twitter: @rolygate

NICE - Smoking: harm reduction

NICE - Smoking: harm reduction Quality Standard QS92, July 2015

Smoking tobacco harm reduction approaches
https://www.nice.org.uk/guidance/qs92
 

This document is the official UK government quality standard for provision of tobacco harm reduction in the medical environment; it is also in effect a position statement and guide, following on from PH45 (2013), and is designed to complement that guidance and to accord with the new TPD where required. The provision of a limited form of access to THR by a requirement to advise that 'unlicensed nicotine products' such as ecigs can be used now appears to be an official requirement.

QS92 - a Quality Standard for provision of harm reduction

There is lots of interest in here - for example, more official support for 'unlicensed nicotine products', i.e. ecigs - though delicately stated. It is an important step to take, making harm reduction provision of a sort a core requirement for medical services. In fact, the importance of this step can hardly be overstated.

It is also good to see that it is well-recognised that smoking is the problem, not necessarily tobacco: the title is smoking harm reduction and not tobacco harm reduction. Obviously, we know from Sweden that tobacco consumption can be close to harmless from a statistical perspective. However another reason for the use of the very accurate term 'smoking harm reduction' (in whatever form - with or without a colon in the middle to perhaps make it more acceptable currently) is that it enables avoidance of the specific term Tobacco Harm Reduction, which is defined as a consumer process of consumer choice by purchase of consumer products. That would be a step too far, currently.

Harm reduction must now be offered to patients

Commissioners of authorised stop-smoking services or SSS (local authorities) and providers must now ensure THR solutions are offered to clients of the services, and these solutions must include advice on how to obtain and use 'unlicensed products' such as ecigs. This is not just implied by the QS but stated. This is a very important statement as it is the opposite position to that pertaining in some other countries or regions, where consumer THR is in effect outlawed for economic reasons [1]. Quality Statement #3 makes clear that harm reduction must be offered, and that products such as ecigs can be discussed.

Note that the use of the term THR is avoided in order to prevent any accusation that the Department of Health supports it. This requires some workarounds and tippy-toeing around the issues, which is amusing in places. Principally, it is important to note that when used as a proper term when capitalised, as THR or Tobacco Harm Reduction, it is the specific definition of a consumer-driven solution: free choice to purchase safer consumer products. The offer of and management of supply of medically-licensed nicotine products for harm reduction such as NRTs is properly termed THM or Tobacco Harm Management: a medical process involving licensed products for harm reduction or more correctly Harm Management. So the avoidance of the term THR is correct (though amusing), but the similar avoidance of THM shows that NICE does not have full approval from the DoH to advise on substitution of safer products for smoking; presumably this problem originates with the fact that the DoH is, for all practical purposes, a pharmaceutical industry property and is aggressively opposed to any reduction in cigarette sales and therefore reduction in pharma revenues for treatment of the inevitable disease resulting [2]. A delicate situation, no doubt.

Licensed nicotine products are again described as 'safe and effective', when they are clearly neither.

  • They are not effective: they have a 9 out of 10 failure rate. To many people the preferred term would be 'virtually useless'. An accurate description would probably be something like 'marginally effective' or 'of no practical use without intensive mentoring to improve the success rates'.
  • Although intrinsically among the safest medicines available - since they are simply a megadose nutritional therapy - because they have a 9 out of 10 failure rate, causing 9 out of 10 patients to return to smoking, which we are told has a 50% risk for death, by straightforward calculation we can immediately see that NRTs have a 45% risk for death. A 45% risk of death is not normally considered a valid definition of 'safe'.

Pharmaceutical interventions for smoking cessation can have some success when supplied in a fully supported environment, and the success rate might perhaps be doubled. However, what is really being measured here is the mentoring effect, and the quality of the mentoring. Mentoring is needed for any real success with all methods of smoking cessation or avoidance and this includes use of ecigs just as much as any other solution; good mentoring gets good results.

Not that old cherry again!

There is a reference to one rather weird, pseudo health-related measurement: measuring cotinine levels in children as a designator of ETS exposure. On the Introduction page, "cotinine levels in children via exposure to tobacco smoke" is given as a desirable measurement procedure.

