This article outlines why some current research projects into the effects of nicotine could be regarded as less than relevant. Or more correctly perhaps: the PR with which they are released is inaccurate and overstated, for reasons unconnected with their medical value and more to do with inflated publicity. These studies tend to give the impression that something new has been discovered about the effects of nicotine, or its implications for use for leisure consumption; or that we don't know if nicotine could be harmful. Nothing could be further from the truth; and in fact, if either the researchers intended to give such an impression, or the associated PR is meant to give that impression, it would constitute an attempt to deceive.
In contrast, nicotine is part of the diet, everyone tests positive for it, attempts to eliminate it from the diet would probably result in sickness, and we have absolute proof that long-term ad lib consumption has little implication for health. As Dr Laugesen said, "Nicotine is one of the safest of drugs" [1].
The following article was written originally in response to a Brown U research project published with the usual sort of PR that we have come to expect with such events, and discussed in a BBC Radio 4 programme that also included material on e-cigarettes, featured elsewhere in The Library ('Medics, money, and e-cigarette regulation') due to its importance for understanding the financial motives behind e-cigarette regulation.
The BBC item is here:
BBC iPlayer - Inside Health: 28/02/2012
The material was first posted here:
http://www.e-cigarette-forum.com/fo...c-radio-4-about-e-cigs-today.html#post5455328
Brown University research
An item in the Radio 4 programme mentioned some new research from Brown U that seems to show nicotine may be harmful. Here we go again...
Nicotine is the most natural of all consumer stimulants and stress relievers as it is part of the diet and everyone tests positive for it. If you take 800 people and test them, they all test positive for nicotine [2]. It is present in many vegetables and is co-located with the vitamin nicotinic acid (niacin or vitamin B3), which is also a metabolyte of nicotine in some circumstances (the literature is extremely sparse here). This means that trying to remove nicotine from the diet would likely also remove vitamin B3 and lead to sickness. Nicotine is a natural part of the diet and it is unhealthy to avoid it. On the other hand, nobody tests positive for coffee, alcohol or chocolate (unless they have consumed it very recently). Nicotine is the most natural and normal of all the consumer products in this class - everybody has some, it is healthy to consume it, and unhealthy to avoid it. Like all such materials, the dose makes the poison (the only difference between a nutrient or medicine and a poison is the dose).
The 25 years-plus data on Snus usage from Sweden shows us that ad lib extended use of nicotine has little implication for health. Super-scale meta-analyses of large numbers of Snus studies by Lee and Hamlin show that a Snus user can expect the same same health outcomes as a non-smoker, since the difference in health outcomes for Snus users versus those who totally quit is not statistically significant.
In fact this data was used recently in the successful extension of NRTs for long-term treatment: the Snus data is the only data in existence on long-term consumption of nicotine (and there is a very large quantity of it). It strongly demonstrates it is safe. There is no increase of risk for any cancer or heart disease. There appears to be a small increase in risk for stroke but not of great significance. (The elevation of risk for stroke is too low to be reliably identified, and far lower than necessary to be clinically significant; but see [3].)
Data on this scale is rock solid: it cannot be massaged, perverted or misapplied. Snus is safe and is shown to be so.
Actually of course, as is often the case, clinical trials are unnecessary here. It isn't necessary to run a clinical trial to prove the sky is blue - just look out of the window. Since the effects are very clear at population level, trials are not really needed. Sweden has many less people dying from smoking than anywhere else comparable, and with mortality falling all the time, so trials are redundant in this respect - Snus saves huge numbers of lives. The national health statistics are the proof: these figures prove what can merely be demonstrated by clinical studies.
Clinical studies with anomalous results
A general principle of science is that you look at all the evidence, not a small part of it. If 150 clinical trials say something is safe, and 3 say there may be a small risk, you go with the 150. A new trial at Brown U might seem to show something interesting. If there are also more than 150 trials over nearly 30 years on essentially the same thing, it might be a good idea to look at them first before jumping to any conclusions. And if you also have rock-solid proof of the effect of what you are purporting to examine in clinical trials, from population level stats over decades, then new studies can be safely ignored unless they examine a previously-uninvestigated issue. We already know that there is no issue here, and in addition about 150 studies say the opposite.
Since we already have plenty of data on ad lib nicotine consumption by tens of thousands of people over several decades in an isolated population where all confounders can be identified and where we have proof and not just study data, we know that nicotine consumption by humans is on average harmless (i.e., supra-dietary nicotine consumption without smoke has an elevation of risk for any disease that is too small to be reliably identified.)
A little humor to conclude with
There is an apocryphal story that a vegetarian applying for a new job failed the smoking test the employer required all new applicants to pass. Even though the person was a non-smoker and could prove it, they failed the cotinine test for smoking, with a reading high enough to make it appear they were a smoker. (Everyone 'fails' this test of course, since all consume nicotine, so there is a level above which a person is assumed to be a smoker.)
Even though such a story is likely to be untrue since it would probably require a diet featuring large amounts of tomatoes, eggplants, potatoes, ketchup and tea, it does point out the problem in an amusing way: sorry, but you can't ban nicotine - and there is no need to anyway. Apart from being a dietary component with implications for its exclusion, it is the most natural consumer stimulant of all when consumed in quantity.
First ban coffee, tea, wine, beer and whisky, since they they are all far more alien and have equal or greater implications for health. There is no evidence that nicotine consumption is any more harmful than coffee consumption. Indeed, since we know that long-term Snus consumption over multiple decades is demonstrated to result in an average reduction in life expectancy of about 6 weeks (the range shown in studies is from 2 weeks to 10 weeks), it may be possible that coffee consumption has greater risks; like many other urban life factors, in all probability.
