A Reflection On Alternative Nicotine Delivery Systems

Mark C. Taylor, MD,. FRCSC

There has been a recent trend among some of the tobacco control community to advocate a new emphasis on the
development and promotion of alternative nicotine delivery system (ANDS). This trend was exemplified by a
conference held in Toronto in early 1997.1 The underlying premise of many advocates of ANDS is the existence of
a very large number of nicotine addicts who receive their dose of nicotine through tobacco products, only a fraction
of whom will be able to quit smoking. A further assumption of this harm reduction approach is that providing
nicotine to these addicts in a delivery vehicle which does not involve ingesting tobacco could dramatically reduce
the aggregate health consequences of tobacco use. One proponent of ANDS cautions unless we establish an
aggressive harm reduction strategy that promotes the use of alternative nicotine delivery products our campaign may
not achieve our goal of reducing [smoking] prevalence to 15%.2
ANDS proponents suggest a market-driven solution to tobacco use could be found in the introduction of new and
safer nicotine consumer products. To expand the availability of new delivery systems for nicotine, they are
suggesting changes by government regulators, nicotine product manufacturers, advertisers and retailers.
Governments are urged to reduce the red-tape faced by pharmaceutical companies. [S]ociety poorly regulates the
cigarette and over regulates nicotine gum. The proper regulatory response is to implement a strategy that levels the
regulatory playing field between the cigarette and AND products.3 Pharmaceutical companies are urged to be more
aggressive marketers. I think it important that drug manufacturers, who will profit from less cigarette sales, pursue
this in their advertising and that they lift any voluntary restraints they have from directly competing with tobacco
products and attacking the tobacco industry. 4 We can give consumers a choice, and manufacturers an incentive to
compete for the nicotine marketwe can allow private enterprise to unleash its creativity in order to address our
leading cause of preventable death."5 The prospect of nicotine products being widely available, at least in a basic
maintenance dose, in such places as overnight convenience stores. 6 is suggested as a progressive step. Advertisers
of new nicotine products are reminded that the successful ANDS product will not forget pleasure.7
Smokers may be less convinced than these theorists that todays alternative nicotine products are satisfactory
substitutes for cigarettes. Currently, there is no widely available delivery system which provides nicotine to the drug
user in ways which approximate cigarette smoke. Gums and nicotine patches do not provide the dramatic peak in
serum nicotine levels which the smokers brain has come to crave. To develop and test such systems and to establish
their safety and efficacy as part of an ANDS strategy will require considerable investment of resources.
Subsequently, extensive marketing will be necessary to convince smokers to switch to the new systems. The
economic investment required to launch such a strategy would eclipse the current investment by western
governments in preventing nicotine use. Not surprisingly, the resources needed to launch alternative nicotine
products are possessed by the tobacco industry, which has already taken dramatic movements in this direction in the
development of the Eclipse cigarette by RJ Reynolds.
There are a number of very serious issues which need to be considered before the tobacco control community
embraces an alternative nicotine delivery strategy. Until now, we have operated from the premise that nicotine
addiction is a disease which young people develop as a result of a number of external influences. The tobacco
industry has worked very hard to addict children through aggressive advertising. We have told governments that the
industry must be kept away from children, through total bans on advertising and sponsorship. Those in the industry
have been discredited as merchants of death, a reputation richly deserved. In industrialized societies, tobacco use
has been eliminated from an ever expanding list of public places, and the effect is that the exposure of children has
been reduced.