They don't mention what the point is of measuring nicotine metabolytes such as this when a significant level is a clear sign of a good diet rich in vegetables; or how they would differentiate between someone with a good diet or someone exposed to ETS, or both. This has all the trappings of a massive fail: complete lack of knowledge of crucial health designators such as correct diet and its measurement in the organism.

This is a repeated fail and occurs regularly among the ignorant.

NICE need to take advantage of the mistakes made previously by others in this area, such as the CDC (it is after all much wiser to learn from others' mistakes), who, not knowing much about diet, when they found that everyone everywhere tests positive for nicotine metabolytes such as cotinine (from dietary sources of course) after carrying out a very large clinical study - 800 subjects, who naturally all tested positive for nicotine metabolytes - decided it showed instead that everyone is exposed to ETS in huge quantities. Realising their mistake later, they tried to bury this clinical study (we show it on the References page). Fails on this scale must surely penetrate down even to the depths of the medics advising NICE and proofreading their materials? Apparently not, otherwise howlers on this scale would not feature.

Technical details: tests using plasma nicotine levels, or plasma (or other) metabolyte levels (e.g. cotinine measurements), must have a cutoff point to differentiate good diet from active tobacco use. Currently, the cutoff is advised as 3ng/ml plasma nicotine measurement by Benowitz: below this figure could be dietary nicotine, above it could be active tobacco use. Due to the minuscule levels that might be caused by exposure to nicotine in ETS, it is clear this measurement is useless for determination of exposure to ETS unless the subject could be previously confirmed as a non-smoker suffering from extreme malnutrition and thus unlikely to show any of the normally-seen metabolytes from compounds in vegetables.

By extension there must be an equivalent cutoff point for cotinine, whether via plasma, saliva or urine measurement; this methodology is at best unreliable and at worst quackery. This method is extremely flaky by nature and it is preferable to use a CO monitor (carbon monoxide tester) to identify smokers. As a method to identify ETS exposure it is disastrously incompetent from the start, as anyone with even basic knowledge of the subject would know. People (including children) consume nicotine in the diet, this is normal and desirable, and unless they test positive for metabolytes they are likely to be suffering from malnutrition. Indeed, the only useful function of a cotinine test for children is to determine if they are likely to have a proper diet.

Thus, the treatment advisable for a child with no measurable cotinine levels is to increase consumption of vegetables; and the treatment (if any) for a child with measurable cotinine levels is to determine whether the diet is good, or exposure to cigarette smoke is taking place, or both, and then act accordingly if that seems desirable; but it is a shaky foundation on which to manage treatment and does not deserve any mention in official documentation unless there are policy objectives and treatment guidelines for both improvement of paediatric diets and protection from exposure to smoke. Currently, it would probably be better to remove such references, especially since the knowledgebase needed to effect improvements in treatment does not seem to exist at NICE.

Because of the potential seriousness of a howler such as this appearing in a national Quality Standard for medical treatment, there are some who might suggest that a doctor without a good nutritional qualification, regularly updated, ought not to be able to have input into national guidelines, since otherwise there is a risk of promoting quackery. Indeed, some might suggest this ought to apply to all doctors.

The MHRA

It is mentioned in QS section #3 that nicotine products 'not regulated by the MHRA' may be used, although with some reservations as quality standards are not known at this time. However, from May 2016, ecigs will be regulated by the MHRA whether licensed or not, so presumably this text will need editing. This is because full and complete oversight, absolute control, enforcement of standards, with reference to fully-documented standards, and legal proceedings instigated for non-compliance with technical and marketing standards is regulation. There isn't any other term that could be used as this is the definition of regulation.

The MHRA will regulate all vapour products, including all medical and consumer ecig-related products. Therefore, any statement that 'the MHRA do not regulate consumer products' or suchlike will be false and will need changing; it remains to be seen whether extreme inaccuracies (aka lies) will be tolerated in official documents, and the statement in its current form will be an outright lie after May 2016. It would be useful if someone who knows something of the situation can advise NICE.

