Karen M Wilson MD MPH FAAP Debra and Leon Black Professor and Division Chief of General Pediatrics ViceChair for Clinical and Translational Research Icahn School of Medicine at Mount Sinai American Academy of Pediatrics ID: 736686
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Addressing E-cigarettes and vaping in your practice
Karen M. Wilson, MD, MPH, FAAPDebra and Leon Black Professor and Division Chief of General PediatricsVice-Chair for Clinical and Translational ResearchIcahn School of Medicine at Mount Sinai
American Academy of Pediatrics
NY Chapter 2 meeting
June 18, 2018
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Disclosure:
In the past 12 months, I have had no relevant financial relationships with the manufacturers of any commercial product or providers of commercial services discussed in this CME activity. I do intend to discuss an unapproved or investigative use of a commercial product or device.
Illustrated Surgeon General’s Report on Smoking - Alfred Gescheidt, 1964Slide3
Support
R01CA181207-01A1 Intervening with smoking parents of inpatients to reduce exposure (INSPIRE)Flight Attendant Medical Research Institute through a grant to the American Academy of Pediatrics Julius B. Richmond Center of ExcellenceIcahn School of Medicine at Mount SinaiSlide4
Julius B. Richmond Center of Excellence
…
dedicated to protecting children from secondhand smoke, and ensuring that all clinicians ask the right questions about tobacco and SHS exposureSlide5
ObjectivesAt the end of the session, participants will be able to:
State what e-cigarettes are and how they are usedDescribe new information on the composition of electronic cigarette aerosol, and potential harmsCounsel teens and parents about the risks of adolescent electronic cigarette use, and how electronic cigarettes may lead to combusted tobacco useDescribe the current regulatory environment around electronic cigarettesSlide6
Definitions and termsElectronic cigarettesElectronic Nicotine Delivery Systems
E-HookahVape pensPersonal vaporizerE-cigarSlide7
First Generation “Cigalikes
”AKA: minis
Examples: Blu, Logic, Vuse, Mark 10Can have manual or automatic heatingDisposable or RechargeableSlide8
Second Generation “Tank Systems”
AKA: Personal Vaporizers, Mid-size, Vape PensExamples: eGo, EVOD, Apollo, Halo, Vapor FiAvailable with many types of atomizers, batteries and mouthpieces
All rechargeableMost have manual heating buttonAvailable in tunable and non-tunable voltage batteriesUsually come in a kit for customizationSlide9
Third Generation “Mods”
AKA: Advanced Personal Vaporizers (APVs)Examples: Apollo, Henley, VolcanoMost advanced form of e-Cigarettes – preferred by hobbyists and
eCig prosFully rebuildable and customizableRechargeable lithium ion batteryMost have manual heating buttonMany customizable functions including: integral liquid feedmultiple style tanksdigital readoutsvariable voltage (voltage amplifiers)
full electronic control Slide10
Heat not burnSlide11Slide12
Dripping“New” method of using electronic cigarette liquidRecent study- 26% of teen Ecig
users (CT) have tried itPlacing liquid directly on coil and inhaling vaporMay increase amount of nicotine and toxic chemicals Slide13Slide14Slide15Slide16
2014 Adults and ENDS Use
Schoenborn & Gindi, 2015 Slide17
Teen vapingSlide18
High school student current tobacco use
National Youth Tobacco Survey (NYTS)
Singh T et al, MMWR April 2016
2013-14
E-cigarette
Use triples
2014-15
No decline in cig use:
First time in almost 2 decadesSlide19
High school student current tobacco use
National Youth Tobacco Survey (NYTS)
Singh T et al, MMWR April 2016
2015-16: drop in overall tobacco use;
Leveled off in 2017Slide20
Percentage of High School Students Who Ever Used Electronic Vapor Products,* by Sex, Grade,†
and Race/Ethnicity,† 2015*E-cigarettes, e-cigars, e-pipes, vape pipes, vaping pens, e-hookahs, and hookah pens such as blu, NJOY, or Starbuzz†10th > 9th, 11th > 9th, 11th > 10th, 12th > 9th, 12th > 10th; H > B, H > W (Based on t-test analysis, p < 0.05.)All Hispanic students are included in the Hispanic category. All other races are non-Hispanic.
