’s comments on UK NICE’s THR guidance scoping draft

posted by Carl V Phillips

The UK National Institute for Health and Clinical Excellence (NICE) has an ongoing process with regard to tobacco policy, and we are a registered stakeholder.  Recently they produced a scoping document on the part that is most relevant to us, entitled “Smoking harm reduction” or “Tobacco – harm-reduction approaches to smoking”.  Following our usual practice of publishing our submissions, we are posting here our responses.

Reading the whole thing requires a bit of effort because the required format, for what is a sort of a peer-review type exercise, involved commenting section by section.  So to understand our comments, which we have attached in full (pdf), it is necessary to cross-read with the draft scoping document.  So, those are linked from this paragraph for those interested in reading our entire message.

For those interested in a simpler reading experience, what appears below is a stand-alone cut-and-past of most of our key points of general interest, organized for reading rather than according to the comment form:

We identified three major concerns with the draft scoping document: a strong emphasis on abstinence in what is supposed to be a THR approach (though not an apparent confusion of the two); an emphasis on simply reducing the number of cigarettes smoked in a day over other harm reduction approaches; and the explicit exclusion of consideration of the low-risk smokeless tobacco products as a substitute for smoking.

Our final point captured some of this with:

As a final note, the emphasis on abstinence and the limited mentions of product substitution leaves us concerned that political forces are on the verge of turning this into an anti-harm-reduction project.  While that will pose no great threat to THR (the anti-THR market is already saturated), it could damage NICE’s credibility.  More important, it would turn this rare opportunity to intelligently examine the potential for THR into yet another ineffective generic anti-nicotine effort.

Part of the problem was a failure to even define what harm reduction means in this case, and we offered the definition:

THR is properly defined as an approach to reducing the harms from smoking that does not include becoming abstinent from nicotine use.  The term is used to refer to either the individual’s behaviour change or policies that promote such change.  At the core of this is substitution of low-risk nicotine products for cigarettes.  These products include modern Western smokeless tobacco products (ST; e.g., snus), which have been shown to cause about 1/100th the health risk of smoking, as well as electronic cigarettes (e-cigarettes) and pharmaceutical nicotine products, which are generally believed to pose about the same risk as ST though this requires extrapolating from the evidence about ST because there is no direct evidence.

Two other changes that are sometime included in and sometimes excluded from THR are reductions in the quantity smoked but with no use of substitute products and changes to cigarettes that create incremental reductions in the hazards.  We do not tend to include either of those in the term, but recognize that they are not clearly excluded.  The latter of these is explicitly excluded in the present context … while the former seems to be implicitly included in some of what is mentioned in the document.

What cannot be legitimately included under the term THR are efforts to become nicotine abstinent or to promote nicotine abstinence.  Such efforts are not THR even if they include product substitution as a method of weaning off of cigarettes so long as the goal is for near-term cessation of those products too.  Harm reduction is a term of art that refers to allowing continuation of some core behaviour (notably including drug consumption), but changing the details of the consumption to reduce the health impact.  It is important to distinguish this from nicotine abstinence because some political opponents of THR, who embrace an abstinence-only approach, have attempted to co-opt the term.  (Sometimes this tactic involves pretending the term has its natural language meaning and pointing out that abstinence reduces harm, so it must be harm reduction.  Other times it results from confusion about use of substitute products for weaning toward abstinence, incorrectly equating short-term low-risk product use with THR.)

In this context, we make the following point, which we think is fairly critical:

No judgment about the relative merits of abstinence versus THR is necessary in order to recognize that they are distinct, and that the present scope is supposed to be about the latter.

Though it does not relate to anything in NICE’s document, we know the political climate.  Somehow many of the fanatical opponents of THR are incapable of clear thinking to the point that they cannot distinguish “I really hate this idea” from “this idea does not really exist”.

Later, re the section about what questions need to be answered, we added this observation on the point about the creeping abstinence-only theme:

There is more emphasis on nicotine abstinence in the “key questions” than there is on harm reduction.  This is both odd and inappropriate.  It is inappropriate because this document is supposed to be about harm reduction, and yet the “key questions” are mostly not about harm reduction.  It is odd because there are far more important open questions about THR than there are about abstinence promotion, which consumes enormous research resources.  So why does the list about what we might want to know about promoting THR suggest that we squander the opportunity by repeating existing and over-supported research on abstinence promotion?

