25 June 2013

My take on the recent UK NICE Guidance on tobacco harm reduction

The following is my take on the recent UK National Institute for Health Care Excellence (NICE) Guidance on “Tobacco: harm-reduction [sic] approaches to smoking”.  (I know I am a bit late to this, but I kept interrupting my work on it for other projects.  There was a lot in the Guidance to dissect.)

For those not familiar, NICE functions vaguely like the USA’s Institute of Medicine – in terms of function it is basically a governmental think-tank, but is somewhat independent of the political process in terms of conducting analysis.  This means that the Guidance does not create or even explicitly propose government policy action, but it does carry the weight of government imprimatur (for those who consider that to be a good thing).  As for the Guidance, it is not actually about tobacco harm reduction (THR) in general as the name implies, but rather is specifically recommendations about encouraging the use of medicine-like products for THR as partial or total substitutes for smoking.

NICE apparently considers this to be important – rather more important that it really is judging from their (grossly inaccurate) headline claim that this report is “a world first for people who cannot stop smoking in one step”.  I will resist discussing the implications of this narrow view of many people working for governments (namely, that something did not happen until they did it) and their apparent obliviousness to what is going on in the real world.  In reality, the Guidance is approximately the one thousandth statement recommending strategies for helping smokers who do not choose to stop smoking by just quitting.  But especially baffling is that this is not even the first such statement by the UK government:  The MHRA (the unit of government that controls sales of medicines, like the CDER (drug) branch of the US FDA), which actually makes binding policy rather than just recommendations, has already created a category of medicines for THR and has approved one product in the category (at least two others are under review).

Though far short of the inaccurate self-promoting rhetoric, the Guidance does have the potential to be somewhat influential.  Much of the reaction to the Guidance from the real public health community (i.e., THR supporters) has been rather negative, but I tend to differ because I think that the real impact of the negative aspects (which definitely do exist) will be trivial and short-lived, while the positive implications will have legs.

The main negative is that the guidance is specifically about the use of “licensed nicotine-containing products” – that is, pharmaceutical industry “NRT” products that are designed as abstinence-promotion medicines and not as fully-satisfying consumer products.  The authors were clearly so desperately worried that someone might interpret their recommendations as applying to all roughly-equally-low-risk products, like unlicensed e-cigarettes or (gasp!) snus, that they included the phrase “licensed nicotine-containing products” approximately once in every 40 words.  The problem with that plan (and the reason this is not such bad news) is that many people who read and make use of this are not stupid.  Many readers will recognize that everything they say applies equally to all of these products.  Indeed, the Guidance authors make basically no affirmative argument to the contrary.  (They throw in a few lies about risks from snus, but they are so buried deep in the research background section that they are unlikely to be noticed.)

You could imagine a document like this including a tedious argument that there is something so different about non-“licensed” products that the recommendations cannot be extrapolated to them.  But it does not include that.  Perhaps the authors actively wanted to avoid such a claim.  Perhaps they just realized they would look like idiots if they tried to argue obviously incorrect claims.  One might even conclude that some of the authors disagreed with the “licensed products only” spirit of this initiative and managed to keep the document implicitly positive about THR in general despite several of the authors clearly opposing this.

Thus, the Guidance is good news merely because it has positive things to say about one (albeit relatively unimportant) approach to THR.  And moreover, whatever the reason why, it was not actively anti-THR for other products, and therefore it will contribute to the promotion of THR in general, even if some of those in charge of the process might wish otherwise.

It is worth noting that there are a couple of e-cigarette-type products in the application pipeline for the aforementioned MHRA approval, and the authors of the Guidance knew that.  Thus, they knew that they were implicitly recommending THR using (some) e-cigarettes.  Of course, right after the release of the Guidance, MHRA declared that they planned to regulate all e-cigarettes as medicines, requiring them to meet the licensing requirements (which almost none could meet).  But it is clear from conversations I had that at least some of the authors of the Guidance did not expect that this would be MHRA’s move, so not much can be read into this juxtaposition.

