Monthly Archives: September 2017

Sunday Science Lesson: Debunking the claim that only 16,000 smokers switched to vaping (England, 2014)

by Carl V Phillips

When this journal letter (i.e., short paper), “Estimating the population impact of e-cigarettes on smoking cessation in England” by Robert West, Lion Shahab, and Jamie Brown came out last year, most of us said “wait, wot?” The authors estimated that in 2014, about 16,000 English smokers became ex-smokers because of e-cigarettes (a secondary analysis offered 22,000 as an alternative estimate). But that year saw an increase of about 160,000 ex-smokers who were vapers in the UK (the year-over-year increase for 2015 versus 2014) according to official statistics. In addition, there were about 170,000 more ex-smokers who identified as former vapers. Since the latter number subtracts from the number of ex-smokers who are vapers in 2015 they need to be added back. So it appears that the year-over-year increase in English ever-vapers among ex-smokers appears to be nearly 200,000, after roughly adjusting for the different populations (England is 80% of the UK population). Thus West et al. are claiming, in effect, that the vast majority of people who went from smoking to vaping did not quit smoking because of vaping.

My calculation is rough, and for several reasons it may be a bit high (e.g., the measured points in 2015 and 2014 demarcate a year that falls slightly later in calendar time than 2014 itself, and the rate of vaping initiation was increasing over time). But we are still talking about well over 100,000 new ex-smoker vapers. Probably closer to 200,000. So this would mean that about 90% of new ex-smoker vapers either would have quit smoking that year even without vaping, had quit tobacco entirely and only later took up vaping, or are not “real quitters” (i.e., they were destined to start smoking again before they would “count” as having quit, which is not a well-defined definition, but the authors seem to use one year as the cutoff). This seems rather implausible, to say the least.

This is an extraordinary claim on its face given what we know about the advantages of quitting by switching, and more so given that more detailed surveys of vapers (example) show almost all respondents believe they would still be smoking had they not found e-cigarettes. It must be noted that most respondents to those surveys are self-selected vaping enthusiasts who differ from the average new vaper, and that a few of them might be wrong and would have quit anyway. But the disconnect is still far too great for West’s weak analysis (really, assumptions) to come close to explaining.

I never bothered to comment on the paper at the time it came out because the methodology was so weak and the result so implausible that I did not think anyone would take it seriously. But the tobacco wars seldom meet a bit of junk science they do not like. In this case, Clive Bates asked me to examine the claim (and contributed some suggestions on this analysis and post) because some tobacco controllers have taken to saying “e-cigarettes only caused only 16,000 people to quit smoking in England! so we should just prohibit people from using them!”

The proper responses to this absurd assessment and demand, in order of importance, are:

  1. It would not matter if they caused no one to quit smoking. It is a violation of the most fundamental human rights to use police powers to prohibit people from vaping if they want to. People have a right to decide what to do with their bodies. Moreover, in this particular case, you cannot even make the usual drug war claims that users of the product are driven out of their minds and do not understand the risks and the horrible path they will be drawn down: Vaping is approximately harmless, most people overestimate the risks, and it leads to no horrible path. It is outlandish — frankly, evil — to presume unto oneself the authority to deny people this choice.
  2. But even if you do not care about human rights and only care about health outcomes or whatever “public health” people claim to care about, causing a “mere” 16,000 English smokers to quit, annually,) is quite the accomplishment. There is no plausible basis for claiming any recent tobacco control policy has done as much. Since there is no measurable downside, this is still a positive. Also, the rate of switching probably could be increased further with sensible policies and truthful communication of relative risks.
  3. The rough back-of-the-envelope approach used in the paper could never provide a precise point estimate even if the inputs were optimally chosen. But the inputs were not well chosen. The analysis included errors that led to a clear underestimate. When a back-of-the-envelope result contradicts a reality check, we should assume that reality got it right.

So I am taking up here what is really a tertiary point.

