to their least-preferred option, smoking?  Asking that question, rather than making affirmative arguments, is probably the best response to anyone who is claiming that there is a gateway effect.

 Finally, even if someone speculates that there are some gateway cases, these are still clearly dwarfed by the number of would-be smokers who choose a low-risk alternative instead.  Thus the low-risk products still provide large net population health benefits.

 Introduction

A typical fallback position for those who want to condemn a drug or behavior, but cannot credibly argue that it is harmful in itself, is to claim that it is a “gateway” to genuinely harmful behaviors.  In the case of tobacco harm reduction (THR) products, the claim is that they cause some people to smoke.  In the early 2000s, anti-THR activists frequently claimed that smokeless tobacco (ST) was a gateway to smoking, though they seem to have largely dropped the argument because it proved much more effective to just mislead people into believing that ST causes substantial risk in itself.  But the rhetoric has recently been revived as an attack on e-cigarettes because attempts to convince the public they are high-risk are falling flat.

A simple analysis reveals that the gateway claim is fatally flawed.  It must be realized that the gateway claim is that the THR product is causing smoking – that is, smoking would not have occurred if the other product did not exist or were not tried by the user.  Mere precedence – e.g., someone puffing an e-cigarette before they ever tried a cigarette and later becoming a smoker – does not suggest there is causation; the smoking habit probably would have happened had the other product not existed.  When the gateway claim is used in anti-THR rhetoric, there is (presumably intentional) conflation of causation and mere precedence, but the implication is always about causation, and thus “gateway” should be interpreted in terms of causation.

While it is theoretically possible for low-risk tobacco product use to cause smoking, there is no empirical evidence that it ever occurs, and indeed anyone who thinks through the scientific analysis will realize that it is vanishingly unlikely.

Empirical evidence

Simply put, there is no empirical evidence of a gateway from low-risk products to smoking.  What was cited as a evidence of this for ST merely showed that people who were inclined to use tobacco liked to use tobacco.  That is, the conclusions were based entirely on the (clearly true and unsurprising) observation that people who used one tobacco product were more likely to become users of another tobacco product than were lifelong never-users (example).  So, in particular, users of ST were more likely to become smokers than were never-users of tobacco.  But this told us nothing about whether they would have been smokers had they never used ST.

In theory, evidence like this could show whether there is a gateway effect by controlling for propensity to smoke.  That is, if many former ST users became smokers even though they were not the type of people who normally become smokers, this would suggest a gateway effect (and if it did not occur, it would be empirical evidence that there was no such measurable effect).  None of the researchers or activists making gateway claims seemed to have even seriously attempted this, nor even to have understood that it was necessary.  One response reanalyzed the data from one of the naive pro-gateway claims that merely observed that those who used one tobacco product were more likely to use another; using with controls for propensity, it showed that most of the claimed association disappeared.  Another study used propensity based matching and did not detect a causal relationship between ST use and later smoking.  However, it is difficult to imagine creating a sufficiently accurate “propensity to smoke” score that could detect the signal amidst the noise of the obvious correlation between liking one tobacco product and liking the other, and the modeling would offer the analyst so many degrees of freedom that it would be easy to bias the results for political purposes.  Thus, there is basically no possibility that this line of research can distinguish between zero gateway effect and a small gateway effect, though it can clearly rule out a large effect.

(Aside: The mere fact that switching from ST to smoking was about as common as the other way around in historical U.S. data is disturbing from a public health perspective, even though it does not support the gateway claim.  This pattern is easily explained by the fact that most Americans were (and largely still are) victims of the anti-THR disinformation campaign that convinced them that smokeless is just as high risk as smoking, so they might as well smoke.  The good news is that willingness to switch products means that THR is likely once someone fully understands and internalizes the truth.)

There have been several studies that provide affirmative observations that are generally contrary to gateway claims about ST.  They found that few cases of ST use were even candidates for the gateway claim, that people who initiated tobacco use with ST were less likely to smoke than those who initiated with cigarettes, and that in Sweden (a population where ST use is common) there was far more switching from smoking to ST than the other way around.

