Foulds et al‘s e-response [1] provides an excellent and scathing critique of the commentary contributed by Tomar et al [2]. Though Foulds et al are far too modest to point this out,
it is important that readers understand that their original review [3] is a substantial and careful piece of work, properly edited and peer-reviewed. In contra...
Foulds et al‘s e-response [1] provides an excellent and scathing critique of the commentary contributed by Tomar et al [2]. Though Foulds et al are far too modest to point this out,
it is important that readers understand that their original review [3] is a substantial and careful piece of work, properly edited and peer-reviewed. In contrast, while Tomar et al response [2] has the appearance of an evidence review, it is a commentary that has not
been peer-reviewed. As Foulds et al [1] very ably demonstrate, their commentary is little more than a catalogue of misinterpretation, misunderstandings and non sequiturs that would not withstand even the most cursory peer review. It is troubling that it stands published in
the paper edition of Tobacco Control, appearing to the untrained eye to have equal status to and, worse still, the last word on the excellent work by Foulds et al [3].
The paper by me and colleagues, Bates et al [4], is not an attempt to review the literature, as this has been done elsewhere and anyone wishing to have an objective appraisal of the evidence can do so. Our attempt was to develop a conceptual and ethical framework for
discussing and managing harm reduction, and to suggest what implications the science has for policy in Europe. Kozlowski et al [5] provide a welcome continuation of that effort by discussing what sort of evidence is required to justify action (or a move from the evidence-free support of the status quo) and remind us that real people are involved by invoking the ‘what-to-tell-your-brother’ thought experiment – which they address with a sane and humane argument.
A disturbing aspect of Tomar et al’s contribution is the way that convoluted argument and a blizzard of mostly meaningless statistics have been deployed to make some sort of case against harm reduction. The style is reminiscent of the ‘keep the controversy alive’ strategies of the tobacco industry – the sort of thing we have seen for years purporting to demonstrate that there is no link between smoking and lung cancer or that passive smoking is harmless. Indeed if distraction was the aim, they will probably be successful. Such
obfuscation is a gift to timid law-makers and regulators seeking an excuse for continuing inaction.. The question is, what are they trying to achieve? And who’s interests do they think they are protecting? At least with the tobacco industry, that bit is obvious.
Equally disturbing is the profound bias against the use of common sense and “reality checking” that Tomar et al display. Many of the findings in Foulds et al [3], and drawn upon in Bates et al [4], are not at all surprising. In case anyone is
disorientated by the arguments here are a few pointers back to the real world:
It is hardly surprising that use of snus is much less hazardous than smoking tobacco. The latter involves drawing a toxic mixture of volatile organics, oxidants and super-heated reactive particulates into the delicate tissues of the lungs. The former doesn’t – there are no
products of combustion or inhalation.
It is hardly surprising that snus would be useful in smoking cessation. NRT is agreed to be effective but in several respects snus has superior characteristic as a substitute for smoking. It offers a stronger bolus of nicotine and some of the other sensory aspects of
tobacco found in cigarettes but not in NRT. Why wouldn’t it be a better cessation aid for smoking than NRT?
It is hardly surprising that Swedish smokers might instinctively know snus is a safer option for continuing nicotine use because of the physical processes involved and therefore switch to it or use it from the outset to control their health risks.
It is hardly surprising that the desperate efforts to find a gateway effect have failed. Sweden has the lowest male smoking prevalence in the world but with high levels of snus use. If snus is a gateway then where are all the smokers emerging the other side of the snus gateway? Snus is a gateway out of smoking and an alternative to it for some that would otherwise smoke – that’s why male smoking
prevalence is so low.
It is hardly surprising that male smoking in Sweden is the lowest in the developed world, and I think the only place where male prevalence is below female. The obvious unique factor is that many men in Sweden use their tobacco and get their nicotine in a different way – through snus. The effort that has gone into denying this simple truth
is astonishing. But the corollary of claiming that snus doesn’t contribute to the low male prevalence is that some other reason must be found, and that the use of snus is in effect additional to smoking. It means male smoking is held at a record low level by some other factor that no-one can convincingly identify. In fact it would be very
surprising if the widespread use of tobacco in another form didn’t reduce smoking, as these are substitute products.
It is hardly surprising that female smoking is also low, even though there is little snus use among women. Admittedly, some of this may be due to Sweden’s tobacco control efforts – but there are no plane-loads of experts from California, Atlanta or Massachusetts trying to discover the secrets of Sweden’s amazing results on per capita programme spend of about one tenth of the top US programmes. There is a less surprising explanation. Doesn’t the tobacco control community see ‘de-normalisation’ as one of the most important approaches. This justifies tireless campaigning for smoke-free environments in the hope that it will de-normalise smoking, remove sensory cues to smoke and provide a temptation-free environment that supports quitting. But
this is exactly what snus use does. And furthermore, it takes the denormalisation of smoke into the home. It would be very surprising if snus use among men in Sweden didn’t drag down female smoking through de-normalisation.
It is hardly surprising that sane public health advocates should call for snus to be un-banned in Europe and no longer lied about in the US. There are no precedents we can think of for banning a many-times
less hazardous variant of the market leader (in this case cigarettes). In fact, if it was attempted in any other area of public life, we would think the perpetrators were acting immorally, and probably illegally. Banning a much less hazardous version of a product that causes a great
deal of harm is just plain dumb.
It is not surprising that the widespread use of a much less hazardous alternative to the market leader tobacco product reduces harm and has a net public health benefit both through reducing active smoking and passive smoking exposure. What is surprising is that legislators in Europe have decided to deny smokers outside Sweden the
option to use products like this to take control of their risks, and have thereby stopped a market in harm reduction products developing. The equivalent American approach appears to be to do this by misleading smokers about smokeless tobacco. Sadly, this credibility-busting
tactic seems to have spread to the once-authoritative US Surgeon General in his recent testimony to Congress, thus supporting those that wish to devalue the science base underpinning tobacco control.