Back of the envelope calculations

West et al. carried out a back-of-the-envelope calculation, a simple calculation based on convenient approximations that is intended to produce a quick rough estimate. It happens to have glaring errors, but I will come back to those. Crude back-of-the-envelope calculations have real value policy analysis. I taught students this for years. In my experience, when there is a “debate” about the comparative costs and benefits of a policy proposal, at least half the time a quick simple calculation show that one is greater than the other by an order of magnitude. The simple estimate can illustrate that the debate is purely a result of hidden agendas or profound ignorance, and also eliminate the waste of unnecessary efforts to make precise calculations.

When doing such an analysis, it is ideal if you get the same result even if you make every possible error as “conservative” as is plausible (i.e., in the direction that favors the losing side of the comparison). West’s analysis would thus be useful if it were presented as follows: “Some people suggest that the health cost from vaping experienced by new vapers outweighs the reduction in the health cost from smoking cessation that vaping causes. Even if we assume that vaping is 3% as harmful as smoking, the total health risk of additional vapers (the annual increase) would be the order of equivalent of the risk for about 5000 smokers. Our extremely conservative calculation yields in the order of 20,000 smokers quitting as a result of vaping. So even with extreme assumptions, the net health effect is clearly positive.”

But the authors did not claim to be offering an extremely conservative underestimate for purposes of doing such a calculation. They implicitly claimed to be providing a viable point estimate. And that requires a more robust analysis rather than rough-cuts, and best point estimates rather than worst-case scenarios. It also requires a reality check about what would have to be true if the ultimate estimate were true, namely that almost everyone who switched from smoking to vaping did not stop smoking because of vaping.

West’s estimation based on self-identified quit attempts

The crux of their calculation is the following: Their surveys estimate that 900,000 smokers self-identify as having attempted to quit smoking using e-cigarettes (please read this and similar statistics with an implicit “in this population, during this period” and I will stop interjecting it). They then assume that 2.5% of them actually did quit smoking because of e-cigarettes.

Where does the 2.5% come from? It is cited to, and seems to be based mainly on, the results of the clinical trials where some smokers were assigned to try a particular regimen of e-cigarettes; the 2.5% is an estimate of the rate at which they quit smoking above those assigned to a different protocol.

Before addressing the problems with using trial results, the second paper they cite as a basis for the 2.5% figure is one by their research group. How they got from that paper’s results to 2.5% is unfathomable. That paper was a retrospective study of people who had tried to quit smoking using various methods and found that those reporting using e-cigarettes were successful about 20% of the time, which beat out the two alternatives (unaided and NRT) by 5 and 10 percentage points. If they had used ~20% instead of ~2% their final result would have been up in the range that would have passed the reality check. So what were they thinking?

I cannot be certain, but am pretty sure. It appears they only looked at differences in cessation rates and not the absolute rates, so the 5 or 10 rather than the full 20. Several things they wrote make it clear this is how they were thinking. This is one of several fatal flaws in their analysis. There are two main pathways via which e-cigarettes can cause someone to quit smoking (which means it would not have happened without them): E-cigarette use can cause a quit attempt to be successful when that same quit attempt would not have otherwise been successful, or it can cause a quit attempt (ultimately successful) that would not have otherwise happened. West et al. are pretty clearly assuming that the second of these never happens. I am guessing that the authors did not even understand they were making a huge — and clearly incorrect — assumption here.

Causing quit attempts is a large portion of cases where e-cigarettes caused smoking cessation. Indeed in my CASAA survey of vapers (not representative of all vapers, but a starting point), 11% of the respondents were “accidental quitters”, smokers who were not even actively pursuing smoking cessation, but who tried e-cigarettes and were so enamoured that they switched anyway. Add to these the smokers who had vague intentions of quitting but only made a concerted effort thanks to e-cigarettes and probably about half of all quit attempts using e-cigarettes do not replace a quit attempt using another method. So if half the 900,000 made the quit attempt because of e-cigarettes and 20% succeeded, we have, right there, a number that is consistent with the reality check I proposed.

Of course they did not use that 20%, and it does seem too high. What they did was assume that 5% would have succeeded in an unaided quit attempt without e-cigarettes — and all the same people would have made that attempt — and so 7.5% (5%+2.5%) actually succeeded when using e-cigarettes. But if half never would have made that attempt then a full 7.5% of them should be counted as being caused to quit by e-cigarettes, which more than doubles the final result (“more than” because their final subtraction, below, would not double but should actually be reduced).

