Tag Archives: NRT

Nicorette ad celebrates the glamour of smoking; tobacco control mysteriously silent

by Carl V Phillips

Another in the series of examples of what we can learn if we just look carefully at what “they” are saying.  It is not quite as smack-to-the-head revealing as yesterday’s, and it is not nearly as important as the one before that, which I think is critical for anyone who is serious about advocacy (and not just wanting to engage in feel-good chatter) to understand.  H/t to @MattGluggles for tweeting a video of a Nicorette video advertisement that adulterates various old movies to show the actors sucking on the Nicorette inhaler instead of the cigarettes they were actually smoking.  I have seen it before, though I cannot say for sure whether it was on television.

Without getting into the general crime of advertisers (as well as Disney, Broadway, etc.) trying to misappropriate every great work of art in the human domain, in order to dumb it down and profit from it, we can observe that this is a blatant attempt to celebrate and then borrow the glamour of smoking to sell NRT.  This contrasts with most e-cigarette marketing, that tends to denigrate smoking, or at least apologize for it (“no foul odor”, “does not affect those around you”, etc.).  But I have not heard a peep of complaint about this ad from the usual suspects who complain that e-cigarette marketing somehow glamorizes or “renormalizes” smoking.  I would be surprised if there has been any such peep.

The reality is, of course, that advertisements for a substitute for cigarettes — NRT or e-cigarettes — sends an anti- not pro-smoking message.  The magnitude of any impact is probably pretty minor, but the sign is obviously negative.  Still, if someone believes that the generally information-heavy e-cigarette ads that do not even evoke smoking are pro-smoking, a flashy NRT ad that shows smoking actors using a similar-appearing substitute must be more so.

The anti-THR liars will seek refuge in some silly claim about NRT being government approved.  The response is: “what does that have to do with the glamorizing imagery?”  Just think about just how stupid their claim is.  How can the fact that it is “approved” (which is to say, declared officially by governments to be an effective smoking cessation method — never mind the inaccuracy) have any relevance whatsoever to the question at hand.  If you stab someone in the eye with a Nicorette inhaler in a bar fight, you are not going to be able to defend yourself in court by saying that it is a government approved cessation device.  The approval has nothing to do with either weaponization or glamorization.

This is one for the top file, to always pull out when responding to silly claims that e-cigarette use celebrates and glamorizes smoking.

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NewZ ecig clinical study, an “I told you so”

by Carl V Phillips

Yesterday I explained why the new clinical trial out of New Zealand should not be touted as important news for e-cigarettes or THR in general.  In addition to the general message that clinical cessation trials are not the right way to study THR products and are just as likely to produce bad results as “good” ones, I pointed out a few particular issues.  First, it was damningly faint praise, claiming that e-cigarettes perform just barely better than nicotine patches, which grossly misrepresents everything we know about their effectiveness.  Additionally, with a plausible different level of luck (random sampling error) that study would have “shown” that e-cigarettes are less effective than patches.  Of course, such a result would have been no more informative about e-cigarettes than the “good” result was, but that is the point.

Sure enough, no sooner had I finished writing my analysis when anti-THR liar Stanton Glantz pretty much made my point for me.  In a post on his pseudo-blog (not really a blog because he censors any critical discussion) Glantz claimed that the study

found no difference in 6 month quit rates among the three groups.

And in a hilarious bit of “do as I say, not as I do”, opined,

Hopefully this study will get ecig promoters to stop claiming that ecigs are better than NRT for quitting.

Of course, the study showed that e-cigarettes did a bit better.  Glantz probably thinks this bald lie is justified by a common misinterpretation of statistics, wherein different numbers that are not statistically significantly different are incorrectly called “the same”.  Anyone with a 21st century understanding of epidemiology knows that this is not the right thing to say, but since Glantz’s paltry understanding of the science seems to be based on two classes he took three decades ago, perhaps this is simple innumeracy and not a lie.

Still, he has a point about the numbers not being very dramatic.  The real lie (and a case of innumeracy much worse than using incorrect terminology) is suggesting that this one little flawed artificial study somehow trumps the vast knowledge we have from better sources.  It is quite funny that he, who has made a career out of ignoring evidence, suggests that everyone else should pay attention to this “evidence” and change their behavior.  Not so funny is my role as Cassandra:  If we start touting misleading studies like this one as being great news when they happen to go our way, it is pretty much guaranteed to hurt us rather than help us.