Note: This graph contains weighted results.National Youth Risk Behavior Survey, 2015Slide21
Why?
Bold et al, Pediatrics, 2016Slide22
Gateway to smoking?
The adolescent brain appears uniquely susceptible to nicotine addictionAnimal studies have demonstrated that nicotine exposure during the adolescent period has long-standing effects in the brain including cell damage that leads to both immediate and persistent behavior changes.These effects are not found with nicotine exposure to the adult, supporting the idea that the adolescent is uniquely susceptible to nicotine addiction. Slottkin, Neurotox & Teratol 2002Slide23Slide24Slide25
E-cigarette use among California Cohorts, 1994-2014 by grade and gender
Jessica L. Barrington-
Trimis
et al. Pediatrics 2016;138:e20153983
©2016 by American Academy of
PediatricsSlide26
Low risk are more likely to transition
Barrington-Trimis et al, Pediatrics 2016Slide27
Low risk are more likely to transition
Barrington-Trimis et al, Pediatrics 2016Slide28
E-cigarette liquidSlide29
Constituents of e-liquids
Propylene glycol: general recognized as safeAcceptable for use in flavorings, drugs, cosmetics and as direct food additiveFew human studies for inhalation, however has been used as a tobacco humectant historicallyCan cause eye and respiratory irritationMSDS from Dow Chemical states “inhalation exposure to [propylene glycol] mists should be avoided”EPA cites a single rat study from 1947 for their inhalation effects)
Werley et al, Toxicology 2011Slide30
Other humectants
Vegetable glycerin: generally recognized as safeWhen heated and vaporized, can form acrolein, which can cause upper respiratory irritation For all: unknown long-term health impacts from repeated inhalationSlide31
Humectant Toxicity – recent evidence
Kosmider et al, Nicotine & Tobacco Research 2014Slide32
Nicotine
Not present in all e-liquidsNicotine effects: low dosesComplex pharmacodynamics – neural stimulant at low doses and a depressant at high dosesNicotine overdose Excess: nausea and vomiting, excessive salivation, abdominal pain, pallor, sweating, hypertension, tachycardia, ataxia, tremor, headache, dizziness, muscle fasciculations, and seizures
Death: several case reports of suicide by nicotineOne child death in the USNew regulations for child safe packagingSlide33
How much do you get per puff?
HIGHLY variable2013 study found 0-35 μg/puff, so minimum of 30 puffs to deliver the 1mg nicotine inhaled from a traditional cigaretteOnly part of the nicotine is vaporized, and of that 50-60% of nicotine is inhaledWide variability in vaping behavior of ten volunteers:Puff duration 1.8 +/- 0.9s, puff volume 70 +/- 68 ml, puffs/session 15 +/- 6. Goniewicz
, et al. Nicotine and Tobacco Research 2013Slide34
Factors that affect aerosol delivery
USER FACTORSPuff durationPuff volume
Puff profile (i.e. bell vs. square – machine smoking)User’s experienceDEVICE FACTORSSolvent (Propylene Glycol/Glycerin)VoltageWick design/efficiency
Draw resistanceAtomizer design (single vs. dual coil)Heating element resistance
Manual versus automatic activationSlide35
Design has large impact on aerosol delivery:Time dependent comparison of plasma nicotine
Farsalinos, K.E., Scientific Reports, 2014, doi
: 10.1038/srep04133Slide36
Flavors
V2: Eucalyptol, Camphor, Menthol, Pulegone, CinnamaldehydePremium: Eucalyptol, Camphor, Menthol, Pulegone, Cinnamaldehyde, Ethyl Salicylate
eSmoke: Eucalyptol, Camphor, Menthol, PulegoneSouth Beach Smoke: Eucalyptol, Camphor, Menthol, Pulegone, CinnamaldehydeSlide37
It’s just water vapor, after allSlide38
What are the harms of the aerosol?
