“..some pretty substantial scientific observers espouse the
view that snus is far less harmful than cigarettes. Nobody is saying that
snus is harmless, but it’s a lot less harmful than
cigarettes”
Paul Adams, Chairman and CEO of BAT
Sunday Independent, 18 June, 2006
There has been heated
debate within the tobacco control community in recent years on the
potential role of smokeless tobacco and other ‘potential reduced-exposure
products’ (PREP’s) in reducing the
burden of tobacco induced disease. The focus of tobacco control has
historically been on prevention and cessation of tobacco use, primarily
among smokers. However as the rates of decline in smoking prevalence in
most developed countries have diminished over the last decade a third
approach has been advocated, that of harm reduction. Central to this
debate has been the ‘Swedish Experience’. The European
Commission exempted Sweden from the 1992 directive 92/41/EC banning the sale of
oral snuff or snus in the EU. This was continued in the 2001 directive
2001/37/EC. Subsequently Sweden has a high prevalence of snus use (22% men and 3%
women) but has the lowest smoking rate, the lowest lung and oral cancer
rates and half the rate of the rest of the European Union. Advocates
believe that the low smoking and tobacco mortality/morbidity rates are
due to the availability and alternative use of snus. As the lobbying for
a review of the 2001 directive 2001/37/EC have gained impetus and the
traditionally non-smokeless sectors of the tobacco industry have become
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increasingly interested in smokeless tobacco there has been
increased reporting of the ‘benefits’ of smokeless tobacco in
the mainstream media.
The tobacco control
community is strongly divided over this issue which has resulted in
conflicting messages to the public which are open to exploitation. As the
tobacco industry and the media is showing if the tobacco control
community doesn’t take control of the issue then they are more than
willing to do so.
In the USA Philip Morris
has begun testing ‘Taboka’ which
comes in small pouches to be placed between the gum and lip, and RJ
Reynolds Tobacco Co. is testing a similar product ‘Camel
Snus’. Both state that the development is in response to smokers
demands, especially because of increasing smoking bans. British American
Tobacco last year launched a pilot in Sweden selling branded snus, believing it to be a healthier
alternative and has been lobbying the European Commission to review
Article 8 of directive 2001/37/EC.
What follows are some key
points of the debate with reference to recent and important published
papers, health and tobacco control organization statements and mainstream
media reporting.
The aim is not to provide
a comprehensive review nor to support one side of the
argument over the other but rather to stimulate the debate with the hope
of making progress towards an evidence based consensus view.
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THE NEED FOR TOBACCO
HARM REDUCTION
Supporters of the harm reduction approach to tobacco
control argue that nicotine is ‘here to stay’, that it is not
feasible to eradicate its use, and that it is more realistic to explore
safer nicotine delivery systems which could contribute to tobacco harm
reduction. While ideally these should be non-tobacco products, the
reality appears to be otherwise. Nicotine replacement therapies to date
have failed to deliver the same nicotine ‘high’ as cigarettes
which make them less appealing to smokers. They are also regulated as
pharmaceuticals and are more expensive than cigarettes thus putting them
at a competitive disadvantage. Other tobacco products seemingly have
greater acceptability in attracting smokers. If these products are less
harmful than smoked tobacco then a change to their use would reduce the
harm to the individual and the burden of tobacco induced disease. A paper
by Kozlowski, O’Connor and Edward (Tobacco Control, 2003) entitled
“Some practical points on harm reduction: what to tell your lawmaker
and what to tell your brother about Swedish snus” outlines the
potential role of snus in smoking cessation.
1. “Quit using tobacco, if you can. This
would provide the greatest health benefit.
2. Try medicinal nicotine. If possible
substitute cleaner forms of nicotine.
3. Try snus as the Swedes do. That Swedish
snus is much safer than cigarettes is supported by ample scientific
evidence. Use a product meeting or exceeding the Gothiatek
standard. Buy it fresh from a retailer who refrigerates the product Use
snus that comes in the individual serving pouches or sachets. Place the
snus under your upper lip, toward the front of your mouth. You are
switching from cigarettes to snus, not US snuff.