Of course, the fact that something isn’t surprising doesn’t make it so – but common sense is a good starting point for reality-checking very convoluted, tenuous or unconvincing arguments [2] and gives extra confidence when careful assessment of the evidence converges with our understanding of how the real world and real people work [3].
Finally, I would like to say that I think this is actually quite a simple issue, not the great complex challenge that some suggest. It is beyond doubt that smokeless tobacco products are much less hazardous and can substitute for the market leader, cigarettes. No-one has the right to stop nicotine users taking responsibility for their health by switching to such products if they choose to or cannot or will not give up tobacco or nicotine. Where did Tomar et al, the US Surgeon General, the European Union and others acquire the authority and astonishing high-handedness to sit in their smoke-free citadels and deny smokers these potentially life-saving choices?
I think a strong regulatory framework is a good idea and that there is an opportunity to achieve it in Europe, if the tobacco control community is clear that its goal is to reduce death and disease, not just have fights with the tobacco industry. But should a new regulatory framework be a pre-requisite for moving from the status quo in which this option is banned outright in the EU? Well, I
also think that the status quo is unacceptable - banning a product that is so much less hazardous than the market leader is such an egregious violation of the right of smokers (and potential smokers) to contain the severe risks they face, that it should be reversed even under the
current regulatory environment.
Should American campaigners be honest with the public about relative risks of smokeless and smoking? In my view there is not even an overwheening paternalist case for misleading people about this, let alone a respectful, honest, citizen-focussed public health justification.
Clive Bates [Former director of Action on Smoking and Health UK, writing in a personal capacity]
[1] Foulds J, Ramstrom L, Fagerstrom K. Effects of smokeless tobacco in Sweden: a reply to Tomar et al. Tobacco Control Online, 5 Dec 2003
[2] Tomar SL, Connolly GN, Wilkenfeld J, et al. Declining smoking in Sweden: is Swedish Match getting the credit for Swedish tobacco control’s efforts? Tobacco Control 2003;12: 368-371
[3] Foulds J, Ramstrom L, Burke M, et al. Effect of smokeless tobacco (snus) on smoking and public health in Sweden. Tobacco Control 2003;12: 349-359
[4] Bates C, Fagerstrom K, Jarvis MJ, et al. European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health. Tobacco Control2003;12 360-367
[5] Kozlowski LT, O’Connor RJ, Quinio Edwards B. Some practical points on harm reduction: what to tell your lawmaker and what to tell your brother about Swedish snus. Tobacco Control 2003;12:372-373
Watching this first salvo in the battle over whose nicotine is safer
and which side eventually makes the big nicotine maintenance bucks, Big
Pharm or Big Oral Tobacco, is sad yet understandable? Even for those few
without any financial stake in the debate, imagine the natural
frustrations born from having turned the wrong research or policy corner
and dedicated two decades of your life to having chosen to fight nicotine...
Watching this first salvo in the battle over whose nicotine is safer
and which side eventually makes the big nicotine maintenance bucks, Big
Pharm or Big Oral Tobacco, is sad yet understandable? Even for those few
without any financial stake in the debate, imagine the natural
frustrations born from having turned the wrong research or policy corner
and dedicated two decades of your life to having chosen to fight nicotine
addiction by feeding nicotine addicts more nicotine.
We've already watched as half-baked pharmaceutical financed science
undertook the intentional destruction of the credibility of earth's most
productive means of nicotine dependency recovery. We watched as Big Pharm
bought the policy door keys and embarked upon a massive campaign to erase
earth's most productive tool from cessation literature around the
globe.[1] In exchange for what, the Swedish experience or NRT?
Before throwing in the towel wouldn't a bit of reflection upon where
your last campaign took us be in order? You threw out the baby with the
bathwater in declaring the life's work, and the daily dependency recovery
programs of thousands, to be unscientific. Why grab hold of a shark when
drowning, when the water is just five feet deep?
The March 2003 OTC NRT meta-analysis published here in TC found that
only 7% succeeded in remaining smoke-free at six months.[2]
A November 2003 persistent NRT use study, also published here in TC,
suggests that as many as 7% of gum users may still be chewing nicotine at
six months.[3] If true, who actually broke free from nicotine while using
it? Unlike the one puff lesson that can eventually flow from repeated
attempts at abrupt cessation, we've known since 1993 that the only lesson
flowing from repeated NRT use is that the odds of relapse increase to
nearly 100%,[4] but that too has been kept a secret from those who needed
to know.
Overzealous public health officials must be held accountable for the
demise of highly effective community-based abrupt nicotine cessation
programs, many of which were achieving 40% midyear nicotine cessation.[5]
Imagine a mind so convinced its right that its willing to pervert the term
"science based" and use it as a weapon in order to destroy the credibility
of superior performance, so that it can claim market share and carry out
its own grand insane nicotine weaning experiment.
Now it's almost as if many of those same so called "experts" who so
badly damaged worldwide cessation (some of whom have never personally
conducted a single cessation clinic program themselves)have given-up on
dependency recovery and embarked upon a massive new social experiment to
try and transfer their failure to "safer" forms of delivery.
Worldwide cessation is in shambles and now we must watch as those
who've made the mess argue whether sloshing nicotine-rich tobacco juices
around in the mouth or allowing NRT to at last live up to its name -
"replacement" not "cessation" - is the answer to all our problems.
No one here argues with the logic of cleaner delivery but we should
all be deeply troubled by the knee-jerk cattle herding tactics and
priorities already employed by those now pushing transfer to "safer"
delivery. Many teach at institutions whose graduates mold society yet
somehow they seem unable to comprehend that, to one degree or another,
every graduate of effective community-based recovery programs became
recovery teachers themselves. High quality short-term abrupt cessation
education, skills development and support programs have now all but
vanished, having lost funding and favor after having been declared non
science-based, and overrun by those toying with months of weaning.
I submit that all nicotine dependent humans are entirely capable of
quitting. I submit that any attempt by science to put a positive spin on
any form of nicotine dependency should cast science in the same mold as
any other drug pusher, as more humans, not less, will become dependent.
