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r E ® F THIS DOCUMENT SUBJECT TO CONFIDfNTIAUTY AGREEMENT. CIGARETTE SMOKING AND DISEASE, 1976 . ® HEARINGS I .. stiTOlE TsE $UBCOMMITTEE ON HEALTH OT TUE COMMITTEE ON LABOR AND' PUBLIC WELFARE UNITED STATES SENATE r'IrETI •FOLTRTH CONGRESS • SECOND SESSION ON S. 2902 TO AMEXD TITLE V OF THE PUBLIC HEALTH SERVICES ACT TO ESTABLISH A\ATIONAL HEALTH RESEARCH AND DEVELOPMENT ADVISORY COJ1)lISSIO\, AND FOR OTHER PURPOSES FEBRUARY 19. )SARCH 24. AND MAY 27. 1976 Printed for the use of the Committee on Labor and Public Welfare U.E. GOVEItNriENT TIINTtNG OTTICE !0 Ot7 0 MAlHINGTON : 1074 C TR HN 014779

1HIS DOCUMENT SUBJECT TO 288 CONFiDENTIAUTY AGREEMENT. Senator Kt:xxEny. Our next panel is \!r. Horxcc Kornr•g:ry. Prr'i- dent. The Tobacco Institute. accompanied hv Dr. Slrt•Idun ~ommor- and Dr. Theodore D. Sterling. director of computing science l,rr,- gram. Simon Fraser University of Canada. There is a vote notv. I can probabl~• go over this this afterrroorr. I want to give ~•ou a chance and I will sta~- K•itlr ~-ou thitil tlre :i nrinutc bell rings ana then come bnck at 2:1 5 or1:8(r. If ' vou hnve got ;r hard hitting commcnt or statement you bettePmake it now becau.t•. ~~~ith :rll due respect to the press, the aftenroon hearings are not as Rell attended. You can make whatever comment you want to make now ancl tht.rj come back this afternoon. So if you would like to use the 5 or f minutes to make whatever comment you would and we will have you back at 2:15. " . Mr. Koexr.rr.»•. I am not a scientist. \fr. Chairman, so I am goirl" to ask Dr. Sommers if he .could go ahend with his statrrncnt tir-t. STATEIiEFT OF SHELDOA C. SOMMERS, M.D., DIRECTOR. I.ABORA- TORIES AT THE LEAO% HILL HOSPITAL, NEW YORK. AND PRO- FESSOR OF PATHOLOGY, COLLEGE OF PHYSICIANS AND t3UBdIANS, • COLUISBI•A IINLQJERSITY OF NEW YORH. ACCOMPA- AIED BY HOB.ACE It. BOBAEt3eY, PRESIDENT, THE TOBACCO IN- BTITUTE, WASHIRGTON, D.C., AND THEODORE D. STERLING. Ph.D., DIEECTOR, CO1iPIITER SCIE!(CE PROGRAM, SIMON T'RASER IINI?F.BSITY, CANADA Dr. Soxist:xs. 111r. (`hairman and members of the committee. 1Jv purlwse. in response to the im•itation to present m~• personal view of the status of knowledge of smoking and henlth- Senator Kesxeni•. You mnv summarize if yon wish and then- Dr. Scat.-,tt:xx.0ivstatentent is a summam•. Senator KEx.eDY. OK. Dr. Ccranrt:R~. 'Mv purJ~. in response to the invitntiorr to present my 1>rrsonal view of the stntus of knowledge of smoking and health. is to review the newer scientific data. This mnterinl is not included in the quotntions from the 1)75 version of the L"SPH.q smnkina and hen)th report cited br Senator Hnrt as justifying bill No. ~. Cognizance of the present day knowledge by fnirnrtnded individual~ casts grave doubt on the existence of any such '°ocerwhelrning evi- dence'as claimed by the distin~,nrislred Senator. Fitst. in respect to the reported overall higher rate of death of smokers than nonsmokers, the results were obtnined h* v stntistir•al eridemiologic methods now reco¢nized a5 erroneou5 nncl u<e of is no longer regarded as justified. One to one comharisont of smokers and nonsmokers inored many confonnding .•nrrnbles. Vc Jtork:rm predicteri the result proved to be a ctntistical artifact. This resulred irom iRnoring tht•ee seriotts sourcec of error : (1) Nonrandom comrarisnnc. menning thnt smokers nnd nnrr- smokers are not random suhsets of the ponnlntion being tested. ~iuok- ers chrince to smoke and others chn(Ae nnt to smoke. antl both vro,rh- are self-selected. nnparentl' v by complex processes not hrescntlv trnder- stood. The crucial error is the use of stnticticnl methods to tert nrn1- random gr•ours. designed for and applicnble only to comraring CTR MN 014't`''80