On the emphasis upon merely cutting back quantity smoked, we wrote:

It should be noted that reducing the quantity someone smokes (not to zero), as is emphasized in this document, particularly in the “key questions”, is not a particularly good harm reduction strategy.  Occasional smoking is considerably lower risk than daily smoking, but just reducing the number of cigarettes consumed while still smoking daily offers less benefit than is widely believed.

Speaking very roughly, the reduction in cancer risk drops about linearly with cigarette quantity reduction, but the cardiovascular disease risk is close to plateauing for fairly few cigarettes per day so may not change much.  Someone with non-cancer lung disease might also see only limited benefit from continuing to smoke, but reducing quantity.  It is worth noting that many avid anti-smoking activists are currently claiming that even very small quantities of smoke cause harms of the same order of magnitude as typical smoking behavior.  We are not endorsing such claims, but note this to point out that mere reduction in quantity smoked is not an approach that is recommended by either those who actively advocate harm reduction or those who promote abstinence and prohibitionist approaches.

Yes, reduction in quantity does reduce harm.  And it is important to note that partial substitution of low-risk products while continuing to smoke some is a very common step on the way to adopting THR through complete substitution.  But emphasizing simply “cutting back” over more beneficial harm reduction options (i.e., full product substitution), as this document often seems to do, seems unwise and difficult to justify.

On the exclusion of smokeless tobacco substitution from consideration as part of a harm reduction strategy, we wrote:

The exclusion of the substitution of Western smokeless tobacco products (ST) for smoking is a fatal flaw in this scoping.  While we understand that those ST products that are most promising for THR are banned in the EU (outside of Sweden), this does not excuse the failure of a scientific or public health analysis to even consider what they could contribute to THR.

Some policy processes ask the question “how can we best implement the mandated policies of the government (or of the super-government in Brussels)?”  While we are not expert on the legalities of the present process (our relevant expertise is in various social and natural sciences and ethics) it is not our impression that this describes the present process.  A serious study of THR in the EU context should include inquiries that might call into question the EU ban of snus, rather that being restricted to the assumption that the ban is wise.

Though e-cigarettes are gaining fast, the majority of successful THR in the world consists of smokers or would-be smokers substituting ST.  Moreover, the evidence that THR is a promising intervention from an individual (and thus public health) perspective is based on the evidence about ST.  Even the pharmaceutical industry has argued that their products should be accepted as low-risk alternatives to smoking based not on evidence about long-term usage of those products, of which there is precious little, but based on the evidence about ST.

ST remains the most promising alternative for many smokers, and even if alternative devices prove more popular with most users, there is no reason to not allow those who prefer ST to use it, the one product for which there is actually evidence of the low-risk.

The document listed something that might be seen as a research agenda in the form of a list of “key questions”.  We found that these really missed the point about what the key relevant questions really are (you can see the proposed questions and our specific critiques of them in the links above, and I wrote a more in-depth analysis of a couple of them at EP-ology).  We proposed that the real key unanswered questions about a policy of promoting THR are:

What are the main barriers that stand between people who are good candidates for adopting THR and actual adoption?  How much is just misinformation?

Are there effective strategies for overcoming those barriers?  Many smokers try low-risk alternatives and decide to not switch; are there ways to make them more likely to complete the switch?  Many smokers insist that they prefer smoking and will not switch; are there strategies for helping them better think “do I like it that much more that it is worth the health costs”?

How can the use of smoke-free nicotine products by smokers in non-smoking situations be leveraged into switching entirely to the low-risk alternative?

A couple of specific criticisms of the questions that are not picked up on in that EP-ology post:  A couple of questions focused on how, basically, to pick winners — to figure out which products are most liked.  But there is no reason to do this other than curiosity:

Implicit … is the suggestion that it ever makes sense to limit someone to one type of substitute product.  We are aware of no basis for recommending this, and substitution studies and interventions that restrict choices to a particular product appear to be either commercial efforts to promote a particular product (rather than to research THR more generally) or intended to fail.  Similarly, the implicit suggestion that particular combinations should be explored and ordained as best by policy makers is misguided.  People have heterogeneous tastes and low-risk nicotine products are a very heterogeneous collection.  The market is large enough to support many low-risk options.

