NOTT FOR THE TOBACCO STR-ATEGY RE*vIEXA,'TEA.Nl
TRAMDERNL&L NICOTINE
1. THFPRODUCT
Nicotine patches are a system of delivering
nicotine into the blood stream. Nicotine
patches,xere introduced onto the market as a
pharmacy-only product in New Zealand
in 1991 and in the U.S.A. they were approved by
the Food and Drug Administralion
for prescnipti on -only sales from 1992.
Pharmaccutical companies manufacturing nicotine
patches arc currently marketing
them for "treatment of nicotine dependence--as a
smoking cessation aid, claiming for
example. the psychopharmacological stimulant
effects of nicotine underlie the tobacco
nicotine addicrion". This paper also considers
issues relating to other potential usts of
the transdtrmal nicotine patch. Le: dual usage by
smokers of patches and cigarettes and
choice of the patch solely for nicotine intakc.
2. AS A WTHOD OF AMflN1lSTFRNG \TICOTIN'E
Guid-:lines for use of nico6ne patches issued by
the manufacturer Ciba Geigy
recomm,:-id that the subject should stop smoking
completely and use patches for no
longer than three months (as treatment period and
doses above 52mg per patch ha%-.
not been evaluated). The guidelines advise
aEiainst use by non-smokers, occasional
smokers and subjects with certain medical
conditions.
Neither the standard nicotine patch (e.g.
Nicotinell) nor the "Sto'%~c" patch match thc
dcliverv pattern or impact of nicotine that is
obtained when smoke is inhaled ftorn a
--hcv do, however, match more closely the pattern
of some other forms of
Cigarette. I .
tobacco usage. e.g. pipes, cigars, and snuff,
although there is some debate on the actual
~11 importance of the peaks and troughs in
nicotine levels associated with inhaling
"'_cigarene smoke.
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Tobacco companies market cigarertes to smokers who
enjoy smoking. Part ofthat
enjoyment may relate to intake of nicotine but the
smoker decides by the way he
smokes whether be receives from 0 to 3 mg nicorine
per cigarene. This is quite unlike
the steady stream ftom the nicotine patch which is
somewhat akin to an intravenous
chip.
While delivering nicotine, patches do not mimic
any of the other facets of smoking
cigarettes. In addition, as presently developed,
they are a totally automatic delivery
system and have none of the flexibility of tobacco
usage, both as to amount and timing
of delivery.
In certain circumstances nicotine-containing
patches are potentially dangerous: they
can be easily misused or tamperedwith and, as
curTently manufactured, can be
mistaken for plasters by the elderly or the young.
The total nicotine content of
individual nicorine parches can be as high as 51
mg, roughly equivalent to the lethal
dose for a man of average wei ght.
Whether by multiple patching, ingestion, or
inadvertent nicotine extraction, nicotine
availability in patches is sufficient to give rise
to the concern that acute toxicity in
adults and possible child fatality could occur.
Salient questions are: What would be
the effect of wearing more than one patch at a
time? If patches were discarded
carrying significant residuals of nicotine what
would be the effect of accidental
ingestion by children' ',k1hat would be the effect
of inadverient extraction of the
nicotine in a patch by spill,-d alcohol (drinks
for example)'
3. FIFFECTIVENESS OF PRODUCT IN SMOKING CESSATION
The evidence produced by the makers of Nicotine]]
(Ciba Geigy) is not convincing and
does not indicate substantial advantages compared
to a placebo. A report by the New
York Times (8th April 1992) su,ogested that those
who quit using patches relapse at
about the same rate as anyone else. In one series
of follow-up studies, six months after
having stopped using the patches, the share of
subjects not smoking ranged from 0 to
48% compared with a rate of 0 to 40% of those who
did not use them.
It has also been suggested that the patches are
relatively ineffective unless used in
conjunction with some form ofbehavioural therapy.
A consumer group is now
complaining to the U.S. Federal Government that
advertisements for the patches are t _n
misleading by imply*ing that the patch is all that
is needed to quit smoking. The group
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is pedrioning for requirement of labels warning
smokers of the risks of smoking while
wearing the patch and that they may also need
counselling to help overcome
"psychological addiction" of smoking.
4. NICOTNE IN RELATION TO NIEURODEGF-N'ER.ATIVE
DISORDERS
AND 0-iHER DISEASES
Current advice from consultants to BAT is that the
epidemiological basis of a negative
association between smoking and incidence of
Alzheimer's disease is hardening. There
is also good evidence that smoking alleviates the
symptoms of Alzheimer's disease.
The situation with resiard to Parkinson's disease
is similar but rather more certain.
These observations are \;idely believed to be due
to nicotine but this has not been
substanriated-aJthough the view is consistenivith
current pharmacological knowiedgt.