I'm not talking about true harm reduction efforts but marketing spin and
easy access that will inevitably snare the curiosity and lives of untold
thousands of youth.
We need only look to Nicorette's current nicotine gum marketing spin
to begin to imagine just how out-of-hand a license to push daily
maintenance will quickly become.
Its website asserts that "Once in your brain, nicotine begins
working. It stimulates the secretion of neurotransmitters (chemicals in
the brain), which appear to enhance awareness and judgment. Nicotine also
increases dopamine levels, improving your mood. The substance has also
been known to even enhance memory and reduce aggression." ... "Heightened
awareness. Enhanced judgment. Better moods. Adrenaline boosts. No wonder
cigarette smoking is hard to quit."[5]
Imagine the tactics that will be employed by the tobacco industry
once Pandora's box is fully opened. Just one question, why would you again
demand the entire world as your stage when any damage could have been
limited to small test communities? It's probably a good thing that TC
does not require disclosure of financial interests. Profits or science?
[1] Polito, Is cold turkey quitting more productive and effective
than NRT? WhyQuit, July 2003 -
http://whyquit.com/whyquit/A_Cold_Turkey.html
[2] Hughes, JR, Shiffman, S, et al., A meta-analysis of the efficacy
of over-the-counter nicotine replacement . Tobacco Control, March
2003;12:21-27 - http://tc.bmjjournals.com/cgi/content/full/12/1/21
[3] Shiffman S, Hughes JR, et al, Persistent use of nicotine
replacement therapy: an analysis of actual purchase patterns in a
population based sample, Tobacco Control 2003 November; 12: 310-316 -
http://tc.bmjjournals.com/cgi/content/abstract/12/3/310
[4] Tonnesen P, et al., Recycling with nicotine patches in smoking
cessation. Addiction. 1993 Apr;88(4):533 -
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8485431&dopt=Abstract
[5] CDC Sept. 4, 1992 MMWR, Public Health Focus: Effectiveness of
Smoking-Control Strategies, United States -
http://www.cdc.gov/mmwr/preview/mmwrhtml/00017511.htm
[6] Nicorette website, How smoking affects your body.
http://nicorette.quit.com/nicr_internal/nrt1.asp
Last week in the BMJ 2003; 327 (6 December), after seeing his
comments on the Enstrom and Kabat paper on second-hand smoke being used by
Forest to advance the tobacco industry’s position, the BMJ Editor says in
a fair and frank admission:
"Reading the quote on a Forest advertisement tightens my anus, but I
wrote it and can't deny it."
Health Professionals who have been working hard towards getting
che...
Last week in the BMJ 2003; 327 (6 December), after seeing his
comments on the Enstrom and Kabat paper on second-hand smoke being used by
Forest to advance the tobacco industry’s position, the BMJ Editor says in
a fair and frank admission:
"Reading the quote on a Forest advertisement tightens my anus, but I
wrote it and can't deny it."
Health Professionals who have been working hard towards getting
chewing tobaccos banned in the many South Asian Communities in the UK had
been using the Snus ban to advance their argument. Many now feel that the
Tobacco Industry will use this paper, as was the Enstrom/Kabat paper in
the reversal of Second Hand Smoke Ban Policies, to undermine the whole
smokeless tobacco ban strategy.
In our experience, chewing tobaccos (many are packaged in shining
packets to entice kids) are the gateway to up taking of smoking later. The
child starts by using a "mouth freshener" pack of Gutkha tobacco and then
after getting addicted to nicotine in the smokeless tobacco, advances to
taking up smoking.
At the 12th World Conference on Tobacco and Health in Helsinki (3-8
August 03), the last smokeless tobacco session was heated and electric.
Bengali, Indian and Pakistani health professionals were concerned about
the impact the lifting of the flood gates of an EU ban would have on their
public health efforts to get gutka, zarda and other smokeless tobacco
banned.
UK South Asian Communities and their use of smokeless tobacco were
seen as the crack/ loophole in EU/UK Tobacco Control Legislation. The Snus
vehicle/bandwagon could be driven through this. This study has just given
the tobacco industry the starter key.
We brace ourselves now. What orifice will the BMJ Editor tighten next
time when this study is used in the undermining of smokeless tobacco use
in the future?
Kawaldip Sehmi's letter seems to advocate ignorance and a kind of
book-burning attitude to understanding this area. But in fact, better
knowledge of the science might help his cause.
The paper by Enstrom and Kabat caused problems not because its
findings conflicted with the established evidence base, but because it was
flawed and the BMJ failed to put its contribution in context with the rest
of the large evidenc...
Kawaldip Sehmi's letter seems to advocate ignorance and a kind of
book-burning attitude to understanding this area. But in fact, better
knowledge of the science might help his cause.
The paper by Enstrom and Kabat caused problems not because its
findings conflicted with the established evidence base, but because it was
flawed and the BMJ failed to put its contribution in context with the rest
of the large evidence base. In contrast, Jonathan Foulds and his
colleagues have done a good job at dispassionately examining and
presenting the evidence on snus in Sweden, and the comparison with Enstrom
and Kabat is unjustified.
Here are two examples where the developments that flow from this
analysis may work to the advantage of the community Kawaldip Sehmi is
concerned about (and where his ideas might cause more harm)...
If a regulatory framework was introduced in Europe for smokeless
tobacco as part of unbanning snus (and this is what the harm reduction
supporters are pressing for), it is likely many of the South Asian
imported products would not meet the standard and have to come off the
market. There may be a market response that reduced the hazardousness of
the range of products available to the S. Asian community - either becase
the S. Asian manufacturers would comply, or because other compliant
products would enter the market to meet the gap. This would be an
improvement on the status quo.
Science might also help re-think the evidence-free campaign to get
these other smokeless tobacco products banned - in the UK or in S. Asia.