Recommendations in the Guidance
So, finally getting to the substance, what does the Guidance recommend?  It recommends everyone involved in smoking cessation (government agencies, medics, specialty clinics, etc.) provide smokers with information about the benefits of cutting down and of substitution.  These do not appear until after the reader wades through the usual recommendations that they tell smokers the shocking news that smoking is bad for you and such, but that is just boilerplate.  The substance is the recommendations about a THR approach.  The same actors are supposed to tell people about the licensed products themselves.  But unless the clinicians et al. lie about the more consumer-friendly products – which, importantly, NICE clearly does not ask them to do – then people should be able to extrapolate.  Indeed we can hope that anyone working with real live human smokers that they care about, rather than just publishing information, will go ahead and actively recommend e-cigarettes (or even semi-black market snus). 

Of course, we will not know what private conversations clinicians will have with people.  But the Guidance also calls for those who create self-help information to incorporate these recommendations.  Will those who did not already endorse THR in their writings start doing so now?  It is not clear that the Guidance will actually have that kind of impact, but at least we will be able to observe this if it happens, unlike the personal conversations. 

The word “reassure” appears a lot in the Guidance, as in “Reassure them that it is better to use these products and reduce the amount they smoke than to continue smoking at their current level.”  This is a nice touch, acknowledging that the anti-tobacco extremists’ years of efforts to mislead people into believing there are no benefits from THR necessitates an affirmative effort to undo.  I am sure this really grated on those members of the authorship committee who are part of the extremist clique and personally contributed to the disinformation that needs to be corrected.  Or maybe it just flew over their heads – part of the tobacco control job description is to avoid thinking critically, after all.

The discussion of how to counsel smokers about perhaps choosing THR is quite lucid and rational.  It reads like the recommendations that good pro-THR medics or real public health people would write.  It even includes the advice to warn smokers that the recommended products are not so satisfying as smoking, so need to be used differently (not in so many words, of course, but that is the upshot of it).

The recommendation that those who educate clinicians educate them about these recommendations is pretty paltry, but it is there.

There are even recommendations about advising smokers about strategies for “temporary abstinence”.  This is not explained, but it seems that it must refer to helping smokers deal with smoking place restrictions.  If so, this is a rather surprising move in the direction of good government – helping people be happier given the constraints they face, rather than trying to force their choices.  The anti-smoking activists, if they actually think through what this implies, are not going to be happy about this; while they publicly justify place restrictions based on protecting bystanders from smoke, most of them clearly consider the fact that the restrictions can make smokers miserable to be a feature, not a bug. 

I wonder if on this point NICE may actually have been a little too respectful of people’s choices.  They failed to push the recommendation to communicate “now that you have discovered that these products are appealing when you have to deal with place restrictions, you should consider using them all the time.”  There is one buried sentence on this theme, but it is a missed opportunity that they did not make the point more clearly.  (Of course, perhaps they recognized that few smokers with these motives are going to find their licensed products to be so satisfying that they might want to use them all the time.)

Manufacturers are encouraged to include the THR information on their packaging and such.  Of course, this only applies to licensed products and does not change any laws, so unapproved claims about “unapproved” products are still, well, unapproved.

Criticisms of the narrow-mindedness
As noted above, the Guidance is restricted to “licensed products” and this provoked a lot of ire when it came out.  The closest they come to acknowledging the reality that exists beyond their licensing paywall is, “little direct evidence is available on the effectiveness, quality and safety of nicotine-containing products that are not regulated by the MHRA. However, they are expected to be less harmful than tobacco.”  While better than denying that they are less harmful, this is still a lie at a couple levels:  There is a lot of evidence about effectiveness, quality, and safety.  (Perhaps they were trying to hide behind the word “direct”, but since it is basically meaningless, there is no refuge there.)  These products are known (not “expect to be”) a lot less harmful than smoking, but not less harmful than “tobacco”, a category that clearly includes smokeless products that are just a low-risk.  (Indeed, in the minds of many, all the products mentioned here, when used on a long term basis for non-medical reasons, form the category “tobacco”, though that does not tend to be the UK way of thinking).   Just because you cannot buy low-risk smokeless tobacco in the UK is no excuse for pretending that it does not exist.  Still, this cryptically acknowledges that e-cigarettes, despite the government not officially granting people permission to use them, are low risk.

