ecigare)es: promise!or!peril? · pdf file · 2015-05-05& children’s...
TRANSCRIPT
E-‐cigare)es:
Promise or Peril? Susanne Tanski, MD, MPH, FAAP
Department of Pediatrics, Geisel School of Medicine at Dartmouth & Children’s Hospital at Dartmouth
Dartmouth Media Research Lab, Norris Cotton Cancer Center AAP Julius B. Richmond Center of Excellence
10th Annual NH Comprehensive Cancer Collaboration Annual Conference
April 1, 2015
Objec/ves – e-‐cigare5es and “vaping” devices
• Who is using them
• What are they
• Public and individual health concerns – Safety of devices/poisoning risk – Poten;al for adolescent nico;ne addic;on – Poten;al to glamourize and re-‐normalize smoking – Evidence for cessa;on/dual use – Evidence for effects of second-‐hand vapor exposure
E-‐cigare)e Prevalence 2013 • 6.1% of youth (6-‐12 grades) had ever tried e-‐cigareHe
– From NYTS 2013 -‐ > 3x rate from 2011 – 20.2% of ever-‐cigareHe smokers and 0.9% of never smokers
• Current US e-‐cigareHe use -‐ 6.9% ever-‐smokers -‐ 0.3% never-‐smokers
• Utah -‐ 5.9% current
• Hawaii -‐ 29% ever 18% current
Bunnell et al. Nicotine and Tobacco Research, 2014; Wills, in press
Legacy US 2014 data Ever and Current Use of E-‐Cigs
Monitoring the Future, 2014 Current Use (30 day) Cigare)e vs. E-‐Cig
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7
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9
16 17
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8th Grade 10th Grade 12th Grade
CigareHes
E-‐cigs
Trends in adult current use of e-‐cigare)es 2010-‐2013
McMillen, et al. “Trends in electronic cigarette use among US adults. In press, 2014
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Overall 18-‐24 years 25-‐44 years 45-‐64 years 65+ years
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2011
2012
2013
What are e-‐cigare)es?
Rachel Grana et al. Circulation. 2014;129:1972-1986
From Cigare)e to Vapor Pen, an evoluMon in technology: Cig-‐alikes,
Tanks and Mods
• GRAS classifica;on: – Generally recognized as safe for use IN FOOD – Based on scien;fic evidence, or, for a substance used in food before 1958, through experience based on common use in food by “substan;al history of consump;on for food use by a significant number of consumers.”
• Exclusions made for certain things – Propylene glycol is excluded from cat food due to Heinz body anemia
ConsMtuents of e-‐juice: humectant, flavoring, +/-‐ nicoMne
ConsMtuents of e-‐juice: humectants: PG/VG
• Propylene glycol: general recognized as safe – Few human studies for inhala;on, however has been used as a tobacco humectant historically
• Can cause eye and respiratory irrita;on • MSDS from Dow Chemical states “inhala;on exposure to [propylene glycol] mists should be avoided”
• Vegetable glycerin: generally recognized as safe – When heated and vaporized, can form acrolein, which can cause upper respiratory irrita;on
• For all: unknown long-‐term health impacts from repeated inhala;on
Werley et al, Toxicology 2011
Humectant Toxicity – recent evidence
Kosmider et al, Nicotine & Tobacco Research 2014
ConsMtuents of e-‐juice: Flavorings
• Have NOT been assessed for safety as inhalants • American e-‐Liquid Manufacturing Standards Associa;on does not allow: – Diacetyl, whole tobacco alkaloids, medicinals, illegal or controlled substances, caffeine, vitamins, ar;ficial food coloring
• Flavors are KNOWN to be appealing to youth
ConsMtuents of e-‐juice: NicoMne
• Nico;ne effects: low doses – Complex pharmacodynamics – neural s;mulant at low doses and a depressant at high doses
• S;mulates memory and alertness. People who use tobacco onen depend on it to help them accomplish certain tasks and perform well.
• Many people feel a sense of well-‐being. • Decreases the appe;te (for this reason, the fear of weight gain affects some people's willingness to stop smoking); boosts mood and may relieve minor depression.
• Increases intes;nal ac;vity, creates more saliva and phlegm, increases heart rate by 10 to 20 beats per minute; increases blood pressure by 5 to 10 mmHg.
