RET/DM/46D 28th July, 1986
PROJECT EMN
meeting held in Millbank, July 25th, 1986
Present Mr.
Mr.
Dr.
Mr.
Mr.
Mr.
Mr.
Dr.
J.L. Mercier
C. Warren
P.J. Dunn
R.J. Pritchard
E.A.A. Bruell
N. Davies
A.L. Heard
R.E. Thornton
Imperial Tobacco
Canada
Brown and Williamson
BATCo.
1. BACKGROUND
1.1 Rationale
There are many constraints operating on the
tobacco industry
in 1986. For example, as a result of the
anti-smoking
lobby, taxation is increasing and consumption is
falling,
and young smokers are declining in number.
Politicians
are not unhappy with these trends. Issues related
to
Product liability also constrained the industry
and all
such issues related to Smoking and Health.
1.2 Opportunities
If we could remove Smoking and Health pressures'
the industry
would stabilize and then grow.
1.3 Obiective
"To work towards the discovery of a 'safe'
cigarette,
'safe' in the eyes of those who say that the
current
cigarette is 'unsafe'."
[Business-ociented, not research oriented].
1.4 Business Aspects
(i) Any return on an investment that led to an
increase
in smoking should be high.
(ii) The potential complexity of the project made
it
difficult for [non-tobacco] competitors to enter.
Contd/...
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Contd/ ...
1.5 Strategy
Briefly the project is related to a programme of
research
related to a three tier approach:
1. Eliminate (undesirable chemicals) and test for
biological activity
2. Modify [the cigarette]
3. Neutralize [by vitamins etc.]
which in turn relate to four research areas:
1 . Chemical Needs
2. Biological Tests
3. Epidemiology
4. Mechanism of Disease Production
2. DISCUSSION
2.1 It was accepted that the world-wide scenario
on Smoking
and Health was not greatly different to that in
Canada.
The importance of variations in the economy of
individual
countries was stressed (e.g. recent increases in
consumption
in Denmank), as was the role of drugs in societies
where
smoking was discouraged.
2.2 There were various views on the necessity and
feasibility,
of reducing specific chemicals. Only tobacco
specific
nitrosamines are unique to tobacco anyway and a
moving
target syndrome was anticipated: Compounds would
always
be added to the list.
2.3 The more pragmatic approach of reducing tar
(probably at
constant nicotine level] was discussed. This
4proach
had been specifically requested by regulatory
authorities
(e.g. U.S.A., U.K.), whereas there was equivocal
advice on
reduction of specific chemicals.
The approach was also consistent with effects of
nicotine
such as the apparent negative association of
smoking with
Alzheimer's Disease, Parkinson's Disease, etc.
It was agreed that this approach complimented the
approach
of Project EMN.
2.4 With regard to the four research areas, it was
agreed that
the first step was an on-going appraisal of the
scientific
literature as discussed in *Rationale for R&D",
A.L. Heard,
29.10.85. Resource in this area was being
increased with
the forthcoming appointment of a Senior Scientific
Adviser
in BATCo, Millbank.
Contd/...
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2.4 Contd/ ...
The Scientific Research Group (S.R.G.) was charged
with
appraising the literature and, if necessary,
organizing
further work. It was noted however that a
considerable
amount of work was already goinj on in all four
areas.
In detail there was discussion as to whether the
concept
of a "threshold" was useful in terms of
chemfcals-in smoke,
the confused status of biological tests, the
inherent
limitations of epidemiology and the current status
of
work on disease mechanisms and role of vitamins
etc.
The S.R.G. would be asked to examine if sufficient
work
was being carried out to meet the requirements of
the
project.
2.5 It was agreed that time scales could not be
set
realistically because of the uncertain nature of
scientific
research. However, all necessary resources would
be
provided.
2.6 It was also agreed that the S.R.G. would
consider the
implications of the tar reduction programme in
terms of
necessary research. In any case the next meeting
of the
S.R.G. (Montreal, August 1986) was already
scheduled to
discuss nicotine in detail.
2.7 The matter would be further discussed at the
1986 Research
Conference (Sydney, September 1986) and at a
projected
meeting of BAT No. l's to be held in due course.
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CONFIDENTIAL
Comments on Project EMN
Author: Dr. F.J.C. Roe'
Date: 21st July, 1986
1. It is nice once more to see optimism and vigour
stemming
from the Tobacco Industry in relation to smoking
and
health problems! These characteristics more or
less
disappeared from the UK scene after the failure of
tobacco
substitutes. The questions is, is there now a firm
basis
on which their revival is justified?
2. In the 1950's and 1960's it was not
unreasonable to
postulate that the carcinogenicity of smoke and,
perhaps,
too the emphysema- enhancing and heart
disease-enhancing
properties of smoke, are due to one or more smoke
ingredients which, if identified, might be
eliminatable by
modification in tobacco or cigarette design. The
fact
that pipe-smoking is relatively much safer than
cigarette
smoking has always given credence to this
approach,
although, alas. the Tobacco Industry has never
considered
any smoking product that did not look rather lilee
a
cigarette to be commercially viable.
3. The fact is that a generation of research on
fractionating
smoke and on comparing the effects of different
tobaccos
and cigarette designs has led to no breakthrough
in
relation to any smoking-associated disease that
could not
be as easily achieved by simple reduction in tar
delivery.
A severe constraint has always been the
acceptability if
the product and manufacturers know very well that
there
is a point in tar and nicotine reduction below
which most
smokers are not prepared to go.
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4. in the case of carcinogens, smoke contains not
just one
carcinogen but a galaxy of them. Furthermore it
is, at
present, inconceivable that carcinogens would not
be
produced during the pyrolysis of any crganic
m~terlal.