(Glantz goes on to post some utter drivel about the nature of RCTs and what previous evidence shows about e-cigarettes, which I have debunked before and will not bother with here.  After a few decades, you learn to not try to fix every little flaw in a particularly slow student’s writings.)

Of course, Glantz does not have the skills to figure out that this study is flawed.  But he might have had some hope had he actually read it.  Or the press release.  Or even one of the news stories.  Instead, it is appears that he just heard some garbled sentence or two about it and wrote his post based on that.  How can we know that?  Because when his post first appeared (screenshot below), it described the comparison as between nicotine gum and e-cigarettes, even though someone who actually spent three minutes studying the material would not have made that mistake.

1st try

Oops. That’s what happens when you don’t do the reading.

Notice that in both the headline and the first sentence he describes the study as using nicotine gum.  Oh, but wait, it gets better.  A few hours later, he changed the first sentence (see screenshot below).  Of course, being who he is, he did not include any sort of statement of correction as an honest researcher or reporter would.  (Quietly fixing a grammar typo or garbled sentence is no big deal — I do that — but when you actually told your readers something wrong and then you try to memory-hole that, rather than actually noting you are making a correction, it is yet another layer of lying.)

2nd try

And this is what happens when you don’t know how to operate your software.

Notice now the first sentence is changed but the headline is still the same.  Did he just not realize he needed to fix that too, or did he have no idea how to change a title on his blog and was desperately calling tech support to try to get them to help hide his error.  Apparently tech support came through, though, because the version you will see if you follow the above link has memory-holed the evidence suggesting he did not even read the study (though you will notice that the link I gave still has “gum” in the URL, but now redirects to the new page where the URL has “patch” in it).

So that is all quite hilarious.  But don’t let it distract you from the main message.  We need to focus on the real sources of knowledge about THR and not buy into a research paradigm that is — often literally — designed to hide THR’s clear successes and benefits.  When e-cigarette advocates embrace studies with bad methods and misleading results (even if they seem to be “good” results), rather than objecting to the bad approach, it hurts the cause.  In this case, even the “good” study can be spun against the truth about THR.

Ecigs = patches?? More largely-uninformative research, but at least this time it works out

by Carl V Phillips

As you have probably already heard, a new clinical study reported in the Lancet found that in the artificial context of a smoking-cessation clinic — using the very odd population of people who go to such clinics — when people were offered an inadequate [Update: possibly inadequate — see * footnote] quantity of low-quality e-cigarettes, they became abstinent from smoking (perhaps temporarily) at about the same rate as those offered nicotine patches.  Woo hoo.

[*I have now seen it reported by a study author that participants had access to as large a quantity as they wanted (gee, you think they might have bothered to mention that in the study methods) despite the observation that participants consumed less than is usually an adequate as a substitute for someone just quitting smoking.  Perhaps they were just not properly advised about how much to try to use or they were scared to use much, given that they are banned where the study took place.  Whatever the reason for it, inadequate quantity of consumption probably reduced the rate of switching.]

My title for this post is way too long, but I still had many other phrases or thoughts I wanted to fit into it, including:

damning with faint praise

social phenomena cannot be effectively studied in a clinic

designed to fail (presumably unintentionally), though not quite enough to manage to fail

and, perhaps most important,

ivory-tower researchers seem to think that a well-established fact, something that everyone who is paying attention to all of the evidence already knows, is not true until they can show it in one of their artificial experiments (or, as the joke goes, “ok, that works in the real world, but let’s see if it actually works in theory”)

I realize that some e-cigarette advocates have embraced it as good and exciting news, but I would suggest not getting too excited, for a few reasons.  First, this study does not actually address the real-world phenomenon of THR.  Real THR does not consist of shoving one particular option into the hands of people and saying “do this rather than smoking”.  Even when that particular option might be ideal for some people (which seems not to be true in this case), it is not ideal for everyone.  Imagine a hypothetical world in which one kind of e-cigarette was more satisfying than smoking for 10% of smokers, another kind for a different 10%, and snus for another 10% (and that no one else liked those products at all).  In that scenario, we can help 30% of all smokers quit and also be happier for having done so.  But any trial that tried to force one of those on people would show that it fails 90% of the time.