4. Next try medicinal nicotine. Try to switch
to cleaner forms of nicotine when you feel able.
5. Next stop using any nicotine if you can.
But you should keep using medicinal nicotine, or even snus, as long as
you need to, to keep you from smoking.”
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REQUIREMENT FOR
COMPREHENSIVE REGULATION
“on average
Scandinavian or American smokeless tobaccos are at least 90% less
hazardous than cigarette smoking. Further, the actual risk can be
controlled through regulation – for example setting maximum
thresholds for specific carcinogens or other toxins such as heavy metals.” Bates, Fagerstrom
et al (2003)
Those advocating the use
of smokeless tobacco as a harm reduction strategy do not deny that
smokeless tobacco use is addictive nor that smokeless tobacco is harmless.
Rather they argue that it is less harmful than smoked tobacco and that
the amount of harm reduction is dependent on the type of smokeless
tobacco used with a graduation of decreasing risk from smoked tobacco
through betel quid, chewing tobacco, oral snuff, to the lowest Swedish
snus.( IARC 2005)
McNeil, Bedi, et al (Tob Control, 2006) investigated the
level of toxins in oral tobacco products in the UK compared to leading US
brands and Swedish snus. There was large variability between the products
for all the measured toxins and carcinogens with the widest being 130
fold. Chewing tobaccos, especially that of the Orient were the most toxic
with Swedish snus having one of the lowest level
of carcinogenic tobacco specific nitrosamines (TSNA’s).
The different curing, blending, processing and storage methods of the
products appear to account for much of the difference. This favors the
regulation of such products and the setting of standards for maximal
levels of toxic constituents with the aim of tightening such standards as
production methods improve to minimize harm. Models for such standards
have been proposed in Sweden (the Gothiatek Standard, http://www.gothiatek.com ) and Canada.
Smokeless
tobacco has not been conclusively linked to the 2 major diseases of
smoking, COPD and lung
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cancer, nor
cancers outside the oral cavity, with limited evidence linking Swedish
snus to oral cancers. If there is a CVS risk with smokeless tobacco it is
substantially less than that of cigarettes and smokeless tobacco produces
no environmental tobacco smoke removing the burden of passive smoking.
The Royal College of Physicians (RCP 2002) estimates that the harm of
smokeless tobacco is 10-1000 times less than that of smoking. If the harm
of smokeless tobacco is only 10% that of smoking then smokeless tobacco
use would have to increase to 10 times that of current smoking before the
total harm would be equivalent.
THOSE FOR AND
AGAINST
The
harm reduction approach has gained support from several key international
organizations. In 2001, the Institute of Medicine (IOM) in the US
released a report “Clearing the Smoke: Assessing the Science Base
for Tobacco Harm Reduction”,( http://newton.nap.edu/catalog/10029.html)and laid the foundation for tobacco-related research
assessing ‘potentially reduced exposure products’ (PREPs) that might reduce the risks associated with
using tobacco.
Their
report concluded that, “harm reduction is a feasible and justifiable
public health policy – but only if it is implemented carefully to
achieve the following objectives:
·
Manufacturers have the necessary incentive to develop and
market products that reduce exposure to tobacco toxicants and that have a
reasonable prospect of reducing the risk of tobacco-related disease.
·
Consumers
are fully and accurately informed of all the known, potential and likely
consequences of using these products.
·
Promotion,
advertising and labeling of these products are firmly regulated to
prevent false or misleading claims, explicit or implicit.
Health
and behavioural effects of using PREPs are monitored on a continuing basis.
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Basic,
clinical and epidemiological research is conducted to establish their
potential for harm reduction for individuals and populations.
Harm
reduction is implemented as a component of a comprehensive national tobacco control program that
emphasizes abstinence-oriented prevention and treatment.”
“With the most intensive application of the most
effective known programs for prevention and cessation, approximately
10-15% of adults in the United States are expected to be regular users of tobacco in 2010,
and they will continue to suffer the consequences. Among this group are
many who cannot, or will not stop using tobacco, and it is to this group
that effective programs and products of harm reduction should be
directed.”