One adviser, Dr. S. Wannacott (University of
Bath), is of the opinion that nicotine has
unique properties and 'protects' nerve cells
against damage leading to
neuredegencrative disordtrs. On this basis she
believes that the pharmaceutical
companies xill not easily be able to develop a
drug to replace nicotine in relation to
Alzheimer's disease. In re:ation to alleviating
symptoms of Parkinson's disease the
posifion is different and another material
(1-dopa) is preferred. This is because
dl fferent regions of the brain are invo lv td.
It has also been suggested over the years that
nicorine may be implicated in some
smoking-associated diseases, more especlalN
cardiovascular disease. This possibility
ha-s not been disDroved although Wald and Froggatt
( 1989) do not find the evidence
persuasive.
Generally speaking this ar.-a Of Work is likely to
increase the interest in nicotine
administration, especiady since Alzheimer's
disease is likely to be a major health issue
in the next century, as life expectancy increases
and birth rates fall.
5. POSSIBLE DEVELOPMENTS
The possible development of more sophisticated
patches can be foreseen, for example
in which compounds other than nicotine could be
co-administered. Patches containing
reduced amounts of nicotine (and shorter useful
contact times) are obviously possible, CD
as are user-controllablt patches.
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Such developments would be expected to make the
product more acceptable to
potential consumers and, possibly, lessen some of
the safety concerns associated with
it.
6. FUTLTRF PRODUCT TZPSEARCH ARRANGTWENTS
The following arrangements have been put in place
as part of BATCo's continui .ng
review of transdermal nicotine patches ("TNPs")_
a] Meeting Aith Stowic Resources (May 19th) - to
ascertain their views on their
product.
b] Informal meeting on May 21st %xith the Chairman
of the U.K. Committee on
Safety on Medicines (Professor M. Rawlins,
University of Newcastle) to hear his
views on the probable approach to nicotine patches
in the U.K.
cl Brief behavioural study to compare the efficacy
of nicotine patches with smokaing
in a vigilance task. (Summer 1992 - subject to
approval from the University of
Reading).
7. PRODUCT ION AND PROFITABILITY POTENTIAL
Patches are a low-technology manufacturing
challenge probably associated with a low
capital investment threshold.
Although TN`Ps and cigarettes have a common
element only in that they both deliver
nicorine, the possible diversification of Tobacco
manufacturers into the production and
marketing of T,Ts is not supported by synergistic
benefits:-
i. The technologies involved are distinct.
11. The fabrication processes are different.
ill'. There is little commonality in terms of raw
materials used.
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iv. The channels of dis-mbution are different.
V. Any potential advantage arising from the use of
common brand
names would be constrained by the fact that TN'Ps
are likely anly
to be available on prescription.
It is believed that profitabifity on a unit basis
is likely to be substantially greater than
cigarenes. Patches will probably be marketed at a
retail price closely equivalent to a
pack of cigarettes, are most likely to be cheaper
to manufacture, and attract no excist
durv.
8. MkRKFTlNG CONSIDERATIONS
Sales of patches in New Zealand are said to have
been better than the makers expected
and it is reported that demand is "amazing" in the
U.S.A. Analysts have said that the
combined sales ofthe three brands in the U.S.
could reach USS I billion annuall-Y.
The products have only been an the market for five
months and the early findings of
research on the products' effectiveness as a
smoking cessation aid are inconclusive. It
is. therefore, difficult to predict their long
term sales potential.
Freedom of Choice. It could be argued that patches
represent an alternate product for
nicotine users (along Arith gums. snuffs and
inhalants), and thus having the potential to
be marketed as a cessation aid or a means of
cutting down smoking. They would
however need to be clearly positioned as not being
an alternative to cigarette smoking,
since this would erroneously suggest that the
cigarene itself is a simple nicotine
delivering device.
;rosion of smokinp franchise- By topping up the
wholebody nicotine reservoir
patches might be expected to reduce daily
consumption of cigarettes. We currently
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know insufficient about the potential demand for
such products and, hence, the
potential business trade-offvalue between patches
and cigarettes is un~zriown.
Dual Usaec Risks. Patches do not appear to be an
effective cessation aid in the
medium term. There is, however, the possibility
that people will use them in addition
to cigarettes, with the possibility of:-
(a) nicotine overdosing for regular smokers-,
(b) habituation to continual body reservoir
nicotine requirement; and
(c) consequential debate that patches actually
synergise rather than antagonise the
smoking habit.
Patches would therefore not appear to be
immediately appropriate for marketing for
use by smokers as an altcmative product in
circumstances where smoking is proscribed
e.g. airlines, theatres, etc.
Association xith Poisor,,Dr-ue. However insulatcd
from cigarettes the patch alternative
may be, it shares a kriov.-n common feature.
nicotine. Patches may focus debate on
nicotine as a psycho-active componcnt of
cigarettes, diverting attention from other
valid aspects of smoking satisfaction (taste,
texture, visual/tactile stimuli) and
potentially focusing on nicotine as a drug and a
poison.
