Tobacco Documents Online

/ I Health a~'i'e~ial's Fired Up over "Tolerable" Cigarettes In case anyone had any doubts before„ they now know for sure. The Secretary of the IDepartmentof Health, Education; and Welfare (HEW), the Directors of the National Cancer institute (IVC1) and the National Heart,Lung; and, Blood Insti- tute (tWHLBI)', and'the Surgeon General of'the United States all agree,vehement- ly. Smoking cigarettes is hazardous to your healt'h.. In fact, their pronouncements came so thick and fast and were so emphatic, an observer might think that someone, a government scientist;for example„ had just asserted that some cigarettes were safe. That did not happen, however. What did happen was this. A govern- ment scientis't, GioB'.• Gori, who iv depu- ty director of the Division of Cancer Cause and Prevention at NCI, de.ticribecl, to an Associated' Press reporter the cnn- tents of a paper he coauthored withi Cornelius !. Lynch of Enviro Control, Inc. I'n the paper, which is soon tohe published' in ithe JournaL'of the Alr•uaricun M'edicnl' Associiition (JAMA); the two scientists conclude that the toxic sub- stances in some brands of cigarettcs, which they narrle; have been reduced to such a degree that an: indlviduil may be able to smoke limited numbers of'the cigarettes without acletcctuhln• increased risk of' dying,as compared to the risk of nonsmokers. Gori, who is fond of saying "The only safe rig,arette is an unlit cifia- SCI.EtyFCE: VOL., 201, II SEPTEMBER 1978 reitc," was careful' to point out that smokers nright: still' be at higher ri.k-a.s much as two times higher-than non- smokers. He maintains, however: that even a risk twice: that of nonsmokers might, he difficult to detect in an epidemi- ological study and, as he wrote in the JASiA paper. "The inability to' verify thii; risk miuhtlead to it being consideretl socially tulerable." I3ut' in Gori's interviews with reporters and the subsequent news accounts there- (iiu lj. (iuri of. ho translated a risk that might h,: •o- cially tolerable into "tolerabl'a rettes," as in the Washingtonf'ost he, tl- line "Some Cigarettes Now 'Tolirah;c,' Doctor Says." And "tolerahle•" .uti- deniv became an intolerahlc word iii !he environs of the NIH and HEW. Reaction was swift as Julius F?ich- mondt the Surgeon General and av,ii.t:,ntt secretary for health at HE W, and Ro'.,,:rt Levy and ' Arthur Upton, director~ oi wHL1&I and iNCI„ respectively. i.a:ol.i statements disavowing, the' pos.il•i';t%', that any level of smoking might be Yaic. Everyone agrees Gori never actli.,tly,aid that. Burthey we:re concerned a',,out am uncritical public being misled hy i!;e word "tulerable'" to: equate a risk -:xo small to be' measured with no risk cu all'k espLciaUy since they are far from ctm- vincecJ that Gori"s conclusions ~%rrcC justified in the first place. Virtually everything that' happen • in Washington has poli'tical ramificarunxs and the smokingistiue is no excepiwn. Gori', hoa, H'EW secretary Joseph ( •.J- it;intr has,been waging a well-publicived- although not particulllrly well-financ<<l, campaign againSt smoking. Exact figt l.i un just how much HIi:W is .pentlini' s eitilcntc [he puhiit: abouC the health h:;i- ards of smoking :ire somewhat h:un!' tu come by. The Officc of' SmokinK rid Ilc,llth estimatc% the amount to be ul Oi_r S2'million in FY 1972{ancliprojc:ct,.pt,i8 l- int of about S6 million for FY' The,c are nrini.cule fit;ures by Vha.h,-c- ttnn aantl,lrdv. hut, additional prup;l.a ,• I'unLled hy tiCllorNiHLB'l are yometanl.:ti citedi as havinF, an an(ismoking co:n- ponent. I!n any evenlL health ofliciill,, who .. finally coming tu grip, %vith the ikic.,preventltln is a cuxt~efTeettve way it)::-: duce the human and economic toll o! ;i- IN~l:tb-Md43~7lV//'190 1-0 795 91NV.Sh/0: Coryrighl C. 197}qAA'AK 795

C ...~.~.,,~' C ness, are already sensitive to criticinm,s from Conuress and convumergr«upr that they give too: little attention to pre- ventive medicine. In, this .rmuwrhurc, the sug6estiun by agovernment scientist that smoking, might he "tolerable" was noi' well receivecP by henltti idPicrilv wliu were afruid' it would undermine their antismoking efTorts, "conccrneJt ahout public umlei:standinl;- or mitiund'eryt(rndinb--uf Gori'v work. The scientii;t, incidentally,,says he never implied there is a threshold. At least in his scientific p.rpers,, he is quite clear about the possibility of those few cig:r- rettes increasing, a smoker's risk by as much ati IfH) percent. Whether you consider the kinds of in- Iniadolitiun, the ruggestion thut peapll• might smoke small yu;rntitie, of cit;a- rettes withuub apr:rrcntl It;u m. tuuchc, on the threshald 'ixsuc, which is hoth highly controversial and lu.utcclh with re.Kul:rturvy implications. You cuuld even call it :r hurning issue. 