How do the campaigners know that the former smokeless tobacco users would
turn to the much higher risk smoking products? How do they know that those
that would have started to use smokeless products would not just start to
smoke instead? (and this would be a great opportunity for predatory
cigarette companies). If they do, then they will be at much higher risk.
In taking that gamble, what are the campaigners hoping to achieve through
a prohibition and do they mind if some people are at greatly increased
risk as a result of their idea? When Sweden joined the EU it was granted
an exemption from the ban on oral tobacco - and it is a good thing too,
because there would be more Swedish smokers now if the ban had been
imposed. From reading Foulds et al's paper even the most extreme flat
earth "quit or die" advocates cannot think that the EU's ban should be
extended to Sweden - surely! But if not, why not? And if not in Sweden,
should that give prohibitionist campaigners pause for thought about their
campaigns to achieve this elsewhere? Sweden's experience issn't
necessarily applicable everywhere - but it is a reason for caution about
banning smokeless tobacco anywhere.
Please let's have less talk of editorial orifices and recognise that
Tobacco Control journal and its editor are doing public health a service
by shining light on this murky former no-go area and challenging some ill-
considered orthodoxies.
Readers should note the following motion placed before the UK
parliament on this topic on 10 December 2003:
SMOKELESS TOBACCO 10.12.03
Flynn/Paul
That this House welcomes the confirmation from Cancer Research UK Action
on Smoking and Health and the Royal College of Physicians that some forms
of smokeless tobacco are between 500 and 1,000 times less hazardous than
smoking tobacco; agrees with the conclusion tha...
Readers should note the following motion placed before the UK
parliament on this topic on 10 December 2003:
SMOKELESS TOBACCO 10.12.03
Flynn/Paul
That this House welcomes the confirmation from Cancer Research UK Action
on Smoking and Health and the Royal College of Physicians that some forms
of smokeless tobacco are between 500 and 1,000 times less hazardous than
smoking tobacco; agrees with the conclusion that, if Britain followed the
Swedish pattern of smokeless tobacco use, tobacco-related deaths among men
would be cut by 44,000 a year; and urges the Government to end the ban on
the sale of snus which will allow inveterate smokers access to a safer
alternative that would add several years to their life expectancies.
The motor racing piece that prominently features tobacco company
sponsorship and brand logos in the August issue of Maxim (News Analysis
2003;13:348) is not alone. That same month, a seven page article provided
similar exposure for Jordan’s association with B&H in FHM, the leading
UK ‘lad mag’ (circulation circa 600,000).
These promotions, of course, reflect standard tobacco industry
strategy of circumventin...
The motor racing piece that prominently features tobacco company
sponsorship and brand logos in the August issue of Maxim (News Analysis
2003;13:348) is not alone. That same month, a seven page article provided
similar exposure for Jordan’s association with B&H in FHM, the leading
UK ‘lad mag’ (circulation circa 600,000).
These promotions, of course, reflect standard tobacco industry
strategy of circumventing advertising bans through coverage of their
sponsorship and promotion of motor racing, and the readership of FHM and
Maxim - predominantly young men - fits a traditionally important market.
Of perhaps greater concern is the appearance of an advertisement for
Subaru sports cars in the sport section of the UK Sunday paper The
Observer, (29 June, 2003). The quarter-page ad, a much more subtle
approach than the glossy picture spreads of FHM, featured a photograph of
winning driver Petter Solberg’s Subaru World Rally Team (SWRT) car at the
2003 Cyprus Rally and the accompanying caption informed readers that they
too could be winners by taking advantage of current prices on a range of
Subaru models. What was noteworthy about the ad was the central place and
visibility given the State Express 555 livery on the car.
The Advertising Standards Authority (ASA), however, saw no problem
with the Subaru promotion, noting in its response to a written complaint:
“the advertisement is for Subaru cars and shows a winning rally car that
features the sponsor’s branding…. [it] is clearly intended to draw
attention to the car and does not place emphasis on tobacco.”
The Observer’s circulation figures generally hover around the 450,000
mark and while not one of the biggest Sunday papers, it could reasonably
assumed to have a much broader readership than the monthly men’s magazines
mentioned above, not least children and teenagers who leaf through the
Sunday papers in their homes.
Like many others, John Polito [1] misses the point about smokeless
tobacco. It is not a health strategy to be widely recommended by doctors,
nor is it a medical smoking cessation treatment, nor should it be part of
a community-based health programme. It is, or should be, part of a market
for nicotine products in which the world will go on allowing the sale of
cigarettes - the most hazardous form of nicotine. It should b...
Like many others, John Polito [1] misses the point about smokeless
tobacco. It is not a health strategy to be widely recommended by doctors,
nor is it a medical smoking cessation treatment, nor should it be part of
a community-based health programme. It is, or should be, part of a market
for nicotine products in which the world will go on allowing the sale of
cigarettes - the most hazardous form of nicotine. It should be a real-
world assumption of all those working in public health that cigarettes
will continue to be sold legally for the foreseeable future, and that
their decline (which I believe is inevitable) will come as people,
communities and wider society turn away by choice and through development
of new norms. The availability of much less hazardous forms of the
product makes sense in that context.
Polito's method may well work for some people some of the time -
though I notice he cites only himself, self-published on his own web site
as evidence for this. But even on the generous assumption that there is
something in his approach, it cannot be the only possible route for
reducing tobacco-related harm. What if people just don't want what he has
to offer? What if people can’t or won’t quit using nicotine? What if they
need to come off nicotine more gradually? Do you just deny them an
alternative to reduce their risks because they are not doing or cannot do
what you think they should? Frankly, that is an authoritarian “quit or
die” mindset that belongs to an earlier century (not even the last one).
Tomar and his colleagues [2] clearly do not like to be referred to as
advocates of “quit or die” - but that is exactly the choice they offer.
However much they dislike it, the label will stick because it is accurate.
Polito takes that prescription a step further into "quit my way or die".