___________________________________
Notes
[1] Quotes
[2] Tobacco Harm Reduction UK -- refs. #9, #10
[3] A recent clinical study at 2014-03 investigated elevation of risk for stroke in long-term Snus consumers and found none. However we will keep Prof Lee's comment that there may be a small elevation of risk since his work is by far the most reliable of any medical statistician in this field.
In contrast, nicotine is part of the diet, everyone tests positive for it, attempts to eliminate it from the diet would probably result in sickness, and we have absolute proof that long-term ad lib consumption has little implication for health. As Dr Laugesen said, "Nicotine is one of the safest of drugs" [1].
The following article was written originally in response to a Brown U research project published with the usual sort of PR that we have come to expect with such events, and discussed in a BBC Radio 4 programme that also included material on e-cigarettes, featured elsewhere in The Library ('Medics, money, and e-cigarette regulation') due to its importance for understanding the financial motives behind e-cigarette regulation.
The BBC item is here:
BBC iPlayer - Inside Health: 28/02/2012
The material was first posted here:
http://www.e-cigarette-forum.com/fo...c-radio-4-about-e-cigs-today.html#post5455328
Brown University research
An item in the Radio 4 programme mentioned some new research from Brown U that seems to show nicotine may be harmful. Here we go again...
Nicotine is the most natural of all consumer stimulants and stress relievers as it is part of the diet and everyone tests positive for it. If you take 800 people and test them, they all test positive for nicotine [2]. It is present in many vegetables and is co-located with the vitamin nicotinic acid (niacin or vitamin B3), which is also a metabolyte of nicotine in some circumstances (the literature is extremely sparse here). This means that trying to remove nicotine from the diet would likely also remove vitamin B3 and lead to sickness. Nicotine is a natural part of the diet and it is unhealthy to avoid it. On the other hand, nobody tests positive for coffee, alcohol or chocolate (unless they have consumed it very recently). Nicotine is the most natural and normal of all the consumer products in this class - everybody has some, it is healthy to consume it, and unhealthy to avoid it. Like all such materials, the dose makes the poison (the only difference between a nutrient or medicine and a poison is the dose).
The 25 years-plus data on Snus usage from Sweden shows us that ad lib extended use of nicotine has little implication for health. Super-scale meta-analyses of large numbers of Snus studies by Lee and Hamlin show that a Snus user can expect the same same health outcomes as a non-smoker, since the difference in health outcomes for Snus users versus those who totally quit is not statistically significant.
In fact this data was used recently in the successful extension of NRTs for long-term treatment: the Snus data is the only data in existence on long-term consumption of nicotine (and there is a very large quantity of it). It strongly demonstrates it is safe. There is no increase of risk for any cancer or heart disease. There appears to be a small increase in risk for stroke but not of great significance. (The elevation of risk for stroke is too low to be reliably identified, and far lower than necessary to be clinically significant; but see [3].)
Data on this scale is rock solid: it cannot be massaged, perverted or misapplied. Snus is safe and is shown to be so.
Actually of course, as is often the case, clinical trials are unnecessary here. It isn't necessary to run a clinical trial to prove the sky is blue - just look out of the window. Since the effects are very clear at population level, trials are not really needed. Sweden has many less people dying from smoking than anywhere else comparable, and with mortality falling all the time, so trials are redundant in this respect - Snus saves huge numbers of lives. The national health statistics are the proof: these figures prove what can merely be demonstrated by clinical studies.
Clinical studies with anomalous results
A general principle of science is that you look at all the evidence, not a small part of it. If 150 clinical trials say something is safe, and 3 say there may be a small risk, you go with the 150. A new trial at Brown U might seem to show something interesting. If there are also more than 150 trials over nearly 30 years on essentially the same thing, it might be a good idea to look at them first before jumping to any conclusions. And if you also have rock-solid proof of the effect of what you are purporting to examine in clinical trials, from population level stats over decades, then new studies can be safely ignored unless they examine a previously-uninvestigated issue. We already know that there is no issue here, and in addition about 150 studies say the opposite.
Since we already have plenty of data on ad lib nicotine consumption by tens of thousands of people over several decades in an isolated population where all confounders can be identified and where we have proof and not just study data, we know that nicotine consumption by humans is on average harmless (i.e., supra-dietary nicotine consumption without smoke has an elevation of risk for any disease that is too small to be reliably identified.)
A little humor to conclude with
There is an apocryphal story that a vegetarian applying for a new job failed the smoking test the employer required all new applicants to pass. Even though the person was a non-smoker and could prove it, they failed the cotinine test for smoking, with a reading high enough to make it appear they were a smoker. (Everyone 'fails' this test of course, since all consume nicotine, so there is a level above which a person is assumed to be a smoker.)
Even though such a story is likely to be untrue since it would probably require a diet featuring large amounts of tomatoes, eggplants, potatoes, ketchup and tea, it does point out the problem in an amusing way: sorry, but you can't ban nicotine - and there is no need to anyway. Apart from being a dietary component with implications for its exclusion, it is the most natural consumer stimulant of all when consumed in quantity.
First ban coffee, tea, wine, beer and whisky, since they they are all far more alien and have equal or greater implications for health. There is no evidence that nicotine consumption is any more harmful than coffee consumption. Indeed, since we know that long-term Snus consumption over multiple decades is demonstrated to result in an average reduction in life expectancy of about 6 weeks (the range shown in studies is from 2 weeks to 10 weeks), it may be possible that coffee consumption has greater risks; like many other urban life factors, in all probability.
___________________________________
Notes
[1] Quotes
[2] Tobacco Harm Reduction UK -- refs. #9, #10
[3] A recent clinical study at 2014-03 investigated elevation of risk for stroke in long-term Snus consumers and found none. However we will keep Prof Lee's comment that there may be a small elevation of risk since his work is by far the most reliable of any medical statistician in this field.
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