Educated consumers have a choice of products and will like some better than others, preferences which will differ across the population.  It simply makes no sense to not always facilitate individual choice of what works best for each individual by offering all the choices.  Indeed, any attempt to do otherwise can only be interpreted as an effort to make THR appear to be less promising than it is or to promote one company’s or industry’s profits over its competitors.

Regarding the question that asked “Does long-term use of pharmacotherapies or ‘nicotine containing products’ to reduce smoking have any ill-effects on health?” we wrote:

This is certainly a legitimate question in theory, but it should be realized that no better answers to it are going to be learned any time soon.  We know most of what is useful to know about ST and are unlikely to ever observe the long-term effects of other current products (because few people will use them close to exclusively for a long time before they are replaced with new technologies).  Thus, our current knowledge about the long-term effects of ST will remain our source of knowledge about this question for the foreseeable future.

The first part of the document included the usual boilerplate about how many people smoking kills and such.  We ignored most of that (it did not really matter whether it was sound science or not because that material is just window-dressing), except for the claims about how many smokers want to and try to quit:

In the context of harm reduction, it is important to understand that “wanting” to quit and “tried” to quit often do not mean what a casual reader might interpret.  Simple self-identification into those categories can mean any number of things, and is thus fairly meaningless.  In particular, the naïve interpretation of preferences is something like, “I want to be abstinent, with all that implies, but somehow cannot do it”.  But what is often really present is a second-order preference (i.e., a preference about having different preferences) like, “I want to be just as happy as a non-smoker as I am as a smoker” or equivalently “I want everything to be unchanged in my life except that I no longer smoke”.  These second order desires are common and are very different from the option that is actually available.  In some sense they represent cases where the smoker really does not want to quit (all things considered), and thus fails to do so (because, despite the self-identification as someone trying to quit, he really prefers a world in which he smokes to one in which he is abstinent).

In that context, many quit attempts can be seen as wishful thinking (spurred on by many of the claims about why people smoke) about abstinence being preferred once it is achieved, which results in disappointment.  The “attempts” might be better seen as experiments rather than “failures”.  Few people are able to articulate that their preferences are really the second-order version, and many have been denied the vocabulary that is required to say, “I successfully quit and was definitely an ex-smoker for a while, but then made the conscious decision that I like life with nicotine better than life without, even considering the costs”.

To the extent that want-to-be-quitters are expressing second-order preferences for wanting to not smoke but wanting even more to be as happy as they are when experiencing the benefits of smoking (primarily self-administration of nicotine), harm reduction is a particularly valuable approach.  Such individuals are practically begging for THR.  Thus, while the other standard boilerplate about smoking in this section is relatively unimportant, understanding this phenomenon and correcting the naïve view is critical in the context of THR.  Some people who assert they would like to be tobacco/nicotine abstinent are really indicating a preference for the benefits of nicotine without the costs of smoking.  This is a key argument in favour of supporting THR rather than an abstinence-only policy.

We questioned why specific subsets of smokers were identified as the target population for harm-reduction interventions:

Even those who are not actively considering quitting or reducing their risks right now should be considered part of the ultimate target group, who can be educated about THR and perhaps adopt it someday.

That covers most of what casual readers of the topic will probably want to read.  Those with a deeper interest in the topic or in the NICE procedure will want to read the full document.

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  • Kate  On May 14, 2011 at 1:06 pm

    Thanks for posting your submission, it’s very interesting, I hope NICE actually listens but won’t be surprised if an anti-ecig/HR outcome was fixed long ago.

  • Sam Munro  On May 14, 2011 at 2:04 pm

    I’d be interested in a reference being available as to the research or studies carried out that leads to the conclusion that electronic cigarettes (or personal vaporizers as many of the e-cig community prefer to refer to the devices as) pose the same threat of health risk as that of smokeless tobacco products such as snus.

