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NICE - tobacco harm reduction Guidance

On June 5th 2013, NICE issued their long-awaited guidance on THR. Here is the full and correct document title:

Tobacco: harm reduction approaches to smoking
Issued: June 2013
NICE public health guidance 45
(web link) guidance.nice.org.uk/ph45
 

What is this Guidance about?

It is necessary to point out, right from the start, that PH45 is not about Tobacco Harm Reduction (THR): the consumer process where cigarettes are substituted with consumer products that are lower-risk, for ongoing use, without cessation [1]. This is about Harm Management [2], or HM, the medical process that uses NRTs and is designed to end with cessation where possible (probably, THM or Tobacco Harm Management could be used to describe the content of this document). There is an occasional nod toward the consumer process.

Whoever wrote this document has been scrupulously careful to avoid use of the proper terms Tobacco Harm Reduction, Harm Reduction, or THR; as far as I can see they are (correctly) not mentioned at all, apart from some use of the term THR in clinical studies over which they probably had no control. Therefore, the document clearly, and correctly, addresses harm reduction in the generic sense. To be specific it describes Harm Management, the medical process. There are two reasons why it (probably) doesn't mention this issue: most of the audience will have never heard of Harm Management; and there is probably some pressure on NICE to be seen to be doing something about 'harm reduction'.

The stakeholders' view

ECCA UK [3] were stakeholders in the consultation exercise. It is important to recognise that ECCA are by far the most important stakeholder in tobacco harm reduction in the UK since they represesent a very large user group by proxy - the near-1 million UK e-cigarette users*; a user group so much larger than any other that their views are of some importance.
* Q4 2013 update: 1.5m plus ecig users by now.
* Q2 2014 update: 2.1 million ecig users confirmed.

As ECCA Secretary at the time, I filled in the consultation return form, with the help of a doctor who is an ECCA member. It is extremely unlikely that any of it made its way into the final result, as we advised a 100% move to consumer products, since that is the definition of Tobacco Harm Reduction, which is what the consultation appeared to be about at that time. Whatever the outcome, it was important that we were seen to do our duty by responding in full, since ECCA is clearly the biggest UK stakeholder and the ecig usergroup is growing so rapidly (there is a realistic prospect of 6 million eventually).

It is fair to say that the e-cigarette user community will never be entirely satisfied with an official health service policy in this area, no matter how progressive it may eventually become, because a national health service organisation cannot support the consumer view, only the medical view (which is properly called Harm Management). Because of that, our view of the NICE THR recommendations is split between relief that 'THR' has finally been recognised, in a manner of speaking, tempered with dismay that they are mightily confusing the issue by not clearly stating they refer to Harm Management. Many will end up seriously confused by this guidance because they will gain the impression that THR uses NRTs, when that is never the case.

Some relevant points are:

(a) THR has to be entirely a consumer-based process otherwise it loses its effectiveness - the further it deviates from a consumer process, the more ineffective it is likely to become. A Harm Management system is going to be about 99% less effective than real THR, in terms of lives saved.

(b) They are confusing the issue by including Harm Management factors irrelevant and incorrect in a THR context, such as cutting down on smoking and the use of medical products. The whole point of Tobacco Harm Reduction is that smoking should be replaced, and with consumer products - or the process is much reduced in effectiveness; but the audience for this guidance document will know of none of this. That this is all about Harm Management and not Harm Reduction is going to cause a lot of confusion.

(c) They appear to be trying to gain ownership of tobacco harm reduction, which in the end is a negative for public health, since:
(i) the consumer process is orders of magnitude more effective;
(ii) people may think that the NICE version is either the best or the most effective (when it cannot even begin to compete with the consumer version in terms of effectiveness or impact on public health).

(d) The prospect of there being a million annual clients for NHS tobacco harm reduction processes is not realistic* - but there will be over 5 million UK e-cigarette users in time. This accurately represents the scale of the issue.
* Unless, of course, e-cigarette products receive pharmaceutical licenses and are then promoted by the NHS - this is an entirely different situation, because in that case there will certainly be a large NHS userbase of hundreds of thousands of new clients.

