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NOTF FOR THF TOBACCO STRATEGY RFVIEW TEAM I ol
TRANSDERNtAL NICOTLNE
1 7,747 PRODUCT
Nicorin: patches are a system of delivering
ni.cotine into the blood stream. Nico6ne
patches were introduced onto the market as a
pharmacy-only product in New Zealand
in ]9q* and in the U.S.A. the-, were approved by
the Food and Drug Administration
for pr-,ic-niprion-only sales from 1992.
Phar=z=ical companies manufacturing nicotine
patches are currently marketing
them. "treatment of nicotine dependence--as a
smoking cessation aid, claiming for
exarr.7::, the psychopharmacological stimulant
effects of nico6ne underlie the tobacco
nicor.:-.t addiction". This paper also considers
issues relating to other potential uses of
the tr=3dermal nicotine patch. i.e- dual usage by
smokers of patches and cigarettes and
choice of the patch solely for nicotine intake.
i AS A METHOD OF ADMINISTERING NrICOTIN-E
Gul C':'rics for use of nicotine patches issued by
the manufacturer Ciba GeIgY
reco=cnd that the subject should stop smoking
complete],. and use patches for no
loner :han three months '~as treatment period and
doses above 52mg per patch have
not evaluated). The guidelines advise against use
by non-smokers, occasional
smok---s and subjects with certain medical
conditions.
the standard nicotine patch (e.g. Nicotinell) nor
the "Stowic" patch match the
deli,_- pattern or impac-. ofnicotine that is
obtained when smoke is inhaled from a
cigartne. They do. however, match more closely the
pattem of some other forms of
tobaczo usage. e.g. pipes, cigars, and snuff,
although there is some debate on th:: actual
impo,-ance of the peaks and troughs in nicotine
levels associated with inhaling
cfiza:,-7e smoke.
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Tobacco companies market cigarettes to smokers who
enjoy smoking. Part of tha:
enjoyment may relate to intake of nicotine but the
smoker decides by the way be
smokes whether he receives from 0 to 3 mg nicotine
per cigarette. This is quite unlikt
the steady stream from the nicotine patch which is
somewhat akin to an intravenous
drip.
While delivering nico6ne, patches do no- mimic any
of the other facets of smokinQ
civarvics. In addition, as presently developed,
they are a totally automatic delive-y
system Lnd have none of the flexibility of tobacco
usage, both as to amount and t-ming
of delive-v.
In certain circumstances nicotine-containing
patches are potentially dangerous. t1n.-Y
can be easily misused or tampered with arid, as
currently manufactured, can be
mistak= for plasters by the elderly or the young.
The total nicotine content of
individ-zal nicotine patches can be as high as 51
ma, roughly equivalent to the
dose fc- a man of average weight-
Whethcr by multiple patching, ingestion. or
inadvertent nicotine extraction, niocz:nc
ilaiciliry in patches is sufficient to give rise
to the concern that acute toxicit,.- '17
val
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adults and possible child fatality could occur.
Salient questions are: What woul_~ be
the c"ccl ot weariniz more than one patch at a
time" If patches were discarded
cart-~itiz significant residuals ofnicotine what
would be the effect ofaccidental
ingestion by children9 What would be the effect of
inadvertent extraction of th-,
nicotir, in a patch by spilled alcohol (dr-Inks
for example)?
3. 7-zFFCTIVENESS OF PRODUCT IN SMOKJNG CESSATION
The evidence produced by the makers ofNicotintll
(Ciba Gcigy) is not convincin'2 and
does not indicate substantial advantages compared
to a placebo. A report by thc New
York Times (8th April 1992) suggested that those
who quit using patches relapse at
about me same rate as anyone else. In one series
of follow-up studies, six mon,_'-s after
havin,z stopped using the patches, the share of
subj ccts not smoking ranged frorr -, to
481,~ compared w~ith a rate of 0 to 40% of those
who did not use the-n.
It has also been suggested that the patches arc
relative!y ineffective unless used 'n
comunc-ion with some form of behavioural therapy.
A consumer group is no,.;,, U-1
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complaining to the U.S. Federal Goverrimcrit that
advertisements for the patcheS are f1i
misl--zdlnp- by implying that the patch is all
that is needed to quit smoking. Thce Zroup kJ-1
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is petitioning fc- -:quirement of labels waminp
smokers of the risks of smoking while
wearing the par--- and that they may also need
counselling to help o"crcome,
,. psychological ---~iiction" of smoking.
4. NICOT-'~-:- IN RELATION TO N-EURODEGENER-ATIVE
DISORT)ERS
AND 07--ER DISFASES
Current advice --= consultants to BAT is that the
epidemiological basis of a negative
associafion bet- -.-i smoking and incidence of
Alzheimer's disease is hardening. There
is also good c-,:-'--nce that smoking alleviates
the symptoms of Alzheimer's disease.
The situation rt2ard to Parkinson's disease is
similar but rather more certain.