    I understand however that as a general rule 97.3% of statistics are made up on the spur of the moment and that the goal of the THR experiment has little to do with bthe public health issue as it does with the governmental revenue issue.

    In all likelihood the MHRA and other bodies involved will more than likely spend a “few dollars more” of the tax payers hard earned money, only to come to the conclusion as electronic cigarettes are concerned that they have no basis to make the claim that it is either harmful or an aid to quiting smoking, it is simply put “an alternative”. An Alternative that should neither be banned (because the law as it stands holds no precedent for such an action, history has proved that prohibition does not work.) Nor unfairly taxed.

  • GC  On May 14, 2011 at 2:59 pm

    “Even the pharmaceutical industry has argued that their products should be accepted as low-risk alternatives to smoking based not on evidence about long-term usage of those products, of which there is precious little, but based on the evidence about ST.”

    I’d love to read a blog post about this.

  • Michael J. McFadden  On May 15, 2011 at 2:40 am

    Aside from Big Pharma’s self-serving doublethink on why their products are wonderful while everythign else sucks, it would be interesting to see some attempt at risk comparisons for ST in comparison with other activities that people enjoy but which also entail some small degree of risk.

    The two examples that spring to mind immediately are exposure to alcohol and sunshine. Both have been labeled by IARC et al as Class A “Known Human Carcinogens” with presumably “no safe level of exposure.” And yet there is little attention paid to mounting any massive global campaign towards alcohol abstinence (picture an FCTC that was an FCAC requiring countries to triple or quadruple the cost of alcohol, ban its advertisement, and ban its consumption in public) and, other than warnings about “over-exposure,” no movement at all toward banning such things as outdoor swimming pools or outdoor patio dining where workers are forced to choose between malignant melanoma and their paychecks.

    Realistic comparisons between such risks, evaluations of their “harm reduction” approaches such as reduced exposure or, in the case of UV radiation, the use of such partial protection as sunscreen and awnings, and the risks of ST, ETS exposures in well-ventilated indoor surroundings, and the risks of low levels of smoking itself would be helpful. (I’m not even touching e-cigs here as there is absolutely ZERO evidence I’m aware of that they pose any health risk at all with normal use.)

    Carl, overall your responses to the questions look very well done! Hope they listen — though my guess is the Antis will want them to be thrown in the trash.

    Michael J. McFadden
    Author of “Dissecting Antismokers’ Brains”

  • Jonathan Bagley  On May 16, 2011 at 8:01 am

    I fear you are wasting your time. I am very cynical about these consultations. As you know, the law relating to snus is effectively under EU control and a Finnish cancer organisation recently managed to stop the export of snus from Sweden to the rest of the EU. You can shout about Swedish life expectancy and cancer statistics until you are blue in the face, but eventually the UK Government will set up a committee of tame academics, many with connections to the pharmaceutical industry, which will produce peer reviewed papers demonstrating substantial risk from snus and ecigs. Drug companies have enormous wealth and power. They need smoking bans to sell their ridiculously priced and unpleasant gum; and they are not going to stand by while a growing number of people find much more enjoyable and far less costly cigarette substitutes.

  • Roland Gate  On May 16, 2011 at 8:14 am

    Why don’t we simply admit that the health service in the UK is just as much the property of the pharma industry as the health industry in the US?

    No decisions will ever be made that in any way threaten pharma income, or the assumption that surgery or pharmaceuticals are the only acceptable solutions to any problem. Any GP will tell you that 75% of the patients they see are in their surgery are there due to lifestyle choices, so the most efficient way to fix their problems is via lifestyle changes – such as true THR. Such an approach is anathema to the the health industry, of course.

    No real THR will ever be approved by the DoH / NHS as it is functionally incapable of such a decision; but at least we don’t have to worry about this in the long term: by 2013 there will be 1 million e-cigarette users in the UK. At some stage, possibly by 2020 and certainly by 2025, 25% of smokers will have switched to electronic cigarettes. By this time we will see the smoking death rate start to visibly decline, due entirely to the presence of e-cigarettes on the market, and despite the utter incompetence of the NHS in reducing smoking deaths.


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