Technology, Policy, And the Future of Nicotine Addiction

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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Technology, Policy, And the Future of Nicotine Addiction