Regulatory Sc ience to Pol icy : Update on e-c igaret tes.

David B. Abrams

T h e S c h r o e d e r I n s t i t u t e F o r To b a c c o R e s e a r c h A n d P o l i c y S t u d i e s a t L e g a c y .

T h e J o h n s H o p k i n s B l o o m b e r g S c h o o l o f P u b l i c H e a l t hG e o r g e t o w n U n i v e r s i t y M e d i c a l C e n t e r / L o m b a r d i

C o m p r e h e n s i v e C a n c e r C e n t e r

CWAG Presentation Park City. Utah. 21st July 2014

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disclosures

• Funding from NIH – FDA

• No other financial relationships to disclose

• Legacy Foundation support

• No support from any industry sources

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Update on e-cigarettes

•Nicotine and Public Health

•Harm Reduction

•Will alternative nicotine delivery systems increase or decrease cigarette use ? How can prudent regulation help and not hinder ?

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Emerg ing Tobacco & N ico t ine Produc ts : D ISRUPTIVE: Evo lu t ion / Revo lu t ion?

End ing the c igare t te cen tu ry be fo re 100 t h SGR

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U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014.

20 million deaths: more than in all the American wars since founding our nation

• 5.6 million children alive today • and 480,000 adults each year

from their tobacco use behavior: primarily combustible products – cigarettes, cigars, hookah, pipe, roll your own…Burn it and you get burned

will die prematurely

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Major Shift: Harm Reduction ?

As articulated in the 2014 Surgeon General’s 50th anniversary Report. Executive Summary (pages 15-17):

“Death... is overwhelmingly caused by cigarettes and other combustibles...

promotion of e-cigarettes and other innovative products is...

likely to be beneficial where

the appeal, accessibility and use of cigarettes are rapidly reduced.” ….and their cost is increased

Despite 50 years progress, reduction in combustible cigarettes has slowed ...

Nicotine and Public Health

Are e-cigs essentially unregulated NRT ?

Comparison between 1st, new, and conventional cigarette

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Need overa l l N ico t ine Regu la t ion Po l i cy tha t b r idges CTP and CDER

Center for Tobacco Products

CigarettesRoll-your-own tobaccoSmokeless tobaccoHookah tobaccoCigars/cigarillos/LCCs E-cigs for harm reduction

Next Generation Products (Aerosol, Pyruvate, Cleaner Nicotine)

Center for Drug Evaluation & Research

Pharma – NRT, Chantix, BuprorionOther medications for cessationRJR Zonnic:Package, Price, Placement

? E cigs for cessation

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What we know?: State of the science on e-cigarettes - ENDS

• Product features and design

• Health and safety

• Advertising and Patterns of Use: Youth and Adults

• Consumer perceptions:

– harm reduction/cessation of combustibles or

– Blurring the boundaries between products & poly use

• Evolving e-cig industry: Big tobacco vs. independents

• Policy considerations: benefits vs. harms

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Publ ic Heal th Impact : Zero Tolerance and Harm Reduct ion Ideology: Data vs Dogma

Abus

e Li

abili

ty

“Ap

peal

”

Toxicity (“Harmfulness”)

Combusted Tobacco:

Cigarettes, Cigars Pipe, Hookah…..

e-cigsENDS

?? Next Generation: Pyruvate

Non-Combusted Tobacco and Nicotine Products:

American Snus

CessationBehav, NRT’s:

inhalerpatch gum…

Smokeless

DissolvablesSwedish

SNUS

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Cessation and used in quit attempts: growing evidence good as NRT

Nov-0

6

Feb-0

7

May

-07

Aug-0

7

Nov-0

7

Feb-0

8

May

-08

Aug-0

8

Nov-0

8

Feb-0

9

May

-09

Aug-0

9

Nov-0

9

Feb-1

0

May

-10

Aug-1

0

Nov-1

0

Feb-1

1

May

-11

Aug-1

1

Nov-1

1

Feb-1

2

May

-12

Aug-1

2

Nov-1

2

Feb-1

3

May

-13

Aug-1

30%

5%

10%

15%

20%

25%

30%

35%

40%

NRT OTC

Med Rx

NHS

E-cig

% o

f th

ose

tryi

ng t

o st

op in

the

pas

t ye

ar w

ho u

sed

supp

ort

NRT OTC: Nicotine replacement therapy bought over the counter; Med Rx: Prescription medication; NHS: NHS Stop Smoking Service; E-cig: Electronic cigarette

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YOUTH Pat terns of USE. (Exper iment ing only and over 90% al ready use convent ional c igs) .

• Adults: Awareness (76%) and use (21%) is growing fast among current smokers and young adults. Perceived as less harmful.

• Youth (CDC MMWR 2013)

• Use doubled middle and high school students 2011–2012, estimated 1.78 million students ever used.

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• Conclusions and Relevance  Use of e-cigarettes was associated with higher odds of ever or current cigarette smoking, higher odds of established smoking, higher odds of planning to quit smoking among current smokers, and, among experimenters, lower odds of abstinence from conventional cigarettes. Use of e-cigarettes does not discourage, and may encourage, conventional cigarette use among US adolescents

• Electronic Cigarettes and Conventional Cigarette Use Among US Adolescents: A Cross-sectional Study. Lauren M. Dutra, ScD1; Stanton A. Glantz, PhD1

• JAMA Pediatr. Published online March 06, 2014. doi:10.1001/jamapediatrics.2013.5488

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P a t t e r n s O f To b a c c o U s e A n d D u a l U s e I n U . S . Yo u n g A d u l t s : T h e M i s s i n g L i n k B e t w e e n Yo u t h P r e v e n t i o n

A n d A d u l t C e s s a t i o n

• 51% had ever smoked cigarettes. First product used: 73% cigarettes, 11% cigars, 5% little cigars/cigarillos/bidis, 4% hookah

• 32% of ever users (18-34) reported product initiation after the age of 18

• Of 23% of young adult current users, 30% report dual use. Among dual Users: cigars 23%, little cigars 26%, hookah 17%, dip snuff 12%, chewing tobacco 12%, e-cigs 9%, snus 7%, dissolvables 3%

• Dual use - higher in younger adults, males, less than high school education, and those not able to meet their expenses.

