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| Journal of the New Zealand Medical Association,
12-March-2004, Vol 117 No 1190
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Time for major roadworks on the tobacco road?
Julian Crane, Tony Blakely, and Sarah Hill
Nicotine replacementInhaling tobacco smoke is a
remarkable and exquisitely refined mechanism for delivering nicotine to the
central nervous system. Remarkable for its acute safety and chronic catastrophe,
and unique because it is tobacco (not nicotine) that causes the damage. The
failure to make this crucial distinction is a tragedy.
Alternative methods of delivering nicotine via tobacco have
been available for centuries in the form of chewing tobacco, snuff, drinks,
enemas, and percutaneous administration—all developed by the aboriginal
peoples of North and South America.1,2
In 1942, Johnston administered nicotine intravenously to
himself and 34 volunteers thus altering smoking behaviour in
recipients.3 Further development of alternative
nicotine delivery took another 30 years with the development of nicotine chewing
gum. This was followed by transdermal, nasal, and oral nicotine vapour inhalers.
These Alternative Nicotine Delivery Systems (ANDS) were developed to decrease
the craving of tobacco withdrawal and improve abstinence.
Many studies confirm the ability of these systems to improve
‘quit rates’ but their impact on long-term tobacco abstinence is
modest.4 Generally, their pharmacokinetics are
designed to provide low doses of nicotine over a prolonged period rather than
the high-dose burst from smoking. Currently, the addicted smoker only has
tobacco to provide this nicotine burst, and only gains access to alternative
nicotine in the context of quitting smoking. Paradoxically, access to the safer
forms of nicotine is often highly restricted, a point that has been previously
emphasised.5,6 Indeed, the relationships
between tobacco and nicotine (in the context of the public’s health) have
only recently been explored.7
Tobacco controlIn the last 30 years, tobacco
control strategies have considerably reduced smoking in some countries. The most
successful have employed multiple approaches, including mandatory packet
warnings, price increases, a ban on tobacco advertising, smoke-free environment
legislation, health education, the provision of quit programmes, and litigation
against the tobacco industry.
New Zealand has employed all of these strategies and,
between 1970 and 2001, per-capita tobacco consumption has reduced by 60%. Adult
smoking prevalence has decreased from 36% in 1976 to 28% in 1990. But since the
1990s, smoking prevalence has remained static. For Maori adults, the reductions
have been much less dramatic (from 58% in 1976 to 51% in 2001). Furthermore, for
Pacific Island adults, there has been an even smaller decrease (from 35% to
31%).
Nowadays, socioeconomic disparity is even greater, with
smoking prevalence three-fold higher for those from families with annual incomes
below $20,000 compared to those with annual incomes above
$120,000.8 In New Zealand, the decline in
smoking prevalence has stalled, and for Maori and Pacific people has been
negligible. This socioeconomic and ethnic disparity in smoking prevalence
clearly illustrates that in New Zealand, at least, tobacco control has largely
benefited the more affluent. In fact, smoking prevalence amongst the poorest
members of New Zealand’s society was higher in 2001 than the overall
smoking prevalence in 1976.
Such disparity is evident elsewhere, for example in the UK,
where a similar three-fold disparity in smoking prevalence exists between the
most and least advantaged groups.9 In the UK,
this disparity is beginning to be recognised for the targeting of smoking
cessation services (with some evidence of
benefit).10
Perversely, the very success of tobacco control has left the
remaining smokers and most of the world’s developing economies in the
unfettered embrace of a demonised tobacco
industry. The outrage from public
health at the tobacco industry’s intransigence and tactics has clouded the
entirely separate issues of tobacco and nicotine, rendering the idea of
developing recreational or long-term replacement nicotine, a heresy. The
introduction of alternative forms of nicotine as abstinence-promoting therapies
have been tightly regulated, initially by prescription and latterly by
restriction to pharmacies. The fundamental flaw has been the failure to
separate nicotine from tobacco, both literally and metaphorically.
New approaches to nicotine replacement are required as Bates
has suggested.11 There are now a large number
of Alternative Nicotine Delivery Systems available. A first step would be to
make them as widely available as tobacco and significantly cheaper.
Specifically, nicotine needs to be taken out of the pharmacy to openly compete
with tobacco at every outlet. Moreover, the role of ANDS needs to be
redefined—from improving abstinence rates to long-term replacement for
tobacco for those smokers unable (or unwilling) to quit.
Studies of ANDS as long-term replacement will be required to
define the most useful therapies singly and in combination—particularly
among low-income and marginalised groups. However to implement a comprehensive
nicotine replacement strategy, an effective inhaled nicotine delivery system
(designed to deliver cigarette-like doses safely) will be needed.
