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. . ` , ~ % ?ODJcCo I ~'DC sTlt! ALSZ~RC8 Co:>:fJTrL~ October S,, 1961 Mr'!ORMTIIIL'4 TO: Tobacco Industry Research Cocaittee JROM: T. V. Sartnett, Chairasa ...... ...._.._..:, ,`• Ae the TIRC approaches the conclusion of its eighth year of existence, it is in order to assay the•current statwe a.nd position of the Coc=itte.'s program and progress, and its course for the future, tak.ing into account its genesis aad evolution. _ To begin, I vould like to eapkasize that the Scientific /ldvisory Board, vhich vaa enlisted in the spring of 1954, retaias a,ll of its original meabers. Th,e only resignation vaa that of Dr. Julius Conroe, vho vas elected after the Board began to function, and vho resigned because of a change in affiliation that prevented his devoting th. necessary tize to serve actively as a Board nsber. He continues to be cooperative on problems in his area of interest. The relationship betveen the Scientific Adv+.so.ry Board, the TIRC stai7, your chairaaa and our public relations couz:sel has been, ar.d continues to be, on. of close coo;,aration aad ssutuall understardin= of ' problems. This is most'gratifyin= in viev of efTorts to impuZz TLRC motives and policy and of direct attempts sade by certa.in antagonists to alienate SAS members. It 1• virtually iapossible to estimate the contribution of sllB r.ezberi vho are. recogss.i:ad ai lea~!eri in the vorid of research ar.d mebiciae. rot only hias the W deve:.oped aa outstassdin; and recogr.ized research program, but its members have beea of continuous help in bringing about a better understanditsg of the problems relating to tobacco ard heal:h in both ths 'soientific and la.y c~+*=:ies. The Board has proved a tcver of strengthwitDout vhich I doubt that ve could have met the va:iety a:d intensity of attacks that continue against tobacco. • The position of the SAB froa the beginning has been that rar.y more research findings are needed before definitive conclusions can be raZe regarding the cause or causes for lung cancer, heart disease ard ot:er $liseases, vhich have been linked to tobacco use. Although auch progress has been made in the study of these diseasec, that original position still holds as firm today as vhea it vas first taken. rurtherrare, it is beir.g accepted more today by the scientific vorld `er.e_-ally th,aa at any previous ti.me because ainy discoveries in the interval have deaonstrated its truth. PLAINTIFF'S EXHIBIT fi/l - C T R It -- 11 N 02 E 3 422 6

2 . This position has bee:: a strong bulvark for the T'.R^ in the several phases it hzs passed t`_ough since its inception. _.~ ~ . ~ i . COWOMTM . 1 For=&tion a:.d Oreanization . Upon the initiatiye of lir. Paul M. Rahn, tvo r.eetings ve.re ' held in Deceaber 1953. At thase asetings the conclusion vas reache3 that the tobacco industry shotild fora the Tobacco Industry Research Cocmittee. On January 4~1~954* aa sanauacerant ad•rertiseaent concerning the Corrlttee appeared in w+ti nevspapers circulated throughout the United States. The responses to the advertiseaant vare suW tYzusands of letters, inquiries and suggestions. These ve.-e received anL harAled for the TLRC by Hill and Knowlton, Inc., public relations counse2. ?ollovins this, Zbn Hoyt vu . aypointed Dcecutive Secretary to forn a aucleus for the adm:.aist,-ation and - necessary further orgsatzation of the Cormittee. By the fotiarth month the meabers of tha SJ3 bad been invited, ' and bad apeed, to serve aa scientific advisors. At its first msetiag in June 1954, the Board selected as its chairran, Dr. Clarence Cook Little. The Board subsequently reco-_snded Dr. Little as SciW-ific Director for the Co=ittee. These steps led to the develop:ant of a research policy a.rsi program under vhich the Board sade the first research avards. Ho: Lntil the tenth month after the forrstion of the Cor.ittee vare the first research grants activated. The fact is that one year of the less than eight years of the Co=ittee'a existence vas largely devoted to the forastion, crga:-' u:ion and inauguration of the research program. One of the results of this careful, thougatf•.al deve_c;z.:nt period vas to dispel a reluctance on the part of soms inrestigators ar.i institutioes to accept Rants from the ir3ustry gro•ap. Actually, the sound basis established in this fo-stive perioi has proved its vorth =y t:=es. ..L~ Er;_nsion and bcperir.entation The second phase of the Cozmittee's activities vas devotei to exparsion of research efforts into untried areaa of investigation and to $ the developa.ent of techniques trit vould ta3:e the grants-in-aid progra.= C mesningful, both in teras of the tobacco question and of the health C problers that vere involved. It vas recognize3 that research grants do ~W not produce immediate results. Grants, once n:ade, usually nust run a ~% span of years before coaplition and, no ssatter hov carefu].ly plaaaed, sou C do not produce si ~ gnitieant results. 1'hia vaa to be expected because much ~ vork vas being encouraged in nev areu . Soze research can be on very W practical matters but sauh aust be of a basic trial-and-error nature ard, cors equently, exploratory character. ... .~ ._ ... W CTR i !N 026427

