VAPING: What s the Evidence?

Transcription

1 VAPING: What s the Evidence? Jen Palminteri, MD Tufts University, Assistant Professor Chest Medicine Associates, Portland, ME Maine Association of Physician Assistants 29 th Annual Winter Conference February 8, 2019

2 No disclosures

3 Objectives Historical context How do I work this thing? State and Local Laws Public Health Issues Impact on Youth Smoking Role in Smoking Cessation

4 1880: mass production of cigarettes From 40,000 hand-rolled to 4 million machine-made cigarettes/day 1964: Surgeon General releases first report on smoking and health Cause of lung/larynx cancer in men, and probably women Most important cause of chronic bronchitis Modern Smoking History

5 History of the e-cigarette 1965: first patent for an e-cigarette 2003: Chinese pharmacist Hon Lik develops the modern e-cig 2006: First US import of e- cigarettes Most recent economic data 466 e-cigarette brands Worldwide $12+ billion in sales 30-50% of the market is on the internet US sales $3.6 Billion Marlboro cigarette maker Altria Group paid $12.8 billion for a 35% share of Juul

6 Basics of E-Cigarettes Electronic nicotine delivery systems (ENDS) Vapes, vaporizers, vape pens, hookah pens, electronic cigarettes, e-pipes, mods Produce an aerosol (vapor) instead of smoke Processed nicotine from tobacco leaves Suspended in a mixture of vegetable glycerin or propylene glycol with water with or without flavoring Ultra fine particles similar to smoke Battery operated

7 How does it work? Activate the the atomizer by inhaling or by pressing a button Atomizer heats and aerosolizes the liquid in the cartridge, creating a vapor

8 Types of Vaping Devices First-generation - ciga-likes Some are reusable Second-generation Pen and tank style Stronger, rechargeable batteries and refillable cartridges Third-generation personalized Adjust the resistance of the atomizer, which produces higher heating temperatures. Increase vapor production and battery life Pod-Mods = Juul Nicotine salts Less cloud, more efficient use of nicotine

9 Released in 2015 by Pax Labs 70% market share JUUL Rechargeable, Juul pods -- SD card-sized cartridges: Nicotine equivalent to one pack of cigarettes Monthly subscriptions, $4/pod! Nicotine salts provide high concentration of nicotine, still tastes good. Equal to one puff off a traditional cigarette Seeking approval as a tobacco cessation treatment Currently marketed as an alternative for adults who smoke tobacco cigarettes, not adults who are trying to quit smoking.

10 E-cigarette liquid components Nicotine Propylene glycol, Vegetable glycerin Flavorings: Most are generally-recognized-as-safe (GRAS) by FDA The designation is for safe INGESTION IN FOOD Most never studied for toxicity via the inhalation route Clean base Thinner Less residue Better throat hit Bigger vapor cloud Thick and gunky Sweet flavor

11 Cloud Chasing

12 Polish study Compared the vapor from 12 popular e-cigs to the Nicorette inhaler Studied 4 groups of toxic compounds present in tobacco smoke: Carbonyl compounds: formaldehyde, acetaldehyde carcinogen, emphysema Volatile organic compounds (VOCs): benzene, toluene carcinogen, neurotoxic, hematotoxic Tobacco-specific nitrosamines (TSNAs): NNN, NNK carcinogen Metals: cadmium, lead, mercury carcinogen, nephrotoxic, neurotoxic, hematotoxic Nicotine isn t harmless, but it isn t a carcinogen

13 Trace levels of metals (equivalent to the Nicorette inhaler) were present in the e-cigarettes 2018 study of 12 Canadian and US devices: Lead found in the disposable cartridges, but not in the bottled refill solutions

14 Nicotine in E-liquid INCONSISTENT TESTING! 1 PPD 40mg 23mg

15 Nicotine Absorbed rapidly after inhalation Nicotine levels peak within 10 seconds Acute effects Reward Increased cognition Increased attention Nicotine Withdrawal irritability depression, anxiety cognitive and attention deficits sleep disturbances increased appetite Gateway drug lowers the threshold for addiction to other drugs

16 What else can you vape? Cannabis Cocaine Supplements, caffeine Morphine, fentanyl, heroin MDMA

17 The Use of Substances Other Than Nicotine in Electronic Cigarettes Among College Students Deric R Kenne 1,2, Rebecca L Fischbein 3, Andy SL Tan 4,5 Past 30-day use of e-cigarettes among college students and Mark Banks 6 has risen 1 from 1.5% in 2009 to 15% in 2014 Division of Drug Research, Center for Public Policy and Health, Kent State University, Kent, OH, USA. 2 Department of Health Policy and Management, College of Public Health, Kent State 1542 undergraduate University, Kent, OH, USA. 3 Department college of Family student and Community e-cigarette Medicine, Northeast Ohio users Medical University, Rootstown, OH, USA. 4 Center for Community-Based Research, Division of 78% using cannabis Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA. 5 Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA. 6 Division of 17% didn t Epidemiology, know The Ohio what State University, the substance Columbus, OH, USA. was! Subs Volu Th Rep sage https DOI: ABSTRACT INTRODUCTION: Electronic cigarettes (e-cigarettes) have grown in popularity, especially among you e-cigarettes were originally intended to vaporize a liquid mixture containing nicotine, there appears to b substance use in e-cigarettes (OSUE).

18 Battery Explosion Lithium battery Required bone repair from his pelvis Following some initial follow-up, we have learned that the patient has been incarcerated for unrelated circumstances and as a result has failed to complete his treatment.