'Irhe esance uf' Iha conr troversy is whethcr ur not there is wnre low cirnccnlr<rtiem-tlte 1 hrc,liiild-he- creuseti (ioni is t;ilkinr ;rhuut ;ts "tolcr- ahlc" dcpendr on your point' of view, however. On ihe one hand, L.evy, :and Upton jutitifiably say they "cannot find an activity that increases the actual ri.kk uf duath t'raim c:rncer ur fn.>m Iteurt LIY.- e:rhe hy, 1(lO percent un more to he tolcr- :rhle." On the uther huncl, and with eyu:,l justificatiirlL Guni points out' thnt the av- Icrw which aicancc,-caurinb agent has no efl'ect. If there is such a threshold, then low concentrations of the,af;enti might be :, permitted in titod, fUr e:rampll. If there ~ is no threshold, as many cancer re- searchers now think,,then no concentra. , tion„ huwevet° low, wuvldl hc "lul'et• ".. able:.. •I'hu,, the threshold controversy giivey health otTicialy,anuthcr reason to be , cr;ige smoker's risk ufdyiitt; uf'lunp can cer is now Ien timcv t;reater'tli:,n that i1i the nonsmoker. Reducing the rellrtivc risk frcrm ten to two wuuldI mean fewur lh;ut 2(D,(1(l0 new c:rsesof lung cancet every yccir, no( ttie curuent 11/U,O(N), tiirch ;r rerluction could even he h:rilecl :~ ,rn!:ulv,uwe in, tVte "W:ir un (':incer,;"' r anyone is still using that pfiru,-,e:

C IM'oreover, there is generallagreement that development ofl a less hazardous cicaretlc.is.algood idea. It is, after all.. one: of the goals of the Smoking, and Health Program of wCI, which was di- rected by Gori until a few weck.,ago. The:Institute haxspcnt about S:I 4 milliomm lodevclopsuch ma ciE:uct!e uver thu pa,t. 5'on6 years. The ju.stific:uion for the p,rop,r.tm is simple. Despite antismoking campaign.: about 60 million people in this country' still'.smok'e and many of them arc not go•ingtoquit:.Tlhu<-.a, Icsshazardutt,ciga• rette could save lives. Epidemiological studics perfitrmcJ undenlhc auspices of the American Health Fuundation and the American Cancer, Society have: already shown a reduction in the death rates from cancer and 'heart disease in individ- uals who smoke low-tar, low-nicotine cigarettes compared to the death rates of smokers of the high-tar, high-nicotine varietyL Individuals who,did not smoke at all had the lowest death rates of'all- however: While no one questions that dcvelop- ment of a less hazardous cicarette could pay off in improved I health, officials at YCI', and NHi.BI doubt whether Goriis conclusions abouu current brands are, jptstified. To reach these conclusions. Gori performed statistical analyses of d5ta collected by other investig:uors: in four large epidemio6ogieal studicr that have linked cigarette smoking, to an in- creased risk of dying from aIL causes. , These studies found thatthe risk ofdying from all causesinereaseswith the:num- ber of;cigarettes smoked daily:. Conversely, as the number of ciga- rettes smoked decreases the risk de- creases. Gori reasoned that the risk, might eventually decline to a, point at: which it is not detectably difTerentlrom that~ofa nonsmoker. Using the:datafrom i those four studies, he then set out to de- terminehystandarde statistical mettiad.sthes number of: c'igarettesan individual could .mokee earchdayh withotuiappurent+ ly increasing his expected morrdity above, that'l of a nonsmoker. He called thisnumherthe critical value:, According to the results of this ;maly- sis- which wcre.puhlishcd in S'rirnce (17Pkcemher 1976).. Ihe critical numlier uf cigarettesofthe: kindd manufactured at the timc lhe cpidcmiological data were collected (beforc 1960) : wastwo. Cipa-rettes produced before 19(d)dclivcre l much higher quantities ofl toxic sub- stances in theirsmoke than do mo.t ci4;t- rcttos loday: 1'roddcd by concerns abuut~ the hatr- arduus nature of cigarcttc sntokc, mantl- ficturers have:overthc years developed. rnt several l br,mds of' cigarettes specifically designed la rcditce thc quanlltiuv of tar and nicotine in their ,mokc. What Gori an has donc in the currcntwork, which in extension uf that publi,hcdd in .Soii•rrcr•..isto.comparcthe amoumt.of,istosic sutr- ,tcmces (tar;.nicol lue,. cnrhunmatnotidc; nitrogen' oxidcs..acrulcm: and' hydrugcn cvanidc) in lhe, smoke of '_7' brcmdsof these Ihw-tar; low-nicotine cigurctte, with their concentration,in the,nwke of thc ave,ragc prc-19(dl cigurcttc. Hc then c>tim;ncdllhe criticdlvuhic, f,r th'c'_7. brands bydctcrmininghuwm;inyci@a- reatcs :would deliver Ihe,sumc, conccntr,r- uon, of'u+rch