On the subject of disclosure of competing interests, I believe
Tobacco Control does require this (though Polito and Tomar et al make
none). None of the authors of the discussion on smokeless tobacco (Bates
et al [3]) is or was in any way supported by any part of the tobacco
industry. We are not wounded by the charge of 'tobacco industry stooges'
(as Tomar et al imply we might be) because it is an inaccurate and empty
rejoinder to the accurate labelling of Tomar et al as advocates of 'quit
or die'. As we explain in our discussion paper, our concern is about
reducing cancer, lung and heart disease, and the rest of the consequences
of tobacco use as effectively as possible. That's all. We worry that some
prominent advocates have uncritically conflated these real goals with the
common tactical aim of attacking the tobacco industry in every possible
situation. In doing so, they have become confused about priorities and
disorientated in the debate on harm reduction.
The "quit or die" philosophy would be easier to explain if it was
straightforward influence-peddling and greed at work on behalf of Big
Pharma, which has clear interests in this area. But I think that is the
wrong (or only partial) explanation. I suggest the real explanation lies
in the realm of ideology, personal views on the relation between the state
and the citizen, vanity about anti-tobacco industry credentials, and on
the pillars of orthodoxy on which tobacco control currently rests with
inadequate critical scrutiny. Talk to people outside the public health
field and the idea that governments ban, or advocates lie about, far less
hazardous forms of the market-leading product and they find it as absurd
as it is unacceptable.
[1] Polito J. "Another simple issue"?. Electronic response to
Tobacco Control, 7 December 2003.
[2] Tomar SL, Connolly GN, Wilkenfeld J, et al. Declining smoking in
Sweden: is Swedish Match getting the credit for Swedish tobacco control’s
efforts? Tobacco Control 2003;12: 368-371
[3] Bates C, Fagerstrom K, Jarvis MJ, et al. European Union policy on
smokeless tobacco: a statement in favour of evidence based regulation for
public health. Tobacco Control 2003;12 360-367
Clive Bates
[Former Director, ASH UK. Writing in a personal capacity]
An important discussion of issues is being missed in a rash of name
calling. Let’s back up, recognize our common goals and see if we can
discuss issues and skip the personalities. We believe that the letters of
Foulds et al and Bates et al badly mangled our comments and took
statements out of context. Foulds et al. and Bates et al. obviously feel
the same about our article. This issue has precipitated name calling,
qu...
An important discussion of issues is being missed in a rash of name
calling. Let’s back up, recognize our common goals and see if we can
discuss issues and skip the personalities. We believe that the letters of
Foulds et al and Bates et al badly mangled our comments and took
statements out of context. Foulds et al. and Bates et al. obviously feel
the same about our article. This issue has precipitated name calling,
questioning of integrity, even rather defamatory slogans used to attack
those with differing opinions ranging from “quit or die” to “flat earth
believers”. Clearly, we disagree on several aspects of the issue, even
while agreeing on others (such as the importance of efforts to reduce
death and disease in those who continue to use nicotine without
undermining prevention and cessation). This core point of agreement is
shared by many of us engaged in this debate. It is unfortunate, and
frankly very discouraging, that the differences seem to be resulting in
more vitriol than are the common values resulting in constructive dialog.
Many of the specific comments of Foulds et al. will be addressed in a
subsequent response. Here we would like to briefly address some of the
main issues. Our commentary takes issue with the position of Bates et al.
and Foulds et al. which calls for a role for smokeless tobacco in tobacco
control efforts to reduce smoking. We believe that Bates et al. and
Foulds et al. overstate the benefits and generality of the Swedish snus
experience and that they understate the risks and areas of uncertainty.
Not surprisingly, they imply that we have overstated the risks and
understated the benefits in our urge for caution and a regulated playing
field. As we note in our commentary:
“If there is a role for oral tobacco in a comprehensive effort to
reduce the death toll from tobacco use, then its manufacture and marketing
must be overseen by an agency with comprehensive regulatory authority. A
regulatory agency should be open to all strategies that are scientifically
based and that will save lives. However, the decision about what role
oral tobacco plays in that overall scheme is a decision that can only be
made by an agency that has all of the relevant information.”
The fact that a population of persons using exclusively smokeless
tobacco is at overall lower risk of most forms of smoking caused disease
is not disputed by us. We do assert that smokeless tobacco has been
repeatedly demonstrated to be a deadly addictive product that causes a
variety of serious and life-threatening diseases as documented in the
Institute of Medicine Report (IOM) (see pages 426-429 and 563-564 for a
review of widely accepted oral diseases and attributable cancer). With
regard to Swedish smokeless tobacco, at least as marketed in Sweden, we
concur with the conclusion of that report on page 167 as follows: “It may
be considered that such products could be used as PREPs [potentially
reduced exposure products] for persons addicted to nicotine, but these
product should undergo testing as PREPs using the guideline and research
agenda contained herein.” Neither we nor the IOM Report are ready to
accept extant data as sufficient for endorsing smokeless tobacco for harm
reduction. Furthermore, we support the general strategies recommended by
the IOM Report to develop the data that would enable such and endorsement.
We apparently differ from Foulds et al. and Bates et al. in our call for
such data. We stand by our position.
Perhaps the most important issue implicit in our concerns about our
colleague’s characterizations of the Swedish experience is their explicit
or implicit judgment that it is relevant outside of Sweden. Bates et al.
do not recite their analysis of the Swedish experience solely for
rhetorical purposes or to support its continuation in Sweden. They cite
it in support of its application outside of Sweden to greater Europe and
beyond. Similarly, because we were asked to provide a commentary for the
Tobacco Control issue as Americans, we responded to this analysis with our
concerns about the application of the Swedish experience to the United
States and elsewhere. We noted that the U.S. Smokeless Tobacco Company
(UST) did not cite the Swedish snus experience in its pleadings before the
Federal Trade Commission in order to gratuitously commend Sweden: UST was
making a pitch to expand its marketing of smokeless tobacco in the United
States, armed with government endorsed harm reduction claims which it
argued could then be made for all if its products, including those known
to be gateways to tobacco use among youth and those that are among the
highest in cancer-causing nitrosamines. In fact, neither the Foulds et
al. nor Bates et al. reviews noted that outside of Sweden, even Swedish
Match products are higher in cancer-causing nitrosamines than they sell in
Sweden.