Second, the results were within the margin of statistical error from the news media being blanketed with a report that said “new study shows e-cigarettes do not work as well as those wonderful ‘approved’ nicotine patches, so there is no reason to allow them on the market.”  In case the enormous importance of that little bit of random good luck is not clear, let me explain.  In the study, e-cigarettes did a bit better than patches, but the difference was less than “statistically significant”, which basically means “the fact that e-cigarettes did a bit better rather than a bit worse is quite conceivably just due to luck of the draw; a repetition of the exact same study might well reverse the order.”

So, a little bit of different random noise in their results, and e-cigarettes would have performed a bit below patches rather than a bit above them in terms of causing smoking abstinence.  Had that occurred, this study would be making headlines as yet another reason to ban e-cigarettes.  And instead of the press embargo being released after business hours on Friday (you are probably not aware, but the journal employed that classic tactic to minimize press coverage of an announcement) it would have been released on a Tuesday morning so it could headline all the health news sections that week.

As I noted in the title, this time it worked out.  But it next time it might not.

And “worked out” is pretty faint praise in this case.  Nicotine patches are a fairly worthless product.  They work well for some never-smokers I know who use them for performance enhancement; they are pretty good for that because they deliver a constant dosage of nicotine, making them kind of like sipping coffee all day, which is perfect for some people.  But history tells us they are pretty useless for quitting smoking (and you do not need any clinical trials to tell you that:  in the USA, they have existed, they have been heavily touted, and yet smoking rates have basically just tracked the uptake of low-risk alternatives — enough said).  Indeed, the claim that e-cigarettes merely worked just as well as patches (or even a little better) is flatly contrary to everything we know about e-cigarettes and how well they work.  This story does not provide further evidence that e-cigarettes work; it implies that they do not work as well as we know they do!

Instead of interpreting the study as important news, it is more useful to view the interpretations of the results as misguided science.  That avoids the problem of buying into a bad scientific paradigm that is ultimately bad for THR.  This is exactly the junk-science interpretation of what constitutes evidence that has been used to deny the overwhelming evidence about THR for the last decade.  Yes, it is nice to be able to respond to those who play this game by saying “ha, we have a study too” — but it is just one and it is a pretty weak result.  Better to focus on fighting the ANTZ’s repeated denial that other evidence is what is useful, which becomes harder if we implicitly endorse the denial when it is convenient.

Clinical trials are simply not a useful way to evaluate whether a consumer product is attractive to consumers for the reasons cited above: the artificial setting, the unrepresentative people, and the inevitable limited range of options.  Disappearance data alone (the quantity of the product sold to consumers) tells us far more than any clinical trial ever could.  Using clinical trials where they are not useful — let alone claiming that they are more useful than the better evidence — is mistaking their tools for the goals.  The fetishizing of the tool of clinical trials (useful for some things but not everything) reminds me two-year-old with a toy wrench playing “fix it”:  “wrenches are used to fix things, I am applying my wrench to an object, therefore I am fixing it.”

People who might be happy with a nicotine patch are not the target for e-cigarettes.  Even less so are those who go to a clinic looking for some magic bullet that will make them not want to smoke (see my series on second-order preferences to understand what they really want and why they are never going to get it).  E-cigarettes work best for the large portion of smokers who have become comfortable with (or resigned to) the fact that they want to keep smoking — or, of course, to do something that is a fully-satisfying substitute.

And all this is to say nothing of the fact that the study report makes clear that the smokers were not given nearly enough e-cigarettes to provide an acceptable substitute (thus intentionally and inappropriately imitating the inadequacy of the patch) and the products were of such low quality that they kept failing.  That is, the study was not a very good picture of what would happen in a clinical setting if you were really trying to get people to switch to e-cigarettes.

In fairness to the authors of this study, no data is worthless if interpreted correctly.  Better to have something rather than nothing.  But that is a big “if”.  The honest interpretation of this study should have been,

We know that e-cigarettes are proving to be a popular and effective method for quitting smoking in the real world and that no serious short-term side-effects have been found based on millions of observations.  We do not know specifically how well e-cigarettes would work in clinical smoking-cessation setting, though the reasonable hypothesis would be “they would work better than the current practice”.  This study confirms, as we already had every reason to believe, that even with really lousy products, e-cigarettes are better liked than nicotine patches.  This suggests (again, as we already pretty much knew) that clinics that really want people to quit smoking should start offering e-cigarettes.