Inhaled nicotineSince the development of the metered
dose inhaler in the 1960s, the pharmaceutical industry has gradually refined and
improved the pulmonary delivery of drugs, principally for the management of
asthma. The recent need to reformulate asthma treatments (such as
beclomethasone) as liquids rather than solid particles in CFC-free carriers has
led to smaller particle sizes and a doubling of potency (12). The goal of these
therapies is to provide high doses locally at the airway mucosa. The aim of
pulmonary nicotine delivery will be to deliver nicotine to the brain via the
lung. Such inhaled nicotine delivery systems are not without risk.
First, a focus on them may distract policy-makers and the
health-promotion workforce from other aspects of ongoing comprehensive tobacco
control. Second, nicotine itself is not without adverse health effect, although
(without doubt) nicotine is much less dangerous to health than tobacco. Third,
the availability of high-dose nicotine may dissuade people from quitting, and
encourage initiation of a new nicotine habit among youth who would not have
commenced smoking tobacco otherwise.
Several key elements would need to accompany any serious
programme to introduce inhaled nicotine, however the devices and their effects
must be acceptable to smokers. Specifically, they must be able to approximate
the nicotine bolus obtained from smoking, and there would be an inevitable
trade-off between sufficient appeal to smokers and insufficient appeal to
experimental adolescents.
Nicotine at some mucosal surfaces is painful. As the tobacco
industry was well aware of this early on, it introduced mentholated cigarettes
(menthol being a weak local anaesthetic) to ease neophytes into their addiction.
The development and marketing of inhaled nicotine would require close
cooperation between state and enterprise to ensure a balance with tobacco
abstinence strategies. The financial and legislative barriers to developing, and
then marketing, the appropriate technology are considerable. Without support,
and a carefully crafted strategic approach from governments, public health, and
the anti-tobacco lobbies, the risks for any industry far outweigh the benefits.
But in an appropriate regulatory climate, in which a long-term strategy for
marketing had been agreed, there could be sufficient incentives for development
of inhaled nicotine and extension of nicotine-delivery programmes.
New Zealand has some characteristics that make it an ideal
country to pioneer such an approach. New Zealand has a strong long-standing
commitment to public health and has pioneered smoke-free legislation, mechanisms
to control tobacco, and the provision of alternative forms of nicotine. Despite
these efforts, continuing reductions in smoking prevalence have slowed
considerably and have largely benefited the more affluent sectors of society.
Regarding extended nicotine programmes, New Zealand is a small isolated country
separated by thousands of kilometres of ocean in all directions frustrating
smuggling and a black market in tobacco. There are also precedents for
partnerships between government and the pharmaceutical industry.
For example, the New Zealand government is currently
investing $200 million developing a vaccine for hyperendemic meningococcal
disease. Meningococcaemia kills approximately 20 people per year in New Zealand,
whereas tobacco kills close to 5000 per year. Currently, the New Zealand
government collects $880 million of revenue from tobacco annually. A small
proportion of this revenue could be used to help develop a comprehensive
nicotine-replacement programme.
There is an urgent need for new approaches to tobacco. The
failure to separate tobacco from nicotine is a major barrier to further progress
in preventing tobacco-related disease. Once separated, there is every reason to
expect that, with an appropriate mix of incentive and regulation, a replacement
nicotine strategy (including inhaled forms), could be developed and successfully
introduced.
Governments need to be reassured that it will be
considerably less harmful than tobacco and that recruitment to a new addiction
industry is minimised. Regular monitoring will be required. Industry must be
satisfied that it is financially viable and that there is an appropriate
legislative framework in place to allow effective market entry. Essentially
‘Big Pharma’ needs to compete with ‘Big Tobacco’. Most
importantly, it must satisfy the addicted smoker who will need to be encouraged
to switch from tobacco to nicotine with a mixture of marketing and financial
incentives. Furthermore, it must be readily available, and sit in a new niche
between recreation and therapy. Once established and acceptable, tobacco as a
nicotine delivery system will gradually disappear, and with it the whole issue
of environmental tobacco-smoke exposure. None of this is likely to be easy, but
neither is it impossible, and the potential gains are enormous.
The use of tobacco is part of almost every culture, and
despite the best efforts of health professionals and regulatory authorities over
the last 30–40 years, it is still readily available in every country and
used by approximately one sixth of the World’s population. In New Zealand,
tobacco control has taken us a considerable way down the road to smoking
abstinence, but the reductions have been inequitable and have lost momentum.
While we need to retain many of the current tobacco control strategies, we
urgently need new approaches and one of these is alternative nicotine
replacement.
Author information:
Julian Crane, Professor, Department of Medicine; Tony Blakely, Senior Research
Fellow, Department of Public Health; Sarah Hill, Registrar in Public Health,
Department of Public Health, Welllington
Correspondence:
Professor Julian Crane, Wellington School of Medicine, University of Otago, PO
Box 7343, Wellington, New Zealand. Fax: (04) 389 5427; email: crane@wnmeds.ac.nz
References:
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