The Guidance goes so far as to say, “Electronic cigarettes are becoming increasingly popular. If the MHRA starts regulating them, or there is positive new evidence of effectiveness, …this guidance should be considered for a rapid update.”  Of course, if e-cigarettes are MHRA-licensed products, the only thing that needs to be updated is adding them to the list of “approved” product types.  Nothing else would need to change.

There are probably a hundred incorrect specific claims in the document, but I am not going to go into that level of detail.  The count goes up to several hundred if you include their “review of the evidence” back-matter; that section is bad enough that it makes me wonder how the recommendations turned out as good as they are.  Indeed, it appears that the authors pretty much used that section for window-dressing and were motivated by better general knowledge, which is a good thing.

A more subtle failure is the refusal to acknowledge how we know that smoke-free tobacco/nicotine products are low risk.  In their desperate attempt to avoid even recognizing the existence of smokeless tobacco, they attribute the knowledge that “licensed” products are low risk to the paltry data about long-term use of those products.  That level of evidence about, say, e-cigarettes would be derided by those who like the medicines as entirely inadequate.  The reason we know that the level of risk caused by smoke-free nicotine is indistinguishable from harmless is the extensive research that shows that smokeless tobacco has no measurable risks.  It is that knowledge that NRT makers cite when they try to argue that their products are low risk.  Too bad NICE could not be as honest.

The recommendations also fail because they think that tobacco harm reduction is really just about harm reduction (see my recent post).  They clearly communicate that the use of low-risk products is always the second-best choice, behind abstinence, and fail to explicitly acknowledge the advantages compared to abstinence.  This was inevitable, of course, but just because it is not surprising does not mean it is not wrong.  The Guidance acknowledges that some smokers do not want to become abstinent, and thereby implicitly acknowledges that there must be some disadvantages to abstinence.  But this is never recognized.  But on the glass-half-full side, those of us inclined to do so can point out that NICE acknowledges that there are benefits from tobacco use.  

Interestingly, the only place where they mention the favorite bogeyman of anti-THR activism, the possibility that some people who would have quit smoking will only reduce if there is any encouragement to do so, is in the cost-effectiveness analysis discussion.  While engineered worries about this in the popular discourse are 90% trumped-up lies, it seems like this should have gotten a bit of explicit attention in the substantive part of the Guidance.  Yes, their recommendations repeatedly include the observation that switching completely or otherwise quitting smoking is much healthier than just reducing, but I would have really liked to have seen some suggested model advice about how to say, “since you are cutting down by using an alternative, you should really consider finishing the switch because any smoking is a lot less healthy than none”.

As an aside from the details of tobacco policy, putting on my political scientist or ethicist hat:  A disturbing theme in the research section of the Guidance (in common with a lot of government activism) is the notion that government should think like a business.  Cost-effectiveness type analysis is great (it is at the core of what I taught for years), but it needs to consider all social costs and benefits.  For a business, something is a good move if it reduces expenditures or increases revenue (or, more precisely, improves the net of those two added together), regardless of its other impacts on the world, and that is exactly why a lot of people, including a large portion of “public health” types, despise business and use “profit” as a rough synonym for “evil”.  But that is what businesses are supposed to do, more or less.  However, it is not what government is supposed to do.  When the government starts trying to maximize its profits, we are all in trouble – that is what feudal and warlord governments do.

Yet the analysis of costs and benefits focuses totally on government net profits.  There is no apparent acknowledgement of the costs and benefits to the product users, by far the most significant costs and benefits.  This is rather odd since the substance of the Guidance acknowledges that people might prefer switching to abstinence – that is, there is a recognition of the real costs and benefits built in.  At least that makes it much better than the usual “analysis” that bludgeoning smokers into abstinence, even though it makes them unhappy, is “cost-effective”.  In some ways, though, that makes the business balance-sheet analysis even more pathetic.

Besides, should the government require cost-effectiveness at all before deciding it should tell its citizens the truth about something very important to them?  Should the government lie if it looks like it would save money?  (Yes, I know the answer is that they will often do just that.  But they certainly should not.)

Concluding thoughts
I really think that this Guidance is good for the promotion of THR – not as good as it could be, obviously, but not harmful.  Because there are no affirmative arguments against any aspect of THR, it is difficult to see the harm.

