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Philip Morris

Editorials Nicotine Use After the Year 2000

Date: 19910518/P
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LEVY,CAROLYN/OFFICE
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2023773704/2023773840/Nicotine Patches
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MARG, MARGINALIA
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d . V•..OL 337: htl+Yl51 199 1 i EDITORI:kLS C/4 tI~ ~ ~. I Li . "J M iicotine use after the year 2000 Cigaretaesmoking is now regarded asa form of drug addiction. A landmark in this process was the, 19S8' reporti of the US Surgeon General, who concludedi that addiction to nicotine resembles addiction to drugs such as hrroinl cocaine;, and! alroltol.' Wrna: distinguishes nicotinc from otherwid'eliy abused drugs is ohat its efTects are subtle and do not cauk socialll disruptivc intoxication,,provokc violence, or impair perforrnance. Yet, deaths due to tobacco far outnumber those caused by all' other drugs. TI:e central paradox is r,hat, while people smoke for nicotine thev die mairnlu from, the tar and other unwanted components in the smoke. Why have governments persisted in allowing the manufacture, extensive adivertising, and promotionof such,a lethally contaminated'drug delivery system as t}6e cigarette, while putting so little pressure onithc tobacco industry to develop more purified fbrms of nicotine delivery? The pressure for change has come instead from the pharnnaceutical industry, dtiwat by the search forr more effective aids to smoking cessation. The inioial development of nicotime,chewiiog gurnt has now been followedl by other products. Nicotine skin patches rrtaintain stable blood nicotine concentrations over. 4--16 h,= whereas nicotine vapour inhalers numic:the rapid absorption frorn~cigarettesmokiing? AClcasa 5ive " pharmaceutical companies have skin patches at various stagcs of testing,, an& clinical use of such ' patches is licensed in some countries. Other products undergoirog, clinical trials include a nasal nicotitnee sprray, nicotine lozenges, and a nicotine vapour puflcr' Although these nicotine replacesrtent products are markaed as aids to stopping smoking, with further refinement some tnay also have potential for long-term use and, if permitted, rnigtit eventually repllace tobaccv on the open market. If a strategy were edopted to sanction andi encourage the tli*c of purified nicotine products as substitutcs fnr smoking„arod at the same time impose stsuiecnt regulations on pcmiissililc constituentsof ci5arettc smoke and prol;ressiNcly lu~ter limits for dclivcrics of harmful cocnponents such as niirosunincs and nitro,gcn:oxidcs, as well as of tar and, carbon monoxide, tlse vutual cliinination ofsrnUkun6, cvuld;bccomc a morc rc•alistic hcaH;h promotion,tarl;ct.. lit could also beachieved more quickly. 'tlte qwcstiarn, is whether pohcy-makcm will consider such a strategy and whcthartihe anusmoking, mcuvcmcnt %t-ouid support or oppose it. Is a ncw strategy needed? Are existing programmes sufficient? There has been, some progress in many countries. In the U1K, for example, the prevalence of cigarette smoking has declined steadily from 46% in 1972 to32% in, 1988, an average rate of abour li°/„ per y,rar.s'But pnogressworldwidc has been swamped by therapid increase in smoking in developing counuies. Progress , with tar reduction prograummesi'slikewise slow. The modest aims of the Tar Yield Directive of the EC Council'of Health Ministers on Nov f 3', 1989, have been hailed as an imporuant mcasure. The Directive sets a limit for tar yields of 15 rng by the end of 1992, and' 12 mg by the endlo( 1997. Greece has derogation allowing higher yields until 2007. Overall, on thrbasis of current;approaches and policies, there seetns little prospect of avertung,Pcto's esiunate of l& million premature deat,lu througlaout tihe,world eachh year during the next century as a result of tobacco usc.