Mr. }lorace Iiorneguy. presi- d by lir. Sheldon C. ;otnmers )r of computing science pro- Ia. go over this this aftcnroon. I v with cou until the 5 minute :2:3(t. If you have got a hard • make it umw becouse. with all arings are not as.cell attended. u want to make now and then would like to use the 5 or 6 r would and we will have you Mr. Chairman, so I atn going head with his statement first. S, N.D., DIRECTOR, LABORA- (TAL, AEW YORg, AND PRO- OE OF PHYSICIAlPS AND ' OF NEW YORH, ACCOMPA• tESIDEAT, THE TOBACCO IA• ) THEODORE D. STERLING. 'E PROGRAM, SIMON FRbSER ~mbcrs of the committee. Nkc: ' ~ present m%• personal view of ~ea)tlt- •ite if~,%•nu wish utd then--- ry. ~ ,ze to the invitation to present ledr,e of smokinfi and health. ris mnterinl is not included in -P •if the l-SP}1~ smokingy ancl - s justifying lril) \o. S. 2902 ge by fairminded indicidunlx 1 rny such "o~•er~~~helminF e~•i- _ •nator. ?rall higher rate of death of were obtained bc -statisticnl " is erroneous nnd u-e of a•hich n nne compariconc of smokers ndin- vnrrnhle-. As 14erksnn tistical artifact. This resulted •or : ing thnt smokers and nnn- otcnlation being tested. Snrnk- nt to smnke, and lxtth grnup,~ rrnce&ses not rrescntly iurcleri ntisticnl methods to te.ct nnn• rplicnble only to comparing THIS DOCUMENT SUBJECT TO 269 CONFIDENTIAUTY AGREEMENT. random groups. Rolliug the loadc•c) dic•c• statistir•nlly );ice. att inc,lid ansa•er. (2) lkJxndeucc• on limited statistical tests for proof. 11'Lc•rr lto-c• and Bell wrote their moatogral,h on rrrdicting lnrrt,.evit., ther resrc•cl factors that might be as.,~ociated with earlyrefu)1y death among a grou J~ of Boston lt'orld 11'ar rI veterans, followed cafu)1y for 3U yeart. A one- to-one comparison of cigarette smoker*tand nonsmokers gave sn,oking thc ntunler one plucx as u predictor. like in nrnn}• other stodie-. lloc% - ever, when multiple factors vr•em included statistically cigarette smoking dropped to somewhere beyond thc• 3uth mou si~rulr,•:rrlr predictor of early death. I)issatisfactinu with jnh l,,ecanu• th~• nunrLrr one predictor. 1 (3) Secularitt•. meaniitg the change in habit l,ntterus of thc• pnl.u• lation from aboitt I:+lu to 1960, xawith increatied J,roPortrnt,; of ette smnker` in each decad(•: A model population (not a t•c•al Ju)l,ul:i- tion) with strch chnuges nver equal tiuic .cill show n stntt=tte:rllx signiticant inc•rvase ill total denth rate as a minoritv ch:nrp•= tmN:,nl a majuritv. This secu)nrity fnctor or S1Lnngc• ill Jrolrulntiou patrrrtl• has rnn health imrlication. For example. ill the original Stn-v(-u Generul's report a tahle showed pipe smnkers to hnve n lo«er cl(-atlj rate than notrsmokem. 11'hi)c• encouraginfi H belief that IrIIH. =tt,u~c r= n•ere the sturdiest humans, a be.ttcr explanation i~•ou)d be thc secularity effect. There were fewer pipe smokers ill each decade. the converse of cigarette smokers. These data are published and available for all to read.l\-hn- ]t:rve tLc• proposers of the bill not heard of them ? It is becnusc tlic• antnt:tl supplements to the Sur eon General's report on smoking and hcaltl~ are limited reviews anrinterJtretations of the medical and ic•ientific literature, from which are screened out articles that do not agree with. call into question. or destror arguments and conclusions supporriVe of the official Government position. As an examJrle, in a presentation prepared for hearing, on n 1~r~~- pos:rl h~• Senntor ~tos.c of I'tah to limit by law the amnunt!z of ni-tinr and cnndencate, sn called tar. in cignrettes. I Jxiinted ont ill thar approximately 1.i91 articles published since 1960 vcere not cited. Lists of these ;vere supJrliecl. On ncrasiou. publications not suhlrortin; the official positinti )reeu suPJrres=ed. The epidemiolofirc proLlemse slrortc•nminre nnd errur= were aired at a panel meeting at the AAAS in 1971. so the abnve is not secret informntion. One regrets that the prohnsers of the I-ill 1,:'A- f• not been made aware of the serions defects. obsolescence. hins nncl incompleteness of the information on which the.% • appear to b:rsc the current proposed bill. Xm%.. au to ]rurg cancer. there is a statistical ns-ncintimr l~of~~~•ru ci~,*u•ette smokinr nnd Jtnte cancer. But at present thr nnturc• of tllc• assoointion or whether it is causal are not known. The test of tLc• orioinal Surgeon General's report deals with the difliculties of :rs' 4zi_•n- ing cancnlit.%•. hut the summnry and cnnclu-4nns brush the-c• nnd assigrt a causnlit\• not demonstrablIV evident in the text. It i~ widcJv known that n statistical as.cncintinn i~ not hN • itk•lf t1t•nnf of catrsntinn. A atatistical assnciatinm mn r troint to exJxvinu•nts thnt ~~ ill helptodetermine R•hethertherr ixcnuce involved. Animal esperiments to my know•led1±e have not succeedecl in thc rrvxlnctinn nf so-called human type lnng cancers in n significnnt lret- t•entnge of an.N• sPecies tested. . CTR M~~ 014~f='6-1-