It needs to be recognised that Sweden is the world leader in the reduction of smoking and the reduction of smoking-related mortality, and has seen a 50% reduction in smoking compared to comparable countries; and in the UK, 7%* of smokers have already switched to an e-cigarette. In both these situations, no government promotion took place, there was no medical involvement, and only consumer awareness caused the move. This is THR, the consumer process. It is so much more effective than any medically-managed process that there is no comparison.
* Now 18% at Q2 2014

The NICE documents

Here are links to the various online docs - the PDF is the best resource.

Full PDF:
http://guidance.nice.org.uk/PH45/Guidance/pdf/English http://www.nice.org.uk/nicemedia/live/14178/63996/63996.pdf

Abstract:
http://www.nice.org.uk/guidance/index.jsp?action=byID&o=14178

Main doc in web page format:
http://publications.nice.org.uk/tobacco-harm-reduction-approaches-to-smoking-ph45
>> and pp following

Their evidence base:
http://guidance.nice.org.uk/PH45/SupportingEvidence

Quick analysis

NICE had to make some sort of a move on harm reduction because the 20% Prevalence Rule means smoking cannot be reduced significantly any further in the UK by following the current methods; plus Sweden smashed the 20% barrier by using consumer THR, making the NHS look incompetent in comparison.

What NICE have therefore tried to do is to start to educate the medical profession in some important areas, and to gain ownership of the term and/or process; for practical reasons it is impossible for them to actually utilise or promote real THR since by definition this means substitution of cigarettes by alternative low-risk consumer products for ongoing use. An official medical body cannot advise the use of consumer products or permanent use. Therefore the NICE version of THR is basically a harm-reduced version of current policy: cut down on smoking, or use medical NRT products for long-term substitution. To be fair to them, it is all they can do in the circumstances.

They state that 'unlicensed' products such as e-cigarettes, or ST (smokeless tobacco such as Snus) are not supported. We could not expect anything else from an official body in the UK as their horizons are so limited. What they have done, though, is clearly state that nicotine is not harmful, and that medical advisers can tell patients that e-cigarettes are better than smoking, although not officially supported. This, in UK establishment terms, is giant progress.


Befuddled
It is abundantly clear that the committee responsible are themselves hopelessly befuddled by the issues. 

Most e-cigarettes include propylene glycol. This chemical is generally considered to be of low toxicity although there appears to be insufficient data concerning its inhalational toxicity.


Here, they are clearly implying that there may be a risk from inhaling PG (propylene glycol) - when they themselves prescribe it for inhalation by lung transplant patients and asthmatics (it is the excipient used in the nebulisers used by transplant patients and some inhalers used by asthmatics). It seems rather obvious that if something is prescribed for inhalation by those with the most delicate lung conditions and in the most fragile health, then it cannot either be toxic or have much in the way of implication for health. Therefore it seems to be a major omission to not seek advice from a consultant pulmonologist of reasonable experience before writing this material, or someone else who could have told them that PG has 70 years' safe clinical history of inhalation and a great deal of research to support its widespread use in inhalable pharmaceuticals.

Employing those who either do not understand the issues, or who are fatally compromised by association with the tobacco control industry (in practice, the propaganda arm of the pharmaceutical industry), appears to be gross negligence when a national clinical guidance organisation are guilty of it.

It is not acceptable for a national clinical guidance organisation to be repeating propaganda distributed by an industry in order to discredit commercial rivals; indeed, it begins to look like incompetence.

Confusion

The size of the problem is revealed by the paragraph that follows; NICE are going to confuse things mightily by this sort of 'guidance', because it is incorrect and should be considered a negative, rather than good, clear advice and an improvement on the current situation.

"However, there are other ways of reducing the harm from smoking, even though this may involve continued use of nicotine. This guidance is about helping people, particularly those who are highly dependent on nicotine, who:
- may not be able (or do not want) to stop smoking in one step
- may want to stop smoking, without necessarily giving up nicotine
- may not be ready to stop smoking, but want to reduce the amount they smoke.

It recommends harm-reduction approaches which may or may not include temporary or long-term use of licensed nicotine-containing products."