As for why they did not use that 20%, I suspect (though they do not say) that when looking at the numbers from that paper, West et al. focused not only on the differences (the error I just discussed) but on the “adjusted” rates of how much more effective e-cigarettes were than the other methods, which were considerably lower than the numbers I quoted from the paper above. This too is an error. Public health researchers think of “adjusting” (attempting to control for confounding) as something you just do, a magical ritual that always makes your result better. This perception is false for many reasons, but a particularly glaring one in this case: The adjusted number is basically the measure of how helpful e-cigarettes would have been, on average, if those who tried to switch to them had the same demographics as smokers using other cessation methods. Smokers who try to switch to e-cigarettes have demographics that predict they are more likely to succeed in switching than the average smoker. Of course they do! People know themselves (a fact that seems to elude public health researchers). The ones who tried switching were who they were; they were not a random cross-section of smokers. So it seems that West et al. effectively said “pretend that instead of self-selecting for greater average success, those who tried to switch were chosen at random, and instead of using the success rate for the people who actually made that choice, we will use instead the number that would have been true if they were random.”

[Caveat: The attempt to control for confounding could also correct for the switchers having characteristics that make them more likely to succeed in quitting no matter what method they tried. So some of the “adjustment” is valid — but only for those who would have tried anyway — but much of it is not.]

Clinical trials

That last point relates closely to the other “evidence” that was cited as a basis for that 2.5% figure, and appears to have dominated it: the clinical trials.

Clinical trials of smoking cessation are useless for measuring real-world effects of particular strategies when they are chosen by free-living people. At best they measure the effects of clinical interventions. But in this case, these rigid protocols are not even a good measure of the effect of real-world clinical interventions in which smoking cessation counselors try to most effectively promote e-cigarettes by meeting people where they are and making adjustments for each individual. I have previously discussed this extensively.

A common criticism that the trials directed subjects toward relatively low-quality e-cigarettes. That is one problem. More important, the trials and did not mimic the social support that would come from, say, a friend who quit smoking using e-cigarettes and is offering advice and guidance. The inflexibility of trials does not resemble the real-world process of trying, learning, improving, asking, and optimizing that real-world decision entail. Clinical trials are designed to measure biological effects (and even then they have problems), not complex consumer choices.

But it is actually even worse than that. A common failing in epidemiology is not having a clue about what survey respondents really mean when they answer questions. There is no validation step in surveys where pilot subjects are given an open-ended debriefing of how they interpreted a question and what they really meant by their answer. (I always do that with my surveys, but I am rather unusual.) So consider what a negative response to “tried to quit smoking with e-cigarettes” really means. If a friend shoved an e-cigarette into a smoker’s hand and said “you should try this”, but she refused to even try it, she would undoubtedly not say she tried to quit smoking with e-cigarettes. But in a clinical trial, if that were her assignment, she would be counted among those who used e-cigarettes to try quitting, thus pulling down the success rate.

If she tried the e-cigarette that was thrust at her, but did not find it promising, chances are that in a survey she would probably not say she tried quitting using e-cigarettes. (She might, but given the lack of any reporting about piloting and validation of these survey instruments, we can only guess how likely that is.) If she passed that first hurdle, of not rejecting e-cigarettes straightaway, but used them sometimes for a few days or weeks, she might or might not say she tried quitting using e-cigarettes. But if she actually quit using e-cigarettes, she would undoubtedly count herself among those who tried to quit using e-cigarettes. I trust you see the problem.

It is the same problem that is common in epidemiology when you read, say, that 20% of the people who got a particular infection died from it. This usually means that 20% of the people who got sick enough from it to present for medical care and get diagnosed died, but countless others had mild or even asymptomatic infections. Everyone in the numerator (died in this case, quit in the case of e-cigarettes) is counted but an unknown and probably very large portion of those in the denominator (got the infection, were encouraged to try an e-cigarette) are not. Clinical trial results are (at best) analogous to the percentage you would get if did antibody tests in the population to really identify who got the infection. This turns out to be the right way to measure the percentage of infected who die. But then if you the applied that percentage to the portion who presented for medical treatment, you would be underestimating the number of them who would die. That is basically what West et al. did. Their 900,000 are those for whom e-cigarettes seemed promising enough to be worth seriously trying as an alternative, but they applied a rate of success that was (again, at best) a measure of the effect on everyone, including those who did not consider them promising enough to try.