The statement that smokers who reduce but do not quit entirely (or, more precisely have not quit entirely, since they still might do so) get some health benefits flatly contradicts currently popular anti-THR lies.  The Guidance agrees with the point that the experts have long been making, that in many cases reducing represents a transition, and in any case the much demonized “dual use” is better than just smoking.  Of course, the anti-THR activists (who do not actually consider evidence, but rather start with their conclusion and then concoct rationalizations for it) can still retreat to their claim that all those people who have cut down would have quit already if they were not taken in by the allure of alternative products, but that is so clearly silly that it becomes much harder for them to defend their rationalization.

It is also gratifying to see the repeated use of language that refers to preferences about tobacco use, rather than suggesting it is some kind of volition-free tic.  There are a few appearances of the “cannot quit” type language, but mostly the languages is about what smokers want – e.g., “may want to stop smoking without necessarily giving up nicotine”, “want to reduce the amount they smoke”, or “may not be able (or do not want) to stop smoking in one step”.  (Yes, they still throw in a bit of the “cannot” language, but at least they still recognize the relevance of “want”).

The implicit acknowledgments of both the use of non-“licensed” products and of the downsides of abstinence are quite useful.  Those of us who want to make points about other products and motives can cite this Guidance and just let the extremists sputter their vapid protests about it just being about medicines.

18 June 2013

Tobacco harm reduction, it’s not just about harm reduction

It has recently occurred to me that perhaps the terminology that I and other pioneers of tobacco harm reduction developed is starting to be a drag on our efforts.  I refer specifically to our defining phrase, “tobacco harm reduction”.

When my colleagues at the University of Alberta and I launched our website in 2005, it was not entirely clear what to call it.  We settled on “TobaccoHarmReduction.org”, but there were other candidates at the time.  That term already existed, though was not in widespread use.  The widespread adoption of that term over the ensuing decade validated our choice (though this might be somewhat circular since our use of the term presumably contributed to the validation). 

The term is now locked-in as the description of everything related to efforts to promote low-risk tobacco/nicotine products, including all efforts at education and defending people’s rights to access to these products.  That “everything”, however, is perhaps unfortunate, because it tends to over-medicalize the entire effort, focusing all attention on the reduction (i.e., the value of alternatives as compared to cigarettes).  The tendency to treat the decision to use low-risk tobacco products as purely as a “cure” for the “disease” of smoking was most recently exemplified by the MHRA decision to classify e-cigarettes as medicines, though the tendency is hardly new.  (I had already drafted most of this post long before that came out.)  

It is more politically correct to focus on low-risk tobacco products as purely a cure for smoking, but sometimes politically correct is not optimal for the long-run, or merely for being fully correct.  I try to hedge a bit when I define THR in my writings, with something neutral like “the substitution of low-risk tobacco/nicotine products for cigarettes”.  This does not actually say that the only reason for using the is because otherwise someone would smoke.  However, it is intended to be close enough to pass for that in the eyes of those who demand such a view, suggesting that efforts related to THR are all about getting people off of smoking, and so probably does not provide any benefit with respect to the issues presented here.

It is clearly true that for many people, this is exactly what e-cigarettes and other THR products are – a cure for their smoking habit that they could not find another acceptable path away from.  I trust it is obvious that I am not trying to downplay that at all.  I do a lot of work focused on exactly that angle (e.g., CASAA’s effort to collectstories from people who successfully used THR to stop smoking -- please give us your story if you are one of them).

But suggesting that low-risk tobacco products are merely a cure for smoking narrows the discussion, hurts the cause, and unintentionally fuels the opposition.  Recognizing that low-risk tobacco products are more like coffee than they are like cigarettes, and a lot more than they are like medicines, is crucial for a sensible policy discussion and advocacy.  Breaking the grip of the narrow-minded “public health” types over the discourse cannot be done by adopting their rhetoric.  These products can be enormously welfare enhancing compared to either smoking or abstinence (I have written more about this in my paper about the basic economics, which I finally released – I will write more about the content of that analysis soon, but you can check it out now).