Thus, a fundamental question for all tobacco control experts is as
follows: If smokeless tobacco has played any overall positive role in
Swedish health, what is the relevance of the experience to other
countries? Moreover, what questions should tobacco control leaders
consider before endorsing smokeless tobacco as a component of
comprehensive tobacco control strategies? We have many questions about
the benefits attributable to snus in Sweden. Moreover, we are very
concerned about the potential for expanded smokeless tobacco marketing in
the absence of comprehensive tobacco and nicotine product regulation,
particularly if endorsed by public health advocates, to cause more damage
to public health than it will to improve public health. The potential
risks are numerous and include: Deadly delays in quitting smoking with
the support of smokeless tobacco to manage smoking restrictions. Uptake
of smokeless tobacco by persons who would not have otherwise used any
tobacco product. Substitution of the most popular high nitrosamine
smokeless products in the U.S. and as available most everywhere but Sweden
for cigarettes as an alternative to complete tobacco cessation.
Graduation from smokeless tobacco use to cigarette smoking as has already
been well documented in the United States.
Finally, it is not as if there are no alternatives to reducing
smoking prevalence. As demonstrated in California, Florida, Mississippi,
and Massachusetts, dramatic reductions in youth smoking initiation and
adult smoking prevalence can occur, as compared to surrounding states,
without advocating snuff use or trading cigarettes for snuff, but rather
on the basis of comprehensive tobacco control efforts.
Other tobacco control experts will need to carefully examine the
data, weigh their concerns, and come to their own conclusions. We remain
concerned about the place of smokeless tobacco in tobacco control and will
continue to insist that that comprehensive tobacco regulation should be
the prerequisite for its further consideration.
Scott L. Tomar,
University of Florida, Division of Public Health Services and Research,
Gainesville, Florida, USA
Greg N. Connolly,
Massachusetts Tobacco Control Program, Boston, Massachusetts, USA
Judith Wilkenfeld,
Campaign for Tobacco-Free Kids, Washington, DC, USA
Jack E. Henningfield,
Pinney Associates, Bethesda, Maryland; and Johns Hopkins University School
of Medicine, Baltimore, Maryland, USA
I read with interest the recent article by Graham and Owen (1), which
explores the socioeconomic differentials in underreporting of smoking
during pregnancy. The authors are to be congratulated for preparing such
an interesting, thought-provoking, and timely study on this subject.
However, it seems important to emphasize that in addition to self-
underreporting (or denial) of smoking status in pregnancy the problem also
li...
I read with interest the recent article by Graham and Owen (1), which
explores the socioeconomic differentials in underreporting of smoking
during pregnancy. The authors are to be congratulated for preparing such
an interesting, thought-provoking, and timely study on this subject.
However, it seems important to emphasize that in addition to self-
underreporting (or denial) of smoking status in pregnancy the problem also
lies in low level of suspicion on the part of health care providers for
addiction to tobacco in pregnant women.
While the illicit drug use in pregnancy has received significant attention
over the past two decades far too little attention has been given to the
consequences of the use of “social drugs” such as tobacco, ethanol and
caffeine, which are by far the most commonly used substances in pregnancy.
While the deleterious effects of cocaine, amphetamines, and opioids on the
mother and the fetus are more pronounced and easier to detect, the
addiction to tobacco, ethanol and caffeine is usually subtle and more
difficult to diagnose (2). As a result recreational use of tobacco in
pregnancy may continue undetected, significantly effecting pregnancy
outcome and obstetric and anesthetic (labor analgesia) management of these
patients.
Approximately 80% of women who smoke before pregnancy continue to smoke
when pregnant (2). Low cigarette consumption prior to pregnancy is the
best predictor for smoking cessation in pregnancy. The majority of
patients with a history of drug use in pregnancy (including tobacco) deny
it when interviewed by primary care physicians, obstetricians and/or
obstetric anesthesiologists (3). Risk factors suggesting tobacco use in
pregnancy include lack of prenatal care, respiratory complications and
history of premature labor. A high index of suspicion for tobacco (as well
as other social and illicit drug) use in pregnancy, combined with non-
judgmental questioning of every parturient is therefore necessary.
REFERENCE:
1. Graham H, Owen L. Are there socioeconomic differentials in under-
reporting of smoking in pregnancy? Tob Control 2003: 12: 434.
2. Kuczkowski KM. Tobacco and ethanol use in pregnancy: implications for
obstetric and anesthetic management. The Female Patient 2003; 28: 16-22.
3. Kuczkowski KM. Labor analgesia for the drug abusing parturient: is
there cause for concern? Obstet Gynecol Surv 2003; 58: 599-608.
I think the most important point to address in Tomar et al’s e-response [1] is their call for more evidence before any change to the status quo (the status quo is a ban on oral tobacco in the EU, and public health disinformation in the US). They say that “neither we nor the IOM Report are ready to accept extant data as sufficient for endorsing smokeless tobacco for harm reduction”. This stance does not reflect the real...
I think the most important point to address in Tomar et al’s e-response [1] is their call for more evidence before any change to the status quo (the status quo is a ban on oral tobacco in the EU, and public health disinformation in the US). They say that “neither we nor the IOM Report are ready to accept extant data as sufficient for endorsing smokeless tobacco for harm reduction”. This stance does not reflect the real-world policy choices and inverts the natural burden of proof.