THIS DOCUMENT SUBJECT TO ' 270 WNFIDENTIAUTY AGREEMENT, Senator KttcN-zDy. Doctor, I am going to have to go. I only have 4 u ' m tutes to gret over there. " e will recess to •rrcaxoox Basto. ~. Senator IaNxcaY. We R•ill come to order. Dr. Sommers, would you continue ? Dr. Soxxcas. In the interest of saving time, before the lunch break. I did not identify myself. I am Sheldoti C. Sommers. i11.D., director of laboratories. Lenox Hill Hospital, New York; clinical professor of Pathology, Columbia Ltniversitv Collef,~e of Physicians and Snriteons, New York, and l ni- versit}- of Sonthern California, Los AnFeles; editor of the Pntholou~• Annual and Pathology Decennial Series; chairman of the Scientifi,Adt'ison• $oard, Cbuncil for Tobacco Research. t'.S.A.. Inc.; with about 260pub1ications. Mr curriculum vitae and publication list are available. I irould like to briefly recnpitulnte the points made already. if vou would like. \1r. Chairman. Diy purJwse, in respnnsc to the invitation to present m~• personal ~-ien• of the status of ktiowledge of smoking and health, is to review the newer scientific data. This material is not included in the quota- tions from the 1975 version of the t'SPHS smoking and health report cited bv Senator Hart as justifying bill S. 29o-3. First, in respect to the reported overall higher death rates of smok- ers than nonsmokers. thc results were obtained by statistical epide- miologic methods now recognized as errnneottc and use of which is no longer regarded as justified. Nonrandom comllarisons. meaning that smokers nnd nonsmokers are not random subsets of the population being tested. Kumber two, dependence ott limited statistical tests for proof. When Rose nnd Bell wrote their monograph on predictinc longe.•it.N•. thev tested factors that might hc associated with early death among . ~ a9 roup 01 noslon ii ol7u ii ar J) vrlrrana. Ju1Fui.ru cri1.-iui~1 ~~.j yen rs '11. A one-to-onc comparison of cigarette smokers and nnnmloker- gnve smnking the numlwr one place nc n predictor. like in mnn.- nther ~ studies. Hmcever, when multiple factor:~ were inclnded ~tnti:ticnll~, ~ ciLmrette smoking droptled to somewhere beyond the 30th most sia- nifirnnt nredictor of early death. Third, secularity. mennine the changm in habit patterns of thr hopn- lntinn from abont*1Q1(1 to 1AR(l..rith increased proportions of cigarette t A model ronnlntion. not a real pnpltlntlon. 1 smoker, in each decadc . ~x with such clranres~ over e(lllal time will show a statlstlC•11l\• stg~tltfic8nt ~ increase in totnl denth rate nc n minority changes toward a maioritN•. i Thic cec»larity factor or change in population patterns has no health implicntinn '. For example. in tlle original Surgeon General's report a tllilc nnn~m~lc~ r,• ~ sllna•ed pipe smokers to have a lower death rate. t1.R. than 1Chilc encouraging a lx~lief that pitle t;mnkers were tho stnr~lie~t humnns, n better explanation ~rould hc the crcularit}• effcct. t tiow, ac tp limw canrcr. there is a statistical association hotccecil ; cigarette smnkin_ and lnng cancer. Rnt at the present the nnture of the aFsociatinn. or whether it is causal are not 1cnoRn. ! CTR t I t''! 0147822

