The following is my take on the recent UK National Institute
for Health Care Excellence (NICE)
Guidance on “Tobacco: harm-reduction [sic] approaches to smoking”.
(I know I
am a bit late to this, but I kept interrupting my work on it for other projects.
There was a lot in the Guidance to
dissect.)
Background
For those not familiar, NICE functions vaguely like the
USA’s Institute of Medicine – in terms of function it is basically a governmental
think-tank, but is
somewhat
independent of the political process in terms of conducting analysis.
This means that the Guidance does not
create or even explicitly propose government policy action, but it does carry
the weight of government imprimatur (for those who consider that to be a good
thing).
As for the Guidance, it is
not actually about tobacco harm reduction (THR) in general as the name implies,
but rather is specifically recommendations about encouraging the use of
medicine-like products for THR as partial or total substitutes for smoking.
NICE apparently considers this to be important – rather more
important that it really is judging from their (grossly inaccurate)
headline claim that this report is “a world first for people who cannot stop smoking in one
step”. I will resist discussing
the implications of this narrow view of many people working for governments
(namely, that something did not happen until they did it) and their apparent
obliviousness to what is going on in the real world. In reality, the Guidance is approximately the one thousandth
statement recommending strategies for helping smokers who do not choose to stop
smoking by just quitting. But
especially baffling is that this is not even the first such statement by the UK
government: The MHRA (the unit of
government that controls sales of medicines, like the CDER (drug) branch of the
US FDA), which actually makes binding policy rather than just recommendations,
has already created a category of medicines for THR and has approved one
product in the category (at least two others are under review).
Though far short of the inaccurate self-promoting rhetoric,
the Guidance does have the potential to be somewhat influential.
Much of the reaction to the Guidance from
the real public health community (i.e., THR supporters) has been rather
negative, but I tend to differ because I think that the real impact of the
negative aspects (which definitely do exist) will be trivial and short-lived,
while the positive implications will have legs.
The main negative is that the guidance is specifically about
the use of “licensed nicotine-containing products” – that is, pharmaceutical
industry “NRT” products that are designed as abstinence-promotion medicines and
not as fully-satisfying consumer products.
The authors were clearly so desperately worried that someone
might interpret their recommendations as applying to all
roughly-equally-low-risk products, like unlicensed e-cigarettes or (gasp!)
snus, that they included the phrase “licensed nicotine-containing products”
approximately once in every 40 words.
The problem with that plan (and the reason this is not such bad news) is
that many people who read and make use of this are not stupid.
Many readers will recognize that
everything they say applies equally to all of these products.
Indeed, the Guidance authors make
basically no affirmative argument to the contrary.
(They throw in a few lies about risks from snus, but they
are so buried deep in the research background section that they are unlikely to
be noticed.)
You could imagine a document like this including a tedious
argument that there is something so different about non-“licensed” products
that the recommendations cannot be extrapolated to them.
But it does not include that.
Perhaps the authors actively wanted to
avoid such a claim.
Perhaps they
just realized they would look like idiots if they tried to argue obviously
incorrect claims.
One might even
conclude that some of the authors disagreed with the “licensed products only”
spirit of this initiative and managed to keep the document implicitly positive
about THR in general despite several of the authors clearly opposing this.
Thus, the Guidance is good news merely because it has positive
things to say about one (albeit relatively unimportant) approach to THR.
And moreover, whatever the reason why,
it was not actively anti-THR for other products, and therefore it will
contribute to the promotion of THR in general, even if some of those in charge
of the process might wish otherwise.
It is worth noting that there are a couple of e-cigarette-type
products in the application pipeline for the aforementioned MHRA approval, and
the authors of the Guidance knew that.
Thus, they knew that they were implicitly recommending THR using (some)
e-cigarettes.
Of course, right
after the release of the Guidance, MHRA declared that they
planned to regulate all e-cigarettes as medicines, requiring them to meet the licensing
requirements (which almost none could meet).
But it is clear from conversations I had that at least some
of the authors of the Guidance did not expect that this would be MHRA’s move,
so not much can be read into this juxtaposition.
Recommendations in the Guidance
So, finally getting to the substance, what does the Guidance
recommend?
It recommends everyone
involved in smoking cessation (government agencies, medics, specialty clinics,
etc.) provide smokers with information about the benefits of cutting down and
of substitution.
These do not
appear until after the reader wades through the usual recommendations that they
tell smokers the shocking news that smoking is bad for you and such, but that
is just boilerplate.
The substance
is the recommendations about a THR approach.
The same actors are supposed to tell people about the
licensed products themselves.
But
unless the clinicians et al. lie about the more consumer-friendly products –
which, importantly, NICE clearly does not ask them to do – then people should
be able to extrapolate.