The evidence from Sweden shows that if there is a gateway effect, it is utterly dwarfed by the THR effect (that is, even if the gateway affects a few people, far more would-be smokers choose ST, so the net effects are overwhelmingly positive).  Sweden has a high and long-standing use of THR products (in particular, snus) and has by far the lowest smoking prevalence of any country where smoking was ever popular.  Moreover, the comparison of men (whose use of snus is more prevalent and occurred earlier in time) and women shows an inverse association: male smoking rates dropped markedly as they took up snus while female smoking rates only followed the steady downward trend observed elsewhere (see, e.g., reference).  If snus were causing many users to smoke, this would not be the case.  (No analogous observation is possible about e-cigarettes because they are not sufficiently popular in any population that a gateway effect would impact population statistics.)

Neither the above-cited studies, nor the Swedish data, nor any conceivable data can rule out that there are some gateway cases.  A few cases would simply not be detectable, and thus cannot be ruled out.  But they do show that there are either few or none.

In the current discussion of e-cigarettes, there are not even any observations about people trying e-cigarettes first and becoming smokers, let alone support for the claim that it is a gateway.  The claims about e-cigarettes are just made up from whole cloth (example).

There are no apparent studies of possible gateway effects at the individual level (for example, testimonials of smokers who report that they eschewed smoking until they became a user of a low-risk alternative and then found themselves drawn to smoking).

Scientific analysis

The empirical evidence fails to demonstrate any gateway effect and shows that it is small if it exists.  The argument that it is non-existent, or close do that, can be found in the logic.  It is absurd to even think that low-risk tobacco/nicotine products would cause smoking.  Consider the combination of traits and choices that would have to be true of someone for someone to be a “gateway” case:

1) He would not smoke if not exposed to the low-risk alternative (otherwise smoking would have occurred anyway, so the other exposure is not causing it).  That is, abstinence is preferred to smoking, perhaps because of the health risks or perhaps just a lack of taste for tobacco use.

2) He chooses to use the low-risk product.  That is, the low-risk product is preferred to abstinence, so he has a preference for tobacco use so long as the risk is low.

3) Having adopted the low-risk product, he then prefers smoking and switches to it.

 A moment’s thought reveals how absurd that combination is.  The low-risk product is preferred to abstinence which is preferred to smoking.  But using the low-risk product does not cause the user to decide he does not like it (and go back to abstinence) or to become a dedicated user of that product.  For some mysterious reason, it somehow causes him to switch to his least-preferred alternative.  Why would this be?  His preference pattern probably reflects the fact that he is concerned about the health effects, even though he likes to use tobacco/nicotine (though it might just be that he just does not like smoke).  Why, exactly, would using the low-risk product cause him to forget about this?

The reason the absurdity of the claim is not immediately obvious to all observers is that tobacco control has convinced many people of their “demonic possession” theory of tobacco use.  That is, contrary to ample evidence, and in contrast with all other consumer choices, they imply that people do not choose to use tobacco or choose among tobacco products because of preferences.  It just sort of happens.  Since people’s actions, according to this story, have nothing to do with preferences or volitions, they must be controlled by demons.  Since demons can behave in completely arbitrary ways, any behavior pattern is thus possible, even when it is clearly absurd if based on an analysis of preferences.

Of course, it might be that someone could craft a non-absurd story of how the gateway works.  But to our knowledge, none of those who assert there is such an effect have ever done so.  We suspect such a story would involve an appeal to a some concept of addiction, but invoking that concept would not explain why an increasing desire for the low-risk product would result in it having less appeal than the previously dispreferred product; some plausible reason for that would be necessary.

The failure of THR opponents to try to produce a mechanism for the gateway effect may be because one part of any plausible explanation does not work in their favor.  When people do not know that smoke-free products pose orders-of-magnitude lower risk than smoking, the barrier for switching in the unhealthy direction is much lower. The aforementioned studies about ST use and smoking in the USA, a population that mistakenly believed the two products posed similar risks, show a similar pattern of switching in both directions.  While it is still the case that most or even all would have still smoked in the absence of ST, some of the switching in the unhealthful direction might have been causal.  Ignorance of the comparative risk alone still does not explain why someone who would have never smoked would be caused to smoke, but it frees that story from one enormous hurdle:  The user is still switching to what was once his least-preferred option, but he does not know that this entails an enormous increase in health risks because he has been tricked into believing that, from the health perspective, he might as well smoke.

