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 somewhatindependent 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 allsocial 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.)
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.