I hate to give the authors a hard time, because they were just doing their jobs as institutionally-constrained researchers (“must use hammer, so call everything a nail”), and were being vaguely pro-THR (though not so much as to risk offending the tobacco control industry, of course).  Most of the blatant lies about this study are concentrated in the press release (and thus in the news reports) which the study authors did not write.  However, if they had veto power over the content, as is likely the case, they share the blame.

The press release tried to portray this result as important and groundbreaking.  Consider the following excerpts from it:

First trial to compare e-cigarettes with nicotine patches…”

Ok, fine, it is the first of those.  Yawn.

…only the second controlled trial to be published which evaluates e-cigarettes, and is the first ever trial to assess whether e-cigarettes are more or less effective than an established smoking cessation aid, nicotine patches, in helping smokers to quit.”

I guess there are some bit of literal truth to be found there, but the overall message is very misleading.  The reader is led to believe that this study tells us something new by conveniently ignoring the absolutely enormous quantity of evidence we have from sources other than trials.  They might as well be saying “this is the first research done in New Zealand on this topic”.

It is also false that the previous clinical trial (presumably referring to the one by Polosa’s group, which found a lot of smokers who were not seeking to quit spontaneously switched to e-cigarettes), for all of its limitations, did not show e-cigarettes worked better than NRT products.  Polosa’s result clearly demonstrated that e-cigarettes work better because we already knew how poorly NRT works.  It did not matter than there was no comparison within the study — you do not have to show them both on the same map to conclude that New Zealand is further away from you than your corner pizza place, after all.

“Our study establishes a critical benchmark for e-cigarette performance compared to nicotine patches and placebo e-cigarettes…”

Nope.  There is nothing critical about this result at all.  As a benchmark it might have some value, telling us that even when you seem to be trying to make e-cigarettes fail in that setting, they still do better than NRT.  And, of course, the concept of a “placebo e-cigarette” (which they called the zero-nic e-cigarettes that some subjects were assigned to) is silly; the benefits of an e-cigarette to someone trying to switch from smoking are not limited to the nicotine, and so there can be placebo nicotine but there is no such thing as a placebo e-cigarette.  (Aside: when Polosa’s study came out, those who fetishize drug trial methodology attacked him for not including a placebo group, but merely nicotine and non-nicotine e-cigarettes.  It will be interesting to see if they say the same when the study was done by their own people.)

The study is also the first to evaluate whether there are any adverse health effects associated with using e-cigarettes in a large (300+) group of people, and in real life, rather than a laboratory, situation.

Um, yeah, except for the slightly larger population of several million people who have used e-cigarettes in real real life.  (Note, all the commas in that quote are in the original — I just wanted to point that out to my editors who complain that I use too many commas.)

There is one useful bit of information in the study, though it is pretty buried:  The subjects who were assigned to e-cigarettes (either with or without nicotine) were enormously more likely to recommend them to other smokers than those assigned the patch were to recommend that.  No shock there, obviously.  But it turns out that we know relatively little about exactly how the social marketing of e-cigarettes plays out.  Unlike the rest of the results (which are mere weak confirmations of what we already knew) this could be useful new knowledge.

Bottom line:  The ivory-tower types need to do arcane artificial studies like this in order to advance their careers.  Health science journals need to publish and tout them in order to try to claim that they are the source of knowledge and so people should buy what they are selling at an enormous profit.  This does not mean that those of us who are interested in the truth should fall for their marketing.  Much like the cigarette companies, they are trying to sell a product that has some benefits, but in this case is ultimately a poor choice compared to alternative methods of inquiry.

Sadly, all but a small handful of the ivory-tower types refuse to soil their hands by actually getting to know real people, THR product users.  They use them as study subjects, but they never talk to them, let alone read their blogs and Facebook posts.  If they did, they would not overstate the value of studies like this.  The real science about what is happening in the world definitively demonstrates the value and success of THR.  If we put our faith in artificial studies, however, we are just as likely to get results that contradict what we know as support it.

