Which of the following would have the greatest public health impact (in terms of respiratory health improvement)?

A. Make nicotine replacement therapy available to all current smokers free of charge

B. Get all current smokers to cut down the amount they smoke by 75%

Assume population of 100 smokers, 20 cigarettes per day, and 8% NRT quit rate

A. Make nicotine replacement therapy available to all current smokers free of charge 8% cessation 8 people quit 160 fewer cigarettes smoked per day

B. Get all current smokers to cut down the amount they smoke by 75% 100 smokers using 15 cigarettes less per day 1500 fewer cigarettes smoked per day

Twist on the Prevention Paradox – Focus on High-Risk for Quitting Rather

than High Risk for Disease

A. High-risk strategy: Intervene among the small minority of smokers who are at high risk for quitting (8% of population)

B. Population strategy: Shift entire distribution of exposure (100% of population)

Source: Rose G. Sick individuals and sick populations. Int J Epidemiol 1985; 14:32–38.

Is There a Product or Approach that Can Cut Cigarette Consumption by 75% Among the

Population that Embraces the Product or Approach?

Is There a Product or Approach that Can Cut Cigarette Consumption by 75% Among the

Population that Embraces the Product or Approach?

Is There a Product or Approach that Can Cut Cigarette Consumption by 75% Among the

Population that Embraces the Product or Approach?

B. Population strategy: Shift entire distribution of exposure (100% of population) by getting smokers to switch to an alternative type of cigarette that is substantially safer OR to cut down on their cigarette consumption by 75% or more

The Public Health Response to Electronic Cigarettes

American Cancer Society: BAN THEMAmerican Heart Association: BAN THEMAmerican Lung Association: BAN THEMCampaign for Tobacco-Free Kids: BAN THEMAction on Smoking and Health: BAN THEMAmerican Legacy Foundation: BAN THEMAmerican Academy of Pediatrics: BAN THEMAssociation for the Treatment of Tobacco Use and

Dependence: BAN THEMFood and Drug Administration (FDA): PARTIALLY

ENFORCED A BAN ON THEM

The Debate Over Harm Reduction in Public Health

“Scientific debates about public health issues can be heated, and the arguments and feelings they provoke can become ad hominem. Why do public health policy disputes often trigger strong emotions including anger, contempt, and disgust?” …

“An example of a public health issue that can provoke emotional disputes is harm reduction, an approach that seeks to address public health problems in a practical way by reducing harm as much as possible. … Debates about harm reduction can quickly turn into emotional quagmires.”

Examples: Abstinence-only sex educationNeedle exchange programsHarm reduction in tobacco control

Source: Alderman J, Dollar KM, Kozlowski LT. Understanding the origins of anger, contempt, and disgust in public health policy disputes: Applying moral psychology to harm reduction debates. Journal of Public Health Policy 2010; 31:1-16.

Should Medical Providers Recommend E-Cigarettes to their Patients as a Smoking Cessation Tool?

YES

Michael Siegel, MD, MPHProfessor

Department of Community Health SciencesBoston University School of Public Health

Disclosure

Dr. Siegel has not received any funding or compensation from any electronic cigarette companies.

However, he is currently seeking funding from electronic cigarette companies to conduct a study of the effects of electronic cigarettes on smoking behavior.

In 2007, the Answer was a Resounding “NO”

All existing harm reduction products were produced by, and marketed by the tobacco industry

Tobacco companies have no incentive to promote smoking cessation using their harm reduction productsIn practice, harm reduction products were used to promote dual use of cigarettes and the alternative productIn practice, “harm reduction” products were not substantially saferMarketing of these products undermined public’s appreciation of health hazards of smoking

The 5 Most Common Arguments Against Harm Reduction in Tobacco Control

1. Promotion of safer alternatives will inhibit smoking cessation/prevention efforts

2. Skepticism about the role of combusted products in harm reduction

3. Alternatives promoted as safer may prove more dangerous, or equally dangerous, leading to false claims and misleading of the public

4. NRT has not been effective, so harm reduction equals harm maintenance

5. Tobacco industry cannot be trusted to develop and market a safer cigarette alternative

Promotion of safer alternatives will inhibit smoking cessation/prevention efforts

1. Smokers who switch to electronic cigarettes are ex-smokers. They have successfully quit smoking.

2. Electronic cigarette marketing is enhancing, not detracting from, the public’s appreciation of the hazards of cigarette smoking.

