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8/8/2019 Technology, Policy, And the Future of Nicotine Addiction
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Kenneth E. WarnerUniversity of Michigan
University of IowaNovember 15, 2002
Technology, Policy, andthe Future of Nicotine
Addiction
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Pillars of Tobacco Control
Prevention of initiation
Assistance with cessation Protection from environmental
tobacco smoke
Harm reduction?
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What is tobacco harm reduction?
Why do we care about it?
What are we going to do about it?
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Tobacco harm reduction:a definition
Minimization of the net damage to
health associated with use of
tobacco products, products including
constituents of tobacco, and other
substitutes for tobacco products.
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Hierarchy of harm reduction
techniques, most to least desirable
Avoidance of initiation (prevention)
Complete cessation
Substitution of least harmful alternatives (e.g.,
medicinal nicotine)
Substitution of moderately harmfulalternatives (e.g., smokeless tobacco)
Substitution of most harmful alternatives (e.g.,
modified cigarettes; reduced smoking)
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Context for the harm reduction debate
Limited success of prevention/cessation
New environment
Perception of hardening of the target
Tobacco industrys publicly acknowledging the dangers
of smoking
USSTs desire to promote smokeless as less harmful
New products Marketing of novel tobacco products
Innovations in nicotine replacement products
Concerns about promotion of harm reduction
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Motives for harm reduction
Public health community:Reducing risk of disease and death for tobacco usersincapable of quitting (or unwilling to quit)
Tobacco industry:Selling product on a sustained basis, with goal of
profiting from sales to consumers they mightotherwise lose
Pharmaceutical industry:Currently, selling product on a short-term basis, withgoal of profiting from increased cessation
(Future???)
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Product type Examples
Modified conventional
cigarettes
Some carcinogens removed;
nicotine-free; fire-safe
Pseudo-cigarettes Unorthodox ignition;
cigarette-like appearance
Smokeless tobacco,
including modified
Nitrosamines greatly
reduced
Novel tobacco and nicotineproducts
Tobacco lozenges; nicotinewater
Nicotine pharmaceuticals Gum; patch; inhaler;
spray; lozenge
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About Eclipse and Your Health
May present less risk of cancer
associated with smoking..
Produces less inflammation in the
respiratory system, which suggests a
lower risk of chronic bronchitis, and
possibly emphysema..
Reduces secondhand smoke by 80%.
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Nicotine Water
The goal of NICOTINE
WATER is to give
cigarette users an
alternative source ofNicotine that is free of the
severe health risks of tar and smoke.
But what good is an alternative if it does not come in
a form or taste that is appealing to the consumer.
That is where NICOTINE WATER has no equal.As
a result of careful development and attention to
detail, with NICOTINE WATER, all you will taste is
the water.
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Pacific Compounds. Nicotine replacement in a sucker! Accessed 17 May 2002.
http://www.pacificcompounds.com/Products/Stop_Smoking/stop_smoking.asp
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Assessing the Science Base for
Tobacco Harm Reduction
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Institute ofMedicine study
Impossible to assess the harm reductionpotential of products, but conceivable thatexposure reduction could be assessed.
Labeled products PREPS, potential reduced-exposure products (not harm reductionproducts).
Called for study of biomarkers and surrogatesthat might suggest harm reduction potential;surveillance and evaluation of product use;regulation of manufacturer claims.
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Potential benefit of PREPs(from public health perspective)
For smokers who cannot or will not quit,PREPs may offer a less risky alternative
to continued smoking. Switching to
PREPs may reduce their risk of seriousdiseases.
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Potential risks of PREPs
May substitute for quitting
May substitute for abstinence (staying quit)
May supplement (and sustain) ongoing use of
conventional tobacco products
May encourage experimentation by children
who would have avoided conventional tobacco
products
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Early interest focused on
pseudo-cigarettes. Why?
Fascination with high-tech products
First splash (Premier, mid-1980s)
Promised large decreases in a majorclass of toxicants, with a new delivery
mechanism
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Interest has switched to
other categories of PREPs
Different reasons for different categories
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#1Modified cigarettes (e.g., Omni
and Advance)
Most likely to appeal to smokers (closest
approximation to the real thing)
Least likely to produce great risk reduction
for the individual
Most likely to increase population harm
Therefore, the greatest source of concern
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#3 Smokeless tobacco products,
including modified (e.g., Exalt, Revel)
Snus history and controversy
Advertising as fill in for times whencant smoke (e.g., Revel)
Fear of substitution forNRT products
Fear of leading to smoking
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#4 Presumed lowest-risk novel
products (e.g., Ariva Cigaletts)
Sheer novelty and our bewilderment about
them
Fear of attraction to children (with risk of
subsequent shift to cigarettes)
Affront to the idea of using these products
when there are proven pharmaceuticals to
substitute for tobacco products
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Little interest focused on nicotine
pharmaceuticals (category #5)?