Erosion of Brand Value. Patches do not offer great
marketing flexibility in terms of
product and brand image differentiation since the
only variables currently available are
amount and relative speed of dosing. If the
nicotine centrality argument generalises
back to cigarettes, which are in themselves
r-,Iativclv homogeneous at product 1--vel,
some consequential brand value erosion could
follow.
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Markerno Corritietence. Patches are most likely to
be controlled as prescription-only
drugs whic' ~s not an area of marketing competence
for BAT. Given the 'drug' profile
of patches :- would also be important to separate
the business completely from c)garer:t
markerinc.
9. 0--:---R CONSIDERATIONS
The class-."-- cation of nicotine patches as a
drug delivery system may or may not apply
in all coun----;Ies. In the U.S.A., tobacco
products are not regulated by the F.D.A. unless
health clai=s are made, e.g. "Premier" came under
the scrutiny of the F.D.A. If
tobacco companies were to market nicotine patches,
this could be seen as a move
towards ----.acco companies being regarded as
pharmaceutical companies. The anti-
smoking- has in the past offensively referred to
the tobacco industry as "no benT7
than druz :!.~shcrs*'.
The issue -.- addlcfion has been Wlidely debated
in respect of smoking and the potentiai
use of nicz--mc through patches is likely to lead
to further public interest in that issue.
The 198S *-'.S. Surgeon General's Report obser-ved
that nearly half of all living adults
who ever ~mokcd have quit but still concluded that
nicotine is addictive. The tobacco
industry's -:sponse is that addiction is a
frequently misused term that has become a
catch ph--as! for many habits. In product
liability litigation tobacco companies assen
that peop': continue to smoke because they enjoy
it and that it is not appropriate to
term smczne as addictive when millions of smokers
have given up voluntarily and
%kithout 2:3istance.
10. S',-NfMARY
In view different product characteristics ofTNPs
and smoking, cur-rent designs
ofTN-Ps would not appear to be a serious threat to
the tobacco industry. It is, howe%-c-.
difficult zc make confident predictions about the
likely success ofTN?s although thtrt
are cleari, some major issues associated with
their wiftsprezd use.
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On the a-ssum:)tion that they are viewed by
consumers as an acceptable and valuable
method of nicotine intake, TN-Ps have the
potential to be a highly profitable business
activity. This is because the likely retail price
of such patches is similar to that for a
pack of cigarettes whilst the manufacturing costs
are likely to be lower than those for
cigarettes and TN?s attract no excise duty.
Arguments against an extension of business
activity into the production and marketing
cfTNPs are:-
i. TNI?s are commodity products. differentiated by
very little except perhaps
spe--dofaction. They %kill, therefore, be very
difficult to invest credibly N4ith
product/brand image differentiation.
ii. BAT would be placed in an invidious and
legally difficult position Ifit
promoied the product-
(a) As an aid to stop smoking - if, as preliminary
studies suggest, the
patches are not effective as a smoking cessation
aid, marketing it would
be likely to lead to an allegation of misleading
claims being made for
the product. It should be noted, however, that if
the product is
ineffective as a cessation aid this is consistent
with the tobacco industr-,
position that smokers are not physically
"addicted" to nicotine but
choose -whether to smoke or not, and therefore
they have no need for
such an aid.
(b) As a product which consumers freely choose in
order to satisfy th~:ir
desire for nicotine uptake, given the fact that
TN?s are likely to bt.
available only on prescription.
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As a dual-usage product for smokers given the lack
of research done on
the safM of use of the patches in conjunction with
smoking
iii. "atches are capable of being misused, and
this is likely to lead to their
disuibution being restricted and/or potential
litigation.
There a:--- no significant technological or
processing synergies between tobacco
manufa=_,ring and the production of patches other
than the use of tobacco waste as a
source 0~'nicotine.
Thus, ft= a business opportunity viewpoint, TNPs
should be viewed as a high profit
potenti-L but high risk venture.
11. ?7CONfNVENDATIONS FOR FURTHER ACTION
If it is d:zided that further investication of the
role of the nicotine patch is to be madc.
it is rezzmmcnded that:-
The potential ofnicotine patches should continue
to be investigated,
particularly against the possibility that improved
patches are developed
Consideration should be given to supporting
research projects in relanic-
to Alzheimer's disease and Parkinson's disease in
view Of the probable
therapeutic value of nicotine with regard to these
conditions and
ltverage ofthe positive perception ofnicotine.
The likelihood of a scenario emerging where people
consume both
TN?s and tobacco products should be evaluated and
estimates made of
the business trade-off value therein.
Qualitative consumer research on the scope for
insulating cigarene
perceprion/usage from patch perception/usage and
the scope for INJ
LTI
branding differentiation of patches should be
investigated. c0
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Ifthe production ofTN?s were considered to be an
acceptable
proposition, the business potential and viability
should be reviewed b,
project team specifically brought together for
this purpose under the
auspices of BAT Industries rather than being based
within one of the
BAT tobacco operations.
19.5.92
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