This would be a fatal flaw in West’s approach even if the trials represented optimal e-cigarette interventions, providing many options among optimal products, and the hand-holding that would be offered by a knowledgeable friend, vape shop, or a genuine smoking cessation counseling efforts. They did not, and so underestimated even what they might have been able to measure.

Final step

As a final step, West et al’s approach debits e-cigarettes with an estimated decrease in the use of other smoking cessation methods caused by those who tried e-cigarettes instead. These are the methods that are believed to further increase the cessation rate above the unaided quitting that West debited across the board (the major error discussed above). We can set aside deeper points about whether estimates of the effects of these methods, created almost entirely by people whose careers are devoted to encouraging these methods, are worth anything. West et al. assume that those methods would have had average effectiveness had they been tried by those who instead chose vaping. They also still assume that every switching attempt would have been replaced by another quit attempt in the absence of e-cigarettes, as discussed above. This lowers their estimate from 22,000 to the 16,000. But a large portion of smokers who quit using e-cigarettes do so after trying many or all of those other methods, often repeatedly. Assuming those methods would have often miraculously been successful if tried one more time makes little sense.

As a related point that further illustrates the problems with their previous steps, recall that the 2.5% is their smoking cessation rate in excess of that of those who tried unaided quitting or some equivalently effective protocol. But it seems very likely that the average smoker who tries to switch to e-cigarettes has already had worse success with that other protocol than has the average volunteer for a cessation trial. This is the “I tried everything else, but then I discovered vaping” story. I am aware of no good estimate for this disparity, but if the average smoker who tried to switch were merely 1 percentage point less likely than average to succeed with the other protocol (e.g., because she already knew that it did not work for her), then the multiplier should have been 3.5% (7.5%-4% rather than 7.5%-5%). This is trivial compared to the error of using the incredibly low estimated success rate suggested by the trials in the first place, of course, but that little difference alone would have increased West’s estimate by 40%. This illustrates just how unstable and dependent on hidden assumptions that estimate is, even apart from the major errors.

Returning to the reality check

But lest we get lost in the details, the crux is still that West implicitly concluded that the vast majority of those who switched from smoking to vaping did not quit smoking because of vaping. The authors never reflect on how that could possibly be the case. They do, however, offer an alternative analysis, in what are effectively the footnotes, that gives the illusion of responding to this problem without actually doing so. They write:

The figure of approximately 16,000–22,000 is much lower than the population estimates of e-cigarette users who have stopped smoking (approximately 560,000 in England at the last count, according to the Smoking Toolkit Study). However, the reason for this can be understood from the following….

What follows is even weirder than their main analysis.

West’s “alternative” analysis

They actually start with that 560,000. That is inexplicable since it is possible to estimate the year-over-year change in 2014, as I did, rather than working with the cumulative figure. The 560,000 turns out to be well under half what you get if you add the current vapers and ex-vapers among ex-smokers from the statistics I cite above. So their number already incorporates some unexplained discounting from what appears to be the cumulative number. But since I am baffled by this disconnect, I will just leave this sitting here and proceed to look at what they did with that number.

As far as I can understand from their rather confusing description of their methods here, their first step is to eliminate those who were already vaping by 2014, and thus did not switch in 2014. That makes sense, though it would have been easier to just start with that. When they do this, they leave themselves with 308,000. So they started with something much lower than what you get from the statistics I looked at, and ended up with something that is half-again higher than the rough estimate from those statistics. Um, ok — just going to leave that here too. But the higher starting figure makes it even more difficult for them to explain away the reality check.