Indeed we
can hope that anyone working with real live human smokers that they care about,
rather than just publishing information, will go ahead and actively recommend
e-cigarettes (or even semi-black market snus).
Of course, we will not know what private conversations clinicians
will have with people.
But the
Guidance also calls for those who create self-help information to incorporate
these recommendations.
Will those
who did not already endorse THR in their writings start doing so now?
It is not clear that the Guidance will
actually have that kind of impact, but at least we will be able to observe this
if it happens, unlike the personal conversations.
The word “reassure” appears a lot in the Guidance, as in
“Reassure them that it is better to use these products and reduce the amount
they smoke than to continue smoking at their current level.”
This is a nice touch, acknowledging
that the anti-tobacco extremists’ years of efforts to mislead people into
believing there are no benefits from THR necessitates an affirmative effort to
undo.
I am sure this really grated
on those members of the authorship committee who are part of the extremist
clique and personally contributed to the disinformation that needs to be
corrected.
Or maybe it just flew
over their heads – part of the tobacco control job description is to avoid
thinking critically, after all.
The discussion of how to counsel smokers about perhaps
choosing THR is quite lucid and rational.
It reads like the recommendations that good pro-THR medics or real
public health people would write.
It even includes the advice to warn smokers that the recommended
products are not so satisfying as smoking, so need to be used differently (not
in so many words, of course, but that is the upshot of it).
The recommendation that those who educate clinicians educate
them about these recommendations is pretty paltry, but it is there.
There are even recommendations about advising smokers about
strategies for “temporary abstinence”.
This is not explained, but it seems that it must refer to helping
smokers deal with smoking place restrictions.
If so, this is a rather surprising move in the direction of
good government – helping people be happier given the constraints they face, rather
than trying to force their choices.
The anti-smoking activists, if they actually think through what this
implies, are not going to be happy about this; while they publicly justify
place restrictions based on protecting bystanders from smoke, most of them
clearly consider the fact that the restrictions can make smokers miserable to
be a feature, not a bug.
I wonder if on this point NICE may actually have been a
little
too respectful of people’s
choices.
They failed to push the
recommendation to communicate “now that you have discovered that these products
are appealing when you have to deal with place restrictions, you should
consider using them all the time.”
There is one buried sentence on this theme, but it is a missed
opportunity that they did not make the point more clearly.
(Of course, perhaps they recognized that
few smokers with these motives are going to find their licensed products to be
so satisfying that they might want to use them all the time.)
Manufacturers are encouraged to include the THR information
on their packaging and such.
Of
course, this only applies to licensed products and does not change any laws, so
unapproved claims about “unapproved” products are still, well, unapproved.
Criticisms of the narrow-mindedness
As noted above, the Guidance is restricted to “licensed
products” and this provoked a lot of ire when it came out.
The closest they come to acknowledging
the reality that exists beyond their licensing paywall is, “little direct
evidence is available on the effectiveness, quality and safety of
nicotine-containing products that are not regulated by the MHRA. However, they
are expected to be less harmful than tobacco.”
While better than denying that they are less harmful, this
is still a lie at a couple levels:
There is a
lot of evidence
about effectiveness, quality, and safety.
(Perhaps they were trying to hide behind the word “direct”,
but since it is basically meaningless, there is no refuge there.)
These products are
known (not “expect to be”) a lot less harmful than smoking, but not
less harmful than “
tobacco”, a
category that clearly includes smokeless products that are just a
low-risk.
(Indeed, in the minds of
many, all the products mentioned here, when used on a long term basis for
non-medical reasons, form the category “tobacco”, though that does not tend to
be the UK way of thinking).
Just because you cannot buy low-risk smokeless
tobacco in the UK is no excuse for pretending that it does not exist.
Still, this cryptically acknowledges
that e-cigarettes, despite the government not officially granting people
permission to use them, are low risk.
The Guidance goes so far as to say, “Electronic cigarettes
are becoming increasingly popular. If the MHRA starts regulating them, or there
is positive new evidence of effectiveness, …this guidance should be considered
for a rapid update.”
Of course, if
e-cigarettes are MHRA-licensed products, the only thing that needs to be
updated is adding them to the list of “approved” product types.
Nothing else would need to change.
There are probably a hundred incorrect specific claims in
the document, but I am not going to go into that level of detail.
The count goes up to several hundred if
you include their “review of the evidence” back-matter; that section is bad enough
that it makes me wonder how the recommendations turned out as good as they
are.
Indeed, it appears that the
authors pretty much used that section for window-dressing and were motivated by
better general knowledge, which is a good thing.
A more subtle failure is the refusal to acknowledge how we
know that smoke-free tobacco/nicotine products are low risk.
In their desperate attempt to avoid
even recognizing the existence of smokeless tobacco, they attribute the
knowledge that “licensed” products are low risk to the paltry data about
long-term use of those products.
