Transcript Morning Report - Thomas Jefferson University

Smoking Cessation
Pulmonary Grand Rounds
Sidharth Bagga MD MBA
Financial Disclosure

BIG tobacco pays me, so I can keep quiet
about smokers!!
In actuality:
 I pay BIG tobacco, so I can keep quiet
about smokers!!


We all are paying a tax in form of SocSec to keep quiet and
tolerate smokers because if they don’t quit we are paying
for their care, and BIG tobacco is walking away with a
profit.
Outline











Who started?
Who spread smoking?
Why we still smoke, despite knowing harms?
Its really not that addictive?
Does stopping even help?
Have any interventions made a difference?
What works? What doesn’t?
What can physicians do?
What can patients do?
Clinic best practices?
Financial impact? To patient? To Physician?
Smoking History (ancient)

As early as 5000 BC in
Shamanistic rituals




Social Activity in Middle
East (Hookah)




Babylonians, Indians, Chinese
Used to contact the spirit
world
Medicinal purposes
(Ayurveda)
Weddings, funerals, etc.
Started with Cannabis 
transitioned to Tobacco
Traders brought to Africa
Europeans to Americas
Smoking History (recent)

1920s



Increased life expectancy,
showed signs of tobacco
abuse
Nazi Germany develops
advocacy against tobacco
(Der Tabakgegner)
[] published statistical link
with tobacco and lung cancer


Nazis condemned smoking
Women smoker unfit for child
bearing, and shunned from
society
Marshall Plan (American)
Free tobacco to Germany





WWII

Post WWII

1929



Doll et al, BMJ (CA link)
1954


Per capita (460 to 1523)
1950


24000 tons in 1948
69000 tons in 1949
Bought by American
government for Germans
British Doctors Study
1964

US Surgeon General’s
report suggesting CA link
Smoking Current & Trends

1.1 billion worldwide

1/3rd adult population

“There is a new Marlboro land, not of lonesome cowboys, but of
social-spirited urbanites, united against the perceived strictures of
public health.”
Smoking Current & Trends
Smoking Current & Trends
World map of countries by number of cigarettes smoked per adult per year
Smoking Current & Trends
Smoking Current & Trends
Why, despite known harms?

Imagine a drug that can:





Enhance concentration,
alertness, and memory
Decrease tension and
anxiety
Promote a feeling of wellbeing
No immediate side effects
Nicotine delivery

Within seconds of
inhalation, a bolus of
nicotine is in brain to bind
to receptor and release
dopamine
Why, despite known harms?
1972
Why, despite known harms?
Tobacco Master Settlement (1998)- payment by the
companies of $365.5 billion over 25 years
Grades
Tobacco bonds states dependent on tobacco for income
‘
Why, despite known harms?
Why, despite known harms?
Addiction: Physiologic / Social

Physiologic



Cigarette smoke is the
perfect nicotine delivery
device
Quick (< 1 sec) and
effective means of
delivering small amount of
nicotine
Alkalization of smoke aids
in efficient delivery of drug

Social





Inhibition of MonoAmine
Oxidase
Smokers claim decreased
stress levels (stress
created by nicotine
dependence)
Rationalization (going to
die anyways, stress relief
worth risk of CA)
Smokers community
Camaraderie, especially in
locations with ban on
indoor smoking
Addiction: Genetic

Genetics



Without proper genetics
patient cannot be addicted
90% smokers have these
genes and are dependent
Only 10% alcoholics, and
50% of heroin addicts are
dependent.

Ten Towns Heart health
Study

Decreased nicotine
metabolism (dec fxn of
CYP2A6 enzyme)


Dopaminergic genotypes


Higher risk of dependance
Regulate nicotine
dependance
Differences in nicotine
metabolism across
ethnic groups
Addiction:
Addiction: Chemical

Degrees of Nicotine
dependency


Fagerstrom Tolerance
Questionnaire or
Fagertrom Test for
Nicotine Dependence
Serum Cotinine levels
Addiction: Chemical (low tar/nicotine)
LIGHTS
Does Stopping Help?