Their next step is the only one that seems valid. They estimate that 9% of ex-smokers who became vapers did so sometime after they had already completely quitting smoking, and subtract them. This is plausible. An ex-smoker who is dedicated to never smoking again still might see the appeal of consuming nicotine in a low-risk and smoking-like manner again. (Note that this should be counted as yet another benefit of e-cigarettes, giving those individuals a choice that makes them better off, even though the “public health” types would count it as a cost because they are not being proper suffering abstinents. It might even stop them from returning to smoking.)

Of course, this only makes a small dent. So where does everyone else go? Most of them go here:

It has to be assumed on the basis of the evidence [6, 7] that only a third of e-cigarette users who stopped smoking would not have succeeded had they used no cessation aid

…and here:

It is assumed that, as with other smoking cessation aids, 70% of those recent ex-smokers who use e-cigarettes will relapse to smoking in the long term [11]

This takes them down to 28,000.

Taking the latter 70% first, any limitations in relying on a single source for this estimate (another West paper) are overshadowed by: (a) There is no reason to assume switching to vaping will work as poorly, by this measure, as the over-promising and under-delivering “approved” aids that fail because they do not actually change people’s preferences as promised. Indeed, there is overwhelming evidence to the contrary. (b) Many of those in the population defined by “started vaping that year and were an ex-smoker as of the end of the year” have already experienced a lot of the “long term”. That is, if we simplify to the year being exactly calendar 2014, some people joined that population in December, and thus a (correct, undoubtedly much lower than 70%) estimate of the discounting between “smoking abstinent for a week or two thanks to e-cigarettes” and “abstinent at a year” (a typical measure for “really quitting” as noted above) is appropriate. But some joined the population in January and are already nearly at the long term. On average, they will have been ex-smokers for about six months, and being abstinent at six months is much better predictor of the long run than the statistic they used (which, again, is wrong to apply to vaping). Combining (a) and (b) makes it clear that this is a terrible estimate.

As for the first of those major reductions, references 6 and 7 do not actually provide any reason that “only a third…has to be assumed”. Those are the same references they cite for the 2.5% above. So this is just a reprise of the 2.5% claim, and suffers from the same errors I cited above.

You see what they did there, right? The reality check I offered is “your results imply that 90% of new ex-smoker vapers did not quit because of vaping; can you explain that?” Either anticipating this damning criticism or by accident, they provided their answer: “Yes, we assume — based on nothing that remotely supports the assumption — that 70% of them would have quit anyway (and 9% were already ex-smokers, and some other bits).”

This step basically sneaks in the same fatal assumptions from their original calculation but is presented as if it offers an independent triangulation that responds to the criticism that their original calculation has implausible implications. Here is a pretty good analogy: Someone measures a length with a ruler that is calibrated wrong by a factor of ten. They are confronted with the fact that a quick glance shows that their result is obviously wrong. So they make a copy of their ruler and “validate” their results with an “alternative” estimation method.

Oh, and at the end of this they knock off another 6000 based using what appears to be double counting, but at this point who really cares?

Conclusions

Their first version of the estimate is driven mainly by their assumption that attempting to switch to vaping is close to useless for helping someone quit smoking compared to unaided quitting, and also that all those who attempted to switch would have tried unaided quitting in the absence of e-cigarettes. There are also other errors. Their second version is based on the “reasoning” that because we have assumed that attempting to switch to vaping is close to useless, it must be that most of those who we have observed actually did switch to vaping must have not really quit smoking because of vaping — and so (surprise!) approximately the same low estimate.

So nowhere do they actually ever address the reality check question:

Seriously? You are claiming that almost everyone who ventured into one of those weird vape shops, who spent hundreds of pounds on e-cigarettes, who endured the learning curve for vaping, who ignored the social pressure to just quit entirely, and who decided to keep putting up with the limitations and scorn they faced as a smoker and would still face as a vaper, that almost all of them were someone who was going to just quit anyway? You are really claiming that almost all of them said, “You know, I think I will just quit buying fags this week — oh, wait, you mean I instead could go to the trouble to learn a new way of quasi-smoking and spend a bunch of money on new stuff and keep doing what I am doing it even though I am really over it and ready to just drop it? Where do I sign up?” Seriously?

