22 nd
FILE
SAFETY EVALUATION OF CIGARETTES D
The evaluation of safety of smokl7n-g-or-of
cigarettes is imposed on t-do main b.3dies, the
cigarette
manufacturers and the pub!.-c authorities. It
might be
said that such an evaluation is entirely the
responsibility
of every adult smoker and for the manufacturer
this is a
tempting proposal. But if this view were to be
sustained
then cigarettes would have to be regard.-td
entirely differently
from most other Items - agro chemicals, cosmetics,
food
additives, motor cars, etc. In any case this
argument
merely transfers the onus of decision - guidance
on the
evaluation would still be required from
manufacturers and
public authority. ' It is unlikely then that the
cigarette
manufacturer can avoid involvement with safety
evaluation
and it might be helpful to look at the factors
involved.
Safety is not a measured or indeed a measurable
factor. Safety is best defined as the degree to
which
attendant risks are judged to be acceptable. And
risk is
the probability and probable severity of harin -
which is
measurable. .Because it is measurable the
evaluation of
risk is susceptible to a scientific approach.
Judging or
evaluating safety (the acceptability of risk)
however is a
normative, political activity and is not therefore
susceptible
to a scientific approach. It is to be expected
then that
there will be .iide variance in safety judgment
between, say
government and interested industry or between one
well
informed smoker and another. There should not be -
and
in truth there is not - as much variance of the
views, on
risk between scientists whether in industry or
public
service.
As far as smoking is concerned there is much
confusion caused by scientists and particularly by
doctors
becoming emotionally involved and making judgments
in the
politiclal area where they may not be competent.
On the
other hand politicians and industrialists venture
into the
scientific area of risk where they may be clearly
incompetent.
The position is not helped by some doctors belief
that they
are trained to be competent in both areas.
Whereas, in my
judgment, their general training quite properly
leads them
to preoccupation with individual (i.e. unique)
decisions
and away from bath social or scientific
generalization.
Q:)
(7 :~)
ON
110
Contd.
BATCo document for Province of British Columbia 26
October 1999


2
But even in the risk area the position is
not clear cut for smzking. In spite of the general
similarity in the results of various
epidemiological studies
there are no pre=--se measurements of the various
risks
involved in smoking. There is also considerable
scope for
different interpretations of data and some fairly
formidable
problems with self selected samples in
epidemiological
studies. Thus although the evidence on which risks
of
smoking may be estimated is well known, perhaps
the only
conclusion supported by all scientists is that the
risk
is above zero.
When it comes to safety evaluation, although it
is true that the same sort-of factors are involved
whether
judgments are made for social or business
purposes, when
presented with a variance in risk probabilities
industrIalists
are justi fiably inclined (at least publicly) to
choose the
lower and those.held responsible for public safety
similarly
to choose the higher risk. There is thus an
-understandable
and justiflabledivergence in the evaluation of the
safety o~
cigarettes. In a highly civilised society it is in
the
interests of all to aim to get these evaluations
to converge.
This can be done by 'more resear=hl to get closer
agreement
on risk. However, value judgments must still be
made and
it may be worthwhile indicating some of the
factors which
are involved in making such judcments. One factor
is
concerned with benefits - and it must be made
clear that
benefits are value judgments. Scientific research
can
indicate efficacies in achieving measurable
results but
it cannot indicate or measure benefits.
The sort of questions which must be asked are
as follows:-
Is the risk voluntary or involuntary?
Is the effect im-nediate or delayed?
Are there alternatives?
Is the risk known with certainty?
Is the exposure essential?
Is the risk encountered occupationally?
Is the hazard common or "dread"?
Does it affect average people or sensitive people?
Will the product be-used as intended or is it
likely
to be misused?
Are the conseauen=es reversible or irreversible?
We are thus concerned with considering, as well
as risk, social cost, custom, reasonableness, best
available
pract.-ce, benefits etc., and In making a decision
these
zeveral or many compi:;nents must be aporaised,
CoMparad and
0 \
BATCo document for Province of British Columbia 26
October 1999


weighed against each other.
The difficulties in food safety evaluation
are similar to those for cigarettes. There are
considerable
differences in judgment on food and it is to be
expected that
there will be wide differences in the judgments of
smokers,
politicians, and industrialists.
The cigarette manufacturers, in my opinion,
are entitled to say: "As long as there is
insufficient
consensus on risk (but not until there is clinical
proof
of the mechanis;-.0 we are not able to make useful
safety
judgments" - this is in effect the tight r--pe.
Coupled
with my previous argument on general
(probabilistic) and
special (mechanistic) causality which enables the
manufacturer to say, even if there ever is
consensus on
risk, this can only be construed as a general
causal
relationship applying to the incidence -" disease
in
populaticns and is not applicable to any unique
individual
these are very effective defensive P.R. and legal
positions.
Coupled further with support for research, a
recognition
that this only can establish (or redu=e) risk
etc.. and
that'in the end safety, benefits, fairness and
balance are
all value judgments our public position is
logically quite
respectable. If at the same time we recognise that
those
with wider respc~nsibilities to the public are
entitled to
make different value judgments with respect to the
acceptability of risk and the loss of benefit and
to act
on them, I believe we have the best public
position
obtainable in'the circumstances. In summary this
is -
(a) Risk is the business of science and there is
not consensus.
(b) Safety is dependent on value judgments and
wide differences are to be expected.
(c) More research at all levels should help
evaluations to converge.
(d) While there is evidence that smoking is
associated
with higher incidences of some diseases and
general causality may be claimed, special
causality can never be proved.
(e) The slogan is informed responsibility 6f
adults
governments and industry.
Q)
Z)
\0
S-J-GPEEN
BATCo document for Province of BritiSh Columbia 26
October 1999