tastoN rder. ng time, before the lunch break, lirector of laboratories. Lenox )feasor of Pathology, Columbia Surgeons. New York. and l-ni- nFeles; editor of the Pathology ies; chairmnn of the Scientific i Research. U.S.A.. Inc.; with list are available. he points made already, if you itation to present my personal ioking and health. is to review al is not included in the quota- 'HS smoking and health report I S. 2902. •all higher death r><tes of amok- • e obtained by atatistical epide- rroneous and use of which-is no _ - that smo)torrs and nonsmokers m beit(R tested. ted statistical tests for proof. ),,rahh on Dredictin¢ longe~•it%•. ~ )ciated with e,arly death among ?rans. followed carefully for 3() ~ctte smokers and nonFmokers a predictor. like in many other '; om were included statisticallv. here beyond the 3nth most sig- ze in habit patterns of the pr,Pti&- ,_ I creased proportions of eiftarette . nulat ion. not aIraJ populotion. II shoR a statistsealh- aiR•nificnnt - rity chnnges toRarcl a maiorit}•. >pulation patterns has no health -F raenn General's report a table leath rate. ri.F. thnn nnn1mnkerce po smokers were the sturdiest M the secularity eftert. . statistical association between tut at the present the nature of .1 are not known. THIS DOCUMENT SUBJECT TO 271 CUNFIDENTIALITY AGREEMENL The te%t of the original Surgeon Ge.neral's report deals .citL tl,L• ditfiirultieb of "iFning cnusality, but the summtn•. and ~-onclji-ioi:- brush thi-x• aside.and assign a causality not detuoitstrably e%idt•tjt itt the text. One wonders about the Surgeon Peneral's report. because it turns out to be a limited review. Articles are screened out that do not =up- 1K,rt the ofticial (io%i•rnment position: Senutor Iit:xx>an-. That ts a very serious charge, Doctor. as .•ou well knme. 1\'hat You are accuFing is the Surgeon (ireneral. and Dr. Cooper and others; ~ou are accusine them of 1,•ing, and fraud, and dereivtng the public. That ie tlte way 1 read tltat language. 1>r. Suat~tr.rtc• \ o. str. . Senator Kr.XXEDY. Well...•hat do you call the selective chnire± I)r. SWN tateac. Sir? Senator Ia:xxsm. That do not agree with. Dr. SuxateRC. Sir. if you r•ead the entire scientific literature- Senator }ir.xxr.nr. I am not a scientist. I am talkiuF about .•our ac- cusntion herr. and that Ynu tnight have a different interl>retntimt of the English 1anFuagr, but I would interpret whnt ~•ou ~cer•e stating here about the selective use of fact and fiQure~ that onl~• agree ~~ itl~ and support a Position. as accusing them of misleading. misrepre;ertt- ing, and committing a fraud in terms of their responsibility. Dt•. No.sir.that 15not true. Tltt•it resl>nnsibility is to inform the public. as I nnderstnwl it. of the danpers of cigarettes with respect to health. MY interest is in disease, and the causes. and pathogenesis of di=ensc. \1 P evidently read ditfirrent literature. Senntor Kt:~xr.r~r. Well. is that not what you are saving here : I>r. S~nr>teKS. Sir. if I ma%• coutimte------ Senator• Kt•:xxenY. That 'is. there is no question about -har tL(snbstunce of the rerrescntntion that they are makinF, and tLat ir ti:t caus-e and re)ntimiship between cigarette smoking and cancer. heart disea,;P. and other lung diseasec. \mw. that hac 64,11 nrnde by the Surgeon (;;enernl. ltr. Ran-rher of the National ('ancer Institute. the two outstanding \olK-l Prize win net•s,and the ChC. .Now, if the substance and thrust of your testimony is to dot I'~. and cross T's. talk about different aspects and sn.• thnt tlu•rc can hP differing internr•etationst that is one thing. If .•ou nre trying. h%• vmtr testimnnr, to impeach the overwhelming substnnce nf 'their 'conclu- sion, that is something else. '.N oIN•. -.vhich is it ? Are vott challengin- their ba~ic and funclamental conclusionz. atld that is ahOllt the cause ancl relationship between smoking nnrl cancer f That is whnt vnn nrr nttncking. Dr. Smtar:ac. \fV personnl belief. sir. is that the cnu:ative relatinn- ship of cignrette smnkin~ to lung cancer is not proved. Senator I~rxxr.m. \ot prctaf,tn what? To an all-olutc intinirr certnintv I mean. dnes am-thinz get proven, an~• more than this partlClllat' fnctrn•. in termr of inedical conclu5ion? Dr. Suav%ter.s. Sir, the data available do not support the conclttrionz. CTR f~t~`~ 0~.4'~%634