Of course, not everyone who has positive things to say about low-risk tobacco products agrees that it is right to think this way.  Many prominent THR supporters come from a medical or public health background, and still fall into those fields’ unfortunate tendency to ignore any human preference other than health.  To them, THR really is only about the “R”.  They often explicitly state that abstinence is always “better” (without defining their basis for that normative claim), which leads conclusions like "we should restrict education about low-risk products so that they only attract smokers who would not otherwise quit smoking" (setting aside the fact that such targeting is impossible, and recognizing that they may well understand this, they still would prefer to do it if it were possible).

This thinking – whether it comes from those who support THR, oppose it, or are reasonably neutral – invites comparisons to methods for abstinence promotion and implicitly denies that substitution has advantages over abstinence.  This results in the typical discussions about how THR is a more effective method for quitting smoking (for those who are not inclined to just quit) than the alternative methods.  I certainly engage in plenty of those discussions, and I believe it is true.  But focusing entirely on this gives comfort to those who would prefer smokers not have access to a pleasant way to reduce their risks (why would anyone prefer that? read here).  It makes it easy for them to make up claims that THR is not really proven to be more effective for many smokers, and that there are officially “approved” alternatives which therefore must be better, and such.  Those claims are generally full of utter lies, of course, but they is effective at tricking casual observers into doubting the value of THR – so long as THR is only about not smoking.

But since low-risk tobacco products occupy basically the same consumer niche as coffee, I would argue that this is not the battle we should be fighting.  It should be possible to move one step above that fight and argue that low-risk products are better than abstinence for many people.  I am not talking about the constructed and often-invoked (but, in reality, empty) category of those who “cannot” quit smoking.  A focus on that category suggests that THR advocates are conceding that that abstinence is best for everyone in theory, and are merely arguing that a second-best solution is needed for some people.  This, in turn, invites the retorts that “better” cessation methods eliminate the need for this second-best and that low-risk tobacco products really are medicines.  After all, if the only reason we should allow people to buy and use e-cigarettes is because otherwise they would continue their smoking habit, which their personal history shows they are unlikely to stop anytime soon, then why not make them available only by prescription to long-term smokers?  (One answer might be “because under that rule, the only products available would be as unappealing as NRT is”, which is a valid worry, but is a rather different point; a market could be created that is still makes high-quality and innovative products, but is open only to those with diagnosed “cannot quit smoking” syndrome.)

So if this is not just about those who need low-risk tobacco products to “cure” their smoking because nothing else will, who is it about?

To some extent it is about those who experience identifiable health benefits from nicotine, or perhaps other aspects of tobacco use, those who find it to be a good treatment for various psychological conditions and a few physical conditions.  That group that represents one my major motivations for working on this topic.  Efforts by “public health” people to deny such people access to low-risk tobacco, insisting on quit-or-die to those who would suffer terribly from tobacco abstinence (both now, in the world of e-cigarettes, but also for a decade before that when it was demonstrated that smokeless tobacco was a low-risk alternative), is cruelty that is arguably genuinely evil.  It is indefensible from the perspective of any accepted modern ethical system, and exists merely as religious persecution of people who are “different”, with all that implies. 

But it is not just that group either.  This is also about the welfare of everyone that likes or might like the experience of using low-risk tobacco products enough to accept the risk that they might cause a very small reduction in life-expectancy (or they might be beneficial for health on net – we do not know for sure).

Many such individuals are, of course, the aforementioned groups of those who “cannot” quit – i.e., do not quit despite every legal effort being taken to make them suffer for their choice – and those who get serious psychological or other health benefits from smoking (these categories probably refer to mostly the same group of people).  There are many such people who will smoke if there were no other satisfying option, and so this their harm is indeed being reduced if low-risk products are made satisfying and available.  But they will also benefit from the products as compared to abstinence.  If they would choose smoking over abstinence but choose the low-risk product over smoking, then they are almost certainly getting great benefit from using the low-risk product rather than being abstinent.