Reality. Check. (And mate.)

For what it is worth, if you asked me to do a back-of-the-envelope estimate for this, I would probably go with something like the following:

There were about 200,000 new vaping ex-smokers. It seems conservative to assume that about half of them quit smoking due to vaping. 100,000. Done.

That is obviously very rough, and the key step is just an educated guess. But an expert educated guess is often far better than fake precision based on obviously absurd numbers that just happen to have appeared in a journal (as a measure of something — in this case, not even the same thing). In this case, it has far better face validity than West et al.’s tortured machinations.

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What is Tobacco Harm Reduction?

by Carl V Phillips

In response to a couple of recent requests and my schooling of FDA in a recent Twitter thread, it seems time for me to again write a primer on the meaning of tobacco harm reduction (THR). Rather than return to a previous version I have written, I am doing this from scratch. This seems best given the evolution of my thinking and changing circumstances.

The key phrase, of course, is “harm reduction”, with “tobacco” denoting the particular area it is applied to. This is important: THR is not a concept that stands apart from HR. It means “the principles of harm reduction, applied to the use of tobacco and nicotine products, and other products that tend to get lumped in with them” (see my previous post for an explanation of that last bit and some other useful background about the current politics). Indeed, when my university research and education group was trying to decide on a name and URL in 2005, it was far from obvious that this was the right term, and we considered others (e.g., “nicotine harm reduction”). While the first prominent use of “THR” appeared in 2001, it was far from established as a common term. (There is probably some endogeneity here, of course — if we had chosen a different term, that might have ascended instead.) In any case, the key to answering “what is THR” is asking “what is HR” rather than thinking it is something different. Continue reading

The War on Nicotine begins

by Carl V Phillips

It has become a habit of many e-cigarette defenders to refer to recent chapters of the War on Tobacco as a war on nicotine, in part because they do not like their favored product being called a tobacco product. As for that motivation, yawn, whatever. But as for the statement, it was simply wrong.

The war on smoking in the USA morphed into a war on tobacco, which basically meant lumping in approximately-harmless smokeless tobacco with the not unreasonable original target of the war. This pretty much tracked the tobacco control industry’s professionalization (read: it went from being a noble — though obviously not universally embraced — hard-fought political cause to a venal business that had a license to print money and was constantly seeking new streams of revenue). Elsewhere in the world, the war was expanded to include Scandinavian smokeless tobacco as well as South Asian and other dip/chew products. Thus it was that for most of recent memory, the War on “Tobacco” was a ridiculously wealthy cabal of a few thousand people (with millions of useful idiots, of course) gunning for consumers and producers of smoked tobacco (tobacco, harmful), Western smokeless tobacco (tobacco, approximately harmless), and other oral products (not tobacco, often harmful).

When e-cigarettes finally became a major commercial product, after a remarkably long delay (which is, of course, a very interesting story, but not the present story), the Tobacco Warriors chose to add them to the list of targets. Thus the war became still more gerrymandered to include e-cigarettes. It was still a fairly well-defined single war, defined in much the same way that World War II was a war, despite really being two largely separate major wars and a few dozen border wars, tribal wars, and colonial struggles.  The war is and was defined in terms of what a particular faction did: it was the Anglophone major powers, plus whoever happened to fight one of the same enemies for whatever reason, versus everyone they fought.

As with WWII, the current enemies of tobacco control (which, interestingly, can also be defined largely in terms of government action by the Anglophone major powers) are increasingly not allies of one another. Perhaps that is a tactical error, but they (we) do have rather conflicting interests. But the Tobacco Warriors themselves — a fairly tightly-knit group of agencies, sock puppets, and funders, working together and maintaining remarkable party discipline — make it a war. They also draw boundaries around it: Despite this being fought like every other awful war on drugs, the people involved barely overlap with the traditional Drug War cabals (and, indeed, often actively oppose them despite looking just like them, but that is yet another story).