ConsMtuents of e-‐juice: NicoMne
• Nico;ne overdose – Excess: nausea and vomi;ng, excessive saliva;on, abdominal pain, pallor, swea;ng, hypertension, tachycardia, ataxia, tremor, headache, dizziness, muscle fascicula;ons, and seizures
– Death: several case reports of suicide by nico;ne • Two child deaths SO FAR from e-‐juice reported (Israel and US) • Surprisingly few deaths given toxicity
NicoMne Toxicity?
• The dose makes the poison – Oral nico;ne ~20% bioavailable
• Lethal dose in rats= 50mg/kg; mice 3mg/kg
• Humans? Stated as 0.8mg/kg (60mg), which would make it more toxic than cyanide – Mul;ple literature reports of survival at 6 mg/kg – Recent review suggests 6.5-‐13mg/kg LD50
Archives of Toxicology, 2013 Mayer, Arch Toxicol 2014
Math • 36mg/ml, 10ml= 360 mg nico;ne
– Conven;onal idea of 60mg=death, this could kill 6 people! – New math= it would s;ll kill an adult – My 4 year old=17kg
• 0.8mg/kg=10mg=0.4 ml!! • 6.5-‐13mg/kg=3-‐6ml
• 18mg/ml is more standard
Poison Control Calls
AAP AcMons & ReacMons • 6/18/14: Senate Commerce CommiHee hearing on “Aggressive E-‐CigareHe Marke;ng and Poten;al Consequences for Youth”
• 7/10/14: Senate bill introduced to require child-‐proof packaging on liquid nico;ne
• 9/16/14: House bill introduced
• 9/17/14: Senate bill passed in commiHee
• 12/31/14: Bill expired
Too late to save a life… • December 9, 2014, EJ Hotaling, an
18 month old from upstate NY, ingested nico;ne refill solu;on while his mother was turning on his favorite TV show
• He seized and never regained consciousness
• He is the first child to die in the US from refillable nico;ne
• NY Governor Cuomo signed a nico;ne packaging bill into law on 12/29/14
Photos: Times Union, 12/30/14
Child NicoMne Poisoning PrevenMon Act of 2015
• Child Nico;ne Poisoning Preven;on Act of 2015 (S. 142) – Re-‐introduced by Sen. Nelson (D-‐FL) and Sen. AyoHe (R-‐NH) and 10 other
Senators – Grants Consumer Product Safety Commission (CPSC) authority to require
child-‐proof packaging for nico;ne refill solu;ons sold to consumers (current law prohibits CPSC from regula;ng any tobacco products)
– The bill is craned narrowly to focus only on liquid nico;ne and its safe containment from children, and does not affect the manufacture of the substance nor the products they are designed to refill
• 2/26/15: Bill passed CommiHee, sent to full Senate
• Awai;ng introduc;on in House (Republican co-‐sponsor needed)
Different Experiences By User… • How much nico;ne DO you get per puff?
– Different bioavailability through puffing than drinking
– Depends on many factors: temperature of the atomizer, how much juice is atomized, size of the atomized droplets, depth of the “puff”, concentra;on of the e-‐juice
• Large droplets will deposit in the oropharynx and upper airway (venous absorp;on)
• Small droplets can get deeper – into alveoli for arterial absorp;on
What are the health harms? • Rela;ve to smoked tobacco, less harmful
– No tar – Variable levels of nico;ne
• Rela;ve to NO tobacco or medical NRT – Growing concerns for decreased lung func;on (aldehydes) – Quality control – adulterated products have been found
• Safety of flavor when heated and inhaled is unknown • Non-‐ and former smokers may become addicted
• May maintain combusted tobacco use
New AddicMon?
• The adolescent brain appears uniquely suscep;ble to nico;ne addic;on
• Animal studies show that nico;ne exposure during adolescence period has long-‐standing effects in the brain including cell damage that leads to both immediate and persistent behavior changes.
Slottkin, Neurotox & Teratol 2002
What are the health harms?
• At present (4/2015), completely unregulated – FDA has issued their Deeming Document for proposed rulemaking, public comments closed in August
– Might come out in June 2015? For ac;on in 2 y… – No Consumer Products Safety Commission oversight (yet!) – ANYONE can manufacture and sell – Most of the market s;ll comes from China
What are the Public Health Harms? • Second-‐hand vapor is NOT just water vapor – Emit variable levels of nico;ne (1/10th that of cigareHes), plus fine par;cles of similar size to that of cigareHes, and comparable concentra;on of fine par;cles
– Emit low levels of other toxins: formaldehyde, acetaldehyde, metals
Czogala et al, Nicotine and Tobacco Research 2013 Fuoco et al, Environmental Pollution 2014
What are the Public Health Harms?