THIS DOCUMENT SUBJECT TO 272 DONFIDENTIAUTY AGREEMENL Senator KtrvwT. Well, how are we supposed to understand all thisT The best scientists that are available, in terms of responsibilities to the public, all agree. • • What do you know that the Nobel Aize winners do not know? Dr. Soxxrats. Sir- • Senator KexirrmY. Or what information do vou have that the 1)e- partment of Health does not htve, or the CDC has not got, or the Surgeon General has not.Fot t Dr. SoxxEtes. Sir, I cannot answer that question, because I do not know what information these different individuals have. All I can.F,ay to you is, sir, that I have been in cancer research for 40 vears. kenator Kexxr.nr. I do not know Rh~- you make a statement ~~ou do not know. The~• are all published reports. Dr. Sox~ctats. From their pttblished rQports, sir, I conclude that the data are insufficient to support the conclusions, that is. for examplc•. cigarette smoking is the major cause or a mnjor cause of lung cancei Senator Iizxrr~r. Do vou think it has any relationship? Dr. Soxxetta. I think it has an association. sir. It is in my statement. if I mav continue. Senitor Ktt. xmr. To what e=tent 4 Dr. SOYYLRS. If I may continue, it will be in my statement. In respect to the 1972 hearing by Senator Aioss of t'tah. it Rac pointed out that approzimatel~• 1,7 90 articles published since 196v Rert• not cited. Lists of these were supplied. We will be glad to update that list to this vear. Tow. as to lung c,ancer, there. is a statistical association between cigarette smoking and lung cancer. But at present the nature of asso- ciatton, or whether it is cattsal are not known. The text of the original Surgeon General's report deals with the difficulties of assigning causality, but the summary and conclusions brush these aside. and migm a causality not demonstrablv evideni in the text. It is RidelvknoRn that a statistical association is not by itself proof of causation. A statistical association may point to experiments that will help to determine whether there is cause involved. Animal ezperiments, to my knowledge. have not succeeded in the production- Senator Kt:rxsny. Before we leave, is that all vou are going to say about the associat ions of cigarette smoking and cancer? Dr. Soxxsxs. \o. sir, I am Froingto it right now. This includes inbred mice exix)sed to heavy cigarette smoke inlial;i- tion over practically their entire lifespatt. t'erlaun false alarms like the Auerbach beagle do and other studies of rats and mice. hi%e stirred hope t.hat a model been achieved, but no cancers that grew. spread. and led to death like human squamous cell lung carcinomas have been reported in animals. After 45 vears of inhalation research. and although expensive efforts continue, no succeas has been achieved in proclucinF experimental lung cancers in any reasonable, or even small numbers of experimental animals. Skin painting is cited in the bill proposal as part of the evidence of carcinopenicity of tobacco smoke condensates. Suffice to snv that in the past 5years, skin painting of animals with tobacco condensate ha~ L,, TR ! t t"t 014784

we swposed to understand all able, in terms of responsibilities Prize winners do not katovr? stion do you have that the De- r the CDC has not got, or the that question. because I do not t individuals'Aave. a.•e been in cancer research for tv vou make a statement you do s. reporur sir, I conclude that the nclusions, that is. for example, r a mnjor cause of lung cancet is any relationshipt ation. sir. It is in my statement. 3* . cill be in my statement. Senator rfoss of L'tah. it Qas •ticles published sinoe 1960 were :his vear. statistical antociation bet.reen t at present the nature of asso- toRn./ :eneral's report deals with the the summar%• and conclusions :v not demonstrably evident in :iical association is not bv itself ition may point to ezperiments I ere is cause involved. ige, have not succeeded in the" , -. is that all you are going to say ;ng and cancer t right now. heat•~• cigarette smoke inhila- pan. t'ertatn false ilarms like itudies of rats and mice. have eved, but no cnncers that grew, -quamous cell lung carcinomas and althouFli expensive e8orts n producing experimental lung ,)all numbers of experimental ~ •osal as part of the evidence of tsates. Suffice to say that in the with tobacco condensate has THIS DOCUMENT SUBJECT TO 273 CONFIDENT1ALlTY AGREEMENT. vielded so few tumors, either benign or maliFnunt. that tlj(• practwo haspractit`ally been gi.