Tobacco harm reduction and new nicotine products – an end to smoking?

31st May 2012

Professor Gerry StimsonKnowledge Action Change

Chair

Dr Karl FagerströmSmokers’ Information Centre, Sweden

Can we extinguish the use of tobacco and nicotine - if not what should we do?

CAN WE EXTINGUISH TOBACCO/NICOTINE? IF

NOT, WHAT SHOULD WE DO?

Karl Fagerstrom PhDFagerstrom Consulting

karl.fagerstrom@swipnet.se

That humanity at large will ever be able to dispense with Artificial Paradises seems very unlikely. Most men and women lead lives at the worst so painful, at the best so monotonous, poor and limited that the urge to escape, the longing to transcend themselves if only for a few moments, is and has always been one of the principal appetites of the soul. Aldous Huxley

CULTURAL DRUGS

• ALCOHOL, BEER, WINE, HARD LIQUER• CAFFEINE, SODA, TEA, COFFEE• NICOTINE, CLEAN NIC., SMOKEFREE,

CIGARETTES

Semi-cultural• THC, marijuana etc

Examples of problems that probably cannot be solved or eliminated

• Prostitution

• Drug use, incl. cultural drugs

• Sexually transmitted infections

What is our purpose? What are we against?

• Addiction

• Tobacco industry

• Smoking related diseases

• Smokers

If ingestion of caffeine by inhalation was common and we knew it could be safer taken brewed what would we do?

Nicotine/tobacco is an ideal area for harm reduction

Used largely because of nicotine

Pure nicotine, and even unburnedtobacco, is not a big part of the problem: the health consequences.

HIGH

NRT

Snu

s

Tra

ditio

nal c

igar

ettes

Mod

ified

cig

arett

es, n

o bu

rnin

g

CONTINUUM OF HARM

Smok

less

toba

cco,

e.g

. In

dia

LOW

Cigarette cessation Success rate (%)(Cochrane, 2011) with placebo

gum 11.2 patch 9.8 varenicline 10.0 bupropion 10.2

Smokeless tobacco Cessation (Cohrane,2011) gum 26.6

patch 25.5 lozenge 21.1 varenicline 33.0 bupropion 19.1

Cessation of long-term use of nicotine replacement therapy (Tonnesen & Mikkelsen, 2012) varenicline 36.0

Success in Stopping Using Different Tobacco/Nicotine Products When Treated With Different Placebo Products

M=10 %

M=25%

M= 36%

Fagerstrom & Eissenberg 2012

CONTINUUM OF DEPENDENCE

HIGH LOWNRT

PatchGum

Traditionalcigarettes

Smokelesstobacco

Tob Contr 2010

Finally!

Should future´s children interested in rebellious and adult behaviour just have cigarettes available – the most harmful form – and when hooked helped to less harmful alternatives?

Can society offer a better solution?

Thank you!

Deborah ArnottAction on Smoking and Health

Why regulating nicotine effectively is the only way to end smoking

Why regulating nicotine effectively will bring an end to smoking

Deborah ArnottChief executive ASH

KAC dialogues31 May 2012

“People smoke for nicotine but they die from the tar”

• Professor Michael Russell BMJ 1976 • Revolutionised our understanding of

smoking

35 years on where are we now?

• Clean nicotine only widely available as a tool for quitting• …… despite deadly nature of smoking cigarettes still

primary source of nicotine• ….smoking still major cause of preventable, premature

death killing than the next six causes put together.

Growth in inequalities

Poorer smokers more addicted

0 1 2 3 4

200

250

300

350

Sal

iva

cotin

ine

(ng/

ml)

Saliva cotinine by deprivationin adult smokers: HSE 1998-2004

c ru d e

a d ju s te d fo rc ig s /d a y

DEPRIVATION SCORE

d e p re v.tc

Tobacco Control crusade

• To end all death and disease caused by tobacco;

• To end nicotine addiction; and, last but not least

• To destroy the tobacco industry

Harm reduction upsets the equilibrium

• Meets first objective: to reduce the death and disease caused by smoking

• But at the expense of the second and third objectives– Nicotine addiction sustained– TI potentially benefits from HR

Hostility to Big Tobacco

• TI documents reveal industry lied about the deadly and addictive nature of its product

• TC community believes industry cannot ever be trusted

• TC community believes industry doesn’t deserve to survive

• Annual global sales $500 bn – profits $35 bn

Skoal Banditsa cautionary tale

• 1985 US Tobacco opened Scottish factory to make smokeless

• Marketing youth oriented• Dramatic increase in youth sales

since 1970s in US • Massive public health campaign• 1989 total ban on sales of oral

snuff (snus) in UK • Subsequently extended to EU

(except Sweden), Australia and Israel

Nicotine harms and misperceptions

• Nicotine is highly addictive which is why few smokers are able to quit

• Addiction does enable the industry to charge high prices

• BUT Nicotine wrongly believed to be harmful- by public and professionals

7 Canada Aust. U.K. U.S.

Nicotine causes most cancer (% answering “true”)