Adopting alternative nicotine delivery as a major emphasis will require a complete reversal of our thinking. We
would have to accept that rather than being a preventable disease, nicotine addiction is a fundamental human
characteristic which we are powerless to change. The role of the health community will be shifted from curing or
preventing nicotine addiction to ensuring that it is satisfied in the least toxic form possible.
As such alternative nicotine products are now and will increasingly be provided by tobacco companies, we will have
to develop a new understanding of the social and economic role of this industry. We will have to accept tobacco
companies as legitimate businesses, and their managers as honest business people. We will have to trust their
actions and be at least passive partners in their research, development and marketing of new tobacco products. The
spectre of the health community approaching government arm in arm with the tobacco industry is one which I found
profoundly disturbing, even as I know that it has already happened in Canada in connection with the Eclipse
cigarette.
Nicotine, of course, is one of the reasons people smoke. In the process of receiving their dose of nicotine, addicts
are exposed to thousands of toxic compounds produced from burning tobacco leaves. Nicotine is probably not
directly responsible for the cancers which tobacco causes, or the respiratory diseases. There is evidence that
nicotine is directly responsible for some of the cardiovascular consequences of tobacco use. While decided
preferable to tobacco smoking, pure nicotine ingestion cannot be considered to be innocuous. Those products
developed by the pharmaceutical industry, including nicotine gum and patches, provide nicotine in what is probably
the safest possible form, and some addicts rely on this products for very extended periods of time. However, for the
majority of smokers, the nicotine is not produced in a satisfactory format, since the hit of nicotine supplied by
smoking is not mimicked with these products.
The product furthest along in development to achieve the objectives of satisfactory nicotine delivery and harm
reduction is RJ Reynolds Eclipse system, currently under development in many countries, including Canada. This
product appears very similar to a cigarette, but heats the tobacco instead of burning it. The result is the delivery of
nicotine in aerosol form to the smoker, with very little production of smoke. The nicotine delivery is the same as
with cigarettes, including the sudden surges in serum level which many smokers require. The concentration of many
toxic compounds is lower than with conventional cigarettes, but the concentration of carbon monoxide is higher.
The health advantages of the Eclipse system are far from proven. A detailed MEDLINE search of the medical
literature from January 1994 to July 1997 turned up only one paper on the subject of tobacco-heating cigarettes.
Interestingly, the paper was from the RJR Reynolds tobacco company, and compared the mutagenicity of the urine
from smokers of regular cigarettes to smokers of a tobacco-heating cigarette.8 While the urine of the test cigarette
group contained lower levels of cancer-causing chemicals than the urine of regular smokers, these chemicals were
still present in significant concentrations. There is no evidence whatsoever that tobacco-heating cigarettes are any
safer than regular cigarettes. The tobacco industry may have data on this question, but until methodologically sound
studies are published in peer-reviewed journals, we have no way of assessing the evidence.
There are high risks associated with introducing such a product to the market.
Pregnant women might switch to Eclipse rather than quitting altogether. New research is documenting how
nicotine and its metabolites cross the placenta and are excreted in breastmilk, suggesting that this may
result in the addiction of infants at the very beginning of life, and predispose children to smoking or other
forms of nicotine addiction.
If allowed to market new alternative nicotine devices, there is good historic reason to believe that the
tobacco industry would do so in a way which recruits children and youth. Such recruitment of a new
generation would needlessly extend the pandemic of tobacco use well into the next millenium.
Smokers may be discouraged from quitting, since they could switch to a safer product.
Former smokers could be recruited back to nicotine addiction in the belief that they could smoke with
impunity.
Initiatives to reduce smoking opportunities through bans on smoking in public and work places could be
stalled.
Smokers could be encouraged to continue smoking in their home, increasing their own tobacco
consumption and providing role models for smoking to their children.
The de-legitimization of tobacco and smoking could be stalled.

A new smoking fad could emerge.

