Early interest focused on pseudocigarettes. Why

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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 major class 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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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

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3 Smokeless tobacco products, including modified
(e.g., Exalt, Revel)

• Snus history and controversy
• Advertising as fill in for times when cant
  smoke (e.g., Revel)
• Fear of substitution for NRT 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 of PREPs, 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
lungcancer 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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Low tar and nicotine share of the cigarette market
Year low t/n 1967-70 (avg.)
3 1971-74 (avg.) 8 1981 58
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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 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.

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The great unknown

• Should smokeless tobacco products be promoted
  as potential harm-reduction products? (Risks
  being accused of tobacco control heresy)

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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

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What is to be regulated?

• All products?
• All new products?
• All new non-conventional products? (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 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?

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Yet another issue
How can we properly educate health
professionals and the public about harm
reduction? What do we tell them?
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Concluding thoughts

• 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?

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Concluding thoughts (contd.)

• 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?

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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
  harm reduction not likely to be popular
  (medicinal nicotine)
• Harm reduction should never supplant emphasis on
  prevention and cessation.

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