ofllhe. iv lovic .uh,tau.'es as two average prc-196f1 c,igarcllra. For example, ten cigarettes, each delivering 10 millicramsoftar, would he cquivalent to two pre-1960 cigarettes that delivered 500 milligramsof' tar each. The critical values he found ranged from 3 to ?3' for the moulern low-utr, low-nicotine cica- rettes: Gori'sConclusions Criticiied Both Gori's earlier puper:md the neww one have been criticized on scientific gounds, however. After the Scieircear-ticJe appeared; statistici;m, John Gart and Marvin Schneiderman o6 A1CI I sub- mitted a letter to the editor of Sciertee (the letter was never publii,hed)'in which the:v describedl the, statisticed, mcthods used'. as -so seriuusli in error that we find the conclosions bctsed on the atatisti- cal analysis and the concept of'criticcd values' to be invalid." They asserted that:Gorilc handling of'f the data ledd too seriiausunderes:timationoflthe: risksassoeiated with a give:n num- ber of ciFarettes: Gart and Schneiderman, suggested an alternative.wayof hand.lingthe r,l.uawhich„in theirezamplc:. Ieadstoa i"tolerable" numberofrigarettcs of om ly 0.?' per day. Gorll says he redid the analysis in accordance with the, .ucgeti- tionsof Gart and Schneiderman and did, nutifind enough~diffcrencc:inithcresultstv w,trran9 changing hi,.amclit,ium,. According to~Upuon, Guriic more re-cen4 calculation of.thceriticnl v;tlucsfur the low-tttr, low=nicotine ciuueucs is sti.pect hcc;msc.it rests our tile ;n,ump-lion th:rL.lhe risk of dyinH will decrease in exact pruportion lu:lheo dccrccroes in the. conc.entrntionv uf those si rtuvic agents. I Ie maint:tins thcrc is no cvidcncc ht .up- purt thisa.vumption. Gt+ri rcicct,Ihic critici,in un thc l;ruunch Ikd~the:uritic.d vulue>in the original an:Jy,i.wcrc oh- taincdfrum datairc:Liling the ri,k <tfdyin},: tttthe, numhcrof cigaircalc,,muketll;urd Ihu, tu Iheamaunnt,altuvic:,uh,tunces dcl i vet'ud.. l"hiv, iwuce isenntplii:ncd hvv unu~cr- tainties regarding the manner in, which the cigarettes may,be smoked. Some oh- serveax think that smokers who switch to low-tars low.nicotine brands may inhale more deeply or smoke more cigarettes than thev did before the switch in order to get the same amounl of saticfnction. Daniel llorn uf the Office of Smoking and Health says there is little reliable dcttcronnh'is point.,His own dalaiindicatu that the smoker' whoi switches' may smoke fewer cigarettes, provided the conccntruions oftarandlnicolinc in the, ncw brmd are:less than'_5 percent lower than in Ihe:old brand: hut ifthe decrease is larger than 25 percent the smoker may smoke moru cigarettes. For this reason„ Horn recommends that smokers who wish to cut hack their tar and nicotinee consumption do so gmduall'o.. Upton also points out that cigarettes eontain additional substancer which were not considered bv Goriland which may, contribute to the development of disease. Gorii concedes,this poinn but suggests that filters designed to produce :n low-utr. low-nicotine cigarette should remove, many oflthese other agents too Another frequently heard criticism1of the JAMA article:revolves around the as- signment of criticallnumbers to specific brands of cigarettes. Several observers have objected to the precision implied Ibyy the assignments and do not think it is jusr tified, by the data. In reply, Gori sayss many of these same critics do not hesi- tate to extrapolate the results of animal studies to humans. He thinks his ownap- proach: involving, the extrapolation of' human data to humans, is more justified. 1n summary, it would be safe, to say that Gori thinks his analysis is correct, whereas many of his colleagues andlsu- pervisors suspect'thatiUis not: And how- ever controversial the JAMA paper is now,. it,passed the internall revieww sys, te:m at NCI' and was cleared for pub- lic:uionlin June 1977 (before the arrival of U pton. as Upton notes):.. Al'.t once time thcree were: rumorss that. Gori would be, fired., as a ~ resull! of the smoking O:rp..The ru.mtxm were fostered by Gori's own statements to the press to the clTect thal'. CaliLrnowas pres.uring. "4C1 to discipline or fire, Gori. Uplon says there cueatbwilutcly no pl:ms,to dis- ciplincGtri. AndlGori, wh'o now-sny.hewas mi.qllotcd, rctains his pnsitiun as DeputyDiicctor oflthe.Division of'Can- ccr C;msc and Prcvention. AltliouEh heie no loncer in charge of the Smoking and I IlctJth Progrtm, Ihat chnngc wa, matdee aepart ofla rcurganizaaictn );oing.onthe. divisionLefhre the: current furor hroke. out. A11 in iall; the smoke: seems to be cfe,urirtl;,-1riN I.. k1Alt\ M tF:Pt(',h;.. vq1...2111