Carl V Phillips PhD

Consulting epidemiologist and economistand

Chief Scientific Officer, Consumer Advocates for Smoke-free Alternatives Association

presentation for IMS Health17 Nov 2014

London

Smoking replacement products appear to fail – but only because we get the economics and epidemiology wrong

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Abstract: Nicotine Replacement Therapy (NRT) products are widely derided as failing to assist smoking cessation about 95% of the time, based on clinical trial evidence. Similar results are expected for clinical trials of e-cigarettes or other harm reduction products. Yet these products serve the needs of some consumers quite well. The problem is a failure to understand the heterogeneity of the target population. Despite most smokers claiming on surveys that they want to quit, most really prefer to smoke; their answer reflects a second-order preference. The failure to appreciate the nuances of what different smokers really want -- the inevitable result of epidemiologists failing to even study it -- results in the naive belief that the appropriate target for replacement products is all smokers who claim to want to quit. Better targeting would better demonstrate product effectiveness and result in much greater cost-effectiveness.

Acknowledgments: This talk was based largely on a paper coauthored with Catherine M Nissen and Brad Rodu.

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• Rhetoric portrays smoking as a disease– but everyone wants basically the same thing with diseases: the

consumer wants it to eliminated, and for the lowest cost possible; advocates all share almost the same goals

• In reality, there are costs and benefits,• and so people have heterogeneous preferences for

smoking, tobacco abstinence, alternative products, etc.– should not exactly comes as a surprise: the same is true for

everything that is a consumption choice

• This has countless implications, including for “treatment” effectiveness and cost-effectiveness measures

Smoking cessation: a heterogeneous world

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• A very small portion of current adult smokers quit every year – according to every available measure

• 73% of all smokers want to quit (or some other absurdly over-precise number) – according to the tobacco control industry

– So what does this disconnect mean? (hint: quitting is always an option; it is often far from painless, but it is certainly an option)

Some background “facts”

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• Nicotine replacement therapy products (NRT) are the proven safe and effective therapy – according to the tobacco control industry, the manufacturers, and many governments

• NRT fails 97% of the time (or some other absurdly over-precise number) – according to opponents of the above entities and particularly e-cigarette supporters

– So what does this disconnect mean? (hint: they are both fundamentally wrong)

Some background “facts”

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• Electronic cigarettes / nicotine vapor products (e-cigarettes) are a public health miracle as aids for smoking cessation – according to e-cigarette supporters

• There is no evidence that e-cigarettes aid smoking cessation, and evidence shows they are no more effective than NRT – according to e-cigarette opponents

– So what does this disconnect mean? (hint: one of them is right, for the same reason they were wrong about NRT)

Some background “facts”

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• Treating technical study results as “the evidence” even though they flatly contradict the real scientific evidence

• Ignoring heterogeneity– and thus it not even occurring to anyone to try to

explain it

• Ignoring the huge benefits of smoking and other tobacco use– people choose to smoke because it has benefits

Errors common across those “facts”

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• Well, yeah.– cognitive enhancement; mood improvement; treatment for

depression, PTSD, schizophrenia, ADHD etc.

• People are have preferences and volition, and and they are choosing to smoke.– this alone makes it obvious that there are benefits– applying (largely meaningless) labels like “addiction” to some of

the sources of preference does not change the fact that behavior is following preferences

Ok, then how do we explain surveys that report that most smokers want to quit?

Benefits? From smoking?

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• Preferences can be thought of as an ordering across states of the world.

• If we have autonomy and volition, preference leads to choice (and so choice reveals preference)

• Unlike with “diseased” vs. “cured”, preferences around behaviors that have both costs and benefits are complicated and vary

Second-order preferences

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• We have preferences about having different true (first-order) preferences– e.g., We would prefer that we preferred working

to playing computer games or watching Z Nation

• Generally these take the form of wishing we liked dispreferred option better– rarely, in self-control situations, the second-order

preferences are so strong we wish the preferred option would be made less attractive to reverse the preference ordering

Second-order preferences

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• Statements of “I want to quit smoking” are usually actually second-order preferences

– “I want to be someone who would prefer abstinence from smoking to smoking, even though my actual preferences put smoking above abstinence”

• How do we know this? – Because almost all of them do not quit smoking– Even more telling, most resume smoking after

stopping – it is not merely that they could not break the habit and survive withdrawal

Second-order preferences

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• Of course, many people lack the vocabulary to express the second order statement

• Part of the reason for that is the propaganda they are subject to, being told that smoking has no benefits and they do not really want to do it– Tobacco control’s implicit theory of why people smoke is

possession by demons– allows them to pretend actions are being taken without

benefits because choices are arbitrary, so there is no reason to be concerned with them

Second-order preferences

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• ...harms consumers themselves because they do not realize the implications of fighting true preferences.