Skepticism about the role of combusted products in harm reduction

Electronic cigarettes are not tobacco products and no combustion takes place.

Alternatives promoted as safer may prove more dangerous, or equally dangerous, leading to false claims and misleading of the public

Product Total Tobacco-Specific Nitrosamines (ng/g or per gum/patch)

Nicorette gum 2.00

NicoDerm CQ patch 8.00

Electronic cigarettes 8.18

Marlboro 6260

Source: Cahn Z, Siegel M. Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes? Journal of Public Health Policy 2010; doi:10.1057/jphp.2010.41.

NRT has not been effective, so harm reduction equals harm maintenance

Abundant anecdotal evidence suggests that electronic cigarettes may be effective for smoking cessation.

Product addresses both the pharmacologic and behavioral aspects of smoking addiction

Preliminary scientific evidence that vaping is effective in decreasing the desire to smoke

Vibrant online community of vapers

Tobacco industry cannot be trusted to develop and market a safer cigarette alternative

Electronic cigarettes are not tobacco products and only 3 of more than 300 brands are marketed by tobacco companies.

An Ethical Framework for Thinking About Harm Reduction

Nonmaleficence“To do no harm”

An Ethical Framework for Thinking About Harm Reduction

Nonmaleficence“To do no harm”

New Products

Existing Products

An Ethical Framework for Thinking About Harm Reduction

Nonmaleficence“To do no harm”

New Products

Existing Products (THE CASE OF CHANTIX)

The Consequences of Failing to Apply an Ethical Framework to Issues of Harm Reduction

Highly toxic productKills 400,000 people each yearFDA Stamp of ApprovalSale and marketing approved by the FDA

Much safer productNot known to kill anyoneFDA Seal of ScornEffectively banned by the FDA

FDA Would Rather Smokers Do This

Than Quit Smoking and Do This

Hypothetical Question

What if we had a non-tobacco, non-combustion device that looked and worked like a cigarette but delivered clean nicotine, was satisfactory to smokers, helped them to quit smoking or greatly reduce the amount that they smoked, and were relatively safe?

We already do!

The future is here.

The electronic cigarette (or some sort of non-tobacco cigarette) is the future for smoking

cessation in the U.S.

WHY?

Theme #1: Bio-behavioral feedback

• Vaping mimics smoking• oral stimuli• throat hit• vapor cloud• inhalation

• Maintains smoking associations• activities (drinking, eating, coffee, driving)

• Ability to swap e-cigarettes into normal daily smoking routine

Theme #1: Bio-behavioral feedback

• “That feeling when it comes down and hits your throat and you inhale it, that's like a big deal for us all.”

• “[…] when I quit cigarettes, my fixation with you know, vaping is very similar. So I like to vape while I'm in the car, I like to vape while after I have a meal or when I have a coffee or when I'm drinking and so on, so it mirrors that almost.”

Theme #2: Social benefits

• There is a vaping community• Online community forums• Social support

• There is a social support network in the vaping community• Vaping clubs• Vapefests

Theme #2 Social benefits

• “Going to the website and you start hearing people’s stories […] you research until you find something and I kept coming back to this and really liked it. There’s a big support community ethic, which is part of it.”

• “You don't hear about 2 people on the patch talking about their patches or what brand their trying or what not.”

Theme #3 Hobby elements

• Vaping as a hobby• Mixing and matching e-cigarette parts and juices• Choosing flavors• Neat devices• Skill formation

• Sense of personal control• You are making the decisions

Theme #3: Hobby elements

• “I learned about […] the different bases and juices. There's so much knowledge out there and I became a nerd. And it became a hobby.”