41% 45% 49% 44%

Nicotine causes most cancer (% answering “true”) LOW INCOME

46% 52% 57% 51%

NRT might harm health (% agree strongly + somewhat)

37% 33% 25% 33%

Potential risks of THR

• Massive business opportunity for tobacco companies to profit from addiction

• Undermines quit message causing extra harm to those who might otherwise have quit completely

• Potential for young people to start with the harm reduction option then move to smoking (‘gateway’ theory)

• Potential for ex-smokers to relapse to the harm reduction option – then to smoking.

• Population level nicotine addiction will stop declining/start growing again

Potential benefits of THR

• Significantly reduces population level harm caused by smoking:– Reduced harm to people that would have otherwise

carried on smoking– Reduced harm arising from passive smoking.– Possible ‘halfway house’ to cessation

• Creates a market incentive for ever-better products to replace cigarettes

• Could lead to smoked tobacco becoming obsolete

Tobacco Harm ReductionEnglish art of compromise

• Government led HR strategy to: – minimise risks and maximise opportunities– Publicly launch plan to public, HCPs and smokers– Target campaigns to address misperceptions about nicotine

amongst public, HCPs and smokers • Light touch medicines regulation for NCPs to ensure

• products coming to the market place are safe and effective• regulation appropriate to the level of addictiveness of the

product• marketing is regulated to prevent promotion to non

smokers/youth• Impact properly evaluated

• Regulated products on market to meet smokers’ needs

Public Health community in support

• Royal College of Physicians

• BMA• Public health

community at large

Where are we now?

• DH tobacco plan 2011 committed to ‘develop new approaches to encourage tobacco users who cannot quit to switch to safer sources of nicotine’

• Working in collaboration with the public health community

• NICE and MHRA playing key roles – May 2013 key date

NICE public health guidanceharm reduction approaches to smoking

• Aimed at professionals and public• THR means reducing the illnesses and deaths

caused by smoking tobacco – among people who smoke and those around them.

• People who smoke can do this by: – stopping smoking altogether – cutting down prior to quitting – smoking less – abstaining from smoking temporarily

NICE public health guidanceharm reduction approaches to smoking

• Includes completely or partially substituting the nicotine from smoking with nicotine from less hazardous non-tobacco sources such as pharmaceutical nicotine and ‘electronic cigarettes’ either temporarily or indefinitely.

• Products containing tobacco not included• Covers people of all ages with the exclusion of

pregnant women. • Particular focus on groups who are more likely to

smoke

MHRA

• Public health remit• 2010 licenced NRT for long-term use on

basis that “it has become widely accepted that there are no circumstances in which it is safer to smoke than to use NRT”

• Launched consultation on how to regulate e-cigarettes and other non-tobacco NCPs

MHRAconsultation result

• Clear support for regulation; but • not for immediate removal of e-cigarettes from

market• Risk to do so would stifle innovation and lead to

potentially useful products being removed from the market

• Further work underway• Final decision on regulation to be announced

May 2013

E-cigarettesproof of demand

• One in five smokers tried• Up from one in ten in 2010• BUT only a third carry on using• Of those 8 in 10 dual users• 2 in 10 switch completely

Electronic cigarettes Potential pitfalls

• MHRA didn’t ban them as recognised risk e-cig users would revert to smoking BUT

• Still marginal, underdeveloped and undermarketed • Concerns about lack of safety and efficacy

Toxic sofas

Regulation needed

Wider regulatory contextfor e-cigarettes

• Already banned in Australia, Brazil, Canada, Panama, Singapore, Saudi Arabia and Thailand

• EU considering banning them too under review of Tobacco Products Directive

• Likely decision will only be legal in EU if come under medicines regulation

Tobacco Industry moving in

Tobacco Industry moving in

Tobacco Industry moving in

Tobacco Industry moving in

Tobacco Industry moving in

Tobacco Industry moving in

Tobacco Industry moving in

Tobacco Industry moving in

Tobacco industry already moving in

The lesson of the electric car

• Does the industry really want alternatives to succeed?

• Without regulation no incentive to change• Once regulatory environment changed GM

trashed its electric cars

Regulation the key

• Need to provide appropriate and effective regulatory environment to encourage innovation and investment

• At same time keep up the regulatory pressure to reduce smoking – making it less attractive and less affordable to the consumer and less profitable for the manufacturers

Conclusions

• 100,000 die in UK • 1 in 5 still smoke• Many more in

disadvantaged communities

• Is it realistic to talk of the end game?

• …Not unless smokers given an alternative…

Dr Delon HumanHealth Diplomats

Respondent

in association with

Present

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