FDA almost kinda sorta following MHRA, almost recognizing THR

by Carl V Phillips

Yesterday, in what was not nearly funny enough that it could be an April Fool’s joke, the US Food and Drug Administration issued a statement that they “may” allow changes to pharmaceutical nicotine product (NRT) labels to reflect a bit of reality.  In particular, the label would not be so restrictive about the period the products can be used and there would not be warnings about simultaneously using multiple tobacco/nicotine products.  Those warnings had many smokers and others convinced, for decades, that violating those protocols put them at dire risk.  Many were convinced that they might as well smoke rather than dare defy the label.

This comes following hearings a few months ago where several of us from CASAA found ourselves in the odd position of testifying on the same side as the pharmaceutical companies.  We were arguing in favor of explicitly allowing long-term use of low-risk nicotine products like their UK equivalent, the Medicines and Healthcare products Regulatory Agency (MHRA), already does, with the recognition that this would also tend to open the door for recognition of other THR options.

First, the bad news:  The unit of FDA that oversees NRT and made this move is the Center for Drug Evaluation and Research.  They are not the unit with the authority to regulate all other tobacco products, the Center for Tobacco Products, and so nothing about this extends beyond NRT except in spirit.  Additionally, the very weak move does not go nearly as far as the MHRA.  The language will still insist that the products should be used only in pursuit of nicotine abstinence.

By contrast, MHRA has approved one NRT product for use as a long-term substitute for smoking, perhaps with no intention of pursuing abstinence (i.e., THR).  This same approval is expected to be granted to other products, including particular e-cigarette products.  (However, though the application process for that is far easier than for a typical drug approval, it is still out of the reach of all but the larger manufacturers.)

Second, the lies:  I will not bother with the boilerplate lies about tobacco use that always show up in writings like this, focusing only on the substance of the statement itself.  FDA states that these particular products do not have “significant potential for abuse or dependence”.  Not only does this indicate their commitment to the bad old model of NRT (“if you use this to become abstinent, you have our blessing and sacred permission, but if you use it, say, just because the effects of nicotine improve your life, then you are abusing it, you evil degenerate”) but it also presents a backhanded indictment of other products by suggesting a contrast.  Since long-term NRT use seems to resemble use of any other tobacco product, particularly e-cigarettes, this implicit distinction is a lie.

The statement also nerfs the recognition that long-term use of these products poses no major health problem by stating, “Consumers are advised to consult their health care professional if they feel the need to use an [over the counter] NRT for longer than the time period recommended in the label.”  But if health care professionals generally had half a clue about this, the move by FDA would be moot.  Those that know the truth have been offering accurate advice about THR (using NRT and other low-risk alternatives) all along.  The others are not going to suddenly acquire any understanding that they currently lack.

Third, the good news.  This opens the door a crack toward the US government to recognizing THR.  It is an embarrassingly small crack, given the accumulated evidence and the move by the British, and is not nearly enough to end the US government’s reign as the worst anti-THR liar in the world, but it is something.

More interestingly, there is an official recognition that the favorite ANTZ bogeyman, “dual use”, poses no harm in itself.  The FDA admits the obvious, that there is “no significant concern” about using multiple products at once.  Of course, the ANTZ will cling to the specific wording:  Since this is a statement about just NRTs, the statement about using multiple products at the same time is phrased in terms of one of them being a pharmaceutical industry product.  Thus, the ANTZ will claim, if someone is using more than one product, and none are made by the pharma industry, then that is somehow still bad.

Yeah, right.

Of course they are going to try that.  It does not mean that the rest of us cannot keep hammering away at the message that the FDA has stated that the evidence does not suggest there is anything harmful about dual use.  (That is, of course, that there is no harm above and beyond any harm from the use of each product in itself, in whatever quantity is being used.  Smoking even a little bit is still far more harmful than just using smoke-free alternatives, though any reduction smoking due to use of the alternatives provides a health benefit.)

So, please recite it with me now, and repeat it often:

The FDA has stated that there is nothing harmful about dual use.

Of course, everyone who is not a liar or one of their useful idiots already knew that.  It is obvious, and there has never been any reason whatsoever to believe there was any harm generated by mixing products from two categories, any more than there was about mixing cigarettes from different packs.  Still, it is fun to say that this knowledge is now “FDA approved”.