° 1'hc,core oftheproblerrt lies in the addictiveness of nicotine. It is nicotine that people can.nor, casily do without, not tobacco; it is nicotine depcndence t12at slows the progress of!existing programmes. As a drug delivery system the rnodetml cigarette is a h:ighk• efficient device for getting nicotine to the brain, but by pharmaceutical standards it is also a very "dirry"'one, the nicotine being contarninated' with nitrosamines and other carcinogens in the tar, as well as with carbon monoxide and other hanrnfi.al gases. Thus it seems logical toOffer either a cleaner product or, better still„ an acceptable source of more pure, less contarnisnated, nicotine. The principle is the same as that of the UK low-car programme,'" albei:t a gigardtic step-too big it seems for regulatory authorities and healtih, professions in the USA. In 1988,, a major US tobacco company released' details of a: highly innovative type of cigarette thcar heats rather than burrns tobaceo:° The smoke particles were vutually, tar-fzee, consisting mainly of water, glycerol, and a small amount of propy,lene glycol. The nicotine yield was low---0-0 •3' mg. Apart from a carbon monoxide yield of 10-6 mg, amounts of,ocher noxious gases were negligible cotnpared with conventional cagarettes, as was the biological activity in extensive tests:11O Itt tcrins of the aims for product modifucatoonn laid down by the UK Indepatdent Scicntific Committee on ~Srnoking and Health,' this would seem a,near-perfect low tar cigarette, and the.re is no doubtt thaticwould be less harm6ul than most other brands on the:rrtarket. Far from welct2tning it in the USA„thc ALncriran
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1192 THE UhdCEl' VOL 337: MAY IS, 1991. Mcdical Association„ the Heart and Lung A'-ssoriation,,the:Amcncan Cancer Soocty,and others cornbincd to petition and spcak against~ it at a special Hearing bcl'orc a Subcortunitltee of the House of Represontatives."' Fvavtually the product was labelled as a nicotine delivery'systern and'attanpts to rnarketit as a tobacno product were abandoned by the ¢ompany„ who meanwhile remain fr2c to promote eonventional cigarettcs to the 50 1million Americans who still smoke after decades of antasr¢tolang policies. There is no cause for oomplaczrtey in the UK. Ih 1'980, when the Gommittee on Safety of Medicines licensed tltemediaaluse of nicotine chewing,gvm as an aid tostoppuzg smoking, the decision was based on the usual grounds of safety andl e96cacy, Not long aftei+wardfi the Advisory' Committee on Borderline Substances rulcdl against its use on National Health Service presertipriotLs, one of the reasons being their doubts about its efficacy, a rnatta, on which they, were not competent to judge. The chewing gum (`Nicorerte') was thus the on13• prescription-only medicine not available on the NHS. From May 1y the 2'm dose of Nirorette but not the 4 mg dbse has becn available over the counter.,Mkanwtlile, other less pure and untested nicotine-containing lozcnges based on tobaccoocuacts were atlbwed to be:promoted and sold without medical prescription or evidenee of clinical ef5caG}'.. t= These examples of regulatory dfcisions in two countries do not augur well for the initiation of any strategy to replace smoking with a purer source of nicotiiae. For such a strategy to succeed, irwould need to be radical. Suitable nicotine;rcplacrment products: would have to be made as acceptabl'e ;and palatable ass ptassible, adverosed, a¢tively, promoted: with hralthi authority abdo:sernent, arndigivcn tax advantages over tobacco. Support from the antismoking movement, coupled with progressive restrictions on tobacco might ultimately lead to an cffkctive ban on smokiitg in pubLic places, which is feasible only if an altematiive is availablc_ As tobacco is phasedout the'amphasis could shift to avoidance of nicotine, if by then it,proves to be an'unacccptable burden,to health. What are the risks oflnicotane itself? It has:roo known role im tobacoo-:-related cancers, neither is it irmpliratedd in chronic obscructiue lung disease. "Phe possibility of endbgetotu formation of carcinogenic nirzosamines from nicotine metabolitcs has been suggcsted."' However, this has not been documented andy if it occurs, the amounts would be negligible compared with those present in tobacco and forRned, when