IOM, Clearing the Smoke: Assessing
the Science Base for Tobacco Harm Reduction. 2001. Preface, page x
A panel in the US (Levy et al (Addictive Behav. 2006)), funded by the IOM, predicted that the
use in the USA of a “harm reduction” policy that required the
smokeless tobacco product meet low nitrosamine standards and be marketed
with a warning label consistent with the evidence of relative health
risks would accelerate the decrease in smoking prevalence from 1.3 to 3.1
percent over 5 years compared to current smokeless usage.
In
2002, the Royal College of Physicians (RCP) in London released a report, “Protecting Smokers, Saving
Lives. The case for a tobacco and nicotine regulatory authority.”http://www.rcplondon.ac.uk/pubs/books/protsmokers/index.asp)
This
report highlighted “the challenges of developments in the tobacco
market” where “tobacco companies are designing products which
claim reduced risk or other benefits, and smokeless tobacco producers are
seeking to exploit very large reductions in risk compared to
smoking.”
Further
to this in 2003, a number of key European tobacco control figures (Bates, Fagerstrom et al) published a statement
“European Union policy on smokeless tobacco. A statement in favour of evidence-based regulation for public
health”. http://www.ash.org.uk/html/regulation/html/eusmokeless.html
This report discusses the EU directive and
comprehensively lays out the case supporting the replacement of Article 8
of directive 2001/37/EC with a comprehensive regulatory framework and the
evidence and arguments for and against a harm reduction approach.
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What all of these organizations support is the use of
smokeless tobacco as a harm reduction strategy only if a comprehensive
tobacco and nicotine regulatory authority and framework is in place and that the prominence of prevention and cessation
in tobacco control remain. This is in keeping with the requirements of
the FCTC.
However, the WHO and CDC/Surgeon Generals Office in
the US promote an opposing view. This year’s World No
Tobacco Day theme, was “Tobacco: deadly in
any form or disguise.”
“All
tobacco products are addictive, harmful and can cause death, regardless
of the form, packaging, or name under which they are presented to the
public.” WHO, 2006
(http://www.who.int/mediacentre/news/releases/2006/pr28/en
The above statement mentioned the increase in
marketing of smokeless tobacco in non-traditional areas such as the Middle East, especially to young women. Consistent with the IOM,
the RCP and Bates, Fagerstrom et al the WHO
also emphasized the importance of comprehensive legislation for all
tobacco products as many products are currently outside most legislative
frameworks.
The 1986 Surgeon Generals Report, “The Health
Consequences of using Smokeless Tobacco”, states that smokeless
tobacco is not a safe alternative to cigarettes, while a 1994 Surgeon
General Report, “Preventing Tobacco Use Among Young People”
concluded that smokeless tobacco was a gateway to cigarette smoking among
American youths. These reports along with the IARC 2005 findings that
smokeless tobacco is carcinogenic have led to the US CDC and the National
Cancer Institute continuing to recommend that the public avoid and
discontinue the use of all tobacco products including smokeless tobacco.
The decision of such organizations not to state
publicly the evidence that smokeless tobacco is less harmful than
cigarettes has riled many in the alternative camp. They argue that this
is unethical.
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However the rationale for this approach appears to be
that giving this message to the public would lead to confusion and the
misunderstanding that less harmful equals harmless. This would also open
an area for exploitation by the tobacco industry. Supporters however
argue that it is unethical to deny the public, especially smokers, such
knowledge when the scientific evidence clearly shows that smokeless 6is
less harmful than smoking.
THE WHY
NOT. GATEWAYS, REDUCED QUITTING, AND HARM
Opponents
to harm reduction have concerns that it would lead to an increase in smokeless
tobacco users, that this would then lead to an increase in young peoples
use of cigarettes via a ‘gateway’ effect and that smokeless
tobacco use would lower the rates of tobacco cessation as users would
continue with the smokeless products rather than moving from smoking to
quitting.
While
it is impossible to predict the effect such a harm reduction strategy may
have the Swedish experience appears to support the opposing view.