No longer sexy
Regulatory approval limited to short-term use
for cessation
Pharmaceutical companies timid about taking
on the tobacco industry
Pharmaceutical companies worries about the
public image associated with advocating long-term use.
Sustaining nicotine addiction vs. overcoming it.
Publics perception of nicotine as a very dangerous
drug.
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What have we learned to this point?
Experience with earlier generations of harm-
reducing cigarettes recommends skepticism.
The risk/use equilibrium addresses the
acceptability of the highest- and lowest-risk
classes ofPREPs, but not those in between.
The need for formal, government-sanctioned
regulation is clearbut its methods are not.
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Earlier generations of harm-reducing cigarettes
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Filter-tipped cigarettes,the response to the lung
cancer scare of the 1950s
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Filter-tip share of the
cigarette market
Year % filters
1950 1
1960 51
(Current }98)
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Low-yield (low tar and nicotine)
cigarettes, the response to the
smoking-and-health scare of the late
1960s, early 1970s
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Year % low t/n
1967-70 (avg.) 3
1971-74 (avg.) 8
1981 58
Low tar and nicotine shareof the cigarette market
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Even today, 30 years after their
introduction, smokers of low tar/nicotine
cigarettes believe their risk is well below
that of full-flavor smokers.
Yet ample evidence demonstrates that
low t/n smokers compensate
And the consequence is that low t/n
smokers are developing cancers further
down in the lung.
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Lessons from the risk-use
equilibrium
(Kozlowski et al., Tobacco Control, Sept. 2001)
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Risk/use equilibrium: lessons
Any combusted tobacco product likely constitutesa very poor prospect for harm reduction. At apopulation level, it is likely to be harm increasing.Combusted products should not be marketed as
harm-reducing.
Medicinal nicotine likely represents an excellentprospect for harm reduction. It should beencouraged by health professionals today, and(more controversially) marketed by thepharmaceutical industry (with FDA approvalsecured) for smokers who cannot or will not quit
altogether.
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The great unknown
Should smokeless tobacco products be
promoted as potential harm-reduction
products? (Risks being accused of tobaccocontrol heresy)
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Whatis to be regulated?
All products?
All new products?
All new non-conventionalproducts? (How define
conventional?)
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Methods of regulation
Approve claims (IOM)
Adopt performance standards (with or
without permitting claims concerning them)
Pre-marketing approval based on probable
degree of decrease in individual risk
Pre-marketing approval based on probable
degree of net benefit or net harm to public
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Difficulties in regulating
How establish individual exposure reduction?
How estimate harm reduction from individualexposure reduction? (the limits of surveillance)
How assess population responses to claims andmarketing? (again, the limits of surveillance)
How combine (weak) estimates of individual harmreduction potential with (weak) estimates ofpopulation response?
How address the political barriers to regulation?
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How can we properly educate healthprofessionals and the public about
harm reduction? What do we tell
them?
Yet another issue
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Is an era of harm reduction inevitably upon us?
In todays (non)regulatory world, yes
Tobacco industry innovation assures it.
Will we ever see more explicit and aggressive competition
from the pharmaceutical industry?
Concluding thoughts
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Concluding thoughts (contd.)
Potential societal benefits of harm reduction areconsiderable:
Could conceivably lead to more eventual complete
renunciation of nicotine and tobacco
May decrease the toll of tobacco
Potential risks are substantial too:
Sustain and potentially increase the level of nicotine
dependence in contemporary society (Necessarily bad?)
Slow progress against the devastating toll of tobacco
Increase nicotine dependence in future generations
Create new health hazards in the process?
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Concluding thoughts (contd.)
Over time, harm reduction may play a large and
increasingly important role within tobacco control.
For the foreseeable future, its contribution is likely
to be small, and possibly negative. The most consumer-attractive products not likely to
produce net improvement in public health (modified
cigarettes)
Products with the greatest potential for true harmreduction not likely to be popular (medicinal nicotine)
Harm reduction should never supplant
emphasis on prevention and cessation.
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