In short, if there are gateway cases, much of the explanation for them is the mistaken belief that the low-risk alternative is actually high risk.  The fact that the same activists who purport to worry about a gateway effect also spread such disinformation suggests that they are not genuinely worried about the gateway effect.  It is also worth noting that the claims refer only to non-pharmaceutical tobacco/nicotine products, though it is equally plausible (which is to say, equally implausible) that nicotine gums, lozenges, and patches could be a gateway to smoking.  Yet those who claim to fear the gateway effect usually support aggressive touting of these products.

It follows from this that accurate communication about low-risk alternatives cannot create a gateway effect.  Even if availability of those product could create some gateway effect (contrary to both the empirical evidence and logic that suggests otherwise), accurate communication about the risks would tend to reduce this.  Thus, it is nonsense to even suggest that informing people about the low risk of available products could cause a gateway effect.

Our position

If anyone who would not have otherwise smoked is caused to smoke, that is unfortunate.  If THR were causing this to happen to a substantial degree, it might be a cause for concern even though the net population effects would still be beneficial.  Ethically, it is debatable whether population benefits always trump uncompensated individual costs.  But given that it is difficult to imagine why it would happen at all, and there is nothing to suggest it is happening to a measurable degree, this abstract debate is moot.

It is clear from their other behaviors that those who make claims about a gateway effect are not genuinely concerned, but are merely following a pattern of making every anti-THR claim they can think of.  Their willingness to mislead about comparative risks, and to express no concern about NRT availability and marketing, make clear that they do not really believe what they are saying.

If there is any gateway effect, the best way to reduce it is to clearly communicate to low-risk product users how much higher risk smoking is.  There is no plausible way such communication could increase the effect.

Based on everything we know, this is simply a non-issue.  Unless those who claim to worry about it are able to produce some argument or evidence, rather than just making vague assertions, there is nothing more that can be said about it.

CASAA draft position statement on ecigs and children

CASAA is currently putting together analytic and position statements about several of the burning topics in the the current THR debate.  Our plan is to create drafts, put them out for peer review and member comments, and then post the final official version.  Below you will find the first of these, posted here for comments.  We welcome peer review comments on the empirical and analytic sections from anyone with expertise, and comments on the position statement from any CASAA members.  Suggestions are also welcome on the labeling of the sections (which we are not thrilled about) and what to even call these.  Something along the lines of “position statement” is typical, but it also implies that it is purely opinion which, as you will see, is not the case — it is mostly scientific analysis.  (As with any review, of course, we will probably not act on every suggestion, but we will definitely consider them all.)

We believe these statements will be useful for people who are involved in the growing number of local fights about e-cigarette regulation and are otherwise engaged in attempts to educate.  To that end, we include a first section which is the sound-bite version of the material that follows.  We think the longer versions will be useful background for more serious conversations.  A lot of the analysis we are including is often talked about, but has not been usefully consolidated anywhere.

**DRAFT** CASAA analysis of and position statement about underage use of e-cigarettes

[This draft version is for review.  It is not CASAA’s official position.  The final version will be published soon.]

Soundbite version

Despite a lot of hype, the evidence shows that few minors are even trying e-cigarettes and few, if any, are actually using them.  The CDC statistics that have been spun as “underage usage has doubled” actually only showed that the number of children who had ever taken one puff doubled, which is basically inevitable given the newness of the product.  Moreover, it is clear that most of those trying e-cigarettes are already smokers, so the e-cigarettes may be playing the same harm reduction role for children that they do for adults, and there is no evidence at all to suggest that e-cigarettes are causing children to smoke.  The reason that some people become worried about underage use is because they mistakenly think that e-cigarettes post similar risks to cigarettes.  To the contrary, of all the indulgences that children could be engaging in, e-cigarettes are among the most benign, and thus are probably reducing total health risks.

Background

A huge amount concern has been expressed about people under the legal age for use of tobacco products (hereafter: children) using e-cigarettes.  This is similar to historical attacks on other low-risk tobacco harm reduction (THR) products, specifically smokeless tobacco, though is rather more aggressive due to the relative novelty of the products.  It is clear that most of this noise is pure political strategy by people using it to serve other agendas, looking for any excuse to restrict or ban adult access to any tobacco product.  The claims are groundless, in that they are scientifically false as well as expressing concern about a non-issue.