These observa-'-ns are %idely believed to be due
to nicotine but this has not been
substantiated- Lih ough the view is consistent
with current pharmacological knowledge.
One adviser, D-. S. Wannacott (University of
Bath), is of the opinion that nicotine has
unique propcr-.:s and 'protects' nerve cells
aeainst damace leadiniz to
neuredegenerai:--t disorders. On this basis she
believes that the pharmaceutical
companies wil'. easily be able to develop a drug
to replace nicotine in relation to
Alzheimer's In relation to alleviating symptoms of
Parkinson's disease the
position is difft7n: and another material (1-dopa
i is preferred. This is because
different regic7z z` -,he brain art involved
It has also been 3~;ggtsted over the years that
nicotine may be implicated in some
smoking-assoc:Z::--' diseases. more especially
cardiovascular disease. This possibility
has not been d:~-70ved although Wald and Froggart
( 1989) do not find the evidence
persuasive.
Generally spea;:~.-,, this area of work is likely
to increase the interest in nicotine
administration. ts-occiall'v since Alzheimer's
disease is likely to be a major health issue
in the next ce7:=7,.. as life expectancy increases
and birth rates fall.
5. POSS:-:;--'-= DEVELOPMENTS
The possible dv-t7opment of more sophisticated
patches can be foreseen. for example
in which compz:--:.nds other than nicotine could
be co-administered. Patches containing
reduced amou-.:s of nicotine (and shorter useful
contact times) are obviously possible, VI
as are user-co-.::--dablc patches CD
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Such de, --lopmenu would be expected to make the
product more acceptable to
potential consume-; and, possibly, lessen some of
the safety concerns associated with
it.
6. F7~71 UTRF "'z'ODUCT RFSEARCH ARRANGEMENTS
The following =anzcments have been put in place as
part of BATCo's. continuing
review of transde7---al nicotine patches
("TNIPs").
a] Meeting A-i---- Stowic Resources (May 19th) -
to ascertain their views on the17
product.
b] Informal rr.,::7:ng on May 21 st w~iih the
Chairman of the U.K. Committee on
Saf,-ry or, V--dicines (Professor M. Rawlins,
University of Newcastle) to bear his
,. i-,,,-s on 'ht 77obable approach to nicotine
patches in the U.K.
cl Briefbeha-,-._-_i7al study to compare the
efficacy ofnicotine patches w~ith smoking
ir. a vlgllan~: -ask. (Surnmer, 1992 - subject to
approval from the Universi-.~- of
Rnding~.
7. PRODUCT',_-\: AND PROF17.ABILITY POTEN71AL
Patches ar: a lo--.2,zhi-ioloev manufacturing
challenge probably associated with a lo,-
capital investmen: iHr--shold-
Althouah T,Ps civarettes have a common element
only in that they both dch,cr
nicotine. the pos. _'.t diversification of Tobacco
manufacturers into the production and
marke-inq ofT\-z 's not supported b~ synergistic
benefits:-
I.. The technolozies involved are distinct
i-.. The fabrication processes are different.
C)
n. 'here is little commonality in terms of raw
materials used.
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iv -: he channels of disnibution are different.
V. Any potential advantage arising from the use of
common brand
-Ps are likely only
names would be constrained by the fact that TN
to be available on prescription.
It is believed that pr:-'itability on a unit basis
is likely to be substantially greater than
cigarenes. Patches probably be marketed at a
retail price closely equivalent to a
pack of cigarettes. 2:: most likely to be cheaper
to manufacture, and attract no excise
duty.
8. MARKETINC --ONSIDERATIONS
Sales of patches in '.'tw Zealand are said to have
been better than the makers expected
and it is reported t---- demand is "amazing" in
the U.S.A. Analysis have said that the
combined sales of---- hree brands in the U.S.
could reach USSI billion annually.
The products have :.-.',% been on the market for
five months and the early Findings of
research on the pr--Z-:ts' effectiveness as a
smoking cessation aid ar!! inconclusive. It
is, therefore, difflc-.~.-. to predict their long
term sales potential.
Freedom of Choice -t could be argued that patches
represent an alternate product for
nicotine users (alon, A;ith gums, snuffs and
inhalants), and thus having the potential to
be marketed as a ct-&iation aid or a means of
cutting down smoking. They would
however need to be :.earlv positioned as not being
an alternative to cigarette smoking,
since this would z=i-zously suggest that the
cigarette itself is a simple nicotine
delivering devict.
Erosion of smokin; ---anchise. By topping up the
-.vholebody nicotine reservoir.
patches might be :-:7ccted to reduce daily
consumption of cigarettes. We CUTTe-Itly
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know insufficient about the potential demand for
such products and, hence, the
potential business rrade-off value between patches
and cigarettes is unknown.
Dual Usaize 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) nico6ne overdosing for regular smokers:
(b) habituation to continual body reservoir
nicotine requirement-. and
(c) consequential dtbate that patches actually
synergise rather than antagonise the
smoking habit.
