Should Medical Providers Recommend E-cigarettes to their Patients as a Smoking Cessation Tool? There is not yet enough Evidence to Recommend EC as a Primary Cessation Aid Neal L Benowitz MD Professor of Medicine, UCSF AMERSA Conference Nov

Disclosures Consultant to pharmaceutical companies that market smoking cessation products, including Pfizer, GlaxoSmithKline and McNeil. Paid expert in litigation against tobacco companies.

My position If a patient has failed initial treatment, has been intolerant to or refuses to use conventional smoking cessation medication, and wishes to use e-cigarettes to aid quitting, it is reasonable to support the attempt. AHA Policy Statement on Electronic Cigarettes, Circulation 2014

Heats a nicotine solution to create an aerosol for inhalation What is an electronic cigarette? Clearomizer Battery

Main components of EC aerosol Nicotine Propylene glycol Glycerin Flavorants

Three Generations of E-cigarettes Cigarette-like: “cigalikes”; Blu, Njoy, V2 Cigs Tank style: pen-like; various colors and shapes; larger batteries and atomizers; refillable tanks; eGo Mods: “personalized vapors”; range of cartidge, atomizer, battery options; adjustable battery voltage; refillable tanks; Apollo, Vapor Zone

Unresolved questions about E- cigarettes Safety concerns – For the user – For non-smokers in close proximity to the user – Accidental poisoning Are EC effective for smoking cessation? How do you counsel about products and how they should be used? Potential adverse societal impact

Safety Concerns

EC liquid and vapor Nicotine Propylene glycol Glycerin Tobacco-derived nitrosamines Particulates (including metals) Volatile organic chemicals (acrolein, formaldehyde) Flavorants Miscellaneous contaminants

Particulates from EC and Conventional Cigarettes (Fuoco et al, 2013)

Battery Voltage Influences Levels of Carbonyls in EC Aerosol Kosmider NTR 2014

Adverse Health effects of E-cigarettes Health effects of long-term use are unknown Based on toxicant analyses and a few clinical studies, EC use like to be much less harmful than cigarette smoking However since products are unregulated, constituents of E-liquids vary widely Concerns about long term propylene glycol and particulate exposure

E-cig store owner says lack of regulations results in production in ‘basements and bathrooms’ Calgary Herald October 1, 2014

Secondhand E-cigarette Aerosol Exposure Secondhand cigarette smoke (SHS) is hazardous; 75% tobacco burned is sidestream smoke EC emissions exhaled by user only Ambient levels of nicotine, particulates and organic chemicals from EC reported to be 10% of SHS Potential for environmental contamination with nicotine Uncertain if any health hazard to non-user, but non- user has right to clean indoor air

Nonsmokers living with cigarette smokers (CS) e-cigarette users (EC) or no exposure (C) Passive Exposure to Nicotine from Cigarettes v. E-cigarettes

The New England Journal of Medicine Nicotine Poisoning in an Infant

DABS: The World’s Most Powerful And Sought After Weed Product

E-cigarettes and smoking cessation

Do E-cigarettes promote cessation or reduce harm? Benefit for smoking cessation in smokers who want to quit is suggestive but as yet inconclusive Concerns that quitting could be inhibited in smokers not contemplating quitting E-cig use reduces cigarette consumption by dual users, but health benefits of reduction not yet proven. Reduced cigarette smoking might promote later quitting.

E-cigarette Smoking Cessation RCT Quitline-based (minimal support) Nicotine e-cigarettes (poor delivery) vs. Zero nicotine e-cigarettes vs. Nicotine patch (21 mg) 13 weeks treatment

EC Smoking Cessation RCT 6 month follow up

Real-world effectiveness of e- cigarettes to aid smoking cessation (Brown et al. Addiction 2014) Cross-sectional household survey of UK households, adult smokers who tried to quit in past 12 mos using EC, NRT (OTC) or no aid Outcome: self-reported abstinence

Real-world Effectiveness of E-cigarettes To Aid Smoking Cessation % Not-SmokingOdds Ratio (** - p < 0.01) Brown et. al., Addiction 2014

E-cigarettes and Smoking Cessation in Cancer Patients (Borderud Cancer 2014) Cohort study of cancer patients attending smoking cessation program at Memorial Sloan Kettering Cancer Center subjects, 56 yo, 26% EC users past 30 d Multicomponent behavioral and pharmacologic treatment 6-12 month follow up Outcome: self-reported abstinence (7 d)

Quit Rates (%) NU = non-user

Other Observations 92% EC users reported dual use E-cigarette users: – Higher % with thoracic and head and neck cancer – More CPD and higher level of dependence – More frequent and longer duration of prior quit attempts – Higher % dropped out of treatment – No reduction in CPD at follow up

Is there a benefit to smoking fewer cigarettes per day? Probably not much for cardiovascular disease Probably some for cancer, COPD and infectious disease risk Difficult to extrapolate from spontaneous reduction studies due to compensation while smoking fewer cpd – may be different with an alternative source of nicotine

Possible Adverse Societal Effects of Promoting E-cigarette Use Renormalization of smoking behavior Sustaining dual use (rather than quitting cigarette smoking completely) Initiation of nicotine dependence in youth; re- initiation of nicotine dependence in former smokers Undermining clean indoor air policies

Conclusions For most patients quitting smoking is the single most important thing they can do to improve health E-cigarettes are a promising new approach to aid smoking cessation However the currently available products are unregulated, with uncertain safety, uncertain efficacy in promoting cessation, and with potential adverse societal harm.

Conclusions I am cautiously optimistic about E-cigarettes for smoking cessation, but there is not yet enough evidence to recommend E-cigarettes as primary cessation aids. We need adequate regulation of product safety and good clinical trials of E-cigarette use for smoking cessation.

My position If a patient has failed initial treatment, has been intolerant to or refuses to use conventional smoking cessation medication, and wishes to use e-cigarettes to aid quitting, it is reasonable to support the attempt. AHA Policy Statement on Electronic Cigarettes, Circulation 2014

Counseling your Patient The EC is likely to be much less toxic than cigarette smoking, but … The products are unregulated ECs contain variable (and unpredictable) levels of toxic chemicals ECs not proven effective as cessation device Consider setting a quit date for EC use (unless needed to prevent relapse to smoking) Do NOT continue cigarette smoking