• ...explains a lot of embarrassingly bad policy that creates a lot of harm,

• ...in particular resistance to tobacco harm reduction (THR; the substitution of low-risk products like smokeless tobacco or e-cigarettes for cigarettes).

• ...is unforgiveable given the overwhelming evidence.

The failure to recognize that stated preferences to quit are second-order...

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1. True first-order preference for abstinence

2. Long-run first-order preference for abstinence but cost of transition creates a short run preference for smoking

3. Second-order preference for abstinence, but not understanding this is not first order

4. Recognize their first-order preference is to smoke, but actively seeking an alternative to make this not so

Four categories of smokers who say they “want to quit”

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Targeting “treatment”

Anything seems to work

No “treatment” will work(absent changing preferences or

offering good substitute)

Smokers who “want to quit”

Candidates for NRT etc.

the few smokers who apparently are

genuinely kept smoking by “dependence”

*Proportions are rough but realistic, based on NRT RCT data.

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• Category 1 (true preference to quit): a disequilibrium state – all they need is any focus to get them to move now rather than putting off another day

– most anything can be the focus – placebos “work”– explains why null treatment arm of studies quit at much

higher than background “spontaneous remission” rate

Clearly there can be no one “best” treatment like there often is for a disease

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• Category 2 (long-term preference to quit): need something to get them “over the hump”; good candidate for NRT or the like

– NRT might work– or THR– still heterogeneous in terms of which over-the-hump aid

will work, but at least they are valid candidates

Clearly there can be no one “best” treatment like there often is for a disease

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• Category 3 (confusing second- and first-order): do not actually want to quit; cessation requires changing preferences or moving into Category 4– victims of the “no one really wants to smoke” propaganda

• causes them direct harm and ensures continuing failure to quit (to the benefit of those who sell cessation aids) by overselling the option

– often quit for a while when studied, but restart• evidence that it is not merely dependence

– NRT etc. do not change their preferences

Clearly there can be no one “best” treatment like there often is for a disease

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• Category 4 (understanding true first-order preferences, but wanting alternative): immediate candidates THR– (i.e., substitution of low-risk alternatives like smokeless

tobacco or e-cigarettes)– prefer smoking to tobacco abstinence, but might prefer

the right tobacco product to smoking

Clearly there can be no one “best” treatment like there often is for a disease

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Targeting “treatment”

Anything seems to work

No “treatment” will work(absent changing preferences or

offering good substitute)

Smokers who “want to quit”

Candidates for NRT etc.

the few smokers who apparently are

genuinely kept smoking by “dependence”

*Proportions are rough but realistic, based on NRT RCT data.

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• Bad targeting– Plastic concept of “addiction” contributes a lot to this, – in addition to the “demonic possession” view

– Of course a lot of it is just government capture, and manufacturers are quite happy with bad targeting; but that is a different story

Giving NRT (etc.) to everyone makes it a “fail”

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• It is possible to use epidemiology to identify ideal target population for a treatment

– pattern of previous periods of long abstinence followed by resumption of smoking (no lack ability to stop, but prefers to smoke)

– previous quit attempts never lasted even a few days (apparent genuine “getting over the hump” problem)

– conditions which contraindicate complete tobacco cessation

Giving NRT (etc.) to everyone makes it a “fail”

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• The good news is that smoking cessation attempts are not serious rivals– i.e., trying one does not preclude trying another in time to

matter, as with many disease treatments– if one particular method fails, there is still time to pursue an

alternative like THR

• So RCT mentality (“which treatment is ‘best’ and should be assigned to everyone”) is badly misguided in this context

• However, a couple of months of additional smoking matters; e.g., creates more health risk than a lifetime of smokeless tobacco use (Phillips 2009)– So abjectly bad targeting matters

Should we care (from a policy perspective)?

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Targeting THR promotion

Smokers who “want to quit”

How many are really in Category 4?

It turns out it is does not really matter much(meaning RCT approach to THR is badly misguided)

Obviously benefit from THR

Might benefit(but if not, no harm)

THR product as trigger(can still quit later)

Good way to get over the hump