They have missed out the single most important item, which should have been #1 on the list:
- may want to continue smoking but without the harm

The continual repetition of the term 'stop smoking' reveals they neither understand what THR is nor intend to promote it. Cigarettes need to be replaced by low-risk consumer products or harm reduction is not really being promoted. THR by definition excludes cessation or the use of licensed products; what is being discussed in this document is Harm Management, and quite frankly they do us all a disservice by trying to pass it off as Harm Reduction.

Ultimately, the NICE approach is yet another route to continuation of the death toll, because by not promoting Harm Reduction, when they had a chance, the end result may be a negative effect overall.

Examination of the committee responsible for the document shows few if any Tobacco Harm Reduction experts but several tobacco control industry members, who are normally funded by the pharmaceutical industry and promote their agenda for them (and pharma's agenda is, obviously, to block access to THR).

Correct THR advice

A far better encapsulation of THR - far more accurate and certainly far more effective for saving many more lives - would be the following:

However, there are better ways of reducing the harm from smoking, even though this may involve continued use of nicotine. Ideally, smoking should be ceased or replaced, not continued at lower consumption volume [i]. This guidance is about helping people, particularly those who are now dependent on nicotine as a result of smoking, who:
- May want to keep smoking, but without the harm
- May be worried about the risks of smoking but do not know how to reduce those risks
- May currently be 'social smokers' and wish to reduce the risk that they may transition to regular smoking
- May want to quit smoking eventually but need a satisfactory and proven successful method in order to transition easily
- May need to supplement their dietary nicotine consumption with the method most acceptable to them

It recommends harm reduction approaches which principally involve the short-term, long-term or permanent use of consumer nicotine-containing products; or if found satisfactory, licensed nicotine-containing products. Medical practitioners should in the first instance recommend consumer products because:
(a) They are far more effective and successful (and safer, by multiple determinants);
(b) There is no cost to the taxpayer.

Patients who request a medically-approved approach may be accommodated, but:
1. There is a minimum 90% probability they will relapse (and as much as a 98% probability of relapse for certain products such as nicotine skin patches);
2. Some products such as psychotropic drugs have significant risk, and have caused hundreds of deaths compared to zero mortality for e-cigarettes for example;
3. The overall 90% failure rate means that use of pharmaceutical products entails a significant risk of mortality [ii].


[i] Advice to 'cut down on smoking' is about the least effective and most harmful form of 'harm reduction' possible. It reeks of a tortuous mechanism to avoid approval of consumer products.
[ii] And this risk of mortality may in some circumstances approach 45% - because if 90 out of 100 smokers relapse due to the 90% failure rate (much worse than this for some therapies), and if they continue to smoke, and if the reported 50% death rate from smoking is correct - then, clearly, there is a 45% risk of mortality for patients receiving pharmaceutical interventions for smoking cessation.

These issues are all obvious enough, but discussion of them appears to be carefully avoided.

It is understood, though, that an official body (a) cannot tell the truth, and (b) can only recommend official solutions. It should be recognised that this medicalised approach to harm reduction can only save a small fraction of the number of lives that a proper consumer-based solution would achieve; by following this approach the UK will save perhaps 1% proportionately of the lives saved in Sweden. Its principal (and only real) value is grudging recognition, suitably well hidden, that there is an alternative to the virtually worthless and discredited pharmaceutical approach.

NICE Guidance - Pros & Cons

Pros:
1. This gives official backing to harm reduction (although in a castrated version that is 99% less effective than real THR).

2. It definitively tells doctors that nicotine is virtually harmless and consumption is preferable to smoking - and this is crucially important, because a recent survey shows that almost half of doctors don't have a clue about this [2]  - they think nicotine is the harmful component in smoking and is associated with cancer.

3. It is the first step on a long road to official support for THR. Version 1 is crippled - but this is a case of baby steps. They'll get there in the end although it will clearly take decades at this rate.

Cons:
1. NICE (and therefore the NHS) appear, to a certain extent, to be attempting to gain ownership of tobacco harm reduction - which is a bit like McDonalds trying to own health food: essentially, ridiculous. It is so wrong, in so many ways, that it would take a separate article to list and explain the reasons.