First, “endorsing smokeless tobacco for harm reduction” in Europe means unbanning and regulating the product as part of the tobacco market. In the US, it would involve health advocates no longer misleading the public about it – as regrettably the Surgeon General recently did. It does not involve doctors prescribing it, health advocates advocating it, or guest slots for UST at the Washington World Conference. What does ‘endorsing’ actually mean in Europe? In reality, there are some quite concrete decisions in Europe which we must take on the available evidence. These include: continue the oral tobacco ban or lift it? Tell the truth or mislead smokers about it? Whether to regulate oral tobacco, and if so, in what way? These are questions that cannot be ducked on the back of too little evidence – the ‘do nothing’ philosophy is simply a decision in favour of the status quo. This amounts to an active endorsement of the ”quit or die” approach, in which smokers are denied less hazardous alternatives to cigarettes, which themselves remain practically unregulated. There is no supporting evidence for leaving the market to the most dangerous products, and it seems illogical to me.
Second, let us be clear about the burden of proof. The 'intervention' in Europe is to ban oral tobacco while not banning cigarettes. It is that intervention that requires an evidence base – a point not considered by the IOM. The burden of proof naturally falls on those making and sustaining this intervention (the EU), but three reasons make the demand for supporting evidence more pressing:
It is highly irregular to ban a less hazardous variant of a product, thereby deliberately denying users of the more hazardous product the choice of a switch and so preventing an individual risk reduction response. There are no precedents for this, and for that reason alone I would expect good evidence to support such an unorthodox approach to consumer safety.
Common sense suggests that it is plausible that addicted smokers would use oral tobacco as an alternative to smoking and to quit, thus reducing harm. Given there is a reasonable hypothesis that smokeless tobacco will reduce harm, there is a commensurate need to show that hypothesis to be flawed if one is to support a ban on oral tobacco without banning smoking tobacco.
The evidence from Sweden shows a compelling public health case against banning the product and no-one in their right mind would seek to extend the EU ban to Sweden. Sweden sends a powerful cautionary signal to the rest of the EU about perverse consequences of clumsy interventions. If it is not right to ban it in Sweden, how can we be so confident that it is right to ban it in the rest of the EU? Given the hypothetical opportunity, would American campaigners really ban smokeless tobacco in the US, while leaving cigarettes under the current weak regulatory regime?
If this was a controlled trial and the intervention (rest of EU, ban on oral tobacco) had consistently worse results than the control (Sweden, no intervention), we would stop the trial and abandon the intervention. To continue with the trial and intervention, the burden of proof would clearly fall on those supporting the intervention to prove that Sweden was not representative or that some other factors are at work in the rest of the EU. Tomar et al haven't any evidence and don't even seem to think they should supply it – perhaps relying on an a priori argument that any ban on any tobacco product represents some sort of progress. Sweden is not a controlled trial of course, but snus is not a medicine and long term changes in market structure do not lend themselves to such trials. Sweden shows us what is possible, and we forego that potential at our peril and at the expense of unfortunate people addicted to smoking and nicotine.
Sweden almost certainly is different to the rest of Europe – if only by virtue of history and the length of time this market has been established. But that is a reason to expect the benefits in the rest of Europe to be less and slower, not a reason to prevent that change in market structure ever occurring or a basis for believing that the effects would be the opposite in the rest of Europe. The EU justified its ban on the basis of a assumption that smokeless tobacco would unleash a plague of oral cancer and be a major gateway into smoking. Though this was muddled thinking from the outset, the evidence is clear from Sweden, and the opposite appears to be the case - there is no gateway and apparently little risk (and minimal compared to smoking). As the economist John Maynard Keynes famously said: “When the facts change, I change my mind. What do you do?”. In Europe, many of us are changing our minds.
So, let me restate the question – where is the evidence base that justifies this highly irregular intervention, especially in the face of evidence from Sweden that not banning the product contributes to a public health gain there? How do Tomar et al know their implicit backing for the highly irregular oral tobacco intervention in Europe isn’t simply killing more Europeans? Given what we know about how it works in Sweden, and given that the evidence shows relatively low risk of serious harm from using this product compared to smoking, don’t they think it would be wise to have some evidence to back the case for maintaining this intervention in the rest of the EU? I say they have implicit support for the EU ban because they raise difficult to impossible evidential hurdles to justify a move away from the ban, while offering no evidence to support it.
Tomar et al worry that people that would otherwise never use tobacco might use oral tobacco if it was unbanned in Europe. The question should be inverted – especially because of what we know in Sweden. How do they know that there are not people that would use snus instead of smoking or quit smoking using snus had it not been banned? Tomar et al pose this question as if it is a ‘red line’ and that it must be shown that no-one who would not otherwise use tobacco would use an oral tobacco product if it was unbanned. What if, more realistically, there was less smoking as smokers switched to snus or quit but some people that did use oral tobacco that would otherwise not have been tobacco users? The balance of risk and benefit (and civil liberties) is on the side of unbanning oral tobacco because oral tobacco is not especially harmful and there is little sign of a gateway to smoking. On the other hand, anyone displacing smoking or quitting with oral tobacco use experiences a considerable reduction in risk. Tomar et al offer no thoughts on this balance, though it is a central concern and has been discussed in Tobacco Control [2].
Tomar et al also resort to setting impossible evidential hurdles – "If smokeless tobacco has played any overall positive role in Swedish health, what is the relevance of the experience to other countries?" I have discussed above how the burden of proof is really with them, but how could anyone prove to their satisfaction how the tobacco market would respond to the unbanning of snus in Europe without unbanning it and conducting market surveillance? But they want the proof as a pre-condition for unbanning it. The most sensible way forward is to unban the product and conduct market surveillance, adjusting the regulatory regime if needed - and, yes, banning it again if it all goes wrong or the manufacturers behave badly. One could even envisage a 'sunset' clause on the lifting of the ban, requiring it to be reaffirmed in 10 years time.
Tomar et al use contradictory arguments at different times. For example they raise the (evidence-free) theory that smokeless tobacco may help smokers deflect the pressure to quit arising from smoke-free policies. In their e-response, they worry about "deadly delays in quitting smoking with the support of smokeless tobacco to manage smoking restrictions." But in their initial commentary [3] they attribute the low smoking prevalence in Sweden to the effectiveness of smoke-free policies specifically amongst men despite their high use of snus, suggesting that: "therefore, men would be more likely than women to be impacted by smoke-free workplace regulations". Hmmm… now which is it?