• Daily cigarette use was similar between dual use and cigarettes only use (no harm reduction due to less cigarettes, rather a harm increase?)

Rath J, Villanti A, Abrams D, Vallone D. Patterns of Tobacco Use and Dual Use in U.S. Young Adults: The missing link between youth prevention and adult cessation. Journal of Environmental and Public Health. 2012.

• Robust ongoing surveillance of NCP advertising is critical to inform the FDA and protect public health.

• Both commercial advertising and public health media campaigns must ensure that

content is not misleading and educates consumers about harm based on the available science.

• The way messages are framed have the potential to decrease tobacco use by promoting rather than undermining cessation of combusted products and/or encouraging exclusive use of less harmful NCPs rather than poly-use of combusted and NCPs.

7. Their ads say, “Switch, Don’t Quit.”Tobacco companies have long tried to discourage smokers from quitting

by marketing cigarette changes as reducing health risk. Some e-cigarette ads carry a similar message.

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SCIENCE Questions: SUMMARY

• Less harmful than cigarettes - when good quality can be regulated to be close to Pharama grade NRT. Some ingredients can produce harmful chemicals when heated (coloring / flavors)

• How can does e-cigarette use and marketing maximize benfits and reduce harms and affect current smokers?

– Delay cessation? Promote cessation?– Reduce cigarette consumption or give the impression of less

harm because of imagined reduced cigarette consumption?– Dual use when one can not smoke and alleviate discomfort

• Do e-cigarettes encourage former smokers to return to nicotine use and relapse to cigarette smoking?

• How do e-cigarettes affect non-smokers ?– Potential uptake among youth and young adults

Nicotine and

Harm reduced products update: Fiore, Schroeder, Baker. NEJM. Jan 2014; Abrams D JAMA Jan 2014

Communicate intelligently about harm reduction

Policy and Practice Proportional to HARM

•Focus on eliminating combustible tobacco products - Not all nicotine-containing products are equal…

• Even if some who give up combuseds will continue indefinitely using:

FDA-approved medicines, e-cigarettes, or smokeless (least harm is Swedish Snus).

  "New approaches must be adopted if we are to dramatically reduce the harms over the next decade. Goal requires that we recognize the unequal dangers resulting from

combustible tobacco use.”

CAN E-cigarettes make lethal combustibles obsolete?

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Conclusions• Stakes are high; lethality of combusted tobacco is worse than

we thought• Alternative frameworks of addiction/appeal/harm are available• Taxes and Policies: Proportional to Harm of product class

• End game strategies aided by future approaches and devices for nicotine delivery that better substitute for the cigarette pridetn regulation maximize benefits minimize harms

• Promotion of e-cigarettes and other innovative products is much more likely to be beneficial in an environment where the appeal, accessibility, promotion, and use of cigarettes are being rapidly reduced

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• Taxes and Policies: Proportional to Harm of product class

• End game strategies aided by future approaches and devices for nicotine delivery that better substitute for the cigarette

• Promotion of e-cigarettes and other innovative products is much more likely to be beneficial in an environment where the appeal, accessibility, promotion, and use of cigarettes are being rapidly reduced

Harm Reduction: Policy and Practice Principles

Thank you

People smoke because they are addicted to nicotine, but nicotine itself is not especially hazardous; it is the other constituents of tobacco smoke that cause most of the harm.

Use of smoke-free nicotine would benefit smokers directly by reducing the personal harm caused by nicotine addiction.

“In Sweden, the availability and use by men of an oral tobacco product called snus, one of the less hazardous smokeless tobacco products, is widely recognised to have contributed to the low prevalence of smoking in Swedish men and consequent low rates of lung cancer.”

Excerpts from: Ending tobacco smoking in Britain; Radical strategies for prevention and harm reduction in nicotine addiction

Royal College of Physicians of London, 2008.

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• Restrict Sales to over 18 years of age, no free samples.• Warning Label that nicotine can be an addictive substance

• Registration, and Product disclosure• Product standards, safe ingredients, child resistant packages

• Substantial equivalence or new product application 2yr grace

• MRTP applications to claim reduced harm: individual and population standard. Pre-approval and post-market surveillance

• Advertising on TV and Targeting youth ?• Flavors attractive to youth (candy) ? • Therapeutic claims for smoking cessation? • Need comprehensive nicotine / tobacco regulatory policy

New FDA proposed deeming and future rulemaking

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Lessons from the united kingdom

• Department of Health committed in its 2011 Tobacco Plan to “develop new approaches to encourage tobacco users who cannot quit to switch to safer sources of nicotine”

• In 2013, both the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Clinical and Healthcare Excellence (NICE) issued guidances embracing tobacco harm reduction and a “light-touch” approach to regulating nicotine-containing products as medicines

–Wide array of approved uses (e.g., reduce to quit, smoking reduction, temporary abstinence, maintenance)

–A handful of applications are apparently pending and the first approval is expected this year

• What could FDA glean from this experience?