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

Disclosures

• Royalties: UpToDate

• Consultant: Achieve Life Sciences

• Research grant, unpaid consultant: Pfizer

• No relationship with tobacco or e-cigarette manufacturers

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

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

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

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

Smoking Cessation: Critical Question

• Will e-cigarettes increase smoking cessation rates at

the population level?

• Population Impact = EFFICACY x REACH

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

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

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

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)

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

JUUL

• Sleek high-tech design

• Better nicotine delivery

• Social media marketing

JUUL - now the U.S. market leader

Source: King B et al. JAMA 2018; 320:1379.

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

Past 30-day tobacco product use by high school students

U.S. National Youth Tobacco Survey, 2011–2018

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

▪ 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

▪ 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

NY Times, 1/12/19

N Engl J Med. Feb. 14, 2019

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)

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

▪ 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?

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.

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