Let us also address the question of regulation. Yes it is true that a regulatory regime for smokeless tobacco and all tobacco products would be ideal. But the real issue is what should happen in what could be a long (or indefinite) interim period before such a regulatory regime is in place. Should the absence of a comprehensive regulatory regime justify the European ban or American disinformation? I believe not, because even without regulation these products are far less hazardous than cigarettes. The difference between smokeless tobacco products is small compared to the difference between smokeless products and cigarettes. Regulation is highly desirable, but not essential to justify a change from the status quo in the EU. If the EU simply moved to the same position as the US, that would represent progress in the EU because smokers would no longer be denied this option and would at least have the choice available in Sweden, if not the ‘endorsement’ of elements of the public health community.
However, there is a very good opportunity in unbanning snus to introduce world-leading regulation in the EU. There is a risk that the opportunity will be bungled, either because the public health community remains in denial and slumbers through the opportunity, or because there will be excessive zeal in applying regulation. In the latter case, the danger is that over-strong regulation would leave in place counter-productive asymmetries in regulation between smoking and smokeless tobacco. Regulation shouldn’t be so exacting and one-sided that it prevents the market functioning for public health in the way it has so far succeeded in Sweden. The same argument applies to pharmaceutical nicotine, where the excessive caution of regulators and manufacturers and over-zealous regulation is a barrier to clean nicotine maintenance products and competitors to tobacco and so, paradoxically, works against the wider public health interest [4].
The EU already has a regulatory regime for marketing – tobacco advertising, sponsorship and promotion is not regarded as legitimate free speech, and is banned. The more challenging regulatory question is whether smokeless companies should have some tightly defined partial exemption from that in order target smokers to switch.
Finally, please note that this response and my others are only from me, not ‘Bates et al’, and therefore do not include my fellow authors of the printed article.
[1] Tomar et al, A Reply to Bates et al. and Foulds et al. Tobacco Control e-response, 19 December 2003.
[2] Kozlowski L. et al. Applying the risk/use equilibrium: use medicinal nicotine now for harm reduction Tob Control 2001;10:201 -203
[3] Tomar SL, Connolly GN, Wilkenfeld J, Henningfield JE. Declining smoking in Sweden: Is Swedish Match getting the credit for Swedish tobacco control’s efforts? Tobacco Control2003; 12:368-59
[4] McNeill A, Foulds J, Bates C. Regulation of nicotine replacement therapies (NRT): a critique of current practice. Addiction 2001; 96: 1757-1768.
A reply to Tomar et al’s flat earth commentary
Foulds et al‘s e-response [1] provides an excellent and scathing critique of the commentary contributed by Tomar et al [2]. Though Foulds et al are far too modest to point this out, it is important that readers understand that their original review [3] is a substantial and careful piece of work, properly edited and peer-reviewed. In contra...
Watching this first salvo in the battle over whose nicotine is safer and which side eventually makes the big nicotine maintenance bucks, Big Pharm or Big Oral Tobacco, is sad yet understandable? Even for those few without any financial stake in the debate, imagine the natural frustrations born from having turned the wrong research or policy corner and dedicated two decades of your life to having chosen to fight nicotine...
Last week in the BMJ 2003; 327 (6 December), after seeing his comments on the Enstrom and Kabat paper on second-hand smoke being used by Forest to advance the tobacco industry’s position, the BMJ Editor says in a fair and frank admission:
"Reading the quote on a Forest advertisement tightens my anus, but I wrote it and can't deny it."
Health Professionals who have been working hard towards getting che...
Kawaldip Sehmi's letter seems to advocate ignorance and a kind of book-burning attitude to understanding this area. But in fact, better knowledge of the science might help his cause.
The paper by Enstrom and Kabat caused problems not because its findings conflicted with the established evidence base, but because it was flawed and the BMJ failed to put its contribution in context with the rest of the large evidenc...
Readers should note the following motion placed before the UK parliament on this topic on 10 December 2003:
SMOKELESS TOBACCO 10.12.03 Flynn/Paul That this House welcomes the confirmation from Cancer Research UK Action on Smoking and Health and the Royal College of Physicians that some forms of smokeless tobacco are between 500 and 1,000 times less hazardous than smoking tobacco; agrees with the conclusion tha...
The motor racing piece that prominently features tobacco company sponsorship and brand logos in the August issue of Maxim (News Analysis 2003;13:348) is not alone. That same month, a seven page article provided similar exposure for Jordan’s association with B&H in FHM, the leading UK ‘lad mag’ (circulation circa 600,000).
These promotions, of course, reflect standard tobacco industry strategy of circumventin...
Like many others, John Polito [1] misses the point about smokeless tobacco. It is not a health strategy to be widely recommended by doctors, nor is it a medical smoking cessation treatment, nor should it be part of a community-based health programme. It is, or should be, part of a market for nicotine products in which the world will go on allowing the sale of cigarettes - the most hazardous form of nicotine. It should b...
An important discussion of issues is being missed in a rash of name calling. Let’s back up, recognize our common goals and see if we can discuss issues and skip the personalities. We believe that the letters of Foulds et al and Bates et al badly mangled our comments and took statements out of context. Foulds et al. and Bates et al. obviously feel the same about our article. This issue has precipitated name calling, qu...
I read with interest the recent article by Graham and Owen (1), which explores the socioeconomic differentials in underreporting of smoking during pregnancy. The authors are to be congratulated for preparing such an interesting, thought-provoking, and timely study on this subject. However, it seems important to emphasize that in addition to self- underreporting (or denial) of smoking status in pregnancy the problem also li...
I think the most important point to address in Tomar et al’s e-response [1] is their call for more evidence before any change to the status quo (the status quo is a ban on oral tobacco in the EU, and public health disinformation in the US). They say that “neither we nor the IOM Report are ready to accept extant data as sufficient for endorsing smokeless tobacco for harm reduction”. This stance does not reflect the real...
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