Surface Contamination Nicotine, which combines with indoor substances such as ozone and nitrous oxide to make irritants and carcingens (TSNAs), collects on surfaces from e-cigarette use
Goniewicz and Lee, Nicotine and Tobacco Research 2014
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30 Serum nicotine
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<5 ppb <5 ppb
1.8% nicotine 0% nicotine Room Air
ppb
Serum nicotine levels are elevated in neonatal mice exposed to 1.8% E-cig emissions twice a day for ten days
What are the Public Health Harms?
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RA 0% NicoMne 1.8% NicoMne
p=<0.001
p=<0.001
Room air 0% nicotine 1.8% nicotine
Alveolar growth is impaired in newborn mice exposed to E-cigarette emissions
Mea
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cept
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bitr
ary
units
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What are the Public Health Harms?
0 0.2 0.4 0.6 0.8
1 1.2 1.4 1.6 1.8
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Room Air 0% Nicotine 1.8% Nicotine
p<0.04 p<0.001
KI67
qua
nMficaM
on
Lung funcMon is impaired in neonatal mice exposed to
E-‐cigare)e emissions
McGrrath-Morrow S, et al. PLoS One, Feb. 2015
What are the Public Health Harms?
• Re-‐normalizing the image of smoking – Allowed in places where smoking is not allowed – Adver;sing is completely unrestricted, with TV ads for the first ;me since 1971
– Largely indis;nguishable from cigareHes
Why e-‐cigare)es/vape pen/e-‐hookah?
• Curiosity • Reduc;on of other tobacco products
• Cessa;on
• Stealth • Percep;on of a safer product
• Social acceptance
Trends in adult current use of e-‐cigare)es 2010-‐2013
McMillen, et al. “Trends in electronic cigarette use among US adults. FAMRI meeting 2014
0
2
4
6
8
10
12
14
16
Overall 18-‐24 years 25-‐44 years 45-‐64 years 65+ years
2010
2011
2012
2013
Is there evidence of efficacy for cessaMon?
Very limited: most suggests that people cut down and don’t stop completely…
More evidence is accumula;ng.
2013 Lancet Paper: as good as NRT patch
Bullen et al, Lancet 2013
Effects of DuraMon of E-‐Cigare)e Use • n=159. Longer e-‐cig use led to higher likelihood of being an ex-‐smoker
than being dual user, & fewer combusted cigareHes among all
Lechner et al. Nicotine and Tobacco Research, 2014
Best Evidence for CessaMon yet… (among those moMvated to quit)
Brown et al. Addiction, 2014
Meta-‐analysis – Glantz et al 2015
11 studies = OR = 0.72 (95% CI 0.53- 0.98)
Smokers who use e-cigarettes are about 30% less likely to quit
What happens now?
• Expected that the market will con;nue to explode
• Expected that FDA will assert jurisdic;on – Improved quality control and produc;on standards
Source: Winston-Salem Journal, September 15, 2013
Vuse – launched 2013 Blu – purchased 2012 MarkTen – launch 2013
What happens now?
• Expected that the market will con;nue to explode
• Expected FDA jurisdic;on – proposed rule April 2014 – Improved quality control and produc;on standards – No sales <18 years – Health warning labels – No vending machine sales – No marke;ng implying “healthy” or “safe”
• Final rule could come as early as June 2015 – Would go into effect 2 years AFTER final rule – Misses several aspects: flavors, child-‐proof packaging, marke;ng, online sales
E-‐Cigare)e Laws by State
So what to do? • Caveat emptor
– Must have a regulated product for an informed consumer, with fully disclosed labeling
• Research is impera;ve to assess second hand vapor effects (of all kinds), addic;on poten;al and dual-‐use maintenance
• Un;l we know more about “e-‐anything” and cessa;on, we can s;ll recommend medicinal NRT, quit lines and support while people are becoming non-‐tobacco users
“Responsibly marketed and properly regulated, it is possible that e-‐cigareHes could benefit public health if they help significantly reduce the number of people who use conven;onal cigareHes and die of tobacco-‐related disease. But in the absence of FDA oversight, the easy availability of nico;ne in uncontrolled quan;;es, packaging and flavors and marke;ng that appeals to youth raises serious concerns.”
– MaH Meyer, Campaign for Tobacco Free Kids, 4/3/14
Discussion