Two Goals







Improves overall prognosis
Increases life span
Lung Cancer




Reduced risk of Lung CA
92-96% over 10-20 years
Improved mortality from
decreased cancer progression
CAD


Continued smoking at greater risk
of second primary
Early stage NSCLC

Cough / expectoration improve
slowly over weeks/months
COPD
Small Cell CA

keeps smokers at risk despite
stopping decades earlier
Chronic Bronchitis


Decrease disease development
Decrease disease progression
Long Latency period


Decrease risk of AMI by 33% in
first year
Smoking > 40 years age

3 months life for each year
smoked
When did we start stopping?

Oldest attempt in Ottoman
Empire / China

Banned for being a threat to
public moral and health.
US Smoking rates





1965 - 42%
2006 – 20.8%
Most quitters affluent white males
Increase in number of cig
consumed per person suggests
that light smokers quit, and heavy
smokers moved to light cigs.
Stagnant over last 3 years!

Target unwilling quitters.
What works?




Prohibition (ancient china)
Social shunning (Nazi Germany)
Behavioral retraining
Nicotine replacement


Alpha4beta2 partial agonist/antagonists


Varenicline, Cytisine
Anti-depressants


Gum, patch, lozenge, inhaler, nasal spray
Bupropion, Nortriptyline
Persistence
What works?
What doesn’t?

Unaided / ‘Cold Turkey’







> 90% relapse rates after 3 months
SSRIs (OR 1.0)
Anxiolytics / Benzodiazepines
Beta blockade
Mecamylamine (old anti-hypertensive, Nicotine receptor Antagonist)
Accupuncture (OR 1.1)
Typically receiving 50% of recommended dose,
and completing < 50% of counseling sessions
What can physicians do?
“All patients should be asked if they use tobacco and should have their tobacco
use status documented regularly. Evidence has shown that this significantly
increases rate of clinician intervention.”
Strength of Evidence = A
Screening
system
Number of
arms
Estimated
OR
(95% CI)
Estimated
Intervention
Rate
(95% CI)
No system
in place
9
1.0
38.5
9
3.1
(2.2-4.2)
65.6
(58.3 – 72.6)
Screening
system
What can physicians do?
Screen: The Fifth Vital Sign
Action
Strategies for implementation
Implement an office wide
system that ensures that,
for EVERY patient at EVERY
clinic visit, tobacco-use
status is queried and
documented.a
Expand the vital signs to include tobacco use or use an alternative
universal identification system.b
VITAL SIGNS
Blood Pressure: _______________________
Pulse: ________ Weight: ___________
Temperature: _________________________
Respiratory Rate: ______________________
Tobacco Use: Current Former Never
(circle one)
What can physicians do? As
ASK
Do you currently use tobacco?
YES
NO
ASK
Have you ever used tobacco?
ADVISE to quit
YES
NO
ASSESS
ASSESS
Are you willing to quit now?
Have you recently quit?
Any challenges?
YES
NO
YES
NO
ASSIST
ASSIST
ASSIST
ASSIST
Provide appropriate
tobacco dependence
treatment
Intervene to increase
motivation to quit
Provide relapse
prevention
Encourage continued
abstinence
ARRANGE FOLLOW-UP
Minimal intervention (< 3mins)
Meta-analysis (1996): Effectiveness of and estimated abstinence rates for
advice to quit by a physician (n = 7 studies)
Advice
No advice to
Number of
Estimated
Estimated
arms
odds ratio
abstinence rate
(95% C.I.)
(95% C.I.)
9
1.0
7.9
10
1.3 (1.1-1.6)
10.2 (8.5-12.0)
quit (reference
group)
Physician
advice to quit
Minimal Intervention (> 3 mins)
Intensity of Clinical Interventions
Meta-analysis (2000): Effectiveness of and estimated abstinence rates for total amount of contact
time (n = 35 studies)
Total amount
of
contact time
Number of
arms
Estimated
odds ratio
(95% C.I.)
Estimated
abstinence rate
(95% C.I.)
No minutes
16
1.0
11.0
1-3 minutes
12
1.4 (1.1, 1.8)
14.4 (11.3, 17.5)
4-30 minutes
20
1.9 (1.5, 2.3)
18.8 (15.6, 22.0)
31-90 minutes
16
3.0 (2.3, 3.8)
26.5 (21.5, 31.4)
91-300 minutes
16
3.2 (2.3, 4.6)
28.4 (21.3, 35.5)
>300 minutes
15
2.8 (2.0, 3.9)
25.5 (19.2, 31.7)
Patient is willing to quit
Patient is unwilling to quit? 5Rs