•en up. Only a feu• govertuneiutal agency exl,rrn• mentsconttnue. Why tumors were produced years ago following skin pairninF but are now rarely produced is unknown. An English book review of a work on tobacco and carcinogenesislit ated that if in the the author had not reported 44 percent skili tumors when other laborat orit•z~ were finding 3 to 5 percent, this field of research might have develol)cd in a more orderly way. On what basis is the claimm}de of 90,(K)O lung cancer cases her year? It is based on death certificates, which are not sctentific doc•nmvrntsi and in general are not corrected by finding~ if an autopsy is lrorforn1eci. Senator ht:xxcnr. lt'ltat lx•rcent do you think ? Dr. SoiturJes. Sir, I come t.o that-I think the- Senator Kax.rEnY. If you can answer my qnestions. becanso Rt, are discussing this point now. You keep saying we are coming to it. and then we are tx-.yond tlw fact. , Dr. Souattxs. I believe the excess factor at least is two-fold in- voh•ed- Senator K>Exxarn•. Ilb you think there are 45,0(x) lung cancer casesl Dr. So3ixexs. I doubt it, sir. Senator fitNxtnr. You said twofold factor. Dr. SouKt:xs. At least twofold. Senator hExxtyn . R'el l, is it 30,060? Dr. Somxcas. Sir, there is no way of determining it. Senator KEx.rDr. Do you thinti it is more than 10,000? Dr. Soatiitexs. I ima ine. Senator }aft is more than ]0.ON. If it is more thnn then why does not this approach make sense, that we are talkin," about here? Dr. SouatcRt. The approach totax- Senator Yes.:~fore than ](t.0(1(i people. WhY does this not make sense, then ? Dr. SOatMERS. Sir. because there is no animal, or other ex1N•rimentll proof. that cigarette oondensate, which you call tar, is a producer of cancer. Senator ICtx\-iny. n'el1, I thought you just said that it was. Dr. So7N11Enl+. No, sir. There has beeti no success in animal experi- ments to produce lunF cancerc like those in Lnman beings. Senator I:Exxtnl•. Well, I have diflicultv following your lino of reasoning there. You are prepared to say there is a given percentngc of cancer because of tobacco, and you are prepared to say it is at least ta•ofold, and then when we give you one-ninth of that, and then y-on move off that fil;ure. Dr. Soxxtnr;. Well, sir, if I may explain, the 10,000. or wltateVcr number of lung cancer cases, like manr other types of cancer. are in my opinion, of unknown cause. You htire accepied cigarette smoking a5 a cause. The evidence, in m}• opinion, does not support that. Senator I1EocF.m-. Do you think it is a cause? One of the cause=? Dr. Soxxr.ee. I'think it might be a cause, but I do not think it has ever been proved. C~°R ~°~N 0~.4~<~~

1'HIS DOCUMENT SUBJECT TO 274 pUNFlDENTIAUTY AGREEMENL Senator Kexxcnr. Do you, or do you not think that it is a cau.'e? Dr. Soitstr.ac. I have ezpressed myself clearly, sir, that I do not be- 1ievc that it has becn proved a cause. Senator htx. soy. Go ahead. Dr. SoxxERs. ll'hen anilysis has been undertaken of:the accuracv of a death certificate dialmnsis of lung cancer. when compared with autopsy findings, slightl~•'less than 50 psment were found to be accurate. Pneumonia and tumors spreading to the hings from other parts of the body, so-called metastases, are most often mistaken for lung can- cer. ReFrettably. we lack a sound data base bV which to establish the true incidence of lung cancar. The figures appear exaggerated tRofold • at least. Lung cancer is not an entity either pathologically or etiologically. There are some 10 dif(erent varieties of lung cancer, each of which is likelv a different disease with a different causation. One type called oat-cell carcinoma recently was reported in nproup of chemical workers, most of whom were nonsmokers, and it appeared that smokers in the same plant were in some a-ay protected. Time. scholatship, and money are needed to work out these dtfficttlt problems. Chronic pulmonarv disease, also'called bronchitis-emph~•sema. or chronic obstructive pulmonary disease• is a serious public liealth prob- 1em. R'hen a disease has several names, it is an indication that not verY much is known about it. Emphysema of the lungs is difficult to diagnose clinically. Also ' patholoiically it is difficult to establish its presence. type and extent. ''even when a panel of ezpertse:amines whole lung sections. These large sections are only available in a few research centers. Experts examining such sections. it was reported, could reach no agreement on whether. how much and what type of emphysema was present. ' Senator HART. Doctor, excuse me just a second. The first page of your statement, you talk about the Berkson stud.