Second-hand vapor is NOT just water vaporEmit variable levels of nicotine (1/10th that of cigarettes), plus fine particles of similar size to that of cigarettes, and comparable concentration of fine particlesEmit low levels of other toxins: formaldehyde, acetaldehyde, metalsCzogala et al, Nicotine and Tobacco Research 2013Fuoco et al, Environmental Pollution
2014Slide39
Role of surface contamination
Surface ContaminationNicotine, which combines with indoor substances such as ozone and nitrous oxide to make irritants and carcinogens (TSNAs), collects on surfaces from e-cigarette useGoniewicz and Lee, Nicotine and Tobacco Research 2014Slide40
Alveolar growth is impaired in newborn mice exposed to E-cigarette emissions
Impact of secondhand aerosol
McGrath-Morrow, 2015 et al PLOS OneSlide41
Overall growth is impaired in newborn mice exposed to E-cigarette emissions
McGrath-Morrow, 2015 et al PLOS OneSlide42
Behavioral effects
Mice exposed to e-cigarette aerosol neonatally:More head dipsHigher levels of rearing activityIncreased markers of locomotor activityBut: increased time in new location in water mazeMarker of cognitive flexibility
Smith, et al PLOS One 2015Slide43
Cardiovascular effectsE cigarette aerosol induces reactive oxygen species and DNA damage in vitroNicotine and other components of e cigarette aerosol disrupted endothelial barrier function
E-cigarette use independent of combusted tobacco use is associated with a 42% higher risk of heart attackSlide44
http://www.buzzfeed.com/stephaniemcneal/vape-pen-horror#.fj0pJ906Z
Feb 29, 2016
Exploding batteriesSlide45
The harm is not just chemical
Re-normalizing the image of smokingAllowed in places where smoking is not allowedAdvertising is unrestricted, with TV ads for the first time since 1971Largely indistinguishable from cigarettesSlide46Slide47
FDA Deeming rule
May 16, 2016Extended FDA’s jurisdiction to include:E-cigarettesCigarsHookahDOES NOT include e-liquids without nicotineWent into effect on August 8, 2016Well, some of the rules, anywaySlide48
Covered in DeemingPre-market review of all new productsMinimum age of sale of 18 years
Free samples prohibitedFalse or misleading advertising prohibitedRequired disclosure of ingredientsRegistration of manufacturersWarning labelsDisclosure of potentially harmful ingredientsSlide49
NOT covered in DeemingMarketing and advertisingUse of flavorsSlide50Slide51
LawsuitsNicopure Labs v FDA
Global Premium Cigars v. FDA Lost Art Liquids v. FDA Larry Faircloth v. FDACyclops Vapor v. FDACigar Association of America v. FDASlide52
Lung juice
Elecampane Root and FlowerMulletein leafOsha Root
Yerba Mansa(whole Plant)Yerba Santa LeafDandelion LeafLicorice rootLobieala RootWater extraction tincture of CordycepsReishi Mushroom Alcohol ExtractionBase of pure grain alcohol, distilled water and vegetable glycerinSlide53
MarijuanaSlide54
www.aap.org/richmondcenter
Audience-Specific Resources
State-Specific Resources Cessation Information
Funding OpportunitiesReimbursement InformationTobacco Control E-mail ListPediatric Tobacco Control GuideTobacco Prevention Policy ToolSlide55
Legal resourceshttp://www.aappublications.org/news/2016/10/04/FDALawsuit100416
https://smokefreemovies.ucsf.edu/take-action/class-action http://publichealthlawcenter.org/blogs/2016-05-05/fdas-new-authority-over-all-tobacco-productshttp://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm394909.htmSlide56
AAP Policy Statementhttp://pediatrics.aappublications.org/content/136/5/998Slide57
Acknowledgements
Julius B. Richmond Center of ExcellenceJonathan Klein, MD, MPHSusanne Tanski, MD, MPH
Robert McMillen, PhDJulie Gorzkowski, MSWMark Gottlieb, JDJames BaumbergerTobacco Product Laboratory Group at CDC
Pat Breysse, MHS, PhDBenjamin Blount, PhD
Joe
LiskoSlide58