Review the personal relevance of quitting



Review the risks of continued use


“We might be able to get you off of BP meds”
Review roadblocks to success


“Your family has a history of lung cancer”
Review the rewards of cessation


“Smoking is raising your blood pressure”
“It’s important to me that you not smoke”
“I can help you be comfortable while you quit”
Repeat the message

Empathy, understanding, and support
Physician counseling

Metanalysis of 14 RCT

Motivation interviewing
increase 6m quit rates by
30%, compared to usual
care

Debunking Myths

Risk of AMI with NRT


Pregnancy


2 studies have shown

Physician counselors (>2h
training) were successful
in 8% with motivational
interviewing vs 2% with
brief advice or usual care

Metanalysis of 9000 pts
with no increased risk of
cardiovascular events
Two studies with no
worsening, One with near
statistical significance of
congenital malformations.
Breastfeeding

21mg patch same as
smoking, otherwise lower
nicotine levels
Patient is still unwilling to quit?

Still prescribe nicotine patch




Meta-analysis of 7 RCTs (2767 unwilling pts) randomized to
NRT had 6 month cessation rates of 9% v 5% in control group
Another study, 1154 pts given gum/patch for 2 months, had
6m quit rate of 17% v 10% control
If continued, smoking decreased by 50% in fifth of population
Nausea was only stat sig adv event (8.7% v 5.3%)
Clinic best practices?

Provide on site care




If treatment delayed or
at separate location,
only 10% will initiate
33% will enter
treatment that is readily
available
Insurance approvals
expedited for
medications
Multiple offers of
treatment


May have benefit as
smokers’ interest in
quitting can change
quickly.
On site samples
What can patients do?
With friends like these…
What can patients do?
Costs
 Harms
 Patterns
 Instructions

Patient Financial Impact?

Cost of continued smoking

Pack a day ($10/pack -> $3,650)




A new wardrobe / TV every 3-6 months
Doesn’t include ancillary purchases, non-productive
time, time spent taking care of chronic illnesses,
hospitalizations
$50-73 billion per year in medical costs
Financial incentives to quit



NEJM 2009, 878 employees of multinational company
Study incentivized workers ($750) for completing
counseling, quitting, staying smoke free for 6 months
and 1 year.
Smoking cessation 9-12m (15% v 5%) and 15-18m
(10% v 4%)
Physician Financial Impact?
Outpatient followup: Level 2 (29), Level 3 (50), Level 4 (74)
Outpatient Consult: Level 3 (99), Level 4 (145), Level 5 (180)
Initial Visit: Level 4 (111), Level 5 (141)
Assumes – 42% average collection rate, > 50% time in counseling
Physician Financial Impact?