•. Dr. Soxur.xs. Yes,sir. Senator HART. Xow. what Ras the date of that Y Dr. Soxst-Exs. It is given in the references on the last page. Senator HAxr.1A55? Dr. Soxxtas.1935. Senator HART. It seems to me that much of orhat vou talk about. thereafter, is based upon that study, is that correct T' Dr. SoxartRS. No. nothing thereafter is based on that stud* v. Senator HART. Page 2, paragraph 3, refers to data collected from 1919 to 1960. You talk about the Berkt;on predictions. and so on. I just wonder how valid that would be 20 years ago? Dr. Soxmenc. Some 1•er~• wise things were said about smoking and health 20 years ago. Berkson simply predicted that when the fnct= were out, or the science was impro~ed, the relationship would be a ver} spurious artifact. v I simply state that I feel he has been supported. Senator H.+nr. Thank you very much. Senator KE%.rrny. Have you done any research in this area }'ourself recentlv i Dr. Soxxms.'Yes. sir, the day before yeeterday. C~°R HN 01 ~~~~'86

>u not+think that it is a cause? •lf clearly, sir, that I do not be- en undertaken of the accuracv g cancer, when compared with 50 percent were found to be - the lungs from other parts of t often mistaken for lung can- base by which to establish~ ~es appear exaggerated tRo pathologically or etiologtcally. f lung cancer, each of which is causation. cently was reported in a group re nonsrookers, and it appeared in some Rav protected. Time, o,rk out these dtfficult problemsd lled bronchitis-emphrsema, or is a serious public heilth prob- it is an indication that not veaW- t to diagnose clinically. Also its presence, type ande:tent. •hole lung sections. These large rch ceAters. Experts examining ach no agreement on whether, was present. a second. •. alk about the Berkson studA •ofthatf ces on the last page. nuch of whnt you talk about, :hat correct P is based on that study. refers to data collected from s. and so on. 20 years ago? were said about smoking and -redicted that when the facts the relationship would be a pported. research in this area yourself est erd a y. THIS DOCUMENT SUBJECT TO 275 CONFIDENTIALITY AGREEMENT. Senator KExrmr. Could you submit the reports? Could N•ou file thF reports? ' Dr. SouuEes. They Tsre also published in the medical literature. Senator KENrEOr. When is the last one, and what medical literx- ture? Dr. SoxxERs. The laBt one that dealt*rith lung cancer specifically % - Senator KEN xEDr. Yes, all right. Dr. SoxxERs: The last one? ' Senator KEN-xmr. That is right. Dr. Soxxcxs. In the nei ghborhood of 1958, I believe. Senator KsNxEDr.19581 Dr. SokxExs. I believe. - Senator KEXxEDr. R'hy have you not published in that area since then? Dr. SoxatEns. Sii, I have not had the material available. Senator KExxEDY.What doyou mean by that ? Dr. SoxxExs. I am a patholoRist, «orkinR with human autopsy. and surgical specimens, and the hospital Rhere I have worked since that time did not have• enou- gli cases on which to base a good sttidv. Senator FiE~N-Eay. What is the basis of vow• testunom• here todov? Dr. Sostxrau:. 11fy continuing interest, and study in tlie field, and a par on.rhich I am now working. Enator KE. xfnr. On .rhat. on the lung ? Dr. Sox a Exs. On t h e l unF, si r. Senator KEN-xEDr. R'hen will it be published ? Dr. SoxxEn.c. Sir, I anticipate within a year. Senator KEx.Ear. But you have done no original research that has been the basis of publication in 18 years f Dr. SoxxExs. It ma~• betrue,sir. Senator KE\\EDr. And you are the best fellow that the industry could come up with? Dr. Soxxcrtc. Sir. knowledge in the held involves reading as well as research, and I am actively interested in the field. As one gets older, sir, one