Smoking less = harm reduction

Reducing the number of cigarettes smoked is described as harm reduction. This illustrates two points:

  1. Less cigarettes = less harm. This is a direct statement of the relationship between the amount smoked and the degree of harm. This is by no means a universal position among governments, or in the Public Health industry, so is of interest.
  2. The rather pathetic and ineffective position of government agencies when they cannot simply advise people to do what works best and properly assist them to do it: substitution and cessation if required. That is, become a vaper or Snuser and quit smoking, with the same health outcomes as if total cessation of all products had occurred (proven - not just strongly demonstrated - in Sweden); then quit the THR products if that suits, since it is far easier to quit vaping than smoking.

QS92 is an improvement in some areas as it reiterates support for harm reduction, although in the small sense of the term. More importantly, it enforces provision of harm reduction on local providers, and since it specifically advises that unlicensed products can be used and tells providers this is an officially-endorsed option and is part of the quality standard, it is an important step. It is very delicately handled indeed, indicating that there are multiple issues here, and we can well imagine what they are.

It also indicates there will be some problems ahead as the MHRA will fully regulate both medical and consumer vaping-related products from May 2016, as required by EU law (the TPD Article 20). It shows there is basic support for harm reduction even in the area of smoking, even in a government agency, when this is directly opposed by other governments and regional governments in larger countries, and of course within the UK government itself. It shows that the DoH has something of a dilemma here as its policymakers, the pharmaceutical industry, are rigidly opposed to any form of consumer harm reduction in this area as it directly impacts significant revenues from disease therapies such as cancer treatments, but its more honest scientific advisors are strongly in favour of (real) harm reduction. It will be interesting to see how that situation plays out.

What the future holds

The MHRA will almost certainly try to eliminate vapour products except for those they cannot ban, such as the tobacco industry's mini ecigs - also known as placebos. At that point, all the effective products will have to go black market and the SSS (official local Stop Smoking Services) will no longer be able to support the use of effective products, since it is hardly likely they will be able to continue to offer vouchers for ecig purchase when those products are 'illegal'. The legal products will be useless for any practical purpose and especially for smoking avoidance or cessation. This means that:

  • THR will no longer be an unofficial but effective option for local SSS providers as the remaining products won't work.
  • Clients will either no longer use local SSS providers or will use black market products in order to successfully avoid smoking.
  • All the good work done by local SSS staff to maximise smoking cessation opportunities, to fully develop results, and to reverse the decline in clients for the SSS - specifically that originated by Louise Ross in Leicester - will probably be at risk. It is extremely unlikely that any usable products (i.e. effective, available, affordable) will remain legally available after the MHRA has been in control of regulation for a couple of years.

The MHRA's agenda is entirely determined by the pharmaceutical industry [3], and the last thing pharma needs is less smoking. So, we already know what direction they will take.

Conclusion

NICE have again supported THR but in the most conservative way possible. It has been asked why they did not go further, but we already know this is impossible. In the balance between the honest scientific advisors who know what will work best and official policy favouring the pharmaceutical industry always implemented by the DoH, a state of equilibrium has been reached: the DoH have had to permit some mention of real and effective harm reduction (i.e. consumer THR), as long as it doesn't go too far. Pharma will not allow anything more, and it is as simple as that. Indeed, the current balance must have been achieved by a massive scrap between the technical advisers and the policymakers that obviously risked going public, or the DoH would never have allowed even this paltry admission of the existence of THR to take place.

We see the same kind of thing happening at Cancer Research UK, where it is clear that their scientific advisors have told them that CRUK must abandon pharma's lies and propaganda campaign or risk losing all scientific support and having the issue blow up in public. This must be a critical issue for CRUK, since by complying with the wishes of their technical advisors and not simply continuing to comply with pharma's orders (to lie blatantly about THR and vaping, as the US cancer groups do, and just keep taking the money in order to protect chemotherapy revenues), they clearly show they need a much higher level of public support and faith than their US equivalents. This would be challenged by a public spat between CRUK and the scientists, so they have been forced to stop protecting profitable cancer (by protecting cigarette sales by blocking THR).