Similarly, alternative nicotine products developed by the pharmaceutical industry cannot be assumed to be benign,
in either their current or future forms. Whether delivered through patch, gums, inhaler or lollipop, nicotine is a
powerful and toxic substance. The capacity of large segments of the population to become addicted to nicotine, to
underestimate the health consequences of its use, and to hold strong beliefs about the benefits of its consumption
(i.e. physical and mental alertness, weight loss), have already been established. There is an historical and established
reluctance of governments to adequately regulate and control nicotine. There is no prima facie reason to believe that
pharmaceutical companies will continue to resist lifestyle advertising and other promotional strategies to encourage
the non-therapeutic long-term use of nicotine products.
There are a number of conditions which should be met before the health community further invests time and
resources to proposals for alternative nicotine delivery systems. First, there must be sound scientific evidence that
the products being promoted are safer. There must be a soundly predictable reduction in morbidity and mortality.
Reliable estimates are needed of the number of smokers who can be moved to alternative nicotine systems. The
economic cost of this market shift, and the impact on cessation should also be measured. Most importantly, reliable
measures are needed of the lives saved by shifting smokers to new nicotine delivery systems. These estimates must
be compared with the number of lives which could be saved by a comprehensive tobacco use reduction strategy
using established policy tools (i.e. total advertising ban, dramatic price increases, access restrictions and effective
education) and by developing new policy tools (i.e. changed legal status of tobacco, reduced availability of tobacco
products).
In addition to epidemiological concerns, there are economic considerations which should weigh against the early
adoption of an ANDS strategy. Shifting smokers to new nicotine products will divert funds theoretically available
to campaigns to reduce tobacco use into a for-profit market of ANDS products. It is impossible at this point to
predict the economic impact of a successful ANDS market. However, shifting the expenditures of only 1% of the
Canadian smoking population to alternative nicotine products would involve a far greater private expenditure on
maintaining nicotine addiction (approximately $80 million per year) than is currently allocated by public funds to
reduce smoking or cure nicotine addiction ($10 million in federal Canadian expenditures in 1997-98).
Lessons on the market potential for or consumer vulnerability to new nicotine products may be found in the early
Canadian experience with the nicotine patch. Between 1991 and 1993, new prescriptions for nicotine patches rose
from 0 to over 600,000.9 That is, almost 10% of Canadian smokers were recruited to try the patch in the second year
of its marketing. Pharmaceutical manufacturers could not advertise the patch directly to consumers, although it was
directly advertised to physicians and promoted to the general public through news and information media. In both
direct and indirect promotion, the patch was represented as a therapeutic aid to smoking cessation. The boom market
did not last long (by 1994 new prescriptions fell to 200,000), but not before one patch manufacturer was penalized
for charging excessive prices for the product10. If 10% of all smokers can be moved without direct advertising to try
an expensive product designed to help them quit, when only 48% of smokers declared themselves to be
contemplating or preparing to quit,11 how much larger is the potential market for substitute nicotine products which
are advertised, affordable and accessible? What is the market for products which are better satisfy the symptoms of
nicotine addiction? What is potential market for nicotine manufacturers if their products are not used therapeutically
for short periods, but become part of a long-term drug use pattern?
A market-driven for-profit solution to tobacco use has no inherent economic superiority over a publicly-funded notfor-profit solution to nicotine addiction. The investment of transnational companies in a harm reduction strategy
which also builds a lasting commercial market for an addictive substance cannot, on health or economic grounds, be
viewed as inherently superior to public investments in reducing smoking.
The development and particularly the marketing of new nicotine products must be taken out of the hands of the
tobacco industry. This industry has proven itself incapable of restraining its activities, particularly in the recruitment
of non-smoking populations, such as children. There is no reason to believe RJ Reynolds will market Eclipse with
any greater respect for public health than it has marketed Camel cigarettes.
Changing emphasis from tobacco use initiation and prevention to concentrating on alternative nicotine delivery
systems would require significant rethinking of our activities on tobacco control, and reallocation of resources and

expertise. Until convincing evidence is available that these products are indeed safer, and until control of their
marketing and development has been taken out of the hands of the tobacco industry, this approach cannot be
recommended. Nicotine addiction is not a fundamental human characteristic, but a tragic childhood disease which
we should continue to work hard to prevent.

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Alternative Nicotine Delivery Systems. Harm Reduction and Public Health. This conference was jointly held by the Addiction
Research Foundation, the Ontario Tobacco Research Unit and the American Society of Addiction Medicine on March 21-23,
1997./
Connolly, Gregory N. Closing the Gaps A public health agenda for nicotine harm reduction. Paper presented at the
Conference on Alternative Nicotine Delivery Systems, Toronto, March 1997.
ibid.
ibid.
Sweanor, D. Alternative nicotine delivery as a harm reduction strategy getting rid of the dirty syringe. Adapted from a paper
used at a panel discussion oat the American Society of Addiction Medicine Conference, October 14, 1995 in Toronto.
Room, R. Control Systems for Pyschoactive substances. Paper presented at the Conference on Alternative Nicotine Delivery
Systems, Toronto, March 1997.
Kozlowski, L. Better, smoother and not a cough in a carload. Lessons from cigarette advertising and attempts to control it in
the United States from 1900 to 1965 with a selective, brief history of earlier tobacco use Paper presented at the Conference
on Alternative Nicotine Delivery Systems, Toronto, March 1997.
Smith, C.J. et al. Human urine mutagenicity study comparing cigarettes which burn or pimarily heat cigarettes. Bowman Gray
Technical Centre, RJ Reynolds Tobacco Company. Mutat-Res. 1996 Sep 26 ; 361(1); 1-9
Data provided by Roberta Ferrence, Senior Scientist, Ontario Tobacco Reduction Unit, Toronto, Ontario.
On October 18, 1994, the Patented Medicine Prices Review Board (PMPRB) obtained a voluntary compliance undertaking
from CIBA Geigy Canada Limited to offset excess revenues of $3.6 million, including a payment to the Government of Canada
of $2.9 million. This is one of only three cases where the PMPRB has used its quasi-judicial powers/
Health Canada. Survey on Smoking in Canada, Cycle Three, Fact sheet No. 6. Readiness to Quit Smoking November
1994.