Smoking Cessation







Average 3 to 4 pts/wk
Minimal clinic resource
Billing is time based
No physical exam
required
No special training /
setup requirements
F/U – 15 mins, level 3 $50 collected
Consult – 30 mins, level
3 - $99 collected

Add On to regular visit





Average 40% of pts are
active smokers
Counsel 3 mins
On top of regular billing
- $12/$35 collected
Avg over 200 pts/wk,
extra ~ $1200-3500
Altruistic goal: return
collections back to patients
as financial incentive to be
smoke free.
Social Impact?
Leading cause of preventable death and
disability in the world
 Over 10 million premature deaths in the
US since 1964
 Average loss of life: 7 years
 Directly responsible for 1 in 5 deaths
 BIG tobacco advertising expenditure: $8
billion on domestic market

Horizon: vaccine (NicVax)




Nabi Biopharmaceuticals
(Rockville, MD)
3'-aminomethylnicotine
molecule
Attached to Pseudomonas
aeuroginosa exoprotein A
Body generates antibodies
to Nicotine (look-alike) and
binds all nicotine after
exposure


Bound nicotine too large to
enter blood-brain barrier
Bye-Bye Dependancy

Phase II Trials

2005, 68 smokers




Safe and well tolerated
Headaches, colds,
URTIs
Most kept smoking
2006, 301 smokers



High nicotine Ab (61
pts)
25% abstinent 6 mos
13/100 placebo
abstinent 5 mos
Horizon: vaccine (NicVax)

Phase III Trials

2010, double blind RCT,
1000 pts


2011, double blind RCT,
1000 pts


Similar quit rates 11% at
16 weeks & 12 mos
Again, no difference
Combination with
Varenicline in
Netherlands
Horizon: E-cigarettes
Horizon: E-cigarettes
Political Mess
 FDA





Unproven nicotine
delivery device
Seized shipments
Appeals court told
to treat as tobacco
product
Fear generation

Toxic chemicals

‘Harm
Reductionists’


Each e-cigarette
replaces an actual
cancer causing
cigarettes
No significant
harms of nicotine
“E-cigarettes could replace much or
most of cigarette consumption in the
U.S. in the next decade,” said William
T. Godshall, the executive director of
Smokefree Pennsylvania.
Horizon: E-cigarettes


FDA:
Failed to disclose the levels of
tobacco-specific nitrosamines
that were detected in the
electronic cigarette cartridges.

Failed to test the control
product (a nicotine inhaler) to
determine the carcinogen
level in that product.

Failed to report the tobaccospecific nitrosamine levels in
conventional tobacco
products, including cigarettes.
Maximum Tobacco-Specific Nitrosamine
Levels in Various
Cigarettes and Nicotine-Delivery Products
Horizon: E-cigarettes

Polosa et al, BMC 2011


At 24 weeks (~6 months)




40 1ppd italians ‘UNWILLING’
to quit
22.5% were abstinent from
cigarettes, confirmed by
exhaled carbon monoxide.
A total of 55% had reduced
their daily cigarettes smoked
by at least half. Most got
down to 3-6 cigarettes a day.
Overall, participants smoked
88% fewer cigarettes.
6/9 quitters were still on ecigs as a coping mechanism
Horizon: Cytisine (Tabex)



Parent compound of
Varenicline
Nicotinic receptor
a4b2
agonist/antagonist
NEJM 2011


Beneficial, cheaper!
Not available in US





740 patients
Willing to quit
> 10 cigs / day
Only treated for 25
days
Only sig adv event: GI
upset
Horizon: technology aided

Arch Int Med,
2009



Meta-analysis
of RCT for
computer/web
based
cessation
22 total trials,
1997-2004
Pooled 29,549
pts; 16,050
enrolled in
intervention;
13,499 control
groups
Horizon: technology aided
Outline














Who started smoking?
Who is still smoking?
Why we still smoke, despite knowing harms?
Its really not that addictive?
Does stopping even help?
Have any interventions made a difference?
What works? What doesn’t?
What can physicians do?
What can patients do?
Clinic best practices?
Financial impact? To patient? To Physician?
E-Cigarettes
Cytisine
Technology aid
Thank you!
TO TELL PTS
Tom Wesselmann (1931-2004)