Empirical evidence

Contrary to the claims, there is basically no evidence that children are using e-cigarettes.  What evidence exists is entirely about children trying e-cigarettes.  In particular, despite the misleading rhetoric they packaged it in [http://www.cdc.gov/media/releases/2013/p0905-ecigarette-use.html], the CDC’s recent survey data on children and e-cigarettes was restricted to trying an e-cigarette ever (perhaps as little as one puff) or trying one within the last 30 days (again, possibly just one puff) [http://www.cdc.gov/MMWr/preview/mmwrhtml/mm6235a6.htm].

These metrics clearly exaggerate the phenomenon.  Perhaps that is intentional, though it might just be blind repetition of measures used for other drugs, but either way it is the wrong measure.  A puff on a cigarette in the last 30 days is reasonably predictive that someone is a smoker, since the rate of daily smoking is about half that of “last 30 day” smoking and about a third of children who try one puff become daily smokers.  One incident of taking meth or cocaine is troublesome, even if it is just one.  But it seems likely that one puff on an e-cigarette is often just that: a smoker trying one once to see if it works for her, or kids at a party passing one around as a lark — a lark that happens to be substantially less hazardous than many other things many of them will do that night.

The most hyped claim from the CDC data, that “use” doubled between 2011 and 2012, referred to only the “one puff ever in your life” statistic, despite the fact that the CDC defined “use” as  “one puff in 30 days.”  Relative measures, like “double,” are often used in propaganda to hide the fact that the absolute numbers are unimpressive.  Among high school students (some of whom are old enough to legally buy tobacco), the number who tried an e-cigarette in the last month was less than 3% and for middle school students it was 1%, though the numbers are often spun to imply that the larger figure also applies to the younger children.  The number who made a regular practice of vaping is obviously smaller still, though CDC did not attempt to determine that.

The number who have tried an e-cigarette once is small compared to the number who smoke (i.e., actually do it as an ongoing practice, not merely those who have ever puffed a cigarette) [http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6245a2.htm] or have recently tried/used other drugs [http://www.samhsa.gov/data/NSDUH/2012SummNatFindDetTables/NationalFindings/NSDUHresults2012.htm].  Indeed, the largest number in the e-cigarette results — that 10% of high school students had ever tried at least one puff (compared to less than 3% of middle school students) — is small compared to the number who have used other drugs in the last month: About 15% of high school students and 7% of middle school students have smoked in the last month; about 20% of high school students and several percent of middle school students have drunk alcohol in the last month; for illicit drugs the estimate for all children is in the range of 10%.

The fact that the “ever tried” statistics increased is not only unsurprising, but inevitable.  E-cigarettes only entered the popular awareness and became widely available in the last few years.  The only direction that “ever tried” could possibly go is up: if one child tried one puff on an e-cigarette in 2011 and one of his classmates did so in 2012, the prevalence of those who had ever tried a puff doubles (but notice that the incidence rate of trying did not increase at all and it might only represent two total puffs).

Perhaps most important, it is clear from the CDC data and further research [http://www.jahonline.org/article/S1054-139X%2813%2900748-9/abstract] that almost all of the children trying e-cigarettes are already smoking.  In the e-cigarette report, the CDC only reported data for trying of cigarettes, as they did with e-cigarettes, and not all of those who had puffed a cigarette in the last 30 days are smokers, but smoking is likely to be an everyday practice for most of them and a frequent practice for many of the rest, in contrast with experimenting with a novel alternative.  Thus, e-cigarette use among children seems to be playing the same role as it does for adults, harm reduction.  But even if the harm reduction was unintentional or turned out not to be effective, it is still important to realize that most of those experimenting with e-cigarettes would have been smoking instead if the e-cigarette were not available.

A specific common claim, including by the CDC, is that children are trying e-cigarettes and this is causing them to become smokers when they would not have otherwise have done so (the standard anti-drug “gateway” story, which we address in a separate statement).  There is no empirical evidence whatsoever that this is occurring.  Indeed, we are not aware of a credible report of it having occurred even once (note that the mere fact that someone tried an e-cigarette before taking up smoking does not mean that e-cigarettes caused the smoking — you need to know a lot more to rule out the more likely possibility that the smoking would have occurred absent the e-cigarette).