leaves research somewhat to younger people. Senator HAxT. OrN`obel prize Rinners? Senator KENxenr. I do not know how old they are. Dr. So~txExs. If I could respond to that. Thou- gentlemen were virologists. and so far as I know, they never worked on lung cancer, and the last Nobel prize given for lung cancer Ras to Fibi>'er for producing it in rats with worms-it is one of the blots on the \ obel prize historv- fienntor Kr.vxenr. Well, I*am sure thev will be intereiited in Your medical evaluation of their scientific contribution. Dr. Sna>tsRC. I know thev are x•onderfol virologists. Senator KENxmT.Of eourse, the Armed Forces Institute of Pathol- og,• which is probably the outstanding center of the world. qitite frankly, completely agrees and supports the Surgeon t;eneral's posi- tion. and does not support yourc. So I think when Re• are talkinR about biolog,•. and pathology, that that ought to be noted forthe record as well. Senator HAx~r. Could I ask for a reference on a previous page. pAae i. of your prepared statement, where you discussed the analysis of the eccuracy of death certificatest CTR Hh~ .~ 14 ~ ~'7

THIS DOCUMENT SUBJECT TO 276 CONFIDENTIALITY AGREEMENT. Dr. Soxxnts. Yes, that is given-those are references number 1! and 11, and they are cited more recently in other publications. SenatorKirx.venr.ll'e hope you send us a copy of your paper. Dr. SoxxLu. I will b46lad to sir. Senator IizN xtDr. Why do we not continue ? • Dr. Soxmr.xs. May I coatinue? SenatorKz.xmr.Please. ~ Dr. Soxxrsts. In the current limited state of knowledge, blaming cigarettes as a cause is premature. Note that emphysema is largel~ :, disease of white men. Black men exposed to the same encironment, ii.- cluding cigarette smokinB, scarcely ever develop emphysema. Women likewise are uncommonly affected. A claim that the cause of emphysenia is known, if ancthing. tends to inhibit resea rch. Coronary heart disease is considered the most common cause of deat!, in the L;ntted StatEs, a8ecting particularly males, the overweight, the diabetic, and individuals %cith certain inherited lipid diseases. T1., Framingham data originally publicized do not withstand critica? evaluation. Studies of twins discordant for smokinQ hace indicated that thr strongest factor is evidently Renetic or constitutional. A certain l,er- sonaltt}• type has been discovered with a striving, time and pressurr life style, evidently particularly predisposed to coronary diseases. To- day actice researchers look elsewhere than cigarettes for the causes of coronarc heart disease. A decision to tax cigarettes in proportion to nicotine and'•tar" would be based on doubtful, specious or mistaken infortttation. The original Surgeon General's report. for example, stated that nicotine is probablY not a significant health hazard. No new persuasive studies contradict this generally held opinion. Etiologic conclusions based upon cigarette condensate (so-callyd tar) suffer from the demonstration that fresh condensate free of arti- facts of storage has cirtually no tumor producing quality. In summary, I wish for better health for Americans. and halr worked hard in the field for 35 cears. In my considered opinion. the bill proposed is scientifically unjustified. and if passed. would Fener- ate such huge sttms of mone}• as would be likely to co-opt and to corrupt most of our medical and scientific research efTort. Thank vou. Senotor Kexrenr. Corrupt and co-opt - and corrupt our medical scientists. Well, T think ecer}• scientific researcher would be interested in that statement, as well. Let me ask vou,what scientific stud,v, what publications in the la;t five years. support your position? Dr. Soxucxs. There are a large number of tliem. sir and I would refer vou to the work of Dr. Philip Burch of England. In EnRlancl there is a somewhat more open medical nress and sense of fair plav. and his controrersy with Sir Richard Doll which is going on. includin.- 19TS. I think you will find very interesting. Senator KixxcnY. Dr. Birch, and what is his - w•hat is the thnist ofhisw•orkf Dr. CoxxExs. I will give you the references. Professor - CT R H U--if 0 1 4 77 6 6