Elimination of carcinogens does not therefore
appear to
be feasible. The same is seemingly true for the
irritants
(especially oxides of nitrogen) responsible for
non-neoplastic lung-disease (emphysema and chronic
bronchitis). In the case of heart disease, carbon
monoxide and nicotine have received most attention
but in
neither case has a causal relationship been
unequivocally
demonstrated. In any event, it is difficult to see
how
either of these smoke constituents could be
eliminated
were it found to be the culprit. At present,
therefore,
it must be concluded that the "E" of "EMN" is no
more than
a pious hope.
5. The scope for further modification is presently
limited
by three considerations, (i) public resistance to
tasteless low-nicotine delivery smoke, (ii) by the
resistance of the Tobacco Industry to depart
radically
from conventional cigarette-type products, and
(iii) by
the unlikelihood that a completely carcinogen an~
irritant-free smoke could be produced.
6. This leaves for consideration the possiblity of
neutralisation, e.g. by the administration of
vitamins
such as Vitamin A and/or C to smokers. This
approach has
not yet been fully or adequately explored.
However, in
the light of what is known about mechanisms of
carcinogenesis and about the causation of
emphysema it
would be surprising if any means of completely
neutralising the adverse effects of smoke on the
risk of
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these diseases were found. I do not doubt that
reduced
food intake generally could largely eliminate
hear,--disease risk. However, unfortunately people
are
even less willing to cut down on eating than they
are to
give up smoking.
7. In my view, therefore, it is most unlikely that
within the
scope of acceptable cigarette design, it will
prove
possible further to reduce substantially the risk
of
smoking associated disease. To achieve this the
Industry
will have to step outside the constraints dictated
by
conventional cigarette design and contemporary
smoking
habits (e.g. in the direction of a return to
pipe-smoking).
8. Reluctantly, therefore, I have to conclude that
the paper
on Project EMN which has been sent to me has the
features of a light-weight patchwork quilt of 1960
design.
I am sorry to have spilt tea on it!
FJCR
21.7.86
01 \
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PROJECT EMN
COMMENTS ON PROJECT BY IMPERIAL TOBACCO LTD.,
CANADA.
Stated Objective
1. "The Study of Tobacco Products for the purpode
of'
alleviating Perceived Health Risks."
The course of action: Design a programme that
takes us from
our present programme of gross reduction of toxic
smoke
components to a program of selective reduction of
specific
tobacco smoke components to reduce the specific
toxicity
of tobacco smoke. This programme will be based on
the
recommendations of medical and scientific experts.
Fundamental research is not, in itself, an
objective; it
is a strategy.
it is a selected course of action which affords
the most
support to the achievement of an objective.
2. The above project is seen in three phases:
Eliminate E
Modify M
Neutralize N
and relates to the views of other people in
respect of
modifications which they think should be made to a
cigarette to reduce perceived health risks.
3. In more detail the project proposed is seen as
follows:
Identify the Undesirables
Eliminate the Undesirables
Modify the Cigarette
Neutralize
Comments
4. The project rationale assumes that there is a
reasonably
solid scientific background on which to proceed,
regardless
of judgements of medical authorities on the
directions
in which to proceed. It is proposed first of all
to
examine the scientific basis for action.
Contd/...
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Contd/ ...
5. There is a degree of unanimity between
regulatory
authorities on compounds in smoke which they
identify as
undesirable, and which do not appear tc relate to
consumer
satisfaction. While we consider their role in
cigarette
smoke to be unclear, we can react or reasonably
anticipate
the views of regulatory authorities by reduci`ng
oT
eliminating these compounds from smoke. In
practice,
elimination of materials from smoke produced in a
combustion
process is practically impossible, although
reductions (of
varying amounts) may be an attainable objective.
6. However, there is not likely to be any
consensus view
on threshold levels other than the view that it
should
be zero, and notwithstanding para. 5 above, this
is the
most obvious target.
7. It will be the role of the Scientific Research
Group
(S.R.G.) to maintain an on-going appraisal of the
scientific
literature. This could include some assessment of
compounds which regulatory bodies have identified.
The
next stage would be a programme of research based
on
cigarette design, combustion and filter research,
designed
to reduce as far as practical, identified
compounds.
This could be a huge amount of work, although some
existing
projects fall within this area.
8. In relation to reductions in specific toxicity,
ranking
of cigarette types in different biological tests
varies
according to the test. As the relevance/importance
of
the tests to real life situations (if any) is
arguable,
there is not yet a firm basis for using such tests
to
direct the project. This position could change,
particularly if work in molecular biology, for
example,
clarified the relevance of particular tests.
9. The scientific basis for a "neutralization"
project is
even less secure than the interpretation of
results from
biological testing, assuming for example that it
relates
to the claimed effects of ingestion of Vitamin A
etc.
In any event this area would impinge on industries
other
than tobacco.
10. What is currently feasible:
Some response, in chemical terms, to the views of
regulatory
authorities.
Contd/...
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10. Contd/. .
A check on the effect of any such chemically
driven
changes by generally accredited short term
biological,
tests. As a starter, to determine ultimate
biological
end points, using existing tests the activity of
the
following four tobacco related products might be
worth
evaluating.
1. High tar plain cigarette.
2. Modern low tar filter cigarette-~
3. Combustible cellulose device with adde
nicotine,-
possible burn additives.
? NSM + nicotine.
4. Favor.
11. This has broad similarities with the stated
objectives
.of uroject EMN (first two parts) although these
comments
indicate that the project should be called IME
(Identify,
Modify, Eliminate).
BATCo document for Province of BritiSh Columbia 28
October 1999