[ insert title here ] · is juul an effective smoking cessation aid? it might be the best...
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Electronic CigarettesFriend or Foe (or Both)?
La cigarette électronique: amie ou ennemie?
Nancy Rigotti, MDProfessor of Medicine, Harvard Medical School
Director, Tobacco Research Center, Massachusetts General Hospital
Boston, MA USA
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Disclosures
• Royalties: UpToDate
• Consultant: Achieve Life Sciences
• Research grant, unpaid consultant: Pfizer
• No relationship with tobacco or e-cigarette manufacturers
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Electronic Cigarette
A nicotine delivery device that looks like a cigarette
Nicotine +
propylene glycol
or glycerin
+ flavor
The devices are changing rapidly
No tobacco burned→ Safer than cigarettes?
Not FDA regulated→ Many knowledge gaps
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ELECTRONIC CIGARETTESMany Questions, Few Answers
◼ How much nicotine do they actually deliver?
◼ Who is using them?
◼ Why are they using them?
To quit smoking
To reduce health risks of smoking
Use where they can’t smoke
Prevalence of e-cigarette use
by smoking status US adults - 2014
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E-Cigarettes - Summary of the Evidence2018 National Academy of Science, Engineering and Medicine Report
• E-cigarettes contain fewer (and lower
levels) of toxic substances than
conventional cigarettes
• While not without health risks, they
are likely to be far less harmful than
combustible tobacco cigarettes
• Long-term health effects of e-cigarettes
are not yet clear
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E-cigarettes – Potential Public Health Effects
The net public health effect of e-cigarettes will depend
on the balance of 3 factors:
• Potential to help current smokers to quit
• Potential to increase the uptake of combustible
tobacco product use
• Toxicity of the product
– Absolute (vs. nonsmoking) - youth
– Relative to combustible tobacco – adult smokers
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Smoking Cessation: Critical Question
• Will e-cigarettes increase smoking cessation rates at
the population level?
• Population Impact = EFFICACY x REACH
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Efficacy vs. Reach
Efficacy: Do they help smokers to quit combustibles?
• How do they compare to existing cessation aids?
Reach / appeal: Do they attract more smokers to try to
quit combustibles?
• Smokers who are not interested in quitting or who repeatedly
failed and have given up trying
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Smoking Cessation – Literature review
• >20 systematic reviews
• Evidence is too limited to make definite conclusions
• 2 Randomized controlled trials
• Bullen 2013 (nicotine e-cig vs. PCB e-cig vs. NRT)
• Caponnetto 2013 (nicotine e-cig vs. PCB e-cig)
• Longitudinal observational studies
• Results are often at odds with results of RCTs
• Population-level studies (mostly cross-sectional)
• Cessation appears related to more frequent use
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Adult Smoking Cessation - Conclusions• Limited evidence that e-cigarettes may be effective aids
to promote smoking cessation overall.
• Insufficient evidence from RCTs about the effectiveness of e-
cigarettes as cessation aids compared to no treatment or to
FDA–approved smoking cessation treatments
• Moderate evidence from observational studies that more
frequent use of e-cigarettes is associated with increased
cessation
10
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Harm Reduction – Conclusions
• Substantial evidence that complete switching from
regular use of combustible cigarettes to e-cigarettes →
reduces short-term adverse health outcomes in several
organ systems
• Insufficient evidence that e-cigarette use changes short-
term adverse health outcomes in smokers who continue to
smoke combustible tobacco cigarettes (dual users)
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E-Cigarettes - Summary of the Evidence2018 National Academy of Science, Engineering and Medicine Report
• Using e-cigarettes may help adults quit
smoking, but more research is needed
• Among youth, e-cigarette use increases
the risk of initiating smoking
• Modelling results indicate that e-cigarettes
will likely result in a net public health
benefit
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JUUL
• Sleek high-tech design
• Better nicotine delivery
• Social media marketing
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JUUL - now the U.S. market leader
Source: King B et al. JAMA 2018; 320:1379.
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Monitoring the
Future Study
NEJM Dec. 2018
Annual cross-sectional school
survey of US adolescents in
grades 8-12
CAVEAT: Prevalence of smoking did not
change and is at a historic low
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Past 30-day tobacco product use by high school students
U.S. National Youth Tobacco Survey, 2011–2018
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FDA Response
“The FDA now believes that youth use of e-cigarettes is reaching
epidemic proportions.” - Scott Gottlieb, FDA Commissioner, September 2018
“In order to close the on-ramp to e-cigarettes to kids, we have to put in place
some speed bumps for adults.” - November 2018
▪ Ban sales of flavored e-cigarettes in retail stores and gas stations,
except tobacco, mint, and menthol flavors
▪ Require tougher age-verification for online sales
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▪ What will be the natural history of this cohort of young never
smoking JUUL users?
▪ How many will switch to combustible cigarettes?
▪ Why would they switch to a “less desirable” product?
▪ If few become smokers, how long will e-cig/JUUL use last?
▪ How many will become nicotine dependent?
▪ How many will they need help to quit e-cigarettes?
▪ If most users continue for many years, how harmful is that?
Critical questions about JUUL
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▪ Is JUUL an effective smoking cessation aid?
▪ It might be the best e-cigarette to promote cessation
among current cigarette smokers.
▪ Efficacy for smoking cessation needs to be tested
▪ How important are flavors to their appeal and success
with adults?
Let’s not forget cigarette cessation
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NY Times, 1/12/19
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N Engl J Med. Feb. 14, 2019
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Hajek P et al. N Engl J Med 2019 Participants▪ 886 adult smokers (15 cig/d)▪ 3 British NHS Stop Smoking Service clinics▪ No preference for NRT vs. e-cigarette to quit
Interventions▪ Choice of type of NRT (combination recommended) – 3 mo.
vs.
▪ E-cigarette starter pack (refillable device + 1 bottle e-liquid)
▪ All got 4 weekly counseling visits
Assessments▪ Cigarette cessation: 4, 26, 52 wk (1o =sustained quit at 52 wk)
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Hajek et al. N Engl J Med 2019
Abstinence Rates and Smoking Reduction at 52 Weeks
Among those who were quit at 1 year:
▪ 80% in e-cig group were still using e-cigs
▪ 9% in NRT group were still using NRT
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▪ In a clinical trial setting, the evidence that e-cigarettes can help
smokers to quit combustible cigarettes is growing
▪ Under what conditions are they most effective?
▪ Which types of devices are most effective? (Is it JUUL?)
▪ How often and how long do e-cigs need to be used?
▪ Are they best used alone or in combination with other cessation aids?
▪ How much (or what type) behavioral support is needed?
▪ How important are flavors to e-cigarettes’ appeal and success as
cessation aids?
Where are we?
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What should you say to a smoker about E-cigarettes?
• E-cigarettes are new products not yet approved by the FDA.
• E-cigarettes are less harmful than continuing to smoke cigarettes.
• Uncertainty exists about their safety for long-term use.
• Recommendations:
• Goal = to stop all combustible tobacco use
• Use FDA-approved treatments first.
• If using, switch completely to e-cigarettes (avoid dual use)
• Eventually, aim to to stop using e-cigarettes and cigarettes.
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What is the goal of tobacco control?
▪ To eliminate deaths due to tobacco smoking? (= eliminate combustible tobacco use)
or
▪ To eliminate nicotine addiction (in youths or in all)?
Can we achieve both?
A Key Question driving the e-Cigarette Controversy