3 Durins this early period, the Doa.-d zade a special effort to avard grants to scientists and institutio:s, vhich vou].d not only support iaportant research but vou].d also enha.r.ce the scientif ic stature of the proiras aad encourage uaderstarl:r.g ard acceptsace of the TLtC program. Also, the Advisory Boar d recogzized its oppor tunity ar.d obligatioa•-to- bsing specific problas to the attention of outstanding research scientists as a group, rather than as individuals. „ One •f the swst imsertant of sueh efforts vss a PatholoQic- Anatonic Stu4Y, desiined and orgsnized by the Advisory Board to pool the laaovledge and efforts of pathologists of tvelva iaportaat hospi-sls in various parts of the United States. The project vas to studyr microscopic slides of tissues obtained from lur.g autopsies for the purpose of build:rg collective knovledse of the subject. This st;4; covered a*period froa 1955 to 1958. The merits of the projeco vere so thorou=.hly established that, upon its termination as a TLRC grant, the pathologists enSaged in the project have been held together and are continuing to cor.duct ats3ies under the support of the U. S. Public 8ealth Serrice. Although the Patholog+.c-A.nitomic Stuyjr vas the largest of the TIRC grants to be contiaued by f'uads provided by public health agencies, other vork originally sponsored by the SAB has also been continued =der other auaDices, thus constituting a tribute to ths Board's planning of important research activities. One notable result of the Pithologic-Arsatomic Study vis developaent of the conference technique for initiating and enco'`-saing research. This technique has been utilized by the Advisory Board in several other areas and has received considerable acclaim by scientists. Conferences on research problams have also helped iameasurably to broaLen the understanding of the TTRC progras throughout the scientific vorld. The conference technique has been to invite leading research investigators to closed sessions davo:ed to topics of scientit:c interest under study or sponsored and finsnced by the A,dvisory Boa.rd. Active investigat.ors can thus meet and coz:-sare their indlvidusl vork, methods, techniques and results, regardless of vhethsr T:.RC-supported. These s:eetings are lntoraal. !fo ssinutes are k.yt, and there is no publicSty. For these re}sa s, Farticipants feel fres to d:sc-sss ideas aad theories and to explore nev approaches to health proble=. The principal benefit tro3 this type of corfer_nce lies in plarui.ng fesearch and in finding the r_ost capable people to corduct it. At the sana tize, the guest participants have an opportunity to beco=a acquainted vith the scientific level and objectivity of the Board's program. Conferences have been held on subjects such as.bioassay and cascinogenesis, tissue culture, lung physiolosy, cardiovascular disease aad psycho-physiological factors in sraking. _ , I COHP[D[NT1A1 ' I I . .. CTR HN 02-842-8

4 - -`--- Tba conferences on bicassay and carcinoSenesis helped sive perspective to the relstive isportance of akin'paintinz techniques coa-,.Lre: vith SnhaLtion techniques in anL's1 experiaents. They have definitely , establisheb that a chesical challenge, to be tsaain.-tul, requires consideration of thU partieular tissue involved. Anothar result vas to establish =e nes.rly aeeeptable standards for preparation of srase anS its darivatives for application in aniul research. ?oll.ovirg tvo elosed cardiovasculas conferences, a irant vas made to the New 7ork AcadeW of Sciences for a three-day public sytposi:: on the "Cardiovaseular I:ffects of Nicotine and Saokia;." An /lcadeay monoRaph, publishins the pape+s and discussions at this symposium, sta-.s as an authoritative d,ocument on this subjeet. Another progrsm of the Board, vYich has von good vill arcnS medical schools and studeats is the avardir.S of research fellowships for aedical students. This vas initiated in 1955 to interest nedical stidet•s in the value of research. An avard of one fsilovship of appro3d-stely . $500 to $600 is offered to sacb udieal school. The schools thesselves select the students to receiw the fellowship aad the subject of the . investigation. This