You can muse about whether there is a better name than “the War on Tobacco” for whatever this is. But one candidate name that was clearly wrong was “War on Nicotine”. For one thing, not all of the targets of the war even contained nicotine. But more important, nicotine in isolation was their thing. It was their peeps who praised, touted, and sold nicotine in its “proper” medicinal form (never mind that NRT is primarily used for the same purpose as the products that are the main targets of their war). One of their favorite go-to tropes was still that cigarette companies’ introduction of lower-nicotine products in the 1970s was some evil plot.

And then something very strange happened. Very strange. Over the last few months, the U.S. FDA suddenly embraced a long-discredited anti-nicotine policy proposal. They announced a policy goal of forcing cigarette manufactures to lower the nicotine content of their products. (Well, legal cigarette manufacturers. The black market would inevitably replace the banned current products — one of the many reasons why this proposal is long-discredited.) Part of this has been an unending blast of government-sponsored anti-nicotine propaganda. The propaganda asserts — without any evidentiary or serious theoretical basis, needless to say — that forced nicotine reductions in cigarettes is the silver bullet that will “keep all new generations from becoming addicted blah blah blah”.

(Aside: I cannot overstate the strangeness and suddenness of this policy. Basically the only people who still supported this zombie idea were those who stood to profit from it. And then suddenly it was at the center of — indeed, is basically the entirety of — FDA’s tobacco policy. I strongly encourage someone who has the time and platform to make it worthwhile to investigate whether there is a money trail from the very small number of companies for whom this policy is an enormous windfall to the pockets of Price or Gottlieb — it is not like there is no history of corruption there. It is probably also worth checking Zeller and company, though they are not the variable here, so that seems like a long-shot. And the Trump campaign, of course, though given that the White House has not managed to put a government in place, it would have been quite a coup to push down such detailed policy from that far up the chain.)

Meanwhile there was the recent paper from Glantz’s shop, elegantly shredded by Chris Snowdon, in which the authors feebly attempt to tar NRT (their nicotine) as part of the evil machinations of the cigarette industry in the 1990s. I won’t even try to explain — there is nothing remotely defensible about it; read Snowdon if you want details. The importance is that Glantz’s current role is as a paid surrogate for FDA. This cannot be coincidence. FDA and tobacco control cannot comfortably fight a war on nicotine when the nicotine-iest products out there are their products that they have always embraced. So they need to muddy the waters round those products. What better way than to manufacture retroactive innuendo that NRT always was a brilliant cigarette industry plot that the hapless tobacco controllers fell for, and not the colossal screw-up on their own part that it was? That exact ploy has worked for them before.

FDA’s Center for Tobacco Products has always been a propaganda shop (they have certainly never been a real regulator). But previously their propaganda was lame pointless messages pitched at ignorant consumers (who do not even know CTP exists, let alone see their messaging), perhaps to provide memes for their useful idiots to publish (and, again, not actually be seen by anyone in their target audience). The current effort is different in terms of both volume and apparent purpose. You can see the volume by checking out the Twitter feeds of @FDATobacco and FDA Director @SGottliebFDA, and also see the content there and by following the links.

This is not the usual background noise of silly anti-tobacco propaganda. This is a clear example of a fixture in the U.S. political system: a concerted push by a government faction to sell their policy. (The most recent high-profile example of this was from the faction trying to destroy the Affordable Care Act.) The target audience for this includes lazy reporters, who will just transcribe the propaganda and get a free byline, and influential pseudo-experts (aka, useful idiots) who do not know enough to not believe everything they read. The general public, the apparent target of CTP’s previous propaganda, is at most an afterthought as an audience. But the most important audience for these propaganda efforts are others in government, or who have similar levels of policy-making influence, trying to persuade those on the fence and to bludgeon those who might oppose the policy.

For example, there was this from NCI (part of the National Institutes of Health, which along with FDA is part of HHS) that came out just after the Glantz propaganda dropped and as it was being touted by FDA and their surrogates.

The cabal at FDA will find it hard to run a full-on War on Nicotine if NCI actively opposes them. Similarly, there are presumably a lot of tobacco controllers further down in government, and in political organizations, who still embrace the old (correct) notion that nicotine — especially their nicotine — is not the problem. Most of them are just puppets, and will dutifully recite that we have always been at war with Eastasia …er, with nicotine, as soon at they get the message. Others can simply be silenced by the deluge from the agency that has more money than the rest of tobacco control combined. That is the playbook for this kind of inward-directed propaganda.