But for those who are or will be abstinent rather than smoking, possible use of low-risk products is not about the harm reduction.  There is no harm to reduce.  Since this includes everyone who could be bludgeoned into abstinence using other methods, failure to consider the welfare of this group is what gives comfort to the enemy.  In the extremists' rhetoric, everyone will soon be in this category (never mind that this is some combination of mistaking a hope for a plan and out-and-out lying on their part – they still make the claim), and so in their imaginary world there is no harm to reduce.  Arguing that “tobacco-free 2025” is an absurd fantasy is simply not effective – it ought to be because the idea is utterly crazy, but somehow it is not.  I am tending toward the conclusion that only by pointing out that this fantasy future is inferior to a world of minimally-harmful or non-harmful tobacco use, rather than merely arguing that the fantasy is not happening, is it possible to gain the upper hand.

If it is just about harm reduction, then their solution of discovering some magic bullet that will eliminate all harm by eliminating all use is indeed a superior option.  Never mind that a hope is not a plan and there is no legitimate expectation; experience makes clear that the anti-tobacco extremists can make such claims without being subject to any scrutiny from the government or the press, or from most of the public.  But they also might find a slightly more honest argument looking at “clinical” interventions (i.e., treating e-cigarettes or other low-risk products as if they were medicines and, in a medical-like setting, trying to push them on average smokers to try to get them to quit) and finding that – when you do not focus on the right group, smokers who want an alternative – relatively few can be pushed to switch.  As evidence about such artificial and inappropriate efforts to push or cajole random smokers into switching trickles in, it shows that this does not work much better than any other aggressive approach.  If (and only if) these products are medicines, then such evidence indeed represents a failure.

But what if we were to focus on the fact that any risks are minor – down in the range of everyday hazards – and there are net benefits to be had?  In other words, this is a choice that is not very similar to cigarettes, and is more like coffee, soda, snacking, travel, sports, and computer games, all of which have their health costs, but substantial and widely-appreciated benefits.  Moreover, as a choice and not a clinical intervention, any observed failure of trying to clinically force products on currently uninterested smokers is is not damning.  That is simply not the role of the products among free living adult consumers.

Yes, there is some such effort now.  But it is not very concerted, and it is overshadowed by the harm-reduction-only rhetoric (which, again, is unfortunately partially locked-in due to terminology).  Yes, that effort would have to struggle against decades of fairly successful demonization of people who use tobacco products.  But that is the point.  Even if people understand that low-risk tobacco use creates about 99% less risk than smoking, it is still creates 50% or perhaps even 99% of the scorn.  This will clearly no longer be the case after low-risk tobacco product use becomes the norm and those who have been brainwashed by anti-tobacco rhetoric slowly come to their sense (or die off).  But that is a long time, and in the meantime there will be needless loss of welfare, both among smokers who are discouraged from quitting and those who benefit from tobacco/nicotine who are discouraged from using anything.  Perhaps the process can be accelerated.

One challenge is that there will be pushback from some people who support THR, but only as HR.  For them, the term is exactly right.  This seems to include most of the medics who have been won over to THR, and includes a few of those who are considered strong public backers of THR.  These are good people trying to make the world better; they genuinely care about health (they want to improve health rather than merely make people behave “correctly”) and they are pragmatic (they favor something that works over mere hopes).  But ultimately, a lot of them are still anti-tobacco extremists – that is, they ultimately hold the extreme anti-tobacco view of preferring a world in which there were no tobacco use, regardless of whether the benefits of use might exceed the costs for many people.  Many of them long refused and still refuse to embrace smokeless tobacco as a THR product (even though it is the proven low-risk product and probably lower risk than e-cigarettes) and endorse e-cigarettes only because they can take refuge in the rather tortured rationalization that “they are not really tobacco”.  While far from being like the “public health” people who actually care more about destroying tobacco companies than they do about improving people’s health, there are plenty of e-cigarette advocates who ultimately still hate all free-chosen tobacco/nicotine use and only like the product that they can think of as being like a medicine.

It is my assessment that attempts to defend access to and promote awareness of low-risk tobacco products – even if motivated primarily or entirely by trying to reduce harm for current smokers – would benefit substantially if there was more attention devoted to arguing that low-risk tobacco products are little different from everyday consumption choices (except in the minds of an zealous minority who think that there is something evil about this plant).  Many of the popular protests about the MHRA announcement focused on the point about e-cigarettes being a consumer choice, not a medicine.  But that may not push quite far enough.  They are not just a choice, but a fairly unexceptional choice – with the added benefit that if a smoker chooses to use them to “cure” their smoking, they can.