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 THEM American Heart Association: BAN THEM American Lung Association: BAN THEM Campaign for Tobacco-Free Kids: BAN THEM Action on Smoking and Health: BAN THEM American Legacy Foundation: BAN THEM American Academy of Pediatrics: BAN THEM Association for the Treatment of Tobacco Use and Dependence: BAN THEM Food 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 education Needle exchange programs Harm 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, MPH Professor Department of Community Health Sciences Boston 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 products In practice, harm reduction products were used to promote dual use of cigarettes and the alternative product  In practice, “harm reduction” products were not substantially safer  Marketing 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

Nicorette gum NicoDerm CQ patch Electronic cigarettes Marlboro

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

2.00

8.00

8.18

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 product Kills 400,000 people each year FDA Stamp of Approval Sale and marketing approved by the FDA Much safer product Not known to kill anyone FDA Seal of Scorn Effectively 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

Recommendations Where 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

Recommendations Where 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.