And so we have, for the first time, an actual War on Nicotine. Note that this does not mean the whole war can be relabeled The War on Nicotine for reasons noted above. This is just part of it. We are still stuck with “War on Tobacco (etc.)” for the larger effort unless someone can come up with something better.

Some commentators who focus only on e-cigarettes appear unaware of what is really happening. Gottlieb and FDA substantially delayed the implementation of the stealth ban on e-cigarettes and have made various noises about embracing e-cigarettes as a low-risk alternative to smoking. So, hey, everything looks good for e-cigarettes!! Some of those commentators have even bought into the FDA propaganda that they FDA policies support harm reduction (at utterly Orwellian claim which I will address in my next post or you can check out my Twitter thread). However, since e-cigarettes are basically a nicotine delivery device, how can there be both a war on nicotine and a more pro-ecig policy?

Indeed, how?

One possible explanation is that FDA is signaling a plan to shift toward the position of British tobacco controllers who have seized control of the vaping mindspace there, intending to use e-cigarettes as just another weapon against smoking and smokers. That playbook involves keeping just enough of a boot on vaping to keep it from being accepted as a normal personal choice (it is only a smoking cessation medicine!), and staying in a position to squash it when supporting it becomes no longer politically expedient.

It could be that. But I find it genuinely hard to find that explanation in what we are seeing.

The two messages are simply too flatly contradictory. It is not exactly novel to see messaging from governments that includes policy proposals alongside stated support for goals that are antithetical to those policy proposals. Especially from this government and from this agency — after all, we heard basically the same happy talk about e-cigarettes even as FDA was marching toward a total ban as rapidly as they could. Obviously anyone other than lazy reporters and political actors who are looking for plausible deniability when they fall in with their faction’s bad policies should focus on the policy, not the contradictory happy talk.

But many do not. Thus this happy talk serves the rather obvious purpose of getting e-cigarette advocates — the most vocal and potentially politically effective opponents of a new War on Nicotine — to sit on their hands until the actual policy goal (whatever its crazy or corrupt motivation) has enough momentum. So we can expect no overt anti-ecig actions by FDA for a while. They still will not approve any new products (so there will be those temporarily grandfathered into minimal paperwork in 2016, and an a high-paperwork maybe-denial grey-zone for later products, still leading to the full-ban in 2022) or allow any merchant claims about the low risk. They are just pausing, not retreating. They might withdrawal their proposed de facto ban of most smokeless tobacco, issued under the guise of being a health and safety regulation, though frankly that would probably only be because it will never survive judicial review (smokeless tobacco and harm reduction advocates are a much smaller voice than e-cigarette advocates).

But if they gain momentum for their War on Nicotine policy, things will probably go downhill quickly. Implementing a substantive policy (for the first time ever) will empower FDA to go ahead and fight the e-cigarette advocates they temporarily appeased. It seems impossible that a hugely impactful and crazy expensive policy of cigarette nicotine reduction, for the chiiiildren, will not spawn limits on e-cigarette nicotine density and “child friendly” flavors. With the delay of the full-on e-cigarette ban they no longer have the luxury of not even trying to actually regulate the products; FDA will be wanting to hurt vapers through other means.

If the proposed policy is quashed things are a bit harder to predict. Perhaps FDA will be shy to take on more fights. Perhaps there could be a real change of heart, but it would be the height of foolishness to read that into the same old rhetoric. Perhaps the political party that controls our government is really so deeply dedicated to consumer welfare and free choice, as some advocates seemed to think before the election, and they will clean house at CTP and change its direction (haha — kidding, of course — if that turns out to be the case, I vow to print this out and eat it).

But it seems most likely we would still see e-cigarette “regulation” that serves only as harassing partial bans as soon as they are no longer all-hands-on with their current policy. That is consistent with everything they have done so far. Moreover, it seems especially difficult for them to walk back on e-cigarettes after campaigning for a War on Nicotine for a year and convincing their useful idiots that we have always been at war with nicotine.