Ramstrom, Foulds (Tobacco Control, 2006) in “Role of snus
in initiation and cessation of tobacco smoking in Sweden”, concluded that snus use was associated with
a reduced risk of becoming a daily smoker and an increased likelihood of
stopping smoking. They found that among men whom attempted to quit
smoking, snus was the most common cessation aid (58% compared to 38% for
all nicotine replacement therapies). Among men who used snus as a single
aid 66% succeeded in stopping completely, compared to 47% using nicotine
gum or 32% using a patch. Similar findings were found with women. are monitored on a continuing basis.
This
supported Furberg et als
study (Tobacco Control, 2005) “Is Swedish snus associated with
smoking initiation or smoking cessation?”
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This study used cross-sectional data and concluded that
snus use was associated with smoking cessation not initiation, and that
Swedish smokers appeared to be using snus as a naturalistic, non-medical
smoking cessation aid. In the discussion the author’s summed up the
debate well;
“We are aware that advocating the use of
one addictive tobacco product to diminish the harm from another is a
controversial issue, particularly as data supporting the use of snus as
an NRT could enhance the market of the tobacco industry. Clearly,
eliminating all forms of tobacco would have the most beneficial effect on
world health; however many smokers are unable to achieve lasting smoking
cessation. From a harm reduction perspective, should snus be shown to be
as effective or superior in efficacy to existing NRT’s
without having adverse health consequences, it may represent a more
acceptable means by which to reduce tobacco related health burden.”
.Haukkala
et al, (Addiction, 2006) studied the progression of oral snuff us among
Finnish 13 –16 year olds but were unable to determine the direction
of causality between combined snuff and cigarette use.
Those
who disagree with the use of smokeless tobacco as a means of tobacco harm
reduction have strong arguments.
These
include, that no form of tobacco is safe and thus no one form should be
advocated over another. All tobacco is addictive,
addiction is a disease and therefore no one form should be advocated over
another. There is presently insufficient evidence to accurately quantify
the health impacts of smokeless tobacco.
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Until this information is available smokeless tobacco
should not be publicized as less harmful than tobacco. Smokeless tobacco
may be a gateway to smoking initiation among youth. Smokeless tobacco as Ua harm reduction method would lead to reductions in
tobacco cessation and potentially an increase in population tobacco
disease burden. Smokeless tobacco has not been compared with NRT in its
efficacy in smoking cessation
Until its efficacy has been shown to be greater than
that of NRT in relation to its increased harm it should not be advocated
for use in smoking cessation. And, that advocating some forms of tobacco
in a harm reduction strategy would be exploited by the tobacco industry.
The
institutional supporters of the harm reduction idea attempt to address
these concerns in their recommendations for comprehensive legislation,
regulation and monitoring of all tobacco products, as well as the need
for ongoing research.
The
institutional supporters of the harm reduction idea attempt to address
these concerns in their recommendations for comprehensive legislation,
regulation and monitoring of all tobacco products, as well as the need
for ongoing research.
The major difference
between the two groups appears to be in the ‘ideals’ of
tobacco control (i.e. eliminating all use of tobacco products) versus the
aim of reducing the burden of tobacco induced morbidity and mortality, as
well as the weight of evidence required to change the tobacco control
approach.
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UNRESOLVED
QUESTIONS
There are many questions in the debate which remain
unresolved.
What is the primary
purpose of tobacco control, a campaign against tobacco or against tobacco
induced morbidity and mortality?
· At what level of reduced risk would the authorities
be negligent in not allowing consumers to be informed about products that
do them less harm?
· Would the ‘Swedish Experience’ be
replicated elsewhere in the world?
· How should claims that are true but may be
misunderstood or understood disproportionately (‘reduced cancer
risk’) be dealt with?
· What happens when some risks
increase and other decrease?
· How do you balance individual risk/benefit versus
societal? How should ‘smokers
rights’ to have access to products that do them much less harm be
reconciled with possible negative consequences at the population level?
· What options are there to ‘promote’
smokeless tobacco as a much safer alternative to smoking, without
promoting tobacco use per se?
· How should tobacco and nicotine products be regulated
and what regulatory standards should be used?
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Dr Murray Laugesen QSO chair; Prof Ross McCormick, Sir John Scott KBE, Trish
Fraser MPH, Dr Marewa Glover, Trustees
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