year, 77 of the 79 med.ical schools receiv!.nj this of f er have ac c ept ed aad ds s igzat ed f ellovs to r ec e ive the award. Ma.n,1r feliovship students haw vo avards for their vok and have published their reports. The Cozaittee has received considerable co=ndstion fr= deans of ined,ical schools for this progrsm. , n t~.he book,, 'Zbbac~co~I~srsL-enltal4and Clinical Studies~." publication of This 800-page moaograph is based on a thorough study of arore than 6,000 articles published in some 1,200 jourr.als, sach of which vas res.d aaA analytically abstracted. It reQuSred six years to asseable, prepare, vrite and publish. The book has been vel_' received ard revieve3 in scientific journals, and has a3reid,y been csed by as.ny writers as an authoritative source. The greatest intensity of plSlicity attacks on tobacco cecu_-rerl during these earl,y periods of TL4C develop=s•nt. S=e atta.cks vers most difficult to contain and tsandle. 0: necessity, stateasnts fros the TZRC had to take into comsidaration res.ction of both the scientific ard lay co-nitiea.- 'tt. was necessary to protect t5e stature, dlgmity and rep't:ts- tion of the Advi.sory Board, the Sc:entific Director and the research p='o3rLM• ~ This called for close cooFeratica a=ong the research scientists, C the TZpC staff and public relations counsel. It also called for an ~.~ ava.: eness of other related problers of the indtstry. ~ . Fsch public states<ent was careftilly prepared ar.d cleared before C issuar.ce by these three Qoups with special corsideration to askir.g sure C that a11 assertions eould be suppor:ed and fully documented. This was ~" rade possible by the ever•BrovinY library facilities of the TIRC. Zbd.ay, v the resources of scientific literature and references on hind in our library have established it as a useful soure s of scientific iafornstio 1~n on tobacco and health second to none. • •r ,:, V T '.  • •  0284229

-S • Ii rz`~ -- J %41.: Liaison betveen research, staff and public relatior.s durin; this period of continuous attack proved able to function efficiently urder the aost difficult eircuWsta,nces. Frequently publicity attacks had to Le chal:.erKed or aasvered on short notice, often on holidays and veekerws v*.e_ Mny scientific meetings are beld. By cor.stantly anticipating and yre;.a:::4 for such attacks, the mutual effor:s aad guidance of all the above nentictci groups vere effectively used. ' ithile its policy has been to keey out of public controversy, the S/l8 issued its first official position state:ent, signed by eacu ne=•.e- of the Board, on lday 1, 1957 tolloviag the publicity on the vell•k:cv= S:',;-~ Group Report. Nore recently, the 3oard has made an ofZicial report to the Comittee msabers. This vas yub4shed in the 1960 /lnnual Report of tLe Scientific Director, aad reiterated its official position on the present state of scientific inforsation. seainasnS in 1956, an Jlrs:ual Report of the Scientific Director . has been issued su=zrizing progress and discussing research activities. A=ual reports include abstraets of e1l vork reported by Rantees. tach abstract is vritten by or elearsd vith the individual grant*e before issuance. In this vay, the published or repo.rted findings of TIRC grantciz are sade available in an organized collection to the scientific eo=:r.ity. To date, 207 papers ha.e been published in scientific journals by T~C Raatees. The TLtC has budgeted for research graats a total of $L,650,000. To date, 172 original grant avsrZs.._.v* bean made and 1°0 reaeval V*aats, ancunting to $4,285,209. Present and Tutvre Development The third phase of the TLRC program is brirging about a refinenent in existina research activities and aa extension of the yr:Zrr,= into research areas that appear to offer most meaning to the tobacco problem. This.began early In 1960 vhen Dr. Little requested addit:cal furds from tha-5cecutive Corzittee of TLCC to assist in tha furthe_- developmsat of the research program. Siyce thea, the Advisory Boar d*.a-s been undertaking to re-design certain research grants to rike then sore effective and to terminate at'the earliest date those projects vhich, for various reisons, do not hol4 promise of nuanin" results. In this ef:c::, the Board has been placing greater erzphasis on four fields of research: ' VIRUSES An PREYIOUS LUNG INF'ECTI01¢S. Scientific findings iadicate that vi=w es are imylicated in some animal cancers and tha: vira.: and othu dana8e to lungs, both anirit and huaan, sr.ay be an importa:t factor in induction of lung cancer. , CTR HN 02"8430

