NOTE FOR THF TOBACCO STRATEGY R MEW TEAM
TR_kNSDER_NtAL NICOTINE ADNIINISMkTTO-14
Ms note ta~.-s account of discussions at the
Scientific Research Group (SRG)
Meeting, ',Icntreal, Canada, 7th May 1992.
1. The Pro&_,ci
Nicotine patches are a system of delivering
nicotine into the blood stream.
Nicotine pa-:.zes were 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 Drur,
Administrat'on for prescription only sales from
1992.
Pharmaceut:=.1 companies manufacturing nicotine
patches are currently
marketing thtm for "treatment of nicotine
dependence--as a smoking cessa6on
aid, claiming for =-nple, the psychophar-malogical
stimulant effects of nicotine
underlie the -obacco 'aicotine' addiction".
Already one company, Dy~na-Gen, a
Massachuse---s biotechnology company is starting
clinical trials of an injectable
non-aiCOEine material which it clairns'elirninates
the need fcr the harmful and
addictive nicotine'.
2. A; a Method of Administering Nicotine.
Guidelines for use of nicotine patches issued by
the ma-nufacturer Ciba Geiev
recommend tat the subject should stop smoking
completely and use patches for
no longer thz-,i three months (as treatment period
and doses above 30cm-' have no-,
been evalua---d). Contraindications listed include
non-smokers, occasional
smokers and subjects with certain medical
conditions.
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relatively ineffective unless used in conjunction
with some form ofbe=vioural
therapy.
However, sales in New Zealand have been better
than the makers ex--~----ted and it
is reported that demand is 'amazing" in the U.SA
Analysts have saic --~at the
combined sales of the three brands in the U.S.
could reach I billion cicLlars
annually. But with the products having been on the
market for just r5v! months it
is difficult to predict their long term value,
particularly in the light of =e early
findings of research on the products'
effectiveness as a smoking cessa-Z:a aid.
4. Nicotine in Relation to Neurode2enerative
Disorders and Otht- Diseases
Current advice L-om consultants to BAT is that the
epidemiological t.-~cis of a
nezative associat-,on between smoking and
incidence of Alzheimer's cL:-,!ase is
hardening: there is also good evidence that
smoking alleviates the sN=torns of
Alzheimer's disease. The situation with regard to
Parkinson's disease --: similar
but rather more certain. I hese observations are
widely be5eved to bt- due to
nicotine but this bas not been substantiated
--although the view is corS:s-.ert with
current pharmacological knowledge. One adviser,
Dr. S. Warinacott t---aiversity of
Bath), is of the opinion that nicotine has unique
properties and 'prottz--s' nerve
cells against dair-age leading to
neuredegenerative disorders. On th-s --asis she
believes that the pharmaceutical compariies w4JI
not easily be able to :,!,.,elop a
drug to replace nicotine in relation to
Alzheimer's disease. In relatioz- :o
alleviating symptoms of Parkinson's disease the
position is different another
material (1-dopa) is preferred. T`hi5 is because
different regions of th-! --,rain are
involved.
It has also been su-,-ested over the vears that
nicotine may be impli- d in some
srriok~ng-associated diseases, more especially
cardiovascular disease. 7his
possibility has not been disproved although Wald
and Froggatt (1989 fo not find
the e%idence per-uasive.
Fir.ally, it should be noted a paper was published
(April 29. 1992) sug--tst-ing that a
gene which protec:s agairist cancer may be a risk
factor for Parkinson: disease.
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Generally speaking this area of work is likely to
increase the interest in nicotine
administration., especially 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. Possibie Deve!opmerits
Toe 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)
a.re obviously possible, as are user-controllable
patches.
6. Future Activities
a] Meeting with Stowic Resources (May 19th) - to
ascertain their views on their
product-
b] Informal meeting with Chairman of UK Committee
on Safety onMedicines
(Professor M. RawLins, University of Newca5tle,
May 21st). To hear the
views of the Chairman on the probable approach to
nicotine patches in the
U. K
c] Behavioural efficacy of nicotine patches. Brief
beha,,ioural srudv to compare
patches with smoking in a vigilance task. Summer
199" - subject to ethical
approval from University of Reading (Professor D.
M. Warburton).
7. Conclusions
A- Scientific:
1. Nicotine patches deliver nicotine: the nearest
equivalent smoking habit
is probably snuff-taking. As a means of delivering
nicotine thev are
quite different to cigarettes, particularly when
the smoke is inhaled.
There are many problems associated with nicotine
patches.
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2. Nevertheless we should continue to investigate
the potential of r~codne
patches, particularly against the possibility that
improved patches aie
developed.
3. We should support research in relation to
Alzheimer's disease inview
of the probable importance of rLicotine with
regard to this condition.
B. Other:
1. The classification of nicotine patches as a
drug dehvery system rr--v or
may not apply in all countries. In the U.S..k
tobacco products are not
regulated by the F.D.A- unless health claims are
made, e.g. TrerEer'
came Linder the scrutiny of the F.D-A- If tobacco
companies were :o
ma-rket nicotine parches, this could be seen as a
move towards tobzcco
companies being regarded as pharmaceutical
companies. The ant-
smoking lobby has in the past offensively referred
to the tobacco
industry as "no better than drug pushers".
2. The issue of addiction has been widely debated
in respea of smoiLng.
The industry's response is that addiction is a
frequendy misused tern
that has become a catch phrase for many habits. It
is not appropr- .zze to
term smoking as addictive when millions of smokers
have given u:)
voluntarily and without assistance. The 1988 U.S.
Surgeon Gene-z..**5
Report observed that nearly half of all living
adults who ever smoked
have quit. In product liability litigation tobacco
comparues assert :::at
people continue to smoke because they enjoy it.
3. Tobacco Companies market their products to
smokers A ho enjoy
smoking. Part of that enjoy-ment may relate to
intake of rucotinel-M-,t
the smoker decides by the way he smokes wheher be
rec.-i%es fro= 0 to
3 mg nicotine per cigarette. This is quite unlike
the steady stream -z-om
the nicotine patch which is somewhat akin to an
intravenous drip.
Nicotine patches may not be appropriate for use by
smokers who
continue to smoke. Pharmaceutical manufacturers
recommend thz: the
patches should not be used when smoking. The
potential toccity c.:
nicotine in large doses suggests that this could
be unsafe.
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