Patches would therefore not appear to be
immediate]%, appropriate for marketing for
use by smokers as Ln alternative product in
circumstances where smoking is proscribed
e.g. airlines, theatres. etc.
Association with ?_-.,on Druz. However insulated
from cigarenes the patch alternative
may be, it shares a ~mo,,,-n common feature,
nicotine. Patches may focus debate on
nicotine as a psych~-active component of
cigarettes. diverting attention from other
valid aspects of smoll-ing satisfaction (taste,
texture, visual/tactile stimuli) and
potentially focusing on nicotine as a drug and a
poison.
Erosion of Brand Vaiuc. Patches do not offer great
markering flexibility in terms of
product and brand innage differentiation since the
only variables currently available are
amount and relative szeed of dosing. If the
nicotine centrality argument generalises
back to cigarettes. ,-nc~ are in thernselves
relatively homogeneous at product level.
some consequential --rand value erosion could
follow.
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~Iarketinv- Comr)eTence. Patches are most likely
to be controlled as prescripticn-only
drugs which is not an area of marketing competence
for BAT. Given the 'dru&'profile
of patches it would also be important to separate
the business completely from cigarette
markeriniz.
9. OTHER CONSIDERATIONS
The classification of nicotine patches as a drug
delivery system may or may not apply
in all countries. In the U.S.A., tobacco products
are not regulated by the F.D.A. unless
health claims are made, e. u- "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 tobacco companies being regarded as
pharmaceutical companies. The anti-
smoking lobby has in the past offensively referred
to the tobacco industry as "no better
than drug pushers".
The issue ofaddiction has been ,k~idzly debated in
respect of smoking and the potential
use of nicotine through patches is likely To lead
to further public interest in that issue.
The 1988 U.S. Surgeon General's Rtport observed
that nearly half of all living adults
who ever smoked have quit but still concluded that
nicotine is addictive. The tobacco
industry's response is that addiction is a
frequently misused term that has become a
catch phrase for many habits. In product liability
litigation tobacco companies assert
that people continue to smokc because they enjoy
it and that it is not appropriate to
term smoking as addictive when millions of smokers
have R-i, en up voluntarily and
without assistance.
10. SUMMARY
In view of the different product characteristics
of TNTs and smoking, cur-rent designs
of TNP5 would not appear to be a se-ious threat to
the tobacco industry. It is, however,
difficult to make confident predictions about the
likely success of TNPs although there
are clearly some major issues associated %vith
their xidespread use.
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On the assumption that they are viewed by
consumers as an acceptable and valuable
method ofniconne intake, T-N-Ps have the poitntial
to be a highly profitable business
activitv. 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
cigarenes and TNPs attract no excise duty.
Arguments against an extension of business
activity into the production and marketing
of TNP s are: -
i. TN?s are commodity products, differentiated by
very little except perhaps
speed ofaction. They therefore, be very difficult
to invest credibly with
product~brand image differentiation.
ii. BAT would be placed in an invidious and
legally difficult position ifit
promoted the product: -
i a) As an aid to stop smoking - if, as
preliminar-y 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 industry
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 their
desire for nicotine uptake, given the fact that
TN,?s are likely to be
available only on prescription.
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(c) As a _`ual-usage product for smokers given the
lack of research done on
the 52~':t-V Of Use of the patches in conjunction
"kith smoking
iii. Patches are zapable of being misused, and
this is likely to lead to their
disnibution *.-!-.ng restricted and,,or potential
litigation.
There are no significant technological or
processing synergies between tobacco
manufacturing and production of patches other than
the use of tobacco waste as a
source of nicotine.
z"7
Thus, from a busin:---,s opportunity viewpoint,
TNPs should be iewed as a high profit . ~ A\
potential but hiszh nzl- venture.
I RFCOMM-=\-DATIONS FOR FURTHER ACTION
If it is decided thaz ~_:nher investigation of the
role of the nicotine patch is to be made,
it is recommended -.-at -
I . Thc ~ Diential of nicotine patches should
continue to be investigated,
parz:zularly against the possibility that improved
patches are developed
Cons:jcration should be given to supporting
research projects in relation
to A.~,ieimer's disease and Parkinson's disease in
vie\;,- of the probable
the.-a::,:utic value of nicotine with regard to
these conditions and
levc7zge of the positive perception of nicotine.
3. The '-.-Kelihood of a scenario emerging \vhere
people consume both
TN-?z and tobacco products should be evaluated and
estimates made of
the '--_Lsiness tTade-off value therein.
4. Qu--*.::ative consumer research on the scope
for insulating cigarette
perz-,-~-tion.!usage from patch perception..'usaze
and the scope for U1
bra7.-"ng differentiation ofpatches should be
investigated. CD
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If the production of TNPs were considered to be an
acceptable
PTOPOSItion, the business po=tial and viability
should be rcvlewe~ b" a
project team specifically brought together for
this purpose under the
auspices of BAT Industfies rather than being based
within one of the
BAT tobacco operations.
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