That
level of evidence about, say, e-cigarettes would be derided by those who like
the medicines as entirely inadequate.
The reason we know that the level of risk caused by smoke-free nicotine
is indistinguishable from harmless is the extensive research that shows that smokeless
tobacco has no measurable risks.
It
is that knowledge that NRT makers cite when they try to argue that their
products are low risk.
Too bad NICE
could not be as honest.
The recommendations also fail because they think that
tobacco harm reduction is really just about harm reduction (see my
recent post).
They clearly communicate
that the use of low-risk products is always the second-best choice, behind
abstinence, and fail to explicitly acknowledge the advantages compared to
abstinence.
This was inevitable,
of course, but just because it is not surprising does not mean it is not wrong.
The Guidance acknowledges that some
smokers do not want to become abstinent, and thereby implicitly acknowledges
that there must be some disadvantages to abstinence.
But this is never recognized.
But on the glass-half-full side, those of us inclined to do
so can point out that NICE acknowledges that there are benefits from tobacco
use.
Interestingly, the only place where they mention the
favorite bogeyman of anti-THR activism, the possibility that some people who
would have quit smoking will only reduce if there is any encouragement to do
so, is in the cost-effectiveness analysis discussion.
While engineered worries about this in
the popular discourse are 90% trumped-up lies, it seems like this should have
gotten a bit of explicit attention in the substantive part of the
Guidance.
Yes, their
recommendations repeatedly include the observation that switching completely or
otherwise quitting smoking is much healthier than just reducing, but I would
have really liked to have seen some suggested model advice about how to say,
“since you are cutting down by using an alternative, you should really consider
finishing the switch because any smoking is a lot less healthy than none”.
As an aside from the details of tobacco policy, putting on
my political scientist or ethicist hat:
A disturbing theme in the research section of the Guidance (in common
with a lot of government activism) is the notion that government should think
like a business.
Cost-effectiveness type analysis is great (it is at the core of what I
taught for years), but it needs to consider
all
social costs and benefits.
For a
business, something is a good move if it reduces expenditures or increases
revenue (or, more precisely, improves the net of those two added together),
regardless of its other impacts on the world, and that is exactly why a lot of
people, including a large portion of “public health” types, despise business
and use “profit” as a rough synonym for “evil”.
But that is what businesses are supposed to do, more or
less.
However, it is not what
government is supposed to do.
When
the government starts trying to maximize its profits, we are all in trouble –
that is what feudal and warlord governments do.
Yet the analysis of costs and benefits focuses totally on government
net profits.
There is no apparent
acknowledgement of the costs and benefits to the product users, by far the most
significant costs and benefits.
This is rather odd since the substance of the Guidance acknowledges that
people might prefer switching to abstinence – that is, there is a recognition
of the real costs and benefits built in.
At least that makes it much better than the usual “analysis” that
bludgeoning smokers into abstinence, even though it makes them unhappy, is
“cost-effective”.
In some ways,
though, that makes the business balance-sheet analysis even more pathetic.
Besides, should the government require cost-effectiveness
at all before deciding it should tell
its citizens the truth about something very important to them?
Should the government lie if it looks
like it would save money?
(Yes, I
know the answer is that they will often do just that.
But they certainly should not.)
Concluding thoughts
I really think that this Guidance is good for the promotion
of THR – not as good as it could be, obviously, but not harmful.
Because there are no affirmative
arguments against any aspect of THR, it is difficult to see the harm.
The statement that smokers who reduce but do not quit
entirely (or, more precisely
have not
quit entirely, since they still might do so) get some health benefits flatly contradicts
currently popular anti-THR lies.
The
Guidance agrees with the point that the experts have long been making, that in
many cases reducing represents a transition, and in any case the much demonized
“dual use” is better than just smoking.
Of course, the anti-THR activists (who do not actually consider
evidence, but rather start with their conclusion and then concoct
rationalizations for it) can still retreat to their claim that all those people
who have cut down would have quit already if they were not taken in by the
allure of alternative products, but that is so clearly silly that it becomes
much harder for them to defend their rationalization.
It is also gratifying to see the repeated use of language
that refers to preferences about tobacco use, rather than suggesting it is some
kind of volition-free tic.
There
are a few appearances of the “cannot quit” type language, but mostly the
languages is about what smokers want – e.g., “may want to stop smoking without
necessarily giving up nicotine”, “want to reduce the amount they smoke”, or
“may not be able (or do not want) to stop smoking in one step”.
(Yes, they still throw in a bit of the
“cannot” language, but at least they still recognize the relevance of “want”).
The implicit acknowle
dgments of both
the use of non-“licensed” products and of the downsides of abstinence are quite
useful.
Those of us who want to
make points about other products and motives can cite this Guidance and just
let the extremists sputter their vapid protests about it just being about
medicines.