19 Battery Explosion Cause of death: E-cigarette exploded and lodged in his skull First US death caused by a vape pen Using a Mod-style device

20 Laws: US and State of Maine US Treated as recreational products and regulated by the Tobacco Product Center of the FDA CAN T SELL ENDS AS A TOBACCO CESSATION DEVICE Most manufacturers of e-cigarettes avoid making explicit claims on cessation JUUL was developed as a satisfying alternative to cigarettes. Maine Statewide ruling in October 2015 Vaping is prohibited in all smoke-free areas, which includes bars and restaurants

21 Laws: Sale of Flavored E-liquid Traditional flavors tobacco, mint and menthol can stay on shelves Flavored e-juice can be sold in 18+ locations, or age-restricted areas of stores. Online: allow to sell flavored e-juice, must have adequate age verification measures in place More than 70 e-liquid brands sell high-nicotine products ( 5%) in bulk ( 30 ml) Equivalent to > 40 cigarette packs

22 Public Health Concerns Smoking bans = de-normalization of smoking behavior May discourage the frequency AND success of quit attempts Encourage relapse among former smokers Increase tobacco use initiation rates among young adults

23 Pubic Health Concerns: Youth Initiation of Smoking : Traditional cigarette smoking declined among middle and HS students!! million US middle and HS kids used e-cigarettes in the past 30 days 5% of middle school students 21% of HS students We are creating ANOTHER generation of nicotine-addicted teenagers Teens and young adults are more likely to try ENDS, even if they never smoked years old: 40% were never smokers Adults (>45 years old)-- only 1.3% had previously never smoked

24 Smoking is a Public Health Catastrophe Leading cause of preventable disease and death in the US Causes nearly 500,000 deaths/year Smoking causes more deaths each year HIV, Illegal drug use, EtOH, MVAs, Gun deaths COMBINED More than 10x as many U.S. citizens have died prematurely from cigarette smoking than have died in all the wars fought by the US Direct health care and lost productivity: $300 billion/year

25 Can ENDS help smokers quit? Tobacco Harm Reduction Tactic for reducing, but not eliminating, risk Some people cannot or will not stop engaging in it. In lieu of abstinence the goal is minimization of potential health risks

26 Can ENDS help smokers quit? Moderate evidence from observation studies More frequent use of ENDS is associated with an increased likelihood of cessation (quit attempts AND quit success) 70% of recent quitters who used e-cigarettes were still using e-cigarettes daily Daily use may be critical in preventing relapse Intensive use may be key to their potential as a smoking cessation aid

27 Population surveys in the US began to measure e-cigarette use around 2010 From 2001 to 2011, the cessation rate ranged from 4.3% to 4.5% 161K smokers surveyed Quit attempt = 24 hours Quit success = 3 months traditional cigarette abstinence BMJ 2017;358:j3262

28 : ENDS users in the US attempted to quit and succeeded in quitting at higher rates than non-users. The overall population smoking cessation rate in increased compared to % increase in cessation rate = 350,000 additional US smokers who quit in successfully tax: 158% rise BMJ 2017;358:j3262

29 National Academies of Science, Engineering, Medicine Requested assessment by the FDA Published January peer-reviewed scientific studies

30 Conclusive or Substantial Data Second Hand Exposure The nicotine and toxic substances released in the vapor are measurable SIGNIFICANTLY lower than tobacco Unknown if it can cause disease Inhaled by nonsmokers, absorbed across the skin, left on surfaces Individual Health Risks ROS and endothelial dysfunction No evidence about CAD Cognitive effects: improved memory, mood Reversal of nicotine withdrawal side effects

31 Conclusive or Substantial Data CANCER RISKS Health effects emerged only after decades of cigarette smoking. Animal studies and intermediate biomarkers of cancer: long-term ENDS use could increase the risk of cancer Vapor chemicals are capable of causing DNA damage Unknown if the levels of exposure are high enough to contribute to human carcinogenesis Certain flavors are more cytotoxic than others -- cinnamon, buttery flavors, caramel Use, Cessation, Harm Reduction Potential for ENDS to induced dependence E-cigarettes may be effective aids to promote smoking cessation Complete substitution reduces exposure to numerous toxicants/ carcinogens results in fewer short-term adverse health outcomes Frequent use of e-cigarettes is associated with increased likelihood of cessation

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33 UK study Randomly assigned adults 450 in each group NRT of their choice for 3 months vs ENDS e-cigarette starter pack (18mg) Treatment included weekly behavioral support for at least 4 weeks Outcomes 1º - sustained abstinence for 1 year, confirmed by exhaled CO2 2º - participant-reported treatment usage and respiratory symptoms

34 Confirmed abstinence at 1 year ENDS group % NRT group - 9.9% (RR 1.83; 95% [CI], ; P <.001) Outcomes ENDS and NRT are less satisfying than cigarettes Cough/phlegm production declined in both groups ENDS - greater satisfaction, more helpful with cravings ENDS - less irritability, restlessness, and inability to concentrate

35 Smoking is TERRIBLE for you! My Practice ENDS Fewer chemicals Treats nicotine withdrawal The risk of cancer, CAD is almost certainly less, but long term data doesn t exist MUST SWITCH OVER COMPLETELY For many smokers, the optimal outcome may be a long-term swapping to vaping, allowing for the small residual risk for a higher likelihood of success

36 Conclusions The use of ENDS is associated with the first rise in population smoking CESSATION rates seen since 2010 We don t have long term data, because they have only been used for 13 years in the US Exclusive use of e-cigarettes is less bad for you than use of traditional cigarettes or dual use They can explode and kill you (or someone around you) E-cigarette use in young adults increases the risk of transitioning to smoking combustible cigarettes

37 Contact