Scientific analysis

Children experiment with drugs, sex, and other behaviors despite the wishes of many adults.  Any children who are inclined to experiment have little difficulty acquiring cigarettes and alcohol, despite age prohibitions, as well as banned drugs, so it is inevitable that they can secure access to e-cigarettes and any other low-risk tobacco products.  Thus, onerous restrictions on adult access to e-cigarettes cannot possibly be justified based on children’s use.

The implication of the rhetoric is that e-cigarettes are purely additive on top of other indulgences, though the reality is almost certainly that they are a substitute for not just cigarettes but other boundary-pushing behavior.  Even if they are additive, it is difficult to see much reason for concern (apart from the speculative and non-credible gateway claims).  If the above numbers were the trend in use of a drug that was as dangerous as alcohol, cigarettes, or many other drugs, then the trend might warrant alarm.  But the health risk from e-cigarette use is trivial and it is increasingly clear that people who use them have a relatively easy time stopping if they so choose.  If they are a substitute for cigarettes (as they appear to mostly be), or for other drugs like alcohol that pose serious physical threats or impair judgment and driving ability (the greatest threat to young people from all but the most rare and extreme drug behaviors), then the net effects are beneficial.  Of all the ways to break the rules or engage in a bit of mild drug use, there are few that are more benign than e-cigarettes.

It is worth addressing, as an aside, the frequent claim that e-cigarettes facilitate vaping of cannabis and that this somehow poses a threat to children.  The obvious responses to this are that while some pieces of expensive “mod” e-cigarettes can be used in rigs that can vaporize cannabis-containing oil, the cheap, widely-sold e-cigarettes cannot be repurposed in that way without substantial re-engineering.  Moreover, there is the obvious absurdity of the implicit claim that a child who has secured access to a supplier of cannabis would somehow not have access to a device for consuming it were it not for e-cigarettes.  It is obvious that the availability of e-cigarettes is not going to create any demand for cannabis.

The current empirical evidence is that children are not using e-cigarettes to any substantial degree.  However, any honest and realistic projection of the future suggests this will change.  E-cigarettes, their next-generation variants, and other THR products will inevitably become as widely used by, and as easily available to, adults as cigarettes, alcohol, and cannabis are now.  Under those circumstances, we would expect that the same substantial portion of children who experiment with and use those other drugs will consider THR products.  But because of the above analysis, this poses little reason for concern, and indeed some reason for hope that they will contribute to reducing harm.

Our position

Based on the above analysis, CASAA does not believe there is any reason for serious concern about children experimenting with e-cigarettes.  Moreover, we believe that it is almost certainly the case that such experimentation has a net health benefit because it largely substitutes for harmful alternatives.  However, we actively support prohibitions on sales of e-cigarettes to children and encourage merchants to voluntarily enforce such restrictions even when they are not required by law.  We similarly do not object to regulations that make it more difficult for children to use e-cigarettes without creating a significant burden on adults, such as prohibiting possession in schools.  (We generally object to criminalizing status offenses for children, but this is sufficiently tangential to our mission that we would likely never take an active role regarding such policies.)

We realize that if – as the evidence and science suggests – e-cigarettes are actually reducing children’s health risk from cigarettes and other drugs, such prohibitions are actually bad for the children.  It is possible, however, that this problem will be somewhat self-correcting. Given the fact that children do find a way to get their hands on cigarettes and other forbidden products, those children who want to use e-cigarettes as a low-risk substitute for smoking will probably find some way to obtain them, just as they did for cigarettes.  Moreover, the ban on underage use might make them more attractive to many children who might dismiss them if they were officially declared to be the legal alternative to smoking.

The main reason for supporting such bans is the political reality that they are important for protecting adult smokers’ access to e-cigarettes, which is the most important role for e-cigarettes.  The specter of children using e-cigarettes is an effective strategy for those who want to prevent adult smokers from switching to low risk alternatives (and they know that, as evidenced by their active opposition to bans on sales of e-cigarettes to minors [https://antithrlies.com/2013/04/25/who-leads-the-fight-against-banning-e-cigarette-sales-to-minors/]).   It is clearly unfortunate that such restrictions will cause some children who might have used e-cigarettes to smoke instead, but at least they would have legal access to a low-risk substitute when they reach majority.  The current political climate means that intentionally denying children access to THR serves the greater good.