Early interest focused on
pseudo-cigarettes. Why?
• Fascination with high-tech products
• First “splash” (Premier, mid-1980s)
• Promised large decreases in a major
class of toxicants, with a new delivery
mechanism
Interest has switched to
other categories of PREPs
Different reasons for different
categories
#1 Modified 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
#3 Smokeless tobacco products,
including modified (e.g., Exalt, Revel)
• Snus history and controversy
• Advertising as “fill in” for times when
can’t smoke (e.g., Revel)
• Fear of substitution for NRT products
• Fear of leading to smoking
#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
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.
– Public’s perception of nicotine as a very
dangerous drug.
What have we learned to this point?
• Experience with earlier generations of “harmreducing” cigarettes recommends skepticism.
• The risk/use equilibrium addresses the
acceptability of the highest- and lowest-risk
classes of PREPs, but not those in between.
• The need for formal, government-sanctioned
regulation is clear…but its methods are not.
Earlier generations of “harmreducing” cigarettes
Filter-tipped cigarettes,
the response to the lung
cancer scare of the 1950s
Filter-tip share of the
cigarette market
Year
% filters
1950
1960
1
51
(Current
98)
“Low-yield” (low tar and nicotine)
cigarettes, the response to the
smoking-and-health scare of the
late 1960s, early 1970s
Low tar and nicotine share
of the cigarette market
Year
1967-70 (avg.)
1971-74 (avg.)
1981
% low t/n
3
8
58
• 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.
Lessons from the risk-use
equilibrium
(Kozlowski et al., Tobacco Control,
Sept. 2001)
Risk/use equilibrium: lessons
• Any combusted tobacco product likely
constitutes a very poor prospect for harm
reduction. At a population level, it is likely to
be harm increasing. Combusted products
should not be marketed as harm-reducing.
• Medicinal nicotine likely represents an
excellent prospect for harm reduction. It
should be encouraged by health professionals
today, and (more controversially) marketed by
the pharmaceutical industry (with FDA
approval secured) – for smokers who cannot
or will not quit altogether.
The great unknown…
Should smokeless tobacco products
be promoted as potential harmreduction products? (Risks being
accused of tobacco control heresy…)
Need for regulation
• Establish the toxic exposures associated with
new products (old and new exposures; e.g., Eclipse)
• Estimate (guestimate?) the health consequences
• Estimate population exposures
• Evaluate the implications of risk communication
to health professionals and the public (and define
acceptable risk communication)
• Monitor legitimacy of claims
• “Level the playing field” between highly regulated
pharmaceuticals and unregulated tobacco
products
What is to be regulated?
• All products?
• All new products?
• All new non-conventional
products? (How define
“conventional”?)
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
Difficulties in regulating
• How establish individual exposure
reduction?
• How estimate harm reduction from
individual exposure reduction? (the limits of
surveillance)
• How assess population responses to
claims and marketing? (again, the limits of
surveillance)
• How combine (weak) estimates of
individual harm reduction potential with
(weak) estimates of population response?
• How address the political barriers to
regulation?
Yet another issue
How can we properly educate
health professionals and the
public about harm reduction?
What do we tell them?
Concluding thoughts
• Is an era of harm reduction
inevitably upon us?
– In today’s (non)regulatory world, yes
• Tobacco industry innovation assures it.
• Will we ever see more explicit and
aggressive competition from the
pharmaceutical industry?
Concluding thoughts (cont’d.)
• Potential societal benefits of harm reduction are
considerable:
– 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?
Concluding thoughts (cont’d.)
• 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 harm
reduction not likely to be popular (medicinal nicotine)
• Harm reduction should never supplant
emphasis on prevention and cessation.