Perhaps it's just a simple matter of less money being available for greasing the wheels in the UK compared to the US. We can probably expect to see more public fundraising drives by CRUK to make up for the shortfall in funding caused by loss of the corrupting pharma funds for propaganda to protect cigarette sales from THR, which is the only viable threat now that the 20% Prevalence Rule operates.

Whatever the reason for CRUK's sudden attack of honesty and its apparent wish to now stop protecting cancer, which is of course a pharmaceutical industry imperative and a very well-funded one, we should congratulate them on leaving the machine and joining the human race at last.

The same principle applies elsewhere and this is what we are looking at with NICE QS92: honest scientific advisors putting pressure on their organisations to stop lying for profit. The DoH will never accede to such requests, since it would require putting a gun to the head of senior staff who will lose monster benefits especially in the form of later employment at massively inflated rates if pharma's orders are ignored (from the 'revolving door' method that industry uses to make policy by controlling government staff). So, the tiny and almost insignificant progress in honesty at NICE must have been the cause of some battles; and though the balance achieved isn't much, it's all we've got in a market area and regulatory area utterly dominated and controlled by the pharmaceutical industry, who have unlimited funds to grease the wheels, who regard protecting cigarette sales as one of their most important policy objectives, and who in effect make the law.

At least we are doing much better than the USA in this regard, which should be a point of national pride; and this progress is entirely due to the unshakeable honesty of many scientific and technical advisors here. This progress must have come at considerable personal cost to them and we need to recognise that.

 

It might also be useful if NICE employed someone with modern basic medical knowledge such as the effect of diet on health. Apparently their staff inhabit lofty realms of ideology or are about 20 years out of date, and are slightly lacking in fundamental knowledge of basic health issues. Perhaps a real doctor could be employed to proofread their materials. Anyone in the 21st century who claims knowledge of health issues but doesn't know that nicotine is an active nutrient consumed by all in the normal diet is nothing more than a quack and a charlatan, and the concept they are setting medical policy is frightening. Perhaps it doesn't matter so much if they keep quiet about the fact - allowing for the wide yellow streak running down the back of many senior medical advisors - but the revelation they know nothing about diet and health in the year 2015 is seriously frightening.




-----------------------------
Notes

[1] The principal opponent of THR is the pharmaceutical industry, who have two giant revenue channels and one minor channel dependent on smoking:
i. The expensive and highly-profitable treatment drugs for serious smoking-related disease, such as chemotherapy drugs, COPD drugs, CVD drugs etc.
ii. The massive boost to the most profitable of general drug sales caused by the increase of general disease attributable to smoking. As an example, a smoker is >40% more likely to be a diabetic than average. This boost applies across the board, and profitable drug sales for diabetes, high cholesterol, high blood pressure and so forth are significantly higher due to the smoking-related disease effect. According to ASH UK, for every one of the 100,000 in the UK reported to die annually from smoking, another 20 are sick; therefore 2 million are constantly sick, and these diseases are expensive and profitable to treat. This may not even be the complete picture, as we don't know if it includes all possible instances of illness, or OTC meds sales, bearing in mind that smokers make chemists (pharmacists) rich with their chest ailments and suchlike.
iii. The small but significant revenue channel from smoking cessation meds. This channel is the fastest to be affected by efficient THR products, though the other two channels are massively larger and more profitable (smoking generates at the very least 10% of pharma's gross revenues; and it is easy to calculate that, in the UK, they make more from smoking than the tobacco industry does).

Smoking is a crucially important revenue driver for pharma. Virtually all opposition to THR that results in practical measures (i.e. laws) can be traced back to the pharmaceutical industry. They are by far the strongest, most prolific and most effective protector of cigarette sales, and they make more from smoking in the UK than the tobacco industry does.

[2] Because the pharmaceutical industry in effect controls government policy in all areas related to health, there is an ongoing contest between their representatives in government versus the honest contingent among the government's scientific advisors. Currently there is something of a balance, and both sides are careful not to antagonise the other in public. There's probably a lot of paddling under the surface though...

[3] Research the term 'regulatory capture'. It applies perfectly to the MHRA, who religiously protect the pharmaceutical industry even at the expense of public health. No decision ever harms pharma profits - such a policy decision is unthinkable.

 

 


created 2015-07-03
update 2015-07-07