tobacco is bu:rned. While the negligible cardiovascular risks in pru~nao••y pipe and cigar smokers who have never smokedlcagarettes" may be reassurira'g;as far as slow buccalabsorptnon is ornncerned, t}iere arc various mcchar.istns t}iroug}i which rapid nic•otaneabsorption f'rorn,agu-crncs might interact with carbon monoxide to c.accrbate' cardiovascular disease. For example, proprn,.olol:larg-ly abolishes the d'eltrterious effeas of smo:::i:, on mo,-a;iry, follo-irtg a first hcart attacl:, indicating that adrenergic meclnanisms are invoived " TTus observation strongiy implicates nicotine, which is the only, tnajor, smoke component with effects on adlmcrgic systems. Thus the view of the Chairrnan and' a merrrber of the UIK Indepaidlmt Scierntific Comtmitt'ee on Smoking and Hkalth rnay bc oversanguine. They state "That nicotine has a role in the cause of cardiovascular disease has its adherents, but the evidence is not eompellung" ," Thlere is no ~good reason why a switch from tobacco products to less harmful nicotine delivery systems should not be encouraged. Smokimg-related' deaths after the year 2000 would fall l steadily an d substantially' if, this can' be achieved. There is no compelling objettion' to the recreational and even addirri ve use ofln'icoto,ne provided it i's not shown to bc physically, psychologically, or, socially harmful to thc user or to others. 1. Nlmdmc..ddicion: a rcpon of dso Sungrors.Grnanl. \t'cah.pa-.: DC'. USDcparoncnt of Hmllh and Human Scnnrns,,l9Rr.:. 2. Abctin T. BucAkr A, MullerP, a.al. Cnntrolkd trial.ufvurudornvl: nKmrinc pacdr inioborn~.wthdnWal. (:nmrr 1989; i: ~-10.. 3: FEl•crabasd C, Russell! MAJrII Arnpid gas=liQL,.~d cL±rorn:coj72phicc nscdsai for.th, dctennirucion ofmorvne aadniwctra vtotoloTcal fFuids. J P4icrn+ nc-+nccnf 1'990; 42: 450-52 4: Russetl. l.L4Nl, JarnisMJ„ Sut}i¢:.land G;, Fcvcnbend'. C.. X;coum:c rcplacvnmt in~.smokrng.mss.ac:on: absorptior•. of nicvtincva,por frorr.rr#c-frc< nga rr,tcs: J.! Mr1 1987; ;257: 1?62-65. 5: Of?irs.of PopuluimCrnsuscsatd Siuvcy~s.Gcser.l Housc.Wj:iIS':ncs. 1988. London: H:M Swuoncrv,Qfficr., 1990. 6. Pno R. 7tT WorldiConfcrcnce.on Toba..--ro.and~.Hcalth; pcrJ+. `csccm Aumnlia, I-5 AprlL, 1990.~ 7. FoLzsh Rrpon of Csc Indcpmdost Sacnofic Comarjncc on Sr.w+:;:.ng u:d Hn7Js: Lmd= HM SuuonmOfr,ct, 198R. 8. W.1G7 N i,Frogg?n P, cds. Niaoune, smoking ;andttsc la+tu pro~vn.-nc Odord: Oicford. Un;,aiity . PTCa. 19R9. 4. RJ. Rtynolds 1'obaccv Compart)'- C<Tninl. and'.biological nc..a¢usrtc ~prototypcs ttut hea instcad oflbumtobacco. Wuu=-Salcrr, NC RJIRnnolos Tob.eam~Co; 1988,~ 10!DcBctJvzv ID, Bocgnding, MF, Doobnk. DJ„ct: al: CY-- ~--a1 sziil biolbgi©I snjdics of .agurnc that hotn nthcr thanbums.tobccn: J. C5~ ~PAcnaora17990. 3o-75S-o3; III.US. Houttw ofRn,racuuvcs. Subcr~inccm on~. Hici.^.and. En.urauncnt Horvtg. Scnil no:lOtl•-68j{+1y 29„l98&. DC USGorcrsvnmt ..Prinnng,Ofrwc, 19BB. 12. Bdohc M, J- MJ„ Su(hcr fandl G:, Nicownc. .bsor,-rjo^ andd dcpardknaon an mc-tbrcounec ard:to~uupsmokirV : 6rh1n:.J1989; 2B!9:: 570. 13. Ho.`Srun D!.tacocinc,. totiaccospcxrfc.prccursordorr,wcv+ogr,s: In:Wald 1:, Froggnn t;, edi: .1}+evune,, smokingg and thc M~ . tuprogrmvnr: Otkird: Oicford t:-crsii5• f'ncs., 19a9! 29=a1. 14. Doll R. PTospccxs for.prcvasuon. Brsl4id J1983:2&r•:445-53 15. Jafri S:M..Tilk... BC.Paren R; Sdsu7u LR,.Goldstcin S. FJtccasof. o®rcnc unokusg and propanolol. Ln tuMi- ofrcucr M.c.ard:ai udatttion. Am JCarGb/'1990; 65: 271 -76 . lti. Froqq.r•.:P,arsld'\,TM.rukafnirotincvtJrcurrcducsiost'"oF'i'ruTic. In: Wald N, Frt,ggan h.,cds. h:ico,usc, snwkrng,and vubW~ uv progr~t c..Dicford: C)cford Ln-nim Pms. 1989i .22~,-)` Tfhe autistic dimension A child usually begins to speak at about: tx.clve months. During that first year an internal'map of the world is constructed ~from a mass of incoming sensor}, , datal Once a ecrtauo dcgree of thought, bascd onr-his expericncc, is achievcds th'e childgoes on toacauire a r«nge of communication skills ofwhich languags is the most importarnt. Cognitive dcvelopment thc::fore dcpcnds on the cvolution of t;hought proccsscs arc

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