• “I like all the flavors, I like the devices. You know, it's my new hobby, my new collection. I don't collect lighters now, I'm collecting juice and devices.”

Theme #4 Personal identity

• Users self-identify as “vapers”• You take on a new identity• Re-define your identity• Sub-identities (type of e-cigarette; type of flavors)• atomizer vs. cartomizer• type of flavor• prepared cartridges or fill your own• PG or VG

Theme #4: Personal identity

• “You know, for years, I loved being able to carry around my pack of cigarettes and my Red Sox lighter. I miss carrying my Red Sox lighter. I still could but it'd be stupid. That's how you feel about your lighter; it's your Red Sox lighter. It becomes who you are. It becomes, you don't do anything without a cigarette in your hand. Now I can still do that and still get the nicotine without disgusting somebody else because I am smoking and it does stink.”

Theme #5: Smoking cessation vs. nicotine cessation

• Smoking cessation with NRT or other drugs requires nicotine cessation; quitting smoking with e-cigarettes does not

• Many smokers do not want to quit using nicotine; e-cigarettes allow them to quit smoking anyway (unlike any other smoking cessation drug)

• Users can make the choice and retain control over whether they want to be tobacco-free or nicotine-free

Theme #5 Smoking cessation vs. nicotine cessation

• “When I first started that was the plan [weaning off nicotine]. But I enjoy it, now. I don't see anything wrong with it.”

• “My goal is to be nicotine free at some point but I’m not in a hurry either.”

Conclusion Why Electronic Cigarettes are

the Wave of the Future

• Electronic cigarettes address the psychological, behavioral, and social aspects of smoking addiction and not just the pharmacologic aspects (unlike any traditional smoking cessation product)

• Electronic cigarettes appeal to the core values of:• Identity• Autonomy• Control• Social Support

RecommendationsWhere do we go from here?

• Address safety issues• Battery safety• Ideal excipient (concern about long-term PG inhalation

and VG leading to formaldehyde formation)• Presence of aldehydes• Quality control

• Address efficacy issues• Efficiency and consistency of nicotine delivery

RecommendationsWhere do we go from here?

• Address regulatory issues• Possibility of modified product provisions, which would be a disaster• Are smoking cessation claims therapeutic claims in the absence of an

intention to treat nicotine dependence?• Need a unique regulatory framework; a simple “deeming” regulation

putting e-cigarettes under the same requirements as cigarettes would be disastrous to the public’s health

• Address public health opposition

Should Medical Providers Recommend E-Cigarettes to their Patients as a Smoking Cessation Tool?

The Answer

Scenario #1

A 59 year-old male presents with exertional dyspnea and is found to have early signs of COPD. He expresses a desire to quit smoking, although he has never attempted to quit in the past. He doesn’t mention anything about e-cigarettes but says he had two friends who quit using the patch.

Scenario #2

A 59 year-old male presents with exertional dyspnea and is found to have early signs of COPD. He expresses a desire to quit smoking. He has tried to quit unsuccessfully multiple times in the past, using methods including cold turkey, NRT, and Chantix. He just found out about e-cigarettes and is excited to try them. Two of his friends just quit using e-cigarettes.

What Would It Take to Justify Not Recommending E-Cigarettes?

• Not substantially safer than cigarettes

• Inhibit smoking cessation

• Enhance nicotine or smoking addiction

The Evidence

Not substantially safer than cigarettes• FALSE – Overwhelming evidence

Inhibit smoking cessation• FALSE – Overwhelming evidence

Enhance nicotine or smoking addiction• FALSE – Very strong evidence

Conclusion

Electronic cigarettes are one viable approach to smoking cessation that are available to the clinician.

There is no reason why this approach should not be offered to at least some patients, those for whom the clinical situation suggest that this approach could be effective.