DIOASSAY A+'~D TISSVE CVLZVRE. This area, vhile r.ot nw to the TIRC progran, is receiving concentration of attention because of progress resulting from TIItC research ar.d because of the plaaaing in closed confererLCer vhich have discussed these fields. Ju noted previously, the Advisory noard pioneered in stasdsrdi:ing cigarette sz~ke cordensates for anirsl skin painting and similar e;xperiaents, thus eliain:tini to a larte extent the use of saoke material carelessly prepared or pretared under unrealistic conditions. Also, through the 3oard's efforts, the culture of* living tissue, especially huaaa tissue, has been advaaced, vid the result that a considerable aumber of researchers hare bean trained in this specific fiald. Currently, the Soard io eapr.asi:iq extension of ticsue culture vork and greater attention to iahaLtion experiments rather than relying on aaimal skin tests. UJ140 PBYSIOLOGY. Recently, pathologists have found that cany lunt cancers that hsve bean classified as the epidermoid type, vhieh vas presuubly ssore coson aau~ smokers, say be actually anothar type of lur.g caacer •• glaadular or adenocarcinoss. These types hare been claSasd to occur less frequently amoni amokers ar.d are not considered to be the result of i.ahaled aatarials. Ths TLqC is supparting 21:rth.r~ vork on this•question so as to distinsuish ssore clearly betveea cancers that origiaate . in the exposed lung sua2ates aad those that originate in daape.• areas or those that spread to the lunp from elsevhare in the body. These zore careful classifications are chaa,tind sors of the ideu about lung c4ncer _ origin. EPID::•ZOLOG7, PSYC80LOGICAS. JUID P8Y5IOLOGICAL RESFARCB. Tte Boa.rd has been exploring, throvih conferences and pilot studies, the expansion of projects' in this area for tvo asjor ressons: 1. Most or many of tSe benefits of r-.rokins probabljr ca.n be learned froa studies in this field, and 2. Only in this field can there be testing of the possibillty that certain types of people sa~y be predisposed to particular health risks and that these people are a1so, aore likaly to be heavy smokess than others. Ona of tha positive results from Z'IRC research had to do vith `asstric ulcers~As a result of tvo projects studying hu= bei:.ts, it vas fou:d that tae secretions that sti=ilate for-ation oS ulcers are not affected by sr.oSciek or nicotine. nov the 3oa.•d feels that, as a result cf this, it aay be that a person vho is especially 11kel,y to develop a ~ p_.rticuls.r 'dises.se •• ulcer, for axs=ple •• could be described by a i "profile" based on psychological and physiological measurerents. L' tr.is profile is found to be especially cocmon ssong heavy smakers, it ni;ht be poasible to shov vhat is nov suspected but not proved -- that ulcer•pror.e persons are more likely to saoke heavily thsn other persons because of their vay of responding to tension or aendsty or because of otber inner traits. This finding might be applied to othsr allr.ents. Ct R Ht `! 026431

I . ~ 7 ~ ~ CONf'n)QYTLAL i Throughout tbe ysars, the policy of the Scientific Advisory Boa.rd progras has been consistent in requiring proof, avoiding eco;ior.aas=, and seeking only seientifie facts. T~s Board h.as never accepted c:ai:s of statistical association as estaclishir.= cause and effect. Without such a policy the Board misht have been alum •d on several occasions into accepting cer tain claims pre=tu.-tly. For axaaple, they gave careful s tudy to theelaims that b.n:pyrene, fo:s.d under certain eondltions 1y cigarette tobacco and paper smoie, constituted a cause of lung cancer Vnd should be reasoved. Their visdon in not accepting this theory has been deaonstrated by the faet that even those peoble'vho, in the ti.in, once urged that this be done, nav accept the fact that vhatever traces of benspyrene aay exist in tobacco smoke probably have no bearing upon lung cancer. The probles of dealing vith the recurring attacks of the anti- tobacco Roups is a.s difficult as ever. Althou# SAS mssbers have avoided the public controversy on tobacco quest:ons they have, as individus.ls and as a Board, provided guida.aee, advice and info.-aation that continues to be invaluable in meetini unfounded health attacks concerning tobacco use. Thh vork of the SAS and the accaslation of the stockpils of factual scientific inforrstion continue to be tloe essential foundation for astablishing a tLir perspective oa the role of tobacco in zodern life. In concluding by saying, "There is tuch more to be dowe, auch nore to be les_-ned," I am quoting the thought s.r.d spirit of ou.- Scientific Director, his associates ard his fellov a,ezoers on the Scientific Advisory Board. I am proud of tr.e s`a:ure they have given to the TiRC ard feel ve ove a Reat debt of gratit•:de to each of them. • T. V. Sartnett TVH:ek . .~ C C C . ~ ~ l7g CTR H~~ C~~~~~~