Conclusion

What they should have done is outlined what real THR is, and told doctors the facts. In a way, they have done this - although it is so deeply buried it would take an expert to dig it out (but this guidance is not for experts).

What they have done is to promote Harm Management, an entirely different animal, without saying so.

It is hard to work out how this will work much better than the current system. The main difference is the official support for extended NRT prescription, which might raise the success rate of nicotine skin patches from 2% to as much as 4% or even 5%. Improving the failure rate from 98% to 95% appears to be seen as progress in the NHS. Compared with the worst-case success rate of around 30% for e-cigarettes and the proven 50% success rate of Snus, this is hardly major progress.

In fairness to them, they could have avoided the issue completely, and carried on down the same road as other national health services: a road that is a dead end. They did bite the bullet, and all credit to them for doing so.

All in all, this is progress - of the official UK type, therefore too little, too late. But it's better than nothing. Its principal value is the recognition that harm reduction exists and the implication that it is likely to work better than other approaches after the 20% prevalence barrier is reached; plus, the official statements that nicotine is relatively harmless, and that e-cigarettes can be used though not officially supported, are both very important steps forward.

This is Britain, after all: the medical establishment is about 20 years behind the times on average, and 40 years when it requires a paradigm shift such as this. So in about 35 years or so, you can expect NICE to support THR (i.e. the real version). By then, about 60% of smokers will have switched to ecigs, so NICE will have figured out by that time that consumer solutions are at least a thousand times more effective than anything the medical establishment (read: the pharmaceutical industry) can come up with - something we already know as it is so blindingly obvious.
 

How to do it properly and actually save life
Try looking at Sweden's unique national health statistics if you want to see how to go about it properly. They are the world leaders in reducing smoking prevalence and smoking-related mortality; and the only developed country in the world with any realistic prospect of reducing smoking mortality to insignificant numbers. Male smoking prevalence falls at 1% per year and will be at 5% in around 3 year's time (2016), with a concomitant fall in smoking-related morbidity and mortality. This is Tobacco Harm Reduction: a 100% consumer-driven process that gets incredible and unprecedented results.

The NICE version is an attempt to paper over the cracks in the NHS and will have very little practical effect; its value is perhaps that it educates doctors, and they are clearly badly misinformed when 44% think nicotine is associated with cancer and 15% even think NRTs can cause cancer [4].

It only goes about 1% as far as it should have gone, which is probably par for the course. As part of an overall process to improve the NHS's effect on smoking morbidity and mortality figures by replacing current methods with something that works, no doubt it is progress of a sort, as alternatives that do work finally get a sort of throwaway mention.

In the end, it should come as no surprise to anyone that even 'harm reduction' can, in the NHS, somehow involve even greater sales of pharmaceuticals. This Guidance is, in the final analysis, just another vehicle to promote long-term use of NRTs.

Tobacco Harm Reduction it is not, in any way, shape, or form.



 


NICE guidance - Expert commentary

Finally: some comments by a scientist expert in THR as opposed to the NICE personnel, who only have a passing acquaintance with it. Carl Phillips says:

"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 of 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 "expected 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.

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.

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 as entirely inadequate by those who support the medicines. 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 statement that smokers who reduce but do not quit entirely (or, more precisely have not [yet] quit entirely, since they still might do so) get some health benefits flatly contradicts currently popular anti-THR lies."


Please read his full article at:
http://ep-ology.blogspot.co.uk/2013/06/my-take-on-recent-uk-nice-guidance-on.html


 

__________________________

Notes

[1] Tobacco Harm Reduction or THR, when capitalised and used as a proper term, refers to a specifically defined process: the consumer substitution of cigarettes by the use of safer, lower-risk consumer products for ongoing use, and without cessation. Its principle differentiator is that it is orders of magnitude more effective in preventing death and disease from smoking than any form of medically-approved process.

[2] When used as a generic term, uncapitalised, tobacco harm reduction applies to any or all types of replacement of cigarettes, including by consumer or medical products; it can therefore mean Tobacco Harm Reduction (the consumer process) or Tobacco Harm Management (the medical process utilising NRTs).

[3] http://www.eccauk.org

[4] References page, Nicotine, 5.